Department of Health and Human Services April 13, 2012 – Federal Register Recent Federal Regulation Documents

The multiagency Tox21 Initiative aims to improve hazard assessment of compounds potentially harmful to humans and the environment. This will be accomplished through the use of integrated high throughput screens that provide information on the ability of a substance to perturb biological pathways related to toxicity. On behalf of the Tox21 Consortium and its Assays and Pathways Working Group, the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) is accepting nominations for HTS biochemical- or cell-based assays. Assays selected for further evaluation and found to be compatible with the HTS program will support Tox21 by providing data on endpoints that serve as markers for initiating or downstream events in toxicity pathways.

The Health Resources and Services Administration (HRSA) announces that the listing of entities, and their Health Professional Shortage Area (HPSA) scores, that will receive priority for the assignment of National Health Service Corps (NHSC) scholarship recipients (Corps Personnel, Corps members) during the period July 1, 2012, through June 30, 2013, is posted on the NHSC Web site at https:// datawarehouse.hrsa.gov/HGDWReports/ OneClickRptFilter.aspx?rptName=NHSCAppSiteList&rptFormat=HTML 3.2. This searchable database specifies all currently approved NHSC service sites, by State, and can be utilized to determine which entities are eligible to receive assignment of Corps members who are participating in the NHSC Scholarship Program based on the threshold HPSA score set forth below. Please note that entities on this list may or may not have current job opportunities for NHSC scholars. Furthermore, not all vacancies associated with sites on the list described below will be for Corps members, but could be for NHSC Scholarship Program participants serving their obligation through the Private Practice Option.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Peter J. Francis, M.D., Ph.D., Oregon Health Sciences University: Based on the report of an investigation conducted by Oregon Health Sciences University (OHSU) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Peter J. Francis, Associate Professor, Casey Eye Institute, OHSU, engaged in research misconduct in research reported in two grant applications, R01 EY021214-01 and resubmitted as R01 EY021214-01A1, that he submitted to the National Eye Institute (NEI), National Institutes of Health (NIH). Specifically, ORI finds that the Respondent fabricated results of a pilot experiment in which he claimed to have injected retinal pigment epithelial (RPE) cells obtained from Rhesus monkey embryonic stem cells (ECS) into a strain of rats (RCS) that develops retinal degeneration. Respondent claimed that after the injection of ECS-derived RPE cells 21 days postnatal, the rats were tested at day 60 postnatal for optomotor acuity, and that the retinal histology of eyes receiving ECS- derived RPE cells, compared to mock-injected controls, showed enhanced photoreceptor preservation and no adverse effects. Respondent admitted that this experiment had not been conducted either by the time the original grant application had been submitted or by the time the later R01 EY021214-01A1 application was submitted. Dr. Francis has entered into a Voluntary Settlement Agreement (Agreement) and has voluntarily agreed for a period of two (2) years, beginning on March 29, 2012: (1) To have his research supervised; Respondent agrees to ensure 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, the institution employing him must submit a plan for supervision of Respondent's duties to ORI for approval; the plan for supervision must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent agrees that he shall not participate in any PHS-supported research after sixty (60) days from the effective date of this Agreement until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed upon supervision plan; (2) that this supervisory plan provided by any institution employing him shall provide assurance that each application for PHS funds, or report, manuscript, or abstract involving PHS supported research in which Respondent was involved was based on actual experiments or was otherwise legitimately derived, that the data, procedures, and methodology were accurately reported in the application, report, manuscript, or abstract, and that the text in such submissions was his own or properly cited the source of copied language and ideas; 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.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that the President's Council on Fitness, Sports, and Nutrition (PCFSN) will hold a meeting. The meeting will be open to the public.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI 209) entitled ``The Judicious Use of Medically Important Antimicrobial Drugs in Food- Producing Animals.'' This guidance is intended to inform the public of FDA's current thinking on the use of medically important antimicrobial drugs in animal agriculture.

The Food and Drug Administration (FDA) is announcing the availability of draft text for a proposed regulation intended to improve the efficiency of FDA's Veterinary Feed Directive (VFD) program. The Agency is making this draft text for a proposal available because of the complex scientific and regulatory issues involved, and because of the potential impact that changes to the VFD regulations may have on stakeholders. The Agency invites the public to submit comments with questions and concerns about the draft text for a proposed regulation.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of cochlear implants, sound masking devices, hearing aids, and transcranial magnetic stimulation medical devices. Scientific information is being solicited to inform our Comparative Effectiveness Review of Evaluation and Treatment of Tinnitus, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.