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Small Business Guide to FDA
(last revised on 03/31/04)

WHO TO CONTACT FOR ASSISTANCE

Knowing whom to contact is the first step in obtaining information you need. It may be helpful to keep in mind that FDA has five Centers, five Regions, and 21 District Offices within those regions. Reaching the right office and, more importantly, the right person who has the information you need, can sometimes be frustrating. This list of contacts should help guide you in the right direction.

Whether you need information related to getting your product approved and on the market, wanting an FDA speaker for your industry meeting, or just need copies of FDA regulations, there are a number of sources to which you can go for general assistance:

Small Business Representatives (SBRs) - FDA has Small Business Representatives who help small businesses whose products are regulated by FDA. They are located in five regions of the country: New York, Philadelphia, Atlanta, Dallas, and Oakland.

OTHER LINKS WITH INFORMATION OR ASSISTANCE FOR INDUSTRY:

DRUGS - [CDER] - http://www.fda.gov/cder/about/smallbiz/default.htm
FOODS, DIETARY SUPPLEMENTS, COSMETICS - [CFSAN] - http://www.cfsan.fda.gov/~dms/industry.html
DEVICES - [DSMICA in CDRH] - http://www.fda.gov/cdrh/industry-asst.html or
"DEVICE ADVICE" - http://www.fda.gov/cdrh/devadvice
BIOLOGICS - [CBER] - http://www.fda.gov/cber/manufacturer.htm
ANIMAL PRODUCTS - [CVM] - http://www.fda.gov/cvm/faqs//faqs.html

These sites are available to deal with the special concerns and/or provide helpful information to small firms and new businesses. They provide information that clarifies how Agency laws and regulations apply to various products or specific circumstances and suggest methods of meeting these requirements. The SBRs can respond to your inquiries, conduct or participate in workshops and conferences, or visit your plant, at your request, to offer assistance.
All FDA speaker requests must be submitted through:

Food and Drug Administration
Office of Public Affairs
Program and Speaker Coordination Staff
5600 Fishers Lane, Room 15A-08
Rockville, MD 20857
FAX 301-827-2823