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