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.     

Medical devices; general and plastic surgery devices; classification of the low energy ultrasound wound cleaner. Final rule

The Food and Drug Administration (FDA) is classifying the low energy ultrasound wound cleaner into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the 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 the class II device.     

International Conference on Harmonisation; guidance on good manufacturing practice for active pharmaceutical ingredients; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients." 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 current good manufacturing practice (CGMP) for manufacturing of active pharmaceutical ingredients (APIs). The guidance is intended to help ensure that all APIs meet the standards for quality and purity they purport or are represented to possess.     

Additional criteria and procedures for classifying over-the-counter drugs as generally recognized as safe and effective and not misbranded. Final rule

The Food and Drug Administration (FDA) is issuing a final rule establishing additional criteria and procedures by which over-the- counter (OTC) conditions may become eligible for consideration in the OTC drug monograph system. The criteria and procedures address how OTC drugs initially marketed in the United States after the OTC drug review began in 1972, and OTC drugs without any U.S. marketing experience, can meet the statutory definition of marketing to a "material extent" and "for a material time" and become eligible. If found eligible, the condition would be evaluated for general recognition of safety and effectiveness in accordance with FDA's OTC drug monograph regulations. FDA is also changing the current OTC drug monograph procedures to streamline the process and provide additional information in the review.     

Registration and reregistration application fees. Confirmation of final rule,remanded for further notice and comment,and response to comments

DEA is publishing a final rule regarding the registration and reregistration fees charged to controlled substances registrants. DEA is required to charge reasonable fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances. To address this mandate, on March 22, 1993 DEA published a final rule in the Federal Register, establishing registration fees for controlled substances registrants (58 FR 15272). Following publication of the final rule, the American Medical Association (AMA) and others filed a complaint in the United States District Court for the District of Columbia objecting to the new fees. The district court issued its final order granting the government's motion for summary judgment and disposing of all claims. The AMA appealed. The United States Court of Appeals for the District of Columbia Circuit found DEA's rulemaking to be inadequate. The appeals court remanded, without vacating, the rule to DEA, requiring the agency to provide an opportunity for meaningful notice and comment on the fee-funded components of the Diversion Control Program. DEA responded to the remand requirement through a document published in the Federal Register on December 30, 1996 (61 FR 68624). This Final Rule supplements the December 30, 1996 Federal Register document and with that document, constitutes the final rule on the Drug Diversion Control Fee Account.     

Medical devices; ear, nose and throat devices; reclassification of the endolymphatic shunt tube with valve. Final rule

The Food and Drug Administration (FDA) is reclassifying the endolymphatic shunt tube with valve from class III (premarket approval) into class II (special controls). The device is intended to be implanted in the inner ear to relieve the symptoms of vertigo and hearing loss due to endolymphatic hydrops (increase in endolymphatic fluid) of Meniere's disease. FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Endolymphatic Shunt Tube With Valve; Guidance for Industry and FDA" (the guidance) as the special control that the agency believes will reasonably ensure the safety and effectiveness of the device. This reclassification is based on new information submitted in are classification petition by E. Benson Hood Laboratories, Inc. (Hood Laboratories). FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing the guidance.     

地方政府结构合理化的三维透视

当前我国地方政府结构优化主要体现在三个层面,即纵向层面的省管县改革、横向层面的区域行政整合和自身的大部门制改革。本文从这三个维度出发,在地方政府结构变革的框架内,探讨了各层面改革的目的、基本走向及其对地方政府结构变化的作用与影响,认为改革体现了政府结构走向合理化的总体趋势。由此提出:只有当地方政府内外整合系统充分发挥作用,地方政府与市场、社会间协调有度,地方政府利益与观念高度同化,地方政府制度衔接性好,地方政府流程顺畅时,才能实现地方政府结构的优化。     

Medical devices; obstetrical and gynecological devices; classification of computerized labor monitoring system. Final rule

The Food and Drug Administration (FDA) is classifying the computerized labor monitoring systems into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems," which will serve as the special controls for these devices. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.     

Control of a chemical precursor used in the illicit manufacture of fentanyl as a List I chemical. Interim rule with request for comments

This rulemaking controls the chemical N-phenethyl-4-piperidone (NPP) as a List I chemical under the Controlled Substances Act (CSA) (21 U.S.C. 801 et seq.). Clandestine laboratories are using this chemical to illicitly manufacture the schedule II controlled substance fentanyl. The recent distribution of illicitly manufactured fentanyl has caused an unprecedented outbreak of hundreds of suspected fentanyl-related overdoses, at least 972 confirmed fentanyl-related deaths, and 162 suspected fentanyl-related deaths occurring mostly in Delaware, Illinois, Maryland, Michigan, Missouri, New Jersey, and Pennsylvania. NPP has been identified as the starting material in several seized fentanyl clandestine laboratories. In addition to DEA's concern regarding the deaths associated with illicitly manufactured fentanyl, DEA is extremely concerned about the safety of law enforcement officers encountering these clandestine laboratories. Therefore, DEA is regulating NPP as a List I chemical through this Interim Rulemaking. DEA is soliciting comments on this Interim Rule. This rulemaking will subject handlers of NPP to the chemical regulatory provisions of the CSA and its implementing regulations, including 21 CFR Parts 1309, 1310, 1313, and 1316. This rulemaking does not establish a threshold for domestic and international transactions of NPP. As such, all transactions involving NPP, regardless of size, shall be regulated. This rulemaking also specifies that chemical mixtures containing NPP will not be exempt from regulatory requirements at any concentration. Therefore, all transactions of chemical mixtures containing any quantity of NPP will be regulated and will be subject to control under the CSA.