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  1. Designating an Orphan Product: Drugs and Biological Products

Contacts for various questions, requests and submissions related to orphan products are included below.

General inquiries: 301-796-8660 or orphan@fda.hhs.gov 

Contact orphan@fda.hhs.gov to:

  • Request a meeting
  • Submit an orphan drug, rare pediatric disease or humanitarian use device designation request
  • Submit changes to your contact information
  • Transfer or change ownership of an orphan drug designation, rare pediatric disease designation or humanitarian use device designation
  • Submit an annual report

Sponsors and others who plan to email information to FDA that is private, sensitive, proprietary or commercial confidential are strongly encouraged to send it from an FDA-secured email address so the transmission is encrypted. The agency will assume the addresses of emails received or email addresses provided as a point of contact are secure when responding to those email addresses.

Sponsors and others can establish a secure email address link to FDA by sending a request to SecureEmail@fda.hhs.gov. There may be a fee to a commercial enterprise for establishing a digital certificate before encrypted emails can be sent to FDA.

See orphan drug designations for more information.

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