Department of Health and Human Services January 31, 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Food and Drug Administration Approval to Market a New Drug
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Draft Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Substances; Chemistry, Manufacturing, and Controls Information; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDAs: Impurities in Drug Substances; Chemistry, Manufacturing, and Controls Information.'' This draft guidance provides recommendations on what chemistry, manufacturing, and controls information to include regarding the reporting, identification, and qualification of impurities in drug substances produced by chemical synthesis when submitting documentation for an abbreviated new drug application (ANDA), drug master file (DMF), or a supplement to support changes in drug substance synthesis or process.
Prospective Grant of Exclusive License: Commercializing Instruments, Reagents and Related Products Used for Template-Dependent Sequencing-by-Synthesis of Nucleic Acids at the Single Molecule Level, Wherein a Polymerase Carries the Donor Label
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 (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the invention embodied in Patent Applications U.S. 60/151,580, filed August 29, 1999; PCT/US00/23736, filed August 29, 2000 and U.S. 10/070,053, filed June 10, 2002; entitled ``High Speed Parallel Molecular Nucleic Acid Sequencing'', to VisiGen Biotechnologies, Inc., having a place of business in Houston, Texas. The patent rights in this invention have been assigned to the United States of America.
OIG Supplemental Compliance Program Guidance for Hospitals
This Federal Register notice sets forth the Supplemental Compliance Program Guidance (CPG) for Hospitals developed by the Office of Inspector General (OIG). Through this notice, the OIG is supplementing its prior compliance program guidance for hospitals issued in 1998. The supplemental CPG contains new compliance recommendations and an expanded discussion of risk areas, taking into account recent changes to hospital payment systems and regulations, evolving industry practices, current enforcement priorities, and lessons learned in the area of corporate compliance. The supplemental CPG provides voluntary guidelines to assist hospitals and hospital systems in identifying significant risk areas and in evaluating and, as necessary, refining ongoing compliance efforts.
Administrative Costs for Children in Title IV-E Foster Care
The Administration for Children and Families (ACF) is proposing to amend the regulations for Child and Family Services with respect to title IV-E administrative costs and eligibility determinations and re-determinations for title IV-E foster care recipients and foster care ``candidates.'' This Notice of Proposed Rule Making (NPRM) proposes rules to implement title IV-E foster care eligibility and administrative cost provisions in sections 472 and 474 of the Social Security Act (the Act) and incorporates previously issued policy guidance.
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