Department of Health and Human Services April 18, 2013 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that effective on March 14, 2013, a Settlement Agreement was made and entered into by and between Dr. Philippe Bois and the United States Department of Health and Human Services (HHS), Kathleen Sebelius, Howard K. Koh, Nancy Gunderson, and Donald Wright (collectively HHS) by and through the United States Attorney for the District of Columbia in Bois v. HHS, et al., Civil Action no. 11-cv-1563, which was pending before the U.S. District Court for the District of Columbia. In the Settlement Agreement, HHS and Dr. Bois agreed to settle the proceedings before the District Court of the District of Columbia as well as to resolve all administrative matters pending at HHS. ORI found that Philippe Bois, Ph.D., former postdoctoral fellow, Department of Biochemistry, St. Jude Children's Research Hospital, engaged in research misconduct in research funded by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grant R01 GM071596, and National Cancer Institute (NCI), NIH, grants P30 CA021765, P01 CA071907, R01 CA072996, and R01 CA100603. In the Settlement Agreement, the parties agreed that ORI found by a preponderance of the evidence that the Respondent committed misconduct in science and research misconduct by: 1. Knowingly and intentionally falsely reporting that FOXO1a was not expressed in cell lysates from alveolar rhabdomyosarcoma (ARMS) tumor biopsies, by selecting a specific FOX01a immunoblot to show the desired result, in Figure 1A of the following paper: Bois, P.R., Izeradjene, K., Houghton, P.J., Cleveland, J.L., Houghton, J.A., & Grosveld, C.G. ``FOXO1a acts as a selective tumor suppressor in alveolar rhabdomyosarcoma.'' J. Cell. Biol. 170:903-912, September 2005 (``JCB 2005'') 2. Falsifying data showing SDS-PAGE for papain digestion of VBS3 and [alpha]VBS, by falsely labeling lane 1 to represent papain only digestion, by falsely labeling lane 5 to represent papain digestion of the [alpha]VBS peptide, and by falsely inserting a band in lane 3 to represent the [alpha]VBS peptide, in Figure 4B of the following paper: Bois, P.R., Borgon, R.A., Vornhein, C., & Izard, T. ``Structural dynamics of [alpha]-actinin-vinculin interactions.'' Mol. Cell. Biol. 25:6112-6122, July 2005 (``MCB 2005''). The parties further agreed that Dr. Bois denied committing research misconduct and, pursuant to 42 CFR part 93, filed a timely request for a hearing at which to contest ORI's findings. An HHS Administrative Law Judge (ALJ) denied Dr. Bois' request for a hearing. HHS subsequently entered a debarment order against Dr. Bois. Dr. Bois filed the above referenced lawsuit in the United States District Court for the District of Columbia asking the Court to vacate the debarment order and remand the matter for further proceedings before HHS, including but not limited to granting Dr. Bois' request for a hearing. On March 2, 2012, Judge Berman Jackson of the United States District Court for the District of Columbia issued an order vacating HHS' debarment order, affirming Finding 1, and remanding the matter to HHS for further proceedings regarding Finding 2. On March 30, 2012, HHS filed a Motion for Reconsideration before Judge Berman Jackson. On March 14, 2013, Dr. Bois and HHS entered into a Settlement Agreement (Agreement) to settle and dismiss the pending civil action. The terms of the Settlement Agreement include that Dr. Bois denied that he committed research misconduct but he agreed not to further appeal ORI's findings of research misconduct set-forth above. Dr. Bois and HHS further agreed to the following administrative actions beginning on March 14, 2013: (1) To have his research supervised for a period of three (3) years beginning on the effective date of the Agreement; he agreed that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which his participation is proposed and prior to his participation in any capacity on PHS- supported research, he 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 his research contribution; he agreed that he shall not participate in any PHS- supported research until such a supervision plan is submitted to and approved by ORI, with such review and approval to be conducted promptly by ORI and not unreasonably withheld; he agreed to maintain responsibility for compliance with the agreed upon supervision plan; (2) that for three (3) years beginning with the effective date of the Agreement, 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 Dr. Bois is involved, a certification to ORI that the data provided by him 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 for a period of three years (3) beginning with the effective date of the Agreement. Dr. Bois further agreed to dismiss his lawsuit with prejudice and to withdraw further proceedings before HHS. Dr. Bois and HHS both agreed to waive or abandon all other claims. This notice supercedes the notice regarding this matter that was previously published in: Federal Register 76:111, June 9, 2011.

The Food and Drug Administration (FDA) has determined that OXYCONTIN (oxycodone hydrochloride) extended-release tablets (10 milligrams (mg), 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, and 160 mg) approved under new drug application (NDA) 20-553 were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for products that reference NDA 20-553.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 4040-0001, which expired on March 31, 2013. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

Section 401(a) of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), Public Law 111-3, amended the Social Security Act (the Act) to enact section 1139A (42 U.S.C. 1320b- 9a). Section 1139A(b) charged the Department of Health and Human Services with improving pediatric health care quality measures. The Agency for Healthcare Research and Quality (AHRQ) is requesting the submission of instruments or domains (for example, key concepts) measuring aspects of the transition from child-focused to adult-focused care in young adults with chronic health conditions from all researchers, vendors, hospitals, stakeholders, and other interested parties. AHRQ is interested in instruments and items through which young adults or parent proxies may assess experiences they have with the health care system, including the transition from pediatric to adult health care. The goal is to develop a standardized instrument for use in assessing the quality of transition from child-focused to adult- focused care in young adults with chronic health conditions.

This announcement governs the proposed award of mandatory grants under the Family Violence Prevention and Services Act (FVPSA) to States (including territories and insular areas). The purpose of these grants is to: (1) assist States in efforts to increase public awareness about, and primary and secondary prevention of, family violence, domestic violence, and dating violence; and (2) assist States in efforts to provide immediate shelter and supportive services for victims of family violence, domestic violence, or dating violence (42 U.S.C. 10401 et seq.). This announcement sets forth the application requirements, the application process, and other administrative and fiscal requirements for grants in Fiscal Year (FY) 2013, 2014 and 2015.