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  1. Developing Products for Rare Diseases & Conditions

Corresponding with the OOPD Drug Designation Programs

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 information provided below is for your convenience and will help us to be more efficient in responding and assisting you.

Topic Telephone Email Mail
       
General information X X  

Request for a meeting

Note: Please see the Guidance for more information

  X  

Original or amended Orphan Drug or RPD request

Note: For amendments, please include updated contact information, if applicable.

    X
Change in contact/agent information   X  

Transfer/change in ownership of ODD or RPD

Note: Please see 21 CFR §316.27 for more information

  X  
Annual Report   X  

 

Please click on the contact methods below for additional information:

Contact Method

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.

When transmitting information to the Orphan Drug Designation Program via email please utilize the mailbox OPDAR@fda.hhs.gov.  The use of automated read receipt is recommended 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.

Hard copy applications must arrive in a binder or report cover. When sending hard copy documents to an OOPD drug designation program, the preferred method is trackable express mail (UPS, 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

Compact Discs (CD)

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

Please provide two identical CDs for Orphan Drug and RPD designation requests

1.  The CD must be protected (i.e. physical media mailer) and be attached securely to or within a jacket (i.e. binder).
2.  The jacket should include a signed cover 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 # (for Amendments)
  • 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 (i.e. DVD, thumb drives, etc.) will be accepted