Pilot Program for Tobacco Product Manufacturers; Center for Tobacco Products eSubmissions Portal, 8079 [2016-03145]

Download as PDF Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices Dated: February 10, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016–03152 Filed 2–16–16; 8:45 am] BILLING CODE 4164–01–P 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. 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. SUMMARY: If you are interested in participating in this pilot program, please submit an electronic application to CTPeSub@fda.hhs.gov. 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, ann.staten@fda.hhs.gov. SUPPLEMENTARY INFORMATION: asabaliauskas on DSK5VPTVN1PROD with NOTICES ADDRESSES: 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 VerDate Sep<11>2014 19:05 Feb 16, 2016 Jkt 238001 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 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 8079 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 CTPeSub@fda.hhs.gov. 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–4462] Point of Care Prothrombin Time/ International Normalized Ratio Devices for Monitoring Warfarin Therapy; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public workshop; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing the following public workshop entitled ‘‘Point of Care Prothrombin Time/ International Normalized Ratio Devices for Monitoring Warfarin Therapy.’’ The purpose of this workshop is to discuss and receive input from stakeholders regarding approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in vitro diagnostic devices for improved clinical management of warfarin therapy in addition to describing the FDA’s process for facilitating the development of safe and effective POC and patient selftesting PT/INR devices. The goal of the workshop is to seek and identify potential solutions to address the scientific and regulatory challenges associated with POC PT/INR devices to ensure safety and effectiveness. The public workshop on ‘‘Point of Care SUMMARY: E:\FR\FM\17FEN1.SGM 17FEN1

Agencies

[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 
CTPeSub@fda.hhs.gov.

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, ann.staten@fda.hhs.gov.

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 CTPeSub@fda.hhs.gov. 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