Restricted Experiments Guidance
Contents
- Changes and Highlights
- Introduction
- Definition of Restricted Experiments
- Examples of Potential Restricted Experiments
- Request to Conduct a Restricted Experiment
- Request to Conduct a Restricted Experiment Using Synthetic Nucleic Acids or Passive Selection
- Request to Generate Intermediate Variants
- Request to Possess the Product resulting from a Restricted Experiment
- Transfer of a Product resulting from a Restricted Experiment
- Restricted Experiments with Select Agents and Toxins Requiring FSAP Approval
- Links and Resources
- Download PDF
Changes and Highlights
Revisions: This is a living document subject to ongoing improvement. Feedback or suggestions for improvement from registered select agent entities or the public are welcomed. Submit comments directly to the Federal Select Agent Program (FSAP) at:
CDC: LRSAT@cdc.gov
APHIS: AgSAS@aphis.usda.gov
Revision History:
August 30, 2013: Initial posting
March 27, 2014 (Revision 1): Added note that the restricted experiment provision dealing with toxins currently only applies to Botulinum neurotoxin. Other changes are editorial errors from previous version.
August 28, 2014 (Revision 2): Added language describing the types of experiments that may fall under the restricted experiment provisions described in Section 13. Modified restricted experiment definition to reflect technical amendment published in the Federal Register on May 12, 2014. Other changes are editorial errors from previous version.
February 27, 2015 (Revision 3): Added language under subheading “Request to conduct a restricted experiment” describing the criteria reviewed and considered by the FSAP when determining if gradient selection experiments or drug efficacy experiments meet the definition of a restricted experiment.
October 21, 2016 (Revision 4): Added language to clarify examples of potential restricted experiments, to add links to Form 1, and to clarify select agents and toxins that require occupational health and medical surveillance procedures.