Document ID: FDA-2017-N-3998-0001
Agency: fda
Document Type: Notice
Title: Flavor Developer and Manufacturer Site Tours Program
Posted Date: 2017-09-19T04:00Z

[Federal Register Volume 82, Number 180 (Tuesday, September 19, 2017)]
[Notices]
[Page 43770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19900]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-3998]

Flavor Developer and Manufacturer 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 an invitation for participation in its 
voluntary Flavor Developer and Manufacturer Site Tours Program. This 
program is intended to give CTP staff an opportunity to visit companies 
that develop and/or manufacture flavors (including flavor mixtures) 
that are sold to tobacco product manufacturers in order to gain a 
better understanding of the development, testing, and production of 
flavors and flavor mixtures used in the manufacturing of tobacco 
products. The site tours in this program are not intended as regulatory 
inspections. The purpose of this notice is to invite parties interested 
in participating in the Flavor Developer and Manufacturer Site Tours 
Program to submit requests to CTP.

DATES: Submit either an electronic or written request for participation 
in this program by November 20, 2017. See section IV of this document 
for information on requests for participation.

ADDRESSES: If your company is interested in offering a site visit, 
please submit a request either electronically to https://www.regulations.gov or in writing to the Dockets Management Staff (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Karla Price, Office of Science, Center 
for Tobacco Products, Food and Drug Administration, Document Control 
Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 
20993-0002, 1-877-287-1373, email: AskCTP@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) was enacted on June 22, 2009, amending the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) by, among other things, adding a 
new chapter (chapter IX) granting FDA the authority to regulate tobacco 
product manufacturing, distribution, and marketing (Pub. L. 111-31). 
The Tobacco Control Act provides FDA authority to regulate cigarettes, 
cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any 
other tobacco products that the Agency by regulation deems to be 
subject to the law. On May 10, 2016, FDA published a final rule 
entitled ``Deeming Tobacco Products to be Subject to the Federal Food, 
Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and 
Tobacco Control Act; Restrictions on the Sale and Distribution of 
Tobacco Products and Required Warning Statements for Tobacco Products'' 
(81 FR 28974), which became effective on August 8, 2016. Under this 
rule, all products that meet the statutory definition of ``tobacco 
product'' set forth in section 201(rr) of the FD&C Act (21 U.S.C. 
321(rr)), including components and parts, but excluding accessories of 
newly deemed products, are now subject to chapter IX of the FD&C Act.
    CTP's Office of Science is conducting the Flavor Developer and 
Manufacturer Site Tours Program to provide its staff an opportunity to 
visit companies that develop and/or manufacture flavors (including 
flavor mixtures) that are sold to tobacco product manufacturers. Flavor 
developers and manufacturers are regulated by FDA if they, among other 
things, manufacture products that meet the statutory definition of a 
``tobacco product'' set forth in section 201(rr) of the FD&C Act. The 
site tours will aid the Agency in gaining a better understanding of the 
development, testing, and production of flavors and flavor mixtures 
used in the manufacturing of tobacco products. The goal for the Flavor 
Developer and Manufacturer Site Tours Program is for CTP staff to gain 
firsthand exposure to how flavors are developed, tested, and produced.

II. Description of Flavor Developer and Manufacturer Site Tours Program

    In the Flavor Developer and Manufacturer Site Tours Program, small 
groups of CTP staff will observe the operations of flavor developers 
and manufacturers, including the development, testing, and production 
of flavors that can be used by tobacco product manufacturers. The site 
tours in this program are not intended as regulatory inspections; 
rather, the program is meant to educate CTP staff and improve their 
understanding of flavors used in the manufacturing of tobacco products. 
It is anticipated that the site tours will take place in 2018.

III. Site Selection

    CTP hopes to be able to tour small, medium, and large flavor 
developers and manufacturers, as well as companies that develop and/or 
manufacture flavors that are used for different categories of tobacco 
products (e.g., cigarettes, cigars, smokeless tobacco, waterpipe 
tobacco, e-liquids). Final site selections will be based on the 
availability of funds and resources for the relevant fiscal year as 
well as the desire to visit a wide variety of flavor developers and 
manufacturers. All FDA travel expenses associated with the Flavor 
Developer and Manufacturer site tours will be the responsibility of 
FDA.

IV. Requests for Participation

    To aid in site selection, your request for participation should 
include the following information:
     A description of your company, including the size of the 
organization;
     A list of the flavors your company develops and/or 
manufactures and the categories of tobacco product (e.g., cigarettes, 
cigars, smokeless tobacco, waterpipe tobacco, e-liquids) for which your 
flavors are typically used;
     The physical address(es) of the site(s) for which you are 
submitting a request; and
     A proposed 1-day tour 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 Dockets Management Staff (see 
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19900 Filed 9-18-17; 8:45 am]
 BILLING CODE 4164-01-P