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Instructions for Submission to FDA Citizen’s Petition
on Unregulated FMT
- Visit https://www.regulations.gov/comment?D=FDA-2020-P-1633-0001
- Submitters must either type NA or provide additional details concerning the electronic submission you will upload.
- Details can include, first name and last name, submitting on behalf of a third party, organization name, and address, category, etc. (This screen and these fields are also used for the submission of comments; therefore, it is labeled and refers to comments because of comment submission instructions).
- After you fill out this section click on the “Choose file” button to upload your submission files.
- Enter name and contact information (optional)
- Mailed submissions will be delayed due to COVID-19 so the FDA is encouraging online submissions.
- However, mailed in letters can be sent to the below address:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Docket ID: FDA-2020-P-1633
Please review the following document: