How to Comment on Citizen Petition Seeking FDA Action on Off-label Use of Puberty Blockers

  1. Click on this link: https://www.regulations.gov/document/FDA-2023-P-3767-0001 or
    1. Go to www.Regulations.gov.
    2. Enter FDA-2023-P-3767 in the search field.
    3. Find the document “Citizen Petition Citizen Petition from Nancy K. Stade et. al”
  2. You can click on the Download button beside the PDF document to download and read the petition if you haven’t already. Then click “Comment” on the upper left side of the page.
  3. Fill in all required fields.
  4. READ ALL INSTRUCTIONS. Your name may be made public with your comment. Do not enter identifying information, such as address or phone number, if you do not wish it to be made public.
  5. If your comment is fewer than 5000 characters, you can enter it in the “Comment” field. If it is longer, simply enter “see attached” in the “Comment” field and upload your document in the “Attach Files” field.
  6. Make sure your comment includes the docket number FDA-2023-P-376
  7. Click on the commenter’s checklist at the top of the page for tips on writing an effective comment or use this resource: https://www.regulations.gov/document/FS-2018-0053-0007

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