Department of Health and Human Services January 2015 – Federal Register Recent Federal Regulation Documents

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Strategies to Treat and Manage Infantile Hemangioma, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Programs. Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).

This notice provides an update of the Department of Health and Human Services (HHS) poverty guidelines to account for last calendar year's increase in prices as measured by the Consumer Price Index.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Patent License to Biohaven Pharmaceuticals Holding Company having its principal place of business in New Haven, Connecticut. The contemplated license would be for the inventions claimed in U.S. Utility Patent Number 8,859,585, issued October 14, 2014 (filed May 25, 2005), PCT Patent Application Number PCT/US2006/19335, filed May 18, 2006, U.S. Patent Application Number 14/478,442, filed September 5, 2014, European Patent Number 1896025, issued December 28, 2011 (and validated in Germany, France, and the United Kingdom), and Canadian Patent Number 2610025, issued July 22, 2014 (filed May 28, 2006). In addition, inventions claimed in any future applications claiming priority to or benefit of these patents and patent applications would also be subject to any license granted pursuant to this Notice. The patent rights in this invention have been assigned to the Government of the United States of America. The territory of the prospective Start-Up Exclusive Patent License Agreement may be worldwide and the field of use may be limited to use of scopolamine for treatment of neuropsychiatric indications.

The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its twentieth meeting on February 5-6, 2015. At this meeting, the Commission will conclude discussions related to the BRAIN Initiative and ongoing work in neuroscience, and begin discussions about the ethical considerations and implications of public health emergency response with a focus on the current Ebola virus disease epidemic.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Treatments for Fecal Incontinence, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Programs. Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).

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 provisions of FDA's requirements on content and format of labeling for human prescription drug and biological products.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Bin Kang, Ph.D., Oklahoma Medical Research Foundation: Based on the Respondent's admission, an assessment conducted by the Oklahoma Medical Research Foundation (OMRF), and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Bin Kang, Postdoctoral Fellow, Immunobiology and Cancer Research Program, OMRF, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grants AI056129 and AI104057. ORI and OMRF found that Respondent engaged in research misconduct by reporting falsified data in: ``Asb2 regulates the activity of SCF E3 ubiquitin ligases by antagonizing CAND1-mediated exchange of F-box proteins,'' submitted to Molecular Cell on June 26, 2014; hereafter referred to as the ``original Molecular Cell manuscript'' the revised version of ``Asb2 regulates the activity of SCF E3 ubiquitin ligases by antagonizing CAND1-mediated exchange of F- box proteins,'' submitted to Molecular Cell on September 29, 2014; hereafter referred to as the ``revised Molecular Cell manuscript grant application CA189216-01 submitted to the National Cancer Institute (NCI), NIH; hereafter referred to as the ``original NCI grant application'' grant application CA189216-01A1 submitted to NCI, NIH; hereafter referred to as the ``revised NCI grant application'' ORI found that Respondent knowingly falsified and/or fabricated Western blot gel images by duplication, reuse and relabeling, and/or alteration through contrast, rotation, and/or scale of the images. Specifically, Respondent included falsified images in all of the figures (Figures 1-6 and S1-5) in the original Molecular Cell manuscript, all of the figures (Figures 1-6 and S1-7) in the revised Molecular Cell manuscript, Figures 2-4, 9, and 11 in the original NCI grant application, and Figures 3-5, 10, and 11 in the revised NCI grant application. Dr. Kang has entered into a Voluntary Settlement Agreement (Agreement) and has voluntarily agreed for a period of three (3) years, beginning on December 23, 2014: (1) To have his research supervised; Respondent agreed 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 his duties to ORI for approval; the plan for supervision must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent agreed that he will 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 plan for supervision; (2) that any institution employing him must 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 and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; 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.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes.'' FDA has received reports of blood and stool traveling through colonoscope irrigation channels and into the water bottle and tubing when the irrigation channel did not have a backflow-prevention mechanism in place. This draft guidance document, when finalized, will highlight the cross- contamination risk associated with specific types of irrigation valves and accessories when used with flexible gastrointestinal endoscopes, clarify terminology used to describe these devices, and outline strategies to mitigate the risk of cross-contamination between patients. This draft guidance is not final nor is it in effect at this time.