[Federal Register Volume 78, Number 110 (Friday, June 7, 2013)]
[Notices]
[Pages 34393-34395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-13532]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0602]


Electronic Submission of Tobacco Product Applications and Other 
Information; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA), Center for Tobacco Products 
(CTP), is announcing a 1-day workshop to obtain public input on topics 
related to the potential electronic submission of tobacco product 
applications and other information. This workshop will focus on the 
technical aspects of electronic submissions, including potential 
standards for content, format, and structure. The input from the public 
workshop may assist the Agency in the potential development and 
implementation of an electronic submission standard for CTP. FDA is 
also opening a public docket to receive comments on this topic.
    Date and Time: The public workshop will be held on July 18, 2013, 
from 9

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a.m. to 3 p.m. Individuals who wish to attend, participate in, or view 
the free Webcast of the public workshop must register by 5 p.m. EDT on 
June 21, 2013. Submit either electronic or written comments to the 
docket by August 19, 2013.
    Location: The public workshop will be held at 9200 Corporate Blvd., 
Rockville, MD 20850, 1-877-287-1373.
    Contact Person: Karen M. Templeton-Somers, Office of Science, 
Center for Tobacco Products, Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD, 20850, 1-877-287-1373, FAX: 240-276-
3655, email: [email protected].
    Registration to Attend the Workshop: 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. EDT on June 21, 2013. Submit electronic requests to 
http://www.surveymonkey.com/s/HWY9KNC. A confirmation email will be 
sent to your registered email address at least 2 weeks prior to the 
workshop date. Those without email access may register by contacting 
Karen M. Templeton-Somers (see Contact Person). Registration is free, 
but early registration is recommended because seating is limited. FDA 
may limit the number of participants from each organization as well as 
the total number of participants based on space limitations. 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. Please note that the Webcast link will not be live until 
the meeting begins at approximately 9 a.m. EDT on July 18, 2013. If 
registration reaches maximum capacity, FDA will post a notice closing 
registration for the workshop at http://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm.
    Requests for Oral Presentations: If you wish to make an oral 
presentation, please 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 in section II of 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 and interested parties, 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 product 
manufacturers. Individuals and organizations with common interests are 
urged to coordinate their presentations or request time for a joint 
presentation. All requests to make oral presentations must be received 
by the close of registration at 5 p.m. EDT on June 21, 2013. 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. Presenters must submit any presentation materials to 
Karen M. Templeton-Somers (see Contact Person) via email no later than 
July 10, 2013. FDA will do its best to accommodate questions during the 
workshop, although questions from the audience may be limited. In 
addition, we strongly encourage submitting comments to the docket (see 
Comments).
    If you need special accommodations because of disability, please 
contact Karen M. Templeton-Somers (see Contact Person) at least 7 days 
before the workshop.
    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 19, 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, rm. 1061, Rockville, MD 20852. It is 
only necessary to send one set of 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, and will be posted to 
the docket at http://www.regulations.gov.

SUPPLEMENTARY INFORMATION:

I. Background and Workshop Topics

    The purpose of this workshop is to obtain public input from 
regulated industry and other stakeholders and interested parties on the 
potential development and implementation of a standardized structure 
for electronic submission of tobacco product applications and other 
information. Stakeholders and interested parties could include, but are 
not limited to, large and small pharmaceutical manufacturers with 
experience in electronic submissions; vendors of software used to 
support electronic submissions; and large and small tobacco product 
manufacturers. The workshop will focus on technical aspects related to 
electronic submissions and standards currently used in other FDA 
centers. The types of submissions potentially subject to any future 
electronic submission standard may include, but are not limited to, 
applications for premarket review of new tobacco products (section 
910(b)(1) of the Federal Food, Drug, and Cosmetic Act) (the FD&C Act) 
(21 U.S.C. 387j(b)(1)), modified risk tobacco product applications 
(section 911(d) of the FD&C Act (21 U.S.C. 387k(d)), and reports 
submitted under section 905(j) of the FD&C Act (21 U.S.C. 387e(j)). In 
particular, FDA would like to discuss how available standardized 
submission structure and technologies facilitate preparation, 
submission, retrieval, processing, review, and archiving of 
submissions. For more information on study data standards resources, 
please see http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm.
    The electronic submission workshop will include discussion on eCTD, 
which is an International Conference on Harmonization (ICH) 
specification developed by ICH and its member parties. The eCTD 
provides an organizational structure for regulatory submissions 
utilizing comprehensive table of contents headings and hierarchy. Other 
FDA centers have been receiving submissions in the eCTD format since 
2003. For more information on eCTD, please see http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm153574.htm.
    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.

II. Workshop Topics for Discussion

    FDA is seeking public input on the following topics:
     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

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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?

    Dated: June 4, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13532 Filed 6-6-13; 8:45 am]
BILLING CODE 4160-01-P