82 FR 4365 - Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 9 (January 13, 2017)

The National Institutes of Health (NIH) considered 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 was discussed at the December 4, 2015, RAC meeting. The proposal was published in the Federal Register on December 29, 2015, (80 FR 81346) with a request for public comment; one comment was received. This notice announces the final NIH action regarding this proposal.

[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4365-4366]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-00766]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

AGENCY: National Institutes of Health (NIH), HHS.

ACTION: Notice of action under the NIH Guidelines.

-----------------------------------------------------------------------

SUMMARY: The National Institutes of Health (NIH) considered 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/

[[Page 4366]]

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 was discussed at the December 4, 2015, RAC meeting. The 
proposal was published in the Federal Register on December 29, 2015, 
(80 FR 81346) with a request for public comment; one comment was 
received. This notice announces the final NIH action regarding this 
proposal.

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

SUPPLEMENTARY INFORMATION: This final action does not allow an 
investigator at the University of Chicago to transfer chloramphenicol 
resistance to three different Rickettsia species: Rickettsia typhi, 
rickettsii, and felis. The investigator also proposed to transfer 
chloramphenicol resistance to a fourth Rickettsia species, R. conorii. 
Transfer of chloramphenicol resistance to R. conorii was previously 
approved by the NIH Director as a Major Action (see 73 FR 32719) and 
therefore did not need to be reviewed and approved under Section III-A-
1-a of the NIH Guidelines. Thus, the University of Chicago investigator 
was allowed to proceed with the transfer of chloramphenicol resistance 
to R. conorii under Section III-B-2 of the NIH Guidelines.
    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 presented to and discussed with the RAC at its December 4, 
2015, meeting. At the March 8, 2016, meeting, the RAC continued the 
discussion which included consideration of the one comment received to 
the December 29, 2015, notice and unanimously recommended (by a vote of 
11 in favor, none opposed, and no abstentions) that the transfer of 
chloramphenicol resistance to R. typhi, rickettsii, and felis should 
not be allowed to proceed. On August 23, 2016, the NIH Director 
disapproved the proposal to transfer chloramphenicol resistance to R. 
typhi, rickettsii, and felis.

    Dated: January 6, 2017.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2017-00766 Filed 1-12-17; 8:45 am]
BILLING CODE 4140-01-P