Proposed Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), 81346 [2015-32810]

Download as PDF 81346 Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices Place: New Orleans Marriott, 555 Canal Street, New Orleans, LA 70130. Contact Person: Michael Selmanoff, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5164, MSC 7844, Bethesda, MD 20892, 301–435– 1119, mselmanoff@csr.nih.gov. Name of Committee: Population Sciences and Epidemiology Integrated Review Group; Social Sciences and Population Studies A Study Section. Date: January 28, 2016. Time: 8:30 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Hotel Palomar, 2121 P Street NW., Washington, DC 20037. Contact Person: Suzanne Ryan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3139, MSC 7770, Bethesda, MD 20892, (301) 435– 1712, ryansj@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: December 22, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–32657 Filed 12–28–15; 8:45 am] BILLING CODE 4140–01–P 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) National Institutes of Health (NIH) . ACTION: Notice of proposed actions under the NIH Guidelines. AGENCY: 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 (https:// 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, asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:17 Dec 28, 2015 Jkt 238001 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 SciencePolicy@ od.nih.gov, 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 (https:// 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 SciencePolicy@od.nih.gov, 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 (https:// 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 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 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 (https://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 DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR–5900–FA–21] Announcement of Funding Awards; Fair Housing Initiatives Program Fiscal Year 2015 Office of the Assistant Secretary for Fair Housing and Equal Opportunity, the Department of Housing and Urban Development, HUD. ACTION: Announcement of funding awards. AGENCY: In accordance with section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989, this announcement notifies the public of funding decisions made by the Department under the Notice of Funding Availability (NOFA) for the Fair Housing Initiatives Program (FHIP) for Fiscal Year (FY) 2015. This announcement contains the names and addresses of those award recipients SUMMARY: E:\FR\FM\29DEN1.SGM 29DEN1

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[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.

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

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 (https://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 
SciencePolicy@od.nih.gov, 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 
(https://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 SciencePolicy@od.nih.gov, 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 (https://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 (https://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
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