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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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SOPP 8107: Official Correspondence with Applicants of Marketing Submissions: Addresses

Version #1

Effective Date: April 16, 2001

  1. Purpose
  1. This document provides the procedure for Center for Biologics Evaluation and Research (CBER) staff to identify the appropriate company representative that should receive correspondence related to marketing submissions.
  1. Definitions
  1. Authorized Official

    The applicant, or other person authorized to sign an application on behalf of the applicant, such as the applicant's attorney or agent.

    Marketing Submissions

    Marketing submissions include all original and supplemental applications/notifications that CBER receives from applicants intending to market products regulated by CBER. Marketing submissions include Biologic License Applications (BLA) and supplements (BLS), Premarket Notifications [510(k)] and Add-To-Files, Premarket Approval Applications (PMA) and supplements (PMS), Product Development Protocols (PDP), New Drug Applications (NDA) and supplements (NDS) and Abbreviated New Drug Applications (ANDA) and supplements (ANDS).

  2. Background
  3. Prior to October 15, 1997, all correspondence between the CBER and manufacturers regarding license applications and supplements was sent to the Responsible Head or Alternate Responsible Head (21 CFR 600.10(a)). The Responsible Head was designated as the person that ".shall exercise control of the establishment in all matters relating to the compliance with the provisions of this subchapter, with authority to represent the manufacturer in all pertinent matters with CBER." Changes to the Responsible Head or Alternate Responsible Head were handled as supplements. For other types of marketing submissions, correspondence was sent to the individual who submitted the application/supplement/notification.

    The Federal Register of October 15, 1997 (FR53537), amended the regulations by deleting the requirement for a single person to be named as the "responsible head" or "designated qualified person." This was necessary, as the complexity of many manufacturing arrangements and multiple manufacturing locations made it impractical and inflexible to expect a single individual to possess expertise in all matters. Effective October 15, 1997, an applicant was permitted to designate more than one person ".with primary responsibility to maintain adequate oversight of multiple manufacturing sites and ensure each is conforming to FDA's requirements for current good manufacturing practices and applicable biologics standards." CBER uses the term "Authorized Official" to identify the company representatives. The Authorized Officials may be company employees, attorneys, or other 3rd party representatives (agent) designated by the company to represent it. Authorized Officials are not subject to review; that is, the addition of a new Authorized Official is not handled as a supplement.

    Companies can designate their Authorized Officials by using several mechanisms. They may choose to provide a list or periodic update of the designated Authorized Officials and their area of responsibility. Also, the person who signs an FDA submission form (e.g., Form 356h) is presumed to have signatory authority for the company, and therefore should be considered an Authorized Official of the company when submitting a BLA or BLS.

    With the designation of several Authorized Officials, it is sometimes difficult to determine the appropriate person to receive correspondence. There have been instances where FDA is unaware of the change in employment for the Authorized Official, and the sponsor's mailroom has returned FDA official correspondence unopened, indicating that the addressee no longer is employed at the firm. To avoid delays and confusion, this SOP will provide a mechanism to determine the Authorized Official to receive correspondence for a particular marketing submission.

  1. Policy
  1. All CBER correspondence associated with marketing submissions will be addressed to the individual who submits the most recent marketing submission under the assigned tracking/reference number, with the exception of amendments. Accordingly, the signatory of the parent original application or supplement should sign all amendments submitted to CBER. FDA correspondence will be addressed to the Authorized Official who signed either the original application or a supplement. If an Authorized Official has not previously submitted an original application or supplement to CBER, this person will be added to the list of Authorized Individuals for the company.
  1. Procedures
  1. When preparing official correspondence to an applicant that relates to a marketing submission, the Application Division will address the letter to the Authorized Official who signed either the original submission or the most recent supplement that CBER is responding to. Accordingly, final actions, e.g., approvals, will be addressed to the signatory of the original application or the supplement.

    Official correspondence should not be addressed to an Authorized Official other than the signatory of the original application or supplement unless CBER has received notification in writing from the applicant identifying a new Authorized Official.

    The Application Division will enter the correspondence action in the associated CBER tracking system. If the addressee is not listed in the tracking system associated with the submission, the Application Division will update that addressee information in the tracking system.

    When appropriate, copies can be sent to other designated individuals such as U.S. Agents. Copies do not have to be sent to all company designated Authorized Officials.

  1. Effective Date
  1. April 16, 2001
  1. History
  1. Written/Revised Approved Approval Date Version Number Comment
    Gilliam B. Conley
    Len Wilson
    Robert Yetter, PhD,
    Assoc. Dir. for Review Management
    April 16, 2001 1 First Issuance of this SOPP