82 FR 43770 - Flavor Developer and Manufacturer Site Tours Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 180 (September 19, 2017)

Page Range		43770-43770
FR Document		2017-19900

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.

Federal Register, Volume 82 Issue 180 (Tuesday, September 19, 2017)

[Federal Register Volume 82, Number 180 (Tuesday, September 19, 2017)]
[Notices]
[Page 43770]
From the Federal Register Online [www.thefederalregister.org]
[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

43770 Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices

Dated: September 14, 2017. I. Background product manufacturers. The site tours in
Anna K. Abram, The Family Smoking Prevention and this program are not intended as
Deputy Commissioner for Policy, Planning, Tobacco Control Act (Tobacco Control regulatory inspections; rather, the
Legislation, and Analysis. Act) was enacted on June 22, 2009, program is meant to educate CTP staff
[FR Doc. 2017–19928 Filed 9–18–17; 8:45 am] amending the Federal Food, Drug, and and improve their understanding of
BILLING CODE 4164–01–P Cosmetic Act (the FD&C Act) by, among flavors used in the manufacturing of
other things, adding a new chapter tobacco products. It is anticipated that
(chapter IX) granting FDA the authority the site tours will take place in 2018.
DEPARTMENT OF HEALTH AND to regulate tobacco product III. Site Selection
HUMAN SERVICES manufacturing, distribution, and
CTP hopes to be able to tour small,
marketing (Pub. L. 111–31). The
Food and Drug Administration medium, and large flavor developers
Tobacco Control Act provides FDA
and manufacturers, as well as
authority to regulate cigarettes, cigarette
[Docket No. FDA–2017–N–3998] companies that develop and/or
tobacco, roll-your-own tobacco,
manufacture flavors that are used for
smokeless tobacco, and any other
Flavor Developer and Manufacturer different categories of tobacco products
tobacco products that the Agency by
Site Tours Program (e.g., cigarettes, cigars, smokeless
regulation deems to be subject to the
tobacco, waterpipe tobacco, e-liquids).
AGENCY: Food and Drug Administration, law. On May 10, 2016, FDA published
Final site selections will be based on the
HHS. a final rule entitled ‘‘Deeming Tobacco
availability of funds and resources for
Products to be Subject to the Federal
ACTION: Notice. the relevant fiscal year as well as the
Food, Drug, and Cosmetic Act, as
desire to visit a wide variety of flavor
SUMMARY: The Food and Drug Amended by the Family Smoking
developers and manufacturers. All FDA
Administration (FDA), Center for Prevention and Tobacco Control Act;
travel expenses associated with the
Tobacco Products (CTP), is announcing Restrictions on the Sale and Distribution
Flavor Developer and Manufacturer site
an invitation for participation in its of Tobacco Products and Required
tours will be the responsibility of FDA.
voluntary Flavor Developer and Warning Statements for Tobacco
Manufacturer Site Tours Program. This Products’’ (81 FR 28974), which became IV. Requests for Participation
program is intended to give CTP staff an effective on August 8, 2016. Under this To aid in site selection, your request
opportunity to visit companies that rule, all products that meet the statutory for participation should include the
develop and/or manufacture flavors definition of ‘‘tobacco product’’ set forth following information:
(including flavor mixtures) that are sold in section 201(rr) of the FD&C Act (21 • A description of your company,
to tobacco product manufacturers in U.S.C. 321(rr)), including components including the size of the organization;
order to gain a better understanding of and parts, but excluding accessories of • A list of the flavors your company
the development, testing, and newly deemed products, are now develops and/or manufactures and the
production of flavors and flavor subject to chapter IX of the FD&C Act. categories of tobacco product (e.g.,
mixtures used in the manufacturing of CTP’s Office of Science is conducting cigarettes, cigars, smokeless tobacco,
tobacco products. The site tours in this the Flavor Developer and Manufacturer waterpipe tobacco, e-liquids) for which
program are not intended as regulatory Site Tours Program to provide its staff your flavors are typically used;
inspections. The purpose of this notice an opportunity to visit companies that • The physical address(es) of the
is to invite parties interested in develop and/or manufacture flavors site(s) for which you are submitting a
participating in the Flavor Developer (including flavor mixtures) that are sold request; and
and Manufacturer Site Tours Program to to tobacco product manufacturers. • A proposed 1-day tour agenda.
submit requests to CTP. Flavor developers and manufacturers Identify requests for participation
are regulated by FDA if they, among with the docket number found in
DATES: Submit either an electronic or other things, manufacture products that brackets in the heading of this
written request for participation in this meet the statutory definition of a document. Received requests are
program by November 20, 2017. See ‘‘tobacco product’’ set forth in section available for public examination in the
section IV of this document for 201(rr) of the FD&C Act. The site tours Dockets Management Staff (see
information on requests for will aid the Agency in gaining a better ADDRESSES) between 9 a.m. and 4 p.m.,
participation. understanding of the development, Monday through Friday.
ADDRESSES: If your company is testing, and production of flavors and
Dated: September 14, 2017.
interested in offering a site visit, please flavor mixtures used in the
manufacturing of tobacco products. The Anna K. Abram,
submit a request either electronically to
goal for the Flavor Developer and Deputy Commissioner for Policy, Planning,
https://www.regulations.gov or in Legislation, and Analysis.
writing to the Dockets Management Staff Manufacturer Site Tours Program is for
CTP staff to gain firsthand exposure to [FR Doc. 2017–19900 Filed 9–18–17; 8:45 am]
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm. how flavors are developed, tested, and BILLING CODE 4164–01–P

1061, Rockville, MD 20852. produced.
FOR FURTHER INFORMATION CONTACT: II. Description of Flavor Developer and DEPARTMENT OF HEALTH AND
asabaliauskas on DSKBBXCHB2PROD with NOTICES

Karla Price, Office of Science, Center for Manufacturer Site Tours Program HUMAN SERVICES
Tobacco Products, Food and Drug In the Flavor Developer and
Administration, Document Control Manufacturer Site Tours Program, small National Institutes of Health
Center, 10903 New Hampshire Ave., groups of CTP staff will observe the
Bldg. 71, Rm. G335, Silver Spring, MD National Heart, Lung, and Blood
operations of flavor developers and Institute; Notice of Closed Meeting
20993–0002, 1–877–287–1373, email: manufacturers, including the
AskCTP@fda.hhs.gov. development, testing, and production of Pursuant to section 10(d) of the
SUPPLEMENTARY INFORMATION: flavors that can be used by tobacco Federal Advisory Committee Act, as

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Document Created: 2018-10-24 14:19:51
Document Modified: 2018-10-24 14:19:51

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
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: [email protected]
FR Citation		82 FR 43770

82 FR 43770 - Flavor Developer and Manufacturer Site Tours Program

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 180 (September 19, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration