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News from the NIH Office of Biotechnology Activities

NIH Amends the NIH Guidelines to Provide Additional Biosafety Guidance on Research Involving Highly Pathogenic Avian Influenza (HPAI) H5N1 Virus – Researchers are increasingly interested in studying highly pathogenic avian influenza H5N1 virus to understand whether it could evolve to become a significant human health threat. Research with this virus – especially that aimed at studying transmissibility in mammals – raises special biosafety concerns given the highly pathogenic nature of the virus when it infects humans.  In light of that, the NIH asked the NIH Recombinant DNA Advisory Committee (RAC) to review the current biosafety requirements of the NIH Guidelines for Research Involving Recombinant DNA Molecules to determine whether they appropriately address the risks of the emerging field of research with HPAI H5N1 viruses that may transmit among mammals by respiratory droplets. 

On January 24, 2013, the RAC held a public meeting with influenza experts, the World Health Organization (WHO), and relevant Federal research and oversight agencies.   As a result of that meeting, the RAC recommended additional biosafety and containment measures for research on mammalian-transmissible HPAI H5N1 virus to supplement the current biosafety requirements already delineated in the NIH Guidelines.  These precautions include facility enhancements, additional biosafety practices, and specific occupational health measures.   Based on the recommendations of the RAC, the NIH Office of Biotechnology Activities (OBA) concluded that more specific guidance regarding recombinant DNA research with mammalian-transmissible HPAI H5N1 virus is warranted and has amended the NIH Guidelines accordingly.

A full description of these amendments can be found in the February 21, 2013 Federal Register.  These changes are effective immediately, but the public is encouraged to submit written comments on this action so that NIH can assess whether further refinement is warranted.  Comments will be accepted until March 25, 2013 and may be submitted to OBA by e-mail at, telephone at 301-496-9838, or fax at 301-496-9839.  Comments may also be submitted 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 these amendments, please contact OBA by e-mail at, or telephone at 301-496-9838.