Department of Health and Human Services March 2005 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 324
National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of the Styrene Expert Panel Meeting and Availability of the Draft Expert Panel Report on Styrene; Request for Public Comment on the Draft Report
The CERHR announces the availability of the draft expert panel report for styrene on March 18, 2005, from the CERHR Web site (https:// cerhr.niehs.nih.gov) or in printed text from the CERHR (see FOR FURTHER INFORMATION CONTACT below). The CERHR invites the submission of public comments on sections 1-4 of the draft expert panel report (see SUPPLEMENTARY INFORMATION below). The expert panel will meet on June 1- 3, 2005, at the Holiday Inn Old Town Select in Alexandria, Virginia to review and revise the draft expert panel report and reach conclusions regarding whether exposure to styrene is a hazard to human development or reproduction. The expert panel will also identify data gaps and research needs. CERHR expert panel meetings are open to the public with time scheduled for oral public comment. Attendance is limited only by the available meeting room space. Following the expert panel meeting and completion of the expert panel report, the CERHR will post the report on its Web site and solicit public comment on it through a Federal Register notice.
Prospective Grant of an Exclusive License: Novel Isosteric Thalidomide Analogs With Enhanced TNF-α Inhibitory Activity
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 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 U.S. Patent Application No. 60/504,724 filed September 17, 2003, entitled ``Thalidomide Analogs'' (DHHS Reference E- 189-2003/0-US-01) and PCT Application No. PCT/US2004/030506 filed September 17, 2004, entitled ``Thalidomide Analogs'' (DHHS Ref. E-189- 2003/0-PCT-02) to Phase 2 Discovery, Inc. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be United States, Denmark, Italy, Ireland, United Kingdom, Germany, France, Sweden, Switzerland, Spain, Czech Republic, Greece, Russia, Australia, Japan, Taiwan, Singapore, China, Argentina and Brazil, and the field of use may be limited to development and sale of a pharmaceutical product useful in treating Amyotrophic Lateral Sclerosis (ALS) and Attention Deficit Hyperactivity Disorder (ADHD).
Health Resources and Services Administration (HRSA); Request for Public Comment on a HRSA Commissioned Report: Newborn Screening: Toward a Uniform Screening Panel and System
The changing dynamics of emerging technology, and the complexity of genetics require an assessment of the state of the art in newborn screening and a perspective on the future directions such programs should take. In 1999, the American Academy of Pediatrics Newborn Screening Task Force recommended that ``HRSA should engage in a national process involving government, professionals, and consumers to advance the recommendations of this Task Force and assist in the development and implementation of nationally recognized newborn screening system standards and policies.'' In response to this need, pursuant to 42 U.S.C. 701(a)(2), the Maternal and Child Health Bureau (MCHB) of HRSA commissioned the American College of Medical Genetics (ACMG) to conduct an analysis of the scientific literature on the effectiveness of newborn screening and gather expert opinion to delineate the best evidence for screening specified conditions and develop recommendations focused on newborn screening, including but not limited to the development of a uniform condition panel. It was expected that the analytical endeavor and subsequent recommendations be based on the best scientific evidence and analysis of that evidence. ACMG was specifically asked to develop recommendations to address: A uniform condition panel (including implementation methodology); Model policies and procedures for State newborn screening programs (with consideration of a national model); Model minimum standards for State newborn screening programs (with consideration of national oversight); A model decision matrix for consideration of State newborn screening program expansion; and The value of a national process for quality assurance and oversight. The ACMG report is a response to the HRSA/MCHB request. The ACMG report, Newborn Screening: Toward a Uniform Screening Panel and System is available at https://mchb.hrsa.gov/screening. In the report, 29 conditions were identified as primary targets or core panel conditions for screening; an additional 25 conditions were listed as conditions that could be identified in the course of screening for core panel conditions. Many of these 25 additional conditions are included in the differential diagnosis of the conditions including in the primary target list. With additional screening, an improvement in the infrastructure for appropriate follow-up and management throughout the lives of children who have been identified as having one of these rare conditions will be needed. A cost analysis for the State of California indicates newborn screening is beneficial to patients and may have some net costs or net savings over time depending on assumptions of expected lifetime costs of medical care. HRSA is now seeking public comments on the report and its recommendations.
New Animal Drugs; Change of Sponsor's Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's address for Wellmark International.
Health Professions Preparatory, Health Professions Pregraduate and Indian Health Professions Scholarship Programs; Correction
The Indian Health Service published a document in the Federal Register on January 19, 2005. The document contained one error.
Limited Competition for Supplemental Grants for Centers for Education and Research (CERTs)
This notice informs the research community that the Agency for Healthcare Research and Quality (AHRQ) is requesting applications for competitive supplemental grants from the seven Centers for Education and Research on Therapeutics (CERTs) for which it provided funding in fiscal year 2004. The purpose of the competitive supplements is to provide funds for existing CERTs research centers to build on and to expand their research work and expertise with respect to comparative effectiveness research specifically to carry out short term projects that will address research gaps in priority subject areas identified and published pursuant to section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA). Since the inception of the CERTs program in 1999, the CERTs research centers have gathered significant data regarding therapeutics, refined research methodologies, and developed collaborative research resources. They are therefore uniquely prepared and suited to efficiently carry out pharmaco-epidemiology and methodological studies related to comparative effectiveness research that is pertinent to developing therapeutic evidence identified as being of high interest to the Medicare, Medicaid or SCHIP programs. For this reason, this solicitation will be for a limited competition among CERTs grantees.
Medicare Program: Changes to the Medicare Claims Appeal Procedures
Medicare beneficiaries and, under certain circumstances, providers and suppliers of health care services, can appeal adverse determinations regarding claims for benefits under Medicare Part A and Part B under sections 1869 and 1879 of the Social Security Act (the Act). Section 521 of the Medicare, Medicaid, and SCHIP Benefits Act of 2000 (BIPA) amended section 1869 of the Act to provide for significant changes to the Medicare claims appeal procedures. This interim final rule responds to comments on the November 15, 2002 proposed rule regarding changes to these appeal procedures, establishes the implementing regulations, and explains how the new procedures will be implemented. It also sets forth provisions that are needed to implement the new statutory requirements enacted in Title IX of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Medicare Program; Meeting of the Advisory Panel on Medicare Education-March 22, 2005: Location Change
In accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 2, section 10(a) (Pub. L. 92-463), this notice announces a meeting of the Advisory Panel on Medicare Education (the Panel) on March 22, 2005. The Panel advises and makes recommendations to the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This notice replaces the meeting notice published on February 25, 2005 (70 FR 9362) due to a change in the meeting location.
Advisory Committee on Organ Transplantation; Request for Nominations for Voting Members
The Health Resources and Services Administration (HRSA) is requesting nominations to fill up to 13 vacancies on the Advisory Committee on Organ Transplantation (ACOT). The ACOT was established by the Amended Final Rule of the Organ Procurement and Transplantation Network (OPTN) (42 CFR Part 121) and, in accordance with Pub. L. 92- 463, was chartered on September 1, 2000.
Revised Compliance Policy Guide Regarding Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Availability
The Food and Drug Administration (FDA) is announcing the availability of draft revisions to Compliance Policy Guide (CPG) Sec. 110.310 entitled ``Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.'' The CPG provides written guidance to FDA and Customs and Border Protection (CBP) staff on enforcement of section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulations, which require prior notice for food imported or offered for import into the United States. The CPG has been revised to provide additional guidance to FDA and CBP staff regarding specific situations covering routine shipments of food that are transported through the United States, arriving from and exiting to the same country, and regarding the Harmonized Tariff Schedule (HTS) code that is part of the planned shipment information.
Risk Assessment of the Public Health Impact from Foodborne Listeria Monocytogenes in Smoked Finfish; and Evaluation of Food Code Provisions That Address Preventive Controls for Listeria Monocytogenes in Retail and Foodservice Establishments; Request for Comments and for Scientific Data and Information
The Food and Drug Administration (FDA) is requesting comments and scientific data and information that would assist the agency in its plans to conduct a risk assessment for Listeria monocytogenes in smoked finfish (smoked finfish risk assessment), and evaluate the provisions of the 2001 Food Code that address preventive controls for L. monocytogenes in retail and foodservice establishments. The purpose of the smoked finfish risk assessment is to ascertain the impact on public health from the reduction and/or prevention of L. monocytogenes growth and recontamination during the manufacturing and/or processing of hot- and cold-smoked finfish. The smoked finfish risk assessment and the evaluation of the Food Code provisions for preventive controls for L. monocytogenes in retail and foodservice establishments support the agency's commitment to the Listeria Action Plan (revised 2003) that FDA and the Centers for Disease Control and Prevention (CDC) developed to reduce L. monocytogenes illnesses associated with the consumption of ready-to-eat (RTE) foods.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Medical Devices; Device Tracking
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Service Surveys
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reports of Corrections and Removals
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.
Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug Applications and 60 Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 76 new drug applications (NDAs) and 60 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Medicare Program; Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B
This proposed rule would implement provisions of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 that require the implementation of a competitive acquisition program for certain Medicare Part B drugs not paid on a cost or prospective payment system basis. Beginning January 1, 2006, physicians will generally be given a choice between obtaining these drugs from vendors selected through a competitive bidding process or directly purchasing these drugs and being paid under the average sales price system. We are seeking comments on which of the proposed approaches we should use to implement the competitive acquisition program as well as the criteria and standards that should be applied in the selection and enrollment of vendors.
Availability of Public Health Assessment Guidance Manual (Update)
This notice announces the availability of the ATSDR Public Health Assessment Guidance Manual (Update). ATSDR is mandated to conduct public health assessment activities at all sites on, or proposed for inclusion on, the National Priorities List (NPL). ATSDR can also conduct public health assessments in response to a request from the public for an evaluation of active waste sites, landfills, and other possible releases of hazardous substances to the environment.
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.
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