
[Federal Register Volume 78, Number 165 (Monday, August 26, 2013)]
[Notices]
[Pages 52776-52777]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20697]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0724]


Documents to Support Submission of an Electronic Common Technical 
Document; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability on the Agency Web site of revised final versions of the 
following four documents that support making regulatory submissions in 
electronic format using the electronic Common Technical Document (eCTD) 
specifications: ``The eCTD Backbone Files Specification for Module 1,'' 
version 2.2 (which includes the U.S. regional document type definition 
(DTD), version 3.2); ``The Comprehensive Table of Contents Headings and 
Hierarchy,'' version 2.2; ``Specifications for eCTD Validation 
Criteria,'' version 3.0; and ``Example Submissions using eCTD Backbone 
Files Specification for Module 1,'' version 1.2. Technical files that 
support these documents are also available on the Agency Web site. A 
complete summary of the revisions made is included in the updated 
documents. FDA estimates it will be able to receive submissions 
utilizing Module 1 Specifications 2.2 by June 2014, and will give 30 
days' advance notice to industry.

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: Constance Robinson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 1105, Silver Spring, MD 20993, 301-796-
1065, email: constance.robinson@fda.hhs.gov; or Joseph Montgomery, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 11400 Rockville Pike, HFM-165, Rm. 4155, Rockville, MD 
20857, 301-827-1332, email: joseph.montgomery@fda.hhs.gov.

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. The majority of new electronic submissions are now received in 
eCTD format. Since adoption of the eCTD standard, it has become 
necessary to update the administrative portion of the eCTD (Module 1) 
to reflect regulatory changes, provide clarification of business rules 
for submission processing and review, refine the characterization of 
promotional marketing and advertising material, and facilitate 
automated processing of submissions. FDA previously announced 
availability of final versions of technical documentation in a Federal 
Register notice dated February 13, 2013 (Docket No. FDA-2011-N-0724). 
The Agency has revised the final documentation and is making available 
revised versions of the following documents:
     ``The eCTD Backbone Files Specification for Module 1, 
version 2.2,'' which provides specifications for creating the eCTD 
backbone file for Module 1 for submission to CDER and CBER (This 
document should be used in conjunction with the guidance for industry 
Providing Regulatory Submissions in Electronic Format--Human 
Pharmaceutical Applications and Related Submissions Using the eCTD 
Specifications, which will be revised as part of the implementation of 
the updated eCTD backbone files specification (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072349.pdf )).
     ``The Comprehensive Table of Contents Headings and 
Hierarchy,'' version 2.2, which reflects updated headings that are 
specified in the document entitled ``The eCTD Backbone Files 
Specification for Module 1,'' version 2.2
     ``Specifications for eCTD Validation Criteria,'' version 
3.0
     ``Example Submissions using eCTD Backbone Files 
Specification for Module 1,'' version 1.2
    Supporting technical files are being made available on the Agency 
Web site.
    A complete summary of the revisions made are included in the 
updated documents. The revisions include the following:

eCTD Backbone Files Specification for Module I
    [cir] changed DTD version references from 3.1 to 3.2, where 
applicable
    [cir] replaced the copy of DTD Version 3.1 in Appendix I with DTD 
Version 3
    [cir] revised text, revised Table 1, and added Table 13 to indicate 
the new required attribute material-id and the new optional attribute 
issue-date which applies to m1-15-2-1
The Comprehensive Table of Contents Headings and Hierarchy
    [cir] added two new attributes for 1.15.2.1
Specifications for eCTD Validation Criteria
    [cir] incorporated changes to US eCTD Module 1
Example Submissions using eCTD Backbone Files Specification for Module 
1
    [cir] modified example 7 to reference the Form FDA 356h in the 
Admin section
    [cir] modified examples 13 through 17 to reference the material-id 
and issue date attributes as applicable, and include the Promotional 
Labeling and Advertising Regulatory Contact
    FDA is not prepared at present to accept submissions utilizing this 
new version of the eCTD Backbone Files Specification for Module 1, 
version 2.2, because eCTD software vendors need time to update their 
software to accommodate this information and because its use will 
require software upgrades within the Agency. FDA estimates it will be 
able to receive submissions utilizing Module 1 Specifications 2.2 by 
June 2014, and will give 30 days advance notice to industry.

[[Page 52777]]

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: August 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20697 Filed 8-23-13; 8:45 am]
BILLING CODE 4160-01-P


