Department of Health and Human Services March 8, 2005 – Federal Register Recent Federal Regulation Documents
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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).
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