June 29, 2020
The FDA’s Center for Veterinary Medicine will re-open its Document Control Unit on a limited basis on Monday, July 6, 2020. Sponsors who have already started the process of submitting information to CVM via the alternative methods described in the May 8 update should continue with those alternative processes. For future submissions that cannot be submitted to CVM via the eSubmitter tool, CVM will start accepting paper submissions by mail and courier again on July 6. For any questions, sponsors may use the same contact information as listed in the May 8 notice below.
May 8, 2020
In response to the Coronavirus Disease 2019 (COVID-19) public health emergency, FDA’s Center for Veterinary Medicine (CVM) is offering alternative options for industry to submit certain documents to the center. CVM 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.
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 the eSubmitter 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. With regard to those submissions, CVM 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 (VMFs), contact your Office of New Animal Drug Evaluation Project Manager. Stakeholders who do not have a project manager assigned may send inquiries to CVM.ONADE.PM@fda.hhs.gov.
For Animal Food premarket submissions, contact Animalfoodfirstname.lastname@example.org.
For Animal Drug Indexing, designation requests, and minor use determinations, contact Dorothy.Bailey@fda.hhs.gov.
For User Fee (ADUFA, 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 (DERs) or Export Certifications. For questions on pending export certifications, contact CVMExportCertification@fda.hhs.gov.
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.