consistent with changes described in FDA memos of 1-16- 02 and
1-26-02, including agreement to require only one copy be submitted.
This package is cleared until November 2003 by which time it will
be combined with 0910-0016. The combined submission shall address
the timing of electronic signatures.
Inventory as of this Action
Providing Regulatory Submissions in
Electronic Format, General Considerations and Draft Guidance for
Industry Providing Regulatory Submissions in Electronic Format for
Food Additive and Color Additive Petitions." These documents are
the first in a series of guidance documents intended to provide
guidance for industry regarding the preparation of regulatory
submissions in elecgtronic format to the Office of Food Additive
Safety, Center for Food Safety and Applied Nutrition (CFSAN). OPA
is providing these draft guidances as part of its implementation of
21 CFR Part 11, the Government Paperwork Elimination Act