
[Federal Register Volume 77, Number 115 (Thursday, June 14, 2012)]
[Notices]
[Page 35691]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14469]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Update to Electronic Common Technical Document Module 1

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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    The Food and Drug Administration (FDA) is announcing the following 
meeting: Update to Electronic Common Technical Document Module 1. The 
topic to be discussed is final documentation of the Electronic Common 
Technical Document (eCTD) Module 1, which is used for electronic 
submission of administrative and prescribing information by industry. 
The purpose of the meeting is to provide clarification and answer 
questions from industry and software vendors regarding the changes 
being made to this module. Registration is required in advance and 
participation will be limited.

DATES:  Date and Time: The meeting will be held on Tuesday, September 
18, 2012, from 8 a.m. to 11:30 a.m.

Location:  The meeting will be held at the FDA White Oak Campus, 10903 
New Hampshire Ave., Bldg. 31 Conference Center, Great Room 1503, Silver 
Spring, MD 20993. The following link contains public meeting attendee 
information as well as frequently asked questions and answers regarding 
public meetings at White Oak: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

Contact: Julie Quinonez, Center for Drug Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1135, 
Silver Spring, MD 20993, 301-796-0282, FAX: 301-796-9876, email: 
Julie.Quinonez@fda.hhs.gov.
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number) to Julie Quinonez (see 
Contact). Registrations will be accepted in the order that they are 
received with a limit of 350.

SUPPLEMENTARY INFORMATION: The eCTD is an International Conference on 
Harmonization (ICH) standard based on specifications developed by ICH 
and its member parties. The Center for Drug Evaluation and Research 
(CDER) and the 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. In fact, 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 labeling and advertising material; and 
to facilitate automated processing of submissions. In the process of 
considering these changes, FDA has previously made available for 
comment versions of documents that support making regulatory 
submissions in electronic format using the (eCTD) specifications. These 
draft documents represented FDA's major updates to Module 1 of the eCTD 
based on previous comments. FDA will make available revised versions of 
these documents in preparation for this meeting. These documents will 
be posted at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm.
    If you need special accommodations due to a disability, please 
contact Julie Quinonez (see Contact) at least 7 days in advance.

    Dated: June 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14469 Filed 6-13-12; 8:45 am]
BILLING CODE 4160-01-P


