[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)]
[Notices]
[Page 8079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03145]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0160]


Pilot Program for Tobacco Product Manufacturers; Center for 
Tobacco Products eSubmissions Portal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Center for Tobacco Products (CTP) in the Food and Drug 
Administration (FDA) is soliciting applications from regulated tobacco 
product manufacturers to participate in a voluntary pilot program to 
help CTP evaluate a potential new portal, the CTP eSubmissions Portal 
(CTP Portal), that is being designed to improve the process in 
connection with providing certain regulatory submissions electronically 
to CTP. CTP plans to accept up to six participants for the pilot 
program. The pilot program is intended to provide CTP regulatory review 
staff with an opportunity to evaluate the CTP Portal, including its 
capability for sending and receiving secure messages and providing 
information as to the documents submitted to it (for example, receipt 
date and tracking number).

DATES: Interested parties should submit an electronic application to 
participate in this pilot program by March 2, 2016. We plan to conduct 
user testing beginning on or about March 18, 2016. See section III of 
this document for information on applications for participation.

ADDRESSES: If you are interested in participating in this pilot 
program, please submit an electronic application to 
[email protected].

FOR FURTHER INFORMATION CONTACT: Ann Staten, Center for Tobacco 
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
75, Rm. G402, Silver Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The Family Smoking Prevention and Tobacco Control Act of 2009 
(Tobacco Control Act) (Pub. L. 111-31) grants FDA important authority 
to regulate the manufacture, marketing, and distribution of tobacco 
products to protect the public health generally and to reduce tobacco 
use by minors. Among its many provisions, the Tobacco Control Act 
created requirements for tobacco product manufacturers and importers, 
among others, to submit certain regulatory documents and information to 
FDA, including, but not limited to, new tobacco product applications, 
documents relating to certain research activities and research 
findings, and documents relating to tobacco product ingredients, 
including harmful and potentially harmful constituents. While certain 
of these documents must be submitted electronically, for others an 
electronic format for submission currently is not required but is 
strongly encouraged to facilitate efficiency and timeliness of data 
submission and management. Also, in June 2013, CTP announced a workshop 
to obtain public input on topics related to the potential electronic 
submission of tobacco product applications and other information and 
opened a docket for public comment on this topic. (For more information 
about this workshop, please see ``Electronic Submission of Tobacco 
Product Applications and Other Information; Public Workshop; Request 
for Comments'' (78 FR 34393, June 7, 2013).
    CTP has reviewed the input received from the comments and other 
sources and is committed to improving the processes for providing 
regulatory submissions electronically to FDA. Consequently, CTP is 
announcing a pilot program to test the functionality of the CTP Portal, 
an electronic submission and communication tool that should enhance 
efficiency, communication, and timeliness.

II. Pilot Program Participation

    The pilot program to evaluate the CTP Portal is to last 
approximately 3 months. During the pilot program, CTP staff will be 
available to answer any questions or concerns that may arise. Pilot 
program participants will receive training and will be asked to submit 
regulatory submissions using data provided to them by CTP for testing 
purposes. Pilot program participants also will be asked to provide 
written and verbal feedback during their training and after their 
participation in the pilot program is over. These comments and 
discussions will assist CTP in its development of the CTP Portal. CTP 
estimates that each individual participant's involvement should take 
about 15 hours.
    CTP is soliciting applications from regulated tobacco product 
manufacturers and, in particular, is interested in hearing from small 
tobacco product manufacturers (STPMs) and tobacco product manufacturers 
that use an authorized agent.

III. Applications for Participation

    Applications to participate in the pilot program should be sent 
electronically to [email protected]. Applications should include the 
following information: Company and contact name; contact phone number; 
contact email address; and whether you are an STPM. Once applications 
for participation are received, FDA will contact interested applicants 
to discuss the pilot program. FDA is seeking a limited number of 
participants (no more than six) to participate in this pilot program. 
The pilot program is expected to last approximately 3 months.

    Dated: February 10, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03145 Filed 2-16-16; 8:45 am]
 BILLING CODE 4164-01-P