[Federal Register Volume 78, Number 14 (Tuesday, January 22, 2013)]
[Notices]
[Pages 4418-4419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-01164]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1255]


Electronic Submission Process for Requesting Export Certificates 
From the Center for Devices and Radiological Health; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of an electronic submission process for requesting export 
certificates for products regulated by FDA's Center for Devices and 
Radiological Health (CDRH). The electronic process will help fulfill 
both the legislative and application time processing requirements set 
out by the FDA Export Reform and Enhancement Act of 1996 and the terms 
of clearance of the Office of Management and Budget approval (OMB 
control number 0910-0498) of the Form FDA 3613 series. The new 
eSubmitter process will complement the current paper-based process.

FOR FURTHER INFORMATION CONTACT: Leila Lawrence, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 2668, Silver Spring, MD 20993-0002, 301-796-5786, 
email: Leila.Lawrence@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. How eSubmitter Impacts FDA's Current Process

    FDA currently accepts requests for export certificates submitted by 
mail. This process will remain in place and would be augmented by the 
new eSubmitter process.
    For general user assistance, contact the Center for Devices and 
Radiological Health (CDRH), Division of Small Manufacturers, 
International and Consumer Assistance (DSMICA) by telephone: 1-800-638-
2041 or 301-796-7100; or by email: dsmica@fda.hhs.gov.
    You can find information about FDA's Electronic Submissions Gateway 
online at: http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. Email questions about the system to FDA's Electronic 
Submissions Gateway Help Desk: esgreg@gnsi.com.

II. Background on the Electronic Submission of Requests for Export 
Certificates

    FDA introduces an electronic option for submitting requests for 
export certificates of devices regulated by CDRH as a voluntary 
alternative to paper submissions. With electronic submissions, CDRH can 
more readily receive and process the export requests.
    The electronic process will be introduced in two phases. In the 
first phase of operation, the CDRH Export Certification Application and 
Tracking System (CECATS) will be made available to industry for the 
electronic submission of requests for export certificates.
    CECATS is a Web-based application used by FDA's CDRH to process, 
manage, and administer certificates for the export of medical devices. 
CDRH will be implementing the electronic submission and review process. 
Industry will have an option to submit electronically or via the paper 
process. CECATS will be accessible through the FDA Unified Registration 
and Listing System (FURLS). A firm must have a FURLS account to access 
CECATS.
    The CECATS module is a part of the FURLS application within the FDA 
Industry Systems Portal utilized to automatically issue the certificate 
to U.S. medical device manufacturers/distributors who wish to export 
their medical devices to foreign countries.
    CECATS will help fulfill both the legislative and application time 
processing requirements set out by the FDA Export Reform and 
Enhancement Act of 1996 (Public Law 104-134) and the terms of clearance 
of the OMB approval of the Form FDA 3613 series.
    CECATS will provide industry the option of submitting export 
requests electronically. Electronic submission will automate many of 
the steps that both industry and CDRH must perform to submit and 
process export certificates. The advantages to industry will be:
     Certificate processing time will be greatly reduced;
     Automated real-time validation will eliminate the need to 
return submissions; and
     Industry will receive real-time updates on the status of 
their requests via the Web.
    In early 2013, FDA will implement phase two for the remainder of 
the export certification, notification, and permit requests listed as 
follows:
     Certificates of Exportability (sections 801(e)(1) and 802 
of the FD&C Act);
     Non-Clinical Research Use Only Certificate;
     Simple Notifications (section 802(g) of the FD&C Act); and
     Export Permit Letter (section 801(e)(2) of the FD&C Act).
    Upon full implementation in 2013, industry will be able to submit 
all export requests electronically. This is a ``win'' for both industry 
and CDRH as it will allow us to process all export requests more 
efficiently and expeditiously. CDRH is developing webinars and will 
hold online training sessions with industry on how to access and use 
CECATS. A schedule and detailed instructions will be sent to industry 
and posted to our Web site at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ImportingandExportingDevices/ucm050521.htm#ref when they become available.
    Evaluation of the electronic submission process will be conducted 
periodically to further enhance both user interface and data collection 
needs as they become known to FDA. Electronic submissions of requests 
for export certificates will remain voluntary at this time.
    The printable forms can be viewed at the following links:
     Form FDA 3613: Supplementary Information Certificate for 
Foreign Government Requests: http://inside.fda.gov:9003/ucm/groups/insidefda-public/@inside-adm-forms/documents/form/ucm012794.pdf;
     Form FDA 3613a: Supplementary Information Certificate of 
Exportability Requests: http://inside.fda.gov:9003/ucm/groups/insidefda-public/@inside-adm-forms/documents/form/ucm012795.pdf;
     Form FDA 3613c: Supplementary Information Non-Clinical 
Research Use Only Certificate: http://inside.fda.gov:9003/ucm/groups/insidefda-public/@inside-adm-forms/documents/form/ucm012797.pdf.

III. What happens when the new eSubmitter process for requesting export 
certificates is implemented?

    Implementation of the eSubmitter process will supplement the 
ability to request export certificates from CDRH via paper. The new 
Web-based application (available at: https://www.access.fda.gov/oaa/index.jsp) uses your existing FURLS account

[[Page 4419]]

information. The Web site provides an alternative to the paper request 
process by enabling online submission of export certificate 
applications.

IV. Paperwork Reduction Act of 1995

    This document refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by OMB under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). The collections of information in CECATS and 
Forms FDA 3613, 3613a, and 3613c have been approved under OMB control 
number 0910-0498.

    Dated: January 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01164 Filed 1-18-13; 8:45 am]
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