Manual of Standard Operating Procedures and Policies

Regulatory - Investigational New Drugs (IND)

Handling IND Submitted with Insufficient Copies

SOPP 8202

Version #1

March 8, 2000
  1. Purpose
    2.

    The purpose of this document is to describe the policies and procedures to be followed by the Document Control Center (DCC) and the CBER review offices when an IND (original or amendment) is received with less than the three (3) required copies.

  2. Background
    3.

    Although 21 CFR 312.23(d) requires the submission of an original and two copies of all submissions to an IND file, CBER, on occasion, receives only an original or an original and one copy. When an IND is missing copies it is difficult to complete the review within the 30 day regulatory timeframe. The extra time and resources required to handle these incomplete submissions have, in the past, been diverted from the processing and review of files that meet regulatory requirements. Due to an increase in the number of IND submissions and a decrease in resources, CBER has reassessed its approach to handling submissions which fail to meet minimum requirements.

  3. Policy
    4.

    21 CFR 312.23(d) requires, "The sponsor shall submit an original and two copies of all submissions to the IND file, including the original submission and all amendments and reports." CBER will enforce this regulation by not regarding an IND submission as officially received until the minimum number of copies is on hand.

  4. Responsibilities and Procedures
    5.

    General information

    • A submission will be date stamped when all 3 copies are received in the DCC. Only 1 receipt date will appear on a submission; that is, the same receipt date will appear on all copies.
    • When less than 3 copies are received, application divisions will inform sponsors that until the required number of copies per 21 CFR 312.23(d) are received in CBER, the review clock will not begin.
    • The application division will return the incomplete number of copies to DCC. DCC will place these in a designated "awaiting additional copies" shelf so that when additional copies are received from the sponsor they can be processed.
    • If the IND (original or amendment) contains 10 pages or less in length, DCC will make the necessary copies and normal processing will proceed.

    When a New IND is received with less than 3 copies

    • DCC will not stamp receiving date on either of the one or two copies received.
    • No IND number will be assigned.
    • Receipt of the one or two copies will be entered into the Document Accountability Tracking System (DATS) and an "L" number assigned for tracking purposes of the receipt of the document. This number will be written on the top of the first page of the copies (without any date stamp).
    • The copy or copies will be sent to the appropriate division with a DCC Question Form indicating that less then the required 3 copies were received (Appendix 1).
    • The application division will either:
      • Make additional copies and return them to DCC for processing along with the DCC Question Form noting that additional copies have been prepared and are attached.
      • Contact sponsor and inform the sponsor that additional copies are required before the IND will be logged as received in CBER and that the "review clock" will not begin until the additional copies have been received. Sponsor must be instructed to include a cover letter and refer to the "L" number when the additional copies are submitted. If this is not done, then there will likely be further delays in processing because DCC will again assume that a new IND is being submitted with less than the required number of copies. The application division will return the incomplete number of copies to DCC along with the DCC Question Form stating that the sponsor has been notified to supply additional copies.

    When an IND Amendment is received with less than 3 copies

    • DCC will not stamp receiving date on either of the one or two copies received.
    • No IND amendment number will be assigned.
    • Receipt of the one or two copies will be entered into DATS and an "L" number assigned for tracking purposes of the receipt of the document. This number will be written on the top of the first page of the copies (without any date stamp).
    • The copy or copies will be sent to the appropriate division with a DCC Question Form indicating that less than the required 3 copies were received (Appendix 1).
      • The application division will either:
        • Make additional copies and return them to DCC for processing along with DCC Question Form noting that additional copies have been prepared and are attached.
        • Contact sponsor and inform the sponsor that additional copies are required before the IND amendment will be logged as received in CBER. The sponsor must be instructed to include a cover letter and refer to the "L" number when the additional copies are submitted. If this is not done, then there will likely be further delays in processing, because DCC will again assume that a new amendment is being submitted with less than the required number of copies. The application division will return the incomplete number of copies to DCC along with the DCC Question Form stating that the sponsor has been notified to supply additional copies.

  5. Effective Date
    6.

    March 8, 2000

  6. Appendix
    7.

    DCC Question Form - Insufficient Copies Received (PDF, 31 KB)

  7. History
    8.

    Written/Revised Approved Approval Date Version Number Comment
    Jules Meisler Bob Yetter March 8, 2000 1 First issuance of this SOPP.

 
Updated: March 9, 2000