E9-25925. 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 a proposed action under the NIH Guidelines.

SUMMARY:

A proposal by Dr. Harlan Caldwell at the Rocky Mountain Laboratories (RML) involving the deliberate transfer of a tetracycline resistance trait to non-ocular strains of Chlamydia trachomatis has been submitted to the NIH Office of Biotechnology Activities (OBA). The introduction of tetracycline resistance could compromise the ability to treat disease caused by Chlamydia trachomatis as doxycycline is currently used to treat disease caused by this organism. Under Section III-A-1 of the NIH Guidelines, 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 NIH Recombinant DNA Advisory Committee (RAC) and approved by the NIH Director.

On September 24, 2007 the NIH Director granted approval to Dr. Daniel Rockey, Oregon State University and Dr. Walter Stamm, University of Washington, to introduce tetracycline resistance into non-ocular strains of Chlamydia trachomatis under the containment level recommended by the RAC—Biosafety level 2 containment with Biosafety level 3 practices (see NIH Guidelines Appendix G-II-B and G-II-C). The requirements regarding containment as well as additional required occupational health measures were published in the Federal Register (72 FR 61661). This approval was specific for Dr. Rockey at Oregon State University and Dr. Stamm at the University of Washington.

Dr. Caldwell at RML is proposing to develop a plasmid-based system to define the experimental conditions required for transformation of non-ocular C. trachomatis strains to tetracycline resistance. The investigators are proposing to perform these experiments under the same containment and implement the same occupational health measures required for the research proposed by Drs. Rockey and Stamm (72 FR 61661). This proposal will be discussed at the December 1-3, 2009 meeting of NIH Recombinant DNA Advisory Committee.

DATES:

The public is encouraged to submit written comments on this proposed action. 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 CONTACT. The NIH will consider all comments submitted by November 25, 2009. Written comments submitted by November 12, 2009 will be reproduced and distributed to the RAC for consideration at its December 1-3, 2009 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 this proposed action. Comments may be submitted to the same email 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 this proposed action will be deliberated, please visit the NIH OBA Web site at: http://oba.od.nih.gov/​oba/​index.html.

SUPPLEMENTARY INFORMATION:

Background information may be obtained by contacting NIH OBA via e-mail at [e-mail] or by going to the OBA Web site at http://oba.od.nih.gov/​rdna_​rac/​rac_​meetings.html.

Dated: October 21, 2009.

Jacqueline Corrigan-Curay,

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