[Federal Register Volume 75, Number 219 (Monday, November 15, 2010)]
[Pages 69687-69688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28698]



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 


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 

[[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]