
[Federal Register Volume 79, Number 94 (Thursday, May 15, 2014)]
[Notices]
[Pages 27872-27873]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11178]


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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 revised final versions of the following four documents 
that support making regulatory submissions in electronic format using 
the electronic Common Technical Document (eCTD): ``The eCTD Backbone 
Files Specification for Module 1,'' version 2.3 (which includes the 
U.S. regional document type definition (DTD), version 3.3); ``The 
Comprehensive Table of Contents Headings and Hierarchy,'' version 2.3; 
``Specifications for eCTD Validation Criteria,'' version 3.1; and 
``Example Submissions using eCTD Backbone Files Specification for 
Module 1,'' version 1.3. Technical files that support these documents 
are also available on the Agency Web site. FDA estimates it will be 
able to receive submissions using Module 1 Specifications 2.3 by the 
fourth quarter of calendar year 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 the Office of 
Communication, Outreach and Development (HFM-40), Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002. 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, 10903 New Hampshire Ave., Bldg. 71, rm. 7328, Silver 
Spring, MD 20993-0002, 240-402-8125, email: 
joseph.montgomery@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    The eCTD is a format for the transfer of regulatory information 
from the pharmaceutical industry to the FDA. It was developed by an 
expert working group of the International Conference on Harmonisation, 
and has been FDA's preferred format for electronic submissions to the 
Center for Drug Evaluation and Research (CDER) and the Center for 
Biologics Evaluation and Research (CBER) since 2008. The majority of 
new electronic submissions are now received in eCTD format. Since 
adoption of the current version of eCTD, it has become necessary to: 
(1) Update the administrative portion of the eCTD (Module 1) to reflect 
regulatory changes, (2) clarify business rules for submission 
processing and review, (3) refine the characterization of promotional 
marketing and advertising material, and (4) facilitate automated 
processing of submissions. FDA previously announced availability of 
final versions of technical documentation in a Federal Register notice 
dated August 26, 2013 (78 FR 52776).
    The Agency revised the final documentation to accommodate the 
redesignation of section 503B as new section 503C of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 353b as 353c). We removed references 
to 503B and 353b and replaced them with ``Pre-Dissemination Review of 
Television Ad'' because of the redesignation of section 503B as section 
503C. We also changed references to DTD version 3.2 to version 3.3 in 
the Specifications for eCTD Validation Criteria. In addition, we 
revised the wording of eCTD validation error 2001 to reflect the 
changes. A full description of the changes is contained in the 
appendices of each document. The Agency is making available revised 
versions of the following documents:
     ``The eCTD Backbone Files Specification for Module 1, 
version 2.3,'' 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 
entitled ``Providing Regulatory Submissions in Electronic Format--Human 
Pharmaceutical Applications and Related Submissions Using the eCTD 
Specifications'');
     ``The Comprehensive Table of Contents Headings and 
Hierarchy,'' version 2.3;
     ``Specifications for eCTD Validation Criteria,'' version 
3.1; and
     ``Example Submissions using eCTD Backbone Files 
Specification for Module 1,'' version 1.3.

Supporting technical files are available on the Agency Web site.
    FDA is not prepared at present to accept submissions using this new 
version of the eCTD Backbone Files Specification for Module 1, version 
2.3, 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 using Module 1 Specifications 2.3 by the fourth 
quarter of calendar year 2014, and will give 30 days' advance notice to 
industry.

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/
FormsSubmissionRequirements/

[[Page 27873]]

ElectronicSubmissions/ucm253101.htm, http://www.regulations.gov, or 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: May 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11178 Filed 5-14-14; 8:45 am]
BILLING CODE 4160-01-P


