Vaccines, Blood & Biologics

CBER Dear Colleague Letter - FDAMA Section 406(b): Communicating with Our Stakeholders

March 23, 1999

Dear Colleague:

The Center for Biologics Evaluation and Research (CBER) and the Office of Regulatory Affairs (ORA) are cohosting two open public meetings to solicit views and comments on how the Food and Drug Administration (FDA) can best meet its statutory obligations under the Food, Drug and Cosmetic Act as amended by the FDA Modernization Act (FDAMA) of 1997. These two public meetings have identical content and are scheduled as follows:

Date and Time:
April 28, 1999, 9:30am to 3:30pm (Eastern time)

Boston University
School of Medicine
715 Albany Street
Boston, MA 02118

Date and Time:
April 28, 1999, 9:30am to 3:00pm (Pacific time)

South San Francisco Conference Center
255 South Airport Boulevard
South San Francisco, CA 94080

Section 406(b) of the FDAMA requires the Agency to consult with its external stakeholders, specifically "appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry." These meetings will include: (1) a live satellite teleconference with Jane E. Henney, M.D., Commissioner of Food and Drugs, and Linda A. Suydam, D.P.A., Associate Commissioner for Strategic Management, entitled, "Talking with Stakeholders about FDA Modernization" to discuss FDA's progress in implementing FDAMA and to seek additional input on specific FDAMA performance targets; and (2) a CBER-specific meeting at which stakeholders can present their views to senior Center management regarding CBER's performance under the Act. I will cohost the CBER-specific portion of the event in South San Francisco with Patricia Ziobro, District Director, San Francisco District Office, and Mark Elengold, Deputy Director (Operations), CBER, will cohost the meeting in Boston with John Marzilli, District Director, New England District Office.

FDA met with its stakeholders through a series of meetings in August and September 1998 to solicit public input on how the Agency can meet its statutory obligations. On November 21, 1998, the Agency published The FDA Plan for Statutory Compliance (see FDA's web site,, which provides the framework and specific performance goals for fiscal year 1999.

The Agency is now entering the second cycle of its formal dialogue with stakeholders on April 28, 1999. Two underlying themes are the focus of this dialogue: (1) strengthening FDA's science base and setting risk-based priorities, and (2) improving communication processes with the public. To help focus discussion, FDA is requesting that stakeholders address the five questions listed below in their oral/written responses as to how the Agency can best strengthen its science base and improve communication with stakeholders:

  1. What actions do you propose the Agency take to expand FDA's capability to incorporate state-of-the-art science into its risk-based decision making?
  2. What actions do you propose to facilitate the exchange and integration of scientific information to better enable FDA to meet its public health responsibilities throughout a product's life cycle?
  3. What actions do you propose for educating the public about the concept of balancing risks against benefits in public health decision making?
  4. What actions do you propose to enable FDA and its product centers to focus resources on areas of greatest risk to the public health?
  5. What actions do you propose for enhancing communication processes that allow for ongoing feedback and/or evaluation of our modernization efforts?

The Agency has established a docket to receive any ideas you may wish to propose. Comments may be submitted in writing to Docket No. 99N-0386 until April 14, 1999, at the following address: Dockets Management Branch, Food and Drug Administration, Room 1061, HFA-305, 5600 Fishers Lane, Rockville, MD 20857.

This public meeting is free of charge; however, due to space limitations, early registration is recommended. If you wish to attend the meeting, please submit your name, affiliation and which location you would like to attend via facsimile or e-mail to: Lorrie Harrison, phone 301-827-5546, FAX 301-827-3843, e-mail Additional information may be found at the Agency's website at If you would like to make a presentation, please send your name, title, affiliation, street address, e-mail address and telephone and fax numbers, along with a short description of the topic you wish to address, to Ms. Harrison. The deadline for receiving requests to speak is Friday, April 9, 1999. Each person who submits a request will receive a response by April 16, 1999, stating whether they have been included in the program.

I look forward to hearing your views and suggestions on how we can continue to implement FDAMA. We are committed to carrying out these consultations in a spirit of candor and cooperation. If you have any questions, please contact Dennis Strickland at 301-827-2000.


-- Signature --

Kathryn C. Zoon, Ph.D.
Center for Biologics Evaluation
      and Research


Federal Register Notice
Live Satellite Conference Flyer
Message to Stakeholders

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

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