[Federal Register Volume 74, Number 207 (Wednesday, October 28, 2009)]
[Notices]
[Page 55568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25925]


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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 a proposed action under the NIH 
Guidelines.

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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 
[email protected], 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 [email protected] 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.
[FR Doc. E9-25925 Filed 10-27-09; 8:45 am]
BILLING CODE 4140-01-P