21 C.F.R. § 1.233

Are there optional items included in the registration form?

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

Yes. FDA encourages, but does not require, you to submit items that are indicated as optional on the Form FDA 3537 that you submit.

[81 FR 45952, July 14, 2016]