[Federal Register Volume 75, Number 219 (Monday, November 15, 2010)]
[Notices]
[Pages 69687-69688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28698]
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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 proposed actions under the NIH
Guidelines.
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SUMMARY: A request to certify Kluyveromyces lactis as a new host-vector
system has been submitted to the NIH Office of Biotechnology Activities
(OBA). The data to be considered for certifying a new host-vector
system can be found in Appendix I of the NIH Guidelines. A new host-
vector system may be certified only after review by the NIH Recombinant
DNA Advisory Committee (RAC) and specifically approved by the NIH
Director as a Major Action.
Part of this request is to exempt from the NIH Guidelines certain
types of research when performed in K. lactis, if K. lactis and its
affiliated plasmids meet the requirements for certification as a host-
vector system. Research that is exempt from the NIH Guidelines when
performed with other certified host-vector systems can be found in
Appendix C of the NIH Guidelines.
DATES: The public is encouraged to submit written comments on these
proposed actions. Comments may be submitted to OBA in paper or
electronic form at the OBA mailing, fax, and e-mail addresses shown
below under the heading FOR FURTHER INFORMATION CONTACT. The NIH will
consider all comments submitted by December 1, 2010. Written comments
submitted by December 1, 2010 will be reproduced and distributed to the
RAC for consideration at its December 7-8, 2010 meeting. In addition,
an opportunity for public comment will be provided at that meeting.
Please check the meeting agenda for the time of this discussion (http://oba.od.nih.gov/rdna_rac/rac_meetings.html). All written comments
received in response to this notice will be available for public
inspection at the NIH OBA office, 6705 Rockledge Drive, Suite 750,
Bethesda, MD 20892 (telephone, 301-496-9838), weekdays between the
hours of 8:30 a.m. and 5 p.m.
FOR FURTHER INFORMATION CONTACT: OBA by e-mail at [email protected], or
telephone at 301-496-9838, if you have questions, or require additional
information about these proposed actions. Comments may be submitted to
the same e-mail address or by fax at 301-496-9839 or sent by U.S. mail
to the Office of Biotechnology Activities, National Institutes of
Health, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, Maryland
20892-7985. For additional information about the RAC meeting at which
these proposed actions will be deliberated, please visit the NIH OBA
Web site at: <http://oba.od.nih.gov/oba/index.html>.
SUPPLEMENTARY INFORMATION: OBA has received a request from the
Institutional Biosafety Committee at New England BioLabs to exempt from
the requirements of the NIH Guidelines research with certain plasmids
when performed in K. lactis. In order for a broad class of research to
qualify for exemption, it must be determined by the NIH Director that
the research does not pose a significant risk to human health or the
environment (Section III-F-6). One way to exempt a broad class of
research from the requirements of the NIH Guidelines is to perform the
research in specific certified host-vector systems (as outlined in
Appendix C of the NIH Guidelines). Currently research with only three
certified host-vector systems is exempt from the NIH Guidelines. These
three certified systems are based upon two bacterial genera:
Escherichia (E. coli K-12) and Bacillus (B. subtilis or B.
licheniformis) and one lower eukaryotic genus: Saccharomyces (S.
cerevisiae or S. uvarum). In order to certify a new host-vector system,
data as outlined in Appendix I-II-B of the NIH Guidelines must be
submitted for review. Specifically, this application will be considered
under Appendix I-II-B-1 (Host-Vector 1 Systems Other than Escherichia
coli K-12). Data to be considered include: (i) The strain's natural
habitat and growth requirements; its physiological properties,
particularly those related to its reproduction, survival, and the
mechanisms by which it exchanges genetic information; the range of
organisms with which this organism normally exchanges genetic
information and the type of information that is exchanged; and any
relevant information about its pathogenicity or toxicity; (ii) a
description of the history of the particular strains and vectors to be
used, including data on any mutations which render this organism less
able to survive or transmit genetic information; and (iii) a general
description of the range of experiments contemplated with emphasis on
the
[[Page 69688]]
need for developing such an Host-Vector 1 system.
Background information may be obtained by contacting NIH OBA via e-
mail at [email protected]. Alternatively, information is available on the
OBA Web site at http://oba.od.nih.gov/oba/news_events_oba.html.
Dated: November 3, 2010.
Jacqueline Corrigan-Curay,
Acting Director, Office of Biotechnology Activities, National
Institutes of Health.
[FR Doc. 2010-28698 Filed 11-12-10; 8:45 am]
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