The comment period for this has expired. You can still access background information on the 1997 FDA Modernization Act and view comments. Updated 03/05/00
April 28th FDA Meeting
The FDA is requesting input into meeting the mandates of The 1997 FDA
Modernization Act. This is an opportunity to address some of the underlying problems such
as communication and utilizing resources efficiently. Since FDA impacts a wide range of
concerns, it is important that this opportunity for input be taken advantage of. The FDA
is not requesting information on specific issues such as food, drug, or cosmetic safety,
but rather input on communication, how to utilize existing resources, and put into place
means of accomplishing the more specific
goals.
The 1997 FDA Modernization Act mandates the FDA (information from the Federal Register
available at:
http://www.fda.gov/ohrms/dockets/98fr/032299e.txt
)
"To consult with its external stakeholders as it moves forward to modernize the
agency; to develop a plan, based on input from stakeholders, for complying with the
agency's obligations under the Federal Food, Drug, and Cosmetic Act (the act); and to
periodically revisit the plan in consultation with stakeholders to make appropriate
adjustments. As a culmination of these requirements, FDA will issue a performance report
to Congress at the end of the 1999 calendar year."
The agency's response to this mandate is:
A. Consult With External Stakeholders (STAKEHOLDERS ARE CONSMERS, INDUSTRY, MEDICAL
PROFESSIONALS, ETC. In other words anyone that has an interest in the outcome)
B. Develop a Plan That Reflects Stakeholders Views
C. Periodically Revisit the Plan in Consultation with Stakeholders
The FDA is now working on this. The FDA specifically wants input on how to: (1) Strengthen
its science base and (2) improve its communication processes. FDA requests that
stakeholders address the five questions below in their oral and/or written views:
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 lifecycle?
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 additional actions do you propose for enhancing communication processes that allow
for ongoing feedback and/or evaluation of our modernization efforts?
Comments need to be submitted by May 14, 1999. They can be submitted via mail, e-mail, or
online website. Be sure to include Docket Number: 99N-0386
Mailing Address: Submit written comments to:
Dockets Management Branch(HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852,
E-mail: FDADockets@bangate.fda.gov
Online Web site: http://www.fda.gov/scripts/oc/fdama/comments.cfm
Comments that have been submitted can be viewed online:
http://www.fda.gov/ohrms/dockets/dockets/99n0386/99n0386.htm
The FDA held a Web and teleconferenced meeting, as well as
regional meetings on the 28th of April. Transcripts, videos, and
Webcast of the teleconferenced meeting are available.
http://www.fda.gov/oc/fdama/fdamawebcast/default.htm
Transcripts of the regional meetings are also available.
"Transcripts of the meetings (from each site listed in section III f this document)
may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 FishersLane, rm. 12A-16, Rockville MD 20857, approximately 15 working
daysafter the meeting at a cost of 10 cents per page. The transcript of the meeting will
be available for public examination at the Dockets Management Branch (address above)
between 9 a.m.
and 4 p.m., Mondaythrough Friday, as well as on the FDA web site http://www.fda.gov
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Site last updated: 03/05/00