Vaccines, Blood & Biologics

SOPP 8117: Issuing Submission Tracking Numbers in Advance of Electronic Submissions

Version #2
Effective Date:
 Sept 4, 2015

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  1. Purpose
    This Standard Operating Policy and Procedure (SOPP) provides guidance to the Center for Biologics Evaluation and Research (CBER) staff on issuing submission tracking numbers in advance of receiving an electronic submission and the initial processing of those submissions.

     

  2. Scope
    1. This SOPP applies to electronically submitted Biologics License Applications (BLA), New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), and related supplements (BLS, sNDA, sANDA), and Investigational and Related Applications (IRA), which include electronically submitted Investigational New Drugs (IND), Master Files (MF), and Emergency Use Authorizations (EUA).
    2. This SOPP does not apply to any pre-application submission (e.g., pre-IND, pre-BLA, etc.). It also does not apply to medical device eCopy submissions.

     

  3. Background
    1. The International Conference on Harmonisation (ICH) developed a standard format for regulatory submissions called the Common Technical Document (CTD) and a standard for electronic regulatory submissions called the Electronic Common Technical Document (eCTD). A submission tracking number is pre-assigned by CBER prior to receiving an eCTD or other electronically submitted original application or supplement to automate receipt and processing of the submission.
    2. The submission tracking number is included within the electronic submission’s XML backbone, as well as, on FDA’s fillable-PDF version of Form FDA 356h or Form FDA 1571 for eBLA and eIRA submissions, respectively. The fillable-PDF versions of these FDA forms are called PDF “SmartForms.” The CBER Electronic Document Room’s (EDR) automated loading process reads the submission tracking number and then automatically loads and routes the submission. If the submission tracking number is missing, errors are generated and the automated loading and validation process fails. Submissions that fail the automated loading process are sent to CBER’s Document Control Center (DCC) for manual loading.

     

  4. Definitions
    1. Common Technical Document (CTD) - A standardized format developed by the ICH for submitting applications to the FDA.
    2. eCTD - A CTD submitted in electronic form with an extensible markup language (XML) backbone.
    3. eCTD XML Backbone - An XML file serves as a hyperlinked table of contents for the eCTD.
    4. Electronic Submissions Gateway (ESG) - The Agency web portal through which electronic submissions are received from sponsors/applicants.
    5. PDF SmartForm - Forms that have embedded XML coding that facilitate the recovery of information supplied by the sponsor/applicant (Forms FDA 1571 and 356h). Note: These forms can be obtained from the FDA forms webpage.

     

  5. Policy
    1. When requested, CBER will issue the submission tracking number to a sponsor/applicant usually no earlier than two weeks in advance of the target receipt date for the electronic submission.
    2. When a sponsor/applicant requests a submission tracking number for an electronic submission, the Regulatory Information Management Staff (RIMS) should provide the number within two business days of the request.
    3. Sponsor/Applicant requests should be made by email to cberrims@fda.hhs.gov.
    4. All electronic, original and related supplemental submissions received through the agency’s ESG, should contain a pre-assigned submission tracking number. The tracking number allows CBER’s EDR to automatically load the submission.
    5. If a submission does not have a pre-assigned submission tracking number, the submission fails the automated process and must be loaded manually by CBER’s DCC.
    6. If CBER’s DCC is unable to load the submission, DCC refers the submission to CBER’s EDR Team for resolution.
    7. There is no pre-assignment of submission tracking numbers for paper based submissions.

     

  6. Responsibilities
    1. Document Control Center (DCC) – Processes all incoming submissions not automatically loaded to the CBER EDR, including manually loading electronic submissions into the EDR (i.e., CD or DVD submissions and electronic submissions that fail the automated load process). Contacts CBER’s EDR team when the electronic submission fails the load process.
    2. Office Electronic Submissions Coordinator (ESC) – Ensures Reviewers have appropriate access to data files. Reviews electronic applications for “usability,” for example: hyperlink opens and points to the correct information.
    3. Regulatory Information Management Staff (RIMS) - Processes request from sponsor/applicant for a pre-assigned submission tracking number. Enters the essential application information required in order to generate the submission tracking number in the appropriate CBER database. Notifies the sponsor/applicant and the product review office of the number assigned.  Periodically voids submission tracking numbers that are pre-assigned when the submission is not received.
    4. Regulatory Project Manager (RPM) or Regulatory Information Specialist (RIS) - Communicates with the sponsor/applicant, as appropriate, if there are issues with the electronic receipt of the submission.
    5. EDR Team – Works with CBER’s DCC to identify the cause of an electronic submission load error so the submission can be loaded as quickly as possible. Resends load notification to the appropriate review office. Communicates, as appropriate, with the product review office if there are issues that can’t be resolved with the electronic receipt of the submission.

     

  7. Procedures
    1. Electronic BLAs, NDAs and ANDAs, and related supplements
      1. Ensures the submission tracking number (STN) is generated in the Regulatory Management System-Biologics License Application (RMS-BLA) based on a request from the applicant and provides the number to the applicant within two business days of the request. [RIMS] Note: if a request is received in the product office, forward the request to RIMS.
      2. Notifies the applicant and the appropriate product review office of the STN assignment.[RIMS]
      3. Advises the applicant to notify CBER RIMS if plans change and there will not be a submission within the targeted submission date. [RIMS]
      4. Instructs the applicant to include the STN on the cover page of the submission and on PDF SmartForm FDA 356(h), as well as in the XML backbone for a submission in the eCTD format.[RIMS]
      5. Notifies the product review office when electronic receipt of the submission fails. [EDR Team]
      6. Communicates with the applicant, as appropriate, if there are issues with the electronic receipt of the submission. [RPM or RIS]
      7. Checks RMS-BLA periodically for pre-assigned STNs that are outdated and not received. [RIMS]
      8. If pre-assigned STNs are outdated, contacts the review office to verify submission status. [RIMS]
        1. If submission status is unknown, contacts the applicant to verify status. [RIMS or RPM]
        2. In consultation with the RPM, voids pre-assigned numbers for submissions where receipt is no longer anticipated or delay is substantial. [RIMS]
    2. Electronic, Original IRAs (IND, MF, EUA)
      1. Generates the submission tracking number (IRA number) in the Biologics Investigational and Related Applications Management System (BIRAMS) and provides the number to the sponsor within two business days of the tracking number request. [RIMS] Note: if a request is received in the product office, forward the request to RIMS.
      2. Notifies the sponsor and the appropriate review office of the IRA number assignment. [RIMS]
      3. Advises the sponsor to notify CBER RIMS if plans change and there will not be a submission within the targeted submission date. [RIMS]
      4. Instructs the sponsor to include the IRA tracking number on the cover page of the submission and on PDF SmartForm FDA 1571, as well as in the XML backbone. [RIMS]
      5. Notifies the product review office when electronic receipt of the submission fails. [EDR Team]
      6. Communicates with the sponsor, as appropriate, if there are issues with the electronic receipt and loading of the submission. [RPM or RIS]
      7. Checks BIRAMS periodically for pre-assigned numbers that are outdated and not received. [RIMS]
      8. If pre-assigned STNs are outdated, contacts the review office to verify submission status. [RIMS]
        1. If submission status is unknown, contacts the applicant to verify status. [RIMS or RPM]
        2. In consultation with the RPM, voids pre-assigned numbers for submissions where receipt is no longer anticipated or delay is substantial. [RIMS]

     

  8. Appendices
    1. N/A

     

  9. References
    1. Web links to the references below can be found in the list following the History Section
      1. Electronic Submissions Gateway
      2. Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
      3. Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Content of Labeling
      4. Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format - Investigational New Drug Applications (INDs)

     

  10. History
Written/ Revised ByApproved ByApproval DateVersion NumberComment
Heather Erdman
Carla Vincent
BPS/RMCC
C. JoneckisAug 30, 20152Updated to reflect process changes, including transferring responsibility of STN pre-assignment from the review offices to RIMS
BPWG/RMCCR. YetterSept 18, 20071First issuance of this SOPP

 

Page Last Updated: 09/04/2015
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