Department of Health and Human Services October 2, 2013 – Federal Register Recent Federal Regulation Documents
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Statement of Organization, Functions, and Delegations of Authority
Statement of organization, functions, and delegations of authority. The Administration for Children and Families (ACF) has reorganized the Office of Child Support Enforcement (OCSE). This reorganization realigns the functions of the Office of Child Support Enforcement. It eliminates the Office of Automation and Program Operations and moves the functions to the Division of Federal Systems. It also eliminates the Division of Special Staffs and moves the functions to the Division of Program Innovation and the Division of Regional Operations. Additionally, it creates the Division of Regional Operations. There are several Division name changes that are as follows: The Division of Management Services to the Division of Business and Resource Management; the Division of Consumer Services to the Division of Customer Communications; the Division of Planning, Research and Evaluation to the Division of Performance and Statistical Analysis; the Division of Policy to the Division of Policy and Training; and the Division of State, Tribal and Local Assistance to the Division of Program Innovation.
Change to the Definition of “Human Organ” Under Section 301 of the National Organ Transplant Act of 1984
This notice seeks public comment on the proposed change in the definition of ``human organ'' in section 301 of the National Organ and Transplant Act of 1984, as amended, (NOTA) to explicitly incorporate hematopoietic stem cells (HSCs) within peripheral blood in the definition of ``bone marrow.'' This would clarify that the prohibition on transfers of human organs for valuable consideration applies to HSCs regardless of whether they were recovered directly from bone marrow (by aspiration) or from peripheral blood (by apheresis). This amendment will also conform section 301 to the provisions of the Stem Cell Research and Therapeutic Act of 2005, as amended.
Proposed Collection; 60-Day Notice Request: Application Process for Clinical Research Training and Medical Education at the Clinical Center and Its Impact on Course and Training Program Enrollment and Effectiveness
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed application information collection, the Clinical Center (CC), the National Institutes of Health (NIH) 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: Robert M. Lembo, MD, Deputy Director, Office of Clinical Research Training and Medical Education, NIH Clinical Center, 10 Center Drive, MSC 1158, Bethesda, MD 20892-1352, or call non-toll-free number (301)-594-4193, or Email your request, including your address to: lembor@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Application Process for Clinical Research Training and Medical Education at the Clinical Center and its Impact on Course and Training Program Enrollment and Effectiveness, 0925-NEW, Clinical Center, National Institutes of Health (CC), National Institutes of Health (NIH). Need and Use of Information Collection: The primary objective of the application process is to allow OCRTME to evaluate applicants' qualifications to determine applicants' eligibility for courses and training programs managed by the office. Applicants must provide the required information requested in the respective applications to be considered a candidate for participation. Information submitted by candidates for training programs is reviewed initially by OCRTME administrative staff to establish eligibility for participation. Eligible candidates are then referred to the designated training program director or training program selection committee for review and decisions regarding acceptance for participation. A secondary objective of the application process is to track enrollment in courses and training programs over time. OMB approval is requested for 3 years. There are capital, operating, and/or maintenance costs of $98,022. The total estimated annualized burden hours are 2,210.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements
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.
National Institute for Occupational Safety and Health Personal Protective Technology Program and National Personal Protective Technology Laboratory Conformity Assessment; Extension of Comment Period
On August 14, 2013, the Director of the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) published a notice in the Federal Register [78 FR 49524] announcing a public meeting. This meeting was held on September 17, 2013 to provide (1) a summary of the work conducted by the NIOSH Personal Protective Technology (PPT) Conformity Assessment Working Group (PCAWG), (2) provide an overview of model Conformity Assessment programs, and (3) solicit input to define a national framework for PPE conformity assessment. NIOSH's National Personal Protective Technology Laboratory (NPPTL) is addressing recommendations of the Institute of Medicine (IOM) and the National Research Council based on a review of NPPTL's program activities. The IOM report identified gaps and inconsistencies in the certification and other conformity assessment processes for non- respiratory PPT. Conformity assessment is defined as the ``demonstration that specified requirements relating to a product, process, system, person or body are fulfilled.'' Conformity assessment processes for PPT products are focused on product effectiveness and include the following primary components: Certification (ISO/IEC 17065), Inspection (ISO/IEC 17020), Testing (ISO/IEC 17025), Accreditation (ISO/IEC 17011), Surveillance (ISO/IEC 17011, ISO/IEC 17065), Supplier's Declaration of Conformity (ISO/IEC 17050), Registration (ISO/IEC 17021) and Quality management systems (ISO/9001). Written comments were to be received by September 30, 2013. NIOSH is extending the public comment period to December 2, 2013. You may submit comments by either of the following methods: Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Mail: NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226. All information received in response to this notice and meeting must include the agency name and docket number (CDC-2013-0015; NIOSH- 237-A). All relevant comments received will be posted without change to https://www.regulations.gov, including any personal information provided. All information will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Room 109, Cincinnati, OH 45226. All electronic comments should be formatted in Microsoft Word. To view the notice and related materials, visit https:// www.regulations.gov and enter CDC-2013-0015 in the search field and click ``Search.''
Submission for OMB Review; 30-day Comment Request; Quantification of Behavioral and Physiological Effects of Drugs Using a Mobile Scalable Device
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), 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 March 29, 2013, Vol.78, No.61, pages 19273-19274, 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 on Drug Abuse (NIDA), the 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.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Nitin Aggarwal, Ph.D., Medical College of Wisconsin and University of Wisconsin-Madison: Based on the reports of the investigations conducted by the Medical College of Wisconsin (MCW) and the University of Wisconsin-Madison (UW) and additional analysis conducted by the ORI in its oversight review, ORI found that Dr. Nitin Aggarwal, former Graduate Student, MCW, and former Assistant Scientist, UW, engaged in research misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grants R01 HL37981, R01 HL54075, and R01 HL57414. ORI found that that the Respondent engaged in research misconduct by falsifying and/or fabricating PHS-supported data in six (6) figures that were included in the following two (2) publications, one (1) grant application to the American Heart Association (AHA), one (1) grant application to NIH, and the Respondent's Ph.D. thesis: Aggarwal, N.T., Pfister, S.L., & Campbell, W.B. ``Hypercholesterolemia Enhances 15-Lipoxygenase Mediated Vasorelaxation and Acetylcholine-Induced Hypotension.'' Arteriosclerosis, Thrombosis, and Vascular Biology 28:2209-2215, 2008 (hereafter the ``ATVB paper''). Aggarwal, N.T., Pfister, S.L., Gauthier, K.M., Chawengsub, Y., Baker, J.E., & Campbell, W.B. ``Chronic hypoxia enhances 15- lipoxygenase-mediated vasorelaxation in rabbit arteries.'' American Journal of PhysiologyHeart Circulation Physiology 296:H678-H688, 2008 (hereafter the ``AJP paper''). Aggarwal, N.T., Principal Investigator (P.I.), National Scientist Development grant application to the American Heart Association No. 11SDG7650072, ``Sulfonylurea rReceptor-2 splice variant and mitochondrial mechanisms for cardioprotection and arrhythmia'' (hereafter the ``AHA grant application''). K99 HL113518-01, ``Mitochondrial ATP-sensitive K-channels and pharmacological approaches for cardioprotection,'' Aggarwal, Nitin, Ph.D., P.I. Aggarwal, N.T. ``Endothelial 15-lipoxygenase regulates vasorelaxation and blood pressure in rabbits in normal and pathological condictions.'' A Dissertation Submitted to the Faculty of the Graduate School of Biomedical Science of the Medical College of Wisconsin in Partial Fulfillment of the Requirements for the Degree of Doctor of Philosophy, Milwaukee, Wisconsin, 2008 (hereafter the ``thesis''). Specifically, ORI found that Respondent engaged in research misconduct by falsifying Western blot loading control data by inverting, duplicating, and cropping source blot films and/or using films from unrelated experiments to construct five (5) false Western blot figures. In the absence of valid blot images, Respondent falsified and/or fabricated the corresponding quantitative data for summary bar graphs and the data statistics in related text. Respondent admitted to falsely reporting the number of mice reported for an experiment reported in Figure 4 in grant application HL113518-01 to support the hypothesis of the research. The falsified and/or fabricated data are: False [szlig]-actin data and statistics in Figures 1A and 1B in the AJP paper and Figures 41A and 41B in the thesis (p. 131) that purport to represent a time-course of 15-LO-1 protein expression in rabbit aortic endothelial cells (RAECs) following hypoxia. false [szlig]-actin and 15-LO-1 data and statistics in Figures 2A and 2B in the AJP paper and Figures 45A and 45B in the thesis (p. 135) that purport to represent 15-LO-1 expression in aortic rings of normoxic and hypoxic rabbits. false [szlig]-actin data and statistics in Figures 3A and 3B in the AJP paper and Figures 46A and 46B in the Respondent's Ph.D. thesis (p. 137) that purport to represent 15-LO-1 expression in different arteries after hypoxia. false [szlig]-actin data and statistics in Figures 1A and 1B in the ATVB paper and Figures 26A and 26B in the thesis (p. 105) that purport to demonstrate changes in 15-LO-1 expression in different arteries of cholesterol-animals; the false [szlig]-actin data in Figure 1A, ATVB was the same image as that used for Figure 1A, AJP but flipped vertically. false GAPDH data and statistics in Figure 7 in the AHA grant application that purport to represent SUR2A-55 expression in murine heart following left ventricular hypertrophy (LVH). false reporting in Figure 4A of grant application HL113518-01 for the number of mice used for the physiological data for ATP-induced potassium influx in murine mitochondria as three to four, when only a single mouse was studied. Dr. Aggarwal has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of three (3) years, beginning on September 17, 2013: (1) To have his research supervised; Respondent agreed that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which his participation is proposed and prior to his participation in any capacity on PHS- supported research, Respondent shall ensure that a plan for supervision of his duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of his research contribution; he agreed that he 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 him 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 himself 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.
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