Labeling for bronchodilators to treat asthma; cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. Final rule

The Food and Drug Administration (FDA) is amending the final monograph (FM) for over-the-counter (OTC) bronchodilator drug products to add additional warnings (e.g., an "Asthma alert') and to revise the indications, warnings, and directions in the labeling of products containing the ingredients ephedrine, ephedrine hydrochloride, ephedrine sulfate, epinephrine, epinephrine bitartrate, racephedrine hydrochloride, and racepinephrine hydrochloride. FDA is issuing this final rule after considering data and information submitted in response to the Agency's proposed labeling revisions for these products. This final rule is part of FDA's ongoing review of OTC drug products.     

Required warnings for cigarette packages and advertisements. Final rule

The Food and Drug Administration (FDA) is amending its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. This rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics, depicting the negative health consequences of smoking, to accompany the nine new textual warning statements required under the Tobacco Control Act. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of nine new textual warning statements. This final rule specifies the color graphic images that must accompany each of the nine new textual warning statements.     

Medicaid program; payment adjustment for provider-preventable conditions including health care-acquired conditions. Final rule

This final rule will implement section 2702 of the Patient Protection and Affordable Care Act which directs the Secretary of Health and Human Services to issue Medicaid regulations effective as of July 1, 2011 prohibiting Federal payments to States under section 1903 of the Social Security Act for any amounts expended for providing medical assistance for health care-acquired conditions specified in the regulation. It will also authorize States to identify other provider-preventable conditions for which Medicaid payment will be prohibited.     

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.     

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.     

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.     

Nachhaltige Bioenergie – Instrumente zur Vermeidung negativer indirekter Landnutzungseffekte

Indirekte Landnutzungs?nderungen beim Anbau von Energiepflanzen k?nnen die Treibhausgasminderungsbilanz von Energie aus Biomasse herabsetzen und Biodiversit?t sowie Boden- und Wasserressourcen beeintr?chtigen. Um derartige Effekte in rechtliche Regelungen über die Nachhaltigkeit von Bioenergie einzubeziehen, wurden verschiedene Ans?tze vorgeschlagen. Eine überzeugende Methodologie steht bis heute jedoch noch nicht zur Verfügung. Der Beitrag gibt einen überblick über die diskutierten Methoden, bietet eine vergleichende Bewertung und leitet hieraus rechtspolitische Empfehlungen ab.     

Deer stand fatalities in Kentucky: two cases of reverse suspension and blunt force trauma

Hunting many types of wild game is an avidly pursued outdoor activity that attracts all ages and both genders at various times of the year. Deer hunting is a popular sport in many regions of North America. A variety of weapons are used in the hunting, trapping, and killing of game. As a variety of different modalities are used, myriad types of injuries unique to the type of hunting can occur. Most deer hunting-related fatalities identified at the Office of the Chief Medical Examiner in Kentucky are accidental firearm injuries. Less commonly encountered are fatalities resulting from elevation of the hunter in a tree stand, often associated with poor design or construction of the perch. We present 2 tree stand-related deaths. One victim died of positional asphyxia due to reverse suspension from a hunting tree stand. The second victim died of multiple blunt force injuries sustained in a 20-foot fall from a tree stand. We summarize the features of morbidity and mortality related to deer hunting based on investigations by the Office of the Chief Medical Examiner.     

A study of multiple bitemarks inflicted in human skin by a single dentition using geometric morphometric analysis

Criticisms of the forensic discipline of bitemark analysis state that the range of distortion in the shape of bitemark impressions in skin has not been scientifically established. No systematic statistical studies exist that explore this problem. As a preliminary investigation of this issue, a single dentition was mounted in a mechanical apparatus and used to create 89 bitemarks in human cadaver skin, both parallel and perpendicular to tension lines. Impressions of the same dentition were also created in wax. 2D scanned images of the biting dentition were obtained. Locations of incisal edges of all 6 anterior teeth as well as the midpoint of the canine were captured as landmarks in all specimens. This set of landmark data was then studied using established geometric morphometric methods. All specimen shapes were compared using Procrustes superimposition methods, and by a variation of Procrustes superimposition which preserves scale information. Match criteria were established by examining the range of variation produced by repeated measurements of the dentition for each class of specimen. The bitemarks were also compared to a population of 411 digitally scanned dentitions, again using the match criteria. Results showed that bitemarks in wax had lower measurement error than scanned images of the dentition, and both were substantially lower than measurement error as recorded in skin. None of the 89 bitemarks matched the measured shape of the biting dentition or bitemarks in wax, within the repeated measurements error level, despite the fact that all bitemarks were produced by this dentition. Comparison of the bitemarks to the collection of 411 dentitions showed that the closest match to the bitemarks was not always the same dentition that produced the bitemarks. Examination of Procrustes plots of matched shapes showed non-overlapping distributions of measurements of bitemarks in skin, wax, and the dentition. All had statistically significant differences in mean shape. Principal component analysis (PCA) and canonical variates analysis (CVA) both showed clear segregation of the three types of data. The patterns of variance revealed by PCA showed several distinct patterns produced by skin distortion; alteration of relative arch width, and varying displacement of non-aligned teeth in the dentition. These initial results indicate that when multiple suspects possess similar dentitions, bitemark analysis should be approached with caution.