Federal register
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The Food and Drug Administration (FDA) is revoking an advisory opinion entitled "FD&C Act Trade Correspondence, TC-61," (hereinafter called TC-61) dated February 15, 1940, because it is out of date with current scientific knowledge and is superseded by the final rule for over-the-counter (OTC) sunscreen drug products. As an advisory opinion, this correspondence was not published in the Federal Register.
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The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) sunscreen drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on the agency's proposed regulation, which was issued in the form of a tentative final monograph, and new data and information on sunscreen drug products that have come to the agency's attention. FDA is also issuing final rules regarding the labeling of certain cosmetic products to inform consumers that these products do not provide protection from the sun.
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The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the U. S. Army Medical Research and Material Command. The purpose of the MOU is to define responsibilities during the research, development, and pre-marketing acquisition of medical material for military applications.
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The Food and Drug Administration (FDA) is publishing a list of documents issued in response to the Food and Drug Administration Modernization Act of 1997 (FDAMA), and clarifying their applicability to medical devices regulated by the Center for Biologics Evaluation and Research (CBER). This notice is intended to inform the public of the availability of these documents, clarify their scope of applicability, and to provide instructions on ways to access them.
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This notice is to inform the public of a planned $1,100,000 cooperative agreement award to Policy Research, Inc., to support the National GAINS Center for People with Co-occurring Disorders in the Justice System. CSAT and CMHS will make this award if the application is recommended for approval by the initial review group and the CSAT and CMHS National Advisory Councils. This is not a formal request for applications; assistance will be provided only to Policy Research, Inc. The purpose of the award is to support developing knowledge, conducting analyses of state-of-the-art practices, and disseminating and transferring information related to treating and managing persons in the justice system who are dually diagnosed with substance abuse and mental disorders. The GAINS Center promotes effective solutions by gathering information, assessing what works, interpreting the facts, networking with key stakeholders, and stimulating change. Eligibility for this program is limited to Policy Research, Inc., a non-profit corporation which operates the National GAINS Center. The GAINS Center has been federally funded by SAMHSA through the National Institute of Corrections/Department of Justice. This resource center has established, on a national level, a locus for the collection and dissemination of information about effective mental health and substance abuse services for people with co-occurring disorders in the justice system. The Center gathers information designed to influence the range and scope of mental health and substance abuse services provided in the justice system, tailors these materials to the specific needs of localities, and provides technical assistance to help them plan, implement, and operate appropriate, cost-effective programs. SAMHSA, for administrative reasons, can no longer fund the Center in this fashion because the former funding mechanism is no longer available. Therefore, SAMHSA will fund the project directly to complete the originally approved term of 5 years. An award to Policy Research, Inc., will enable the GAINS Center to build upon prior work and current activities underway in its work plan. This conversion to direct SAMHSA (CSAT and CMHS) funding will permit several important projects to be completed.