Department of Health and Human Services June 3, 2005 – Federal Register Recent Federal Regulation Documents
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National Toxicology Program (NTP); Meeting of the NTP Board of Scientific Counselors Nanotechnology Working Group
The National Toxicology Program (NTP) has established the Nanotechnology Working Group (``the NWG'') to the NTP Board of Scientific Counselors in order to enhance public and stakeholder input into the NTP nanotechnology research program. The NWG is a technical advisory body established to provide a structured and formal mechanism for bringing stakeholders together to learn about NTP nanotechnology research related to public health, address issues related to that research, and promote dissemination of those discussions to other Federal agencies, nanotechnology stakeholders, and the public. The first meeting of the NWG is scheduled for June 24, 2005, at the NIEHS, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709.
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.
Fleet Alternative Fuel Vehicle Acquisition and Compliance Report
Pursuant to 42 United States Code 13218(b), the Department of Health and Human Services gives notice that the Department's FY 2004 Fleet Alternative Fuel Vehicle Acquisition and Compliance Report is available on-line at https://www.knownet.hhs.gov/log/AgencyPolicy/ HHSLogPolicy/afvcompliance.htm
Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and FDA's Division of Dockets Management.
Sentinel Network for Detecting Emerging Infections Among Allograft Donors and Recipients
Over the last decade, there has been a large increase in the number of allografts (e.g., solid organs and other tissues) recovered from donors for use in transplants. Each year in the United States, over 25,000 solid organs are recovered, and over a million tissue allografts are distributed for life-saving transplantations, including bone, musculoskeletal, vascular, and corneal tissues. Organs and tissues are distributed to different settings: Organs are distributed to transplant services in hospitals, and tissues are distributed to tissue banks, biotechnology companies, and healthcare consignees, including hospitals, outpatient centers, and individual surgeons. A single donor with undetected infection potentially can infect over a hundred organ and tissue recipients located around the world. In addition, tissues may be stored for up to ten years; thus, infections may be transmitted to recipients many years after the death of the donor. Recent investigations have demonstrated severe infections and death from transmission of various agents from donors to recipients, including: Clostridia spp. (e.g., C. sordellii, C. perfringens, C. septicum), West Nile virus, Group A Streptococcus, Trypanosoma cruzi, Lymphocytic choriomeningitis virus, rabies virus, and others. A recent Institute of Medicine report highlighted the urgent need to detect infectious diseases among organ and tissue donor and transplant recipients. Recently, additional regulatory mechanisms have been put in place. For solid organs, through the Organ Procurement and Transplantation Network (OPTN), new standards have been put in place to detect and report adverse events among organ transplant recipients; for other tissues, there will be new FDA rules for organ and tissue procurement organizations (OPOs) and tissue banks, implemented May 1, 2005. Despite these new regulatory standards, challenges remain. A surveillance network for surveillance of allograft-associated infections that would enhance communication between public health officials and organizations responsible for recovering and processing tissues would have high potential as a tool for risk assessment and response, in collaboration with regulatory efforts.
New Animal Drugs; Change of Sponsor
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 16 approved new animal drug applications (NADAs) from Purina Mills, Inc., to Virbac AH, Inc.
New Animal Drugs; Change of Sponsor's Name
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Steris Laboratories, Inc., to Watson Laboratories, Inc.
Findings of Scientific Misconduct
Notice is hereby given that the Office of Research Integrity (ORI), the Acting Assistant Secretary for Health, and another Federal agency have taken final action in the following case: Jason W. Lilly, Ph.D., Boyce Thompson Institute: Based on the report of an investigation conducted by the Boyce Thompson Institute (BTI Report), the investigation report of another Federal agency, and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Jason W. Lilly, Ph.D., former postdoctoral fellow at BTI, engaged in scientific misconduct in research supported by the National Research Service Award, National Institutes of Health (NIH) postdoctoral fellowship, F32 GM64276. This case has been jointly handled by ORI and another Federal agency under the government-wide debarment regulations. Specifically, PHS found that: A. Dr. Lilly falsified Figure 4, presenting a hierarchical cluster analysis of differential mRNA accumulation in cells grown in medium deficient in sulfate or phosphate in ``The Chlamydonomas reinhardtii organellar genomes respond transcriptionally and post-transcriptionally to abiotic stimuli,'' The Plant Cell 14:2681:2706, 2002 (hereafter referred to as the Plant Cell paper) by claiming it was an average of three experiments when only one had been conducted; B. Dr. Lilly further falsified Figure 4 of the Plant Cell paper by falsely coloring two cells in the blown-up portion of the figure that illustrated the induction of high levels of mRNA from the Sac1 gene; C. Dr. Lilly falsified the supplemental gene array experiments published online claimed to be replicate assays by manipulation of both spreadsheet and image data from a single assay to make the altered data sufficiently different to appear to be separate assays; D. Dr. Lilly falsified the text describing Figure 5 of the Plant Cell paper by claiming that the run-on assays had been replicated when they had not been; E. Dr. Lilly falsified the purported replicates of run-on transcription experiments provided in the on-line supplemental material by manipulation of a single assay to make the variant versions appear different; and F. Dr. Lilly falsified Figure 1 of the Plant Cell paper by using the same 16S control bands for RNA blots of two different genes (psbF and PsaG). Dr. Lilly has been debarred by the lead agency for a period of two (2) years, beginning on March 4, 2005, and ending on March 4, 2007, and has entered into a Voluntary Exclusion Agreement (Agreement ) with PHS in which he has voluntarily agreed: (1) 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 consultant, for a period of four (4) years, beginning on April 18, 2005; and (2) That he will ensure that any institution employing him submits, in conjunction with each application for PHS funds or report, manuscript, or abstract of PHS funded research in which Dr. Lilly is involved, a certification that the data provided by Dr. Lilly 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 for a period of two (2) years, beginning on April 18, 2007, approximately corresponding to the termination date of the debarment period initiated by the lead agency. Dr. Lilly must ensure that the institution also sends a copy of the certification to ORI.
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.
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