80 FR 81346 - Proposed 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 80, Issue 249 (December 29, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 249 (December 29, 2015)
| Page Range | 81346-81346 | |
| FR Document | 2015-32810 |
[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)] [Notices] [Page 81346] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-32810] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![81346 Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices
Place: New Orleans Marriott, 555 Canal 2016 RAC meeting. The public is express chloramphenicol acetyl
Street, New Orleans, LA 70130. encouraged to provide comments on transferase (CAT). In addition, the
Contact Person: Michael Selmanoff, Ph.D., this proposed action. investigator proposes to transfer
Scientific Review Officer, Center for
Scientific Review, National Institutes of DATES: To ensure consideration, chloramphenicol resistance to R. felis
Health, 6701 Rockledge Drive, Room 5164, comments must be submitted in writing via a shuttle vector that is designed to
MSC 7844, Bethesda, MD 20892, 301–435– by January 28, 2016. replicate in both E. coli and Rickettsia.
1119, mselmanoff@csr.nih.gov. ADDRESSES: Comments may be This shuttle vector will be generated by
Name of Committee: Population Sciences submitted by email at SciencePolicy@ fusion of an R. felis plasmid to an E. coli
and Epidemiology Integrated Review Group; od.nih.gov, by fax at 301–496–9839, or plasmid that expresses CAT. In
Social Sciences and Population Studies A by mail to the Office of Science Policy, addition, the R. felis plasmid also
Study Section. National Institutes of Health, 6705 contains DNA sequences that are
Date: January 28, 2016. homologous to those necessary for
Time: 8:30 a.m. to 6:00 p.m. Rockledge Drive, Suite 750, Bethesda,
Agenda: To review and evaluate grant Maryland 20892–7985. All written bacterial conjugation. A goal of this
applications. comments received in response to this work is to discover whether the shuttle
Place: Hotel Palomar, 2121 P Street NW., notice will be available for public vector (and chloramphenicol resistance)
Washington, DC 20037. inspection at the NIH Office of Science may be transmitted from R. felis to other
Contact Person: Suzanne Ryan, Ph.D., Policy (OSP), 6705 Rockledge Drive, Rickettsia via conjugation.
Scientific Review Officer, Center for Suite 750, Bethesda, MD 20892–7985, The proposal to transfer
Scientific Review, National Institutes of weekdays between the hours of 8:30 chloramphenicol resistance to R. typhi,
Health, 6701 Rockledge Drive, Room 3139, rickettsii, and felis was discussed with
a.m. and 5 p.m. and may be posted to
MSC 7770, Bethesda, MD 20892, (301) 435– a working group of the RAC via a
1712, ryansj@csr.nih.gov. the NIH OSP Web site (http://
osp.od.nih.gov/). In addition, an teleconference call on October 22, 2015.
(Catalogue of Federal Domestic Assistance
opportunity for public comment will be The recommendations of this group
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333, provided at the RAC meeting, to be held were initially presented to and
93.337, 93.393–93.396, 93.837–93.844, March 8–10, 2016. The meeting location discussed with the RAC at its December
93.846–93.878, 93.892, 93.893, National will be announced on the NIH OSP Web 4, 2015, meeting. As indicated above,
Institutes of Health, HHS) site at a later date. the RAC will continue to consider this
Dated: December 22, 2015. FOR FURTHER INFORMATION CONTACT: If proposal and make recommendations to
Melanie J. Gray, you have questions, or require the NIH Director at its upcoming
additional background information meeting on March 8–10, 2016. An
Program Analyst, Office of Federal Advisory
Committee Policy. about this proposed action, please agenda will be available on the NIH OSP
contact the NIH and by email at Web site (http://osp.od.nih.gov/) in
[FR Doc. 2015–32657 Filed 12–28–15; 8:45 am]
SciencePolicy@od.nih.gov, or by advance of this meeting. The public is
BILLING CODE 4140–01–P
telephone at 301–496–9838 and encouraged to submit written comments
reference this notice. on this proposed action.
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: The NIH Dated: December 21, 2015.
HUMAN SERVICES has received a request to consider Lawrence A. Tabak,
experiments that involve the deliberate Deputy Director, National Institutes of Health.
National Institutes of Health transfer of a drug resistance trait to a [FR Doc. 2015–32810 Filed 12–28–15; 8:45 am]
microorganism such that the acquisition BILLING CODE 4140–01–P
Proposed Action Under the NIH could compromise the use of the drug
Guidelines for Research Involving to control disease in humans, veterinary
Recombinant or Synthetic Nucleic Acid medicine, or agriculture. This type of
Molecules (NIH Guidelines) DEPARTMENT OF HOUSING AND
research falls under Section III–A–1–a URBAN DEVELOPMENT
AGENCY: National Institutes of Health of the NIH Guidelines, requiring NIH
(NIH) . Director approval for the experiment to [Docket No. FR–5900–FA–21]
ACTION: Notice of proposed actions proceed and is thus considered to be a
Major Action (http:// Announcement of Funding Awards;
under the NIH Guidelines. Fair Housing Initiatives Program Fiscal
www.osp.od.nih.gov/sites/default/files/
SUMMARY: The NIH is considering a NIH_Guidelines.html#_Toc351276270). Year 2015
proposal to conduct research involving An investigator at the University of AGENCY: Office of the Assistant
the deliberate transfer of a Chicago has proposed to transfer Secretary for Fair Housing and Equal
chloramphenicol resistance trait to chloramphenicol resistance to four Opportunity, the Department of Housing
Rickettsia typhi, conorii, rickettsii, and different Rickettsia species: Rickettsia and Urban Development, HUD.
felis. The acquisition of this antibiotic typhi, conorii, rickettsii, and felis. The ACTION: Announcement of funding
resistance trait could possibly transfer of chloramphenicol resistance awards.
compromise the use of a class of to R. conorii was previously approved
antibiotics for the treatment of by the NIH Director as a Major Action SUMMARY: In accordance with section
Rickettsia infections in humans. Under (see 73 FR 32719) and therefore does not 102(a)(4)(C) of the Department of
the NIH Guidelines (http:// need to be reviewed and approved Housing and Urban Development
asabaliauskas on DSK5VPTVN1PROD with NOTICES
www.osp.od.nih.gov/sites/default/files/ under Section III–A–1–a. Reform Act of 1989, this announcement
NIH_Guidelines.html), these The proposed experiment entails notifies the public of funding decisions
experiments can proceed only after they transferring chloramphenicol resistance made by the Department under the
are reviewed by the NIH Recombinant to R. rickettsii and R. typhi via vectors Notice of Funding Availability (NOFA)
DNA Advisory Committee (RAC) and that are based upon Escherichia coli for the Fair Housing Initiatives Program
specifically approved by the NIH pET or pUC plasmids. These plasmids (FHIP) for Fiscal Year (FY) 2015. This
Director as Major Actions. This proposal confer resistance to chloramphenicol announcement contains the names and
will be discussed at the March 8–10, since they contain transposons that addresses of those award recipients
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Document Created: 2015-12-29 10:15:42
Document Modified: 2015-12-29 10:15:42
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of proposed actions under the NIH Guidelines. | |
| Dates | To ensure consideration, comments must be submitted in writing by January 28, 2016. | |
| 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. | |
| FR Citation | 80 FR 81346 |
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