Medical Devices; general and plastic surgery devices; classification of contact cooling system for aesthetic use. Final rule

The Food and Drug Administration (FDA) is classifying the contact cooling system for aesthetic use into class II (special controls). The special control that will apply to the device is the guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use." The Agency is classifying the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type.     

TRICARE: certified mental health counselors. Interim final rule

This rule is submitted as an interim final rule (IFR) in order to meet the Congressional requirement set forth in the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2011, Section 724, which required the Department of Defense to prescribe regulations by June 20, 2011, to establish the criteria, as had previously been studied in accordance with Section 717 of the NDAA 2008, that would allow licensed or certified mental health counselors to be able to independently provide care to TRICARE beneficiaries and receive payment for those services. Under current TRICARE requirements, mental health counselors (MHCs) are authorized to practice only with physician referral and supervision. This interim final rule establishes a transition period to phase out the requirement for physician referral and supervision for MHCs and to create a new category of allied health professionals, to be known as certified mental health counselors (CMHCs), who will be authorized to practice independently under TRICARE. During this transition period the MHCs who do not meet the requirements for independent practice as established in this rule, may continue to provide services to TRICARE beneficiaries under the requirements of physician referral and ongoing supervision. This transition period, ending December 31, 2014, will allow time for those MHCs who seek to continue providing services under the TRICARE program to meet the independent practice requirements as outlined in this notice. After December 31, 2014, the Department of Defense will no longer recognize those mental health counselors who do not meet the criteria for a CMHC and will no longer allow them to provide services even upon the referral and supervision of a physician.     

TRICARE: elimination of co-payments for authorized preventive services for certain TRICARE Standard beneficiaries. Final rule

The Department of Defense is publishing this final rule to implement section 711 of the National Defense Authorization Act (NDAA) for Fiscal Year 2009 (FY 2009), Public Law 110-417. Section 711 eliminates copayments for authorized preventive services for TRICARE Standard beneficiaries other than Medicare-eligible beneficiaries. This rule also realigns the covered preventive services listed in the Exclusions section of the regulation to the Special Benefits section in the regulation.     

Medical devices; reclassification of the topical oxygen chamber for extremities. Final rule

The Food and Drug Administration (FDA) is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class II. This device is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers, such as bedsores. This reclassification is on the Secretary of Health and Human Services's own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Medical Device Amendments of 1976 (the 1976 Amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities,' which will serve as the special control for this device.     

Medical devices; general and plastic surgery devices; classification of the low level laser system for aesthetic use. Final rule

The Food and Drug Administration (FDA) is classifying the low level laser system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is entitled ``Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.' The Agency is classifying the 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 a guidance document that will serve as the special control for this device type.     

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.     

Schedules of controlled substances: placement of ezogabine into Schedule V. Final rule

With the issuance of this final rule, the Administrator of the Drug Enforcement Administration (DEA) places the substance ezogabine, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into Schedule V of the Controlled Substances Act (CSA). This action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking.     

Advisory committee; Medical Imaging Drugs Advisory Committee; re-establishment

The Food and Drug Administration (FDA) is announcing the re-establishment of the Medical Imaging Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. This rule amends the current language for the Medical Imaging Drugs Advisory Committee in the Agency's list of standing advisory committees in FDA's regulations.     

利用未公开信息交易罪疑难问题探析

《刑法修正案(七)》增加的利用未公开信息交易罪填补了证券市场中出现的基金业"老鼠仓"刑法规制的空白,为有效打击基金业"老鼠仓"提供了刑罚利器。然而,作为一个独立罪名,与同处《刑法》第180条的内幕交易罪缺乏应有的协调性,同时也缺乏应有的周延性。该罪的犯罪主体、未公开信息的范围、情节严重的标准等的不明确可能会给司法带来一定的困难,应该通过司法解释明确未公开信息的范围、犯罪主体,还应将泄露未公开信息也纳入该罪的范畴。     

Intergenerational continuities and discontinuities in intimate partner violence: a two-generational prospective study

This study focuses on intergenerational continuity in violent partner relationships. We investigate whether exposure to caregiver intimate partner violence (IPV) during adolescence leads to increased involvement in IPV during early adulthood (age 21-23) and adulthood (age 29-31). We also investigate whether this relationship differs by gender. Although there is theoretical and empirical support for intergenerational continuity of relationship violence, there are few prospective studies of this issue. We use data from the Rochester Youth Development Study (RYDS), a longitudinal study of the development of antisocial behavior in a community sample of 1,000 urban youth followed from age 14 to adulthood. The original sample includes 73% men and 85% African American or Hispanic youth. Measures come from a combination of interviews and official records. The Conflict Tactics Scale (CTS) is used to assess IPV and severe IPV in the youth and parent generations. Analyses controlled for child physical abuse, race/ethnicity as well as parent education, family stability, and poverty. In multivariate models, adolescent exposure to caregiver severe IPV resulted in significantly increased risk of relationship violence in early adulthood (age 21-23). Furthermore, there is an indirect effect of adolescent exposure to severe IPV on later adult involvement in IPV (age 29-31), mediated by involvement in a violent relationship in early adulthood. These results were largely invariant by gender. However, we observed a direct pathway between IPV exposure and adult IPV for women (marginally significant) suggesting that adolescent exposure to caregiver IPV may set in motion women-specific processes.