[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)]
[Notices]
[Page 81346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32810]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Action Under the NIH Guidelines for Research Involving 
Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

AGENCY: National Institutes of Health (NIH) .

ACTION: Notice of proposed actions under the NIH Guidelines.

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SUMMARY: The NIH is considering a proposal to conduct research 
involving the deliberate transfer of a chloramphenicol resistance trait 
to Rickettsia typhi, conorii, rickettsii, and felis. The acquisition of 
this antibiotic resistance trait could possibly compromise the use of a 
class of antibiotics for the treatment of Rickettsia infections in 
humans. Under the NIH Guidelines (http://www.osp.od.nih.gov/sites/default/files/NIH_Guidelines.html), these experiments can proceed only 
after they are reviewed by the NIH Recombinant DNA Advisory Committee 
(RAC) and specifically approved by the NIH Director as Major Actions. 
This proposal will be discussed at the March 8-10, 2016 RAC meeting. 
The public is encouraged to provide comments on this proposed action.

DATES: To ensure consideration, comments must be submitted in writing 
by January 28, 2016.

ADDRESSES: Comments may be submitted by email at 
[email protected], by fax at 301-496-9839, or by mail to the 
Office of Science Policy, National Institutes of Health, 6705 Rockledge 
Drive, Suite 750, Bethesda, Maryland 20892-7985. All written comments 
received in response to this notice will be available for public 
inspection at the NIH Office of Science Policy (OSP), 6705 Rockledge 
Drive, Suite 750, Bethesda, MD 20892-7985, weekdays between the hours 
of 8:30 a.m. and 5 p.m. and may be posted to the NIH OSP Web site 
(http://osp.od.nih.gov/). In addition, an opportunity for public 
comment will be provided at the RAC meeting, to be held March 8-10, 
2016. The meeting location will be announced on the NIH OSP Web site at 
a later date.

FOR FURTHER INFORMATION CONTACT: If you have questions, or require 
additional background information about this proposed action, please 
contact the NIH and by email at [email protected], or by 
telephone at 301-496-9838 and reference this notice.

SUPPLEMENTARY INFORMATION: The NIH has received a request to consider 
experiments that involve the deliberate transfer of a drug resistance 
trait to a microorganism such that the acquisition could compromise the 
use of the drug to control disease in humans, veterinary medicine, or 
agriculture. This type of research falls under Section III-A-1-a of the 
NIH Guidelines, requiring NIH Director approval for the experiment to 
proceed and is thus considered to be a Major Action (http://www.osp.od.nih.gov/sites/default/files/NIH_Guidelines.html#_Toc351276270). An investigator at the University 
of Chicago has proposed to transfer chloramphenicol resistance to four 
different Rickettsia species: Rickettsia typhi, conorii, rickettsii, 
and felis. The transfer of chloramphenicol resistance to R. conorii was 
previously approved by the NIH Director as a Major Action (see 73 FR 
32719) and therefore does not need to be reviewed and approved under 
Section III-A-1-a.
    The proposed experiment entails transferring chloramphenicol 
resistance to R. rickettsii and R. typhi via vectors that are based 
upon Escherichia coli pET or pUC plasmids. These plasmids confer 
resistance to chloramphenicol since they contain transposons that 
express chloramphenicol acetyl transferase (CAT). In addition, the 
investigator proposes to transfer chloramphenicol resistance to R. 
felis via a shuttle vector that is designed to replicate in both E. 
coli and Rickettsia. This shuttle vector will be generated by fusion of 
an R. felis plasmid to an E. coli plasmid that expresses CAT. In 
addition, the R. felis plasmid also contains DNA sequences that are 
homologous to those necessary for bacterial conjugation. A goal of this 
work is to discover whether the shuttle vector (and chloramphenicol 
resistance) may be transmitted from R. felis to other Rickettsia via 
conjugation.
    The proposal to transfer chloramphenicol resistance to R. typhi, 
rickettsii, and felis was discussed with a working group of the RAC via 
a teleconference call on October 22, 2015. The recommendations of this 
group were initially presented to and discussed with the RAC at its 
December 4, 2015, meeting. As indicated above, the RAC will continue to 
consider this proposal and make recommendations to the NIH Director at 
its upcoming meeting on March 8-10, 2016. An agenda will be available 
on the NIH OSP Web site (http://osp.od.nih.gov/) in advance of this 
meeting. The public is encouraged to submit written comments on this 
proposed action.

    Dated: December 21, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015-32810 Filed 12-28-15; 8:45 am]
 BILLING CODE 4140-01-P