Document ID: FDA-2013-N-0385-0001
Agency: fda
Document Type: Notice
Title: Document to Support Submission of an Electronic Common Technical Document--Specifications for File Format Types Using Electronic Common Technical Document Specifications; Availability
Posted Date: 2013-04-16T04:00Z

[Federal Register Volume 78, Number 73 (Tuesday, April 16, 2013)]
[Notices]
[Page 22554]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08867]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0385]

Document to Support Submission of an Electronic Common Technical 
Document--Specifications for File Format Types Using Electronic Common 
Technical Document Specifications; 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 the following document that supports making regulatory 
submissions in electronic format using the electronic Common Technical 
Document (eCTD) specifications: ``Specifications for File Format Types 
Using eCTD Specification.''

ADDRESSES: Submit written requests for single copies of the documents 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002 or Office of Communication, 
Outreach and Development (HFM-40), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label 
to assist that office in processing your requests. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the 
documents.

FOR FURTHER INFORMATION CONTACT: Virginia Hussong, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 1161, >Silver Spring, MD 20993, email: 
virginia.hussong@fda.hhs.gov; or Stephen Ripley, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    The eCTD is an International Conference on Harmonisation (ICH) 
standard based on specifications developed by ICH and its member 
parties. FDA's Center for Drug Evaluation and Research (CDER) and 
Center for Biologics Evaluation and Research (CBER) have been receiving 
submissions in the eCTD format since 2003, and the eCTD has been the 
standard for electronic submissions to CDER and CBER since January 1, 
2008. Previously, formats for files contained within eCTD submissions 
were limited to those specified in the ``eCTD Backbone File 
Specification for Modules 2 through 5.3.2.2.'' However, as review tools 
and methods have changed and with the acceptance of advertising and 
promotional labeling in the eCTD format, it has become necessary to 
expand the range of file types accepted.

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm, http://www.regulations.gov, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: April 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08867 Filed 4-15-13; 8:45 am]
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