Department of Health and Human Services October 2006 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 279
Notice of Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmb@osophs.dhhs.gov.
Medicare Program; Hospital Inpatient Prospective Payment Systems and Fiscal Year 2007 Rates: Final Fiscal Year 2007 Wage Indices and Payment Rates After Application of Revised Occupational Mix Adjustment to Wage Index
This notice contains tables listing the final occupational mix adjusted wage indices, hospital reclassifications, payment rates, impacts, and other related tables as a result of the application of the occupational mix adjustment to 100 percent of the wage index effective for fiscal year (FY) 2007.
Oral Dosage Form New Animal Drugs; Omeprazole
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Merial Ltd. The supplemental NADA provides for administration of omeprazole paste to horses for 8 or 28 days for the prevention of gastric ulcers.
Office of the National Coordinator for Health Information Technology; American Health Information Community Biosurveillance Workgroup Meeting
This notice announces the tenth meeting of the American Health Information Community Biosurveillance Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-4363, 5 U.S.C., App.).
Notice of Hearing: Reconsideration of Disapproval of Oregon State Plan Amendment 05-003
This notice announces an administrative hearing to be held on December 8, 2006, at 2201 6th Street, Suite 1101, Seattle, Washington 98121, to reconsider CMS' decision to disapprove Oregon State plan amendment 05-003. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by October 23, 2006.
Fogarty International Center (FIC) 2007-2011 Strategic Plan
The FIC is initiating a strategic planning process to culminate in the FIC Strategic Plan 2007-2011. To anticipate and set priorities for global health research and research training, FIC requests input from scientists, the general public, and interested parties. The goal of this strategic planning process is to identify current and future needs and directions for global health research. The existing FIC strategic plan can be viewed at https://www.fic/nih.gov/ about/plan/StrategicPlan.pdf.
Prospective Grant of an Exclusive License: Development and Commercialization of Therapeutic Products for Autoimmune Diseases Including Rheumatoid Arthritis (RA), Inflammatory Bowel Disease (IBD) and Psoriasis
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in United States Patent Application Number 60/ 181,909 entitled ``Identification of a Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' filed February 11, 2000 (HHS Ref. No. E-095- 2000/0-US-01); U.S. Patent Application No. PCT/US01/04125 entitled ``Identification of a Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' filed February 9, 2001, 2000 (HHS Ref. No. E-095-2000/0-PCT- 02); U.S. Patent Application No. 10/203,495, filed August 9, 2002, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' (E- 095-2000/0-US-03); U.S. Patent Application No. 60/694,015 entitled ``Amelioration of Inflammatory Arthritis Targeting the Pre-ligand Assembly Domain (PLAD) of Tumor Necrosis Factor Receptors'' filed June 24, 2005 [E-095-2000/2-US-01]; U.S. Patent Application No. 60/717,589 entitled ``Amelioration of Inflammatory Arthritis Targeting the Pre- ligand Assembly Domain (PLAD) of Tumor Necrosis Factor Receptors'' filed September 16, 2005 [E-095-2000/3-US-01]; U.S. PCT Application entitled ``A Potential Novel Therapeutic Protein Molecule of Inflammatory Arthritis Targeting the Pre-ligand Assembly Domain (PLAD) of Tumor Necrosis Factor Receptor Type 1'' filed February 9, 2001 [E- 095-2000/4-PCT-01]; European Patent Application No. 01910476.9 entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' filed February 9, 2001 [E-095-2000/0-EP-06]; Australian Patent Application No. 2001238076 entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' issued on February 9, 2001 [E-095-2000/0-AU- 04]; and Canadian Patent Application No. 2399388 entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' filed February 9, 2001, [E-095-2000/0-CA-05] to Domantis, Inc. The prospective exclusive license territory may be worldwide and the field of use may be limited to therapeutic applications for autoimmune diseases including rheumatoid arthritis (RA) inflammatory bowel disease (IBD) and psoriasis as covered under the agreement and based upon the Patent Rights.
Request for Nominations for Nonvoting Members Representing Industry Interests on Public Advisory Panels or Committees
The Food and Drug Administration (FDA) is requesting nominations for nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) and certain device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health.
Guidance for Industry on Bar Code Label Requirements-Questions and Answers; Availability
The Food and Drug Administration (FDA) is announcing the availability of additional questions and answers that are being incorporated into the final guidance document entitled ``Guidance for Industry: Bar Code Label RequirementsQuestions and Answers.'' This final guidance is dated October 2006. The additional questions and answers relate to blood and blood components intended for transfusion and requirements that their container labels bear certain machine- readable information. These requirements were part of the final rule on bar code label requirements for human drugs published on February 26, 2004.
Head Start Program
This rule finalizes the provisions of the proposed rule published on May 30, 2006 and responds to public comments received as a result of the proposed rule. This final rule authorizes approval of annual waivers, under certain circumstances, from two provisions in the current Head Start transportation regulation (45 CFR part 1310): the requirement that each child be seated in a child restraint system while the vehicle is in motion, and the requirement that each bus have at least one bus monitor on board at all times. Waivers would be granted when the Head Start or Early Head Start grantee demonstrates that compliance with the requirement(s) for which the waiver is being sought will result in a significant disruption to the Head Start program or the Early Head Start program and that waiving the requirement(s) is in the best interest of the children involved. The rule also revises the definition of child restraint system in the regulation to remove the reference to weight which now conflicts with Federal Motor Vehicle Safety Standards. The regulation also reflects new effective dates for Sec. 1310.12(a) and 1310.22(a) on the required use of school buses or allowable alternate vehicles and the required availability of such vehicles adapted for use of children with disabilities, as the result of enactment of Section 224 of Public Law 109-149 and Section 7012 of Public Law 109-234.
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled ``Low Vision Rehabilitation Demonstration (LVRD),'' System No. 09-70-0582. The program is mandated by Section 641 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) (Public Law (Pub. L.) 108-173), enacted into law on December 8, 2003, and amended Title XVIII of the Social Security Act (the Act). The LVRD program seeks to establish a new demonstration project to examine Medicare beneficiaries who are diagnosed with moderate to severe visual impairment and who may be eligible to receive covered vision rehabilitating services. Rehabilitation may be conducted under general supervision of a qualified physician in an appropriate setting including in the home of the beneficiary receiving the services. Improvements in these areas are expected to generate savings to the Medicare program to offset the costs of the performance payments. The primary purpose of the system is to collect and maintain identifiable information on Medicare beneficiaries who participate in Medicare Part B fee-for-service coverage, qualified physicians, such as ophthalmologists or optometrists, qualified occupational therapists, and vision rehabilitation therapists who are certified by the Academy for Certification of Vision Rehabilitation Professionals. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant, or grantee; (2) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) assist an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support litigation involving the agency; and (5) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the new system in the Supplementary Information section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.
Office of the National Coordinator for Health Information Technology; American Health Information Community Chronic Care Workgroup Meeting
This notice announces the tenth meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
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