Manual of Standard Operating Procedures and Policies

Regulatory - Communication

Handling of Regulatory Electronic Communications

SOPP 8119

Version #1

September 16, 2008
  1. Purpose
    2.

    The purpose of this SOPP is to describe the policies and procedures for the Center for Biologics Evaluation and Research (CBER) staff on the handling of regulatory electronic messages (emails). Regulatory emails may be either internal communications or messages received from or sent to sponsors/applicants.

    Outgoing emails can be used in place of telephone communication to relay regulatory issues and requests for information.

    Internal emails may document a decision reached by a review committee or a decision regarding a regulatory submission.

  2. Definitions

    3. Regulatory Email

    A regulatory email is an electronic message received or sent by CBER as part of an investigational or marketing application or pre-application. A regulatory email may be a stand alone message or a message with an attached file.

    Secure Email

    A secure email is an electronic message received or sent from a sponsor/applicant that has exchanged secure email certificates with FDA. Secure email certificates may include the entire corporate or organization structure of a sponsor/applicant or a subset of users.

    Administrative File

    Administrative file means the file or files containing all documents pertaining to a particular administrative action, including internal working memoranda, and recommendations. (21 CFR 10.3)

    Administrative Record

    Administrative record means the documents in the administrative file of a particular administrative action on which the Commissioner relies to support the action. (21 CFR 10.3). Administrative records include sponsor/applicant submissions, CBER/FDA generated documents, and CBER/FDA database records.

  3. Background
    4.

    Increasing overall review efficiency was a significant component of the Prescription Drug User Fee Act (PDUFA) at its inception. Additional efforts to increase review efficiency, including the Medical Device User Fee Modernization Act (MDUFMA), PDFUA reauthorizations, development of electronic submission infrastructure such as the CBER Electronic Document Room (EDR) and the Agency Electronic Submission Gateway (ESG), necessitate streamlining the review process.

    This streamlining in no way mitigates our responsibility to maintain a complete and accurate administrative file ensuring that all actions are appropriately documented. The Office of Chief Counsel (OCC), Food and Drug Administration (FDA) determined that emails are legal communications acceptable as regulatory documents upon which decisions can be made and transmitted. The OCC advised that CBER should follow the guidelines in 21 CFR 601.14.

  4. Policy

    5. A secure email account is not required for email communication. CBER staff should strongly encourage the sponsor/applicant to establish an FDA secure email account. A secure email account may be established by sending a request to ITCallCenter@FDA.HHS.GOV.

    Applicants or sponsors authorized to use secure email are listed in the EDR on the main screen, using the "Secure Partners" tab on the second line drop down list, near the top of the screen.

    Once secure email is established, the emails sent from your computer to the applicant or sponsor do not require additional configuration."

    A sponsor or applicant may authorize unsecure e-mail communication by a statement to that effect in the cover letter of a regulatory submission. Including an e-mail address in the letterhead, or elsewhere in the file, does not provide authorization for FDA to communicate by e-mail. You may also receive the sponsor/applicant's authorization to use non-secure email in a telephone conversation or by fax; the authorization must be documented in the administrative file.

    For all outgoing non-secure email CBER staff will include a signature block that includes name, organization address, and phone/fax numbers. CBER staff will use the following disclaimer:

    "THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please immediately notify the sender immediately by e-mail or phone."

    All email communication must meet HHS requirement for accessibility (Section 508).

    Incoming regulatory emails and attachments

    Incoming emails will ordinarily contain responses to information requests or meeting requests related to specific existing submissions, e.g., IRA, BLA, 510(k), PMA or to pre-application submissions.

    It is CBER policy that incoming regulatory emails and attachments:

    1. Will be treated as official communication and will be entered into the administrative file and regulatory database if CBER either requests the email or the sponsor/applicant and CBER reached an agreement on the acceptance of the email as the official document.
      1. Emails received that were not requested or agreed to will not be acknowledged as part of the administrative file for the submission. Regulatory decisions/actions will not be made on the basis of these types of emails.
      2. CBER staff will consider whether or not acceptance of the email will either start or stop a review clock.
    2. Will not be accepted by CBER in lieu of submitting a formal initial/ original investigational or marketing submission.
    3. Should be sent to the following CBER personnel who will be responsible for the further processing of incoming emails:
      1. the Regulatory Project Manager (RPM) or designee in the appropriate product Application Division, or
      2. the Division of Manufacturing and Product Quality (DMPQ) in the Office of Compliance and Biologics Quality (OCBQ) or
      3. Consumer Safety Officer (CSO) in the Advertising and Promotional Labeling Branch (APLB)/Division of Case Management (DCM/OCBQ), or the
      4. Regulatory Management Staff in the Office of Cellular, Tissue, and Gene Therapies (OCTGT).
    4. The FDA/CBER receipt date will be the date acknowledged by CBER staff. In most cases this date will be consistent with the date on the email. The email must be received before 4:30 PM (16:30) EST (DST) on a regular business day. If the email is received after that time or on a non-business day, the receipt date will be the next business day.

      5. Note: Even though the official receipt date is the date CBER acknowledges receipt, the sponsor/applicant will be aware of when the email arrived based on their email records. It is imperative that processing of the email be completed as soon as possible.

    5. The emailed submission should be complete. It cannot be a partial submission with additional pages in a subsequent email.
    6. If CBER receives an email or attachment that is incomplete or cannot be read, the sponsor/applicant will be notified by phone within one business day of receipt. CBER and the sponsor/applicant will reach a decision on whether the email should be resent or should be submitted in hard copy.

    Outgoing regulatory emails and attachments or internal emails and attachments

    1. CBER staff will send outgoing regulatory emails containing confidential or product information through secure email unless the sponsor/applicant agrees to non-secure communications (see above).
    2. CBER staff will avoid creating email strings when communicating information regarding regulatory applications, regulatory reviews and decisions. This includes internal email communications and emails sent to sponsor/applicants. This is further outlined in Responsibilities and Procedures under the Outgoing and Internal email sections.

  5. Responsibilities and Procedures

    6. Incoming Regulatory Emails

    1. When a sponsor/applicant is requesting to communicate with CBER via email the RPM must instruct the firm that:
      • The email must be a complete submission.
      • The email should be sent only to the RPM in the appropriate product Application Division, DMPQ/OCBQ, or APLB/DCM/OCBQ or the Regulatory Management Staff in OCTGT to ensure records management integrity.
      • If a CBER reviewer other than the RPM agrees with a sponsor/applicant to communicate via email, that person is responsible for notifying the RPM immediately of the decision.

      NOTE: If an email is sent to a reviewer rather than an RPM, then the CBER recipient is obligated to immediately forward the email to the RPM for processing. If the CBER recipient does not notify the RPM, that person is responsible for insuring administrative processing occurs.

      The RPM (or designee) receiving the email should, within two working days of receipt,

      • Review the incoming email and attachments to determine its acceptability as outlined in Section 4 of this SOPP.
      • Review the document and obtain concurrence from the chairperson or reviewers to determine the regulatory action to be taken based on the content, e.g., resubmission, response to a clinical hold, meeting request, response to Complete Response Letter, requested information or revisions.
      • Enter the email in the appropriate database and identify the submission as an email.
      • Provide CBER's Document Control Center (DCC) with a full electronic version of the email per DCC Procedure Guide #26.

    2. Follow-up hard copies:
      • Hard copies of documents emailed to CBER are not necessary and are to be discouraged.
      • If a firm decides to send in a hard copy once an email is received, the subsequent hard copy will be treated as a new submission, e.g., new amendment.

    Outgoing Regulatory Emails

    When an email is sent to a sponsor/applicant:

    • The author is responsible for entering the data into the appropriate database and loading a copy into CBER's EDR.
      • The outgoing email should be entered in the appropriate regulatory database. The outgoing email will be entered under the document type rather than “email,” for example, letter, memo, meeting minutes, etc.
      • Procedures for entering emails can be found in the User Guide/Data Dictionary for the appropriate regulatory database.
    • The RPM is ultimately responsible for ensuring all communication is captured in the database and resides with the administrative file located in CBER's EDR.
    • If the email's author is not the RPM, the RPM will be included as a convenience copy (cc:) on the email.
    • The email will not be followed up with a hard copy.
    • The email will be included in the administrative file as a CBER communication.
    • The date of the outgoing email and the date the action was taken should be the same. If there is a difference, the date the action was taken is the date to be entered in the appropriate regulatory database.
    • CBER staff will not use the “Reply” or “Reply to All” functions when responding to a sponsor/applicant's email communication but will create a new email. This new email will clearly cite or summarize the firm's email and will be addressed to the appropriate sponsor/applicant contact. The email may have other FDA staff listed on the cc: address line.
    • The email's subject line will clearly define the topic addressed in the communication.

    Internal Emails Related to Regulatory Actions

    Emails between FDA staff that capture regulatory actions or decisions are records and must be captured in the corresponding administrative file.

    • The author of the email will be responsible for insuring the record copy is captured in the correct regulatory database and loaded into CBER's EDR.
    • The content of the email should be limited to one specific product for a Marketing submission and one specific sponsor for IRA submissions.
    • All emails should be viewed as business correspondence and must maintain professional language and tone.
    • In order to control email strings CBER staff will judiciously use the “Reply” or “Reply to All” functions when responding to internal emails
    • If an email string is started, it must be broken if the string moves away from the original topic. Emails should never discuss more than one submission with the exception of a Trans-BLA.
    • When filing an email string the date of the document must be the date of the last email. The author must ensure all relevant responses found in the email string are included prior to filing.
    • Each reply (not part of a string) to an email must be entered into the regulatory database and loaded into CBER's EDR as a new record so that the email response stands independent of the originating email.
      • The email's subject line will clearly define the topic addressed in the communication.

  6. References

    7. 21 CFR 601.14

    508 accessibility requirements web page: http://www.hhs.gov/web/policies/webstandards/accessemail.html

    DCC Procedure Guide #26: Process for Handling Regulatory Electronic Communications

  7. Effective Date

    8. September 16, 2008

  8. History
    9.

    Written/Revised Approved Approval Date Version Number Comment
    Thomas R. A. Yetter, PhD September 12, 2008 1 First issuance of this SOPP

 
Updated: September 16, 2008