Department of Health and Human Services May 29, 2014 – 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: Helen Freeman, Ph.D., Harvard Medical School and Beth Israel Deaconess Medical Center: Based on an investigation conducted by Harvard Medical School (HMS) and Beth Israel Deaconess Medical Center (BIDMS) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Helen Freeman, former HMS Postdoctoral Fellow at BIDMS, engaged in research misconduct in research supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grant R37 DK053477. ORI found that the Respondent engaged in research misconduct by knowingly and intentionally falsifying three (3) figures and/or legends and one (1) supplemental movie legend in a manuscript submitted for publication to the journal Nature (Freeman, H.C., Kong, D., Sidman, R.L., & Lowell, B. ``Inhibition of UCP2 Prevents Neurodegenerative Diseases in Mice.''). Specifically, ORI found that Respondent: Falsified Figure 6 and its legend in a manuscript submitted to Nature by claiming that the experiment represented histological and rotarod results from 5 week old pcd3J-/- mice treated with saline or pcd3J-/- mice treated with genipin when the genotype, treatment conditions, numbers of mice used, and mice age were not as claimed; these falsified data also were presented to a colleague for use in related experiments falsified Figure 4, Supplementary Figure 3, and Supplementary Movie 1 and/or its legends in a manuscript submitted to Nature by claiming that the knockout of UCP2 rescues the ataxic phenotype of pcd3J-/- mice when she knew this to be false. Dr. Freeman has voluntarily agreed for a period of three (3) years, beginning on May 6, 2014: (1) To have her research supervised if employed by an institution that receives or applies for U.S. Public Health Service (PHS) funding; Respondent agreed 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 she 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; (2) that any institution employing her 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 (3) to exclude herself 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.

The Food and Drug Administration (FDA) is announcing Booz Allen Hamilton's final comprehensive findings and recommendations submitted as part of their independent assessment of the process for the review of medical device submissions. The assessment is part of the FDA performance commitments relating to the Medical Device User Fee Amendments of 2012 (MDUFA III), which reauthorized device user fees for fiscal years (FYs) 2013-2017. The assessment is described in section V, Independent Assessment of Review Process Management, of the commitment letter entitled ``MDUFA Performance Goals and Procedures'' (MDUFA III Commitment Letter). The assessment is being conducted in two phases. The final comprehensive findings and recommendations are the last of a series of deliverables, as outlined in the contract statement of work, to be published as part of Phase 1 of the assessment.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on December 30, 2013, pages 79472-79473 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Child Health and Human Development, National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.

The Food and Drug Administration (FDA) has determined that SODIUM PERTECHNETATE TC-99M (technetium Tc-99m sodium pertechnetate) Injection, Oral, 2 to 100 millicuries per milliliter (mCi/mL) and 10 to 60 mCi/mL, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for technetium Tc-99m sodium pertechnetate, injection, oral, 2 to 100 mCi/mL and 10 to 60 mCi/mL, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) has determined the regulatory review period for XARELTO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) is classifying the pancreatic drainage stent and delivery system into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the pancreatic drainage stent and delivery system classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.