Department of Health and Human Services April 2005 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (``HHS'') gives notice of a decision to designate a class of employees at the Mallinckrodt Chemical Company, Destrehan Street Plant, in Saint Louis, Missouri as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 11, 2005, the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Community Services Block Grant (CSBG) Act of 1981, as amended, (Section 680 (a)(2) of the Community Opportunities, Accountability, and Training and Educational Services Act of 1998), authorizes the Secretary of the U.S. Department of Health and Human Services to make grants to provide technical and financial assistance for economic development activities designed to address the economic needs of low-income individuals and families by creating employment and business development opportunities. Pursuant to this Announcement, OCS will award operational project grants to Community Development Corporations (CDCs) that are experienced in implementing economic development projects. The primary purpose of the Operational Projects (OPs) is to assist eligible CDCs, including American Indian and Native Alaskan, and faith based organizations that are CDCs that have in place: (1) Written commitments for all projected non-Community Economic Development (CED) funding, (2) project operations, (3) site control for their economic development projects and (4) referral sources (from which low-income individuals will be referred to the project). Low- income beneficiaries of such projects include those who are living in poverty as determined by the HHS Guidelines on Poverty (at https:// aspe.hhs.gov/poverty/poverty.shtml). They may be unemployed; public assistance recipients, including recipients of Temporary Assistance for Needy Families (TANF), individuals transitioning from the prison system into the community, at-risk youth, custodial and non-custodial parents; residents living in public housing; persons with disabilities; and persons who are homeless. Operational Projects are designed to encourage rural and urban community development corporations to create projects intended to provide employment and business development opportunities for low-income people through business or commercial development. The opportunities must aim to improve the quality of the economic and social environment of TANF recipients; low-income residents including displaced workers; individuals transitioning from the prison system into the community; at-risk youth; non-custodial parents, particularly those of children receiving TANF assistance; individuals residing in public housing; individuals who are homeless; and individuals with disabilities. Grant funds under this announcement are intended to provide resources to eligible applicants (CDCs) but also have the broader objectives of arresting tendencies toward dependency, chronic unemployment, and community deterioration in urban and rural areas. Eligible applicants must submit a business plan that shows the economic feasibility of the venture. Applicants for an OP must have in place written commitments for all projected non-CED funding required for the project. Written proof of commitments from third parties must be submitted with the application. Letters of support, only, are insufficient. The application must also clearly document in detail the extent to which site control has been acquired.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application 10/129,907, filed May 10, 2002 [DHHS Ref. E-263- 1999/0-US-03], entitled ``Methods for treating inflammatory bowel disease using cholera toxin B subunit,'' to SBL Vaccin AB, which is located in Stockholm, Sweden. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of cholera toxin B as a therapeutic treatment of inflammatory bowel disease, specifically Crohn's disease.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Merial Ltd. to Farnam Companies, Inc.

The Food and Drug Administration (FDA) is requesting nominations for voting consumer representatives to serve on its advisory committees that are under the purview of the Center for Drug Evaluation and Research (CDER). FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on its advisory committees and, therefore, encourages nominations of qualified candidates from these groups.

The Food and Drug Administration (FDA) is amending the animal drug regulations that reflect approval of a new animal drug application (NADA) for dichlorophene and toluene capsules used in dogs and cats for removal of certain intestinal parasites. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of the NADA.

This notice cancels the April 13, 2005 Advisory Board Meeting on the Demonstration of a Bundled Case-Mix Adjusted Payment System for End-Stage Renal Disease (ESRD) Services. We published the meeting notice in the Federal Register on March 25, 2005 (70 FR 15343).

Through this notice, the Secretary announces that trivalent influenza vaccines are covered vaccines under the National Vaccine Injury Compensation Program (VICP), which provides a system of no-fault compensation for certain individuals who have been injured by covered childhood vaccines. This notice serves to include trivalent influenza vaccines as covered vaccines under Category XIV (new vaccines) of the Vaccine Injury Table (Table), which lists the vaccines covered under the VICP. This notice ensures that petitioners may file petitions relating to trivalent influenza vaccines with the VICP even before such vaccines are added as a separate and distinct category to the Table through rulemaking.

The Department of Health and Human Services, the National Institutes of Health (NIH), has decided, after completion of a Final Environmental Impact Statement (EIS) and a thorough consideration of the public comments on the Draft EIS to implement the Proposed Action, which is identified as the Preferred Alternative in the Final EIS. This action is to partially fund the construction of a state-of-the-art National Biocontainment Laboratory (NBL), which will be known as the Galveston National Laboratory (GNL), on the University of Texas Medical Branch (UTMB) Campus in Galveston, Texas.

On November 19, 2004 the National Institutes of Health (NIH) published for public comment in the Federal Register proposed Best Practices for the Licensing of Genomic Inventions [69 FR 67747]. These Best Practices are recommendations to the intramural Public Health Service (PHS) technology transfer community as well as to PHS funding recipients. Comments on the proposed Best Practices were requested with a deadline of January 18, 2005. This Notice presents the NIH's final Best Practices for the Licensing of Genomic Inventions together with NIH's response to the public comments received.