e-journal
New Entity CDC Select Agent Registration Process—A Practical Guide to Lessons Learned
Abstract:
Entities planning to conduct work in the United States with biological select agents and toxins (BSAT) must be registered with either the Centers for Disease Control and Prevention (CDC) or the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA). Information pertaining to registration is described in a Guidance Document for Completing Form 1 which is available on the National Select Agent Registry (NSAR) website; however, the registration process involves substantial preparation before and after the Form 1 is submitted, and no recommended strategy guides are available to assist with navigating through the process as a whole. The National Biodefense Analysis and Countermeasures Center (NBACC) successfully completed the registration process by employing, what we believe, are industry best practices as described in the “Critical Lessons Learned” text box to effectively streamline the application process. The purpose of this article is to benchmark and share these practices with the biocontainment community.
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