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 updated and standardized and have new features and capabilities ( Added Features for version 4.0 forms ).

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 (301) 827-4023.

CVM Electronic Submissions Process

Anyone sending in electronic submissions to the Center by e-mail must first register and follow all requirements in the Guidance for Industry #108 How to Submit Information in Electronic Format by E-mail and the certification requirements to the Agency outlined in 21 CFR 11.100(c).

Guidances and Forms

NOTE: Version 4.0 is available for the Forms, but older versions of the PDF forms will be accepted for a limited time.

USER HINT: When a PDF Smart Form link is chosen and viewed from your internet browser, the PDF Smart Form's full electronic functionality is not activated (e.g., Saving and Sending to CVM).  In order to access the needed functionality, first you must download the desired PDF Smart Form to your computer and open it using Adobe Acrobat.

To download a PDF Smart Form to your computer follow these steps:

1. Using your mouse, right click on the desired PDF Smart Form link.

2. Select the Save Target As option.

3. The Save As window opens. Choose a location to download the PDF Smart Form to using the Save In drop down list.

4. Once you select a location, click on the Save button.

5. The Download window opens. When the Download Complete message appears, click on the Close button.

The PDF Smart Form has been downloaded.

How to Submit Information by E-mail

• Guidance for Industry #108: How to Submit Information in Electronic Format by E-Mail

• Form FDA 3538 (ESS Participant Password or Addition Form, version 4.0) – NEW Release!

  • Instructions for completing the form

• Form FDA 3538 (version 1.0)

Notices of Claimed Investigational Exemptions

• Guidance for Industry #59: How to Submit a Notice of Claimed Investigational Exemption in Electronic Format by E-Mail

• Form FDA 3458 (version 4.0) – NEW Release!

• Form FDA 3458 (version 3.2)

Notices of Final Disposition of Animals not Intended for Immediate Slaughter

• Guidance for Industry #86- How to Submit a Notice of Final Disposition of Investigational Animals Not Intended for Immediate Slaughter in Electronic Format by E-Mail

• Form FDA 3487 (version 4.0) – NEW Release!

• Form FDA 3487 (version 3.1)

Notices of Intent to Slaughter for Human Food Purposes

• Guidance for Industry #87- How to Submit a Notice of Intent to Slaughter for Human Food Purposes in Electronic Format by E-mail

• Form FDA 3488 (version 4.0) – NEW Release!

• Form FDA 3488 (version 3.1)

Requests for a Meeting or Telephone Conference with the Office of New Animal Drug Evaluation

• Guidance for Industry #88 - How to Submit a Request for a Meeting or Teleconference in Electronic Format by E-mail

• Form FDA 3489 (version 4.0) – NEW Release!

• Form FDA 3489 (version 3.1)

Protocols for Non-clinical Laboratory and Effectiveness Studies

• Guidance for Industry #107: How to Submit a Protocol in Electronic Format by E-Mail

• Form FDA 3536 (version 4.0) – NEW Release!

• Form FDA 3536 (version 1.2)

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 and Guidance for Industry: Providing Regulatory Submissions in Electronic Format - NDA.

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. The Center is working on CVM specific guidance for NADAs.

Future Electronic Submissions and Guidances

• Submission of Information supporting a New Animal Drug Application
  Currently the Electronic Dockets references the Center for Drug Evaluation and Research guidance for a New Drug Application. CVM is working on a guidance document specific for the varied information needed to support approval of animal drugs.

Initiatives, Guidances and Working Models from other Centers in the Agency

• Guidance for Industry #157 : Part 11, Electronic Records, Electronic Signatures--Scope and Application, August 2003

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 |

• Draft Guidance for Industry #165: Providing Regulatory Submissions in Electronic Format--General Considerations, October 2003 | doc | | 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 |

• CDER's Electronic Regulatory Submissions and Review Page

  • CDER is currently working on a Guidance for Industry addressing submitting Drug Master Files electronically

• CBER's Regulatory Submissions in Electronic Format Page

• CDRH Electronic Submissions Page

• CFSAN's Draft Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format for Food Additive and Color Additive Petitions was published for comment July 2001

• Information Management: Challenges in Managing and Preserving Electronic Records , June 2002 is a report to Congressional Requesters authored by United States General Accounting Office (GAO)

FAQs for CVM's Electronic Submission System

• If there are other questions you would like to be included in the FAQs please send them to CVMSTARS@fda.gov . The question will be researched and may be added to the FAQ's

Presentations on CVM's Electronic Submission System

• Document Management Strategy - 16th Annual DIA-Sponsored Document Management Conference: presented at FDA Overview, Updates and Panel Discussion, February 13, 2003 | text version | | Download for printing |

• Electronic Submissions System - DIA Document Management Conference presented at Drug Information Association, FDA Electronic Submission Initiatives Panel Discussion, February 14, 2002

• Update on the STARS and the Electronic Submissions System presented at Animal Drug Institute Animal Drug Section Meeting, November 14, 2001

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