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CVM provides alternative document submission options

Certain submissions unsuitable for eSubmitter system will not be processed if received through mail or via courier.

In response to the coronavirus disease 2019 (COVID-19) public health emergency, the Food & Drug Administration’s Center for Veterinary Medicine (CVM) is offering alternative options for industry to submit certain documents to the center.

CVM said it expects this to be relevant to only a small number of industry submissions. This transition to electronic submissions, where feasible, is necessary to address the impact of the COVID-19 public health emergency on day-to-day operations in CVM, the announcement said.

CVM continues to evaluate new animal drug applications and food additive petitions and issue responses to these and other industry submissions. The center’s eSubmitter tool is still available for most industry submissions to CVM. For information on how to register to use this tool, see the CVM eSubmitter Resource Center. For CVM Electronic Submission System (ESS) registration letters, contact CVMDCU@fda.hhs.gov or (240) 402-7062.

However, there are some submissions for which eSubmitter is not used, and with regard to those, CVM said it will not process submissions received by mail or courier until further notice but will accept and process submissions received by certain alternative methods.

Sponsors should use the contact information listed below to discuss alternative methods for submitting information based on submission type. Sponsors that sent a submission to CVM by mail or courier after April 13, 2020, can also use the contact information below to verify the status of their submission.

For animal drug premarket submissions, including Veterinary Master File submissions, contact an Office of New Animal Drug Evaluation project manager. Stakeholders who do not have an assigned project manager may send inquiries to CVM.ONADE.PM@fda.hhs.gov.

For animal food premarket submissions, contact Animalfood-premarket@fda.hhs.gov.

For animal drug indexing, designation requests and minor use determinations, contact Dorothy.Bailey@fda.hhs.gov.

For user fee (ADUFA and AGDUFA) waiver requests and sponsor changes, contact Jason.Smith@fda.hhs.gov.

For other submissions or general questions, contact AskCVM@fda.hhs.gov.

At this time, there are no changes to the submission process for Drug Experience Reports or export certifications. For questions on pending export certifications, contact CVMExportCertification@fda.hhs.gov.

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