Department of Health and Human Services March 2006 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 332
Annual Comprehensive List of Guidance Documents at the Food and Drug Administration
The Food and Drug Administration (FDA) is publishing its annual comprehensive list of all guidance documents currently in use at the agency. This list is being published under FDA's good guidance practices (GGPs) regulations. It is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past year.
Public Meeting of the President's Council on Bioethics on April 20-21, 2006
The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its twenty-fourth meeting, at which, among other things, it will hear presentations on and discuss issues in two broad areas: (1) Children and clinical research and (2) organ procurement and transplantation. Subjects discussed at past Council meetings (though not on the agenda for the present one) include: Cloning, assisted reproduction, reproductive genetics, IVF, ICSI, PGD, sex selection, inheritable genetic modification, patentability of human organisms, neuroscience, aging retardation, and lifespan-extension. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), and Taking Care: Ethical Caregiving in Our Aging Society (September 2005).
Decision to Evaluate a Petition to Designate a Class of Employees at Blockson Chemical Company, Joliet, Illinois, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Blockson Chemical Company, in Joliet, Illinois, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Blockson Chemical Company. Location: Building 55. Job Titles and/or Job Duties: Utility Engineer, Laborer, Research Chemist, Relief Operator, Plant Operator, Maintenance and Pipefitter, Lead Mixer, Operator, and Supervisor HF Acid. Period of Employment: October 10, 1952 through December 31, 1962.
Memorandum of Understanding Between the Food and Drug Administration, Department of Health and Human Services, of the United States of America and the Certification and Accreditation Administration of the People's Republic of China Covering Ceramicware Intended for Use in the Preparation, Serving or Storage of Food or Drink and Offered for Export to the United States of America
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration, Department of Health and Human Services, of the United States of America and the Certification and Accreditation Administration of the People's Republic of China (CNCA). The purpose of this MOU is to establish a certification system that increases the likelihood that daily-use ceramicware manufactured in the People's Republic of China (China) and offered for import into the United States complies with U.S. law. To that end, this MOU sets forth the criteria for certification of ceramicware to be exported directly from China to the United States and intended for use in the preparation, serving, or storage of food, and for certification of firms in China that are manufacturing such ceramicware. These certifications will enable FDA to reduce the frequency of its sampling of daily-use ceramicware from factories in China certified by CNCA/ China Entry-Exit Inspection and Quarantine Bureaus (CIQs) and offered for import into the United States, in accordance with FDA's confidence in the effectiveness of the CNCA/CIQ factory certification system.
National Institute for Occupational Safety and Health; Changes to the NIOSH-IREP Lung Cancer Risk Model Under the Energy Employees Occupational Illness Compensation Program Act of 2000
The National Institute for Occupational Safety and Health (NIOSH) has changed a guideline for determining the probability of causation under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) for energy employees with cancers of the lung, trachea, or bronchus. The change affects only the NIOSH- Interactive RadioEpidemiological Program (IREP) cancer risk model termed ``Lung (162).'' The new guideline, which became effective on February 28, 2006, with the introduction of NIOSH-IREP Version 5.5, requires the use of both a National Institutes of Health (NIH)-IREP lung model implemented by NIH in 2003 and the original NIOSH-IREP lung model implemented by NIOSH in 2002. NIOSH-IREP Version 5.5 calculates separately the probability of causation produced under each model for each cancer of the lung, trachea, or bronchus. The result from the model that produces the higher probability of causation at the upper 99th percentile credibility limit is reported as the probability of causation result of record for the claim. NIOSH-IREP Version 5.5 also incorporates a bias correction factor for random errors in dosimetry for those energy workers who had not smoked cigarettes (``never smokers'') and who were exposed to radon. This correction was previously applied to smokers, but had been inadvertently omitted for never smokers. These changes may result in the Department of Labor (DOL) calculating higher probability of causation determinations for select cases of cancer of the lung, trachea, or bronchus among previously decided and current EEOICPA cancer claims. The changes cannot result in any lower probability of causation determinations. Although this change to the NIOSH-IREP lung cancer risk model took effect February 28, 2006, NIOSH will fully consider all comments received regarding this change and may reconsider this change or consider further revisions to the lung cancer risk model based on public comment.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Food and Drug Administration Rapid Response 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.
Workshop on Mine Escape Planning and Emergency Shelters
The Mine Safety and Health Administration (MSHA) and the National Institute for Occupational Safety and Health (NIOSH) are hosting a workshop to identify the major issues and concerns related to mine escape planning and emergency shelters in the mining industry, and share information with the mining community. The workshop will provide for an exchange of information among all segments of the mining community involved with mine emergency preparedness and will generate an agenda for research to improve technology for mine safety in these areas.
Findings of Scientific Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Hiwot A. Woreta, Duke University Medical Center: Based on the report of an inquiry into admitted fabrication of data conducted by the Duke University Medical Center (DUMC) and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Hiwot A. Woreta, former medical student, DUMC, engaged in research misconduct while supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grant P30 DK034987. Specifically, PHS found that Ms. Woreta engaged in research misconduct by fabricating data included in Figure 2 of her third year Medical School Thesis at DUMC. These data were also included in a poster presented during the Alpha Omega Alpha Honor Society symposium in May 2004. Ms. Woreta has entered into a Voluntary Exclusion Agreement in which she has voluntarily agreed, for a period of three (3) years, beginning on February 24, 2006: (1) To exclude herself from serving in any advisory capacity to PHS including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as consultant; and (2) That any institution that submits an application for PHS support for a research project on which the Respondent's participation is proposed or which uses the Respondent in any capacity on PHS supported research, or that submits a report of PHS-funded research in which the Respondent is involved, must concurrently submit a plan for supervision of the Respondent's duties to the funding agency for approval. The supervisory plan must be designed to ensure the scientific integrity of the Respondent's research contribution. Respondent agreed to ensure that a copy of the supervisory plan is also submitted to ORI by the institution. Respondent agreed that she will not participate in any PHS-supported research until such a supervisory plan is submitted to ORI.
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Correction
The Food and Drug Administration (FDA) is correcting a final rule that published in the Federal Register of May 25, 2004 (69 FR 29786). The final rule required human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to screen and test cell and tissue donors for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases. The document was published with an error in the codified section. This document corrects that error.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2005
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October 2005 through December 2005, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations. Finally, this notice includes a list of Medicare-approved carotid stent facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.
Medicare Program; Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG): Announcement of a New Member
This notice announces the selection of a new member of the Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG). The purpose of the EMTALA TAG is to review regulations affecting hospital and physician responsibilities under EMTALA to individuals who come to a hospital seeking examination or treatment for medical conditions.
Medicare Program; Request for Nominations for Members of the Medicare Coverage Advisory Committee and Notice of Meeting of the Medicare Coverage Advisory Committee-May 18, 2006
This notice requests nominations for consideration for membership on the Medicare Coverage Advisory Committee (MCAC). The Committee provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This notice also announces a public meeting of the MCAC. The meeting will address the use of non-invasive imaging technologies versus cardiac catheterization in the diagnosis of coronary artery disease. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)). Nominations: Deadline and Address: Nominations will be considered if postmarked by April 23, 2006 and mailed to the Executive Secretary (see FOR FURTHER INFORMATION CONTACT). Secretary's Charter: Obtain a copy of the Secretary's Charter for the Medicare Coverage Advisory Committee from Maria Ellis, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop: 1-09-06, Baltimore, MD 21244; (410) 786-0309; Maria.Ellis@cms.hhs.gov. This charter is also posted on the following Web site: https://www.cms.hhs.gov/FACA/ downloads/mcaccharter.pdf. Meeting: Date and Location: The public meeting will be held in the main auditorium of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, on Thursday, May 18, 2006, from 7:30 a.m. until 4:30 p.m., e.d.t. Presentation and Comments: Interested persons can present data, information, or views orally or in writing on issues pending before the Committee. Please submit written comments to the Executive Secretary by mail or email (see FOR FURTHER INFORMATION CONTACT). Deadline for Written Comments and Presentations: Written comments and presentations for the public meeting must be received by April 24, 2006, 5 p.m., e.d.t. The presentation that will be submitted must be your final presentation; no further changes will be accepted. Deadline for Registration to Attend Meeting: For security reasons, individuals wishing to attend this meeting must register by close of business on May 11, 2006. Special Accommodations: Persons attending the meeting who are hearing or visually impaired, or who have a condition that requires special assistance or accommodations, are asked to notify the Executive Secretary by May 11, 2006 (see FOR FURTHER INFORMATION CONTACT). Web site: You may access up-to-date information on this meeting at https://www.cms.hhs.gov/FACA/02MCAC.asp#TopOfPage.
Medicare Program; Application for Deeming Authority for Medicare Advantage Health Maintenance Organizations and Local Preferred Provider Organizations Submitted by URAC
This proposed notice announces URAC's submission of an application for deeming authority as a national accreditation organization for health maintenance organizations and local preferred provider organizations participating in the Medicare Advantage program. This announcement describes the criteria to be used in evaluating the application and provides information for submitting comments during a public comment period that will span at least 30 days.
Medicare Program; Public Meetings in Calendar Year 2006 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations
This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2006 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. Discussion will be directed toward responses to our specific preliminary recommendations and will include all items on the public meeting agenda.
Request for Applications for the National Centers of Excellence in Women's Health (CoE) and the National Community Centers of Excellence in Women's Health (CCOE)-Ambassadors for Change Program
The National Centers of Excellence in Women's Health and the National Community Centers of Excellence in Women's Health programs provide funding to academic health centers and community-based organizations to enhance their women's health programs through the integration of these components: (1) Leadership development for women, (2) training for lay, allied health, and professional health care providers, (3) public education and outreach with special emphasis on outreach to minority women, (4) comprehensive health service delivery that includes gender and age-appropriate preventive services and allied health professionals as members of the comprehensive care team, and (5) basic science, clinical and community-based research. In addition, the community centers must replicate their National Community Center of Excellence in Women's Health (CCOE) model in another organization or community.
Determination of Regulatory Review Period for Purposes of Patent Extension; MYCAMINE
The Food and Drug Administration (FDA) has determined the regulatory review period for MYCAMINE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; VESICARE
The Food and Drug Administration (FDA) has determined the regulatory review period for VESICARE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ALAMAST
The Food and Drug Administration (FDA) has determined the regulatory review period for ALAMAST and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.
Announcement of Availability of Funds for Adolescent Family Life (AFL) Demonstration Projects
Briefly provide a statement of the proposed demonstration project indicating that this is a CARE demonstration project and whether it is for a local or statewide project; Type of organization applying (school, state agency, voluntary agency, etc.); Geographic area to be served (urban, rural, suburban); Description of target population to be served; Statement of the program intervention; Brief description of the proposed project. Description of Applicant Organization: Describe the decision-making authority and structure (e.g. relationship to the Board of Directors), its resources, experience, existing program units and/or those to be established if funding is obtained. This description should cover personnel, time and facilities and contain evidence of the organization's capacity to provide the rapid and effective use of resources needed to conduct the project, collect necessary data and evaluate it. Rationale: Describe the rationale for use of the proposed approach based upon previous practice and review of the literature and/ or evaluation findings. Geographic Area: Describe the geographic area to be served. Document the incidence of adolescent pregnancy, and describe economic conditions, income levels, existing services and unmet needs in the proposed service area. Program Outcome Objectives: Provide a clear statement of results or benefits expected that are consistent with the OAPP performance measures. Objectives should be specific, measurable, achievable, realistic, and time-framed. Care Services Demonstration Model: Describe the program, including how services will continue to be provided to clients after the birth of the child to enable parents to acquire good parenting skills and to ensure that their children are developing normally physically, intellectually and emotionally. Describe how the applicant will add care services to supplement existing adolescent health services in a school, hospital or other community setting. Describe how the applicant will provide directly, or by referral, each of the required ten core services and any supplemental services as appropriate. As appropriate, state how the project will be coordinated, integrated and linked to existing services within the service area. Describe case management and follow-up procedures. Describe the population, recruitment methods and selection criteria. Describe how the applicant will as appropriate, involve families, voluntary associations, religious and charitable organizations and other groups in the private sector. Workplan and Timetable: Provide a year long work plan and timetable, which spans at least three years of program implementation. Numbers and Types of Clients: Provide estimates of clients expected to be served during the first year (e.g. adolescent mothers, extended family members, fathers of their children, husbands, and/or male partners with whom they are in a long-term relationship). Documentation of Support: Provide a summary of the views of public agencies, providers of services and the general public in the geographical area to be served. Provide documentation of the support from other community agencies. Continuation Funding: Describe the plan regarding continuation of services at the termination of this Federal funding. Evaluation Plan: The evaluation plan must clearly articulate the program interventions and/or processes to be tested; theory upon which the program intervention is based; proposed questions/hypotheses the evaluation will address; instruments, including information regarding reliability and validity of instruments; sampling plan and data collection schedule; data analysis plan, including statistical tests. Describe how the evaluation is consistent with the program, particularly how data will be used for mid-course corrections and ongoing program improvements. Discuss how the evaluator will ensure confidentiality of the data. Describe the qualitative methodology planned and how it will be integrated with the required quantitative design. Describe how the data will be collected. Appendices: Include articles of incorporation and mission statement for private nonprofit organizations. Resumes of key staff and detailed position descriptions. How the project will obtain parental consent. Letters of commitment and support from other providers. Provide evidence of a working agreements with an evaluator affiliated with a college or university located in the applicant's State. The entities to be involved in the evaluation must be identified, their willingness to participate documented, their role (s) described and their capability documented by an attached curriculum vitae. Provide a copy of the table of contents of the proposed curriculum, plus a list of any other instructional materials that will be an integral part of the proposed project. Applicants must be familiar with Title XX in its entirety to ensure that they have complied with all applicable requirements. A copy of the legislation is included in the application kit. A Dun and Bradstreet Universal Numbering System (DUNS) number is required for all applications for Federal assistance. Organizations should verify that they have a DUNS number or take the steps necessary to obtain one. Instructions for obtaining a DUNS number are included in the application package, and may be downloaded from the OPA Web site.
Oral Dosage Form New Animal Drugs; Orbifloxacin
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 Schering-Plough Animal Health Corp. The supplemental NADA provides for revised animal safety labeling for orbifloxacin tablets used in dogs and cats for the management of diseases associated with susceptible bacteria.
Amendment of February 4, 2004, Order To Embargo Birds and Bird Products Imported From Albania, Azerbaijan, Cameroon, and Myanmar
On February 4, 2004, the Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services issued an order to ban immediately the import of all birds (Class: Aves) from specified Southeast Asian countries, subject to limited exemptions for returning pet birds of U.S. origin and certain processed bird-derived products. HHS/CDC took this step because birds from these countries potentially can infect humans with avian influenza (influenza A/ [H5N1]). The February 4, 2004, order complemented a similar action taken at the same time by the Animal and Plant Health Inspection Services (APHIS) within the U.S. Department of Agriculture (USDA). On March 10, 2004, HHS/CDC lifted the embargo of birds and bird products from the Hong Kong Special Administrative Region (HKSAR) because of the documented public-health and animal health measures taken by Hong Kong officials to prevent spread of the outbreak with the HKSAR, and the absence of highly pathogenic avian influenza H5N1 cases in Hong Kong's domestic and wild bird populations. USDA/APHIS took a similar action. On September 28, 2004, HHS/CDC extended the embargo on birds and bird products to include Malaysia because of the documented cases of highly pathogenic avian influenza A H5N1 in poultry in Malaysia. On July 20, 2005, USDA/APHIS adopted as a final rule the interim rule that became effective on February 4, 2004, which amended its regulations to prohibit or restrict the importation of birds, poultry, and unprocessed birds and poultry products from regions that have reported the presence of highly pathogenic avian influenza H5N1 in poultry. (See 70 Federal Register 41608 [July 20, 2005].) As the United Nations Food and Agriculture Organization and the World Organization for Animal Health (OIE) have confirmed additional cases of highly pathogenic avian influenza (H5N1), USDA/APHIS has added additional countries to its ban. On December 29, 2005, HHS/CDC added the Republic of Kazakhstan, Romania, the Russian Federation, the Republic of Turkey, and Ukraine to its current embargo because of documented cases of highly pathogenic avian influenza H5N1 in poultry in those countries. On February 8, 2006, HHS/CDC added Nigeria to its embargo because of the documentation of highly pathogenic avian influenza H5N1 in poultry. On February 22, 2006, HHS/CDC added India to its embargo because of documentation of highly pathogenic avian influenza H5N1 in poultry. On February 27, 2006, added Egypt to its embargo because of documentation of highly pathogenic avian influenza H5N1 in poultry. On March 2, 2006, CDC issued an amendment adding Niger to its embargo after H5N1 was confirmed in poultry. On February 24, 2006, OIE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Azerbaijan. On March 7, 2006, OIE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Albania. On March 11, 2006, OIE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Cameroon. On March 12, 2006, OIE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Myanmar. USDA/APHIS subsequently added Albania, Azerbaijan, Cameroon, and Myanmar to their ban. At this time, HHS/CDC is adding Albania, Azerbaijan, Cameroon, and Myanmar to its current embargo. This action is effective on March 15, 2006, and will remain in effect until further notice.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses: Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses''. This guidance document describes a means by which Reagents for detection of specific novel influenza A viruses may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify Reagents for detection of specific novel influenza A viruses into class II (special controls). This guidance document is immediately in effect as a special control for Reagents for detection of specific novel influenza A viruses, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Medical Devices; Immunology and Microbiology Devices; Classification of Reagents for Detection of Specific Novel Influenza A Viruses
The Food and Drug Administration (FDA) is classifying Reagents for detection of specific novel influenza A viruses into class II (special controls). Special controls that will apply to the device are the guidance document entitled, ``Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses'' and limitations of distribution of these reagents. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is a special control for this device.
New Animal Drugs; Adamantane and Neuraminidase Inhibitor Anti-influenza Drugs; Extralabel Animal Drug Use; Order of Prohibition
The Food and Drug Administration (FDA) is issuing an order prohibiting the extralabel use of anti-influenza adamantane and neuraminidase inhibitor drugs in chickens, turkeys, and ducks. We are issuing this order based on evidence that extralabel use of these anti- influenza drugs in chickens, turkeys, and ducks will likely cause an adverse event in humans.
Prospective Grant of Exclusive License: The Use of IL13-PE38 for the Treatment of Asthma and Pulmonary Fibrosis
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 (HHS), is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 60/337,179 filed December 4, 2001, entitled ``IL-13 Receptor-Targeted Immunotoxins Ameliorates Symptoms of Asthma and of Allergy'' [HHS Reference No. E-296-2001/0-US- 01], PCT Application No. PCT/US02/00616 filed February 28, 2002, entitled ``Alleviating Symptoms of TH2-Like Cytokine Mediated Disorders by Reducing IL-13 Receptor-Expressing Cells in the Respiratory Tract'' [HHS Reference No. E-296-2001/0-PCT-02], U.S. Patent Application No. 10/497,804 filed June 4, 2004, entitled ``Alleviating Symptoms of TH2- Like Cytokine Mediated Disorders by Reducing IL-13 Receptor-Expressing Cells in the Respiratory Tract'' [HHS Reference No. E-296-2001/0-US- 03], Australian Patent Application No. 2002258011 filed June 8, 2004, entitled ``Alleviating Symptoms of TH2-Like Cytokine Mediated Disorders by Reducing IL-13 Receptor-Expressing Cells in the Respiratory Tract'' [HHS Reference No. E-296-2001/0-AU-04], Canadian Patent Application No. 2469082 filed February 28, 2002, entitled ``Chimeric Molecule for the Treatment of TH2-Like Cytokine Mediated Disorders'' [HHS Reference No. E-296-2001/0-CA-05], and European Patent Application No. 02727815.9 filed June 29, 2004 entitled ``Alleviating Symptoms of TH2-Like Cytokine Mediated Disorders by Reducing IL-13 Receptor-Expressing Cells in the Respiratory Tract'' [HHS Reference No. E-296-2001/0-EP-06], including background patent rights to U.S. Patent No. 4,892,827, issued on January 9, 1990, entitled ``Recombinant Pseudomonas Exotoxins: Construction of an Active Immunotoxin with Low Side Effects'' [HHS Reference No. E-385-1986/0-US-01], U.S. Patent No. 5,919,456, issued on July 6, 1999, entitled ``IL-13 Receptor Specific Chimeric Proteins'' [HHS Reference No. E-266-1994/0-US-07], U.S. Patent 6,518,061, issued on February 11, 2003, entitled ``IL-13 Receptor Specific Chimeric Proteins and Uses Thereof'' [HHS Reference No. E-266-1994/0-US-08], to NeoPharm, Inc., which has offices in Waukegan, Illinois. The patent rights in these inventions have been assigned and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the treatment of asthma and pulmonary fibrosis with IL13-PE38. This notice replaces the Prospective Grant notice published in the Federal Register on Monday, March 6, 2006 (71 FR 11213).
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 Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Announcement of an Independent Scientific Peer Review Meeting on the Use of In Vitro Testing Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity Tests and Request for Comments
NICEATM in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces a public, independent, scientific peer review meeting to evaluate the validation status of the in vitro 3T3 and normal human keratinocyte (NHK) neutral red uptake (NRU) basal cytotoxicity test methods for estimating starting doses for in vivo acute oral toxicity tests. These two in vitro cytotoxicity test methods are proposed as adjuncts to the in vivo acute oral toxicity tests to refine (i.e., to lessen or avoid pain and distress) and/or reduce animal use. At this meeting, a scientific peer review panel (``Panel'') will peer review the background review document (BRD) on the 3T3 and NHK cytotoxicity test methods, evaluate the extent that the BRD addresses established validation and acceptance criteria, and provide comment on the draft ICCVAM recommendations on the proposed use of these test methods, draft test method protocols, and draft performance standards. NICEATM requests public comments on the BRD, draft ICCVAM test method recommendations, draft test method protocols, and draft performance standards.
Prospective Grant of Exclusive License: The Use of HMG-CoA Inhibitors for the Treatment of Adenocarcinomas and Ewing's Sarcoma
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent No. 6,040,334 issued March 21, 2000, entitled ``Use of Inhibitors of 3-Hydroxy-3-Methylglutaryl Coenzyme A reductase as a Modality in Cancer Therapy'' [HHS Reference E-146-1992/0-US-23] and related foreign applications to Nascent Oncology, Inc., which has offices in Chapel Hill, North Carolina. The patent rights in these inventions have been assigned and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the treatment of adenocarcinoma and Ewing's sarcoma with HMG-CoA inhibitors.
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