[Federal Register Volume 76, Number 207 (Wednesday, October 26, 2011)]
[Notices]
[Page 66311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27658]
[[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,
[email protected]; 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 protected].
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]
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