21CFR Part 312.23

General Instructions – IND Template

How many copies do I send?

  • Three Copies (the original and 2 copies)
  • Submit in ACCO-like pressboard report covers. They look like this:

  • Colors – Original (grey), Copies (colors other than grey, we use red and black)

Where do I send my IND?

*For CBER submissions: Staff names should NOT be placed on the document packaging or envelope address.

April 2012

21CFR Part 312.23

For a Drug:

Food and Drug Administration

Center for Drug Evaluation and Research

Central Document Room

5901-B Ammendale Road

Beltsville, MD20705-1266

ATTN: [Insert Appropriate Name]

For a Therapeutic Biological Product:

Food and Drug Administration

Center for Drug Evaluation and Research

Therapeutic Biological Products Document Room

5901-B Ammendale Road

Beltsville, MD20705-1266

ATTN: [Insert Appropriate Name]

April 2012

21CFR Part 312.23

For a Biologic:

Food and Drug Administration

Center for Biologics Evaluation and Research

Document Control Center

10903 New Hampshire Avenue

WO71, G112

Silver Spring, MD 20993-0002

Whom do I address in the submission?

The initial submission is usually sent to the attention of a Division Director. You can use the organization chartsat the FDA website to find the right person ( However, please just contact us and we will set you up with the correct name.

What happens after I send the IND?

  • You will usually/often receive an AcknowledgementLetter with your assigned IND number within a few weeks (though sometimes you find out by email)
  • The letter will identify your contact person at the FDA for all future correspondence related to the IND.
  • If the FDA has no issues with your IND, your IND becomes ‘effective’ 30 days after FDA receipt.
  • In general, you will not get an ‘approval’ letter from the FDA. However, you may sometimes get an email or letter where the Agency states that you are ‘safe to proceed’. However, this should not be expected.
  • If FDA issues cannot be resolved within the 30 day window, then your studycould be placedon ‘clinical hold’.

Where can I get more information?

(or )

April 2012