Department of Health and Human Services March 2005 – Federal Register Recent Federal Regulation Documents

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.

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.

Notice is hereby given that the Office of Research Integrity (ORI) and the Acting Assistant Secretary for Health have taken final action in the following case: Gary M. Kammer, M.D., Wake Forest University: Based on the Wake Forest University (WFU) Investigation Report, the respondent's admission, and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Gary M. Kammer, M.D., former Professor, Division of Rheumatology, Department of Internal Medicine, and Department of Microbiology and Immunology at the WFU School of Medicine, engaged in scientific misconduct by falsification and fabrication of research in grant application 2 R01 AR39501-12A1, ``T Lymphocyte Dysfunction in Lupus Erythematosus,'' submitted to the National Institute of Arthritis and Musculoskeletal Skin Diseases (NIAMS), National Institutes of Health (NIH), and in 1 R01 AI46526-01A2, ``Protein Kinase A-II in the Pathogenesis of Lupus,'' submitted to the National Institute of Allergy and Infectious Diseases (NIAID), NIH. Specifically, PHS found that: The respondent fabricated Families 2 and 3 in Figure 6 and related text in application 2 R01 AR39501-12A1 (pp. 29-30), entitled (``T Lymphocyte Dysfunction in Lupus Erythematosus'') by: a. Making up both of the pedigrees, b. Fabricating 13 PKA-I and 13 PKA-II values for these non-existent affected and unaffected family members, and c. Composing the false text describing these two fabricated families. The respondent falsified the text describing the results in Figure 20 (``Inhibition of c-fos luciferase activity in S49 T cells transiently transfected with pIRES2-RIIb-EGFP and treated with 8-Cl- cAMP'') in application 1 R01 AI46526-01A2 (p. 27), by falsely reporting N = 4, P less than 0.002, when the experiment had been performed only one time at the time that the application was submitted. PHS also concluded that the respondent further demonstrated a lack of present responsibility as a Principal Investigator by submitting NIH grant proposals with additional unsupported experimental results: The pedigree and data for the family reported in grant application 2 R01 AR39501-12 and for Family 1 in grant application 2 R01 AR39501-12A1 are incorrect and the data pertaining to this family that Dr. Kammer subsequently provided to WFU after the inquiry were not the data reported in the applications. Dr. Kammer stated that he did not recall who in his laboratory gave him this pedigree. ORI noted that the actual PKA data for the ``proof-of-principle'' family, while suggesting that low PKA values may be hereditary (the presence of low PKA-I values in three generations), do not support the claims of the fabricated and mixed up pedigree and data that show that low PKA-I values were associated with Systematic Lupus Erythematosus (SLE) (application 2R01 AR39501-12). In application, R01 AI39501-12A1, the following unsupported statement was also included: ``In both normal and disease controls, all T cells express CD59+ and there is no significant difference in its cell surface expression on CD4+, CD45RA+, CD4+, CD45RO+, CD8+, CD45RA+, CD8+, CD45RO+ subsets (n=4 each control group; data not shown).'' No data could be produced to support the information in the grant application about these control experiments. Dr. Kammer has entered into a Voluntary Exclusion Agreement (Agreement ) in which he has voluntarily agreed for a period of three (3) years, beginning on February 15, 2005: (1) 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, and (2) 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'' as defined in the debarment regulations at 45 CFR part 76. This voluntary exclusion precludes the respondent from receiving Federal research, research training, or other research related funds from the Federal Government for three (3) years, but shall not apply to the respondent's participation in a Federal health care program as defined in section 1128B(f) of the Social Security Act and shall not apply to Federal funds used solely for purposes of teaching or training medical students, residents, or fellows in clinical medical matters.

The Office of Public Health and Science, DHHS, is seeking nominations of qualified candidates to be considered for appointment as a member of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides science-based advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on a broad range of issues and topics pertaining to chronic fatigue syndrome (CFS). CFSAC, which was formerly known as the Chronic Fatigue Syndrome Coordinating Committee, was established by the Secretary of Health and Human Services on September 5, 2002. The appointments of six Committee members are scheduled to end on September 30, 2005. Nominations of qualified candidates are being sought to fill these scheduled vacancies.