论保险条款、费率之审批

保险合同条款、费率的审批须遵循一定的原则。保险条款符合要求的,应予审批,但若保险条款应经审批而未审批的,不应因此而导致保险合同无效。保险条款、费率的备案制比审批制更有利于提高监管效率。     

违法宣传超声刀医疗美容引发的监管思考

超声刀在美国作为医疗器械管理,但在我国尚未纳入医疗器械且未准入其进口。上海市卫生行政部门以违法宣传的医疗服务项目为切入点,查处使用超声刀开展医疗美容的超范围诊疗行为,采取多维度惩戒手段,起到了良好的威慑、警示作用。市场监督管理部门、卫生行政部门、网络信息主管部门应当齐抓共管、综合执法,进一步提升整治效果。     

Administration of grants and agreements with institutions of higher education, hospitals, and other non-profit organizations; direct grant programs--DoE. Final regulations

The Secretary amends 34 CFR parts 74 and 75 to add the Office of Management and Budget (OMB) control numbers to certain sections of the regulations. Those sections contain information collection requirements approved by OMB. The Secretary takes this action to inform the public that these requirements have been approved.     

Evaluation of two instrumental methods of comparing writing paper

An organization had approved the sample of writing paper, and accordingly the supplier had to execute the supply. The supply received was suspected to be of different quality from approved one. The organization sent the samples for comparison to the Forensic Science Laboratory. Both the approved and supplied samples were compared using Tensile Testing Method with the Material Testing Machine and Fluorescence and spectral analysis using the Video Spectral Comparator (VSC2000). The difference between the mean loads at peak before rupture in the tensile testing mode for the two samples was about 33%. The two samples differed significantly in terms of UV fluorescence, and there was about 5% average difference in the percentage of maximum reflected intensity in the wavelength region of 400-900 nm. It has been observed in this study that these two methods can adequately distinguish paper samples of different origin.     

论单位犯罪的自首制度

既然单位犯罪已经得到理论和立法的广泛认可,那么就应认可单位犯罪的自首制度。对确立单位犯罪自首制度的可能性与必要性、单位犯罪自首的认定及单位犯罪自首的处罚三个方面的问题进行了探讨。     

Reforming the Mental Health Act 1983: an approved social worker perspective

The government green paper, 'Reform of the Mental Health Act 1983', was published in November 1999, for consultation by end of March 2000. This article offers comment on the operation of the Mental Health Act 1983 and the proposals for change, from an approved social worker perspective. Under the Mental Health Act 1983, approved social workers undertake social assessments of mental health crises, deciding upon the need for compulsory admission and treatment. To the debate on legislative change they bring a detailed social perspective on the processes and outcomes of statutory mental health intervention. Approved social workers' main concerns relate to the social context of mental health need, the availability of social resources, civil liberties, protections for people subject to statutory mental health interventions and the effective regulation of practice and services. Current proposals include options that would significantly reduce approved social worker involvement in decisions about compulsory admission and treatment; the implications of this are discussed.     

Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. Final rule

The Food and Drug Administration (FDA) is amending its regulations regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval application (PMA). This final rule provides that a supplemental application submitted under certain FDA regulations is appropriate to amend the labeling for an approved product to reflect newly acquired information and to add or strengthen a contraindication, warning, precaution, or adverse reaction if there is sufficient evidence of a causal association with the drug, biologic, or device, as defined in other FDA regulations and guidance documents.     

STANDARDS AND GUIDELINES FOR SUPERVISED VISITATION NETWORK PRACTICE: INTRODUCTORY DISCUSSION

In 1996, members of the Supervised Visitation Network approved initial standards and guidelines for practice. The approach taken was to develop standards of good practice that could be both educational and advisory. It was recognized that the standards as approved were a start and also that they would need to be revised with time and experience. That review is currently in process. The standards and guidelines are published here to reach practitioners in the field, including attorneys and court personnel whose clients require supervised visitation, and to encourage comments and debate. This introduction reviews the evolution of the guidelines, outlines the contents, and identifies areas needing further development.     

Medicare and Medicaid programs; approved information collection requirements and HCFA's claims collection authority--HCFA. Final rule with comment period

This final rule updates our display of control numbers assigned by the Office of Management and Budget (OMB) to approved "collection of information" requirements contained in regulations governing the Medicare and Medicaid programs. In addition, it incorporates a technical change to our regulations to reflect increased agency authority under the Federal Claims Collection Act, 31 U.S.C. 3711 et seq. This rule is issued in accordance with OMB regulations concerning approved collections of information and to conform to changes made by Public Law 101-552.     

Broadcasting Regulation and Building the Multicultural Canadian Nation: Understanding the CRTC's Al-Jazeera Arabic Decision

The Canadian Radio-Television and Telecommunications Commission provoked extensive debate in 2004 when, in a seminal decision, it approved controversial and popular satellite television network Al-Jazeera Arabic for Canadian distribution. While the broadcast regulator's decision placed what some consider onerous responsibilities on potential Al-Jazeera carriers, others argue that given past egregious incidents of abusive speech on the network, it should not have been approved at all. This article accounts for the policy and regulatory context in which the Al-Jazeera decision is situated and the factors leading to the decision. The article argues that in proscribing abusive speech on the airwaves, the regulator locates freedom of expression within the context of a mandate to ensure that the Canadian broadcasting system makes a tolerant, multiethnic and multicultural Canadian nation imaginable.     

Opioid drugs in maintenance and detoxification treatment of opiate addiction; addition of buprenorphine and buprenorphine combination to list of approved opioid treatment medications. Interim final rule

This interim final rule amends the Federal opioid treatment program regulations by adding buprenorphine and buprenorphine combination products to the list of approved opioid treatment medications that may be used in federally certified and registered opioid treatment programs. The Food and Drug Administration (FDA) recently approved Subutex[reg] (buprenorphine) and Suboxone[reg] (buprenorphine in fixed combination with naloxone) for the treatment of opiate dependence. These two products will join methadone and ORLAAM[reg] as medications that may be used in opioid treatment programs for the maintenance and detoxification treatment of opioid dependence. Opioid treatment programs that choose to use these new products in the treatment of opioid dependence will adhere to the same Federal treatment standards established for methadone and ORLAAM[reg]. The Secretary invites public comments on this action.     

The legal question of the obtention of human stem cells for biomedical research. Legislation policy considerations]

The future Law on Biomedical Research, whose draft bill has been approved by the Council of Ministers and that will soon begin its parliamentary process of approval, will regulate, among other matters, the research with embryos. Likewise, it will make a pronouncement on the so-called therapeutic cloning. This report makes a detailed analysis of different matters that must be borne in mind by the legislator in order to face the process of evaluation and approval of said Law in relation with the aforementioned matters. It makes a special analysis of the legal texts of an international nature to which Spain is unavoidably subjected to, in such a way that the legislative text that will finally be approved is not contrary to the dispositions that are within such.     

Medicare, Medicaid, and CLIA programs; personnel requirements for cytotechnologists--HCFA. Final rule with comment period

This rule amends certain personnel requirements for cytotechnologists that perform testing in laboratories subject to the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). We are providing an adequate period of time for individuals to gain the necessary 2 years experience performing cytology testing which is currently included in two of the provisions for qualifying as a cytotechnologist. Also, we are extending the time for individuals to either meet the educational qualifications by virtue of completing training in an approved cytotechnology training program or be certified by an approved organization. We are making these changes to prevent the loss of qualified personnel in the field of cytotechnology.     

Authority for practitioners to dispense or prescribe approved narcotic controlled substances for maintenance or detoxification treatment. Final rule

DEA is amending its regulations to allow qualified practitioners not otherwise registered as a narcotic treatment program to dispense and prescribe to narcotic dependent persons Schedule III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment. This Final Rule is in response to amendments to the Controlled Substances Act by the Drug Addiction Treatment Act of 2000 (DATA) that are designed to expand and improve treatment of narcotic addiction. This Final Rule is intended to accomplish the goals of DATA while preventing the diversion of Schedule III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration specifically for maintenance / detoxification treatment.     

Labeling and effectiveness testing; sunscreen drug products for over-the-counter human use. Final rule

The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).     

Medical devices; reports of corrections and removals; lift of stay of effective date--FDA. Final rule; lift of stay of effective date

The Food and Drug Administration (FDA) is lifting a stay of the effective date of certain provisions in a final rule on establishing procedures for submission of reports of corrections and removals of medical devices. The Office of Management and Budget (OMB) has approved the collection of information requirements contained in the final rule.     

Medicaid program; review and approval process for Section 1115 demonstrations. Final rule

This final rule will implement provisions of section 10201(i) of the Patient Protection and Affordable Care Act of 2010 that set forth transparency and public notice procedures for experimental, pilot, and demonstration projects approved under section 1115 of the Social Security Act relating to Medicaid and the Children's Health Insurance Program (CHIP). This final rule will increase the degree to which information about Medicaid and CHIP demonstration applications and approved demonstration projects is publicly available and promote greater transparency in the review and approval of demonstrations. It will also codify existing statutory requirements pertaining to seeking advice from Indian health care providers and urban Indian organizations for section 1115 demonstration projects, and for the first time impose as regulatory requirements tribal consultation standards that were previously only published as guidance documents.     

Fatal case of BOTOX-related anaphylaxis?

Anaphylactic drug reactions are rare and often serious events. The Botulinum toxin A, marketed as BOTOX, was recently approved by the Food and Drug Administration for cervical dystonia and glabellar wrinkles, after its approved use and success with blepharospasm, strabismus, and disorders of the 7th cranial nerve. It has been well received due to its efficacy in improving facial lines. This case report documents the first death associated with a Botox-lidocaine mixture given to a woman for chronic neck and back pain. Based on the medical records, autopsy, and laboratory findings, the cause of death was determined to be anaphylaxis to the Botox-lidocaine mixture. The history, indications, off-label uses and possible future applications of Botox are reviewed as well as the uses and complications of lidocaine. Although the anaphylaxis cannot be definitively proven to be due to Botox alone, this case warns of an adverse reaction related to Botox, a drug that is rapidly expanding in range of use as well as increased usage.     

Fatal accident with a special automobile

The authors report on a traffic accident in which the passenger of a Light Four-wheeled Vehicle (Microcar) approved for use by a disabled person was killed after a rear collision with a compact car. The severity of the accident trauma was critically determined by the vehicle's light construction. Consideration is also given to the legal situation regarding registration and driver's license issues.