Document ID: FDA-2011-N-0240-0001
Agency: fda
Document Type: Notice
Title: Site Tours Program
Posted Date: 2011-04-18T04:00Z

[Federal Register Volume 76, Number 74 (Monday, April 18, 2011)]
[Notices]
[Page 21753]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9260]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0240]

Site Tours Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA), Center for Tobacco 
Products (CTP) is announcing a notice 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 tobacco products. These visits are intended 
to provide CTP staff with the opportunity to gain a better 
understanding of the tobacco industry and its operations. 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 June 17, 2011. 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: Lucinda Miner, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 877-287-1373, e-mail: lucinda.miner@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control 
Act (Pub. L. 111-31; 123 Stat. 1776) 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. This includes, among other things, the authority to issue 
regulations related to health warnings, tobacco product standards, good 
manufacturing practices, as well as tobacco product constituents, 
ingredients, and additives.
    CTP is instituting 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 
manufacturing facilities of cigarette, roll-your-own, and smokeless 
tobacco companies. 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; 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 tobacco manufacturing facility, a 
burley tobacco farm, a flue-cured tobacco farm, a tobacco rolling paper 
facility, and a tobacco warehouse. All travel expenses associated with 
the site tours 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: April 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9260 Filed 4-15-11; 8:45 am]
BILLING CODE 4160-01-P