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Teratogenicity assessment in pregnant rats receiving 0.2-4 mg/kg intramuscularly during days 6-15 of pregnancy found no effects on fetuses or organ development

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( 2 ) If requested, cooperation in good faith with ONC-ACB surveillance of the ASM participant's health information technology certified under the ONC Health IT Certification Program as authorized by 45 CFR part 170, subpart E, to the extent that the technology meet, or can be used to meet, the definition of CEHRT, including by permitting timely access to the technology and demonstrating its capabilities as implemented and used by the ASM participant in the field

On top of this, you have to track your doses, store your vials properly, and manage complete sterility throughout the process