Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE Reserve Select for certain members of the selected reserve; Transitional Assistance Management Program; early eligibility for TRICARE for certain reserve component members. Interim final rule with comment period

This interim final rule establishes requirements and procedures for implementation of TRICARE Reserve Select. It also revises requirements and procedures for the Transitional Assistance Management Program. In addition, it establishes requirements and procedures for implementation of the earlier TRICARE eligibility for certain reserve component members. The rule is being published as an interim final rule with comment period in order to comply with statutory effective dates.     

Medicare, Medicaid and CLIA programs; extension of certain effective dates for clinical laboratory requirements and personnel requirements for cytologists--HCFA. Final rule with comment period

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, which implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and announces our approval of a certifying organization for qualifying cytotechnologists. This rule extends the date by which an individual must enroll in an HCFA-approved cytology proficiency testing (PT) program and the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. In addition, we are extending the phase-in of the quality control requirements applicable to unmodified, moderate complexity tests cleared for commercial distribution by the Food and Drug Administration (FDA). We are extending the date to meet applicable CLIA QC requirements for laboratories using commercial, nonmodified tests to fulfill certain quality control (QC) requirements. These effective date extensions do not reduce the current requirements for quality test performance. The date extensions are necessary due to the limited number and scope of currently operating cytology PT programs, resource constraints that have prevented commencement of the substantial number of quality control reviews, and inability of many laboratory directors to complete certification requirements within the time period originally specified.     

Effective date of requirement for premarket approval for a pacemaker programmer. Final rule

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 pacemaker programmers. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device 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.     

英美法中诉因记载的法定要求及其借鉴意义

诉因记载的法定要求经历了从严格形式主义到实质主义的转变,诉因记载的法定要求表现在诉因记载的特定性、诉因的单一性、诉因的选择与预备记载、诉因的合并记载上。我国现行法未对起诉书的记载做出具体规定,诉因记载的法定要求为我国规定如何记载起诉书提供了借鉴。     

Effective date of requirement for premarket approval for an implantable pacemaker pulse generator. Final rule

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 implantable pacemaker pulse generators. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device 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.     

Effective date of requirement for premarket approval for cardiovascular permanent pacemaker electrode. Final rule

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 cardiovascular permanent pacemaker electrode. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and the benefits to the public from the use of the device. This action implements certain statutory requirements.     

有限责任公司股权转让制度之重构

有限责任公司股权转让制度在我国现行《公司法》中作了基本的规定,但该规定无论在转让实质要件上、规制对象上,还是在转让形式要件上均存在不足之处,应予重构。     

Medicare, Medicaid, and CLIA programs; extension of certain effective dates for clinical laboratory requirements under CLIA. Centers for Disease Control and Prevention (CDC) and Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, that implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule extends the phase-in date of the quality control requirements applicable to moderate and high complexity tests and extends the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. These effective dates are extended to allow the Department to revise quality control requirements and establish the qualification requirements necessary for individuals with doctoral degrees to serve as directors of laboratories performing high complexity testing. These effective date extensions do not reduce the current requirements for quality test performance.     

论法庭科学实验室认可的特殊要求

本文从价值观、证据资格和优质法庭科学服务3个方面分析了法庭科学实验室认可特殊性的产生根源;分析和总结了ILAC和部分国家法庭科学实验室认可的特殊要求,给此项工作在我国的开展提供了借鉴。     

论合同生效要件之证明责任分配

民法教义学中,合同履行请求权至少应包括合同生效要件。其中,合同的特别生效要件由原告承担证明责任,学说及实践中已无异议;合同的＂一般生效要件＂,并无＂符合＂与否的问题,而只有＂违反＂如何的问题。私法自治原则要求,证明责任分配在参与民法外部体系的构建时,将合同效力要件规定为＂效力阻却要件＂,交由被告承担证明责任,所以,应对《证据规定》第5条规定之＂生效要件＂作目的性限缩。此种以证明责任为解释目标的进路,表明证明责任分配也是法规范之关联脉络的一种,解释论亦应以证明责任分配为解释目标。     

Self-certification and employee training of mail-order distributors of scheduled listed chemical products. Interim final rule with request for comment

On October 12, 2010, the President signed the Combat Methamphetamine Enhancement Act of 2010 (MEA). It establishes new requirements for mail-order distributors of scheduled listed chemical products. Mail-order distributors must now self-certify to DEA in order to sell scheduled listed chemical products at retail. Sales at retail are those sales intended for personal use; mail-order distributors that sell scheduled listed chemical products not intended for personal use, e.g., sale to a university, are not affected by the new law. This self-certification must include a statement that the mail-order distributor understands each of the requirements that apply under part 1314 and agrees to comply with these requirements. Additionally, mail-order distributors are now required to train their employees prior to self certification. DEA is promulgating this rule to incorporate the statutory provisions and make its regulations consistent with the new requirements and other existing regulations related to self-certification.     

Effective date of requirement for premarket approval for three class III preamendments devices. Final rule

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 following three class III preamendments devices: Ventricular bypass (assist) device; pacemaker repair or replacement material; and female condom. The Agency has summarized its 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.     

Audit requirements for institutions of higher education and other nonprofit organizations--Department of Commerce. Interim final rule with request for comments

The Department of Commerce is implementing Office of Management and Budget (OMB) guidance provided in Circular A-133, "Audits of Institutions of Higher Education and Other Nonprofit Organizations." As a result of this interim final rule, institutions of higher education and other nonprofit organizations that receive Federal assistance are required to periodically perform audits and submit the audit reports to the Federal government. This interim final rule establishes uniform audit requirements applicable to these organizations and defines the Department's responsibilities for implementing and monitoring these requirements.     

Import and production quotas for certain List I chemicals. Interim final rule with request for comment

In March 2006, Congress enacted the Combat Methamphetamine Epidemic Act of 2005, which mandates that DEA establish total annual requirements, import quotas, individual manufacturing quotas, and procurement quotas for three List I chemicals--ephedrine, pseudoephedrine, and phenylpropanolamine. DEA is promulgating this rule to incorporate the statutory provisions and make its regulations consistent with the new requirements.     

Hazardous materials: revision to standards for infectious substances. Final rule

RSPA is revising transportation requirements for infectious substances, including regulated medical waste, to: adopt defining criteria and packaging requirements consistent with international standards; revise the current broad exceptions for diagnostic specimens and biological products; and authorize bulk packaging options for regulated medical waste consistent with requirements in international standards and DOT exemptions. These revisions will assure an acceptable level of safety for the transportation of infectious substances, and facilitate domestic and international transportation.     

Medicaid program; correction and reduction plans for intermediate care facilities for the mentally retarded--HCFA. Final rule

This final rule amends the portions of the Medicaid regulations under which an intermediate care facility for the mentally retarded (ICF/MR) with substantial deficiencies that did not pose an immediate jeopardy to the health and safety of clients could continue participation in the Medicaid program. These regulations gave State Medicaid agencies the option of submitting written plans to either correct deficiencies or permanently reduce the number of beds in the certified portion of the facility. This rule removes all requirements for submitting, approving, and monitoring correction plans for ICFs/MR. The requirements for submitting and approving correction plans are being removed because the time limit for submission of these plans has passed. The provisions for monitoring correction plans are being removed because there are no remaining facilities for which these provisions apply. This final rule also removes requirements for submitting and approving reduction plans for ICFs/MR because the time limit for submitting these plans has passed. It retains and updates the requirements for monitoring and compliance that apply to those ICFs/MR for which reduction plans were approved by January 1, 1990.     

Records and reports regulations for radiation emitting electronic products--FDA. Final rule

The Food and Drug Administration (FDA) is amending its regulations regarding the requirements for recordkeeping and reporting of adverse experiences and other information relating to radiation emitting electronic products. This rule reduces recordkeeping and reporting requirements for some products, requires only abbreviated reporting for other products, and clarifies certain requirements. The timing and content of certain reports will be revised to enhance the usefulness of the information. These amendments will improve protection of the public health while reducing regulatory burdens on manufacturers, dealers, and distributors of radiation emitting electronic products.     

论行政契约撤销原因的确定

行政契约的合法要件主要有契约方式使用合法、契约主体适格、意思表示真实、契约内容合法、契约缔结程序合法。行政契约撤销原因的确定,应当充分借鉴行政行为撤销的理论及法制、私法契约撤销的理论及法制,具体分析行政契约合法要件的缺失对行政契约效力的不同影响,在此基础上还应当充分权衡撤销行政契约对于行政契约利害关系人所产生的实际影响。     

对于弱智女性实施强制性绝育的民事法律制度研究

对于弱智女性实施强制性绝育是指在不经本人同意的情况下由监护人或法院决定而实施的绝育。目前,英国、加拿大、苏格兰、美国部分州、德国均在严格的限制条件下准许强制性绝育。立法在准许实施强制性绝育者的年龄、实体法上的理由、程序等方面有很大的不同。我国目前的强制性绝育立法还有不足,应该加以完善。我国某儿童福利院决定切除两少女子宫的行为违反了《民法通则》规定的监护制度。     

Medicare, Medicaid, and CLIA programs; clinical laboratory requirements--extension of certain effective dates for clinical laboratory requirements under CLIA--CDC, HCFA. Final rule with comment period

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, and subsequently revised December 6, 1994, that implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule extends the phase-in date of the quality control requirements applicable to moderate and high complexity tests and extends the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. These effective dates are extended to allow the Department additional time to issue revised quality control requirements and to ensure laboratory directors are able to complete certification requirements. These effective date extensions do not reduce the current requirements for quality test performance.