Revisions to the requirements applicable to blood, blood components and source plasma. Direct final rule

The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.     

Medical devices: immunology and microbiology devices: classification of in vitro human immunodeficiency virus drug resistance genotype assay. Final rule

The Food and Drug Administration (FDA) is classifying an in vitro human immunodeficiency virus (HIV) drug resistance genotype assay into class II (special controls). The special control that will apply to this device is the guidance document entitled "Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay." FDA is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.     

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.     

Medical devices; general hospital and personal use devices; classification of the filtering facepiece respirator for use by the general public in public health medical emergencies. Final rule

The Food and Drug Administration (FDA) is classifying the filtering facepiece respirator for use by the general public in public health medical emergencies into class II (special controls). The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of these devices and is specifying what those special controls are. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, "Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies." This guidance document will serve as one of the special controls, along with certification of the respirator by the National Institute for Occupational Safety and Health (NIOSH) in accordance with its regulations for non-powered air-purifying particulate respirators, found in 42 CFR part 84, as specified in the classification regulation.     

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.     

Optometrists as "acceptable medical sources" to establish a medically determinable impairment. Final rules

We are revising the Social Security and Supplemental Security Income (SSI) disability regulations regarding sources of evidence for establishing a medically determinable impairment under titles II and XVI of the Social Security Act (the Act). The revised regulations expand the situations in which we consider licensed optometrists to be "acceptable medical sources."     

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.     

新农村建设中的地方政府学习:动因、模式与效果

近年来,在新农村建设中各级地方政府开展了广泛的、各式各样的学习活动。虽然地方政府学习的重要意义已经得到人们的普遍认识,但是地方政府学习的动因、模式和效果等问题仍有待于进一步的研究。本文研究发现,地方政府面临的制度环境、政治体制、竞争压力是学习的首要原因,上级政府、科研机构等思想库、其他地区的实践、本地的试验是地方政府的主要学习源,环境的相似性、学习能力与偏好、政策项目特征等是影响地方政府学习效果的重要因素。地方政府通过学习提高了政府绩效,却也造成了负面的社会效果,需要通过改革和多种激励措施推动地方政府学习、提高地方政府学习能力,从而在根本上提高地方政府学习的社会效果。     

论我国农业保护的制度安排及政策选择

农业是个弱质产业,其特点是投资大、回收期长、风险高,具有特殊的食物安全及生态保护等多样化功能,这些特点和功能为农业保护提供了理论依据,而对农业实施保护是国际惯例。我国长期以来对农业实施的是负保护,导致了"三农"问题的深层次矛盾。必须通过合理的制度安排和政策选择,消除二元经济结构,解决好"三农"问题。现阶段,我国对农业的保护方面尚有许多可利用的空间,应该加大投入力度,积极调动和整合社会资源,力求形成政策合力,使其发挥最大效用,实现农业持续稳定发展的目标。     

国债、国债规模及其管理:研究综述

近三十年来,宏观管理国债规模的研究,呈现出行政学和公共经济学交融的新趋势。本研究将重点关注政府宏观管理体制下,国债规模管理与预算赤字、国家税收和政府支出等关键变量的联系。文章梳理了宏观管理国债规模的主要研究进展,并分析了既有研究的内在联系及可能存在的研究空间。研究认为,在目前我国政府行政体制改革全面推进和经济高速发展的大环境下,政府运用好国债工具是保证经济持续稳定增长、促进社会和谐发展的主要经济手段,同时也是政府经济执政能力提高的重要标志。