[Federal Register: June 10, 2008 (Volume 73, Number 112)]
[Notices]
[Page 32719-32720]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10jn08-56]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Office of the Director, Office of Biotechnology Activities;
Recombinant DNA Research: Action Under the NIH Guidelines for Research
Involving Recombinant DNA Molecules (NIH Guidelines)
AGENCY: National Institutes of Health (NIH), DHHS.
ACTION: Notice of a final action under the NIH Guidelines and notice of
additions to Appendix D of the NIH Guidelines.
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SUMMARY: Proposal to conduct research involving the deliberate transfer
of a drug resistance trait to a microorganism that causes disease in
humans has been reviewed by the Recombinant DNA Advisory Committee
(RAC) and approved by the NIH Director.
DATES: The final action is effective April 7, 2008.
FOR FURTHER INFORMATION CONTACT: Background documentation and
additional information can be obtained from the Office of Biotechnology
Activities (OBA), National Institutes of Health, 6705 Rockledge Drive,
Suite 750, MSC 7985, Bethesda, Maryland 20892-7985; e-mail at
oba@od.nih.gov, or telephone at 301-496-9838. The NIH/OBA Web site is
located at: http://www4.od.nih.gov/oba/.
SUPPLEMENTARY INFORMATION: This final action allows Dr. David Walker,
University of Texas Medical Branch at Galveston to deliberately
introduce a gene encoding chloramphenicol resistance into Rickettsia
conorii. This approval is specific to Dr. Walker. His research with
these resistant organisms may only occur under the conditions outlined
below. It should be noted that any work involving the introduction of
chloramphenicol resistance into R. conorii by other investigators would
need to be reviewed by the RAC and specifically approved by the NIH
Director.
Background Information and Response to Comments: On July 24, 2007,
background on the proposed action and information on how to submit
public comment, was published
[[Page 32720]]
in the Federal Register (72 FR 40320). On September 17, 2007, and
December 5, 2007, the RAC discussed this proposed action and a proposed
action to allow the transfer of chloramphenicol resistance into R.
typhi. The RAC reviewed the three public comments received regarding
the transfer of chloramphenicol resistance to R. conorii and to R.
typhi. The RAC unanimously recommended that the transfer of
chloramphenicol resistance to R. conorii be approved at this time and
the majority of the members present did not recommend the transfer of
chloramphenicol resistance to R. typhi. On April 7, 2008, the NIH
Director approved the transfer of chloramphenicol resistance to R.
conorii with the following containment provisions/stipulations:
(1) Perform all research involving the introduction of
chloramphenicol resistance into Rickettsia conorii at minimum biosafety
level 3 (BL-3) containment. Access will therefore be restricted to
well-trained personnel whose presence is required for the conduct of
this work. In addition, there must be a standard training procedure to
make sure that personnel are trained and training is ongoing.
(2) Maintain at least one back-up power source to insure computer
based security remains in place at all times.
(3) Include a signature nucleic acid sequence (``bar-code'') to
allow identification of laboratory-created (chloramphenicol resistant)
strains.
(4) Incorporate the following elements into a health surveillance
program for individuals working with chloramphenicol resistant R.
conorii:
(a) Exclude those with a known allergy or sensitivity to
tetracycline, and in particular doxycycline, from working with
chloramphenicol resistant R. conorii;
(b) Obtain and store a baseline blood sample from laboratory
workers;
(c) Do not permit pregnant individuals to work in any laboratory in
which chloramphenicol resistant rickettsia is being handled;
(d) Provide workers education on the possible clinical
manifestations of a rickettsial laboratory acquired infection;
(e) Develop a medical card that would be carried by all laboratory
workers that includes at a minimum the following:
(i) Identification of the organism to which the labworker has been
exposed;
(ii) Identification of key personnel responsible for providing
diagnosis and treatment;
(iii) A CDC telephone number for reporting the infection and
obtaining treatment recommendations; and
(iv) A twenty-four hour contact number for the principal
investigators.
(5) Have a detailed standard operating procedures outlining the
specific steps to be taken in the case of a laboratory exposure or
infection containing at a minimum:
(a) Identification of key personnel who would provide diagnostic
testing and treatment; and
(b) Instructions on managing exposures or infections discovered
during off hours (after close of business, holidays, weekends, etc.).
Additions to Appendix D of the NIH Guidelines: In accordance with
Section III-A of the NIH Guidelines, Appendix D of the NIH Guidelines
will be modified as follows to reflect the recent approvals for the
transfer of drug resistance traits to microorganisms. Specifically,
Appendix D will be modified to include approval of experiments to be
conducted by Dr. Daniel Rockey, Oregon State University and Dr. Walter
Stamm, University of Washington in which tetracycline resistance will
be transferred into Chlamydia trachomatis (72 FR 61661) and approval of
the Dr. Walker's experiment to transfer chloramphenicol resistance to
Rickettsia conorii.
Appendix D-116. Dr. Daniel Rockey at Oregon State University and
Dr. Walter Stamm at the University of Washington may conduct
experiments to deliberately transfer a gene encoding tetracycline
resistance from Chlamydia suis (a swine pathogen) into C. trachomatis
(a human pathogen). This approval is specific to Drs. Rockey and Stamm
and research with these resistant organisms may only occur under the
conditions specified by the NIH Director. It should be noted that any
work involving the introduction of tetracycline resistance into C.
trachomatis by other investigators would need to be reviewed by the RAC
and specifically approved by the NIH Director. This approval was
effective as of September 24, 2007 (72 FR 61661).
Appendix D-117. Dr. David Walker at the University of Texas Medical
Branch at Galveston may conduct experiments to deliberately introduce a
gene encoding chloramphenicol resistance into Rickettsia conorii. This
approval is specific to Dr. Walker and research with these resistant
organisms may only occur under the conditions specified by the NIH
Director. It should be noted that any work involving the introduction
of chloramphenicol resistance into R. conorii by other investigators
would need to be reviewed by the RAC and specifically approved by the
NIH Director. This approval was effective as of April 7, 2008.
Dated: June 3, 2008.
Amy P. Patterson,
Director, Office of Biotechnology Activities.
[FR Doc. E8-12924 Filed 6-9-08; 8:45 am]
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