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 If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing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 http:// www.workplace.samhsa.gov and http://www.drugfreeworkplace.gov.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Linde Ceramics Plant, Tonawanda, 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 Linde Ceramics Plant, Tonawanda, 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: Linde Ceramics Plant. Location: Tonawanda, New York. Job Titles and/or Job Duties: All employees. Period of Employment: January 1, 1954 through July 31, 2006 (during the applicable covered residual radiation period).
Notice of a Public Meeting
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following public meeting to discuss NIOSH's Respirator Standards Development Efforts and the Personal Protective Technology (PPT) Program Action Planning Efforts.
Notice of Meeting of the Advisory Council on Blood Stem Cell Transplantation
Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the third meeting of the Advisory Council on Blood Stem Cell Transplantation (ACBSCT), Department of Health and Human Services (HHS). The meeting will be held from approximately 8:30 a.m. to 5 p.m. on December 15, 2008, and from 8:30 a.m. to 3:30 p.m. on December 16, 2008, at the Hyatt Regency Bethesda, One Bethesda Metro Center, Bethesda, Maryland 20814. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).
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: Jusan Yang, M.S., M.D., University of Iowa: Based on the report of an investigation conducted by the University of Iowa (UI) and additional analysis conducted by the Office of Research Integrity (ORI) in its oversight review, this settlement resolves proposed U.S. Public Health Service (PHS) findings that Dr. Jusan Yang, former Assistant Research Scientist, UI, engaged in scientific misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grant R01 HL48058. PHS finds the Respondent engaged in scientific misconduct by falsifying and fabricating data that were reported in a scientific manuscript intended for publication entitled ``Increased renin transcription after inhibition of NF-YA with RNAi reveals through regulation of Ea element and Ear2'' and at two professional scientific meetings. Specifically, PHS found that: 1. Respondent falsified Figure 1 in the manuscript that purports to show the effectiveness of four plasmids targeting different parts of the NF-Y coding sequence in inhibiting NF-Y expression by (1) Claiming in Figure 1A that the loading control bands were obtained by reprobing a Western blot with antibody to GAPDH when he used a prominent background (nonspecific) band from the blot probed with antibody to NF- YA, (2) inappropriately enhancing and manipulating the NF-YA band in Figure 1A claiming decreased expression of NF-YA in cultures transfected with 2 of the 4 constructs, and (3) falsely claiming in Figure 1B that the quantitative data for NF-YA expression obtained by scanning Western blot films were based on an n of 4 and that the expression of NF-YA in cultures treated with two constructs was statistically significantly lower than the control. Versions of the same falsified blot and histogram also were reported in several of the Respondent's public presentations. 2. Respondent falsified Figures 4, 5, 6, and 8 in the manuscript by claiming in the figure legends that 4 independent repetitions contributed to each figure's results when the actual numbers of repetitions were n=3 for Figure 4, n=1 for Figure 5, n=3 for Figure 6, and n=2 for Figure 8; in Figure 5, error bars based on the Student's t test further falsely claim that n was >2. He further falsified Figures 6 and 8 by reporting smaller standard errors of the mean than were obtained from the actual data, thereby giving an enhanced impression of rigor for the reported experiments. Respondent reported Figures 5, 6, and 8 (without legends) at the American Heart Association Council for High Blood Pressure meeting in September 2003, and he reported Figures 5 and 8 at the Experimental Biology meeting in April 2004. Respondent stated that he does not intend to apply for or engage in PHS-supported research. However, if such a circumstance were to arise, Respondent agreed for a period of five (5) years, beginning on October 14, 2008: (1) 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 him in any capacity on PHS supported research, or that submits a report of PHS funded research in which he 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 he will not participate in any PHS- supported research until such a supervision plan is approved by ORI; (2) That any institution employing the Respondent submits, in conjunction with each application for PHS funds or report, manuscript, or abstract of PHS funded research in which he 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, and methodology are accurately reported in the application or report; the Respondent must ensure that the institution also sends a copy of the certification to ORI; and (3) To exclude himself 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.
Agency Emergency Processing Under Office of Management and Budget Review; Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728
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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the burden hours required for the Animal Generic Drug User Fee Cover Sheet, Form FDA 3728 and the timeframe requirement under the Animal Generic Drug User Fee Act of 2008 (AGDUFA) (21 U.S.C. 379j-21) for implementing the new user fee cover sheet Form FDA 3728.
Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2009
This notice sets forth an update to the 60-day national episode rates and the national per-visit amounts under the Medicare prospective payment system for home health services, effective on January 1, 2009.
Fiscal Year (FY) 2009 Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $625,000 (total costs) per year for up to five years to the Community Anti-Drug Coalitions of America (CADCA). This is not a formal request for applications. Assistance will be provided only to the Community Anti-Drug Coalitions of America (CADCA) based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SP-09-004. Catalog Of Federal Domestic Assistance (CFDA) Number: 93.243. Authority: Sections 509, 516 and 520A of the Public Health Service Act, as amended. Justification: Only the Community Anti-Drug Coalitions of America (CADCA) is eligible to apply. The Substance Abuse and Mental Health Services Administration (SAMHSA) is seeking to award a single source grant to the Community Anti-Drug Coalitions of America (CADCA) to leverage existing resources and conference support to expand SAMHSA's scope and capacity to provide training and technical assistance to a large number of community leaders across the country who are committed to substance abuse prevention, substance abuse/addiction treatment and recovery support, and substance abuse/addiction-related mental health issues. The Community Anti-Drug Coalitions of America (CADCA) is uniquely qualified to carry out the activities of this program because the purpose of the program is to partner with a national organization that has special expertise and unique broad, national-level experience in working with community anti-drug coalitions. CADCA is the only national organization that annually provides training and technical assistance through a national leadership conference for thousands of members of community coalitions dedicated to preventing substance abuse. CADCA currently is the sole organization that plays a major role in helping to strengthen and develop the nation's prevention infrastructure of anti-drug coalitions in support of on-going activities funded by SAMHSA's priority grant programs including: the Substance Abuse Prevention and Treatment Block Grant, the Strategic Prevention Framework State Incentive Grant, and the Drug Free Communities Support Program. CADCA is the only identified organization that currently meets this experience level and national reach to over 5,000 identified anti- drug coalitions across the country. CADCA has long been recognized in communities as well as States throughout the nation as the national voice for the advocacy and technical support of anti-drug coalitions. As such, it is uniquely qualified and positioned to carry out the requirements of this announcement. Contact: Shelly Hara, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Room 8-1081, Rockville, MD 20857; telephone: (240) 276-2321; E-mail: email@example.com.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level
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 the information collection contained in the guidance for industry on formal dispute resolution.
Proposed Collection; Comment Request; Follow-Up of Kidney Cancer Patients From the Central European Multicenter Case-Control Study
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: Follow-up of Kidney Cancer Patients from the Central European Multicenter Case-Control Study. Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of this questionnaire is to obtain information on the 5-year survival status of kidney cancer patients that were enrolled in a Central European Case-Control Study of Kidney Cancer that was conducted between 2001-2004. The aim is to assess survival, the prevalence of recurrent disease and progression, and to investigate patient, tumor and genetic determinants of survival among cases. The questionnaire will collect information on patient related factors, tumor related factors not collected during the initial study, and the type of treatment(s) received since the patients were last contacted for the case-control study. This questionnaire adheres to The Public Health Service Act, section 412 (42 U.S.C. 285a-1) and section 413 (42 U.S.C. 285a-2), which authorizes the Division of Cancer Epidemiology and Genetics of the National Cancer Institute (NCI) to establish and support programs for the detection, diagnosis, prevention and treatment of cancer; and to collect, identify, analyze and disseminate information on cancer research, diagnosis, prevention and treatment. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Individuals that had previously participated in the Central European Renal Cancer Case-Control Study between 2001-2004 and physician abstractors. The estimated total annual burden hours requested is 296. The annualized cost to respondents is estimated at $5174. There are no additional capital costs, operating costs, and/or maintenance costs to report.
Oral Dosage Form New Animal Drugs; Firocoxib Tablets
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 Merial Ltd. The supplemental NADA provides for veterinary prescription use of firocoxib chewable tablets in dogs for the control of postoperative pain and inflammation associated with orthopedic surgery.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Infant Formula Recall Regulations
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Infant Formula Recall Regulations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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: ``AHRQ Healthcare Innovations Exchange Innovator Interview and AHRQ Healthcare Innovations Exchange Innovator E-mail Submission Guidelines.'' 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. This proposed information collection was previously published in the Federal Register on August 2008 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
Request for Public Comment: 30-Day Proposed Information Collection: Behavioral Health Preventive Care Assessment Focus Group Guide
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection project was previously published in the Federal Register (73 FR 23254) on April 29, 2008 and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917-NEW, ``Behavioral Health Preventative Care Assessment Focus Group.'' Type of Information Collection Request: Three year approval for this new information collection, 091 7-NEW, ``Behavioral Health Preventive Care Assessment Focus Group Guide.'' Form Number(s): None. Need and Use of Information Collection: The IHS goal is to raise the health status of the American Indian and Alaska Native people to the highest possible level by providing comprehensive health care and preventive health services. To support the IHS mission, IHS uses the Government Performance Act (GPRA) to assess quality of care among its Federal, urban, and Tribal health programs. The IHS has been largely successful in meeting GPRA targets for selected clinical performance measures at the national level. However, there is significant variability in performance among IHS and Tribal service units. Until this time, IHS has not undertaken any comprehensive studies to evaluate the reasons for that variability or the factors that contribute to high quality care at the local level. The IHS has three GPRA measures relating to behavioral health, a high priority for the Agency and one of the IHS Director's Initiatives. This study will focus on these three GPRA behavioral health measures: Depression Screening in adults age 18 and over, Domestic/Intimate Partner Violence screening in women ages 15-40 and Alcohol Screening (to prevent Fetal Alcohol Syndrome) in women ages 15-44. Tribal programs voluntarily report their GPRA results quarterly and annually for national reporting. GPRA data collected for these three behavioral health measures includes: The number of patients eligible for a screening (denominator), number of eligible patients who receive a screening (numerator), and the resulting screening rate (percentage). IHS has developed a methodology to identify superior and poor performers on these measures in both Tribal and Federal sites using fiscal year 2005, 2006, and 2007 GPRA performance results. IHS will convene focus groups with employees at 17 of these programs (7 IHS and 10 Tribal) in order to identify the factors contributing to (and when appropriate, the barriers preventing) the provision of high quality behavioral health care at the local level. These focus groups will allow employees to provide detailed data regarding program practices, screening and documentation procedures, initiatives, resources, and other factors relating to the provision of behavioral health preventive care at their health program. A total of two to three focus groups, organized by occupational specialty, will be convened at each program. Using the Chronic Care Model and Institute of Medicine recommendations, IHS will analyze the information collected during these site visits, along with background information that is publicly available (e.g., information found on clinic Web pages) on other qualitative and quantitative features of individual programs, such as staffing and funding levels, community demographics, and organizational structure, to develop a behavioral health preventive care model relevant to the unique system of IHS delivery. Affected Public: Individuals. Type of Respondents: Tribal employees at Tribal health programs. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Number of total annual responses, Average burden hour per response, and Total annual burden hour(s).