[Federal Register Volume 78, Number 73 (Tuesday, April 16, 2013)]
[Notices]
[Page 22554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08867]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0385]
Document to Support Submission of an Electronic Common Technical
Document--Specifications for File Format Types Using Electronic Common
Technical Document Specifications; 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 document that supports making regulatory
submissions in electronic format using the electronic Common Technical
Document (eCTD) specifications: ``Specifications for File Format Types
Using eCTD Specification.''
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:
[email protected]; or Stephen Ripley, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852, 301-827-6210.
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. Previously, formats for files contained within eCTD submissions
were limited to those specified in the ``eCTD Backbone File
Specification for Modules 2 through 5.3.2.2.'' However, as review tools
and methods have changed and with the acceptance of advertising and
promotional labeling in the eCTD format, it has become necessary to
expand the range of file types accepted.
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: April 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08867 Filed 4-15-13; 8:45 am]
BILLING CODE 4160-01-P