Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule

The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.     

Food labeling: health claims; calcium and osteoporosis, and calcium, vitamin D, and osteoporosis. Final rule

The Food and Drug Administration (FDA) is amending its labeling regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to include vitamin D so that, in addition to the claim for calcium and osteoporosis, an additional claim can be made for calcium and vitamin D and osteoporosis; eliminate the requirement that the claim list sex, race, and age as specific risk factors for the development of osteoporosis; eliminate the requirement that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general U.S. population, and that the claim identify the populations at particular risk for the development of osteoporosis; eliminate the requirement that the claim identify the mechanism by which calcium reduces the risk of osteoporosis and instead make it optional; eliminate the requirement that the claim include a statement that a total dietary intake greater than 200 percent of the recommended daily intake (2,000 milligrams (mg) of calcium) has no further benefit to bone health when the food contains 400 mg or more of calcium per reference amount customarily consumed or per total daily recommended supplement intake; and allow reference for the need of physical activity in either of the health claims to be optional rather then required. This final rule is, in part, in response to a health claim petition submitted by The Beverage Institute for Health and Wellness, LLC.     

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.     

Parent-to-child deeming from stepparents. Final rule

We are changing the Supplemental Security Income (SSI) parent-to-child deeming rules so that we no longer will consider the income and resources of a stepparent when an eligible child resides in the household with a stepparent, but that child's natural or adoptive parent has permanently left the household. These rules respond to a decision by the United States Court of Appeals for the Second Circuit, codified in Social Security Acquiescence Ruling (AR) 99-1(2), and establish a uniform national policy. Also, we are making uniform the age at which we consider someone to be a "child" in SSI program regulations and are making other minor clarifications to our rules.     

International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes a process for the evaluation and recommendation by the ICH Q4B Expert Working Group (EWG) of selected pharmacopeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Following favorable evaluations, ICH will issue topic-specific annexes with information about these texts and their implementation (the Q4B Outcomes). Implementation of the Q4B annexes is intended to avoid redundant testing by industry in favor of a common testing strategy in each ICH regulatory region.     

体现北京中心城区特点突出首都历史文化特色——北京市西城区奥运马拉松比赛途经路线周边环境综合整治工程侧记

2008年第29届北京奥运会马拉松比赛路线,途经崇文、东城、宣武、西城、海淀、朝阳6个区,其中西城区段途经北京西城区界的西长安街、复兴门内大街、太平桥大街、赵登禹路、平安里西大街、车公庄大街6条大街,全长8.3 km,内设西单(水站/湿海绵站)、政协礼堂(饮料站)、官园桥周边(水站/湿海绵站)3个供给点.     

西南地区在全国禁毒斗争中的战略地位和作用

几十年的禁毒实践证明,在全国禁毒人民战争中,西南地区是禁毒的主阵地。其特殊的地理位置确立了它在禁毒斗争中重要的战略地位,是毒品渗透与反渗透的“兵家”必争之地,是中国实施“无国界”禁毒行动的发源地和示范地。因此,在禁毒工作中,西南地区无疑应起到禁毒主力军作用,堵截“毒品通道”的壁垒作用,勇于开拓、创新、敢为人先、率先实践的作用,以为全球禁毒做出积极贡献．     

韩国首尔市垃圾处理的启示与思考

一、首尔市垃圾处理的基本经验 韩国首尔市行政面积605.95 km2,人口约1042万,下设25个行政区.2008年生活垃圾平均日产生量约11525 t,其中食物垃圾约3350 t(家庭占2094 t,餐饮食堂占1256 t).人均日产生垃圾约1.1 kg.建筑垃圾平均日产生量约30671 t.     

我国地方政府绩效模型的构建与分析

本文在归纳政府绩效影响因素的基础上,构建了地方政府绩效模型的一般形式和特殊形式。并通过模型的一般形式进行量化分析、变量分析,对模型的特殊形式进行乘积形式分析、对数形式分析得出提升政府绩效的启示,即:只有在能力转化力为正的情况下,政府绩效才有可能提高;在等绩效线上公示政府绩效,能激励政府绩效的提高;提高政府绩效的关键在于政府能力和能力转化率的共同提高。     

行业协会在产业升级中的作用:文献评论

在当代中国,产业升级已然成为热门议题。行业协会与政府、企业一起在产业升级中各自发挥着重要作用。国内外行业协会推动经济发展、促进产业升级的作用表明,行业协会遵循对外争取资源、对内提供服务促进会员集体合作的逻辑,论者们在理论上将其归纳为影响逻辑和会员逻辑。行业协会促进产业升级的作用发挥以完善的内部治理结构、外部市场竞争压力与政府的规约激励等为前提条件。