[Federal Register Volume 73, Number 112 (Tuesday, June 10, 2008)]
[Notices]
[Pages 32719-32720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-12924]


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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 
[email protected], 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]
BILLING CODE 4140-01-P