Department of Health and Human Services May 26, 2006 – Federal Register Recent Federal Regulation Documents
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Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Toxicology Program (NTP); NTP Workshop: Biomarkers for Toxicology Studies
For more than a quarter century, the NTP testing program has provided extensive and useful scientific information for predicting human health hazards and protecting public health. The NTP periodically conducts reviews of models used in its testing program to critically analyze their predictive power and determine whether study protocols should be altered. As part of this effort, the NTP is convening a workshop titled ``Biomarkers for Toxicology Studies.'' The meeting will be held on September 20-21, 2006, at the NIEHS in Research Triangle Park, NC. The workshop will include plenary sessions and three simultaneous breakout group sessions for in-depth discussion. The workshop's overall goal is to identify biomarkers for carbohydrate/lipid metabolism and lung and cardiac function and then evaluate their utility for inclusion in rodent toxicology studies to better characterize endpoints of environmentally induced diseases or biological processes related to disease etiology. This meeting is open to the public with time set aside for public comments during the plenary session on the first day. The public is invited to attend the breakout groups as observers. A copy of the agenda and any additional information about the workshop, including background materials, public comments, and invited participants, will be posted on the NTP Web site when available (see NTP Web site https://ntp.niehs.nih.gov select ``Calendar of Upcoming Events'').
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Medicare Program; Approval of URAC for Deeming Authority for Medicare Advantage Health Maintenance Organizations and Local Preferred Provider Organizations
This final notice announces the approval of URAC for deeming authority as a national accreditation organization for health maintenance organizations and local preferred provider organizations participating in the Medicare Advantage program, for a term of 6 years upon publication of this notice in the Federal Register. This notice describes the processes and criteria used in evaluating the application. We did not receive any public comments during the public comment period, which ended on April 28, 2006.
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Investigational Device Exemptions Reports and Records.
Public Awareness on Embryo Adoption and/or Donation
The Office of Public Health and Science (OPHS) announces the availability of Fiscal Year (FY) 2006 funds to support a total of three to four new cooperative agreement grant projects, with the goal of increasing public awareness of embryo donation and/or adoption. Approximately $1,000,000 in funding is available on a competitive basis for cooperative agreements each in the range of $250,000 to $350,000 per year. Projects will be funded in annual increments (budget periods) and for a project period of two years. Funding for all budget periods beyond the first year of the cooperative agreement is contingent upon the availability of funds, satisfactory progress of the project, and adequate stewardship of Federal funds. The OPHS intends to fund at least one project in each of three distinct categories (professional meeting(s); training for professionals to equip them with the skills necessary to provide information and education; and an evidence-based assessment of the emerging field of embryo donation and/or adoption) with the goal of increasing public awareness regarding embryo donation and/or adoption. Entities may apply for more than one category; however, a separate application is required for each category identified in this announcement. Applicants must demonstrate experience with embryo donation and/or adoption programs that conform with professionally recognized standards governing embryo donation and/or adoption and other applicable Federal or State requirements. For the purposes of this announcement, embryo donation and/or adoption is defined as the donation of frozen embryo(s) from one party to a recipient who wishes to bear and raise a child or children.
Medicare Program; Revisions to the Payment Policies of Ambulance Services Under the Fee Schedule for Ambulance Services
We are proposing to set forth changes to the fee schedule for payment of ambulance services by adopting revised geographic designations for urban and rural areas as set forth in Office of Management and Budget's (OMB) Core-Based Statistical Areas (CBSAs) standard. We propose to remove the definition of Goldsmith modification and reference the most recent version of Goldsmith modification in the definition of rural area. In addition, we propose to add the definition of urban area as defined by OMB and revise our definitions of emergency response, rural area, and specialty care transport (SCT). We also propose to discontinue the annual review of the conversion factor (CF) and of air ambulance rates. We would continue to monitor payment and billing data on an ongoing basis and make adjustments to the CF and to air ambulance rates as appropriate to reflect any significant changes in these data.
Medicare Program; Public Meeting in Calendar Year 2006 for New Clinical Laboratory Tests for Payment Determinations
This notice announces a public meeting to discuss payment determinations for specific new Physicians' Current Procedural Terminology (CPT) codes for clinical laboratory tests. The meeting provides a forum for interested parties to make oral presentations and submit written comments on the new codes that will be included in Medicare's Clinical Laboratory Fee Schedule for calendar year 2007, which will be effective on January 1, 2007. Discussion is directed toward technical issues relating to payment determinations for a specified list of new clinical laboratory codes. The development of the codes for clinical laboratory tests is performed by the CPT Editorial Panel and will not be discussed at the public meeting.
Medicare Program; State Health Insurance Assistance Program (SHIP)
This rule adopts as final the provisions in the interim final regulation that published June 1, 2000, which explain the terms and conditions that apply to State grants for counseling and assistance to Medicare beneficiaries, and makes several minor technical clarifications.
Acquisition Regulations
The Department of Health and Human Services proposes to amend its acquisition regulations (HHSAR) to make administrative and editorial changes to reflect organizational title changes resulting from Office of the Secretary (OS) and Operating Division (OPDIV) reorganizations and to update or remove outdated text and references. The intent of the proposal is to bring the HHSAR up to date and to make the HHSAR consistent with the latest amendments to the Federal Acquisition Regulations (FAR).
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