Department of Health and Human Services October 11, 2011 – Federal Register Recent Federal Regulation Documents
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Office of Biotechnology Activities; Recombinant DNA Research: Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
The Office of Biotechnology Activities (OBA) is updating Appendix B of the NIH Guidelines to specify the risk group (RG) classification for several common attenuated strains of bacteria and viruses that are frequently used in recombinant DNA research. OBA is also specifying the risk group for several viruses not previously listed in Appendix B. In addition, a reference to Appendix B will be added to Section II-A of the NIH Guidelines, which addresses the risk assessment for research with recombinant DNA. Background: The NIH Guidelines provide guidance to investigators and local Institutional Biosafety Committees (IBCs) for setting containment for recombinant DNA research. Section II-A, Risk Assessment, instructs investigators and IBCs to make an initial risk assessment based on the RG of the agent (see Appendix B, Classification of Human Etiologic Agents on the Basis of Hazard). The RG of the agent often correlates with the minimum containment level required for experiments subject to the NIH Guidelines. The classification of agents into various RG categories is based largely on their ability to cause human disease and the availability of treatments for that disease. For the most part, the organisms listed in Appendix B are wild-type, non-attenuated strains and a distinction is not made between the RG classification for the wild-type organism and a corresponding attenuated strain. A few attenuated strains are classified in Appendix B at a lower RG than that of the wild-type organism. However, there are a number of well-established attenuated strains commonly employed in research that are not specifically listed and thus by default are included in the same RG as the wild-type organism. Therefore, the biosafety level (BL) specified for research subject to the NIH Guidelines may be identical for experimentation with either the attenuated or the wild-type strain. OBA has conducted an evaluation of certain attenuated strains, focusing on those for which a risk assessment had been undertaken and containment recommendations determined in the Centers for Disease Control and Prevention (CDC)/NIH publication Biosafety in Microbiological and Biomedical Laboratories (BMBL) (5th edition). In addition, the NIH Recombinant DNA Advisory Committee (RAC) discussed the appropriate containment for two attenuated strains of Yersinia pestis (lcr(-) and pgm(-) mutants) at its meeting on June 16, 2010. (A webcast of that discussion is available at https:// oba.od.nih.gov/rdnarac/racpastmeetings2010.html.) Specifying the risk groups for attenuated strains in Appendix B of the NIH Guidelines will lead to more uniform containment recommendations that are commensurate with the biosafety risk. In addition, OBA has identified several RG3 viruses that are not currently specified in Appendix B or are a member of a family of viruses otherwise classified as RG2. Therefore, Appendix B is being updated to address these viruses as well. OBA consulted the NIH RAC as well as other subject matter experts from NIH, CDC, and academia. These proposed changes were published in the Federal Register (76 FR 44339) on July 25, 2011, and one comment was received. This comment, from the American Biological Safety Association (ABSA), suggested that ``OBA should consider adding additional information to Section II-A-3 covering the assignment of Risk Group to commonly used attenuated strains.'' Section II-A of the NIH Guidelines provides a framework for conducting a comprehensive risk assessment. These proposed changes to Appendix B and ABSA's comment were discussed at the September 13, 2011, meeting of the RAC. OBA and the RAC appreciated ABSA's comments and will add a reference to Appendix B to the last sentence of the first paragraph of Section II-A- 3. The last sentence of the first paragraph of Section II-A-3 currently reads: ``Certain attenuated strains or strains that have been demonstrated to have irreversibly lost known virulence factors may qualify for a reduction of the containment level compared to the Risk Group assigned to the parent strain (see Section V-B, Footnotes and References of Sections I-IV).'' It will be amended to read: Certain attenuated strains or strains that have been demonstrated to have irreversibly lost known virulence factors may qualify for a reduction of the containment level compared to the Risk Group assigned to the parent strain (see Appendix B, Classification of Human Etiologic Agents on the Basis of Hazard and Section V-B, Footnotes and References of Sections I-IV). In addition to the change to the first paragraph of Section II-A-3, the following additions will be made to Appendix B-II-A. Risk Group 2 (RG2)Bacterial Agents Including Chlamydia:
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experiment To Evaluate Risk Perceptions of Produce Growers, Food Retailers, and Consumers After a Food Recall Resulting From a Foodborne Illness Outbreak
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).
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Shamarendra Sanyal, PhD Duke University: Based on an inquiry conducted by Duke University (Duke), admissions by the Respondent, and additional analysis conducted by ORI in its oversight review, ORI and Duke found that Dr. Shamarendra Sanyal, former postdoctoral scholar, Duke, engaged in research misconduct by falsifying data in a grant application submitted to the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH). Specifically, ORI found that the Respondent falsified Figure 2C of grant application 1 R01 HL107901-01, ``Store-operated calcium entry in airway inflammation,'' by altering the gain settings in the instrument used to measure store-operated current (SOC) densities in a whole cell patch clamp experiment comparing Stim 1+/- mouse airway cells and wild type mouse airway cells. Respondent also falsified the calcium response data in Figure 5A (right panel) of the grant application referenced above by adding ATP as a reagent to the mouse airway epithelial cells to sharpen the results purported to be caused by PGN without disclosing that ATP had been added and without disclosing that ATP was not added to the control sample. The questioned research was not submitted for publication. Dr. Sanyal has entered into a Voluntary Settlement Agreement with ORI and Duke, in which he voluntarily agreed to the administrative actions set forth below. The administrative actions are required for two (2) years beginning on the date of Dr. Sanyal's employment in a research position in which he receives or applies for PHS support on or after the effective date of the Agreement (September 16, 2011); however, if he has not obtained employment in a research position in which he receives or applies for PHS support within three (3) years of the effective date of the Agreement, the administrative actions set forth below will no longer apply. Dr. Sanyal has voluntarily agreed: (1) To have his research supervised as described below and to notify his employer(s)/institutions(s) of the terms of this supervision; Respondent agrees to ensure that prior to the submission of an application for PHS support for a research project on which Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS supported research, the institution employing him will submit a plan for supervision of Respondent's duties to ORI for approval; the plan for supervision must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent agrees that he will not participate in any PHS supported research from the effective date of this Agreement until a plan for supervision is submitted to and approved by ORI; Respondent agrees to be responsible for maintaining 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 contract 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 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.
Pilot Program To Evaluate Proposed Proprietary Name Submissions; Public Meeting on Pilot Program Results Will Not Be Held
The Food and Drug Administration (FDA) is announcing that it will not hold a public meeting to discuss the results of a 2-year voluntary pilot program that enabled participating pharmaceutical firms to evaluate proposed proprietary names and submit the data generated from those evaluations for FDA to review. FDA anticipated holding a public meeting at the end of fiscal year 2011 to discuss the results of the pilot program, but the Agency did not receive sufficient pilot submissions to form a basis for discussion. Interested parties may submit to the docket any additional comments on the pilot program. As previously announced, FDA plans to publish a draft guidance describing the best test methods for proprietary name evaluation.
Pilot Program for Parallel Review of Medical Products
The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) (the Agencies) are soliciting nominations from sponsors of innovative device technologies to participate in a pilot program for concurrent review of certain FDA premarket review submissions and CMS national coverage determinations. The Agencies announced the intention to initiate a pilot program in the Federal Register of September 17, 2010. The Agencies are now providing notice of the procedures for voluntary participation in the pilot program, as well as the guiding principles the Agencies intend to follow.
Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2013 and Other Proposed Changes; Considering Changes to the Conditions of Participation for Long Term Care Facilities
The proposed rule would revise the Medicare Advantage (MA) program (Part C) regulations and prescription drug benefit program (Part D) regulations to implement new statutory requirements; strengthen beneficiary protections; exclude plan participants that perform poorly; improve program efficiencies; and clarify program requirements. We are also considering changes to the long term care facility conditions of participation pertaining to pharmacy services.
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