[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]
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