Department of Health and Human Services April 18, 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
Intramammary Dosage Forms; Ceftiofur
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The NADA provides for the veterinary prescription use of ceftiofur hydrochloride suspension, by intramammary infusion, for the treatment of subclinical mastitis in dairy cattle at the time of dry off.
Draft Guidance for Industry on User Fee Waivers for Fixed Dose Combination Products and Co-Packaged Human Immunodeficiency Virus Drugs for the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR.'' This draft guidance describes the circumstances under which certain applications for fixed dose combination (FDC) and copackaged versions of previously approved antiretroviral therapies for the treatment of human immunodeficiency virus (HIV) under the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief (PEPFAR) will not be assessed user fees. The draft guidance also describes circumstances under which some of the applications that will be assessed fees may be eligible for a public health or a barrier-to-innovation waiver.
Kareem I. Batarseh; Filing of Food Additive Petition
The Food and Drug Administration (FDA) is announcing that Kareem I. Batarseh has filed a petition proposing that the food additive regulations be amended to provide for the safe use of a mixture of hydrogen peroxide, silver nitrate, phosphoric acid, tartaric acid, glutamic acid, and sodium tripolyphosphate as an antimicrobial agent in bottled drinking water.
Designation of a Class of Employees for Addition to the Special Exposure Cohort
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:
HIPAA Administrative Simplification; Enforcement
The Secretary of Health and Human Services is proposing rules for the imposition of civil money penalties on entities that violate rules adopted by the Secretary to implement the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996, Pub. L. 104-191 (HIPAA). The proposed rule would amend the existing rules relating to the investigation of noncompliance to make them apply to all of the HIPAA Administrative Simplification rules, rather than exclusively to the privacy standards. It would also amend the existing rules relating to the process for imposition of civil money penalties. Among other matters, the proposed rules would clarify and elaborate upon the investigation process, bases for liability, determination of the penalty amount, grounds for waiver, conduct of the hearing, and the appeal process.
Office of Community Services; Community Services Block Grant Program; Community Economic Development; Discretionary Grant Program-Operational Projects
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.
Office of Community Services; Community Food and Nutrition Program
The Community Services Block Grant (CSBG) Act, as amended, authorizes the Secretary of Health and Human Services to make funds available under several programs to support program activities that will result in direct benefits targeted to low-income people. This program announcement covers the grant authority found at Section 681 of the Community Services Block Grant Act, (The Act) (Pub. L. 97-35) as amended by the Community Opportunities, Accountability, and Training and Educational Services Act of 1998 (Pub. L. 105-285), Community Food and Nutrition Program. The Act authorizes the Secretary to award grants on a competitive basis to eligible entities for community-based, local, statewide and national programs including programs benefiting Indians (as defined in section 677(e) of the CSBG Act) and migrant farm workers. Grant funds are provided to: (1) Coordinate private and public food assistance resources, wherever the grant recipient involved determines such coordination to be inadequate, to better serve low-income populations; (2) assist low-income communities to identify potential sponsors of child nutrition programs and to initiate such programs in underserved or unserved areas; and (3) develop innovative approaches at the State and local level to meet the nutrition needs of low-income individuals. Office of Community Services views this program as a capacity building program, rather than a food delivery program. OCS encourages eligible applicants with programs addressing obesity to submit applications. Eligible applicants with programs benefiting Native Americans and migrant or seasonal farm workers are also encouraged to submit applications. Public and non-profit agencies, faith-based and community-based organizations reaching underserved populations are encouraged to apply.
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