82 FR 43768 - Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range		43768-43770
FR Document		2017-19928

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry entitled ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.'' This guidance is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA.

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

[Federal Register Volume 82, Number 180 (Tuesday, September 19, 2017)]
[Notices]
[Pages 43768-43770]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-19928]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0508]

Registration and Product Listing for Owners and Operators of
Domestic Tobacco Product Establishments; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised guidance for industry entitled ``Registration
and Product Listing for Owners and Operators of Domestic Tobacco
Product Establishments.'' This guidance is intended to assist persons
making tobacco product establishment registration and product listing
submissions to FDA.

DATES: The announcement of the guidance is published in the Federal
Register on September 19, 2017.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:

[[Page 43769]]

Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2009-D-0508 for ``Registration and Product Listing for Owners and
Operators of Domestic Tobacco Product Establishments.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of this guidance to the
Center for Tobacco Products, Food and Drug Administration, Document
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the guidance document may be sent. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Matthew Brenner, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002,
email: CTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a revised guidance for
industry entitled ``Registration and Product Listing for Owners and
Operators of Domestic Tobacco Product Establishments.'' This guidance
is intended to assist persons making tobacco product establishment
registration and product listing submissions to FDA. We are issuing
this guidance consistent with our good guidance practices regulation
(Sec. 10.115 (21 CFR 10.115)). We are implementing this guidance
without prior public comment because we have determined that prior
public participation is not feasible or appropriate given the upcoming
compliance deadline for registration and listing for certain owners and
operators of tobacco product manufacturing establishments. In addition,
the compliance policy for certain product listing labeling submissions
set forth in this revised guidance presents a less burdensome policy
consistent with the public health (Sec. 10.115(g)(2)). Although this
guidance document is immediately in effect, it remains subject to
comment in accordance with FDA's GGP regulation.
This revised guidance communicates a compliance policy for certain
product listing labeling submissions. Specifically, FDA does not, at
this time, intend to enforce the requirement that owners and operators
of tobacco product establishments submit the labeling for each
individually listed tobacco product if the registrant submits
information that represents the labeling for a selected line of
products. In deciding whether a registrant's submitted information
falls within this compliance policy, FDA may consider whether the
tobacco products' labeling is essentially identical (e.g., the same
formatting, fonts, colors, background text, and images) and whether the
variations are limited to package size, nicotine strength, propylene
glycol/vegetable glycerin ratio, and flavor. Under this compliance
policy, a registrant could submit information that represents the
labeling for a selected line of products, and FDA would not intend to
enforce the requirements in subsections 905(i)(1)(A) and (B) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
387e(1)(A) and (B)) with regard to labeling submissions.
This revised guidance also updates the compliance date for
registration and listing for persons who owned or operated domestic
manufacturing establishments engaged in the manufacture of newly deemed
products prior to August 8, 2016, and continued to own or operate such
establishment(s) on or after August 8, 2016. Such persons are required
to register and submit product listing information under section 905 of
the FD&C Act by December 31, 2016. However, in a guidance issued in May
2017, FDA announced that it does not intend to enforce these
requirements with respect to newly deemed products provided the
registration and product listing submissions are received by FDA on or
before September 30, 2017.
The guidance represents the current thinking of FDA on this topic.
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in section 905 of the FD&C Act have been
approved under OMB control number 0910-0650.

III. Electronic Access

Persons with access to the internet may obtain an electronic
version of the guidance at either https://www.regulations.gov or
https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

[[Page 43770]]

Dated: September 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19928 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

VerDate Sep<11>2014 17:12 Sep 18, 2017 Jkt 241001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\19SEN1.SGM 19SEN1

Document Created: 2018-10-24 14:18:57
Document Modified: 2018-10-24 14:18:57

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 of availability.
Dates		The announcement of the guidance is published in the Federal Register on September 19, 2017.
Contact		Matthew Brenner, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, email: [email protected]
FR Citation		82 FR 43768

82 FR 43768 - Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; Guidance for Industry; Availability

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