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Federal Register / Vol. 70, No.

106 / Friday, June 3, 2005 / Notices 32619

FOR FURTHER INFORMATION CONTACT: Alternative Fuel Vehicle Acquisition have taken final action in the following
Sandra M. Peay, Contract Representative and Compliance Report is available on- case:
Or line at http://www.knownet.hhs.gov/log/ Jason W. Lilly, Ph.D., Boyce
Renee Hallman, Case Management AgencyPolicy/HHSLogPolicy/ Thompson Institute: Based on the report
Assistant, Federal Trade Commission, afvcompliance.htm of an investigation conducted by the
Premerger Notification Office, Bureau of Boyce Thompson Institute (BTI Report),
FOR FURTHER INFORMATION CONTACT: Jim the investigation report of another
Competition, Room H–303, Washington, Kerr at (202) 720–1904, or via e-mail at
DC 20580, (202) 326–3100. Federal agency, and additional analysis
jim.kerr@hhs.gov. conducted by ORI in its oversight
By Direction of the Commission. Dated: May 24, 2005. review, the U.S. Public Health Service
Donald S. Clark, (PHS) found that Jason W. Lilly, Ph.D.,
Evelyn M. White,
Secretary. former postdoctoral fellow at BTI,
Acting Assistant Secretary for Administration
[FR Doc. 05–11027 Filed 6–2–05; 8:45 am] and Management. engaged in scientific misconduct in
BILLING CODE 6750–01–C [FR Doc. 05–11075 Filed 6–2–05; 8:45 am] research supported by the National
BILLING CODE 4161–17–P Research Service Award, National
Institutes of Health (NIH) postdoctoral
DEPARTMENT OF HEALTH AND fellowship, F32 GM64276. This case has
HUMAN SERVICES DEPARTMENT OF HEALTH AND been jointly handled by ORI and
HUMAN SERVICES another Federal agency under the
Office of the Secretary government-wide debarment
Office of the Secretary regulations.
Fleet Alternative Fuel Vehicle Specifically, PHS found that:
Acquisition and Compliance Report Findings of Scientific Misconduct A. Dr. Lilly falsified Figure 4,
AGENCY: Department of Health and presenting a hierarchical cluster
AGENCY: Office of the Secretary, HHS. analysis of differential mRNA
Human Services (HHS).
ACTION: Notice of availability. ACTION: Notice. accumulation in cells grown in medium
deficient in sulfate or phosphate in
SUMMARY: Pursuant to 42 United States SUMMARY: Notice is hereby given that ‘‘The Chlamydonomas reinhardtii
Code 13218(b), the Department of the Office of Research Integrity (ORI), organellar genomes respond
Health and Human Services gives notice the Acting Assistant Secretary for transcriptionally and post-
that the Department’s FY 2004 Fleet Health, and another Federal agency transcriptionally to abiotic stimuli,’’ The
EN03JN05.008</GPH>

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32620 Federal Register / Vol. 70, No. 106 / Friday, June 3, 2005 / Notices

Plant Cell 14:2681:2706, 2002 (hereafter Oversight, Office of Research Integrity, Network (OPTN), new standards have
referred to as the Plant Cell paper) by 1101 Wootton Parkway, Suite 750, been put in place to detect and report
claiming it was an average of three Rockville, MD 20852, (301) 443–5330. adverse events among organ transplant
experiments when only one had been recipients; for other tissues, there will
Chris B. Pascal,
conducted; be new FDA rules for organ and tissue
B. Dr. Lilly further falsified Figure 4 Director, Office of Research Integrity.
procurement organizations (OPOs) and
of the Plant Cell paper by falsely [FR Doc. 05–11017 Filed 6–2–05; 8:45 am] tissue banks, implemented May 1, 2005.
coloring two cells in the blown-up BILLING CODE 4150–31–P Despite these new regulatory standards,
portion of the figure that illustrated the challenges remain. A surveillance
induction of high levels of mRNA from network for surveillance of allograft-
the Sac1 gene; DEPARTMENT OF HEALTH AND associated infections that would
C. Dr. Lilly falsified the supplemental HUMAN SERVICES enhance communication between public
gene array experiments published health officials and organizations
online claimed to be replicate assays by Centers for Disease Control and
Prevention responsible for recovering and
manipulation of both spreadsheet and processing tissues would have high
image data from a single assay to make potential as a tool for risk assessment
Sentinel Network for Detecting
the altered data sufficiently different to and response, in collaboration with
Emerging Infections Among Allograft
appear to be separate assays; regulatory efforts.
D. Dr. Lilly falsified the text Donors and Recipients
describing Figure 5 of the Plant Cell Announcement Type: New. I. Funding Opportunity Description
paper by claiming that the run-on assays Funding Opportunity Number:
had been replicated when they had not AA081. Authority: 42 U.S.C. 247b(k)(2)
been; Catalog of Federal Domestic Purpose: The purpose of the program
E. Dr. Lilly falsified the purported Assistance Number: 93.283. is to develop a national sentinel
replicates of run-on transcription Key Dates: network of organizations that recover,
experiments provided in the on-line Letter of Intent Deadline: July 5, 2005. process, and distribute tissues from
supplemental material by manipulation Application Deadline: August 2, 2005. organ/tissue donors. The participants in
of a single assay to make the variant Executive Summary: Over the last this activity can include OPOs, tissue
versions appear different; and decade, there has been a large increase processors, tissue distributors, and
F. Dr. Lilly falsified Figure 1 of the in the number of allografts (e.g., solid others. This collection of participants
Plant Cell paper by using the same 16S organs and other tissues) recovered from has been termed the tissue community.
control bands for RNA blots of two donors for use in transplants. Each year At present, many procurement
different genes (psbF and PsaG). in the United States, over 25,000 solid organizations provide regional tissue
Dr. Lilly has been debarred by the organs are recovered, and over a million recovery services. This program
lead agency for a period of two (2) years, tissue allografts are distributed for life- addresses the ‘‘Healthy People 2010’’
beginning on March 4, 2005, and ending saving transplantations, including bone, focus area(s) of Immunization and
on March 4, 2007, and has entered into musculoskeletal, vascular, and corneal Infectious Diseases.
a Voluntary Exclusion Agreement tissues. Organs and tissues are Measurable outcomes of the program
(Agreement ) with PHS in which he has distributed to different settings: Organs will be in alignment with the following
voluntarily agreed: are distributed to transplant services in performance goal for the National
(1) To exclude himself from serving in hospitals, and tissues are distributed to Center for Infectious Diseases (NCID):
any advisory capacity to PHS including tissue banks, biotechnology companies, Protect Americans from death and
but not limited to service on any PHS and healthcare consignees, including serious harm caused by medical errors
advisory committee, board, and/or peer hospitals, outpatient centers, and and preventable complications of
review committee, or as consultant, for individual surgeons. A single donor healthcare.
a period of four (4) years, beginning on with undetected infection potentially This announcement is only for non-
April 18, 2005; and can infect over a hundred organ and research activities supported by CDC/
(2) That he will ensure that any tissue recipients located around the ATSDR. If research is proposed, that
institution employing him submits, in world. In addition, tissues may be portion of any application will not be
conjunction with each application for stored for up to ten years; thus, reviewed or considered for funding. For
PHS funds or report, manuscript, or infections may be transmitted to the definition of research, please see the
abstract of PHS funded research in recipients many years after the death of CDC Web site at the following Internet
which Dr. Lilly is involved, a the donor. Recent investigations have address: http://www.cdc.gov/od/ads/
certification that the data provided by demonstrated severe infections and opspoll1.htm.
Dr. Lilly are based on actual death from transmission of various
experiments or are otherwise agents from donors to recipients, Objectives
legitimately derived, and that the data, including: Clostridia spp. (e.g., C. The objective of the network will be
procedures, and methodology are sordellii, C. perfringens, C. septicum), to detect and prevent emerging
accurately reported in the application or West Nile virus, Group A Streptococcus, infectious diseases through:
report for a period of two (2) years, Trypanosoma cruzi, Lymphocytic • Improved communication among
beginning on April 18, 2007, choriomeningitis virus, rabies virus, and those in the tissue community (e.g.,
approximately corresponding to the others. A recent Institute of Medicine tissue recovery organizations, OPOs that
termination date of the debarment report highlighted the urgent need to recover tissues, tissue processors, tissue
period initiated by the lead agency. Dr. detect infectious diseases among organ distributors), healthcare facilities, and
Lilly must ensure that the institution and tissue donor and transplant public health officials, concerning
also sends a copy of the certification to recipients. Recently, additional potential risks for transmission of
ORI. regulatory mechanisms have been put in infection.
FOR FURTHER INFORMATION CONTACT: place. For solid organs, through the • Improved identification and
Director, Division of Investigative Organ Procurement and Transplantation tracking of tissues to facilitate

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