Section 725.150 - Procedural requirements for this subpartGeneral requirements for all MCANs under this part are contained in subparts A through C of this part. In addition, the following requirements apply to MCANs submitted under this subpart:
(a)When to submit a MCAN. A MCAN must be submitted at least 90 calendar days prior to manufacturing or importing a new microorganism and at least 90 calendar days prior to manufacturing, importing, or processing a microorganism for a significant new use.(b)Section 5(b) of the Act. The submitter must comply with any applicable requirement of section 5(b) of the Act for the submission of test data.(c)Contents of a MCAN. Each person who submits a MCAN under this subpart must provide the information and test data described in §§ 725.155 and 725.160 .(d)Recordkeeping. Each person who submits a MCAN under this subpart must comply with the recordkeeping requirements of § 725.65 .