Would I be required to have documentation to support the use of an alternative, and would I be required to submit that documentation to FDA?

We do not propose to require you to submit scientific data or information in support of
an alternative to us for review or approval prior to marketing. However, we would
require that you establish and maintain a record of any such scientific data or
information, including any analytical information, and make such data and information
available to us to evaluate upon request (see proposed §§ 112.12(c) and 112.166).