Amendment to the current good manufacturing practice regulations for finished pharmaceuticals. Direct final rule

The Food and Drug Administration (FDA) is amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. We are amending the regulations to modernize or clarify some of the CGMP requirements, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. These amendments are also consistent with current industry practice. We are taking this action as part of our continuing effort to revise outdated regulations without diminishing public health protection. We are issuing a direct final rule for this action because FDA expects there will be no significant adverse comments on these amendments. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under our usual notice-and-comment rulemaking procedures, 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. The companion proposed rule and direct final rule are substantively identical.     

Respiratory protective devices--NIOSH. Notice of proposed rulemaking

This proposed rule addresses NIOSH's and the Department of Labor/Mine Safety and Health Administration's (MSHA) certification requirements for respiratory protective devices. Specifically, the proposal would replace existing MSHA regulations with new public health regulations, while also upgrading current testing requirements for particulate filters. This action is the first of a series of modulates which will, over the next several years, upgrade current respirator requirements. This modular approach will allow improvements to be implemented on a priority basis as well as facilitate adaptation to new requirements by the manufacturers and users of respirators. Except for the particulate-filter requirements, most requirements of existing regulations would be incorporated into the new regulations without change. The proposed testing requirements for particulate filters would significantly improve the current approach to evaluating the effectiveness of an air-purifying respirator's filter to remove toxic particulates from the ambient air, updating existing provisions to be consistent with two decades of advances in respiratory protection technology. The certification of air-purifying respirators under these proposed requirements would also enable respirator users to select from a broader range of certified respirators that meet the current performance criteria recommended by CDC for respiratory devices used in health-care settings for protection against Mycobacterium tuberculosis, the infectious agent that causes tuberculosis (TB). This Notice also announces an informal public meeting on the proposed rule, as indicated below. Elsewhere in this issue of the Federal Register, MSHA is publishing a proposal to remove existing regulations at 30 CFR part 11, which would be made obsolete by a final rule resulting from this proposed rule.     

Delegations of authority and organization--FDA. Final rule

The Food and Drug Administration (FDA) is revising the regulations to set forth the current organizational structure of the agency as well as the current addresses for headquarters and field offices.     

Equipment acquired under public assistance programs--HHS. Final rule

This rule revises and consolidates current HHS regulations concerning Federal financial participation in the cost of equipment under HHS supported public assistance programs. The rule also revises and consolidates current regulations on the management and disposition of equipment under these programs. The rule would permit State public assistance agencies to claim the cost of most of their equipment acquired at the time of purchase rather than depreciating the equipment over its useful life as required by the current regulations. This change would allow these agencies to claim Federal financial participation in the cost of the equipment at an earlier date than under the current regulations and would simplify the accounting requirements associated with the equipment.     

论清偿抵充

2009年出台的最高人民法院《关于适用〈中华人民共和国合同法〉若干问题的解释(二)》首次规定了清偿抵充制度。然而,基于司法救急的原因,《合同法司法解释二》没有规定指定抵充。我国民法典应当按照《德国民法典》的债务人指定模式对指定抵充进行规定,同时,应当在《合同法司法解释二》相关规定的基础上,借鉴大陆法系国家和地区民法典关于清偿抵充的立法经验,进一步完善法定抵充制度。     

Medicare program; changes concerning interest rates charged on overpayments and underpayments--HCFA. Final rule

We are revising the Medicare regulations to provide for the assessment of the higher of the private consumer rate or the current value of funds rate of interest on overpayments and underpayments to health care providers and suppliers. This change is being made to protect the Government's interest, as provided by the rules of the Secretary of the Treasury applicable to charges for late payments. We are also making clarifying changes in the regulations.     

Revision of requirements applicable to albumin (human), plasma protein fraction (human), and immune globulin (human). Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements. FDA is taking this action as part of the agency's "Blood Initiative" in which FDA is reviewing and revising, when appropriate, its regulations, policies, guidance, and procedures related to blood products, including blood derivatives.     

Beverages: bottled water. Final rule

The Food and Drug Administration (FDA) is amending its bottled water quality standard regulations by revising the existing allowable level for the contaminant arsenic. As a consequence, bottled water manufacturers are required to monitor their finished bottled water products for arsenic at least once each year under the current good manufacturing practice (CGMP) regulations for bottled water. Bottled water manufacturers are also required to monitor their source water for arsenic as often as necessary, but at least once every year unless they meet the criteria for the source water monitoring exemptions under the CGMP regulations. This final rule will ensure that the minimum quality of bottled water, as affected by arsenic, remains comparable with the quality of public drinking water that meets the Environmental Protection Agency's (EPA's) standards.     

机动车交易中的物权变动

机动车交易中涉及的所有权何时变动,在我国司法实践中历来认为以办理过户手续为准。这种 认识是不合适的,因为这种认识不符合世界上通行的物权变动制度,也不符合机动车的动产特 性。世界上通行的物权变动制度是动产以交付为准、不动产以登记为准,我们也应确立这样的物 权变动制度。     

Revisions to the requirements applicable to blood, blood components and source plasma. Direct final rule

The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.     

Eligibility determination for donors of human cells, tissues, and cellular and tissue-based products. Final rule

The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to screen and test cell and tissue donors for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases. The agency is amending the current good manufacturing practice (CGMP) and quality system (QS) regulations that apply to HCT/Ps regulated as drugs, medical devices, and/or biological products to clarify the role of the new donor-eligibility regulations in relation to existing CGMP regulations. By preventing the transmission of communicable disease by the wide spectrum of HCT/Ps that are marketed now or may be marketed in the future, the agency's action will improve protection of the public health and increase public confidence in new technologies.     

对海上格式条款立法规制的完善

大量存在的海上格式条款在促进海上交易、提高效率的同时,引起交易方权利义务不平衡等许多问题。《海商法》对海上格式条款的规制不够完善。通过对海上格式条款存在的必然性、立法规制缺陷等的分析,可以明晰完善海上格式条款立法规制的意义,提出完善立法规制的具体建议。     

用人单位非法解除劳动合同若干法律问题研究

当前劳动法及其他相关法律法规对用人单位非法解除劳动合同的规定相当粗糙,有必要对用人单位非法解除劳动合同中相关法律问题进行比较详尽的研究,为相关法律规定的修改及《劳动合同法》的制定提供理论支持。     

充分发挥宪法在中国特色社会主义建设中的法制保障作用——纪念我国1982年《宪法》颁布30周年

2012年12月4日,是我国现行《宪法》颁布实施30周年的纪念日。现行宪法被公认为是新中国建立以来制定的最好的宪法,其全面规定了中国特色社会主义经济政治文化和社会建设的主要任务和基本内容,对于我们建设中国特色社会主义市场经济、社会主义民主政治、社会主义先进文化和社会主义和谐社会,具有重要的法制保障作用。     

The new EMTALA regulations and the on-call physician shortage: in defense of the regulations

This Article examines the new Emergency Medical Treatment and Labor Act (EMTALA) regulations, focusing on the on-call provisions, in light of the practical realities of the on-call physician shortage. It provides an historical account of issues surrounding the delivery of emergency care by on-call physicians and the legal background of EMTALA insofar as it relates to on-call physicians. Ultimately, the author concludes that, although the current shortage of on-call physicians has caused hospitals to anticipate EMTALA liability and advocate for more specific regulations, a closer look reveals that hospitals' fears are overstated. As long as hospitals have proper procedures in place, the new regulations will not put them in violation of EMTALA.     

合规制度的公司法设计及其实现路径

公司法作为合规制度的最重要载体,对整个合规制度的构建具有基础和核心作用。为此,既需要对国外涉及合规要求的制度进行必要的甄别和借鉴,又需要对我国现有的涉及合规要求的规则和制度进行提炼、归集和升华。在兼收并蓄的基础上制定出一部既能满足公司的营利性和道德性双重需要,又能对世界公司法发展起一定引领作用的模范公司法典。具体的实现路径是:首先以塑造公司的良好道德品格为基点,从基本原则层面将合规要求作为公司组织和相关成员的基本义务;然后从具体制度设计层面将其规定为公司组织、公司负责人和公司工作人员的基本行为准则;最后通过缜密的法律责任制度,强化公司的合规意识和道德担当意识。促成公司在成为先进生产力践行者的同时,还要成为社会责任的积极承担者和公序良俗的模范遵守者。     

Revision of requirements applicable to albumin (human), plasma protein fraction (human), and immune globulin (human); companion document to direct final rule. Food and Drug Administration, HHS. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by removing, revising, or updating specific regulations applicable to blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements. FDA is taking this action as part of the agency's "Blood Initiative" in which FDA is reviewing and revising, when appropriate, its regulations, policies, guidance, and procedures related to blood products, including blood derivatives. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. FDA is taking this action because the proposed changes are noncontroversial and FDA anticipates that it will receive no significant adverse comment.     

Revisions to the requirements applicable to blood, blood components and source plasma; confirmation of effective date and technical amendment. Direct final rule; confirmation of effective date and technical amendment

The Food and Drug Administration (FDA) is confirming the effective date of February 19, 2008, for the direct final rule that appeared in the Federal Register of August 16, 2007 (72 FR 45883). The direct final rule amends the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. In addition, FDA is making technical amendments to the biologics regulations in response to comments received on the direct final rule.     

协议管辖:问题、原因及其改革设想

我国《民事诉讼法》有关协议管辖的规定,在立法体例、适用范围,以及协议成立条件的规定上都存在诸多缺陷。基于当事人的诉权保障和我国当今社会对于民事司法救济权利保护的现实要求,比较、借鉴国外多数国家的有关立法例,可以发现,对于协议管辖的现行规定,有必要进行适当的修改与完善。