Regulacje i polityka gospodarcza · 5.09.2012

Final Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)

On March 4, 2009, the National Institutes of Health (NIH) Office of Biotechnology Activities, Office of Science Policy (NIH/OBA) published a proposal in the Federal Register (74 FR 9411) to revise the NIH Guidelines in two regards. The first was to address biosafety considerations for research with synthetic nucleic acids. The proposal modified the scope of the NIH Guidelines specifically to cover certain basic and clinical research with nucleic acid molecules created solely by synthetic means. The second proposed revision was to modify the criteria for determining whether an experiment to introduce drug resistance into a microorganism must be reviewed by the Recombinant DNA Advisory Committee (RAC) and approved by the NIH Director (as a Major Action under Section III-A-1-a of the NIH Guidelines). Comments submitted were discussed at the "NIH Public Consultation on Proposed Changes to the NIH Guidelines for Synthetic Nucleic Acids" on June 23, 2009 (http://oba.od.nih.gov/rdna_rac/rac_pub_con.html". This notice sets forth final changes to the NIH Guidelines regarding those two proposals. The scope of the NIH Guidelines is being modified to cover certain classes of basic and clinical