How to Comment
The comment period opens March 2, 2018. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance within 60 days from when the comment period opens.
Submit electronic comments to https://www.regulations.gov to docket number FDA-2018-D-0075
Submit written comments to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2018-D-0075.