Listing of Ingredients in Tobacco Products; Revised Guidance for Industry; Availability, 96003-96004 [2016-31587]
Download as PDF
96003
Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
submission. In addition, the burden
hours per response were determined
based on reports from a sample of
ADSSP and ADI grants.
Number of
respondents
Instrument
Type of respondent
ADP–DRT .........................................
ADP–DRT .........................................
Local Program Site ..........................
Grantee ............................................
Estimated Total Annual Burden
Hours: 983.44.
Dated: December 22, 2016.
Edwin L. Walker,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2016–31528 Filed 12–28–16; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0524]
Listing of Ingredients in Tobacco
Products; Revised Guidance for
Industry; Availability
AGENCY:
ACTION:
Food and Drug Administration,
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a revised
guidance for industry entitled ‘‘Listing
of Ingredients in Tobacco Products.’’
The revised guidance document is
intended to assist persons making
tobacco product ingredient submissions
to FDA as required by the Family
Smoking Prevention and Tobacco
Control Act (Tobacco Control Act). We
received several comments to the draft
guidance, and those comments were
considered as the guidance was
finalized.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
18:41 Dec 28, 2016
Jkt 241001
76
38
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
HHS.
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–0524 for ‘‘Listing of Ingredients
in Tobacco Products.’’ 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 Division of Dockets
Management 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
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Responses
per
respondent
Burden hours
per response
2
2
4.67
3.6
Total burden
hours
(annual)
709.84
273.6.
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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the revised draft 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 20993–2000. Send one selfaddressed 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 document.
FOR FURTHER INFORMATION CONTACT:
Katherine Collins, Center for Tobacco
Products, Food and Drug
Administration, Document Control
Center, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, Silver Spring, MD
20993–2000, 1–877–287–1373, email:
AskCTP@fda.hhs.gov.
E:\FR\FM\29DEN1.SGM
29DEN1
96004
Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a revised guidance for industry entitled
‘‘Listing of Ingredients in Tobacco
Products.’’ We are issuing this guidance
consistent with our good guidance
practices regulation (21 CFR 10.115).
The revised guidance document is
intended to assist persons making
tobacco product ingredient submissions
to FDA as required by the Tobacco
Control Act.
The Tobacco Control Act (Pub. L.
111–31), enacted on June 22, 2009,
amends the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) and
provides FDA with the authority to
regulate the manufacture, marketing,
and distribution of tobacco products to
protect the public health. Among its
many provisions, the Tobacco Control
Act added section 904 to the FD&C Act
(21 U.S.C. 387d), establishing
requirements for tobacco product
ingredient submissions.
The revised guidance discusses
tobacco products that are newly deemed
subject to chapter IX of the FD&C Act.
Cigarettes, cigarette tobacco, roll-yourown tobacco (RYO), and smokeless
tobacco were immediately covered by
FDA’s tobacco product authorities in
chapter IX of the FD&C Act, including
section 904, when the Tobacco Control
Act went into effect. As for other types
of tobacco products, section 901(b) of
the FD&C Act (21 U.S.C. 387a) grants
FDA authority to deem those products
subject to chapter IX of the FD&C Act.
Under that authority, FDA issued a rule
deeming all other 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)), except
for accessories of those products, as
subject to chapter IX of the FD&C Act
(81 FR 28974). FDA published the final
rule on May 10, 2016 and it became
effective on August 8, 2016. As a result,
manufacturers or importers (or their
agents) of tobacco products subject to
the deeming rule are now required to
comply with chapter IX of the FD&C
Act, including the ingredient listing
requirements in section 904(a)(1).
Section 904(a)(1) of the FD&C Act
requires each tobacco product
manufacturer or importer, or agent
thereof, to submit a listing of all
ingredients, including tobacco,
substances, compounds, and additives
that are added by the manufacturer to
the tobacco, paper, filter, or other part
of each tobacco product by brand and by
quantity in each brand and subbrand.
For cigarettes, cigarette tobacco, RYO,
and smokeless tobacco products on the
VerDate Sep<11>2014
18:41 Dec 28, 2016
Jkt 241001
market as of June 22, 2009, the list of
ingredients had to be submitted by
December 22, 2009. For cigarettes,
cigarette tobacco, RYO, and smokeless
tobacco products not on the market as
of June 22, 2009, section 904(c)(1)
requires that the list of ingredients be
submitted at least 90 days prior to
delivery for introduction into interstate
commerce. Section 904(c) of the FD&C
Act also requires submission of
information whenever any additive, or
the quantity of any additive, is changed.
As described in the preamble to the
final deeming rule, for products other
than cigarettes, cigarette tobacco, RYO,
and smokeless tobacco that are on the
market as of August 8, 2016, FDA does
not intend to enforce the section
904(a)(1) ingredient listing submission
requirement until 6 months from the
effective date of the rule or 12 months
from the effective date for small-scale
tobacco product manufacturers.
However, in the revised guidance, FDA
is announcing an additional 6-month
compliance policy for newly deemed
tobacco products on the market as of
August 8, 2016. Under this policy, FDA
will not enforce the ingredient listing
submission requirement until August 8,
2017, for businesses that are not
considered small-scale tobacco product
manufactures, and February 8, 2018, for
small-scale tobacco product
manufacturers. Manufacturers of
tobacco products introduced into
interstate commerce after August 8,
2016, must submit the ingredient
information required by section
904(a)(1) at least 90 days before the
product is delivered for introduction
into interstate commerce, as with
cigarettes, cigarette tobacco, RYO, and
smokeless tobacco first marketed after
June 22, 2009 (section 904(c)(1) of the
FD&C Act).
II. Significance of Guidance
FDA is issuing this revised guidance
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ingredient listing. 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.
III. Paperwork Reduction Act of 1995
This revised guidance also refers to
previously approved collections of
information found in FDA regulations.
The revised draft guidance includes
information and recommendations for
how to provide ingredient listing
submissions. The collections of
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
information in section 904(a)(1) of the
FD&C Act have been approved under
OMB control number 0910–0650.
IV. Electronic Access
Persons with access to the Internet
may obtain an electronic version of the
revised guidance at either https://
www.regulations.gov or https://
www.fda.gov/TobaccoProducts/
Labeling/RulesRegulationsGuidance/
default.htm.
Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31587 Filed 12–28–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0002]
Abbott Laboratories, et al.; Withdrawal
of Approval of Four New Drug
Applications and Two Abbreviated
New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of four new drug applications
(NDAs) and two abbreviated new drug
applications (ANDAs) from multiple
applicants. The holders of the
applications notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
SUMMARY:
DATES:
Effective Date: January 30, 2017.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: The
holders of the applications listed in the
table have informed FDA that these drug
products are no longer marketed and
have requested that FDA withdraw
approval of the applications pursuant to
the process in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
E:\FR\FM\29DEN1.SGM
29DEN1
Agencies
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96003-96004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31587]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0524]
Listing of Ingredients in Tobacco Products; Revised Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a revised guidance for industry entitled ``Listing of
Ingredients in Tobacco Products.'' The revised guidance document is
intended to assist persons making tobacco product ingredient
submissions to FDA as required by the Family Smoking Prevention and
Tobacco Control Act (Tobacco Control Act). We received several comments
to the draft guidance, and those comments were considered as the
guidance was finalized.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: You may submit 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:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-0524 for ``Listing of Ingredients in Tobacco Products.''
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 Division of Dockets Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the revised draft
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 20993-2000. 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 document.
FOR FURTHER INFORMATION CONTACT: Katherine Collins, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-2000,
1-877-287-1373, email: AskCTP@fda.hhs.gov.
[[Page 96004]]
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a revised guidance for
industry entitled ``Listing of Ingredients in Tobacco Products.'' We
are issuing this guidance consistent with our good guidance practices
regulation (21 CFR 10.115).
The revised guidance document is intended to assist persons making
tobacco product ingredient submissions to FDA as required by the
Tobacco Control Act.
The Tobacco Control Act (Pub. L. 111-31), enacted on June 22, 2009,
amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and
provides FDA with the authority to regulate the manufacture, marketing,
and distribution of tobacco products to protect the public health.
Among its many provisions, the Tobacco Control Act added section 904 to
the FD&C Act (21 U.S.C. 387d), establishing requirements for tobacco
product ingredient submissions.
The revised guidance discusses tobacco products that are newly
deemed subject to chapter IX of the FD&C Act. Cigarettes, cigarette
tobacco, roll-your-own tobacco (RYO), and smokeless tobacco were
immediately covered by FDA's tobacco product authorities in chapter IX
of the FD&C Act, including section 904, when the Tobacco Control Act
went into effect. As for other types of tobacco products, section
901(b) of the FD&C Act (21 U.S.C. 387a) grants FDA authority to deem
those products subject to chapter IX of the FD&C Act. Under that
authority, FDA issued a rule deeming all other 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)), except for accessories of
those products, as subject to chapter IX of the FD&C Act (81 FR 28974).
FDA published the final rule on May 10, 2016 and it became effective on
August 8, 2016. As a result, manufacturers or importers (or their
agents) of tobacco products subject to the deeming rule are now
required to comply with chapter IX of the FD&C Act, including the
ingredient listing requirements in section 904(a)(1).
Section 904(a)(1) of the FD&C Act requires each tobacco product
manufacturer or importer, or agent thereof, to submit a listing of all
ingredients, including tobacco, substances, compounds, and additives
that are added by the manufacturer to the tobacco, paper, filter, or
other part of each tobacco product by brand and by quantity in each
brand and subbrand. For cigarettes, cigarette tobacco, RYO, and
smokeless tobacco products on the market as of June 22, 2009, the list
of ingredients had to be submitted by December 22, 2009. For
cigarettes, cigarette tobacco, RYO, and smokeless tobacco products not
on the market as of June 22, 2009, section 904(c)(1) requires that the
list of ingredients be submitted at least 90 days prior to delivery for
introduction into interstate commerce. Section 904(c) of the FD&C Act
also requires submission of information whenever any additive, or the
quantity of any additive, is changed.
As described in the preamble to the final deeming rule, for
products other than cigarettes, cigarette tobacco, RYO, and smokeless
tobacco that are on the market as of August 8, 2016, FDA does not
intend to enforce the section 904(a)(1) ingredient listing submission
requirement until 6 months from the effective date of the rule or 12
months from the effective date for small-scale tobacco product
manufacturers. However, in the revised guidance, FDA is announcing an
additional 6-month compliance policy for newly deemed tobacco products
on the market as of August 8, 2016. Under this policy, FDA will not
enforce the ingredient listing submission requirement until August 8,
2017, for businesses that are not considered small-scale tobacco
product manufactures, and February 8, 2018, for small-scale tobacco
product manufacturers. Manufacturers of tobacco products introduced
into interstate commerce after August 8, 2016, must submit the
ingredient information required by section 904(a)(1) at least 90 days
before the product is delivered for introduction into interstate
commerce, as with cigarettes, cigarette tobacco, RYO, and smokeless
tobacco first marketed after June 22, 2009 (section 904(c)(1) of the
FD&C Act).
II. Significance of Guidance
FDA is issuing this revised guidance consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the current thinking of FDA on ingredient listing. 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.
III. Paperwork Reduction Act of 1995
This revised guidance also refers to previously approved
collections of information found in FDA regulations. The revised draft
guidance includes information and recommendations for how to provide
ingredient listing submissions. The collections of information in
section 904(a)(1) of the FD&C Act have been approved under OMB control
number 0910-0650.
IV. Electronic Access
Persons with access to the Internet may obtain an electronic
version of the revised guidance at either https://www.regulations.gov
or https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.
Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31587 Filed 12-28-16; 8:45 am]
BILLING CODE 4164-01-P