[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Notices]
[Pages 48992-48993]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19992]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0853]
Tobacco Product Manufacturing Facility Visits
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA), Center for Tobacco
Products (CTP) is announcing an invitation for participation in its
Tobacco Product Manufacturing Facility Visits. This program is intended
to give FDA staff an opportunity to visit facilities involved in the
manufacturing of tobacco products, including any related laboratory
testing, and observe the manufacturing operations of the tobacco
industry. The purpose of this notice is to invite parties interested in
participating in Tobacco Product Manufacturing Facility Visits to
submit requests to CTP.
DATES: Submit either an electronic or written request for participation
by October 15, 2012. See section IV of this document for information on
requests for participation.
ADDRESSES: If your facility is interested in participating in Tobacco
Product
[[Page 48993]]
Manufacturing Facility Visits, 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: Lindsay Tobias, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 877-287-1373, email: lindsay.tobias@fda.hhs.gov
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (Public Law 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. The new provisions include, among other things, the
authority to issue regulations related to tobacco product manufacturing
practice in order to protect the public health and to assure that
tobacco products are in compliance with the FD&C Act. Specifically,
section 906(e) of the FD&C Act (21 U.S.C. 387f(e)) provides that ``in
applying manufacturing restrictions to tobacco, the Secretary shall * *
* prescribe regulations (which may differ based on the type of tobacco
product involved) requiring that the methods used in, and the
facilities and controls used for, the manufacture, preproduction design
validation (including a process to assess the performance of a tobacco
product), packing, and storage of a tobacco product conform to current
good manufacturing practice, or hazard analysis and critical control
point methodology.''
CTP is instituting Tobacco Product Manufacturing Facility Visits to
provide FDA staff with the opportunity to:
Observe tobacco product manufacturing operations--from the
receipt of raw materials to the distribution of finished products, and
Learn about the manufacturing practices and processes
unique to your facility and regulated tobacco products.
This program will also inform FDA staff as they implement the
tobacco provisions of the FD&C Act.
II. Description of the Tobacco Product Manufacturing Facility Visits
In this program, groups of FDA staff plan to observe the following
facilities and their operations:
Manufacturing facilities, including facilities that
process, package, label, and distribute different types of regulated
tobacco products (cigarettes, cigarette tobacco, roll-your-own tobacco,
and smokeless tobacco products),
Laboratory facilities that perform tobacco testing
(whether third-party or in-house),
Manufacturing facilities for components, parts, and
accessories (including, but not limited to, cigarette paper, tipping
paper, filters), and
Manufacturing facilities for materials used for further
processing in finished tobacco products (including, but not limited to,
flavors, casings).
Please note that Tobacco Product Manufacturing Facility Visits are
not intended to include or replace official FDA inspections of
facilities to determine compliance with the FD&C Act; rather, these
facility visits are meant to educate FDA staff and improve their
understanding of the tobacco industry and its manufacturing operations.
III. Site Selection
CTP plans to select one or more of each of the following:
Cigarette manufacturers,
Cigarette tobacco and roll-your-own tobacco manufacturers,
Smokeless tobacco manufacturers,
Tobacco laboratories,
Importers of finished tobacco products,
Distributors and wholesalers of regulated tobacco
products,
Manufacturers of components, parts, accessories, and
Manufacturers of materials used for further processing in
finished tobacco products.
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, as applicable: (1) Compliance status of the
requesting facility and affiliated firm; (2) whether the requesting
facility is in arrears for user fees; and (3) whether the requesting
facility will be engaged in active manufacturing or processing during
the proposed time of the visit. All travel expenses associated with
Tobacco Product Manufacturer Facility Visits will be the responsibility
of CTP.
IV. Requests for Participation
The request for participation should include the following
identification information:
The name and contact information (including address, phone
number, and email) of your point of contact for the request,
The physical address(es) of the site(s) for which you are
submitting a request,
The type of processes (e.g., manufacturing, laboratory
practices, packaging, labeling, and distribution activities) performed
at your facility,
The type of tobacco products tested, processed, or
manufactured at your facility, and
A proposed program agenda.
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: August 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19992 Filed 8-14-12; 8:45 am]
BILLING CODE 4160-01-P