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We welcome your comments. For your convenience, we have set up an email account so we can answer your questions about this software. Please email your questions or comments to the eSubmitter support team at: esubmitter@fda.hhs.gov.

Send questions about FDA regulations to the specific program office listed below. Please be sure to include your name, company name and contact information in the email.

• CDRH - OIVD and Radiological Health regulatory questions: Contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at dsmica@cdrh.fda.gov or at 1-800-638-2041.
• CDRH - eMDR regulatory questions: eMDR@fda.hhs.gov
• CBER - OBRR regulatory questions: Send all comments and questions that apply to a submission for CBER’s eSubmitter Pilot Evaluation Program to CBER_eSubmitter_program@fda.hhs.gov.
• CTP - For questions regarding the Guidances or the Tobacco Control Act, contact CTP904&905Questions@fda.hhs.gov. For Tobacco Industry technical support you may email the address below or call 1-877-FDA-1CTP.

eSubmitter Technical Support e-mail address: esubmitter@fda.hhs.gov

Web address: www.fda.gov/ForIndustry/FDAeSubmitter

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