Department of Health and Human Services August 2005 – Federal Register Recent Federal Regulation Documents
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Meeting of the Citizens' Health Care Working Group
In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting and hearing of the Citizens' Health Care Working Group mandated by section 1014 of the Medicare Modernization Act. In addition, the Working Group will sponsor a community forum in which members of the working group will participate.
Prospective Grant of Exclusive License: Development and Use of Cripto-1 as a Biomarker and Treatment for Neurodegenerative Disease
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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application 60/508,750, filed October 3, 2003 [DHHS Ref. E-075- 2003/0-US-01] and PCT Application PCT/US04/32649 [DHHS Ref. E-075-2003/ 0-PCT-02], entitled Use of Cripto-1 as a Biomarker for Neurodegenerative Disease and Method of Inhibiting Progression Thereof, to Neuronascent, Inc., which is located in Clarksville, Maryland. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the development and use of Cripto small molecule inhibitors to treat and prevent Alzheimer's disease in humans.
National Toxicology Program (NTP); Liaison and Scientific Review Office; Meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee (TRR Subcommittee). The primary agenda topic is the peer review of the findings and conclusions of ten draft NTP Technical Reports (TR) of rodent toxicology and carcinogenicity studies conducted by the NTP (see Preliminary Agenda below). TRR Subcommittee meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on any draft technical report discussed at the meeting. The TRR Subcommittee deliberations on the draft technical reports will be reported to the NTP Board of Scientific Counselors (NTP Board) at a future date.
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 system titled ``Federal Reimbursement of Emergency Health Services Furnished to Undocumented Aliens (Section 1011),'' System No. 09-07-0546. The system will contain enrollment and payment request information, in support of a short-term program which pays hospitals, certain physicians, and ambulance providers (including Indian Health Service (IHS) facilities whether operated by the IHS or by an Indian Tribe or tribal organization) for their otherwise un-reimbursed costs of services provided under the provisions of section 1867 (Emergency Medical Treatment and Labor Act) (EMTALA) of the Social Security Act (the Act) and related hospital inpatient and outpatient services and ambulance services furnished to undocumented aliens, aliens paroled into the United States (U.S.) at a U. S. port of entry for the purposes of receiving such services, and Mexican citizens permitted temporary entry to the U.S. for not more than 30 days under the authority of a biometric machine readable border crossing identification card (also referred to as a ``laser visa'') issued in accordance with the requirements of regulations prescribed under the Immigration and Nationality Act. This system is being established under provisions of Section 1011 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 Modernization Act of 2003 (MMA). The primary purpose of the system is to maintain information collected on individuals who submit an enrollment application and make payment requests associated with Section 1011 of the MMA, and other information designed to support the enrollment, claims payment, and research reporting functions of the Section 1011 program. Information retrieved from this system will also be disclosed to: (1) Support regulatory, payment activities, and policy functions performed within the agency or by a designated contractor or consultant; (2) combat fraud and abuse in certain health benefits programs; (3) 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 a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal; (4) funds support constituent requests made to a Congressional representative; and, (5) support litigation involving the agency. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that the ``routine use'' portion of the system be published for comment, CMS invites comments on all portions of this notice. See DATES section for comment period.
Medicaid Program; Meeting of the Medicaid Commission-August 17-18, 2005
This notice announces a public meeting of the Medicaid Commission. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Medicaid Commission will advise the Secretary on ways to modernize the Medicaid program so that it can provide high-quality health care to its beneficiaries in a financially sustainable way.
Proposed Collection: Comment-Request; Revision of OMB No. 0925-0002/exp. 08/31/05, Individual Ruth L. Kirschstein National Research Service Award Applications and Related forms
In compliance with the requirement of Section 3407(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director (OD), Office of Extramural Research (OER), the National Institutes of Health (NIH) has submitted to the Office of management and budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 16, 2005, Volume 70, No. 50, page 12889 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
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; Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures
This proposed rule sets forth the general requirements and procedures that would allow certain entities who are identified for exclusion from the Medicare program to request that CMS act on their behalf to recommend to the Inspector General that their exclusion from Medicare be waived because of a hardship that would result on Medicare beneficiaries. This proposed rule would implement section 949 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).
Medicare Program; Hospice Wage Index for Fiscal Year 2006
This final rule sets forth the hospice wage index for fiscal year 2006 and identifies the revised labor market and metropolitan core based statistical areas. In addition, this final rule responds to public comments and implements provisions of sections 408 and 946 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2006
In this final rule we update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year (FY) 2006. Annual updates to the PPS rates are required by section 1888(e) of the Social Security Act (the Act), as amended by the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA), the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), relating to Medicare payments and consolidated billing for SNFs. This final rule also responds to public comments submitted on the proposed rule published on May 19, 2005 (70 FR 29070), and promulgates provisions set forth in that proposed rule, along with several additional technical revisions to the regulations.
Agency Information Collection Activities; Proposed Collection; Comment Request; Importer's Entry Notice
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 information collection provisions for the Importer's Entry Notice.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Temporary Marketing Permit Applications; Correction
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of July 26, 2005 (70 FR 43159). The document announced Office of Management Budget approval for State petitions for exemption from preemption. The document was published with an incorrect title and an incorrect docket number. This document corrects those errors.
Prospective Grant of Exclusive License: Adaphostin as a Novel Cancer Therapy
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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in: 1. E-013-1998/0-US-01, ``Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs'', by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number 60/076,330 (filed February 27, 1998); 2. E-013-1998/0-PCT-02, ``Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs'', by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number PCT/US99/04002 (filed February 24, 1999);
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.
Prospective Grant of an Exclusive License: Therapeutics for the Treatment of Kidney Cancer and Thyroid Neoplasms
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in 1. E-199-2002/0-US-01, ``Treatment Method and Therapeutic Agent of Kidney Cancer'', by Susan Bates, and Yoshinori Naoe, Pat. Application No. 60/369,868 (filing date April 5, 2002); 2. E-199-2002/0-PCT-02, ``Treatment Method and Therapeutic Agent of Kidney Cancer'', by Susan Bates, and Yoshinori Naoe, Pat. Application No. PCT/US03/03823 (filing date March 27, 2003); 3. E-199-2002/0-US-04, ``Depsipeptide for Therapy of Kidney Cancer'', by Susan Bates, and Yoshinori Naoe, Pat. Application No. 10/ 508,958 (filing date October 5, 2004); 4. E-199-2002/0-JP-08, ``Depsipeptide for Therapy of Kidney Cancer'', by Susan Bates, and Yoshinori Naoe, Pat. Application No. 20003581847 (filing date October 5, 2004); 5. E-199-2002/0-EP-05, ``Depsipeptide for Therapy of Kidney Cancer'', by Susan Bates, and Yoshinori Naoe, Pat Application No.037155033-2107 (filing date October 8, 2004); 6. E-286-2000/0-US-01, ``Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms'', by Tito Fojo and Susan Bates, Pat. Application No. 60/260,733 (filing date January 10, 2001); 7. E-286-2000/0-US-02, ``Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms'', by Tito Fojo and Susan Bates, Pat. Application No. PCT/US02/0714 (filing date January 9, 2001); 8. E-286-2000/0-EP-03, ``Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms'', by Tito Fojo and Susan Bates, Pat. Application No. 02718823.4 (filing date January 9, 2001); 9. E-286-2000/0-AU-04, ``Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms'', by Tito Fojo and Susan Bates, Pat. Application No. 2002249938 (filing date January 9, 2001); 10. E-286-2000/0-CA-04, ``Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms'', by Tito Fojo and Susan Bates, Pat. Application No. 2434269 (filing date January 9, 2001); 11. E-286-2000/0-US-07, ``Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms'', by Tito Fojo and Susan Bates, Pat. Application No. 10/250,320 (filing date June 26, 2003); 12. E-286-2000/0-JP-05, ``Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms'', by Tito Fojo and Susan Bates, Pat. Application No. 2002-556736 (filing date July 10, 2003)
Prospective Grant of an Exclusive License: Anti-Cancer Vaccines
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the National Institutes of Health, 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. 60/498,238, filed August 26, 2003, entitled ``Anti- cancer Vaccines'' (E-179-2004/0-US-01); U.S. Patent Application No. 10/ 926,852, filed August 26, 2004, entitled ``Anti-cancer Vaccines'' (E- 179-2004/0-US-03); and PCT Application No. PCT/US04/27790, filed August 26, 2004, entitled ``Anti-cancer Vaccines'' (E-179-2004/0-PCT-02), to Vaccine Company, having a place of business in Carmel-by-the-Sea, California. The patent rights in these inventions have been assigned to the United States of America and MD Anderson Cancer Center (Part of the University of Texas System). The prospective exclusive license territory may be worldwide, and the field of use may be limited to development and sale of diagnostic and pharmaceutical products useful in diagnosis and treatment of myeloid neoplasms.
Prospective Grant of Exclusive License: Treatment of Inflammatory Diseases Using Ghrelin
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, is contemplating the grant of an exclusive license to practice the invention embodied in U.S. provisional patent application, S/N 60/569,819 filed May 11, 2004, entitled ``Methods for Inhibiting Proinflammatory Cytokine Expression Using Ghrelin'' and converted to PCT on May 11, 2005 (E-016-2004/0-PCT- 02), [Inventors: Vishwa D. Dixit, Dennis D. Taub, Eric Schaffer, and Dzung Nguyen (NIA)], to Gastrotech Pharma (hereafter Gastrotech), having a place of business in Copenhagen, Denmark. The patent rights in these inventions have been assigned to the United States of America.
Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop
The Food and Drug Administration (FDA) is planning a 2-day workshop to explore approaches and potential obstacles to developing drugs, disease biomarkers, medical devices, and vaccines to prevent or reduce the risk of illness. The agency plans to hold the workshop as part of its Critical Path Initiative. Speakers at the workshop will be asked to discuss the challenges in developing chemoprevention therapies (i.e., prevention therapies other than lifestyle changes, dietary supplements, or dietary choices that could reduce the risk of certain illnesses such as cancer, diabetes, and obesity). Because prevention of illness is widely recognized to be an important goal and the possible scope of this workshop is very broad, FDA welcomes comments related to the scope of this workshop.
Request for Public Comment: 60-Day Proposed Information Collection: Final Rule To Implement Title V of the Tribal Self-Governance Amendments of 2000
The Department of Health and Human Services (DHHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Indian Health Service (IHS) is providing a 60- day advance opportunity for public comment on a proposed extension of current information collection activity to be submitted to the Office of Management and Budget for review. Proposed Collection: Title: 0917-0026, ``Final Rule to Implement Title V of the Tribal Self-Governance Amendments of 2000''. Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917-0026, ``Final Rule to Implement Title V of the Tribal Self-Governance Amendments of 2000''. Form Number: None. Forms: None. Need and Use of Information Collection: The ``Tribal Self-Governance Amendments of 2000'', Pub. L. 106-206 (the act), repeals Title III of the Indian Self-Determination Act, Pub. L. 93-638, as amended, (ISDA) and enacts Title V that established a permanent Self-Governance program within DHHS. Thus, Indian and Alaska Native Tribes are now able to compact for the operation, control, and redesign of various IHS activities on a permanent basis. The final rule has been negotiated among representatives of Self-Governance and non- Self-Governance Tribes and the DHHS. The final rule included provision governing how DHHS/IHS carries out its responsibility to Indian Tribes under the Act and how Indian Tribes carry out their responsibilities under the Act. As required by section 517(b) of the Act, the Department has developed this final rule with active Tribal participation of Indian Tribes, inter-Tribal consortia, Tribal organizations and individual Tribal members, using the guidance of the Negotiated Rulemaking Act, 5 U.S.C. 561 et seq. Health status reporting requirements will be negotiated on an individual Tribal basis and included in individual compacts of funding agreements. Response to the data collection continues to be voluntary; however, submission of the data is essential to participation in the Tribal Self-Governance process. Self-Governance Tribes have the option of participating in a voluntary national uniform data collection effort with the IHS. The department is seeking continued OMB approval of the collection of information identified in the following sections of regulations: subpart CSelection of Tribes for Participation in Self-Governance, subpart D and ECompact and Funding Agreement, subpart NConstruction Projects, and Subpart P Appeals. Affected Public: Individual Tribes. Type of Respondents: Tribal representatives. The table below provides the estimated burden hours for this information collection:
Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Loan Repayment Program
The Department of Health and Human Services, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested date can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Indian Health Service (IHS) is providing a 60-day advance opportunity for public comment on a proposed extension of current information collection activity to be submitted to the Office of Management and Budget for review. Proposed Collection: Title: 0917-0014, ``Indian Health Service Loan Repayment Program.'' Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917- 0014, ``Indian Health Service Loan Repayment Program.'' Form Number: None. Forms: The IHS Loan Repayment Program Information Booklet contains the instructions and the application formats. Need and Use of Information Collection: The IHS Loan Repayment Program (LRP) identifies health professionals with pre-existing financial obligations for education expenses that meet program criteria and who are qualified and willing to serve at, often remote, IHS health care facilities. Under the program, eligible health professionals sign a contract under which the IHS agrees to repay part or all of their indebtedness for professional training education. In exchange, the health professionals agree to serve for a specified period of time in IHS health care facilities. Eligible health professionals that wish to apply must submit an application to participate in the program. The application requests personal, demographic and educational training information, including information on the educational loans of the individual for which repayment is being requested (i.e., date, amount, account number, purpose of each loan, interest rate, the current balance, etc.). The data collected is needed and used to evaluate applicant eligibility; rank and prioritize applicants by speciality; assign applicants to IHS health care facilities; determine payment amounts and schedules for paying the lending institutions; and to provide data and statistics for program management review and analysis. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides the estimated burden hours for this information collection:
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