Irradiation in the production, processing and handling of food. Final rule

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of ionizing radiation for control of food-borne pathogens, and extension of shelf-life, in fresh iceberg lettuce and fresh spinach (hereinafter referred to in this document as "iceberg lettuce and spinach") at a dose up to 4.0 kilo Gray (kGy). This action is in partial response to a petition filed by The National Food Processors Association on behalf of The Food Irradiation Coalition.     

Standards for protection against radiation--Nuclear Regulatory Commission. Final rule

The Nuclear Regulatory Commission (NRC) is revising its standards for protection against ionizing radiation. This action is necessary to incorporate updated scientific information and to reflect changes in the basic philosophy of radiation protection. The revision conforms the Commission's regulations to the Presidential Radiation Protection Guidance to Federal Agencies for Occupational Exposure and to recommendations of national and international radiation protection organizations.     

Institutional Radiation Safety Committee--Nuclear Regulatory Commission. Final rule

The Nuclear Regulatory Commission (NRC) is amending its regulations regarding hospitals licensed to use radioactive byproduct material for human applications. Currently, such a license requires that the hospital have a Medical Isotopes Committee to review clinical aspects of the use of radioactive materials within the hospital. The amendment requires instead a Radiation Safety Committee with a simplified membership that will focus on the radiation safety of workers and the general public. The rule change acknowledges the Food and Drug Administration's role in regulating the safety and effectiveness of radioactive drugs with respect to the patient. The membership of the new Radiation Safety Committee will include the hospital management and the nursing staff in decisions affecting radiation safety at the hospital and will be easier for smaller hospitals to recruit.     

Irradiation in the production, processing, and handling of food. Final rule

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of ionizing radiation for control of Vibrio species and other foodborne pathogens in fresh or frozen molluscan shellfish (e.g., oysters, mussels, clams, etc.). This action is in response to a petition filed by the National Fisheries Institute and the Louisiana Department of Agriculture and Forestry.     

Quality management program and misadministrations--Nuclear Regulatory Commission. Final rule

The Nuclear Regulatory Commission (NRC) is amending regulations governing therapeutic administrations of byproduct material and certain uses of radioactive sodium iodide to require implementation of a quality management program to provide high confidence that the byproduct material or radiation from byproduct material will be administered as directed by an authorized user physician. The Commission believes this performance-based amendment will result in enhanced patient safety in a cost-effective manner while allowing the flexibility necessary to minimize intrusion into medical judgments. This amendment also modifies the notification, reporting, and recordkeeping requirements related to the quality management program and misadministrations.     

Standards for protection against radiation; extension of implementation date--NRC. Final rule

The Nuclear Regulatory Commission (NRC) is extending the implementation date for its revised standards for protection against radiation and making a conforming change to its regulation. See SUPPLEMENTARY INFORMATION for specific regulatory parts affected. This rule extends the date by which NRC licensees are required to implement the revised standards for protection against radiation to January 1, 1994. The 1-year extension provides licensees additional time to examine and implement the regulatory guidance developed to support the rule. It also establishes a concurrent implementation date for NRC licensees and Agreement State licensees.     

Food labeling: nutrient content claims, expansion of the nutrient content claim "lean". Final rule

The Food and Drug Administration (FDA) is amending its food labeling regulations for the expanded use of the nutrient content claim "lean" on the labels of foods categorized as "mixed dishes not measurable with a cup" that meet certain criteria for total fat, saturated fat, and cholesterol content. This final rule responds to a nutrient content claim petition submitted by Nestlé Prepared Foods Co. (Nestlé) under the Federal Food, Drug, and Cosmetic Act (the act). This action is also being taken to provide reliable information that would assist consumers in maintaining healthy dietary practices.     

Biomedical waste disposal--Nuclear Regulatory Commission. Final rule

The NRC is amending its regulations to permit licensees greater leeway in disposing of liquid scintillation media and animal carcasses containing tracer levels of hydrogen-3 (tritium) or carbon-14. These rule changes will primarily affect NRC licensed hospitals and medical research institutions. Most licensees presently dispose of these items by sending them to a radioactive waste burial ground or by obtaining special authorization from NRC for incineration or onsite burial. Under the new regulations, the licensee may dispose of specified concentrations of these materials without regard to their radioactivity. The NRC is also amending its regulations to raise the annual limits for disposal of hydrogen-3 and carbon-14 by release to the sanitary sewerage systems. The rule changes will conserve waste burial capacity that is already in short supply.     

Revision of fee schedules; 100% fee recovery; clarification of size standards--Nuclear Regulatory Commission. Final rule

The Nuclear Regulatory Commission (NRC) is amending its regulations concerning the payment of annual fees to clarify the provisions that identify the size standards used to determine whether an NRC licensee would qualify as a "small entity" under the Regulatory Flexibility Act for the purpose of paying a reduced annual fee. This clarification is necessary because the size standards presented in the regulations did not clearly indicate the complete range of size standards adopted by the NRC.     

Medical use of byproduct material: issues and request for public input--NRC. Request for public input on rule development

The U.S. Nuclear Regulatory Commission (NRC) has developed a program for revising the regulations governing the medical use of byproduct material. The decision to revise this regulation resulted from the NRC Strategic Assessment and Rebaselining Initiative (SA), a process involving identification of the direction-setting issues and associated options for the future of NRC activities. This notice describes the NRC's program for revising the medical use regulation; notifies the public of the availability of documents associated with this action on the NRC Technical Conference Forum and through the NRC Public Document Room; and solicits informal public input on development of proposed rule language and associated documents. The Commission plans to formally propose specific rulemaking text for public comment during summer of 1998.     

再审程序若干概念辨析

审判监督程序与再审程序的概念应区别开 ,再审程序才是诉讼法中规范的概念 ,应当摒弃审判监督程序的提法。从“诉”与“诉权”的角度 ,研析“申诉”、“申请再审”、与“再审之诉”的区别与关系 ,应当将不具有“诉”的性质的申诉从诉讼程序中取消 ,以再审之诉取代申请再审。我国立法关于申请再审的条件表述不严谨、不科学。应当借鉴国外的做法 ,规定具体的、可操作的提起再审之诉的条件。     

Over-the-counter drug products containing analgesic/antipyretic active ingredients for internal use; required alcohol warning; final rule; compliance date. Food and Drug Administration, HHS

The Food and Drug Administration (FDA) is establishing a compliance date of October 22, 1999, for the regulation that published in the Federal Register of October 23, 1998 (63 FR 56789). The regulation established warning statements that advise consumers with a history of heavy alcohol use to consult a physician for advice about the use of OTC internal analgesic/antipyretic drug products. The compliance date applies to all affected OTC drug products, whether marketed with or without an approved application. FDA is taking this action in response to correspondence and a citizen petition requesting more time to relabel these products.     

Criteria for the release of individuals administered radioactive materials--NRC. Final rule

The Nuclear Regulatory Commission (NRC) is amending its regulations concerning the criteria for the release of patients administered radioactive material. The new criteria for patient release are based on the potential dose to other individuals exposed to the patient. The new criteria are consistent with the recommendations of the National Council on Radiation Protection and Measurements (NCRP) and the International Commission on Radiological Protection (ICRP). This final rule required the license to provide written instructions to patients on how to maintain the doses to others as low as is reasonably achievable if the total effective dose equivalent to any other individual exposed to the released patient is likely to exceed 1 milisievert (0.1 rem). This final rule responds to three petitions for rulemaking regarding the criteria for release of patients administered radioactive material.     

Irradiation in the production, processing, and handling of food. Final rule

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of a carbon dioxide laser for etching information on the surface of fresh, intact citrus fruit. This action is in response to a petition filed by Durand-Wayland, Inc.     

Microbiology devices; reclassification of hepatitis A virus serological assays. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to reclassify hepatitis A virus (HAV) serological assays from class III (premarket approval) into class II (special controls). FDA is taking this action after reviewing a reclassification petition submitted by Beckman Coulter, Inc. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled "Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays" that will serve as the class II special control for these devices.     

Listing of color additives for coloring sutures; [phthalocyaninato(2-)] copper. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending the color additive regulations to provide for the safe use of [phthalocyaninato(2-)] copper in coloring nonabsorbable sutures for general and ophthalmic surgery made from a blend of poly(vinylidene fluoride) and poly(vinylidene fluoride-co-hexafluoropropylene). This action responds to a petition filed by Ethicon, Inc.     

Food labeling: health claims; soluble fiber from certain foods and risk of coronary heart disease. Final rule

The Food and Drug Administration (FDA) is amending its regulation authorizing a health claim on the relationship between soluble fiber from certain foods and risk of coronary heart disease (CHD). The amendment exempts certain foods from the nutrient content requirement of "low fat." The exemption will apply if the food exceeds the "low fat" requirement due to fat content derived from whole oat sources. The amendment expands the use of this health claim to some whole oat products that are currently ineligible for the health claim. FDA is taking this action in response to a petition submitted by the Quaker Oats Co.     

Natural rubber-containing medical devices; user labelling--FDA. Final rule; interpretation

The Food and Drug Administration (FDA) is providing notice that it does not intend to apply to combination products currently regulated under human drug or biologic labeling provisions its September 30, 1997, final rule requiring certain labeling statements for all medical devices that contain or have packaging that contains natural rubber that contacts humans. FDA is taking this action, in part, in response to a citizen petition and other communications from industry that the agency has received since the publication of the final rule. FDA intends to initiate a proceeding to propose natural rubber labeling requirements for drugs and biologics, including combination products that are currently regulated under drug and biologic labeling provisions. Such a proceeding may include a combination of rulemaking and guidance and will offer opportunity for public comment.     

涉诉信访法治化的路径选择

涉诉信访已成为困扰我国司法与行政的一大顽疾,解决的根本在于将其纳入法治的轨道。重塑涉诉信访,首先要从"权限"和"程序"两个方面对其进行规制,规范信访机构的受理与处理行为;其次要对现有的"四级两审"诉讼制度进行改革,完善法的可诉性;最后,构建真正的以司法独立为根基的多元纠纷解决机制,彻底实现当事人的息诉罢访目的。     

The issue of constitutional law legitimacy on "human assisted reproduction" between reasonableness of the choices and effectiveness of the protection of all involved subjects.

This artiche analyzes the constitutionality petition to the constitutional Court against Law 40 of 2004 on "human assisted reproduction", where it prohibits the "preimplantatory genetical diagnosis", because it could be against the mother's right to health (art. 32 Italian Constitution) and the egalitarian protection clause (art. 3 Italian Constitution). In the constitutionally petition the ordinary judge proposes an interpretation in accordance with Constitution of the contested disposition (art. 13 of Law 40 of 2004) and this could be the possibility to teste the "living law" theory and its relation with the "adequate interpretation" of the law and the Constitution.