Office of the Secretary July 18, 2008 – Federal Register Recent Federal Regulation Documents

Pursuant to the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Sunshine in the Government Act of 1976 (5 U.S.C. 552b, as amended), 41 CFR 102-3.140 and 41 CFR 102- 3.150, announcement is made of the following committee meeting of the Defense Task Force on Sexual Assault in the Military Services (hereafter referred to as the Task Force).

Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.65, the Department of Defense gives notice that it is renewing the charter for the Missile Defense Advisory Committee (hereafter referred to as the Committee). The Committee is a discretionary federal advisory committee established by the Secretary of Defense to provide the Department of Defense and the Director, Missile Defense Agency independent advice and recommendations on all matters relating to missile defense, including system development, technology, program maturity and readiness of configurations of the Ballistic Missile Defense System. The Committee, in accomplishing its mission: (a) Conducted an assessment of the MDA's Capabilities-Based Acquisition approach; (b) made recommendations in the areas of Approach, Transition to Production and Sustainment, Block Names, and MDA-Managed Systems; (c) assessed the U.S. ballistic missile defense capabilities against a certain potential level of threat; and (d) set forth recommendation in the areas of Deterrence, Research and Development, and Combatant Commands and Services. The Committee shall be composed of not more than 10 members, who are distinguished authorities in the field of national defense policy, acquisition and technical areas relating to Ballistic Missile Defense System Programs. Committee members appointed by the Secretary of Defense, who are not federal officers or employees, shall be appointed as experts and consultants under the authority of 5 U.S.C. 3109 and with the exception of travel and per diem for official travel, shall serve without compensation, unless otherwise authorized by the Secretary of Defense. The Secretary of Defense shall renew the appointments of these Special Government Employees on an annual basis. The Committee shall select the Chairperson from the total Committee membership. The Committee shall be authorized to establish subcommittees, as necessary and consistent with its mission, and these subcommittees or working groups shall operate under the provisions of the Federal Advisory Committee Act of 1972, the Government in the Sunshine Act of 1976, and other appropriate federal regulations. Such subcommittees or workgroups shall not work independently of the chartered Committee, and shall report all their recommendations and advice to the Committee for full deliberation and discussion. Subcommittees or workgroups have no authority to make decisions on behalf of the chartered Committee nor can they report directly to the Department of Defense or any federal officers or employees who are not Committee members.

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: J. Keith Hampton, St. Luke's Hospital: Based on the report of an investigation conducted by St. Luke's Hospital (SLH) in Chesterfield, MO, and additional analysis conducted by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that J. Keith Hampton, MSN, APRN, former Clinical Research Associate, SLH, engaged in scientific misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), awards U10 CA69651, U10 CA12027, and U10 CA33601. PHS found that Mr. Hampton engaged in scientific misconduct by falsifying and fabricating data that were reported to the National Surgical Adjuvant Breast & Bowel Project (NSABP) and Cancer and Leukemia Group B (CALGB) cooperative research groups. Specifically, PHS found that: 1. For protocol CALGB 90206, Respondent: (a) Falsified a patient's CT scan reports and registration forms and reported the falsified CT scan reports and registration worksheet to CALGB, (b) Falsified a patient's performance status records (giving 80% performance status) and registration forms and reported the falsified performance status report and registration form to CALGB. 2. For protocol NSABP B-35, Respondent: (a) Falsified eligibility data related to hematology and chemistry assays and to the performance of a pelvic exam on one patient's registration form and reported the falsified registration forms to the National Cancer Institute Cancer Trial Support Unit (CTSU), (b) Falsified pelvic exam eligibility on a second patient's registration form and reported the falsified registration form to the CTSU, (c) Falsified hematology and chemistry assay eligibility on a third patient's registration form and reported the falsified registration form to the CTSU. 3. For protocol NSABP B-36, Respondent falsified a patient's multigated acquisition test (MUGAa test of heart function) records, cardiac function, and registration forms, certified the patient's eligibility, and reported the falsified MUGA test, cardiac function, and registration forms to the CTSU. 4. For protocol NSABP B-38, Respondent falsified hematology, chemistry, and MUGA eligibility for a patient on the registration form and reported the falsified registration form to the CTSU. 5. For protocol NSABP C-08, Respondent: (a) Falsified urine protein/creatinine ratio eligibility for one patient on the registration form and reported the falsified registration form to the CTSU, (b) Falsified urine protein/creatinine ratio eligibility for a second patient on the registration form and reported the falsified registration form to the CTSU, (c) Falsified claims of the urine protein/creatinine ratio and PT(INR) eligibility for a third patient on the registration form and reported the falsified registration form to the CTSU. 6. For protocol NSABP R-04, Respondent falsified a patient's colonoscopy report and eligibility at registration and reported the falsified colonoscopy report and registration form to the CTSU. Mr. Hampton has entered into a Voluntary Exclusion Agreement (Agreement) in which he has voluntarily agreed for a period of three (3) years, beginning on June 17, 2008: (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); 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 or contractor to PHS.