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CVM to resume accepting hard-copy submissions

Agency had suspended accepting paper documents for certain types of applications.

The U.S. Food & Drug Administration’s Center for Veterinary Medicine (CVM) announced June 29 that it will reopen its Document Control Unit on a limited basis on July 6, 2020.

CVM said sponsors who have already started the process of submitting information to the agency via the alternative methods described in a 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.

On May 8, CVM said in response to the COVID-19 public health emergency, it was 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 at CVM.

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