
[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Notices]
[Pages 22620-22621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08900]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1109]


Tobacco Farm Site Tours Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), Center for Tobacco 
Products (CTP), is announcing an invitation for participation in its 
voluntary Tobacco Farm Site Tours Program. This program is intended to 
give CTP staff an opportunity to visit farms that grow tobacco for sale 
to tobacco product manufacturers in order to gain a better 
understanding of tobacco farming and the processes involved in curing 
and preparing tobacco intended for sale to tobacco product 
manufacturers. This program is not an FDA regulatory inspection, and 
tobacco farms are not regulated entities unless they are also a tobacco 
product manufacturer or controlled by a tobacco product manufacturer. 
The purpose of this notice is to invite parties interested in 
participating in the Tobacco Farm Site Tours Program to submit requests 
to CTP.

DATES: Submit either an electronic or written request for participation 
in this program by June 17, 2016. See section IV of this document for 
information on requests for participation.

ADDRESSES: If your farm is interested in offering a site visit, please 
submit a request either electronically to http://www.regulations.gov or 
in writing to the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Allison Hoffman, Office of Science, 
Center for Tobacco Products, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 5426, Silver Spring, MD 20993-0002, 1-
877-287-1373, email: CTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Pub. L. 111-31) into law, amending 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and giving FDA 
authority to regulate tobacco product manufacturing, distribution, and 
marketing.
    CTP's Office of Science is conducting the Tobacco Farm Site Tours 
Program to provide its staff an opportunity to visit farms that grow 
tobacco for sale to tobacco product manufacturers (a ``tobacco product 
manufacturer'' is defined as any person, including any repacker or 
relabeler, who manufactures, fabricates, assembles, processes, or 
labels a tobacco product, or imports a finished tobacco product for 
sale or distribution in the United States (section 900(20) of the FD&C 
Act (21 U.S.C. 387(20))). Although farms that grow tobacco are not FDA-
regulated entities unless they are also a tobacco product manufacturer 
or controlled by a tobacco product manufacturer (see section 901(c)(2) 
of the FD&C Act (21 U.S.C. 387a(c)(2))), tobacco farm site visits will 
aid the Agency in gaining a better understanding of tobacco farming and 
the processes involved in curing and preparing tobacco leaf intended 
for sale to tobacco product manufacturers. The goal for the Tobacco 
Farm Site Tours Program is for CTP staff to gain firsthand exposure to 
tobacco farming practices, including cultivation, harvesting, curing, 
and preparation for sale of tobacco leaf to tobacco product 
manufacturers.

II. Description of Tobacco Farm Site Tours Program

    In the Tobacco Farm Site Tours Program, small groups of CTP staff 
plan to observe the operations of farms that grow tobacco for sale to 
tobacco product manufacturers. Please note that FDA does not regulate 
these farms and the Tobacco Farm Site Tours Program is not an 
inspection of facilities to determine compliance with the FD&C Act; 
rather, this program is meant to educate CTP staff and improve their 
understanding of tobacco farming. It is anticipated that the tobacco 
farm site tours will take place in the fall of 2016.

III. Site Selection

    CTP hopes to be able to tour small, medium, and large farms, and 
farms that grow tobacco for different kinds of tobacco products. Final 
site selections will be based on the availability of funds and 
resources for the relevant fiscal year as well as the desire to visit a 
wide variety of types of tobacco farms. FDA plans on visiting nine or 
fewer farms. All FDA travel expenses associated with the farm site 
tours will be the responsibility of FDA.

IV. Requests for Participation

    To aid in site selection, your request for participation should 
include the following information:
     A description of your farm, including the size of the 
farm;
     A list of the type(s) of tobacco grown and the kinds of 
tobacco product manufacturers to whom you sell tobacco;
     The physical address(es) of the site(s) for which you are 
submitting a request; and
     A proposed 1-day tour agenda.
    Identify requests for participation with the docket number found in 
brackets in the heading of this document. Received requests are 
available for public examination in the Division of Dockets Management 
(see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.


[[Page 22621]]


    Dated: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08900 Filed 4-15-16; 8:45 am]
 BILLING CODE 4164-01-P


