Department of Health and Human Services July 2008 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 261
Medicare Program; Announcement of Three New Members to the Advisory Panel on Ambulatory Payment Classification (APC) Groups
This notice announces three new members selected to serve on the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary, DHHS (the Secretary), and the Administrator, CMS (the Administrator), concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the annual updates of the hospital outpatient prospective payment system (OPPS).
Medicare Program; Request for Nominations and Meeting of the Practicing Physicians Advisory Council, August 18, 2008
This notice invites all organizations representing physicians to submit nominations for consideration to fill two seats on the Practicing Physicians Advisory Council (the Council) that will be vacated by current Council members in 2009. This notice also announces a quarterly meeting of the Council. The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.
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.
Revised Draft Document “Asbestos Fibers and Other Elongated Mineral Particles: State of the Science and Roadmap for Research”
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following revised draft document available for public comment entitled ``Asbestos Fibers and Other Elongated Mineral Particles: State of the Science and Roadmap for Research.'' The document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/review/public/099-A/. Public Comment Period: July 24, 2008 through September 30, 2008. Status: Written comments may be mailed to the attention of Diane Miller, NIOSH Docket Office, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS-C34, Cincinnati, Ohio 45226, telephone (513) 533-8450, facsimile (513) 533-8285. Comments may also be submitted by e-mail to nioshdocket@cdc.gov. All material submitted to the Agency should reference the NIOSH Docket number 099-A. All electronic comments should be formatted as Microsoft Word. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Purpose: To obtain comments from the public on the revised draft document entitled, ``Asbestos Fibers and Other Elongated Mineral Particles: State of the Science and Roadmap for Research,'' referred to as Roadmap. Asbestos has been a highly visible issue in public health for over three decades. Many advances have been made in the scientific understanding of worker health effects from exposure to asbestos and other elongated mineral particles (EMPs), and it is now well documented that fibers of asbestos minerals, when inhaled, can cause serious diseases in exposed workers. Yet, many questions and areas of scientific uncertainty remain. Background: As the Federal agency responsible for conducting research and making recommendations for the prevention of worker injury and illness, NIOSH is undertaking a reappraisal of how to ensure appropriate protection of workers from exposure to asbestos fibers and other EMPs. NIOSH prepared a first draft of the document ``Asbestos and Other Mineral Fibers: A Roadmap for Scientific Research,'' and invited comments at a public meeting, from the Internet, and from selected expert peer reviewers on the occupational health issues identified and the framework for research. As a result of comments received during the public and expert peer review process, NIOSH has substantially revised the earlier draft and is now inviting comments on a revised draft of the document with the new title ``Asbestos Fibers and Other Elongated Mineral Particles: State of the Science and Roadmap for Research.'' The previous draft, public comments, peer review comments, and the responses to peer reviewers' comments on the previous draft can be found at https://www.cdc.gov/niosh/docket/NIOSHdocket0099.html. The purpose of the revised draft Roadmap is to outline major areas of controversy and to recommend a research agenda that can serve as a guide for the development of specific research programs within and across disciplines. The intended goal is to provide answers to current scientific questions, reduce scientific uncertainties, and provide a sound scientific foundation for future policy development so that optimal health protection can be assured. NIOSH is seeking comments on the scope and information used to support the development of a research framework for asbestos fibers and other EMPs. Of special interest are comments on the following revisions to the draft document: 1. A discussion of particle characteristics (e.g., dimension, chemistry) and their potential influence on biological responses (Sections 1.6.1, 1.6.2, 1.6.3, and 1.6.4). 2. Toxicological research with EMPs (Section 2.2). 3. Epidemiological studies of workers exposed to EMPs (Section 2.3.3). 4. Capabilities and limitations of analytical instruments used to identify EMPs (Section 2.4.2). Also of special interest are comments on the entirely new content in the document: 1. A rephrasing of the NIOSH recommended exposure limit (REL) for asbestos and related EMPs (Section 1.8.2). 2. The inclusion of ``How the proposed research could lead to the development of improved public health policies for asbestos and other EMPs'' (Section 2.5). 3. Clinical issues (Section 1.4). 4. Recommendations for clinical research (Section 2.3.4). NIOSH continues to be interested in available and forthcoming research results that can help answer the questions set forth in the Roadmap, as well as information on existing workplace exposure data, health effects, and control technologies. Submitted comments on the revised draft Roadmap should indicate the pertinent page(s) and line(s) in the draft document being addressed. Contact Person for Technical Information: Paul Middendorf, Office of the Director, NIOSH, CDC, telephone (513) 533-8606, e-mail pmiddendorf@cdc.gov.
Prospective Grant of Exclusive License: Respiratory Syncytial Virus Vaccine or Therapeutic
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Centers for Disease Control and Prevention (CDC), Technology Transfer Office, Department of Health and Human Services (DHHS), is contemplating the grant of a worldwide exclusive license to practice the inventions embodied in the patent referred to below to Trellis Bioscience, Inc., having a place of business in South San Francisco, CA. The patent rights in these inventions have been assigned to the government of the United States of America. The patent(s) to be licensed are: U.S. Patent Application 11/139,372 entitled ``Compositions and Methods for Modulating RSV Infection and Immunity,'' priority date 10.18.2000, and all related foreign patent applications. CDC Technology ID No. I-022-00. Status: Published. Priority Date: 10.18.2000 The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. Technology: This technology provides new methods for prevention and treatment of respiratory syncytial virus (RSV) infection.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``National Study of the Hospital Adverse Event Reporting Follow-Up Survey.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.
Cost Allocation Methodology Applicable to the Temporary Assistance for Needy Families Program
This final rule applies to the Temporary Assistance for Needy Families (TANF) program and requires States, the District of Columbia and the Territories (hereinafter referred to as the ``States'') to use the ``benefiting program'' cost allocation methodology in U.S. Office of Management and Budget (OMB) Circular A-87 (2 CFR part 225). It is the judgment and determination of HHS/ACF that the ``benefiting program'' cost allocation methodology is the appropriate methodology for the proper use of Federal TANF funds. The Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) of 1996 gave federally-recognized Tribes the opportunity to operate their own Tribal TANF programs. Federally-recognized Indian tribes operating approved Tribal TANF programs have always followed the ``benefiting program'' cost allocation methodology in accordance with OMB Circular A-87 (2 CFR part 225) and the applicable regulatory provisions at 45 CFR 286.45(c) and (d). This final rule contains no substantive changes to the proposed rule published on September 27, 2006.
Designation of Medically Underserved Populations and Health Professional Shortage Areas
The Health Resources and Services Administration (HRSA) received many substantive comments on the proposed rule and will consider these comments carefully. Based on a preliminary review of the comments, it appears that HRSA will need to make a number of changes in the proposed rule. Instead of issuing a final regulation as the next step, HHS will issue a new Notice of Proposed Rulemaking for further review and public comment prior to issuing a final rule.
Food Safety and Security Monitoring Project
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Federal-State Relations (DFSR), is announcing the availability of cooperative agreements for equipment, supplies, personnel, training, and facility upgrades to Food Emergency Response Laboratory Network (FERN) chemistry laboratories of State, local, and tribal governments. The cooperative agreements are to enable the analyses of foods and food products in the event that redundancy and/or additional laboratory surge capacity is needed by FERN for analyses related to chemical terrorism. These grants are also intended to expand participation in networks to enhance Federal, State, local, and tribal food safety and security efforts.
Directory of State and Local Officials and State Food Safety Resource Survey Support Project
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Federal-State Relations (DFSR) is announcing the availability of a Sole Source to the Association of Food and Drug Officials (AFDO) to provide funding for a 3-year cooperative agreement award to support a Special Project Cooperative Agreement program. No other applications are solicited. This cooperative agreement is intended to have AFDO update and maintain the FDA Directory of State and Local Officials and to update the AFDO document ``State Food Safety Resource Survey (2000)'' by providing funding for additional personnel, equipment, and supplies to support activities related to these projects.
Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Postponement of Meeting
The Food and Drug Administration (FDA) is postponing the meeting of the Peripheral and Central Nervous Drugs Advisory Committee scheduled for August 6 and 7, 2008. This meeting was announced in the Federal Register of July 8, 2008 (73 FR 39017). The postponement is due to difficulties in empanelling the necessary experts due to both scheduling conflicts and conflict-of-interest issues.
Advisory Commission of Childhood Vaccines; Request for Nominations for Voting Members
The Health Resources and Services Administration (HRSA) is requesting nominations to fill three vacancies on the Advisory Commission on Childhood Vaccines (ACCV). The ACCV was established by title XXI of the Public Health Service Act (the Act), as enacted by Public Law (Pub. L.) 99-660 and as subsequently amended, and advises the Secretary of Health and Human Services (the Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP).
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: Roxana Gonzalez, Carnegie Mellon University: Based on reports submitted by Carnegie Mellon University's (CMU) inquiry and investigation committees, the Respondent's own admission in sworn testimony, and additional analysis conducted by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that Roxana Gonzalez, graduate student, Department of Social and Decision Sciences and Psychology, CMU, engaged in scientific misconduct in research supported by National Institute of Mental Health (NIMH), National Institutes of Health (NIH), grants R01 MH56880, R03 MH62376, and R24 MH67346. Specifically, PHS found that Ms. Gonzalez engaged in the following acts of scientific misconduct: 1. Respondent altered the main dependent variable (life events; life expectation) in the electronic file and the manipulation check variables for ease-of-thought generation so that the reported study results are largely unsupported in: (a) Publication: Lerner, J.S., & Gonzalez, R.M. ``Forecasting one's future based on fleeting subjective experiences.'' Personality and Social Psychology Bulletin 31:454-466, 2005; (b) 2005 Manuscript: Lerner, J. S., & Gonzalez, R. M. ``On perceiving the self as triumphant when happy or angry''; (c) Review Article: Lerner J. S., Tiedens, L.Z., & Gonzalez, R. M. ``Portrait of the angry decision maker: How appraisal tendencies shape anger's influence on cognition.'' Journal of Behavioral Decision Making: Special Issue on Emotion and Decision Making. 2. Respondent falsified cortisol values, and possibly cardiovascular measures and optimistic appraisals (as measured by LOT), so that a large portion of the mediation analyses of Table 3 does not reflect the data actually collected and analyzed for the study reported in a publication (Lerner, J.S., Gonzalez, R.M., Dahl, R.E., Hariri, A.R., & Taylor, S.E. ``Facial expressions of emotion reveal neuroendocrine and cardiovascular stress responses.'' Biological Psychiatry 58:743-750, 2005). Respondent further allowed one of her collaborators to report the results from this study at the Annual Meeting of the American Psychological Society held in Los Angeles, California in May 2005, although Respondent's collaborator did not know at the time that the results were tainted by Respondent's acts of research misconduct. 3. Respondent falsified the analyses based on participants' responses to the manipulation check items (including the data for self reported fear) in a study reported in a publication (Fischhoff, B., Gonzalez, R.M., Lerner, J.S., & Small, D.A. ``Evolving judgments of terrorism's risks: Foresight, hindsight, and emotion.'' Journal of Experimental Psychology: Applied 11:124-139, 2005. 4. Respondent falsified the main dependent variable (reservation price, BDM) in the electronic file for 48 of the 175 subjects participating in a study reported in a 2005 manuscript (Lerner, J.S., Gonzalez, R.M., Small, D.A., Lowenstein, G., & Dahl, R.E. ``Emotional influence on economic behavior among adolescents.''). Respondent directed the alteration of the paper files for those subjects in order to match the altered electronic file. One of Respondent's collaborators included a qualitative description of the results of the research that is the subject of this study in an NIH grant application, although Respondent's collaborator did not know at the time that the results were tainted by the Respondent's acts of research misconduct. ORI acknowledges Ms. Gonzalez' extensive cooperation with CMU's research misconduct proceedings. Ms. Gonzalez has entered into a Voluntary Exclusion Agreement (Agreement) in which she has voluntarily agreed, beginning on June 26, 2008: (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 a consultant or contractor to PHS, for a period of three (3) years; (2) That for a period of three (3) years, any institution that submits an application for PHS support for a research project on which the Respondent's participation is proposed or that 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 agrees to ensure that a copy of the supervisory plan is also submitted to ORI by the institution; Respondent agrees that she will not participate in any PHS-supported research until such a supervisory plan is submitted to ORI; (3) for a period of three (3) years to ensure that any institution employing her submits, in conjunction with each application for PHS funds or report, manuscript, or abstract of PHS-funded research in which the Respondent is involved, a certification that the data provided by the Respondent are based on actual experiments or are otherwise legitimately derived, and that the data, procedures, analyses, and methodology are accurately reported in the application, report, manuscript or abstract; the Respondent must ensure that the institution sends a copy of the certification to ORI; and (4) to write ORI-approved letters to (a) collaborators/coauthors of the manuscripts and published papers cited above, stating what she falsified/fabricated and offering restitution; and (b) editors of the journals in which papers were published (even if they have been retracted/corrected) to state that her falsifications/fabrications were the underlying reason for the retraction/correction.
Medicare Program; Evaluation Criteria and Standards for Quality Improvement Program Contracts (9th Scope of Work)
This notice with comment period describes the general criteria we intend to use to evaluate the efficiency and effectiveness of the Quality Improvement Organizations (QIOs) who will enter into contract with CMS under the 9th SOW on August 1, 2008. The evaluation of the QIOs' performance related to their Statement of Work (SOW) will be based on evaluation criteria specified within the themes, tasks, and subtasks set forth in the QIO's 9th SOW.
Food and Drug Administration Critical Path Workshop on Clinical Trials for Local Treatment of Breast Cancer by Thermal Ablation
The Food and Drug Administration (FDA) is announcing a public workshop to discuss the issues associated with the development and implementation of feasibility trials for local treatment of breast cancer by thermal ablation (i.e., cryoablation, focused ultrasound, interstitial laser, microwave, radiofrequency ablation). We are inviting individuals, companies, organizations, and other stakeholders to attend this public workshop to discuss how standardized protocols for evaluation of tissue biopsy pathology, selection of tumors amenable to ablation, image guidance for ablation, post-ablation imaging and assessment, and tissue pathology of ablated specimens can be developed and used in breast cancer thermal ablation clinical trials. The public workshop will also serve as a forum for discussing where within the multispecialty care path involving operative therapy, chemotherapy, and radiation therapy, thermal ablation may play a role. Date and Time: The public workshop will be held on September 15, 2008, from 9 a.m. to 6 p.m. Online registration is available at https:// www.blsmeetings.net/2008ThermalAblationWorkshop until 5 p.m. on August 30, 2008 (see section III of this document for details). Location: The public workshop will be held at the FDA White Oak Campus, conference rooms 2047 F and G (https://grouper.ieee.org/groups/ scc34/sc2/meetinginfo/MeetingWhiteOak15-18OCT2007/WhiteOak CampusInfo2007.pdf) located at 10903 New Hampshire Ave., Silver Spring, MD 20993. Contact: Binita Ashar, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3600, e-mail: Binita.Ashar@FDA.HHS.gov. If you need special accommodations due to a disability, please contact Paula Gumbs at 301-594-4453 at least 7 days in advance.
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Kellex/Pierpont facility in Jersey City, New Jersey, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 30, 2008, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Brookhaven National Laboratory, Upton, NY, 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 Brookhaven National Laboratory, Upton, New York, 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: Brookhaven National Laboratory. Location: Upton, New York. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1947 through December 31, 2007.
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