Department of Health and Human Services October 2011 – Federal Register Recent Federal Regulation Documents
Results 201 - 305 of 305
Guidance for Industry on Incorporation of Physical-Chemical Identifiers Into Solid Oral Dosage Form Drug Products for Anticounterfeiting; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Incorporation of Physical-Chemical Identifiers Into Solid Oral Dosage Form Drug Products for Anticounterfeiting.'' This guidance provides recommendations on design considerations for incorporating physical-chemical identifiers (PCIDs) into solid oral dosage forms (SODFs), supporting documentation to be submitted in new drug applications (NDAs) or abbreviated new drug applications (ANDAs) to address the proposed incorporation of PCIDs in SODFs, supporting documentation to be submitted in postapproval submissions to report or request approval to incorporate PCIDs into SODFs, and procedures for reporting or requesting approval to incorporate PCIDs into SODFs as a postapproval change.
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.
Submission for OMB Review; Comment Request; A Generic Submission for Theory Development and Validation (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), 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 August 2, 2011 (76 FR 46307) and allowed 60-days for public comment. No public comment were received. The purpose of this notice is to allow an additional 30 days for public comment. 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. Proposed Collection: Title: A Generic Submission for Theory Development and Validation (NCI). Type of Information Collection Request: NEW. Need and Use of Information Collection: In order to carry out NCI's legislative mandate to conduct and support research with respect to the causes and prevention of cancer, it is beneficial for NCI, through initiatives in the Behavioral Research Program (BRP), to conduct and support behavioral research informed by and informing theory. Formative research in the area of theory development and validation would provide the basis for developing effective cancer prevention and control strategies, allow for a better understanding of theoretical constructs that influence decisions and actions related to cancer, and ultimately contribute to reducing the U.S. cancer burden. Data collections that result from this generic clearance would inform and clarify the use of theory in BRP-supported initiatives and funding announcements. Specifically, this research would allow NCI to conduct research to: (1) Identify psychological, biobehavioral, demographic, and individual difference predictors of cancer prevention and control behaviors and outcomes; (2) Develop and refine integrative theories; (3) Identify and observe theoretical and innovative trends in cancer prevention and control research; and (4) Determine feasibility and usefulness of collaborative and multidisciplinary approaches to cancer prevention and control. Frequency of Response: Will be determined by each project. Affected Public: Individuals or households; Businesses or other for profit; Not-for-profit institutions; Federal Government; State, Local, or Tribal Government. Type of Respondents: Members of the public including, but not limited to health professionals, physicians, and researchers. Table 1 outlines the estimated burden hours and cost required for a three-year approval of this generic submission.
Medicare Program; Establishment of the Medicare Economic Index Technical Advisory Panel and Request for Nominations for Members
This notice announces the establishment of the Medicare Economic Index Technical Advisory Panel and discusses the group's purpose and charter. It also requests nominations for individuals to serve on the panel.
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the General Electric Co. in Evendale, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 31, 2011, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Tobacco Products, Exemptions From Substantial Equivalence Requirements; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of September 12, 2011 (76 FR 56200). The document announced that an information collection had been approved by the Office of Management and Budget (OMB). The document was published with an incorrect expiration date. This document corrects that error.
Countermeasures Injury Compensation Program (CICP): Administrative Implementation, Final Rule
This document adopts the Countermeasures Injury Compensation Program Administrative Implementation Interim Final Rule as the final rule with technical amendments. The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to establish the Countermeasures Injury Compensation Program (CICP or Program). The Department of Health and Human Services (HHS) is issuing this final rule to adopt the administrative policies, procedures, and requirements for the CICP set out in the interim final rule, which was published and effective on October 15, 2010. This Program is designed to provide benefits to certain persons who sustain serious physical injuries or death as a direct result of administration or use of covered countermeasures identified by the Secretary in declarations issued under the PREP Act. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as the direct result of such covered injuries or their health complications. The Secretary makes only minor technical amendments to the interim final rule, described below, and otherwise adopts the regulation as published on October 15, 2010.
Agency Information Collection Activities: Proposed Collection; Comment Request
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: ``Evaluation of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) Quality Demonstration Grant Program.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 3rd, 2011 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
Proposed Revision of Performance Standards for State Medicaid Fraud Control Units
This notice seeks comment on an OIG proposal to revise standards for assessing the performance of the State Medicaid Fraud Control Units (MFCUs or Units). This proposal would replace and supersede standards published on September 26, 1994 (59 FR 49080).
Submission for OBM Review; Comment Request; New Proposed Collection, Environmental Science Formative Research Methodology Studies for the National Children's Study
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 reinstatement of approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on April 27, 2011, pages 23603-23605, and allowed 60 days for public comment. Two written comments and two verbal comments were received. The verbal comments expressed support for the broad scope of the study. The written comments were identical and questioned the cost and utility of the study. The purpose of this notice is to allow an additional 30 days for public comment. 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. Proposed Collection: Title: Environmental Science Formative Research Methodology Studies for the National Children's Study (NCS). Type of Information Request: New. Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106-310) states:
Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety Modernization Act; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act.'' FDA is issuing this guidance to provide answers to common questions that might arise about the new fee provisions and FDA's plans for their implementation in fiscal year (FY) 2012.
Meeting of the National Advisory Council for Healthcare Research and Quality
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Center for Devices and Radiological Health; Standard Operating Procedures for Network of Experts; Request for Comments
The Food and Drug Administration (FDA) is announcing the availability of draft standard operating procedures (SOPs) for a new ``Network of Experts.'' The draft SOPs describe a new process for staff at the Center for Devices and Radiological Health (CDRH, the center) to gain access to scientific, engineering, and medical expertise when it is needed to supplement existing knowledge and expertise within the Center.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.
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. 207 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.
Proposed Collection; Comment Request; STAR METRICS (Science and Technology for America's Reinvestment: Measuring the EffecTs of Research on Innovation, Competitiveness and Science)
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 data collection projects, the Office of the Director of 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. Proposed Collection: Title: STAR METRICS (Science and Technology for America's Reinvestment: Measuring the EffecTs of Research on Innovation, Competitiveness and Science). Type of Information Collection Request: Reinstatement of OMB number 0925-0616, expiration date 01/31/2011. Need and Use of Information Collection: The aim of STAR METRICS is twofold. The goal of STAR METRICS is to continue to provide mechanisms that will allow participating universities and Federal agencies with a reliable and consistent means to account for the number of scientists and staff that are on research institution payrolls, supported by Federal funds. In subsequent generations of the program, it is hoped that STAR METRICS will allow for measurement of science impact on economic outcomes (such as job creation), on knowledge generation (such as citations and patents) as well as on social and health outcomes. Frequency of Response: Quarterly. Affected Public: Universities and other research institutions. Type of Respondents: University administrators. The annual reporting burden is as follows: Estimated Number of Respondents: 100. Estimated Number of Responses per Respondent: 4. Average Burden Hours per Response: 2.5. Estimated Total Annual Burden Hours Requested: 1,315. The annualized cost to respondents is estimated to be $65,750. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
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. 207 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.
Availability of Draft NTP Monograph on the Health Effects of Low-Level Lead; Request for Comments; Announcement of a Panel Meeting to Peer Review Draft Monograph
The NTP announces the availability of the Draft NTP Monograph on the Health Effects of Low-level Lead (available at https:// ntp.niehs.nih.gov/go/36639) that will be peer-reviewed by an NTP Peer Review Panel at a meeting on November 17-18, 2011. The meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on the draft monograph (see Request for Comments below).
Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728, Animal Generic Drug User Fee Act Cover Sheet
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection burden of the Animal Generic Drug User Fee Cover Sheet Form FDA 3728 that further implements certain provisions of the Animal Generic Drug User Fee Act of 2008 (AGDUFA).
Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request
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: ``Evaluation of the Technical Assistance to ARRA Complex Patient Grantees Project.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 3rd, 2011, and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Submission of Bioequivalence Data
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; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
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.
Deborah Martinez Seldon: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Deborah Martinez Seldon from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Seldon was convicted of multiple felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Ms. Seldon was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Ms. Seldon failed to respond. Ms. Seldon's failure to respond constitutes a waiver of her right to a hearing concerning this action.
Preemption Review
The Food and Drug Administration (FDA) is announcing that it has determined, after conducting a review of its existing regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the Agency to preempt State law, that three FDA regulatory preambles contain or refer to statements about preemption that are not legally justified. FDA conducted this review in response to the President's May 20, 2009, ``Memorandum for the Heads of Executive Departments and Agencies,'' which outlined the Administration's policy on preemption, in keeping with the principles in Executive Order 13132 on Federalism. The President's memorandum included a directive that such a review be conducted. FDA is also taking this opportunity to clarify certain preamble statements related to preemption resulting from express preemption provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act) concerning nonprescription drugs and food labeling.
Medicare, Medicaid, and Children's Health Insurance Programs; Meeting of the Advisory Panel on Outreach and Education (APOE), November 17, 2011
This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Scott Weber, Ed.D., MSN, University of Pittsburgh: Based on the letters from the Research Integrity Officer at the University of Pittsburgh (UP), ORI's oversight review, and an admission by the Respondent, ORI found that Dr. Scott Weber, former Assistant Professor, Health and Community Systems, School of Nursing, UP, engaged in research misconduct by (1) plagiarizing text and falsifying data from two publications supported by U.S. Public Health Service (PHS) funding (P30 MH60570; HS5 SM52671; PHS employee generated article) in two unpublished manuscripts, and (2) including significant portions of that plagiarized text in two grant applications to the National Institutes of Health (NIH) (1 L30 NR010444-01; 1 R03 HD062761-01). ORI found that the Respondent engaged in research misconduct by plagiarizing text, falsifying data and references, and fabricating data from two publications (Mufson, L., Dorta, K.P., Wickramaratne, P., Nomura, Y., Olfson, M., Weissman, M.M. ``A randomized effectiveness trial of interpersonal psychotherapy for depressed adolescents.'' Arch Gen Psychiatry 61(6):577-84, 2004 June; hereafter referred to as ``Mufson et al. 2004;'' and Cho, M.J., Mo[sacute]cicki, E.K., Narrow, W.E., Rae, D.S., Locke, B.Z., Regier, D.A. ``Concordance between two measures of depression in the Hispanic Health and Nutrition Examination Survey.'' Soc Psychiatry Psychiatr Epidemiol. 28(4):156-63, 1993 August; hereafter referred to as ``Cho et al., 1993'') supported by PHS in two journal article submissions. Specifically, ORI found that the Respondent plagiarized more than 90 percent of the text from Mufson et al. 2004 in a manuscript entitled ``A randomized effectiveness trial of psychiatric-mental health nurse practitioner-administered interpersonal psychotherapy for sexual minority adolescents with depression in primary care clinics'' and submitted to the Journal of the American Academy of Nurse Practitioners (JAANP MS). Furthermore, the Respondent plagiarized approximately 66 percent of the text from Cho et al. 1993 in a manuscript entitled ``Assessing the diagnostic predictive power of a screening tool for depression: Concordance between the CES-D and DIS in the Parent Identity Survey'' and submitted to the Journal of GLBT Family Studies (JGMS MS). In both manuscripts, the Respondent falsified and fabricated tables and figures by using all or nearly all of the data in tables and graphs from the plagiarized articles while altering numbers and changing text to represent data as if from another subject population; he also copied most of the original bibliographic references but falsified 35% of the copied references from JAANP MS and 25% of the copied references from JGMS MS, by changing volume numbers and/or publication years, apparently to hinder detection of the plagiarism. The data fabrication occurred when the Respondent altered or added values to Table 2 in each manuscript describing the demographic characteristics of the study population that was never studied. ORI also finds that the Respondent engaged in research misconduct by plagiarizing text from Cho et al. 1993 in two NIH grant applications (1 L30 NR010444-01 and 1 R03 HD062761-01) by copying substantial word- for-word portions of the text describing the test instrument to be used in the proposed study without citing the Cho et al. 1993 paper. Dr. Weber has voluntarily agreed for a period of three (3) years, beginning on September 7, 2011: (1) To exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility 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 OMB Guidelines to Agencies on Governmentwide Debarment and Suspension, 2 CFR part 180 (collectively the ``Debarment Regulations''); and (2) 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.
Bundled Payments for Care Improvement Initiative
This notice extends the deadlines for the submission of the Bundled Payments for Care Improvement ``Model 1'' letters of intent and applications.
Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2012 Proposed Guidance Development
The Food and Drug Administration (FDA) is announcing the Web site location where the Agency will post a list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for development. In addition, FDA has established a docket where stakeholders may provide comments and/or draft language for those topics as well as suggestions for new or different guidances.
Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas; Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas.
Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase Transparency By Promoting Greater Access to the Agency's Compliance and Enforcement Data; Availability
As part of the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase Transparency By Promoting Greater Access to the Agency's Compliance and Enforcement Data.'' This report includes eight draft proposals to make FDA's publicly available compliance and enforcement data more accessible and user-friendly. FDA is seeking public comment on these draft proposals. The Transparency Task Force will ultimately recommend specific draft proposals to the Commissioner of Food and Drugs (the Commissioner) for consideration based on the comments it receives, the feasibility of the draft proposal, relative priority, and available resources.
Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the Office of the Secretary, Office of the National Coordinator for Health Information Technology (ONC), HHS has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).
Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review
In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety and is proposing to amend and republish the list as required by the Bioterrorism Response Act. Further, on July 2, 2010, the President signed Executive Order 13546, ``Optimizing the Security of Biological Select Agents and Toxins in the United States'' that directed the Secretaries of HHS and Agriculture (USDA) to designate a subset of the select agents and toxins list (Tier 1) that presents the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure; or public confidence; explore options for graded protection for these Tier 1 agents and toxins to permit tailored risk management practices based upon relevant contextual factors; and consider reducing the overall number of agents and toxins on the select agents and toxins list. E.O. 13546 also established the Federal Experts Security Advisory Panel (FESAP) to advise the HHS and USDA Secretaries on the designation of Tier 1 agents and toxins, reduction in the number of agents on the Select Agent List, establishment of suitability standards for those having access to Tier 1 select agents and toxins, and establishment of physical security and information security standards for Tier 1 select agents and toxins. The tiering of the select agents and toxins list will allow the application of more optimized security measures for those select agents or toxins which pose a higher risk to public health and safety should they be stolen or otherwise misused. In addition to addressing the FESAP recommendations in this Notice of Proposed Rulemaking (NPRM), we are also proposing to add two agents, Lujo and Chapare viruses to the list; adding definitions; and clarifying language concerning security, training, biosafety, and incident response. These changes will increase the usability of the select agents and toxins regulations as well as providing for enhanced program oversight.
Notice of Intent To Prepare an Environmental Impact Statement
In accordance with the National Environmental Policy Act, the National Institutes of Health (NIH), an agency of the Department of Health and Human Services (HHS), is issuing this notice to advise the public that an environmental impact statement will be prepared for the NIH Animal Center at Poolesville Master Plan, Poolesville, Montgomery County, Maryland. For Further Information Contact: Valerie Nottingham, Chief, Environmental Quality Branch, Division of Environmental Protection, Office of Research Facilities, NIH, B13/2S11, 9000 Rockville Pike, Bethesda, Maryland 20892, telephone 301-496-7775; fax 301-480-8056; or e-mail nihnepa@mail.nih.gov. Supplementary Information: The NIH Animal Center is located on 513 acres 4 miles southwest of the City of Poolesville, a small agricultural community located in western Maryland. The campus is a component of the National Institutes of Health (NIH), one of the world's largest biomedical research facilities and the Federal government's focal point for medical and behavioral research. The NIH Animal Center at Poolesville is a major extension of animal holding and production facilities at Bethesda and consists of a number of buildings used to house, quarantine, and study the behavior and immunological conduct of a variety of animal models. The NIH Animal Center at Poolesville conducts and supports research protocols for various Institutes and Centers, which includes the studies of animal behavior, conduct of immunologic procedures and sampling, and surgical investigation. Total building space on the campus amounts to approximately 364,507 gsf. Approximately 199 people work at the NIH Animal Center site. A Master Plan is an integrated series of documents that present in graphic, narrative, and tabular form the current composition of NIH campuses and the plan for their orderly and comprehensive development over a 20-year period. The plan provides guidance in coordinating the physical development of NIH campuses, including building locations, utility capacities, road alignments, parking facilities, and the treatment of open spaces. General design guidelines are also used to provide detailed guidance for the placement and design of physical improvements. The proposed action is to develop a long-range physical master plan for the NIH Animal Center. The plan will cover a 20-year planning period and address the future development of the NIH Animal Center site, including placement of future construction; vehicular and pedestrian circulation on- and off-campus; parking within the property boundaries; open space in and around the campus; required setbacks; historic properties; natural and scenic resources; noise; and lighting. The plan will examine potential growth in the NIH Animal Center personnel, and consequent construction of space over the planning period. Future construction on the site could include such facilities as: new animal holding, research laboratories, and support facilities. In accordance with 40 CFR 1500-1508 and DHHS environmental procedures, NIH will prepare an Environmental Impact Statement (EIS) for the proposed master plan. The EIS will evaluate the impacts of the master plan should development occur as proposed. Among the items the EIS will examine are the implications of the master plan on community infrastructure, including, but not limited to, utilities, storm water management, traffic and transportation, and other public services. To ensure that the public is afforded the greatest opportunity to participate in the planning and environmental review process, the NIH is inviting oral and written comments on the master plan and related environmental issues. The NIH will be sponsoring a public Scoping Meeting to provide individuals an opportunity to share their ideas on the master planning effort, including recommended alternatives and environmental issues the EIS should consider. The meeting is planned for 6:30 p.m. to 9 p.m. on October 25, 2011 at the Town Hall Building at 19721 Beall Street, Poolesville, Maryland 20837. All interested parties are encouraged to attend. The NIH has established a 30-day public comment period for the scoping process. Scoping comments must be postmarked no later than November 18, 2011 to ensure they are considered. All comments and questions on the EIS should be directed to Valerie Nottingham at the address listed above, telephone 301-496-7775; fax 301-480-8056; or e- mail nihnepa@mail.nih.gov.
Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of Automatic Class III Designation); Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``De Novo Classification Process (Evaluation of Automatic Class III Designation).'' The purpose of this document is to provide guidance to FDA staff and industry on the process for the submission and review of petitions submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act), also known as the de novo classification process. FDA is issuing this draft guidance to provide updated recommendations for efficient interaction with FDA, including what information to submit, when seeking a path to market for a novel device via the de novo process. This draft guidance is not final nor is it in effect at this time.
Medicare Program; Comprehensive Primary Care Initiative
This notice announces a solicitation for health care payer organizations to participate in the Comprehensive Primary Care initiative (CPC), a multipayer model designed to improve primary care.
Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
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