For Industry

Corresponding with the OOPD Drug Designation Programs

Thank you for your interest in the OOPD designation program for Orphan Drugs or for Rare Pediatric Diseases. If you have an inquiry, a meeting request, and/or wish to send a document to an OOPD drug designation program, the contact information provided below is for your convenience and will help us to be more efficient in responding and assisting you.

Topic
 Preferred Contact Method
General Information about the Orphan Drug or Rare Pediatric Disease (RPD) Designation ProgramsGeneral information can be found on the FDA website including FAQs.   General inquiries can be sent to the OOPD building address below, orphan@fda.hhs.gov (mailto: orphan@fda.hhs.gov )  or by calling 301-796-8660.  
Questions about correspondence received from OOPD  such as a designation letter, deficiency letter, or exclusivity letter The contact person and contact information are provided in the letter from OOPD.
Request for an in-person or teleconference  meeting  Send a request to orphan@fda.hhs.gov (mailto: orphan@fda.hhs.gov ) or call 301-796-8660.
Meeting materials for scheduled meeting with OOPD Regular or express mail, or email orphan@fda.hhs.gov  (mailto: orphan@fda.hhs.gov ) materials two weeks in advance of the meeting.
Original or amended  Orphan Drug or RPD designation request  Regular or express mail.   Email submissions will not be accepted.  An orphan drug or RPD designation request may be provided on a mailed CD.  Please provide two identical CDs for an RPD designation request.  [For Amendments, please include updated contact information, especially email addresses.]
Self-certification about marketing application Same as an amendment, unless otherwise directed by an OOPD staff member.
Change in contact/agent  information Mail or email a signed letter, not both.
Transfer/ change in ownership of an Orphan Drug or RPD designation

Mail signed transfer and acceptance letters from the current sponsor and new sponsor, or  email signed letters to OPDAR@fda.hhs.gov (not both).

Annual report of holder of an Orphan Drug designation

Emailing an attached report (to OPDAR@fda.hhs.gov)  is preferred; otherwise mail the report.


Hard Copy Submissions:  When sending hard copy documents to an OOPD drug designation program, the preferred method is trackable express mail (DHS, FedEx, DHL, etc.).  The use of couriers is not recommended.  The mailing address is as follows:

Office Of Orphan Products Development
Attention: Orphan Drug [or Rare Pediatric Disease] Designation Program
Food and Drug Administration
WO32-5295
10903 New Hampshire Avenue
Silver Spring,  MD   20993-0002

 

Telephone Communications:  When applicable, telephone communications may be the easiest and most expedient method of getting a general question answered or providing follow-up information to an Orphan Drug Designation Program staff member.  Call the general number: 301-796-8660.  It may be necessary to leave a voice mail message indicating the nature of the call and the appropriate staff member will return the call.

Following a "substantive" or formal telephone meeting, the discussion may need to be documented and the documentation reviewed/validated by the participants.  "Substantive" refers to information conveyed over the phone that could possibly affect a specific regulatory action or decision.  The process of documentation, if required, will be determined among the participants during the call.

Email Correspondence: When transmitting information to the Orphan Drug Designation Program using email, please utilize an automated read receipt to avoid calling to verify receipt of the email.  Sponsors and others who plan to email information to FDA that is considered to be private, sensitive, proprietary, or commercial confidential are strongly encouraged to send it from an FDA secured email address so the transmission is encrypted.  The OOPD will assume that the addresses of emails received or email addresses provided as a point of contact, are FDA 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 as part of the set-up process before emails can be sent to FDA encrypted.

Compact Discs (CD): When transmitting information to the Orphan Drug or RPD Designation Programs on a CD, please adhere to the following requirements:

1. The CD must be protected (e.g., in a sleeve, jewel case, or physical media mailer) and be attached securely to or within a jacket (e.g. notebook, binder).
2.  The jacket should include a signed paper transmittal letter with the CD.
3.  The CD can only contain pdf documents.  CDs with executable files or ZIP files will not be accepted.
4.  Scan the CD for viruses prior to mailing.  Note in the transmittal letter that the submission is on a CD and is virus free. 
5.  Each CD should be labeled with the following:
     * Orphan Drug Designation Request, Amendment, or References
     * FDA Designation Request # (if known)
     * Company Name
     * Drug Name
     * Submission Date
     * Disk/CD # and total number submitted, i.e., #of#
6.  *The CD should contain a pdf copy of the signed transmittal letter.

Note - no other type of physical media (DVD, thumb drives, etc.) will be accepted.

              

 

Page Last Updated: 10/05/2017
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