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EXCLUSION GUIDANCE DOCUMENT : 42 CFR §§ 73.3, 73.4; 9 CFR §§ 121.3, 121.4; 7 CFR § 331.3
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07/01/2019
[PDF-524.92 KB]
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Description:The Federal Select Agent Program (FSAP) oversees the use, possession, and transfer of select agents and toxins at registered entities throughout the United States. The select agent regulations provide criteria for the exclusion of select agents and toxins (See 42 CFR §§ 73.3, 73.4; 9 CFR §§ 121.3, 121.4; 7 CFR § 331.3). This guidance document provides additional information to entities or individuals who request to exclude attenuated strains of select agents or select toxins modified to be less potent or toxic from the requirements of the select agent regulations.
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