[Federal Register Volume 72, Number 141 (Tuesday, July 24, 2007)]
[Notices]
[Pages 40320-40321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14215]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of Biotechnology Activities; Recombinant DNA Research: 
Proposed Actions Under the NIH Guidelines for Research Involving 
Recombinant DNA Molecules (NIH Guidelines)

ACTION: Notice of consideration of proposed actions under the NIH 
Guidelines.

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SUMMARY: Proposals to conduct research involving the deliberate 
transfer of a chloramphenicol resistance trait to Rickettsia typhi and 
conorii has been submitted to the NIH Office of Biotechnology 
Activities (OBA). The acquisition of this antibiotic resistance trait 
could possibly compromise the use of a class of antibiotics for the 
treatment of Rickettsia infections in humans. Under the NIH Guidelines, 
these experiments can proceed only after they are reviewed by the NIH 
Recombinant DNA Advisory Committee (RAC) and specifically approved by 
the NIH Director as Major Actions. These proposals will be discussed at 
the September 17-19, 2007 RAC meeting.

DATES: The public is encouraged to submit written comments on these 
proposed actions. Comments may be submitted to the OBA in paper or 
electronic form at the OBA mailing, fax, and e-mail addresses shown 
below. Comments submitted by September 6,

[[Page 40321]]

2007 will be reproduced and distributed to the RAC for consideration at 
its September meeting. In addition, an opportunity for public comment 
will be provided at that meeting. All written comments received in 
response to this notice will be available for public inspection at the 
NIH OBA office, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892 
(telephone, 301-496-9838), weekdays between the hours of 8:30 a.m. and 
5 p.m.

FOR FURTHER INFORMATION CONTACT: Contact OBA by e-mail at 
[email protected], or telephone at 301-496-9838, if you have questions, or 
require additional information about these proposed actions. Comments 
may be submitted to the same e-mail address or by fax at 301-496-9839 
or sent by U.S. mail to the Office of Biotechnology Activities, 
National Institutes of Health, 6705 Rockledge Drive, Suite 750, MSC 
7985, Bethesda, Maryland 20892. For additional information about the 
RAC meeting at which these proposed actions will be deliberated, please 
visit the NIH OBA Web site at: http://www4.od.nih.gov/oba/.

SUPPLEMENTARY INFORMATION: OBA has received information regarding 
proposed experiments, which, to proceed, would require Major Actions 
under Section III-A-1-a of the NIH Guidelines. Under this section, if 
the deliberate transfer of a drug resistance trait to micro-organisms 
could compromise the use of the drug to control disease in humans, 
veterinary medicine, or agriculture the experiment must be reviewed by 
the RAC. Dr. David Walker, Chairman, Pathology Department, University 
of Texas Medical Branch, proposes to introduce DNA constructs encoding 
resistance to the antibiotic chloramphenicol into Rickettsia conorii 
and Rickettsia typhi with the goal of developing genetic tools to study 
the biology of these organisms and in particular the genes associated 
with virulence. Dr. Abdu Azad, Professor of Microbiology, University of 
Maryland proposes a similar experiment in R. typhi. Dr. Walker's 
ultimate goal is to develop a vaccine for Rickettsia prowazekii, a 
Select Agent that causes epidemic typhus.
    Rickettsiae are spread to humans by arthropods and human to human 
transmission does not occur directly. R. conorii causes Mediterranean 
Spotted Fever, a disease endemic to southern Europe and Africa. 
Clinically, it typically presents with high fever, flu-like symptoms, 
headache and a maculopapular rash. The disease is generally mild but 
severe forms include major neurological manifestations and multi-organ 
failure with a mortality rate estimated up to 2.5%. R. typhi is found 
in the United States and many other parts of the world, although it is 
relatively uncommon. The clinical presentation in humans includes 
fever, headache, other constitutional symptoms and, in up to 40% of 
adults, neurological symptoms. Although generally mild it has a 1-4% 
mortality rate. Current first-line treatment for R. typhi and R. 
conorii is doxycycline or chloramphenicol. Due to its safety profile, 
doxycycline is the preferred antibiotic but chloramphenicol is 
indicated in certain patients. Background information may be obtained 
by contacting NIH OBA via e-mail at [email protected]. Alternatively, 
information is available on the OBA Web site at http://www4.od.nih.gov/oba/rac/latestnewsrac.htm.

    Dated: July 17, 2007.
Amy P. Patterson,
Director, Office of Biotechnology Activities, National Institutes of 
Health.
[FR Doc. E7-14215 Filed 7-23-07; 8:45 am]
BILLING CODE 4140-01-P