Office of Biotechnology Activities; Recombinant DNA Research: Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), 28811 [2010-12453]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 99 / Monday, May 24, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of Biotechnology Activities;
Recombinant DNA Research:
Proposed Actions Under the NIH
Guidelines for Research Involving
Recombinant DNA Molecules (NIH
Guidelines)
ACTION: Notice of consideration of a
proposed action under Section III–A–1
of the NIH Guidelines.
The NIH Guidelines requires
certain recombinant research to be
reviewed by the NIH Recombinant DNA
Advisory Committee and approved by
the NIH Director (Section III–A–1). Such
research involves the introduction of
drug resistance into a microorganism if
the introduction of that drug resistance
trait can compromise the ability to treat
disease caused by the microorganism in
humans, animals or agriculture. In order
to meet the threshold for consideration
under Section III–A–1, the
microorganism must be able to cause
disease in humans, animals or
agriculture.
A proposal to deliberately transfer a
chloramphenicol resistance trait into an
attenuated strain (CO92 lcr-) of Yersinia
pestis has been submitted to the NIH
Office of Biotechnology Activities
(OBA) by the Institutional Biosafety
Committee at Lawrence Livermore
National Laboratory (LLNL). Treatment
guidelines recommend streptomycin as
the first-line antibiotic for treatment of
disease caused by wild type Y. pestis,
and gentamicin is recommended when
streptomycin is not available.
Doxycycline and chloramphenicol are
also effective and ciprofloxacin is
recommended as prophylaxis and has
been shown to treat disease in animal
models. The LLNL investigators will be
using Y. pestis CO92 lcr- strains that
have already been made resistant to
ciprofloxacin or doxycycline through
exposure of these attenuated strains to
these antibiotics. The proposed research
involves the addition of
chloramphenicol resistance into these
strains, thereby creating lcr- Y. pestis
strains that are resistant to multiple
antibiotics used to treat disease caused
by this organism.
A fundamental question with respect
to this line of proposed research is
whether this specific strain (lcr-) has the
ability to cause disease in humans and
therefore should be subject to Section
III–A–1 of the NIH Guidelines. While
there is evidence that the strain is
attenuated, this does not necessarily
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
14:51 May 21, 2010
Jkt 220001
mean the strain is avirulent, and the
RAC will review the evidence regarding
the ability of this strain to cause disease.
The recent death of a researcher at the
University of Chicago while working
with an attenuated strain of Yersinia
pestis highlights that attenuated strains
may be pathogenic in certain
populations. If a determination is made
that that lcr- strains do pose a potential
public health risk, then these
experiments will be considered at this
meeting under Section III–A–1 of the
NIH Guidelines. A recommendation will
then be made as to whether this
research should be allowed to proceed
and, if so, under what containment
conditions.
The RAC will review of this proposed
work at its June 16–17, 2010 meeting,
which will be held at the Hilton
Washington DC/Rockville Hotel 1750
Rockville Pike, Rockville, MD and is
open to the public. The public may also
submit written comments.
DATES: The public is encouraged to
submit written comments on this
proposed action. Comments may be
submitted to the OBA in paper or
electronic form at the OBA mailing, fax,
and e-mail addresses shown below
under the heading FOR FURTHER
INFORMATION CONTACT. All comments
should be submitted by June 10, 2010.
All written comments received in
response to this notice will be available
for public inspection in the NIH OBA
office, 6705 Rockledge Drive, Suite 750,
MSC 7985, Bethesda, MD 20892–7985,
(Phone: 301–496–9838) weekdays
between the hours of 8:30 a.m. and
5 p.m.
FOR FURTHER INFORMATION CONTACT:
Contact OBA by e-mail at
oba@od.nih.gov, or telephone at 301–
496–9838, if you have questions, or
require additional information about
this line of research. For additional
information about the RAC meeting at
which this line of research will be
discussed, please visit the NIH OBA
Web site at: https://oba.od.nih.gov/oba/
index.html.
SUPPLEMENTARY INFORMATION: Yersinia
pestis is the causative organism for
plague and it regulated by the
Department of Health and Human
Services (HHS) as a Select Agent
pursuant to the Select Agent
Regulations (42 CFR part 73). There are
a number of attenuated strains of
Yersinia pestis that do not contain
certain virulence factors. The strain that
will be used in the proposed research,
Yersinia pestis CO92 lcr-, lacks the
plasmid called pCD1 or the ‘‘low
calcium response-lcr’’ plasmid since it
confers calcium dependence for growth
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
28811
at 37° C. Loss of the pCD1 plasmid is
accompanied by a concomitant loss of
virulence as indicated in studies using
several animal models. This strain is
excluded from the HHS list of Select
Biological Agents and Toxins https://
www.selectagents.gov/Select%20
Agents%20and%20Toxins%20
Exclusions.html#hhsAgents.
Additional background information
may be obtained by contacting NIH OBA
via e-mail at oba@od.nih.gov or by going
to the OBA Web site at https://
oba.od.nih.gov/rdna/news_
events_oba.html#RAC.
Dated: May 17, 2010.
Jacqueline Corrigan-Curay,
Acting Director, Office of Biotechnology
Activities, National Institutes of Health.
[FR Doc. 2010–12453 Filed 5–21–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Statement of Organization, Functions,
and Delegations of Authority
Part C (Centers for Disease Control
and Prevention) of the Statement of
Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (45 FR 67772–76, dated
October 14, 1980, and corrected at 45 FR
69296, October 20, 1980, as amended
most recently at 75 FR 2282 1–29, dated
April 30, 2010) is amended to establish
the Human Capital Management Office,
Office of the Chief Operating Officer,
Centers for Disease Control and
Prevention.
Section C–B, Organization and
Functions, is hereby amended as
follows:
After the mission statement for the
Office of Health and Safety (CAJP),
insert the following:
Human Capital Management Office
(CAJQ). (1) Develops goals and
objectives and provides leadership,
policy formation, oversight, and
guidance in program human capital
planning and development; (2) plans,
directs, and manages CDC-wide training
programs; (3) develops, designs, and
implements a comprehensive strategic
human resource leadership and career
management program for all
occupational series throughout CDC; (4)
provides technical assistance in
organizational development, career
management, employee development,
and training; (5) maximizes economies
of scale through systematic planning
E:\FR\FM\24MYN1.SGM
24MYN1
]]>Agencies
[Federal Register Volume 75, Number 99 (Monday, May 24, 2010)]
[Notices]
[Page 28811]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-12453]
[[Page 28811]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Office of Biotechnology Activities; Recombinant DNA Research:
Proposed Actions Under the NIH Guidelines for Research Involving
Recombinant DNA Molecules (NIH Guidelines)
ACTION: Notice of consideration of a proposed action under Section III-
A-1 of the NIH Guidelines.
-----------------------------------------------------------------------
SUMMARY: The NIH Guidelines requires certain recombinant research to be
reviewed by the NIH Recombinant DNA Advisory Committee and approved by
the NIH Director (Section III-A-1). Such research involves the
introduction of drug resistance into a microorganism if the
introduction of that drug resistance trait can compromise the ability
to treat disease caused by the microorganism in humans, animals or
agriculture. In order to meet the threshold for consideration under
Section III-A-1, the microorganism must be able to cause disease in
humans, animals or agriculture.
A proposal to deliberately transfer a chloramphenicol resistance
trait into an attenuated strain (CO92 lcr-) of Yersinia pestis has been
submitted to the NIH Office of Biotechnology Activities (OBA) by the
Institutional Biosafety Committee at Lawrence Livermore National
Laboratory (LLNL). Treatment guidelines recommend streptomycin as the
first-line antibiotic for treatment of disease caused by wild type Y.
pestis, and gentamicin is recommended when streptomycin is not
available. Doxycycline and chloramphenicol are also effective and
ciprofloxacin is recommended as prophylaxis and has been shown to treat
disease in animal models. The LLNL investigators will be using Y.
pestis CO92 lcr- strains that have already been made resistant to
ciprofloxacin or doxycycline through exposure of these attenuated
strains to these antibiotics. The proposed research involves the
addition of chloramphenicol resistance into these strains, thereby
creating lcr- Y. pestis strains that are resistant to multiple
antibiotics used to treat disease caused by this organism.
A fundamental question with respect to this line of proposed
research is whether this specific strain (lcr-) has the ability to
cause disease in humans and therefore should be subject to Section III-
A-1 of the NIH Guidelines. While there is evidence that the strain is
attenuated, this does not necessarily mean the strain is avirulent, and
the RAC will review the evidence regarding the ability of this strain
to cause disease. The recent death of a researcher at the University of
Chicago while working with an attenuated strain of Yersinia pestis
highlights that attenuated strains may be pathogenic in certain
populations. If a determination is made that that lcr- strains do pose
a potential public health risk, then these experiments will be
considered at this meeting under Section III-A-1 of the NIH Guidelines.
A recommendation will then be made as to whether this research should
be allowed to proceed and, if so, under what containment conditions.
The RAC will review of this proposed work at its June 16-17, 2010
meeting, which will be held at the Hilton Washington DC/Rockville Hotel
1750 Rockville Pike, Rockville, MD and is open to the public. The
public may also submit written comments.
DATES: The public is encouraged to submit written comments on this
proposed action. Comments may be submitted to the OBA in paper or
electronic form at the OBA mailing, fax, and e-mail addresses shown
below under the heading FOR FURTHER INFORMATION CONTACT. All comments
should be submitted by June 10, 2010. All written comments received in
response to this notice will be available for public inspection in the
NIH OBA office, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, MD
20892-7985, (Phone: 301-496-9838) weekdays between the hours of 8:30
a.m. and 5 p.m.
FOR FURTHER INFORMATION CONTACT: Contact OBA by e-mail at
oba@od.nih.gov, or telephone at 301-496-9838, if you have questions, or
require additional information about this line of research. For
additional information about the RAC meeting at which this line of
research will be discussed, please visit the NIH OBA Web site at:
https://oba.od.nih.gov/oba/.
SUPPLEMENTARY INFORMATION: Yersinia pestis is the causative organism
for plague and it regulated by the Department of Health and Human
Services (HHS) as a Select Agent pursuant to the Select Agent
Regulations (42 CFR part 73). There are a number of attenuated strains
of Yersinia pestis that do not contain certain virulence factors. The
strain that will be used in the proposed research, Yersinia pestis CO92
lcr-, lacks the plasmid called pCD1 or the ``low calcium response-lcr''
plasmid since it confers calcium dependence for growth at 37[deg] C.
Loss of the pCD1 plasmid is accompanied by a concomitant loss of
virulence as indicated in studies using several animal models. This
strain is excluded from the HHS list of Select Biological Agents and
Toxins https://www.selectagents.gov/Select%20Agents%20and%20Toxins%20Exclusions.html#hhsAgents.
Additional background information may be obtained by contacting NIH
OBA via e-mail at oba@od.nih.gov or by going to the OBA Web site at
https://oba.od.nih.gov/rdna/news_events_oba.html#RAC.
Dated: May 17, 2010.
Jacqueline Corrigan-Curay,
Acting Director, Office of Biotechnology Activities, National
Institutes of Health.
[FR Doc. 2010-12453 Filed 5-21-10; 8:45 am]
BILLING CODE 4140-01-P
