Department of Health and Human Services December 13, 2010 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification Requests and Recordkeeping
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 regulations governing batch certification of color additives manufactured for use in foods, drugs, cosmetics or medical devices in the United States.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Sagar S. Mungekar, PhD, New York University School of Medicine: Based on the Respondent's written admission and set forth below, the New York University School of Medicine (NYUSOM) and the Office of Research Integrity (ORI) found that Sagar S. Mungekar, PhD, former MD/ PhD student in the Sackler Institute of Graduate Biomedical Sciences at NYUSOM, engaged in research misconduct in research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grants R01 GM35769, R01 GM55624, and T32 GM07308, and National Institute of Allergy and Infectious Diseases (NIAID), NIH, grant T32 AI007180. Dr. Mungekar admitted that in his PhD thesis he ``increased statistical significance of the calculated means and standards of deviation [sic] of the UV spectrophometic [sic] data presented by discarding certain experimental data and thus presented data that was falsified. In addition, as the repression ratios calculated and conclusions reached based on these data that included falsified data, those values and conclusions are fabricated. Approximately, 60-75 of the [Respondent's] PhD research data was changed or falsified.'' Dr. Mungekar also admitted ``while doing these experiments, I did not sequence all of the constructs that I constructed, thus, I could not be certain of the exact identity of the plasmids in question.'' ORI found that Dr. Mungekar engaged in research misconduct (42 CFR 93.103) by fabricating and falsifying data. Specifically, ORI found that Dr. Mungekar falsified five tables and five figures (Tables 2-1, 2-2, 3-1, 4-1, 4-2 and Figures 2-3, 3-1, 3-2, 4-3, and 4-4) in his Ph.D. thesis entitled ``Autoregulation of Ribonuclease E,'' by discarding certain spectrophotometric data, to increase statistical significance, used to calculate repression ratios and RNA decay rates. Dr. Mungekar also claimed to have constructed 53 different reporter plasmids with RNase E mutants, when sequencing data did not exist to support this claim. Dr. Mungekar has entered into a Voluntary Settlement Agreement in which he has voluntarily agreed, for a period of three (3) years, beginning on November 22, 2010: (1) That any institution that submits an application for PHS support for a research project on which the Respondent's participation is proposed or that uses him in any capacity on PHS-supported research, or that submits a report of PHS-funded research in which he is involved, must concurrently submit a plan for supervision of his duties to ORI for approval; the supervisory plan must be designed to ensure the scientific integrity of his research contribution; Respondent agrees that he will not participate in any PHS-supported research until such a supervision plan is submitted to ORI; (2) that any institution employing him submits, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-funded research in which he is involved, a certification to ORI that the data provided by the Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application or report; and (3) to exclude himself voluntarily from serving in any advisory capacity to the U.S. Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
Medical Device User Fee Program; Meetings on Reauthorization; Request for Notification of Patient and Consumer Advocacy Group Intention to Participate
The Food and Drug Administration (FDA) is issuing this notice to request that patient and consumer advocacy groups notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Medical Device User Fee Amendments of 2007 (MDUFA) (the Food and Drug Administration Amendments Act of 2007). The statutory authority for MDUFA expires September 30, 2012. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next MDUFA program. The FD&C Act also requires that FDA hold continued discussions with representatives of patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these discussions by establishing consistent patient and consumer advocacy group representation.
Implementation of Section 2695 (42 U.S.C. 300ff-131) of Public Law 111-87: Infectious Diseases and Circumstances Relevant to Notification Requirements
The Ryan White HIV/AIDS Treatment Extension Act of 2009 (Pub. L. 111-87) addresses notification procedures for designated officers, medical facilities, and State and community public health officers regarding exposure of emergency response employees (EREs) to potentially life-threatening infectious diseases. The Secretary of Health and Human Services (Secretary) has delegated authority to the Director of the Centers for Disease Control and Prevention (CDC) to issue a list of potentially life-threatening infectious diseases, including emerging infectious diseases, to which EREs may be exposed in responding to emergencies (including a specification of those infectious diseases that are routinely transmitted through airborne or aerosolized means); guidelines describing circumstances in which employees may be exposed to these diseases; and guidelines describing the manner in which medical facilities should make determinations about exposures. CDC is seeking comment on the list of diseases and guidelines contained in this notice.
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