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The Center for Veterinary Medicine (CVM) has developed and implemented methods to accept electronic files as legal, original submissions for review. This electronic submission process was made possible by the publication of FDA's Final Rule on Electronic Records and Electronic Signatures (21 CFR 11) in March 1997, which set the standards for Electronic Records for FDA and its regulated industries.
The current list of submissions acceptable in electronic format is available on the Agency Electronic Submissions Dockets. Guidances and forms for all acceptable submission types are available in Fill-in PDF Forms which communicate with the Center's tracking database and process the submissions into the Center for review automatically. The PDF forms have been upgraded for Adobe® 8.0 and are compatible with Adobe® Acrobat® 6.0 and later.
Compliance information on Electronic Records; Electronic Signatures is available from the Office of Regulatory Affairs Compliance Reference Title 21 CFR Part 11 - Electronic Records/Signatures page. This site includes links to information for Agency compliance initiatives and current activity.
Questions concerning Electronic Submissions to CVM should be addressed to HFV-016 at (240) 276-9143.
CVM Electronic Submissions Process using the Electronic Submissions System (ESS II) NEW
Anyone sending in electronic submissions to the Center must first register with the FDA Electronic Submissions Gateway (http://www.fda.gov/esg) and follow all requirements for setting up an account with the Gateway (FDA ESG). Once you have established your FDA ESG account, you must register with CVM and follow the requirements in the Guidance for Industry #108 How to Submit Information in Electronic Format to CVM using the FDA Electronic Submission Gateway.
Digital Signatures using Adobe® Acrobat® NEW
We have provided some screen shots to aid you in configuring your Adobe Acrobat for digital signatures and how to apply your signature to the PDF Forms. Configuring Adobe for Digital Signatures and Applying Digital Signatures
Using the FDA ESG WebTrader NEW
We have provided some screen shots on how to use the FDA ESG WebTrader to send electronic submissions to CVM, what the FDA ESG receipts look like, what CVM’s sponsor notifications look like, and what the FDA CVM Digital Signature looks like. FDA Gateway Submissions and Receipts.
Guidances and Forms
How to Submit Information by E-mail
Notices of Claimed Investigational Exemptions
Notices of Final Disposition of Animals Not Intended for Immediate Slaughter
Notices of Intent to Slaughter for Human Food Purposes
Requests for a Meeting or Telephone Conference with the Office of New Animal Drug Evaluation
Protocols for Non-clinical Laboratory and Effectiveness Studies
In addition, for those wishing to submit some of the information supporting a New Animal Drug Application (NADA) or for a technical section, the Center is willing to accept information in hard electronic media if the sponsor follows the general guidance in the Center for Drug Evaluation's guidance on file content, organization and format. See Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations
Any sponsors wishing to submit this type of information should contact the Center for Veterinary Medicine and discuss size and format prior to submitting electronic hard media.
Initiatives, Guidances and Working Models from other Centers in the Agency
Docket No. 03D-0060, CDER 200399. Guidance for Industry on Part 11, Electronic Records; Electronic Signatures--Scope and Application; Availability. Pages 52779-52781 September 5, 2003 [FR Doc. 03-22574] | htm | | pdf |
Docket No. 2003D-0465, CDER 2000152. Draft Guidance for Industry #165 on Providing Regulatory Submissions in Electronic Format--General Considerations; Availability. Page 60395 [FR Doc. 03-26571] October 22, 2003 | htm | | pdf |
FAQs for CVM's Electronic Submission System
Presentations on CVM's Electronic Submission System
Web Page Updated by hd - November 25, 2008, 5:00 PM ET