[Federal Register: October 28, 2009 (Volume 74, Number 207)]
[Notices]
[Page 55568]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc09-81]
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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
oba@od.nih.gov, 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 oba@od.nih.gov 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]
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