2010-28698. 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.

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 [e-mail], 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 need for developing such an Host-Vector 1 system.

Background information may be obtained by contacting NIH OBA via e-mail at [e-mail]. 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.