[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Pages 48992-48993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19992]



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 

[[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


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 
     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 

    Dated: August 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19992 Filed 8-14-12; 8:45 am]