
[Federal Register Volume 77, Number 151 (Monday, August 6, 2012)]
[Notices]
[Pages 46763-46764]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19087]


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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 final versions of 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 2.0'' (which includes the 
U.S. regional document type definition (DTD), version 3.0) and 
``Comprehensive Table of Contents Headings and Hierarchy, version 
2.0.'' Supporting technical files are also being made available on the 
Agency Web site. These documents represent FDA's major updates to 
Module 1 of the eCTD, which contains regional information. 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 2.0 by September 2013, 
but this is not a firm date and we 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: 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: 
Esub@fda.hhs.gov; or Mary Padgett, Center for Biologics Evaluation and 
Research (HFM-25), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852, 301-827-0373, email: 
mary.padgett@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, to provide clarification of business 
rules for submission processing and review, to refine the 
characterization of promotional marketing and advertising material, and 
to facilitate automated processing of submissions. In preparation for 
the Module 1 update, FDA made available draft technical documentation 
for public comment in a Federal Register notice dated October 26, 2011 
(Docket No. FDA-2011-N-0724). After considering comments submitted, FDA 
revised the draft documentation and is making available final versions 
of the following documents:
     ``The eCTD Backbone Files Specification for Module 1, 
version 2.0,'' 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 ``Providing 
Regulatory Submissions in Electronic Format--Human Pharmaceutical 
Product Applications and Related Submissions Using the eCTD 
Specifications,'' which can be found online (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072349.pdf), and which will be revised as part of the implementation 
of the updated eCTD backbone files specification.
     ``Comprehensive Table of Contents Headings and Hierarchy, 
version 2.0,'' which reflects updated headings that are specified in 
the draft document entitled ``The eCTD Backbone Files Specification for 
Module 1, version 2.0,'' as well as mappings to regulations and 
legislation.
    Supporting technical files are also being made available on the 
Agency Web site. The documents include changes that:
     Allow submission of promotional label and advertising 
materials to CDER in eCTD format;
     Provide for processing of grouped submissions (e.g., a 
supplement that can be applied to more than one new drug application or 
biologics license application);
     Provide detailed contact information so that companies can 
specify points of contact to discuss technical matters that may arise 
with a submission;
     Clarify headings;
     Use attributes in place of certain headings to provide 
flexibility for future changes without revising the specification 
itself.
    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 2.0 by 
September 2013, but this is not a firm date and we will give 30 days 
advance notice to industry.

[[Page 46764]]

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: July 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19087 Filed 8-3-12; 8:45 am]
BILLING CODE 4160-01-P


