Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
National Vaccine Injury Compensation Program: Addition to the Vaccine Injury Table to Include All Vaccines Against Seasonal Influenza
Through this notice, the Secretary of the U.S. Department of Health and Human Services (the Secretary) announces that all FDA- approved vaccines against seasonal influenza are covered under the National Vaccine Injury Compensation Program (VICP), which provides a system of no-fault compensation for certain individuals who have been injured by covered childhood vaccines. Prior to this publication, trivalent influenza vaccines were included under Category XIV on the Vaccine Injury Table (Table) and will continue to be listed in that category. This notice serves to include all vaccines against seasonal influenza (not already covered under Category XIV) as covered vaccines under Category XVII of the Table (new vaccines covered under the VICP). This notice ensures that petitioners may file petitions relating to all vaccines against seasonal influenza (not already covered under the VICP) with the VICP even before such vaccines are added as a separate and distinct category to the Table through rulemaking.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Hao Wang, M.D., Ph.D., Western UniversityCanada (formerly University of Western Ontario): Based on the report of an investigation conducted by Western UniversityCanada (WU) and ORI's subsequent oversight analysis, ORI found that Dr. Hao Wang, former Associate Professor of Surgery and Pathology, Schulich School of Medicine and Dentistry, WU, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), subaward 0016244 from Prime Award U01 AI074676 to the University of Pittsburgh. ORI found that Respondent engaged in research misconduct by falsifying data that were included in: An abstract and poster presentation for the 2011 American Transplant CongressAbstract [1537.5]: Wang, H., Baroja, M., Lan, Z., Arp, J., Lin, W., Relmann, K., Garcia, B., Jevnikar, A., & Rothstein, D. ``Combination of Novel Anti-CD45RB and Anti-CD40 Chimeric Antibodies Proglons Renal Allograft Survival in Cynomolgus Monkeys.'' Specifically, ORI found that the Respondent falsified the status of two animals as successfully treated renal allograft recipients in a 2011 American Transplant Congress abstract and meeting presentation and in false representations to the project principal investigators and colleagues. Respondent falsely claimed long term survival, normal serum creatinine concentrations, and lack of adverse effects in two Cynomolgus monkeys treated with chimeric antibodies following bilateral nephrectomies and receipt of renal allografts, when in fact the transplant surgery had failed and the animals' survival was due to a native kidney that was left in place in each animal. Respondent also falsified or failed to correct known falsifications (identifying the two monkeys as transplant recipients) in numerous clinical records, including anesthesia records, progress, notes, treatment records, and clinical laboratory reports. It is expressly agreed that while Respondent asserts that there are extenuating factors for his actions, Respondent agrees to enter into the Agreement because contesting the findings would cause him undue financial hardship and stress, and Respondent wishes to seek finality. Respondent also claims that based on the data obtained from the same experimental group, the removal of these two monkeys from the data would not alter the scientific conclusion. Dr. Wang has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of three (3) years, beginning on October 22, 2013: (1) To have his research supervised; Respondent agreed that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which the Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of his duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent agreed that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed-upon supervision plan; (2) that any institution employing him shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived, that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract, and that the text in such submission is his own or properly cites the source of copied language and ideas; and (3) to exclude himself voluntarily 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 Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Draft Report on Carcinogens Monographs for ortho-Toluidine and Pentachlorophenol and By-products of Its Synthesis; Availability of Documents; Request for Comments; Notice of Rescheduled Meeting
The notice announces the meeting to peer review the Draft Report on Carcinogens (RoC) Monographs for ortho-Toluidine and Pentachlorophenol and By-products of its Synthesis (hereafter referred to as ``pentachlorophenol''). These documents were prepared by the Office of the Report on Carcinogens (ORoC), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS). The peer-review meeting, originally scheduled for October 7-8, 2013 (78 FR 51733), was cancelled due to the Federal government shutdown, and has been rescheduled for December 12-13, 2013. Written public comments previously submitted for the originally scheduled meeting are applicable for this meeting and do not need to be resubmitted. Persons planning to attend the meeting and/or present oral comments are asked to re-register.
Evaluation of Trichloroethylene for the Report on Carcinogens; Request for Nominations of Scientific Experts for Proposed Webinar
The National Toxicology Program (NTP) Office of the Report on Carcinogens (ORoC) requests nominations of speakers for a proposed webinar to obtain information related to evaluating the potential association of exposure to trichloroethylene (TCE) and cancer.
Determination That Adderall (Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate) Tablet and 13 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.