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Request Regarding Restricted Experiment

ICR 201804-0920-015 · OMB 0920-0576 · Object 82563901.

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Request Regarding Restricted Experiment
shari steinberg
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2015-07-13
2026-10-10
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Request Regarding a Restricted Experiment

An individual or entity may not conduct, or possess products resulting from, the following experiments unless approved by and conducted in accordance with the conditions prescribed by the HHS Secretary:
(1) Experiments that involve the deliberate transfer of, or selection for, a drug resistance trait to select agents that are not known to acquire the trait naturally, if such acquisition could compro-mise the control of disease agents in humans, veterinary medicine, or agriculture. 
(2) Experiments involving the deliberate formation of synthetic or recombinant DNA con-taining genes for the biosynthesis of select toxins lethal for vertebrates at an LD[50] < 100 ng/kg body weight (42 CFR 73.13 (a)).  CDC has not developed standardized forms to use in the above situation.  Rather, the entity should provide the information as requested in the appropriate section of the regulation.
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