Department of Health and Human Services December 9, 2014 – Federal Register Recent Federal Regulation Documents
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Findings of Misconduct in Science
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Kaushik Deb, Ph.D., University of Missouri-Columbia: Based upon the evidence and findings of an investigation report by the University of Missouri-Columbia (UM) transmitted to the United States Department of Health and Human Services (HHS), Office of Research Integrity (ORI) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Kaushik Deb, former Postdoctoral Fellow, Life Sciences Center, UM, engaged in misconduct in science in research that was supported by National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), grants 2 R01 HD021896 and 5 R01 HD042201-05 and National Center for Research Resources (NCRR), NIH, grant 5 R01 RR013438-07. ORI found that the Respondent intentionally, knowingly, and recklessly fabricated and falsified data reported in the following published paper: Deb, K., Sivarguru, M., Yong, H., & Roberts, R.M. ``Cdx2 gene expression and trophectoderm lineage specification in mouse embryos.'' Science 311:992-996, 2006 (hereafter referred to as ``Science 311''); this paper was retracted on July 27, 2007 An earlier version of Science 311 had been previously submitted to Nature on or about June 24, 2005 (hereafter referred to as ``Nature #1''). It was revised and resubmitted to Nature on or about August 24, 2005, and ultimately was rejected by Nature on September 14, 2005 (hereafter referred to as ``Nature #2''). Specifically, ORI finds by a preponderance of the evidence that the Respondent engaged in misconduct in science by intentionally, knowingly, and recklessly: 1. Falsifying and/or fabricating three panels of data in Figure 1 (Figures 1C, 1D, and 1E) in Science 311 and in Nature #1 and Nature #2, by photo-manipulating confocal fluorescent images to falsely represent three-, four-, and six-cell embryos, thereby supporting the paper's central premise that cells derived from a late-dividing blastomere would be positive for a transcription factor, Cdx2, while the cells derived from a leading blastomere would be Cdx2 negative 2. using photo-manipulation to falsify and fabricate at least 13 panels of confocal image data in Figures 2, 3, and S2, including Figures 2K, 2L, 2Q, 2R, 2V, 2X, 3G, 3H, 3I, S2s, S2t, S2u, and 2W, in Science 311 and in corresponding figures in Nature #1 and Nature #2 so that these images falsely supported the central premise in Science 311 that Cdx2-expressing cells were peripherally located in the embryo 3. falsifying Figures 2G, 3J, 3L, S2V, S2X, S6I, S6J, and S6K in Science 311, Figures 2A, 2C, S4v, and S4x in Nature #1, and Figures 2G, 3I, 3J, and 3K in Nature #2 by reusing and re-labelling the same image to represent different embryos and different experimental conditions 4. falsifying Figure 4 in Science 311 and corresponding figures submitted in Nature #1 and Nature #2 to falsely illustrate that the first dividing cell of a two-cell mouse embryo will ultimately differentiate into the trophoblast; specifically, Respondent: Falsely colored and photomanipulated a single bright-phase image of a three-cell embryo to make it appear as four separate embryos that had been differentially injected with TRD falsely colored and photomanipulated a four-cell embryo to make TRD appear distinctly located in the lagging cell and in its descendent cell, when the actual embryo contained diffuse staining within the sub-zonal, extracellular space photomanipulated a damaged, non-viable two-cell embryo to make it appear viable re-used, falsely colored, and relabeled seven images from an unrelated experiment to falsely represent a time lapse course of eight different images 5. falsifying Figures 5K, 5L, 5N, and 5O in Science 311 by photo- manipulating a single confocal image to falsely represent four different images at two different stages of embryonic development. The images also were presented as Figures 4k, 4l, 4n, and 4o in Nature #1. The Respondent failed to take responsibility for the fabrication and falsification described in ORI's findings. The following administrative actions have been implemented for a period of three (3) years, beginning on November 17, 2014: (1) Respondent is debarred from any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement programs of the United States Government referred to as ``covered transactions'' pursuant to HHS' Implementation (2 CFR part 376 et seq) of Office of Management and Budget (OMB) Guidelines to Agencies on Governmentwide Debarment and Suspension, 2 CFR part 180 (collectively the ``Debarment Regulations''); and (2) Respondent is prohibited 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.
Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion'' dated December 2014. The draft guidance document provides blood collection establishments and transfusion services with recommendations for initial testing (primary testing) for bacterial contamination of platelets intended for transfusion, and provides additional considerations for blood collection establishments and transfusion services for subsequent retesting (secondary testing) of platelets prior to transfusion. The recommendations for primary testing of platelets and the additional considerations for secondary testing of platelets described in this guidance are expected to enhance the detection of bacteria in platelet products and thus enhance transfusion safety. The draft guidance, when finalized, is intended to supersede the recommendation in section VII.A.2, in regard to bacterial contamination testing in the document entitled ``Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods'' dated December 2007.
Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: A3 Adenosine Receptor (A3AR) Agonists as an Orally-Administered Analgesic for Treatment of Chronic Neuropathic Pain
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Evaluation Option License Agreement to BioIntervene, Inc., a company having a place of business in Saint Louis, Missouri to practice the inventions embodied in the following patent applications and patents: 1. U.S. Patent 8,735,407, issued May 27, 2014, titled ``Purine Derivatives As A3 Adenosine Receptor-Selective Agonists'' [HHS Ref. No. E-140-2008/0-US-06]; 2. European Patent Application 09728154.7, filed March 24, 2009, titled ``Purine Derivatives As A3 Adenosine Receptor-Selective Agonists'' [HHS Ref. No. E-140-2008/0-EP-05]; 3. Canadian Patent Application 2720037, filed March 24, 2009, titled ``Purine Derivatives As A3 Adenosine Receptor-Selective Agonists'' [HHS Ref. No. E-140-2008/0-CA-04]; 4. Australian Patent 2009231978, issued February 20, 2014, titled ``Purine Derivatives As A3 Adenosine Receptor-Selective Agonists'' [HHS Ref. No. E-140-2008/0-AU-03]; 5. U.S. Patent Application 13/371,081, filed February 10, 2012, titled ``A3 Adenosine Receptor Agonists And Antagonists'' [HHS Ref. No. E-140-2008/1-US-01]; 6. U.S. Provisional Application 61/909,742, filed November 27, 2013, titled ``A3 Adenosine Receptor Agonists'' [HHS Ref. No. E-742- 2013/0-US-01]; and 7. U.S. Provisional Application 62/033,723, filed August 6, 2014, titled ``A3 Adenosine Receptor Agonists'' [HHS Ref. No. E-210-2014/0- US-01]. The patent rights in these inventions either have been assigned to the Government of the United States of America, or have been granted exclusive rights to the Government of the United States of America. The territory of the prospective Start-up Exclusive Evaluation Option License Agreement may be worldwide, and the field of use may be limited to: ``The use of an A3 Adenosine Receptor (A3AR) agonist as an orally- administered analgesic, either as monotherapy or as an add-on analgesic, for treatment of chronic neuropathic pain conditions''. Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, BioIntervene will have the exclusive right to execute a Start-up Exclusive Patent License Agreement which will supersede and replace the Start-up Exclusive Evaluation Option License Agreement, with no greater field of use and territory than granted in the Start-up Exclusive Evaluation Option License Agreement.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.'' The draft guidance is intended to assist those sponsors of new drug applications (NDAs), biologics license applications (BLAs) for therapeutic biologics, and supplements to such applications who are planning to conduct clinical studies in pediatric populations. Effectiveness, safety, or dose finding studies in pediatric patients involve gathering clinical pharmacology information, such as information regarding a product's pharmacokinetics and pharmacodynamics pertaining to dose selection and individualization. This draft guidance addresses general clinical pharmacology considerations for conducting studies so that the dosing and safety information for drugs and biologic products can be sufficiently characterized, leading to well-designed trials to evaluate effectiveness.
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications; Correction
The Food and Drug Administration (FDA) is correcting a document entitled ``Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications'' that appeared in the Federal Register of August 1, 2014. The document announced the generic clearance for the collection of qualitative data on tobacco products and communications. The document was published with the incorrect docket number. This document corrects that error.
Two-Phased Chemistry, Manufacturing, and Controls Technical Sections; Draft Guidance for Industry; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period for a notice of availability of draft guidance for industry (GFI #227) entitled ``Two-Phased Chemistry, Manufacturing, and Controls Technical Sections'' that appeared in the Federal Register of October 20, 2014. In that notice, FDA made available for comment the draft guidance, which provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) data submissions. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Draft Guidance for Industry on Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers.'' This draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). The draft guidance describes FDA's expectations for prescription drug wholesale distributors (wholesale distributors) and third-party logistics providers (3PLs) about reporting to FDA under the DSCSA.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for revision of the approved information collection assigned OMB control number 0990- 0390 which expires on February 28, 2015. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
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