Department of Health and Human Services November 24, 2006 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Clifford R. Robinson, Ph.D., University of Delaware: Based on the reports of investigations conducted by 3-Dimensional Pharmaceuticals, Inc. (3DP) and the University of Delaware (UD) and additional analysis conducted by ORI during its oversight review, the U.S. Public Health Service (PHS) found that Clifford R. Robinson, Ph.D., Assistant Professor, Department of Chemistry and Biochemistry, UD, engaged in misconduct in science involving research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grants 1 R43 GM58950-01 and 2 R44 GM58950-02, ``Four- helix bundle analog of a G-protein coupled receptor (C. Robinson, Principal Investigator [P.I.]). The following grant applications also were involved in Dr. Robinson's misconduct in science: 1 R43 GM62708-01, ``Improved method for protein refolding'' (C.R. Robinson, P.I.), submitted March 30, 2000; approved but not funded, withdrawn. 1 P20 RR017716-01, ``Design of hierarchical recognition motifs,'' Project V, ``Determinants of stability and assembly of integral membrane proteins'' (C.R. Robinson, Project Investigator), submitted March 1, 2002, funded September 16, 2002, to August 30, 2007. 1 R01 GM074789-01, ``Folding and stability of integral membrane proteins'' (C.R. Robinson, P.I.), submitted October 1, 2004; scored not competitive, not funded. 1 R01 GM075891-01, ``Membrane protein expression, solubilization, and refolding'' (C.R. Robinson, P.I.), submitted January 24, 2005; approved but not funded, pending. 1 R21 GM07953-01, ``Mini-receptor analogs of GPCRs'' (C.R. Robinson, P.I.), submitted January 25, 2005; not funded. Specifically, PHS found that Dr. Robinson engaged in the following acts of misconduct in science. With regard to the following paragraphs numbered 1-6, nothing herein shall be deemed as an admission of liability on the part of Dr. Robinson. 1. While at 3DP, Dr. Robinson systematically substituted crystallized chicken ovalbumin in place of [beta]2-AR-NQ and repeatedly provided these crystalline preparations to other scientists to conduct molecular analyses. Dr. Robinson made false claims about his progress on characterizing [beta]2-AR-NQ and falsely claimed to have supplied purified [beta]2-AR-NQ to 3DP staff in project team meetings (PTM) held on at least five occasions between July 14, 1998, and July 7, 1999. 2. Dr. Robinson made multiple false claims about his research on [beta]2-AR-NQ in NIH grant applications R44 GM58950-02, submitted April 1, 1999, supplemental material for the same application submitted on July 7, 1999, and NIH grant application R43 GM62708-01, submitted March 30, 2000. 3. Dr. Robinson made similar claims as in item 1 above concerning the wild type form of [beta]2-AR, by substituting canine ovalbumin. Dr. Robinson's false claims were made to 3DP staff at PTM meetings on at least three occasions between September 7, 1999, and March 30, 2000, and in NIH grant application R43 GM62708-01, and after moving to UD, in NIH grant application 1 P20 RR017716-01, submitted on March 1, 2002. 4. Dr. Robinson was unable to adequately produce recombinant [beta]2-AR in E. coli and made false claims at PTM meetings in September and October 1999 that he had successfully expressed active protein and had purified it for crystallization trials. Dr. Robinson also made false claims in NIH grant applications R43 GM62708-01 and 1 R01 GM07589-01, submitted January 24, 2005, that he had purified large amounts of [beta]2-AR-NQ from E. coli and that he had reconstituted the protein into its native biologically active form. 5. Dr. Robinson made false claims about his ability to produce, purify, and characterize a recombinant fragment of [beta]2- AR-NQ containing four transmembrane domains ([beta]2-AR-4HB) at PTM meetings in October 1998 and in NIH grant applications R44 GM58950-02 and 1 P20 RR017716-01. 6. Dr. Robinson falsified fluorescence spectra and circular dichroism measurements in Figure 7 (both left and right panels) of NIH grant application R44 GM58950-02 by substituting results obtained with different proteins. 7. After moving to UD, Dr. Robinson made false claims in NIH grant application 1 P20 RR017716-01, including presenting falsified data in both panels of Figures V.5 (fluorescence spectra and circular dichroism measurements) and V.9 (falsified experimental conditions). 8. While at UD, Dr. Robinson falsified circular dichroism and fluorescence data in NIH grant application 1 R01 GM074789-01 (Figures 5A, 5B, and 6) and circular dichroism data in NIH grant applications 1 R01 GM075891-01 (Figure 6) and 1 R21 GM075953-01 (Figure 5). 9. In presentations at the Biophysical Society annual meeting and a Cornell University Consortium meeting, both in 1999, Dr. Robinson falsely represented data obtained with cytochrome b562 as being obtained with [beta]2-AR. Dr. Robinson has entered into a Voluntary Exclusion Agreement in which he has voluntarily agreed, for a period of five (5) years, beginning on October 23, 2006: (1) To exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility for or involvement in nonprocurement programs of the United States Government as defined in the debarment regulations at 45 CFR Part 76; 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.

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in co-sponsorship with the Risk Management Small Business Development Center (RMSBDC), is announcing a public workshop entitled ``Food Defense Workshop.'' This public workshop is intended to provide information about food defense, the regulations authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and other related subjects to FDA-regulated food facilities (farms, manufacturers, processors, distributors, retailers, and restaurants). Date and Time: This public workshop will be held on March 29, 2007, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Hoblitzelle Auditorium at the Bill Priest Campus of El Centro College, 1402 Corinth St., Dallas, TX 75215. Contact: David Arvelo, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, Suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-4970, or e-mail: david.arvelo@fda.hhs.gov. Registration: Registration by March 15, 2007, is encouraged. The RMSBDC has a $20 registration fee to cover the cost of facilities and refreshments. Please submit your registration as soon as possible. Those accepted into the workshop will receive confirmation. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $25, payable to RMSBDC. If you need special accommodations due to a disability, please contact David Arvelo (see the Contact section of this document) at least 7 days in advance. Registration Form Instructions: To register, please complete the RMSBDC registration form and submit along with payment to RMSBDC, Attn: Saira Roberts, 1402 Corinth St., Dallas, TX 75215. You may fax the completed registration form to RMSBDC at 214-860-5867. To obtain a copy of the registration form, please call RMSBDC at 214-860-5887 or 214- 860-5849. The registration form is also available online at https:// www.ntsbdc.org/. Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Workshop handouts may be requested through the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page.

On January 22-23, 2007, the NIEHS is hosting a workshop titled ``Children's Environmental Health Research: Past, Present, and Future.'' The goal of this workshop is to develop new strategies for research, exposure and effects monitoring, intervention and prevention in children's environmental health. Specific objectives are to maximize the effectiveness of scientific researchbasic science, exposure monitoring/biomonitoring, epidemiology, toxicology, clinical medicine and multidisciplinary studiesand to enhance the translation of research to the bedside, to the community and to public policy. This meeting is open to the public with attendance limited only by the space available. Time will be set aside for public discussion. Additional information about the workshop and on-line registration are available from the NIEHS Web site at https://www.apps.niehs.nih.gov/conferences/ od/cehr/. The first day will begin with discussions of two case studies that demonstrate the successful implementation of evidence-based intervention/prevention strategies that became possible once links between environmental exposures and a disease in children had been identified. The first case study will focus on lead and neurotoxicity. Findings on the adverse effects of lead on neurodevelopment ultimately led to efforts to reduce exposures to lead. Asthma will be used as a second case study because it provides a clear example of environmental triggers and some science-based prevention/intervention strategies that are already being implemented. The second day of the workshop will focus on applying lessons learned from the two ``success'' case studies to two children's disorders that appear to have environmental etiologies but are less well understood: disorders of lipid and carbohydrate metabolism and attention deficit/hyperactivity disorder (ADHD). A discussion will follow each case study presentation to consider the opportunities, the barriers and the design challenges that confront future clinical, toxicological, epidemiological, exposure monitoring, and basic research in children's environmental health. Specific topics include: Past approaches to research translation to see what worked and what failed to work. The critical mass of researchers and mix of disciplines needed to most efficiently advance research in children's environmental health. Biomarkers of exposure, susceptibility, or subclinical dysfunction. The use of ``omics'' technologies that might be incorporated into future toxicological, epidemiological and/or biomonitoring studies to enhance their sensitivity and efficiency. Is there a point at which the use of new scientific tools might slow the pace of progress? New approaches to accelerating the translation of science to treatment, prevention, and the remediation of environmental risks to children's health. Potential study populations at uniquely high risk of disease. Data resourcesrecords, disease registries, well- characterized cohort populations, tissue banks, or stored DNAin the U.S. or abroad that might facilitate future studies. New partnerships in research.

This notice announces our decisions regarding deemed status of Joint Commission for the Accreditation of Health Care Organization- accredited Medicare Advantage plans. These decisions follow business decisions made by Joint Commission for the Accreditation of Health Care Organization in late 2005 which affect its deeming operations beginning January 1, 2006 and continue until Joint Commission for the Accreditation of Health Care Organization's deeming authority expires on March 24, 2008.

This notice announces the rechartering of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) by the Secretary of DHHS (the Secretary) for a 2-year period with the new Charter effective until November 21, 2008.

This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system, and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 and the Deficit Reduction Act (DRA) of 2005. In this final rule with comment period, we describe changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2007. In addition, this final rule with comment period implements future CY 2009 required reporting on quality measures for hospital outpatient services paid under the prospective payment system. This final rule with comment period revises the current list of procedures that are covered when furnished in a Medicare-approved ambulatory surgical center (ASC), which are applicable to services furnished on or after January 1, 2007. This final rule with comment period revises the emergency medical screening requirements for critical access hospitals (CAHs). This final rule with comment period supports implementation of a restructuring of the contracting entities responsibilities and functions that support the adjudication of Medicare fee-for-service (FFS) claims. This restructuring is directed by section 1874A of the Act, as added by section 911 of the MMA. The prior separate Medicare intermediary and Medicare carrier contracting authorities under Title XVIII of the Act have been replaced with the Medicare Administrative Contractor (MAC) authority. This final rule continues to implement the requirements of the DRA that require that we expand the ``starter set'' of 10 quality measures that we used in FY 2005 and FY 2006 for the hospital inpatient prospective payment system (IPPS) Reporting Hospital Quality Data for the Annual Payment Update (RHQDAPU) program. We began to adopt expanded measures effective for payments beginning in FY 2007. In this rule, we are finalizing additional quality measures for the expanded set of measures for FY 2008 payment purposes. These measures include the HCAHPS survey, as well as Surgical Care Improvement Project (SCIP, formerly Surgical Infection Prevention (SIP)), and Mortality quality measures.