Office of Biotechnology Activities; Recombinant DNA Research: Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), 26415 [E7-8900]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 72, Number 89 (Wednesday, May 9, 2007)]
[Notices]
[Page 26415]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8900]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: Proposals to conduct research involving the deliberate 
transfer of a tetracycline resistance trait to Chlamydia Trachomatis 
have 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 Chlamydia 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 approval by 
the NIH Director as Major Actions. These proposals will be discussed at 
the June 19-21, 2007 meeting of NIH Recombinant DNA Advisory Committee.

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 under the heading FOR FURTHER INFORMATION. The NIH will consider 
all comments submitted by June 15, 2007. Written comments submitted by 
May 24, 2007 will be reproduced and distributed to the RAC for 
consideration at its June 19-21 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 
oba@od.nih.gov, 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 20892-7985. For additional information about 
the RAC meeting at which these proposed actions will be deliberated, 
please visit the NIH OBA Web site at: https://www4.od.nih.gov/oba/.

SUPPLEMENTARY INFORMATION: OBA has received information from two 
Institutional Biosafety Committees 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 microorganisms 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. Dan Rockey 
and Dr. Walter Stamm (at Oregon State University and the University of 
Washington, respectively), are proposing to develop a genetic 
transformation system to study the pathogenesis of Chlamydia 
trachomatis, a human pathogen that is a leading cause of sexually 
transmitted disease worldwide and, mostly in the developing world, a 
preventable cause of blindness. Per the investigators, the lack of 
genetic tools to study the mechanisms of pathogenesis in these obligate 
intracellular bacterial parasites hinders research. The recent 
discovery of naturally occurring tetracycline resistant strains of C. 
suis (a swine pathogen) may provide the necessary genetic elements to 
develop such a transformation system. To accomplish this goal, 
experiments are planned to transfer tetracycline resistance from C. 
suis into C. trachomatis (a human pathogen). It is asserted that 
success in these proposed studies will lead to opportunities for 
``rapid developments in our understanding of chlamydial biology.'' The 
investigators are proposing to perform these experiments under 
Biosafety Level 2 containment.
    Background information may be obtained by contacting NIH OBA via e-
mail at oba@od.nih.gov. Alternatively, information is available on the 
OBA Web site at https://www4.od.nih.gov/oba/rac/latestnewsrac.htm.

    Dated: May 3, 2007.
Amy P. Patterson,
Director, Office of Biotechnology Activities, National Institutes of 
Health.
[FR Doc. E7-8900 Filed 5-8-07; 8:45 am]
BILLING CODE 4140-01-P