Department of Health and Human Services August 2006 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 288
Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Correction
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of July 25, 2006 (71 FR 42031). The document amended the voluntary nutrition labeling regulations by updating the names and the nutrition labeling values for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States. The document published with incorrect units of measures for nutrients and an incorrect number in the Final Regulatory Impact Analysis section. This document corrects those errors.
Privacy Act of 1974; Report of a Revised System of Records
Notice is hereby given that the Office of the Assistant Secretary for Administration and Management, Program Support Center, HHS, is proposing to amend its existing System of Records (SOR) entitled, ``PSC Parking Program and PSC Transhare Program Records, No. 09-40-0013.'' This amendment will change the name of the system and incorporate the activities of the PSC security and personal identification verification services into the existing SOR and provide for a more effective application of services. We have provided background information about the amended system in the SUPPLEMENTARY INFORMATION section below.
Medicare Program; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Supplier Accreditation Applications From Independent Accrediting Bodies
This notice informs independent accreditation organizations of an opportunity to submit an application to participate in the durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) accreditation program. DMEPOS accreditation is required for DMEPOS suppliers. This notice contains information on how to apply for CMS approval.
Public Meeting of the President's Council on Bioethics on September 7-8, 2006
The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its twenty-sixth meeting, at which, among other things, it will hear presentations on and discuss issues in two broad areas: (1) Organ procurement, allocation, and transplantation and (2) the personal, social, and policy-related significance of genetic information and knowledge. The discussions in both areas are continuations of previous Council discussions. Subjects discussed at past Council meetings (although not on the agenda for the September 2006 meeting) include: human dignity, therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, 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).
Fees for Sanitation Inspections of Cruise Ships
This notice announces fees for vessel sanitation inspections for fiscal year 2007 (October 1, 2006, through September 30, 2007).
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 of the Citizens' Health Care Working Group (Working Group) mandated by section 1014 of the Medicare Modernization Act.
Office of the National Coordinator, American Health Information Community Biosurveillance Data Steering Group Meeting
This notice announces the fourth meeting of the American Health Information Community Biosurveillance Data Steering Group in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator; American Health Information Community Biosurveillance Workgroup Meeting
This notice announces the eighth meeting of the American Health Information Community Biosurveillance Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Confidentiality and Security Workgroup Meeting
This notice announces the rescheduled date of the first meeting of the American Health Information Community Confidentiality and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.). The Confidentiality and Security Workgroup was created by the American Health Information Community as a cross-cutting Workgroup comprised of privacy, security, clinical, and technical experts, as well as representation from the consumer perspective. New Date Time: August 21, 2006, 1 p.m. to 4 p.m. This meeting was previously scheduled to be held on August 4, 2006.
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.
Draft Guidance for Industry on an Amendment Involving Donor Deferral for Transfusion in France Since 1980 to “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products”; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to `Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products,''' dated August 2006. The draft guidance document, when finalized, is intended to amend FDA's ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products'' dated January 2002. This draft guidance, which is a level I guidance document, would add to the January 2002 guidance a donor deferral recommendation for donors who have received a transfusion of blood or blood components in France since 1980. After we review comments received on this draft guidance, we intend to incorporate this donor deferral recommendation and reissue the revised January 2002 guidance as a level II guidance document for immediate implementation.
Guidance for Industry on Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin G (IgG) Antibodies; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease- Associated and Other Immunoglobulin G (IgG) Antibodies,'' dated August 2006. The guidance document is intended to assist Source Plasma manufacturers in submitting to FDA the appropriate information when implementing an IgG antibody collection program or when adding a new IgG antibody collection to an existing program. This guidance finalizes the draft guidance entitled ``Guidance for Industry: Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies,'' dated October 2005, and supersedes the draft reviewers' guide entitled ``Disease Associated Antibody Collection Program,'' dated October 1, 1995.
Privacy Act of 1974; Proposed Altered System of Records
In accordance with the requirements of the Privacy Act of 1974, as amended (Privacy Act), the National Institutes of Health (NIH) hereby publishes a notice of a proposal to alter System of Records, No. 09-25-0168, ``Invention, Patent, and Licensing Documents Submitted to the Public Health Service by its Employees, Grantees, Fellowship Recipients, and Contractors, HHS/NIH/OD.'' NIH proposes a new legal authority for the maintenance of the System to read: 15 U.S.C. 3710, 3710a, 3710c & 3710d and 35 U.S.C. 200 et seq. provide authority to maintain the records; 37 CFR part 401 ``Rights to Inventions Made by Nonprofit Organizations and Small Business Firms under Government Grants, Contracts, and Cooperative Agreements;'' 37 CFR part 404 ``Licensing of Government Owned Inventions;'' and 45 CFR part 7 ``Employee Inventions.'' NIH is also proposing new routine uses for this System. These records will be maintained by the Office of Technology Transfer (OTT), OIR/OD; Office of Financial Management (OFM), OD; Office of Reports and Analysis (ORA), OER/OD; Health and Human Services Technology Development Coordinators and HHS Contract Attorneys who retain files supplemental to the records maintained by the Office of Technology Transfer; and the Extramural Inventions and Technology Resources Branch, OPERA/OER/OD.
Privacy Act of 1974; Proposed Altered System of Records
The Department of Health and Human Services proposes to alter System of Records, 09-25-0168, ``Invention, Patent, and Licensing Documents Submitted to the Public Health Service by its Employees, Grantees, Fellowship Recipients, and Contractors, HHS/NIH/OD.'' NIH proposes a new legal authority for the maintenance of the System to read: 15 U.S.C. 3710, 3710a, 3710c & 3710d and 35 U.S.C. 200 et seq. provide authority to maintain the records; 37 CFR Part 401 ``Rights to Inventions Made by Nonprofit Organizations and Small Business Firms under Government Grants, Contracts, and Cooperative Agreements;'' 37 CFR Part 404 ``Licensing of Government Owned Inventions;'' and 45 CFR Part 7 ``Employee Inventions.'' NIH is also proposing new routine uses for this System. These records will be maintained by the Office of Technology Transfer (OTT), OIR/OD; Office of Financial Management (OFM), OD; Office of Reports and Analysis (ORA), OER/OD; Health and Human Services Technology Development Coordinators and HHS Contract Attorneys who retain files supplemental to the records maintained by the Office of Technology Transfer; and the Extramural Inventions and Technology Resources Branch, OPERA/OER/OD.
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.
Proposed Collection; Comment Request; Pre-Testing of NCI Communication Messages
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Pretesting of NCI Communication Messages. Type of Information Collection Request: EXTENSION (OMB 0925-0046, expires 10/31/06). Need and Use of Information Collection: In order to carry out NCI's legislative mandate to educate and disseminate information about cancer prevention, detection, diagnosis, and treatment to a wide variety of audiences and organizations (e.g. cancer patients, their families, the general public, health providers, the media, voluntary groups, scientific and medical organizations), it is beneficial for NCI to pretest their communications strategies, concepts, and messages while they are under development. The primary purpose of this pretesting, or formative evaluation, is to ensure that the messages, communication materials, and information services created by NCI have the greatest capacity of being received, understood, and accepted by their target audiences. By utilizing appropriate qualitative and quantitative methodologies, NCI is able to (1) understand characteristics of the intended target audiencetheir attitudes, beliefs, and behaviorsand use this information in the development of effective communication tools and strategies; (2) produce or refine messages that have the greatest potential to influence target audience attitudes and behavior in a positive manner; and (3) expend limited program resource dollars wisely and effectively. Frequency of Response: On occasion. Affected Public: Individuals or households; Businesses or other for profit; Not-for- profit institutions; Federal Government; State, Local, or Tribal Government. Type of Respondents: Adult cancer patients; members of the public; health care professionals; organizational representatives. The annual reporting burden is as follows: Estimated Number of Respondents: 13,780; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: .1458; and Estimated Total Annual Burden Hours Requested: 2,010. The annualized cost to respondents is estimated at: $34,155. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
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 Exclusive License: Treatment of Cardiovascular Conditions With Nitrite Therapy
This is notice, in accordance with 35 U.S.C. Sec. 209(c)(1) and 37 CFR Sec. (a)(1)(I), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the invention embodied in: PCT patent application PCT/US2004/041256 filed December 9, 2004, entitled: ``Methods for Suppressing an Immune Response or Treating a Proliferative Disorder'' [HHS Reference Number: E-259-2003/0-PCT-02], to Sahajanand Medical Technologies Pvt. Ltd., registered as a private limited company in accordance with the Companies Act of India, having a principle place of business in Surat, India and U.S. headquarters in Gaithersburg, Maryland. The field of use may be limited to the use of 2-(4-piperazinyl)-8-phenyl-4H-1-benzopyran-4-one (LY303511), for the treatment and prevention of stenosis and restenois and/or other proliferative disorders. The United States of America is an assignee of the patent rights in these inventions.
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 expeditions 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.
Proposed Collection: Comment Request; National Institute of Diabetes and Digestive and Kidney Diseases Information Clearinghouses Customer Satisfaction Survey
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institutes of Health (NIH), is giving public notice that the agency proposes to request reinstatement of an information collection activity for which approval has expired. Proposed Collection: Title: NIDDK Information Clearinghouses Customer Satisfaction Survey. Type of Information Requested: Reinstatement, with change, of a previously approved collection for which approval has expired. The OMB control number 0925-0480 expired on July 31, 2003. Need and Use of Information Collection: NIDDK is conducting a survey to access the efficiency and effectiveness of services provided by NIDDK's three clearinghouses: the National Diabetes Information Clearinghouse (NDIC); the National Digestive Diseases Information Clearinghouse (NDDIC); and the National Kidney and Urologic Diseases Information Clearinghouse (NKUDRIC). The survey responds to Executive Order 12821, ``Setting Customer Service Standards,'' which requires agencies and departments to identify and survey their ``customers to determine the kind and quality of service they want and their level of satisfaction with existing services.'' Frequency of Response: On occasion. Affected Public: Individuals or households; business and for profit organizations; not-for-profit agencies, Type of Respondents: Physicians, healthcare professionals, patients, family and friends of patients. The annual reporting burden is as follows: estimated number of respondents: 5,112; estimated number of responses per respondent: 1; estimated average burden hours per response: 0.025; and estimated total annual burden hours requested: 128. The annualized costs to respondents are estimated at $6,400. There are no capital costs to report. There are no operating or maintenance costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of the information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
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.
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 Exclusive License: Recombinant Antibodies and Immunoconjugates Targeted to CD-22 Bearing Cells and Tumors
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 U.S. Patent Application No. 09/381,497, filed September 20, 1999, entitled ``Recombinant Antibodies and Immunoconjugates Targeted to CD-22 Bearing Cells and Tumors'' [E-059-1997/0-US-07]; European Patent Application No. 98912977.0, filed October 13, 1999, entitled ``Recombinant Antibodies and Immunoconjugates Targeted to CD-22 Bearing Cells and Tumors'' [E-059-1997/0-EP-05]; Japanese Patent Application No. 10- 540812, filed March 19, 1998, entitled ``Recombinant Antibodies and Immunoconjugates Targeted to CD-22 Bearing Cells and Tumors'' [E-059- 1997/0-JP-06]; Australian Patent No. 740904, issued on February 28, 2002, entitled ``Recombinant Antibodies and Immunoconjugates Targeted to CD-22 Bearing Cells and Tumors'' [E-059-1997/0-AU-03]; and Canadian Patent Application No. 2284665, filed March 19, 1998, entitled ``Recombinant Antibodies and Immunoconjugates Targeted to CD-22 Bearing Cells and Tumors'' [E-059-1997/0-CA-04]; to Cambridge Antibody Technology, Ltd., which has offices in Cambridge, United Kingdom. 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 use of the BL22 and HA22 and variants thereof as claimed in the licensed patent rights for the treatment of hematologic malignancies.
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