Office of Biotechnology Activities Recombinant DNA Research: Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)

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.