This letter is seeking your input into a public forum addressing how the Center for Drug Evaluation and Research (CDER) of the U. S. Food and Drug Administration (FDA) can best fulfill its mission – protecting and promoting the public health by assuring that safe and effective drugs are available to the American people.

CDER will be holding a public meeting to address Section 406(b) of the FDA Modernization Act (FDAMA). The topic to be discussed is how FDA can best meet its non user-fee statutory obligations under the Federal Food, Drug and Cosmetic Act. The meeting will be held on Monday, August 17, 1998, from 9:00 a.m. to 5:00 p.m. at the Department of Health and Human Services, Hubert H. Humphrey Building, Penthouse Conference Room (Room 800), 200 Independence Ave., SW., Washington, DC 20201.

Other Centers within the FDA will also be holding public meetings at about the same time. The dates for all meetings will be listed in the Federal Register Notice of July 24, 1998. The agency will have a public meeting on September 14, 1998 to obtain stakeholder views on potential recurring themes and the best approach for consolidating these themes agency-wide. Further information about all meetings, and about how to submit written responses to the docket, in addition to the Federal Register Notice of July 24, 1998, can be obtained on the FDA website <http://www.fda.gov>.

The Federal Register Notice contains six objectives for the FDA modernization plan, and provides questions related to these objectives. In addition to these six objectives, CDER would also like to consider the six CDER-specific areas listed on the following page.

If you would like to make a presentation at the CDER public meeting, 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 Susan Carey at the address below. The deadline for receiving requests to speak is Friday, July 31, 1998. Each person who submits a request will receive a response by August 5 stating whether they have been included in the program.

Thank you for your interest in the Center for Drug Evaluation and Research.

Sincerely,

/s/

Janet Woodcock, M.D.
Director, CDER

CDER contact for public meeting on August 17, 1998:
Susan Carey
e-mail: CAREYS @cder.fda.gov
phone: (301) 827-1496
fax: (301) 827-0509
address: HFD-011, FDA, 5600 Fishers Lane, Rockville, MD 20857

Attachment: CDER Specific Questions