[Federal Register Volume 75, Number 185 (Friday, September 24, 2010)]
[Notices]
[Page 58411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23972]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0481]


Center for Veterinary Medicine eSubmitter Workshop; Public 
Workshop; Request for Comments

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled: ``Center for Veterinary Medicine (CVM) eSubmitter 
Workshop.'' The purpose of the public workshop is to provide the 
regulated animal health industry that submits new animal drug 
applications to CVM's Office of New Animal Drug Evaluation (ONADE) 
access to the beta-release of the electronic submission tool 
(eSubmitter) developed by CVM as agreed to in the Animal Drug User Fee 
Amendments (ADUFA II) of 2008 (http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm044941.htm). The ONADE will be soliciting 
feedback on both the eSubmitter tool and its compatibility with the 
industry's current IT systems, as well as the questions asked within 
the tool.
    This workshop will fulfill one of the 10 workshops agreed to in 
ADUFA II. The workshop will provide insight on the eSubmitter template 
development and its customization for the animal health industry as 
well as providing break-out sessions in which specific submissions will 
be built as part of the demonstration. Lastly, the ONADE will be 
seeking up to nine participating companies 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). 
Information about the workshop and availability of the eSubmitter tool 
can be found on FDA's eSubmitter Web site at http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm.
    Dates and Time: The public workshop will be held on October 21, 
2010, from 9 a.m. to 4 p.m. (EST/EDST).
    Location: The public workshop will be held virtually through both 
Adobe Connect Pro on-line and with conference call-in numbers. Both the 
call-in numbers and the Adobe Connect Pro web link will be emailed to 
all registrants.
    Contact Person: Charles Andres, Center for Veterinary Medicine 
(HFV-100), Food and Drug Administration, 7520 Standish Pl., Rockville, 
MD 20855, 240-276-8229, email: [email protected].
    Registration: Registration for the workshop can be made at: https://collaboration.fda.gov/cvm_esubmitter_workshop_oct21/event/registration.html on or before October 15, 2010. There is no 
registration fee for the public workshop. If you need special 
accommodations due to a disability, please contact Charles Andres (see 
Contact Person) at least 7 days in advance.
    Comments: FDA is holding this public workshop to obtain information 
about the eSubmitter tool. The deadline for submitting comments 
regarding this public workshop is December 31, 2010.
    Regardless of whether a person attended the public workshop, 
interested persons may submit either electronic or written comments 
regarding this document. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville MD 20852. It is only necessary to send one set of 
comments. It is no longer necessary to send two copies of mailed 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Transcripts: Transcripts of the public workshop may be requested in 
writing from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, 
approximately 15 working days after the public workshop at a cost of 10 
cents per page. A recording of the public workshop will be available on 
the Internet at http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm.

    Dated: September 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23972 Filed 9-23-10; 8:45 am]
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