[Federal Register Volume 81, Number 115 (Wednesday, June 15, 2016)]
[Notices]
[Pages 39053-39054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14139]


=======================================================================
-----------------------------------------------------------------------

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 newly deemed tobacco products and their components and 
parts, including any related laboratory testing, and to observe the 
manufacturing operations of the tobacco industry. The purpose of this 
document 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 August 15, 2016. See section IV of this document for information on 
requests for participation.

ADDRESSES: If your facility is interested in participating in Tobacco 
Product 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: Matthew Brenner, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, Bldg. 
71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
877-287-1373, email: [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. 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 newly deemed tobacco 
products, and
     Learn about the manufacturing practices and processes 
unique to your facility and newly deemed 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 establishments that 
process, package, label, and distribute different types of newly deemed 
tobacco products (e.g., dissolvable products, gels, cigars, pipe 
tobacco, waterpipe tobacco products, and electronic nicotine delivery 
systems (ENDS) (including e-cigarettes, e-hookah, e-cigars, vape pens, 
advanced refillable personal vaporizers, and electronic pipes) and 
liquid nicotine and flavors) (see 81 FR 28973, May 10, 2016),
     Laboratory facilities that perform tobacco testing 
(whether third-party or in-house), and
     Manufacturing facilities for tobacco products for further 
manufacturing into finished tobacco products (including, but not 
limited to, components, parts, flavors, casings, e-liquids).
    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 sites from one or more of each of the following 
categories:
     Dissolvable products,
     Gels,
     Cigars,
     Pipe tobacco,
     Waterpipe tobacco products,
     ENDS (including e-cigarettes, e-hookah, e-cigars, vape 
pens, advanced refillable personal vaporizers, and electronic pipes) 
and liquid nicotine and flavors,
     Tobacco laboratories,
     Importers of finished tobacco products,
     Distributors and wholesalers of regulated tobacco 
products, and/or
     Manufacturers of tobacco products for further 
manufacturing into finished tobacco products (including, but not 
limited to, components, parts, flavors, casings, e-liquids).
    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 or affiliated firm, if applicable, has a significant request 
or marketing application or submission pending with FDA; 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;

[[Page 39054]]

     The physical address(es) of the site(s) for which you are 
submitting a request;
     The type of processes (e.g., manufacturing, laboratory 
practices, mixing, 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.
    Identify requests for participation with the docket number found in 
brackets in the heading of this document. Received requests 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: June 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14139 Filed 6-14-16; 8:45 am]
BILLING CODE 4164-01-P