September 24, 2010
The Food and Drug Administration (FDA) is holding a public workshop on Thursday, October 21, 2010 from 9 a.m. to 4 p.m. (EST/EDST) to present the beta-release of the electronic submission tool eSubmitter. Developed by the Center for Veterinary Medicine (CVM), eSubmitter is a tool for the regulated animal health industry to submit new animal drug information electronically to CVM’s Office of New Animal Drug Evaluation (ONADE).
Registration is required for this workshop, and there is no fee. To register, go to https://collaboration.fda.gov/cvm_esubmitter_workshop_oct21/event/registration.html and follow the instructions. Registration will be accepted through October 15, 2010. The workshop will be held virtually using both Adobe Connect Pro on-line and conference call-in numbers. Both the call-in numbers and the Adobe Connect Pro web link will be emailed to all registrants.
This public workshop will provide the regulated animal health industry access to eSubmitter, insight on the eSubmitter template development and its customization, and opportunities for break-out sessions in which specific submissions will be built into the demonstrations.
ONADE will be soliciting feedback on the eSubmitter tool and its compatibility with the industry’s current IT systems, as well as feedback of the questions that are asked within the tool to create each submission. ONADE will also seek up to nine companies participating in the workshop to work with CVM in testing the transmission of eSubmitter developed files through FDA’s electronic submission gateway (ESG) and CVM’s electronic submission system (ESS).
This public workshop will meet one of the ten workshops agreed to in the Animal Drug User Fee Act (ADUFA II) of 2009 (see http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm044941.htm).
Please go to FDA’s FDA’s eSubmitter website at http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm for additional information about the eSubmitter tool or to download and install eSubmitter.
Interested individuals may submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted to http://www.regulations.gov. Comments should be identified with the full title and Docket number FDA 2010-N-0481.
Additional information about the workshop may be found in the September 24, 2010 Federal Register and from Dr. Charles Andres, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 Standish Place, Rockville, MD 20855, 240-276-8229 or e-mail: charles.andres@fda.hhs.gov.