July 18, 2013
9 a.m. to 3 p.m.
Center for Tobacco Products
9200 Corporate Blvd.
Rockville, MD 20850
This workshop will focus on the technical aspects of electronic submissions, including potential standards for content, format, and structure. FDA will select speakers to address aspects of the submission of data and technical matters relating to the standardization of electronic regulatory submissions. The input from the public workshop is expected to provide valuable information that may assist the Agency in developing and implementing an efficient, well-structured, broadly applicable electronic submission standard for CTP. FDA is also opening a public docket to receive comments on this topic.
Who Should Attend this Workshop?
FDA is interested in obtaining input from a range of stakeholders, including, but not limited to, large and small pharmaceutical manufacturers experienced with electronic Common Technical Document (eCTD); vendors of software used to support electronic submissions; and large and small tobacco manufacturers.
Registration to Attend the Workshop or View the Webcast:
Registration is free, but early registration is recommended because seating is limited. Onsite registration on the day of the workshop will be based on space availability. CTP plans to provide a free-of-charge, live webcast of the workshop. (see Webcast).
If you wish to attend the workshop, make an oral presentation at the workshop, or view the free webcast, you must register by submitting an electronic or written request by 5 p.m. on June 21, 2013. Submit electronic requests to http://www.surveymonkey.com/s/HWY9KNC. Those without email access may register by contacting Karen M. Templeton-Somers (see Contact for Questions). When registering, please provide your contact information including name, title, affiliation, address, email address, and telephone number. Successful registrants will receive a confirmation email at least two weeks prior to the workshop date. If registration reaches maximum capacity, FDA will post a notice closing registration for the workshop on this website.
FDA Invites Public Comments on Electronic Submission of Tobacco Product Applications and Other information
Docket for submitting public written comments:
Regardless of attendance at the public workshop, interested persons may submit comments on any of the topics for discussion in section II of this document by August 18, 2013. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the Docket No. FDA-2013-N-0602. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Requests for Oral Presentations:
If you wish to make an oral presentation, you must state your intention on your registration submission and submit your name, title, company or organization (if applicable), address, telephone number, and email address. FDA has included specific topics for discussion later in this document. You should identify by number each discussion topic(s) you wish to address in your presentation, and the approximate desired length of your presentation. FDA is interested in obtaining input from a range of stakeholders, including, but not limited to, large and small pharmaceutical manufacturers experienced with electronic Common Technical Document (eCTD); vendors of software used to support electronic submissions; and large and small tobacco manufacturers. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. Following the close of registration, FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by June 28, 2013.
Background and Workshop Topics
The purpose of this workshop is to obtain public input from regulated industry and other stakeholders on the potential development and implementation of a standardized structure for electronic submission of tobacco product applications and other information. Stakeholders could include, but are not limited to, large and small pharmaceutical manufacturers; vendors of software used to support electronic submissions; and large and small tobacco manufacturers. The workshop will focus on technical aspects related to electronic submissions and standards currently used in other FDA centers. The discussion on electronic regulatory submissions may apply to, but is not limited to, the following types of submissions: applications for premarket review of new tobacco products (Section 910(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), modified risk tobacco product applications (Section 911(d) of the FD&C Act), and reports submitted under section 905(j) of the FD&C Act. In particular, FDA would like to discuss how available standardized submission structure and technologies facilitate preparation, submission, retrieval, processing, review, and archiving submissions.
The electronic submission workshop will include discussion on the electronic Common Technical Document (eCTD), which is an International Conference on Harmonization (ICH) specification developed by ICH and its member parties. Other FDA centers have been receiving submissions in the eCTD format since 2003. The eCTD provides an organizational structure for regulatory submissions utilizing comprehensive table of contents headings and hierarchy. FDA encourages standardized submissions and study data using Agency-supported data standards.
CTP is interested in receiving input at the workshop and in the docket on the potential standardization of electronic tobacco product submissions. The input from the workshop may assist the Agency in developing and implementing a harmonized electronic submission standard at CTP.
Workshop Topics for Discussion
FDA will explore all or some of the following topics during this public workshop:
- How have other regulated industries standardized the structure of submissions to FDA and how has that facilitated the submission and review process? What aspects may be applicable to tobacco product submissions?
- What technologies do tobacco companies currently use to prepare their submissions? Is a document management system used? Are specific technologies used? Is electronic data capture used in clinical trials or other studies? What systems and standards currently are used to manage data and documents?
- How are data collected and managed for submission to CTP? Is a laboratory information management system used?
- Are there any technical limitations CTP should consider in developing and implementing any harmonized electronic submission standard?
- Would a pilot program designed to test a modified eCTD be useful?
Registration to Attend or View the Webcast: June 21, 2013
Deadline for Requests for Oral Presentations: June 21, 2013
Deadline for Submission of Comments to the Docket: August 18, 2013
If you need special accommodations because of disability, please contact Karen Templeton-Somers (see Contact for Questions) at least 7 days before the workshop.
Contact for Questions:
Karen Templeton-Somers, Ph.D.
Office of Science
Center for Tobacco Products
Food and Drug Administration
9200 Corporate Blvd.
Rockville, MD 20850
Telephone: 1-877-287-1373 (choose Option 5),