Department of Health and Human Services August 17, 2009 – Federal Register Recent Federal Regulation Documents

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration.'' This guidance, when finalized, will provide industry with information on how to label beers that are subject to FDA's labeling laws and regulations. This draft guidance is being issued in light of the recent ruling by the Alcohol and Tobacco Tax and Trade Bureau (TTB) (formerly The Bureau of Alcohol, Tobacco, and Firearms (ATF)) clarifying that certain beers do not meet the definition of a ``malt beverage'' under the Federal Alcohol Administration Act (FAA Act). Because these beers are not subject to the labeling provisions of the FAA Act, they are subject to the labeling provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). FDA, in this draft guidance, also reminds manufacturers that the labeling of wine beverages containing less than 7 percent alcohol by volume, such as wine coolers, diluted wine beverages, dealcoholized or partially dealcoholized wine and ciders, is also subject to FDA labeling requirements. FDA is also announcing an opportunity for public comment on the proposed collection of certain information by the agency.

The Department of Health and Human Services (HHS) published a document in the Federal Register of July 17, 2009, requesting OMB reauthorization of the form ``Sterilization of Persons in Federally Assisted Family Planning Projects.'' The document contained an incorrect citation to the HHS sterilization regulations; incorrectly identified the Office of Population Affairs (OPA), rather than the Public Health Service (PHS), as the agency within HHS that administers programs of health services which are supported by Federal financial assistance and which are required to obtain informed consent from persons undergoing sterilizations; incorrectly described the form that is required to be used to obtain informed consent; and incorrectly referred to the regulations to which the consent form is appended as OPA regulations rather than PHS regulations.