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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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SOPP 8416: CBER Initiated Second Level STNs

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Version #2 

Effective Date: February 27, 2012


  1. Purpose
     
    1. The purpose of this document is to describe the policies and procedures for Center for Biologics Evaluation and Research (CBER) staff to follow when initiating and tracking second level Submission Tracking Numbers (STNs) for Biologics License Applications (BLAs) for CBER correspondence not in response to a pending applicant submission.

       
  2. Scope
     
    1. This procedure applies to Biologics License products tracked in RMS-BLA.
       
    2. This SOPP does not cover the pre-assigned STNs under SOPP 8117: Issuing Submission Numbers in Advance of the Receipt of the Electronic Submission.

       
  3. Background
     
    1. When CBER regulatory tracking databases were developed, the assumption was that an STN would only be generated based on an incoming submission from an applicant.
       
    2. Because of the changes in the statute under the Food and Drug Administration Amendments Act (FDAAA) of 2007 and the resulting business procedures, the need has arisen for documenting and tracking outgoing CBER initiated correspondence not directly related to an incoming submission. Generally, we will be expecting that CBER initiated correspondence will be in response to an applicant submission. However, there will be occasions as outlined below when CBER will need to contact an applicant for an issue not specifically related to a pending submission or to document CBER’s postmarketing safety evaluations. In these cases, this SOPP will be followed.
       
    3. For all correspondence related to an applicant submission, CBER staff will follow the appropriate SOPPs, for example, SOPP 8405: Complete Review and Issuance of Action Letters.
       
  4. Definitions
     
    1. CBER staff should refer to the Regulatory Management System- Biologics License Application (RMS-BLA) Data Dictionary for an explanation of terms used in this SOPP.

       
  5. Policy
     
    1. The following CBER initiated document types will be entered in RMS-BLA as a pre-assigned STN:
       
      1. Post Marketing Requirement/Commitment (PMR/PMC) requests for overdue information.
         
      2. Safety Labeling change request based on new safety information.
         
      3. Request for Risk Evaluation and Mitigation Strategies (REMS) based on new safety information.
         
      4. Request for Post Marketing Requirement (PMR) follow up for study/clinical trial based on new safety information.
         
      5. Office of Pediatrics Therapeutics/Pediatric Advisory Committee (OPT/PAC) Review
         
      6. Biological Product Shortages
         
    2. The following CBER initiated document types will be entered in RMS-BLA as a stand alone second level STN:
       
      1. Filing foreign post approval inspection reports (refer to DCC Procedure Guide #14)
         
      2. Section 915 Postmarketing Drug Safety Information for Patients and Providers; reviews that are prepared after use of the drug by 10,000 patients
         
      3. Section 915 Postmarketing Drug Safety Information for Patients and Providers: 18 month reviews that are prepared and use in 10,000 patients has not been reached or any pertinent elective review conducted on efficacy supplement approvals
         
      4. Section 921 Potential Safety Issue Reports/Reviews; does not apply to Vaccines
         
    3. If an Office needs to send another letter type to an applicant, or needs to include a CBER initiated document as part of the administrative file, the Office may contact the Associate Director for Review Management (ADRM) to see if the communication would qualify as a one -time exception to this SOPP.
       
    4. All second level STNs must have a Final Action Memo, letter or closure entry in RMS-BLA and must be filed in CBER’s Document Control Center (DCC). (Refer to DCC Procedure Guide #23.)
       
  6. Responsibilities
     
    1. Regulatory Project Manager (RPM):
       
      1. Initiates the creation of the second level STN
         
      2. Oversees the assignment and receipt of any subsequent submission
         
      3. Forwards the Final Action Package to DCC
         
  7. Procedures

    The procedures for review and processing of safety labeling change requests based on new safety information, requests for REMS, and requests for PMR follow up for clinical study/trial based on new safety information can be found on CBER’s Intranet Review web page (see References)
    Please refer to regulatory job aid JA 860.05: Creation of FDAAA Section 915 Safety Reviews for BLA Documents posted on CBER’s Intranet Web page for additional information.

    1. Pre-assign a second level STN in the RMS-BLA regulatory database for the documentation of the subject matter or for the expected applicant response, and if applicable, reference the pre-assigned STN in the initial outgoing document from CBER, i.e., don’t assign a second level STN to the CBER document. [RPM]
       
      1. Generate the STN using the Enter New Submission screen by selecting the “Does not have DATS Login ID” radio button.
         
      2. All date fields should reflect the date the STN was assigned
         
      3. Select one of the following “Submission Origin” codes as appropriate:
         
        1. 915 Review
           
        2. 18 Month Review
           
        3. 921 Review
           
        4. OPT/PAC Review
           
        5. Miscellaneous (use for Foreign Inspections)
           
        6. Pre-Assigned STN (use for all others)
           
      4. For a postmarketing requirement or commitment, enter the information in the RMS-BLA PMR/PMC screen; send letter to CBER RIMS
         
    2. Notify the applicant of the STN in the outgoing letter and request the STN be used in their response, if applicable. [RPM]

    3. Remind the applicant to place the BLS STN on the cover page of the submission and on the Form FDA 356(h). All applicant responses will be processed according to current procedures. [RPM]

      NOTE:
      if the applicant fails to include the BLS STN on the cover sheet, the RPM is responsible for making the association to the CBER communication and the applicant submission in RMS-BLA.
       
    4. Use the most recent approved letter template posted on CBER’s Intranet Review Template Letters Web page, as applicable. [RPM]

    5. Enter the CBER document as a communication to the pre-assigned STN. [RPM]

    6. Monitor outstanding pre-application submission numbers to determine which CBER initiated second level STNs referred to in this SOPP have not received applicant submissions. [RPM]

    7. Initiate follow up with the applicant as appropriate, depending on the CBER initiated correspondence type. [RPM]

    8. Forward completed Final Action Package (FAP) or eFAP to DCC [RPM]

  8. Appendix

    N/A

     
  9. References
     
    1. References below are located on CBER’s Intranet Web Page (unless otherwise noted)
       
      1. Interim Procedure: Title IX, Section 901: New FDAAA Required Post-Marketing Safety Labeling Changes, Risk Evaluation and Mitigation Strategies (REMS) and Post-market Studies/Clinical Trials (PMR)
         
      2. DCC Procedure Guide #14: Procedure for Filing Foreign Post Approval Inspection Reports for Marketing Applications
         
      3. DCC Procedure Guide #23: Procedure for Filing Final Action Packages containing electronic FDA communication for Marketing Applications
         
      4. RMS-BLA Data Dictionary (located in RMS-BLA)
         
      5. JA 860.05: Creation of FDAAA Section 915 Safety Reviews for BLA Documents
         
    2. Web links to the references below can be found in the list following the History Table
       
      1. Food and Drug Administration Amendments Act (FDAAA) of 2007
         
      2. SOPP 8405: Complete Review and Issuance of Action Letters
         
      3. SOPP 8117: Issuing Submission Numbers in Advance of the Receipt of the Electronic Submission
         
  10. History
  11.  
Written/RevisedApprovedApproval DateVersion NumberComment
DixonR. A. Yetter, PhDFebruary 10, 20122Include additional Submission Origin Types; update to new format
DixonR. A. Yetter, PhDSeptember 12, 20081First issuance of this SOPP