Document ID: FDA-2011-N-0724-0001
Agency: fda
Document Type: Notice
Title: Draft Documents to Support Submission of an Electronic Common Technical Document; Availability
Posted Date: 2011-10-26T04:00Z

[Federal Register: October 26, 2011 (Volume 76, Number 207)]
[Notices]               
[Page 66311]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26oc11-64]                         

[[Page 66311]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Draft Documents To Support Submission of an Electronic Common 
Technical Document; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the following draft versions of documents that support 
making regulatory submissions in electronic format using the electronic 
Common Technical Document (eCTD) specifications entitled ``The eCTD 
Backbone Files Specification for Module 1, version 2.0'' (which 
includes the U.S. regional document type definition, 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 draft documents represent FDA's major updates to 
Module 1 of the eCTD, which contains regional information.

DATES: Submit either electronic or written comments on the draft 
documents by December 27, 2011.

ADDRESSES: Submit written requests for single copies of the documents 
to the Division of Drug Information, Center for Drug Evaluation and 
Research (CDER), 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 (CBER), 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.
    Submit electronic comments on the draft documents to http://
www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

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, 
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, 
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. CDERCBER 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 
is making available for comment the following draft documents:
     ``The eCTD Backbone Files Specification for Module 1, 
version 2.0'' 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.
     ``The Comprehensive Table of Contents Headings and 
Hierarchy, version 2.0'' 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 draft documents include the following changes:
     Providing for processing of bundled submissions (e.g., a 
supplement can be applied to more than one new drug application or 
biologics license application),
     Providing detailed contact information so that companies 
can specify points of contacts to discuss technical matters that may 
arise with a submission,
     Clarifying headings, and
     Using attributes in place of certain headings to provide 
flexibility for future changes without revising the specification 
itself.

The draft documents contain complete lists of the changes to Module 1.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding the 
draft documents. It is only necessary to send one set of comments. It 
is no longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

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

    Dated: October 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-27658 Filed 10-25-11; 8:45 am]
BILLING CODE 4160-01-P