Organ Procurement and Transplantation Network; final rule revision of comment period and effective dates--HRSA. Extension of comment period and delay of effective date for the Organ Procurement and Transplantation Network

This document sets forth the revisions required by the Fiscal Year 1998 Supplemental Appropriations Act, Public Law 105-174, signed into law by the President on May 1, 1998. Section 4002 of that Act states that public comments on the Organ Procurement and Transplantation Network (OPTN) Final Rule are permitted until August 31, 1998, and that the OPTN rule will not become effective before October 1, 1998. This document is provided to notify the public about these provisions and to make corresponding changes to the regulation.     

Smallpox vaccine injury compensation program: Smallpox (Vaccinia) Vaccine Injury Table. Adoption of interim final rule as final rule with an amendment

This document adopts the Smallpox (Vaccinia) Vaccine Injury Table (the Table) Interim Final Rule as the Final Rule with an amendment, as follows: the Final Rule clarifies that, in order for the presumption of causation to apply, the time intervals listed on the Table refer specifically to the period in which the first symptom or manifestation of onset of injury must appear following administration of the smallpox vaccine or exposure to vaccinia, and that the time intervals listed have no relevance to time of diagnosis of the injury.     

Smallpox Vaccine Injury Compensation Program: administrative implementation. Adoption of interim final rule as final rule with amendments

This document adopts the Smallpox Vaccine Injury Compensation Program (the Program) Administrative Implementation Interim Final Rule as the Final Rule with amendments, as follows: explains how the term "child" survivor is defined; updates the effective period of the Secretary's Declaration Regarding Administration of Smallpox Countermeasures (the Declaration); corrects an error in Sec. 102.20(d) to clarify that one of the Smallpox (Vaccinia) Vaccine Injury Table requirements to establish a covered Table injury is the first symptom or manifestation of onset of the injury in the Table time period specified; reflects the change in name from the Special Programs Bureau to the Healthcare Systems Bureau; provides the new address of the Bureau's Associate Administrator, and the new address of the Program Office; clarifies that no payments are authorized for fees or costs of personal representatives, including those of attorneys; and corrects a typographical error in Sec. 102.83(c) to make clear that the Secretary determines the timeframe for submission of required documentation.     

Regulation for the enforcement of federal health care provider conscience protection laws. Final rule

The Department of Health and Human Services issues this final rule which provides that enforcement of the federal statutory health care provider conscience protections will be handled by the Department's Office for Civil Rights, in conjunction with the Department's funding components. This Final Rule rescinds, in part, and revises, the December 19, 2008 Final Rule entitled "Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law" (the "2008 Final Rule"). Neither the 2008 final rule, nor this final rule, alters the statutory protections for individuals and health care entities under the federal health care provider conscience protection statutes, including the Church Amendments, Section 245 of the Public Health Service Act, and the Weldon Amendment. These federal statutory health care provider conscience protections remain in effect.     

Control of a chemical precursor used in the illicit manufacture of fentanyl as a List I chemical. Final rule

The Drug Enforcement Administration (DEA) is finalizing the Interim Rule with Request for Comment published in the Federal Register on April 23, 2007. The Interim Rule controlled the chemical N-phenethyl-4- piperidone (NPP) as a List I chemical under the Controlled Substances Act. Clandestine laboratories are using this chemical to illicitly manufacture the schedule II controlled substance fentanyl. No comments to the Interim Rule were received. This Final Rule finalizes the regulations without change.     

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.     

Representing the healthcare organization in a post-Sarbanes-Oxley world: new rules, new paradigms, new perils

The Sarbanes-Oxley Act (Act) significantly changed the expected corporate behavior of public companies. The Act governs the relationship between corporate organizations and their in-house or outside counsel. Under Section 307 of the Act, the Securities and Exchange Commission initially proposed expansive rules regarding counsel's duties. After comments and criticism from much of the bar, a final, narrower, version of rules under Section 307 (Final Rule) was adopted. The Final Rule contains alternative reporting procedures, attorney responsibilities, and sanctions for violations. In addition to the Act, the American Bar Association's (ABA) Task Force on Corporate Responsibility(Task Force), which was itself a reaction to Enron, reported on the importance of counsel's role in a corporate setting (Cheek Report). The ABA adopted amendments to its Model Rules of Professional Conduct (Model Rules) 1.6 and 1.13 as proposed in the Cheek Report. The Final Rule and amended Model Rules together suggest that attorneys may owe duties beyond those owed to their clients.     

Closing the Organ Gap: A Reciprocity-Based Social Contract Approach

Organ transplantation has become a proven, cost-effective lifesaving treatment, but its promise is contingent on the number of available organs. The growing gap between the demand and supply results in unnecessary loss and diminished quality of life as well as high costs for surviving patients and health insurers. Twenty years after the enactment of the National Organ Transplantation Act, it is time to rethink the moral basis and overall design of organ transplantation policy. We propose a national plan for organ transplantation insurance under which the federal government would assume responsibility for increasing the organ supply and would cover all costs associated with transplantation for patients not otherwise covered.     

Elimination of exemptions for chemical mixtures containing the list I chemicals ephedrine and/or pseudoephedrine. Final rule

The Drug Enforcement Administration (DEA) is finalizing, without change, the Interim Rule with Request for Comment published in the Federal Register on July 25, 2007 (72 FR 40738). The Interim Rule removed the Controlled Substances Act (CSA) exemptions for chemical mixtures containing ephedrine and/or pseudoephedrine with concentration limits at or below five percent. Upon the effective date of the Interim Rule, all ephedrine and pseudoephedrine chemical mixtures, regardless of concentration and form, became subject to the regulatory provisions of the CSA. DEA regulated the importation, exportation, manufacture, and distribution of these chemical mixtures by requiring persons who handle these chemical mixtures to register with DEA, maintain certain records common to business practice, and file certain reports, regarding these chemical mixtures. No comments to the Interim Rule were received. This Final Rule finalizes the Interim Rule without change.     

Healthy Tomorrows Partnership for Children program (HTPC). Final rule

This Final Rule sets forth the Secretary's proposal to require HTPC grant recipients to contribute non-Federal matching funds in years 2 through 5 of the project period equal to two times the amount of the Federal Grant Award or such lesser amount determined by the Secretary for good cause shown.     

Procedures for transportation workplace drug and alcohol testing programs. Final rule

The Department of Transportation is amending certain provisions of its drug and alcohol testing procedures to change instructions to collectors, laboratories, medical review officers, and employers regarding adulterated, substituted, diluted, and invalid urine specimen results. These changes are intended to create consistency with specimen validity requirements established by the U.S. Department of Health and Human Services and to clarify and integrate some measures taken in two of our own Interim Final Rules. This Final Rule makes specimen validity testing mandatory within the regulated transportation industries.     

Exemption of chemical mixtures. Final rule

On December 15, 2004, the Drug Enforcement Administration (DEA) published a Final Rule corrected January 4, 2005) that implemented new regulations concerning chemical mixtures that contain any of the 27 listed chemicals. The Final Rule added a new provision not previously raised by DEA in any proposed rulemaking. This newly introduced provision exempted domestic and import transactions in chemical mixtures that are regulated solely due to the presence of the List II solvent chemicals acetone, ethyl ether, 2-butanone, or toluene from the Controlled Substances Act (CSA) recordkeeping and reporting requirements. Because this exemption was not previously proposed in any rulemaking, DEA implemented this exemption on an interim basis and requested public comment on this exemption provision. Based upon a review of all comments, DEA is finalizing this exemption. As such, domestic and import transactions in chemical mixtures containing the List II chemicals acetone, ethyl ether, 2-butanone, and toluene shall be exempt from CSA chemical recordkeeping and reporting requirements.     

我国人体器官捐赠移植立法问题研究

文章对我国人体器官捐赠移植立法的必要性和立法模式问题、器官捐赠合同问题、捐赠器官的法律形式问题、人体器官移植专家委员会的设置与职能问题 ,以及我国人体器官捐赠移植法的体系和基本原则进行了深入研究 ,指出 :我国人体器官捐赠移植立法宜采用统一立法模式 ,并遵循鼓励捐赠遗体器官、器官自愿无偿捐赠、禁止器官交易、无伤害和非优先五项原则     

我国人体器官捐赠移植立法问题研究

文章对我国人体器官捐赠移植立法的必要性和立法模式问题、器官捐赠合同问题、捐赠器官的法律形式问题、人体器官移植专家委员会的设置与职能问题，以及我国人体器官捐赠移植法的体系和基本原则进行了深入研究，指出：我国人体器官捐赠移植立法宜采用统一立法模式，并遵循鼓励捐赠遗体器官、器官自愿无偿捐赠、禁止器官交易、无伤害和非优先五项原则。     

《刑法修正案(八)》器官犯罪规定之解析

《刑法修正案(八)》第35条增设了有关器官犯罪的规定,其核心内容是新增了一个罪名。该罪名应确定为组织出卖人体器官罪。该罪中的人体器官既包括《人体器官移植条例》所指的器官的全部或者部分,也应包括角膜等人体组织。本罪客观方面表现为组织出卖他人人体器官的行为,主体是一般主体,主观方面是故意。非法摘取活体器官与尸体器官的行为不构成该罪,应视其情况分别认定为故意杀人罪、故意伤害罪或盗窃、侮辱尸体罪。     

Implementation of the Methamphetamine Production Prevention Act of 2008. Final rule

In October 2008, the President signed the Methamphetamine Production Prevention Act of 2008 (MPPA), which clarifies the information entry and signature requirements for electronic logbook systems permitted for the retail sale of scheduled listed chemical products. On March 23, 2010, DEA published a Notice of Proposed Rulemaking to implement the provisions of the MPPA and make its regulations consistent with the new requirements. This action finalizes without change the Notice of Proposed Rulemaking published on March 23, 2010. The Final Rule will make it easier for regulated sellers to maintain electronic logbooks by allowing greater flexibility as to how information may be captured.     

Classification of two steroids, prostanozol and methasterone, as Schedule III anabolic steroids under the Controlled Substance Act. Final rule

With the issuance of this Final Rule, the Administrator of the DEA classifies the following two steroids as "anabolic steroids' under the Controlled Substances Act (CSA): prostanozol (17[beta]-hydroxy-5[alpha]-androstano[3,2-c]pyrazole) and methasterone (2[alpha],17[alpha]-dimethyl-5[alpha]-androstan-17[beta]-ol-3-one). These steroids and their salts, esters, and ethers are Schedule III controlled substances subject to the regulatory control provisions of the CSA.     

Ethical criteria for procuring and distributing organs for transplantation

This article provides an ethical analysis and assessment of various actual and proposed policies of organ procurement and distribution in light of moral principles already embedded in U.S. institutions, laws, policies, and practices. Evaluating different methods of acquisition of human body parts--donation (express and presumed), sales, abandonment, and expropriation--the author argues for laws and policies, including required request, to maintain and facilitate express donation of organs by individuals and their families. Such laws and policies need adequate time for a determination of their effectiveness before society moves to other major alternatives, such as a market. In organ allocation and distribution, which have close moral connections with organ procurement, the author defends the judgment of the federal Task Force on Organ Transplantation that the community should have dispositional authority over donated organs, that professionals should be viewed as trustees and stewards of donated organs, and that the public should be heavily involved in the formation of policies of allocation and distribution. Concentrating on policies being developed in the United Network for Organ Sharing, the author examines the point system for cadaveric kidneys, the access of foreign nationals to organs donated in the U.S., and the multiple listings of patients seeking transplants. He concludes by identifying two major problems of equitable access to donated organs that will have to be addressed by social institutions other than UNOS: access to the waiting list for donated organs and the role of ability to pay in extrarenal transplants.     

Waiver of two-year home-country physical presence requirement, foreign medical graduates, exchange visitor program--USIA. Final rule

Section 220 of the Immigration and Nationality Technical Corrections Act of 1994 (Pub. L. 103-416) amended Section 212(e) of the Immigration and Nationality Act (8 U.S.C. 1182(e)) and added a new subsection (k) to section 214 of that Act (8 U.S.C. 1184) regarding waiver of the two-year foreign residence requirement as it applies to foreign medical graduates. An Interim Final Rule with request for comments was published in the Federal Register on April 3, 1995 (60 FR 16785). This final rulemaking amends the Exchange Visitor Program regulations to reflect those legislative changes.     

毛泽东邓小平治国方略与法制思想比较研究

毛泽东“人治加群治”的治国方略 ,实质上是“人治底下的群治” ,是人治的当代形态 ,收效甚微 ,负面作用为主 ,乃至某种程度上造成国无宁日 ,以一场浩劫告终。邓小平提出了“以经济建设为中心”的治国路线 ,实行“三有利”原则的社会主义本质观和功利主义法价值观 ,为使中国从人治走向法治开辟了道路。但由于历史的局限性 ,不可能完全摆脱人治的痕迹 ,给其后继者留下了继续革故鼎新的空间。