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

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Anil Potti, M.D., Duke University School of Medicine: Based on the reports of investigations conducted by Duke University School of Medicine (Duke) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Anil Potti, former Associate Professor of Medicine, Duke, engaged in research misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grant R01 HL072208 and National Cancer Institute (NCI), NIH, grants R01 CA136530, R01 CA131049, K12 CA100639, R01 CA106520, and U54 CA112952. ORI found that Respondent engaged in research misconduct by including false research data in the following published papers, submitted manuscript, grant application, and the research record as specified in 1-3 below. Specifically, ORI found that: 1. Respondent stated in grant application 1 R01 CA136530-01A1 that 6 out of 33 patients responded positively to dasatinib when only 4 patients were enrolled and none responded and that the 4 CT scans presented in Figure 14 were from the lung cancer study when they were not. 2. Respondent altered data sets to improve the accuracy of predictors for response to treatments in a submitted paper and in the research record by: Reversing the responder status of 24 out of 133 subjects for the adriamycin predictor in a manuscript submitted to Clinical Cancer Research switching the cancer recurrence phenotype for 46 out of 89 samples to validate the LMS predictor in a file provided to a colleague in 2008 changing IC-50 and R-code values for the cisplatin predictor in a data set provided to NCI in 2010 3. Respondent reported predictors and/or their validation by disregarding accepted scientific methodology so that false data were reported in the following: Blood 107:1391-1396, 2006: Describing a predictor for thrombotic phenotypes New England Journal of Medicine 355:570-580, 2006: Describing a predictor of lung cancer relapse Nature Medicine 12:1294-1300, 2006: Describing a predictor for the response to the chemotherapeutic drugs topectan and docetaxol Journal of Clinical Oncology 25:4350-4357, 2007: Describing a predictor for the response to the chemotherapeutic drug cisplatin Lancet Oncology 8:1071-1078, 2007: Describing a predictor for the response to the combination of the chemotherapeutic drugs flurouracil, epirubicin, and cyclophosphamide or docetaxol, epirubicin, and docetaxol Journal of the American Medical Association 299:1574-1587, 2008: Describing a predictor for breast cancer relapse Public Library Science One 3:e1908, 2008: Describing a predictor for the response to the chemotherapeutic drugs paclitaxel, 5- fluouracil, adriamycin, and cyclophosphamide Proceedings of the National Academy of Sciences 105:19432- 19437, 2008: Describing a predictor of colon cancer recurrence Clinical Cancer Research 15:7553-7561, 2009: Describing a predictor for the response to the chemotherapeutic drug cisplatin As a result of Duke's investigation, the published papers listed above were retracted. Respondent has entered into a Voluntary Settlement Agreement with ORI. Respondent neither admits nor denies ORI's findings of research misconduct; the settlement is not an admission of liability on the part of the Respondent. The parties entered into the Agreement to conclude this matter without further expenditure of time, finances, or other resources. Respondent has not applied for or engaged in U.S. Public Health Service (PHS)-supported research since 2010. Respondent stated that he has no intention of applying for or engaging in PHS-supported research or otherwise working with PHS. However, the Respondent voluntarily agreed: (1) That if the respondent obtains employment in a research position in which he receives or applies for PHS support within five years of the effective date of the Agreement (September 23, 2015), he shall have his research supervised for a period of five years; (2) that prior to the submission of an application for 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 Respondent's 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; (3) 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 and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; and (4) 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 period of five years beginning on September 23, 2015.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled ``Monitoring and Reporting for the Core State Violence and Injury Prevention Program Cooperative Agreement.'' CDC will use the information collected to monitor cooperative agreement awardees and to identify challenges to program implementation and achievement of outcomes.

This rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2016. This rule is necessary to ensure that ESRD facilities receive accurate Medicare payment amounts for furnishing outpatient maintenance dialysis treatments during calendar year 2016. This rule will also set forth requirements for the ESRD Quality Incentive Program (QIP), including for PYs 2017 through 2019.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), 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 a new collection. 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.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed extension of the Laboratory Response Network information collection.

The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, and the Food and Drug Administration (FDA) are announcing the availability of a draft guidance entitled ``Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs.'' The draft guidance is intended for institutions and IRBs that are responsible for the review and oversight of human subject research conducted or supported by the U.S. Department of Health and Human Services (HHS) or regulated by FDA. The purpose of the draft guidance is to assist institutions and IRBs in preparing and maintaining minutes of IRB meetings (also referred to in the guidance as minutes) that meet the regulatory requirements for minutes set forth in FDA and HHS regulations. The draft guidance also provides general recommendations on the type and amount of information to be included in the minutes.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Representatives of the Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL), will be conducting a federal review on December 1-4, 2015 of the Connecticut Office of Protection and Advocacy for Persons with Disabilities (OPA). AIDD is soliciting comments from interested parties on your experiences with the work, program, and strategies employed by OPA in meeting the needs of individuals with developmental disabilities and their families in Connecticut. You are encouraged to share your experiences by way of any of the following methods: Email: Clare.Barnett@acl.hhs.gov. Telephone: 202-357-3426. Mail Comments To: Clare Barnett, Program Specialist, Administration on Intellectual and Developmental Disabilities, Administration for Community Living, One Massachusetts Avenue NW., Room 4204, Washington, DC 20201. Comments should be received by December 4, 2015 in order to be included in the final report.

On April 6, 2015, the Director of the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), published a notice in the Federal Register [80 FR 18427] announcing a collaboration with the Labour Inspection, Labour Administration and Occupational Safety and Health Branch of the International Labour Office (ILO) in developing a set of digital reference radiographs for the ILO International Classification of Radiographs of Pneumoconiosis (ILO Classification). Today we are announcing the re-opening of the public comment period for an additional 60 days.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry and Food and Drug Administration StaffClass II Special Controls Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

The National Institute on Drug Abuse (NIDA), one of the components of the National Institutes of Health (NIH), announces the Challenge, ``Addiction Research: There's an App for that''. With this Challenge, NIDA aims to develop novel mobile applications (apps) for future addiction research explicitly created on Apple Inc.'s ResearchKit framework. ResearchKit is open-source software which makes it easy for researchers and developers to create apps for specific biomedical research questions by circumventing development of custom code. Contestants will create the solicited app for use by addiction researchers to engage mobile device users in future society-changing research.