E7-8900. 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 [e-mail], 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: http://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 [e-mail]. Alternatively, information is available on the OBA Web site at http://www4.od.nih.gov/​oba/​rac/​latestnewsrac.htm.

Dated: May 3, 2007.

Amy P. Patterson,

Director, Office of Biotechnology Activities, National Institutes of Health.