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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Adopts Updated Process for Accepting Drug Sponsor Information Electronically

by Jon F. Scheid, Editor
FDA Veterinarian Newsletter 2007 Volume XXII, No III

The Center for Veterinary Medicine can now accept certain information from drug sponsors through an improved electronic submission system that includes an “Electronic Submission Gateway” (ESG) developed by the Food and Drug Administration.

CVM officially moved to the improved electronic submission system on June 29 and announced the change in a series of revised “Guidance for Industry” documents posted to CVM’s Web site. The key guidance is #108, “Guidance for Industry: How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway.” It describes the new electronic submission process, which includes using the FDA gateway, and explains what drug sponsors need to do before they can begin providing electronic submissions to CVM.

CVM has been accepting data from sponsors electronically since 1997 using an e-mail system. Over the years, that system became outdated. FDA modernized its e-mail system in 2006, giving CVM an opportunity to modernize its electronic submission process to include the newer FDA gateway interface.

FDA developed its ESG system to accept information from all FDA stakeholders, including sponsors of human drugs and medical devices, as well as veterinary drug sponsors. The ESG process was initiated as a collaborative effort between CBER and CDER and has been leveraged to other Centers to aid in providing a single point of entry for all electronic submissions to the Agency.

Veterinary drug sponsors who want to use the ESG need to first register with the ESG and CVM. As part of CVM’s registration process, drug sponsors identify one individual in the company to serve as the point of contact for CVM. That individual will file a digital signature with CVM, which will be used to verify the authenticity of any electronic submission from that company.

Once a company is registered with CVM and the gateway, the company can use it to send six types of submissions associated with new animal drug reviews (Notice of Claimed Investigational Exemptions, Final Disposition of Animals Not Intended for Slaughter, Notice of Intent to Slaughter for Human Food Purposes, Request for Meeting or Teleconference, Protocol for Non-Clinical Laboratory and Effectiveness Studies, and Electronic Submission System Participant Management Form) via the ESG.

Before it could accept these submissions electronically, CVM had to develop electronic formats for each of them. The electronic submissions must have a specific structure. They cannot be as loosely organized as paper submissions, according to Dr. Margaret Zabriski, project coordinator for CVM. Developing the standardized format for each submission type took a significant amount of time and effort on the part of the reviewers of CVM’s Office of New Animal Drug Evaluation, she added.

More electronic submission types will be added later, after CVM drug review experts have decided what information they need on the submission and how the information should be organized. However, she added, the largest amount of work was the develpment of the gateway interface. Now that the gateway interface is in place, CVM can focus on developing other electronic submission for drug application information. The process will be like adding “more cars to the train,” according to Howard Conrad, with Booz Allen Hamilton, the contracting company that is creating the programs necessary for use on the gateway.

Companies can still submit this information in a paper format. However, documents submitted electronically will be organized in a manner CVM developed, which will permit efficient review by CVM staff.

According to Mr. Conrad, a longer-term goal is to have all documents associated with drug applications available electronically, which will permit rapid and easy search, compared with paper-document searches.

He added that one key improvement CVM sponsors will notice in using the ESG will be the amount of information they can submit electronically. As an example, drug sponsors frequently request meetings with CVM officials who are or will be reviewing their drug applications so the sponsors can be sure what information CVM will want. Under the previous system, a sponsor’s request for a meeting came with not much more than an agenda. By using the new electronic submission system, drug sponsors can send significantly more information. For instance, they can send copies of presentations, including slides, and as much data as needed for the discussion.