Department of Health and Human Services September 5, 2012 – Federal Register Recent Federal Regulation Documents

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 (https://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 research with synthetic nucleic acids while exempting others. As discussed herein, the majority of research with synthetic nucleic acids that are not designed to replicate does not raise significant biosafety concerns that warrant oversight under the NIH Guidelines. Because of the modification of the scope of the NIH Guidelines, the title of the NIH Guidelines will be revised from NIH Guidelines for Research Involving Recombinant DNA Molecules to NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acids Molecules. These changes also clarify the criteria for determining whether an experiment to introduce drug resistance into a microorganism raises sufficient public health issues to warrant the experiment being reviewed by the RAC and approved by the NIH Director under Section III- A-1-a of the NIH Guidelines. While the current criteria for determining whether an experiment requires review under Section III-A-1-a are being retained, additional language is being added regarding the assessment of whether a drug is therapeutically useful. In addition, NIH/OBA has clarified that Institutional Biosafety Committees (IBCs) can consult with NIH/OBA regarding a specific experiment that does not meet the criteria for review under Section III-A-1-a but nonetheless raises important public health issues. Finally, a section is added to give NIH/OBA the authority to approve new experiments utilizing the same drug resistance trait and organism used in an experiment previously reviewed by the RAC and approved by the NIH Director. In March 2009, NIH/OBA also proposed changes to Section III-E-1 of the NIH Guidelines, which sets containment for recombinant experiments involving two-thirds or less of the genome of certain viruses in tissue culture. In response to the comments on the proposed changes to Section III-E-1, NIH/OBA revised the proposal and published a notice for comment on April 22, 2010 (75 FR 21008). Comments received in response to this notice were discussed at the June 16, 2010, public meeting of the RAC and additional discussions of subsequent revisions to the proposed changes took place at the June 7, 2011, meeting of the RAC. As these changes are not yet finalized, NIH/OBA will move forward with the other changes outlined below pending finalization of changes to Section III-E-1.