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 In this section:

        For Industry

Small Business Assistance

                        
                Letter: Proper Consideration of Small Entities in Agency Rulemaking Home
          For Industry
          Small Business AssistanceFor Industry Small Business Assistance
  	
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    PrintThe Food and Drug Administration (FDA) recognizes that dealing with a large organization can frequently be a time consuming, frustrating experience. Although there is no acceptable panacea, FDA has instituted a number of activities aimed at easing this problem for regulated small businesses.

These include the establishment of the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health, CDER Small Business and Industry Assistance (SBIA), Assistance Programs in the five FDA regional offices, and the creation of small business assistance offices in each of the Centers.

These units provide technical assistance to small companies, hold exchange meetings to hear the views and perspectives of small businesses, conduct educational workshops, develop informational materials, and provide an accessible, efficient channel through which small businesses can acquire information from the FDA.

**Are you a small business with questions about your FDA-regulated product?
Or, do you wonder if your product needs to be approved by the FDA?
Contact us!**

U.S. Food and Drug Administration (FDA) Headquarters
	**Center for Biologics Evaluation and Research (CBER)**
	Office of Communication, Outreach and Development (OCOD)
	Division of Manufacturers Assistance and Training (DMAT)
	Manufacturers Assistance and Technical Training Branch(MATT)
	Food and Drug Administration
	10903 New Hampshire Avenue
	Building 71, Room 3103
	Silver Spring, MD 20993-0002
	Phone: 800-835-4709 or 240-402-7800
	Email: Industry.Biologics@fda.gov

	**Center for Drug Evaluation and Research (CDER)**
	Office of Communications
	Division of Drug Information (DDI)
	Brenda Stodart, PharmD
	CDER Small Business and Industry Assistance (CDER SBIA)
	10903 New Hampshire Avenue
	WO-51- 2201
	Silver Spring, MD 20990-0002
	Phone:
	Toll-free and International: 866-405-5367
	Local: 301-796-6707
	Fax: 301-847-8715
	Email: CDERSBIA@fda.hhs.gov

	**Center for Devices and Radiological Health (CDRH)**
	Office of Communication and Education (OCE)
	Division of Industry and Consumer Education (DICE)
	10903 New Hampshire Ave.
	Silver Spring, MD 20993
	Phone: 301-796-7100 or 800-638-2041
	Email: DICE@fda.hhs.govDICE Homepage

	Center for Food Safety and Applied Nutrition (CFSAN)
	Division of Education, Outreach & Information
	Information Center Branch
	Food and Cosmetic Information Center, HFS-009
	Food and Drug Administration
	5001 Campus Drive
	College Park, MD 20740
	1-888-SAFEFOOD1-888-723-3366
	10 AM - 4 PM ET
	Closed Thursdays 12:30 PM – 1:30 PM ET
	Inquiries: Submit Your Question

	**Center for Tobacco Products (CTP)**
	Document Control Center
	Building 71, Room G335
	10903 New Hampshire Avenue
	Silver Spring, MD 20993-0002
	Phone: 1-877-CTP-1373 (1-877-287-1373)
	Monday–Friday, 7:30 a.m.–6:00 p.m. EDT
	E-mail: SmallBiz.Tobacco@fda.hhs.govTobacco Small Business Assistance Website

	**Center for Veterinary Medicine (CVM)**
	7500 Standish Place
	Rockville, MD 20855
	Phone: 240-402-7002
	Email: AskCVM@fda.hhs.govCVM Small Business Assistance

	**Office of International Programs (OIP)**
	White Oak Building 32
	10903 New Hampshire Avenue
	Silver Spring, MD 20993
	Phone: 301-796-4600
	E-mail: OIPCommunications@fda.hhs.govInternational Programs Website
	FDA Office of Regulatory Affairs (ORA)
	**ORA Small Business Representative****David Arvelo**
	FDA - Dallas District Office
	1201 Main Street, Suite 7200
	Dallas, Texas 75202
	Phone: 214-253-4979

	**FDA Public Affairs Specialists and ORA District Offices**
	Contacts for ORA and District Offices can be found in the following resources:

	ORA Directory
		FDA Public Affairs Specialists
		ORA District OfficesPlease contact the nearest ORA district office listed in the ORA Directory or contact FDA Headquarters at 1-888-INFO-FDA (1-888-463-6332). Access more information about FDA.

                                                                                  Content current as of:
      09/28/2020
                  
                   
Regulated Product(s)
		 DrugsSmall Business Assistance                
                          

                        Letter: Proper Consideration of Small Entities in Agency Rulemaking
 
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