CdiffSurvivorSampleLetter

 

CdiffPatientSampleLetter

 

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Instructions for Submission to FDA Citizen’s Petition on Unregulated FMT

 

Electronic:

• 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)

 

Mail-In:

• 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:

FDA-CitizenPetition2020 (1)