Document ID: FDA-2014-N-0889-0001
Agency: fda
Document Type: Notice
Title: Site Tours Program
Posted Date: 2014-07-17T04:00Z

[Federal Register Volume 79, Number 137 (Thursday, July 17, 2014)]
[Notices]
[Pages 41698-41699]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16794]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0889]

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), Office of Science is announcing an invitation for 
participation in its Site Tours Program. This program is intended to 
give CTP staff an opportunity to visit facilities involved in the 
growing, processing, or manufacturing of tobacco or currently regulated 
tobacco products (i.e., cigarettes, roll-your-own, and smokeless 
tobacco). These visits are intended to provide CTP staff with the 
opportunity to gain a better understanding of the tobacco industry and 
its operations and are not intended as regulatory inspections or 
facility visits for the purposes of developing Tobacco Product 
Manufacturing Practice regulations. The purpose of this notice is to 
alert parties interested in participating in the Site Tours Program to 
submit requests to CTP.

DATES: Interested parties should submit either an electronic or written 
request for participation by September 15, 2014. The request should 
include a description of your facility, including as applicable, a list 
of all tobacco products processed and/or manufactured there. Please 
specify the physical address(es) of the site(s) for which you are 
submitting a request along with a proposed 1-day tour agenda.

ADDRESSES: If your facility is interested in offering a site visit, you 
should submit a request to participate in the program 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: Carolyn Dresler, Center for Tobacco 
Products, Food and Drug Administration, 10903 New Hampshire Ave., 
Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993-
0002, 240-402-4067, carolyn.dresler@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control 
Act (Pub. L. 111-31) was signed 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 continuing the Site Tours Program to 
provide its scientific and regulatory staff the opportunity to gain a 
better understanding of the tobacco industry and its operations, 
including tobacco product manufacturing and aspects of tobacco growing, 
processing, and storage that may affect the physical and chemical 
properties of tobacco. Although FDA generally does not regulate tobacco 
farms and tobacco warehouses, the Agency believes that gaining a better 
understanding of the operations performed at these facilities may be 
helpful. The goals of the Site Tours Program are to: (1) Provide CTP 
firsthand exposure to industry's manufacturing processes; (2) learn 
about control measures used by tobacco product manufacturers to ensure 
product consistency; (3) understand the processing of different forms 
of tobacco and the manufacturing processes used for various types of 
tobacco products and their influences on product constituents; and (4) 
understand how growing conditions, curing, storage, and manufacturing 
processes might influence the levels of tobacco or tobacco smoke 
constituents.

II. Description of Site Tours Program

    In the Site Tours Program, small groups of CTP staff plan to 
observe the operations of tobacco growers, tobacco warehouses, and 
tobacco product manufacturing facilities of cigarettes, roll-your-own, 
and smokeless tobacco companies, including the manufacturing of paper, 
filters, and pouch materials. Please note that the Site Tours Program 
is not intended to include official FDA inspections of facilities to 
determine compliance with the FD&C Act or for the purposes of 
developing Tobacco Product Manufacturing Practice regulations; rather, 
the program is meant to educate CTP staff and improve their 
understanding of the tobacco industry and its operations.

III. Site Selection

    CTP plans to select one or more of each of the following types of 
facilities: A large cigarette manufacturing facility, a small cigarette 
manufacturing facility, a smokeless manufacturing facility, a burley 
tobacco farm, a flue-cured tobacco farm, a tobacco rolling paper 
facility, a tobacco warehouse and a tobacco processing facility. All 
travel expenses associated with the site tours

[[Page 41699]]

will be the responsibility of CTP. Final site selections will be based 
on the availability of CTP funds and resources for the relevant fiscal 
year, as well as the following factors: (1) Compliance status of the 
requesting facility and affiliated firm, if applicable; (2) whether the 
requesting facility is in arrears for user fees; (3) whether the 
requesting facility or affiliated firm, if applicable, has a 
significant request or marketing application or submission pending with 
FDA; and (4) whether the requesting facility will be engaged in active 
manufacturing or processing during the proposed time of the visit.

IV. Requests for Participation

    Requests are to be identified with the docket number found in 
brackets in the heading of this document. Requests received by the 
Agency are available for public examination in the Division of Dockets 
Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: July 14, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-16794 Filed 7-16-14; 8:45 am]
BILLING CODE 4164-01-P