Office of the Secretary February 2006 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Deputy Assistant Secretary for the Office of Acquisition Management and Policy of the Department of Health and Human Services (HHS) has taken final agency action in the following case: Paul H. Kornak, Stratton VA Medical Center, Albany, New York: Upon recommendations from the Office of Research Integrity (ORI), Acting Assistant Secretary for Health for the Department of Health and Human Services (HHS), the Office of Research Oversight (ORO), and the Under Secretary for Health, Department of Veterans Affairs (VA), that were based on the criminal convictions of making and using a materially false statement, in violation of 18 U.S.C. 1001(a)(3); mail fraud, in violation of 18 U.S.C. 1341 and 1346; and criminally negligent homicide, in violation of 18 U.S.C. 13 and New York Penal Law Sec. 125.10, the HHS debarring official has permanently debarred Mr. Paul Kornak, former research coordinator at the Stratton VA Medical Center. This action is taken pursuant to the HHS government-wide nonprocurement debarment and suspension regulation at 45 CFR part 76. As such, Mr. Kornak is excluded for life from participating in any and all Federal agency transactions, both procurement and nonprocurement, as set forth in part 76. Of the 48 criminal charges contained in his Indictment, Paul Kornak pled guilty to the three criminal charges listed above. See United States of America v. Paul H. Kornak, Criminal Action No. 03-CR-436 (FJS), U.S. District Court (N.D.N.Y.) (January 18, 2005). In addition to the 71-month term of imprisonment imposed, Mr. Kornak was directed to pay restitution to two pharmaceutical companies and the VA in the amount of approximately $639,000. As part of his guilty plea, Mr. Kornak admitted to the following facts: In August 2000, Mr. Kornak applied for employment to the VA, submitting a false ``Declaration for Federal Employment'' form. Mr. Kornak denied that he had been convicted or on probation in the preceding 10 years, whereas in fact, he had been convicted of mail fraud in 1992 and placed on probation for 3 years. By October of 2000, Mr. Kornak was responsible for organizing, coordinating, implementing, and directing all research elements in the Stratton VA Medical Center oncology research program. Specifically, Mr. Kornak was the site coordinator at the Stratton VA Medical Center for the ``Iron (Fe) and Atherosclerosis Study'' (FeAST), cancer studies known as Tax 325 and Tax 327, and a bladder cancer study. The FeAST study was a clinical trial that tested a novel procedure for controlling atherosclerosis, also known as hardening of the arteries, by reducing the iron in the body through blood drawing. The Tax 325 cancer treatment study involved the administration of pharmaceutical products to patients with metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. The Tax 327 study involved the administration of pharmaceutical products to patients with metastatic hormone refractory prostate cancer. The purpose of the bladder cancer study, which was co- sponsored by the National Cancer Institute, National Institutes of Health, was to compare the use of difluoromethylornithine (DFMO) to the use of a placebo in patients with low grade superficial bladder cancer according to time to first recurrence of the tumor and toxicities. From May 14, 1999, to July 10, 2002, in connection with the above protocols, Mr. Kornak participated in a scheme to defraud the sponsors of the clinical studies in that ``he would and repeatedly did submit false documentation regarding patients and study subjects and enroll and cause to be enrolled persons as study subjects who did not qualify under the particular study protocol.'' Mr. Kornak caused the death of a study subject when he ``failed to perceive a substantial and unjustifiable risk that death would occur when he knowingly and willfully made and used * * * documents falsely stating and representing the results of [the study subject's] blood chemistry analysis * * *, which false documents purported that [the study subject] met the inclusion and exclusion criteria for participation in Tax 325 when the actual results did not meet the inclusion and exclusion criteria and showed impaired kidney and liver function, and [the study subject] thus was administered the chemotherapeutic drugs docetaxel, cisplatin, and 5-FU in connection with Tax 325 on or about May 31, 2001, and died as a result thereof on or about June 11, 2001.'' Based on the criminal conviction and the facts admitted to above, HHS and VA believe that a debarment period longer than the standard length of debarment is warranted in this case. Mr. Kornak admitted to a dishonest handling of the research records and demonstrated a complete disregard for the well-being of vulnerable human subjects under his care. In pleading guilty to criminally negligent homicide, Mr. Kornak admitted that a reasonable person would have perceived a substantial and unjustifiable risk of death if an ineligible subject were enrolled in the cancer study in question and that his failure to perceive such a risk in enrolling the ineligible subject constituted a gross deviation from the standard of care. Moreover, a longer debarment period is warranted in this case because of an established pattern of misconduct and criminal behavior on the part of Mr. Kornak. As stated above, Mr. Kornak has a prior conviction of mail fraud. In addition, the Office of Personnel Management excluded Mr. Kornak from all Federal nonprocurement transactions for an indefinite period, effective July 22, 1993. Nonetheless, beginning in 1999, Mr. Kornak actively participated in federally sponsored research protocols in violation of the imposed exclusion. A lifetime debarment of Mr. Kornak is necessary to protect the public interest overall. Given the scope of his criminal conviction, his longstanding pattern of criminal behavior, and his total disregard for the safety and well-being of human subjects, Mr. Kornak's responsibility to engage in transactions with the Federal Government cannot be assured at any time in the future.

This document removes part 343, ``Under Secretary of Defense for Personnel and Readiness (USD(P&R))'' in Title 32 of the Code of Federal Regulations. This part has served the purpose for which it was intended in the CFR and is no longer necessary.

The Defense Science Board Task Force on VTOL/STOL will meet in closed session on February 22, 2006; at Strategic Analysis Inc., 3601 Wilson Boulevard, Arlington, VA. This meeting continues the task force's work and will consist of classified and FOUO briefings on current technologies and programs. The mission of the Defense Science Board is to advise the Secretary of Defense and the Under Secretary of Defense for Acquisition, Technology & Logistics on scientific and technical matters as they affect the perceived needs of the Department of Defense. At these meetings, the Defense Science Board Task Force will: Assess the features and capabilities VTOL/STOL aircraft should have in order to support the nation's defense needs through at least the first half of the 21st century. In accordance with Section 10(d) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App. II), it has been determined that these Defense Science Board Task Force meetings concern matters listed in 5 U.S.C. 552b(c)(1) and that, accordingly, the meetings will be closed to the public.

The Department of Defense, Under Secretary of Defense (Personnel and Readiness), Federal Voting Assistance Program, revised Standard Form 76, Federal Post Card Application for Registration and Absentee Ballot; SF 76A, Registration and Absentee Ballot Request Federal Post Card Application (FPCA) (Electronic); SF 186, Federal Write-in Absentee Ballot; and SF 186A, Federal Write-in Absentee Ballot (Electronic) to meet new Federal laws and technology, including but not limited to, the use of electronic transmission (faxing) for transmitting the form. The SF 76 and SF 186 will be stocked by GSA, Federal Acquisition Inventory Management Branch, 819 Taylor Street, Ft. Worth, TX 76102, and available February 6, 2006.

The Defense Policy Board Advisory Committee will meet in closed session at the Pentagon on March 9, 2006 from 0900 to 1800 and March 10, 2006 from 0830 to 1400. The purpose of the meeting is to provide the Secretary of Defense, Deputy Secretary of Defense and Under Secretary of Defense for Policy with independent, informed advice on major matters of defense policy. The Board will hold classified discussions on national security matters. In accordance with Section 10(d) of the Federal Advisory Committee Act, Public Law 92-463, as amended [5 U.S.C. App II (1982)], it has been determined that the meeting concerns matters listed in 5 U.S.C. 552B(c)(1)(1982), and that accordingly this meeting will be closed to the public.

The Office of the Secretary of Defense is altering a system of records to its existing inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.

This Notice is published in accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463). The topic of the meeting on March 14-15, 2006 are to review new start and continuing research and development projects requesting Strategic Environmental Research and Development Program funds in excess of $1M. This meeting is open to the public. Any interested person may attend, appear before, or file statements with the Scientific Advisory Board at the time and in the manner permitted by the Board.

The Department is eliminating its rule that currently prohibits each airline that owns, controls, or operates a computer reservations system (``CRS'' or ``system'') from denying system access to two or more carriers whose flights share a single designator code and discriminating against any carrier because the carrier uses the same designator code as another carrier. The Department has determined that this rule is no longer necessary. This action is consistent with the Department's decision at the end of 2003 to eliminate its comprehensive rules governing system operations, 14 CFR part 255.

Notice is hereby given that the Office of Research Integrity (ORI), the Assistant Secretary for Health, and another Federal agency have taken final action in the following case: Amy Beth Goldring, University of California at Los Angeles: Based on an investigation conducted by the University of California at Los Angeles (UCLA) and additional analysis conducted by the Office of Research Integrity (ORI) in its oversight review, ORI found that Ms. Goldring, former graduate student, Department of Psychology, UCLA, engaged in scientific misconduct by falsifying or fabricating data and statistical results for up to nine pilot studies on the impact of vulnerability on decision-making from Fall 2000 to Winter 2002 as a basis for her doctoral thesis research. The falsified or fabricated data was included in a manuscript submitted to Psychological Science, in National Institutes of Mental Health (NIMH), National Institutes of Health (NIH), grant application 1 R01 MH65238-01A1, and in NIMH, NIH, pre-doctoral training grant T32 MH15750. Ms. Goldring has been debarred by another agency with joint jurisdiction for a period of three (3) years, beginning on May 13, 2005, and ending on May 13, 2008. On December 16, 2005, Ms. Goldring received a detailed explanation of ORI's proposed finding and was given thirty (30) days to contest the finding and the proposed administrative action. The thirty-day period has elapsed and ORI has not received a response. Accordingly, the following administrative action has been implemented for a period of three (3) years, beginning on January 18, 2006: (1) Ms. Goldring is prohibited 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 Secretary of Health and Human Services is adopting rules for the imposition of civil money penalties on entities that violate rules adopted by the Secretary to implement the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (HIPAA). The final rule amends the existing rules relating to the investigation of noncompliance to make them apply to all of the HIPAA Administrative Simplification rules, rather than exclusively to the privacy standards. It also amends the existing rules relating to the process for imposition of civil money penalties. Among other matters, the final rule clarifies and elaborates upon the investigation process, bases for liability, determination of the penalty amount, grounds for waiver, conduct of the hearing, and the appeal process.

The Department of the Interior, Office of the Secretary is announcing a public meeting of the Exxon Valdez Oil Spill Public Advisory Committee.

The notice announces the date, time, location, and agenda for the next meeting of the Department of Homeland Security Data Privacy and Integrity Advisory Committee. This meeting will include an administrative session, which will be closed to the public.