
[Federal Register Volume 78, Number 30 (Wednesday, February 13, 2013)]
[Notices]
[Pages 10181-10182]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03319]


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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 of the following revised final versions of documents that 
support making regulatory submissions in

[[Page 10182]]

electronic format using the electronic Common Technical Document (eCTD) 
specifications: ``The eCTD Backbone Files Specification for Module 1, 
version 2.1'' (which includes the U.S. regional document type 
definition, version 3.1), and ``Comprehensive Table of Contents 
Headings and Hierarchy, version 2.1.'' 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 2.1 by September 2013 and will give 30 days advanced 
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, 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, 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; 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 announced availability of 
final versions of technical documentation in the Federal Register of 
August 6, 2012 (77 FR 46763). FDA has revised the final documentation 
and is making available revised versions of the following documents:
     ``The eCTD Backbone Files Specification for Module 1, 
version 2.1,'' which provides specifications for creating the eCTD 
backbone file for Module 1 for submission to CDER and CBER. It should 
be used in conjunction with the guidance for industry entitled 
``Providing Regulatory Submissions in Electronic Format--Human 
Pharmaceutical Applications and Related Submissions,'' which will be 
revised as part of the implementation of the updated eCTD backbone 
files specification.
     ``Comprehensive Table of Contents Headings and Hierarchy, 
version 2.1,'' which reflects updated headings that are specified in 
the document entitled ``The eCTD Backbone Files Specification for 
Module 1, version 2.1.''

Supporting technical files are also 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:
     The 1.16 heading regarding risk management was modified 
and subheadings were added.
     The application-type attribute file was modified to 
include PMA and 510(k).
     Attribute files were modified to allow the version, date, 
and number to be machine readable.
    FDA is not prepared at present to accept submissions utilizing this 
new version, 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 2.1 by 
September 2013 and will give 30 days advanced notice to industry.

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: February 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03319 Filed 2-12-13; 8:45 am]
BILLING CODE 4160-01-P


