Department of Health and Human Services April 7, 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Risk Evaluation and Mitigation Strategies: Modifications and Revisions.'' This guidance provides information on how FDA will define and process submissions for modifications and revisions to risk evaluation and mitigation strategies (REMS), as well as information on what types of changes to approved REMS will be considered modifications of the REMS and what types of changes will be considered revisions of the REMS. There are different procedures for submission of REMS modifications and revisions to FDA as well as different timeframes for FDA review and action of such changes. In addition, this guidance provides information on how REMS modifications and revisions should be submitted to FDA and how FDA intends to review and act on these submissions. The definitions of REMS modifications and revisions apply to all types of REMS.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, regarding the opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH), Office of Disease Prevention (ODP) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Paris Watson, Senior Advisor, NIH Office of Disease Prevention, 6100 Executive Blvd., Room 2B03, Bethesda, MD 20892 or call (301) 496-1508 or email your request, including your address to prevention@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.

Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of three 1-day Tribal Consultation Sessions to be held between the Department of Health and Human Services, Administration for Children and Families, OHS leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, Section 640(l)(4)].

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Ryousuke Fujita, Ph.D., Columbia University: Based on the report of an investigation conducted by Columbia University (CU) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Ryousuke Fujita, former Postdoctoral Scientist, Taub Institute for the Aging Brain, Departments of Pathology and Cell Biology and Neurology, CU Medical Center, engaged in research misconduct in research supported by National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), grant R01 NS064433 and National Institute of Aging (NIA), NIH, grant R01 AG042317. ORI found that Respondent engaged in research misconduct by falsifying and fabricating data for specific protein expressions in human-induced neuronal (hiN) cells derived skin fibroblasts of Alzheimer's disease patients and unaffected individuals in seventy-four (74) panels included in figures in the following two (2) publications and one (1) unpublished manuscript: Cell 146:359-371, 2011 (hereafter referred to as ``Cell 2011''). Nature 500:45-53, 2013 (hereafter referred to as ``Nature 2013''). ``Human induced neuron models of APOE4-associated Alzheimer's disease display altered APP endocytosis and processing.'' Unpublished manuscript. ORI found that Respondent engaged in research misconduct by knowingly and intentionally fabricating and falsifying research in seventy-four (74) panels included in figures in Cell 2011, Nature 2013, and the unpublished manuscript. Respondent inflated sample numbers and data, fabricated numbers for data sets, manipulated enzyme-linked immunosorbent assay (ELISA) analysis, mislabelled immunoflourescent confocal images, and manipulated and reused Western blot images.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) 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 1/27/2015 page 4,291 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 Heart, Lung and Blood Institute (NHLBI), 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.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) 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 February 13, 2014, page 8723 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 Mental Health (NIMH), 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.