[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]
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