81 FR 22620 - Tobacco Farm Site Tours Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 74 (April 18, 2016)

Page Range		22620-22621
FR Document		2016-08900

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.

Federal Register, Volume 81 Issue 74 (Monday, April 18, 2016)

[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Notices]
[Pages 22620-22621]
From the Federal Register Online  [www.thefederalregister.org]
[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: [email protected].

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

22620 Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices

Accreditation Criteria’’ provides In the Federal Register of October 21, information. No comments were
information for those interested in 2015 (80 FR 63806), FDA published a received.
participating in this voluntary program. 60-day notice requesting public FDA estimates the burden of this
comment on the proposed collection of collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response

Request for accreditation ..................................................... 1 1 1 80 80
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: April 12, 2016. 5630 Fishers Lane, Rm. 1061, Rockville, II. Description of Tobacco Farm Site
Leslie Kux, MD 20852. Tours Program
Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: In the Tobacco Farm Site Tours
[FR Doc. 2016–08893 Filed 4–15–16; 8:45 am] Allison Hoffman, Office of Science, Program, small groups of CTP staff plan
BILLING CODE 4164–01–P Center for Tobacco Products, Food and to observe the operations of farms that
Drug Administration, 10903 New grow tobacco for sale to tobacco product
Hampshire Ave., Bldg. 75, Rm. 5426, manufacturers. Please note that FDA
DEPARTMENT OF HEALTH AND Silver Spring, MD 20993–0002, 1–877– does not regulate these farms and the
HUMAN SERVICES 287–1373, email: CTPRegulations@ Tobacco Farm Site Tours Program is not
fda.hhs.gov. an inspection of facilities to determine
Food and Drug Administration
SUPPLEMENTARY INFORMATION: compliance with the FD&C Act; rather,
this program is meant to educate CTP
[Docket No. FDA–2016–N–1109] I. Background staff and improve their understanding of
On June 22, 2009, the President tobacco farming. It is anticipated that
Tobacco Farm Site Tours Program
signed the Family Smoking Prevention the tobacco farm site tours will take
AGENCY: Food and Drug Administration, and Tobacco Control Act (Pub. L. 111– place in the fall of 2016.
HHS. 31) into law, amending the Federal III. Site Selection
ACTION: Notice. Food, Drug, and Cosmetic Act (the
FD&C Act) and giving FDA authority to CTP hopes to be able to tour small,
SUMMARY: The Food and Drug regulate tobacco product manufacturing, medium, and large farms, and farms that
Administration (FDA), Center for distribution, and marketing. grow tobacco for different kinds of
Tobacco Products (CTP), is announcing tobacco products. Final site selections
CTP’s Office of Science is conducting
an invitation for participation in its will be based on the availability of
the Tobacco Farm Site Tours Program to
voluntary Tobacco Farm Site Tours funds and resources for the relevant
provide its staff an opportunity to visit
Program. This program is intended to fiscal year as well as the desire to visit
farms that grow tobacco for sale to
give CTP staff an opportunity to visit a wide variety of types of tobacco farms.
tobacco product manufacturers (a
farms that grow tobacco for sale to FDA plans on visiting nine or fewer
‘‘tobacco product manufacturer’’ is
tobacco product manufacturers in order farms. All FDA travel expenses
defined as any person, including any
to gain a better understanding of tobacco associated with the farm site tours will
repacker or relabeler, who
farming and the processes involved in be the responsibility of FDA.
manufactures, fabricates, assembles,
curing and preparing tobacco intended processes, or labels a tobacco product, IV. Requests for Participation
for sale to tobacco product or imports a finished tobacco product
manufacturers. This program is not an To aid in site selection, your request
for sale or distribution in the United
FDA regulatory inspection, and tobacco for participation should include the
States (section 900(20) of the FD&C Act
farms are not regulated entities unless following information:
(21 U.S.C. 387(20))). Although farms
they are also a tobacco product that grow tobacco are not FDA-regulated • A description of your farm,
manufacturer or controlled by a tobacco entities unless they are also a tobacco including the size of the farm;
product manufacturer. The purpose of product manufacturer or controlled by a • A list of the type(s) of tobacco
this notice is to invite parties interested tobacco product manufacturer (see grown and the kinds of tobacco product
in participating in the Tobacco Farm section 901(c)(2) of the FD&C Act (21 manufacturers to whom you sell
Site Tours Program to submit requests to U.S.C. 387a(c)(2))), tobacco farm site tobacco;
CTP. visits will aid the Agency in gaining a • The physical address(es) of the
DATES: Submit either an electronic or better understanding of tobacco farming site(s) for which you are submitting a
written request for participation in this and the processes involved in curing request; and
program by June 17, 2016. See section and preparing tobacco leaf intended for • A proposed 1-day tour agenda.
IV of this document for information on
mstockstill on DSK4VPTVN1PROD with NOTICES

sale to tobacco product manufacturers. Identify requests for participation
requests for participation. The goal for the Tobacco Farm Site with the docket number found in
ADDRESSES: If your farm is interested in Tours Program is for CTP staff to gain brackets in the heading of this
offering a site visit, please submit a firsthand exposure to tobacco farming document. Received requests are
request either electronically to http:// practices, including cultivation, available for public examination in the
www.regulations.gov or in writing to the harvesting, curing, and preparation for Division of Dockets Management (see
Division of Dockets Management (HFA– sale of tobacco leaf to tobacco product ADDRESSES) between 9 a.m. and 4 p.m.,
305), Food and Drug Administration, manufacturers. Monday through Friday.

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Document Created: 2016-04-16 01:46:01
Document Modified: 2016-04-16 01:46:01

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
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: [email protected]
FR Citation		81 FR 22620

81 FR 22620 - Tobacco Farm Site Tours Program

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 74 (April 18, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration