Vaccines, Blood & Biologics

SOPP 8101.2: Scheduling and Documentation of Liaison Meetings With Industry Trade Organizations

Version #3
Effective Date: March 30, 2015

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  1. Purpose
    This guidance describes the process the Center for Biologics Evaluation and Research (CBER) Staff should follow to schedule and document liaison meetings with industry trade associations.


  2. Scope
    This SOPP applies to periodic meetings requested by industry trade organizations to discuss topics of mutual interest with CBER.


  3. Background
    1. Over the years, a number of organizations have requested that recurring meetings be held with CBER, and this trend is expected to continue. Whenever possible, CBER has made a policy of meeting with outside organizations to provide an opportunity for stakeholder input as well as to provide information on CBER's operations. This SOPP provides a uniform method for handling liaison meetings across CBER, to decrease confusion and avoid duplication of effort.
    2. Overall, the Federal government has made numerous efforts to assure that opportunities are provided for an appropriate level of meaningful public participation to enhance an open decision making process. These efforts are exemplified by the Federal Advisory Committee Act (FACA), which governs the use of covered advisory committees within the Executive Branch, and provides mechanisms which assure public access to advisory committee meetings and documents. In addition, FDA has implemented a number of initiatives to provide an opportunity for public input such as:
      • Publication of FDA's Good Guidance Practices document which sets forth FDA's general policies and procedures for developing, issuing and using guidance documents to help ensure that Agency guidance documents are developed with adequate public participation;
      • Availability of guidance documents to the public, and
      • Ensuring an understanding that guidance documents are not applied as binding requirements.
    3. In calendar year 2012, CBER Office of Communication, Outreach, and Development (OCOD) collected information while participating in the FDA-Track Measures program by evaluating formal Liaison Meetings held with CBER, including a measure of resources involved in holding the meetings. In July 2014, the CBER Center Director notified requestors of liaison meetings of the decision to limit CBER participation to one formal liaison meeting annually. CBER is willing to consider the option to hold one executive level meeting with Center and Office management annually in addition to the formal liaison meeting.


  4. Definitions
    1. Formal Liaison Meeting: a meeting between CBER and an organization representing a segment of regulated industry (the AABB and the American Association of Tissue Banks, etc.), which provides an opportunity to discuss topics of mutual interest to CBER and the organization. Formal liaison meetings occur at the request of the organization, on a periodic basis, rather than occurring on an ad hoc basis in response to a specific situation.
    2. Executive Liaison Meeting: an ad hoc, narrowly focused liaison meeting between CBER Center and Office management and corresponding executives from an organization representing a group of interested parties, to hold a high level discussion of a topic or narrow list of topics of mutual interest.
    3. Lead Office: The Office with primary responsibility for the topic of the liaison meeting is the Lead Office. For example, the Office of Blood Research and Review (OBRR) would be the lead office for a liaison meeting with AABB.


  5. Policy
    It is the policy of the Center that periodic meetings between CBER staff and outside organizations may be set up to discuss important issues of mutual interest. The purpose of liaison meetings will be an exchange of information to allow outside organizations to inform CBER of specific concerns, to discuss events which have occurred for products of interest, and to obtain information on how the Center operates.


  6. Responsibilities
    1. CBER Staff:
      Directs any inquiry received from an outside organization concerning the possibility of a liaison meeting to the Division of Manufacturers Assistance and Training (DMAT)/Manufacturers Assistance and Technical Training Branch (MATTB), WO-71, Rm 3103, 240-402-8020.
    2. DMAT/MATTB:
      Serves as the CBER contact point and processes all requests for formal and executive liaison meetings.
    3. Lead Office(s):
      1. Submits liaison meeting agenda questions and/or topics to DMAT/MATTB by the requested deadline.
      2. Brings potential topics, which arise prior to the meeting but after circulation of an agenda, to the attention of DMAT/MATTB as soon as possible.
      3. Assists DMAT/MATTB as necessary in the drafting and finalizing of meeting summary.
      4. Circulates attendance sign-in sheets to be signed by all attendees during the meeting.
    4. Liaison Meeting Presenter:
      1. Prepares presentations as assigned by supervisors.
      2. Provides a sufficient number of handouts for the meeting attendees, if prepared.


  7. Procedures
    1. DMAT/MATTB:
      1. Informs the outside organization of their responsibilities for the liaison meeting:
        1. Submit formal request for a liaison meeting to DMAT/MATTB.
        2. Schedule adequate facilities for the meeting.
        3. Submit agenda questions and/or topics to DMAT/MATTB no later than four weeks prior to the meeting. Failure to provide an agenda may be grounds for cancellation or postponement of the meeting.
        4. Bring potential topics, which arise prior to the meeting but after circulation of an agenda, to the attention of DMAT/MATTB as soon as possible.
      2. Informs the outside organization of the format for liaison meetings:
        1. Limits formal liaison meetings to not more than three hours, with exceptions to be approved at the discretion of the Center Director or Deputy Center Director(s).
        2. Sets up agenda items as a presentation of issues, an opportunity for response (when appropriate), and time for discussion of the issue(s).
        3. Responsibilities for meeting action items, if any, are assigned at the time of the meeting.
        4. Formal Liaison meetings are held on an annual basis.
        5. Dates for formal liaison meetings will be mutually agreeable, and may be scheduled to coordinate with other important meetings when appropriate.
      3. Informs the outside organization that they may obtain a copy of the liaison meeting summary by submitting a Freedom of Information (FOI) request to Freedom of Information Staff, HFI-35, Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20852.
      4. Seeks, receives and collates proposed agenda items from within CBER, within other sections of FDA and from the outside organization.
      5. Distributes a proposed agenda incorporating the suggested topics and questions for concurrence to appropriate FDA staff and the outside organization prior to the meeting.
      6. Requests attendance by representatives from CBER's Immediate Office of the Center Director (IOD), other CBER Offices, and other sections of FDA as needed based on the topics to be discussed.
      7. Prepares a meeting summary with the assistance of representatives of the Lead Office, if necessary:
        1. Summary consists of a brief summary of topics and action items.
        2. Summary should be drafted within 10 working days of the meeting.
        3. Submits draft summary to designated CBER attendees for review/comment.
      8. Maintains a copy for the record of liaison meeting summary and any FDA presentations.
      9. Informs the outside organization of the format for one optional executive meeting annually:
        1. Limits executive meetings to not more than 1.5 hours
        2. Receives and distributes agenda topic(s) to CBER IOD and Lead Office management officials for consideration of executive level meeting.
        3. Coordinates meeting location on the White Oak Campus for limited number from IOD and CBER Lead Offices and Industry (maximum attendees, 4-6 FDA including 1 OCOD representative, and 4-6 industry, in total. No more than 2 per office at office level of Director/Deputy Director).


  8. Appendix


  9. References


  10. History
Written/ Revised Approved By Approval Date Version Number Comment
Faye Vigue Chris Joneckis, PhD March 26, 2015 3 Incorporates changes to responsibilities in OCOD (formerly OCTMA); incorporates Executive meeting options.
Seamus O'Boyle Robert Yetter, PhD November 17, 2000 2 Incorporates changes in the structure of, and responsibilities in, OCTMA.
Karen Groover
Lorrie Harrison
Rebecca Devine January 20, 1999 1 First issuance of this SOPP.


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