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Office of Science Policy, Office of Biotechnology Activities; Recombinant or Synthetic Nucleic Acid Molecule Research: Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
Notices
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National Institutes of Health
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The Office of Biotechnology Activities (OBA) is updating Appendix B (Classification of Human Etiologic Agents on the Basis of Hazard) of the NIH Guidelines by specifying the risk group (RG) classification for two organisms: Middle East Respiratory Syndrome coronavirus (MERS-CoV) and Pseudomonas aeruginosa. Background: The NIH Guidelines provide guidance to investigators and local Institutional Biosafety Committees (IBCs) for setting containment for research involving recombinant or synthetic nucleic acid molecules. Section II-A, Risk Assessment, instructs investigators and IBCs to make an initial risk assessment based on the RG of the agent that will be manipulated (see Appendix B, Classification of Human Etiologic Agents on the Basis of Hazard). The RG of the agent often correlates with the minimum containment level required for experiments subject to the NIH Guidelines. Updating Appendix B by revising the risk groups for certain organisms, or adding new organisms, leads to more uniform containment recommendations that are commensurate with the biosafety risk. The resulting amendments are ``Minor Actions'' under Section IV-C- 1-(b)-2 of the NIH Guidelines and, therefore, will be implemented immediately upon publication in the Federal Register. However, the OBA welcomes public comment to inform any future changes to Appendix B.
78 FR 66751
https://www.govinfo.gov/app/details/FR-2013-11-06/2013-26612
2013-26612
fr06no13-49
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https://www.govinfo.gov/app/details/FR-2013-11-06/2013-26612
https://www.govinfo.gov/content/pkg/FR-2013-11-06/html/2013-26612.htm
https://www.govinfo.gov/content/pkg/FR-2013-11-06/pdf/2013-26612.pdf
2 p.
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Office of Science Policy, Office of Biotechnology Activities; Recombinant or Synthetic Nucleic Acid Molecule Research: Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines); Federal Register Vol. 78, Issue
NOTICE
2013-26612
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
4140-01-P
2013-26612
Notice of Final Action under the NIH Guidelines.
The Office of Biotechnology Activities (OBA) is updating Appendix B (Classification of Human Etiologic Agents on the Basis of Hazard) of the NIH Guidelines by specifying the risk group (RG) classification for two organisms: Middle East Respiratory Syndrome coronavirus (MERS-CoV) and Pseudomonas aeruginosa. Background: The NIH Guidelines provide guidance to investigators and local Institutional Biosafety Committees (IBCs) for setting containment for research involving recombinant or synthetic nucleic acid molecules. Section II-A, Risk Assessment, instructs investigators and IBCs to make an initial risk assessment based on the RG of the agent that will be manipulated (see Appendix B, Classification of Human Etiologic Agents on the Basis of Hazard). The RG of the agent often correlates with the minimum containment level required for experiments subject to the NIH Guidelines. Updating Appendix B by revising the risk groups for certain organisms, or adding new organisms, leads to more uniform containment recommendations that are commensurate with the biosafety risk. The resulting amendments are ``Minor Actions'' under Section IV-C- 1-(b)-2 of the NIH Guidelines and, therefore, will be implemented immediately upon publication in the Federal Register. However, the OBA welcomes public comment to inform any future changes to Appendix B.
Comments may be submitted to the OBA in paper or electronic form at the mailing, fax, and email addresses shown below under the heading ``For Further Information.'' All comments should be submitted by December 6, 2013. All written comments received in response to this notice will be available for public inspection in the NIH OBA office, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, MD 20892-7985, weekdays between the hours of 8:30 a.m. and 5:00 p.m.
If you have questions, or require additional information about these changes, please contact the OBA by email at oba@od.nih.gov or by telephone at 301-496-9838. Comments may
Guidelines for Research:
Recombinant or Synthetic Nucleic Acid Molecules
,
oba@od.nih.gov
http://www.bacterio.net/hazard.html#group2
http://www.cdc.gov/coronavirus/mers/
http://www.cdc.gov/coronavirus/mers/guidelines-lab-biosafety.html
http://www.cdc.gov/hai/organisms/pseudomonas.html
http://www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/pseudomonas-spp-eng.php
http://www.who.int/csr/disease/coronavirus_infections/faq/en/index.html
http://www.who.int/csr/sars/archive/2003_05_07a/en/print.html
Federal Register
Vol. 78, no. 215
Office of the Federal Register, National Archives and Records Administration
2013-11-06
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Table of Contents:
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