83_FR_26729 83 FR 26618 - Regulation of Flavors in Tobacco Products; Extension of Comment Period

83 FR 26618 - Regulation of Flavors in Tobacco Products; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 111 (June 8, 2018)

Page Range26618-26619
FR Document2018-12369

The Food and Drug Administration (FDA or Agency) is extending the comment period for the advance notice of proposed rulemaking (ANPRM) that appeared in the Federal Register of March 21, 2018. In the ANPRM, FDA requested information related to the role that flavors play in tobacco products. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

Federal Register, Volume 83 Issue 111 (Friday, June 8, 2018)
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Proposed Rules]
[Pages 26618-26619]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12369]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1100, 1140, and 1143

[Docket No. FDA-2017-N-6565]
RIN 0910-AH60


Regulation of Flavors in Tobacco Products; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking; extension of comment 
period.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is extending 
the comment period for the advance notice of proposed rulemaking 
(ANPRM) that appeared in the Federal Register of March 21, 2018. In the 
ANPRM, FDA requested information related to the role that flavors play 
in tobacco products. The Agency is taking this action in response to 
requests for an extension to allow interested persons additional time 
to submit comments.

DATES: FDA is extending the comment period on the ANPRM published on 
March 21, 2018 (83 FR 12294). Submit either electronic or written 
comments by July 19, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before July 19, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of July 19, 2018. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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

[[Page 26619]]

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): 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-2017-N-6565 for ``Regulation of Flavors in Tobacco Products.'' 
Received comments, those filed in a timely manner (see ADDRESSES), 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.pdf.
    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.

FOR FURTHER INFORMATION CONTACT: Laura Rich or 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, 1-877-287-1373, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of March 21, 2018, 
FDA published an ANPRM with a 90-day comment period to obtain 
information related to the role that flavors play in tobacco products. 
Specifically, the ANPRM is seeking comments, data, research results, or 
other information about, among other things, how flavors attract youth 
to initiate tobacco product use and about whether and how certain 
flavors may help adult cigarette smokers reduce cigarette use and 
switch to potentially less harmful products. FDA is seeking this 
information to inform regulatory actions FDA might take with respect to 
tobacco products with flavors, under the Federal Food, Drug, and 
Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco 
Control Act. Potential regulatory actions include, but are not limited 
to, tobacco product standards and restrictions on sale and distribution 
of tobacco products with flavors.
    The Agency has received a number of requests for a 90-day extension 
of the comment period for the ANPRM and one request for a 105-day 
extension. FDA has considered these requests and is extending the 
comment period for the ANPRM for 30 days, until July 19, 2018.
    The Agency believes that a 30-day extension allows adequate time 
for interested persons to submit comments without significantly 
delaying any potential regulatory action on these important issues.

    Dated: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12369 Filed 6-7-18; 8:45 am]
 BILLING CODE 4164-01-P



                                                26618                      Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Proposed Rules

                                                confidential information that you or a                  information on the cover sheet and not                   Dated: June 5, 2018.
                                                third party may not wish to be posted,                  in the body of your comments and you                   Leslie Kux,
                                                such as medical information, your or                    must identify this information as                      Associate Commissioner for Policy.
                                                anyone else’s Social Security number, or                ‘‘confidential.’’ Any information marked               [FR Doc. 2018–12367 Filed 6–7–18; 8:45 am]
                                                confidential business information, such                 as ‘‘confidential’’ will not be disclosed              BILLING CODE 4164–01–P
                                                as a manufacturing process. Please note                 except in accordance with 21 CFR 10.20
                                                that if you include your name, contact                  and other applicable disclosure law. For
                                                information, or other information that                  more information about FDA’s posting                   DEPARTMENT OF HEALTH AND
                                                identifies you in the body of your                      of comments to public dockets, see 80                  HUMAN SERVICES
                                                comments, that information will be                      FR 56469, September 18, 2015, or access
                                                posted on https://www.regulations.gov.                  the information at: https://www.gpo.gov/               Food and Drug Administration
                                                  • If you want to submit a comment
                                                                                                        fdsys/pkg/FR-2015-09-18/pdf/2015-
                                                with confidential information that you                                                                         21 CFR Parts 1100, 1140, and 1143
                                                do not wish to be made available to the                 23389.pdf.
                                                                                                           Docket: For access to the docket to                 [Docket No. FDA–2017–N–6565]
                                                public, submit the comment as a
                                                written/paper submission and in the                     read background documents or the                       RIN 0910–AH60
                                                manner detailed (see ‘‘Written/Paper                    electronic and written/paper comments
                                                Submissions’’ and ‘‘Instructions’’).                    received, go to https://                               Regulation of Flavors in Tobacco
                                                                                                        www.regulations.gov and insert the                     Products; Extension of Comment
                                                Written/Paper Submissions                                                                                      Period
                                                                                                        docket number, found in brackets in the
                                                   Submit written/paper submissions as                  heading of this document, into the
                                                follows:                                                                                                       AGENCY:   Food and Drug Administration,
                                                                                                        ‘‘Search’’ box and follow the prompts                  HHS.
                                                   • Mail/Hand delivery/Courier (for                    and/or go to the Dockets Management
                                                written/paper submissions): Dockets                                                                            ACTION: Advance notice of proposed
                                                                                                        Staff, 5630 Fishers Lane, Rm. 1061,
                                                Management Staff (HFA–305), Food and                                                                           rulemaking; extension of comment
                                                                                                        Rockville, MD 20852.
                                                Drug Administration, 5630 Fishers                                                                              period.
                                                Lane, Rm. 1061, Rockville, MD 20852.                    FOR FURTHER INFORMATION CONTACT:
                                                   • For written/paper comments                         Deirdre Jurand or Nate Mease, Center for               SUMMARY:   The Food and Drug
                                                submitted to the Dockets Management                     Tobacco Products, Food and Drug                        Administration (FDA or Agency) is
                                                Staff, FDA will post your comment, as                   Administration, Document Control                       extending the comment period for the
                                                well as any attachments, except for                                                                            advance notice of proposed rulemaking
                                                                                                        Center, 10903 New Hampshire Ave.,
                                                information submitted, marked and                                                                              (ANPRM) that appeared in the Federal
                                                                                                        Bldg. 71, Rm. G335, Silver Spring, MD
                                                identified, as confidential, if submitted                                                                      Register of March 21, 2018. In the
                                                                                                        20993, 1–877–287–1373, AskCTP@
                                                as detailed in ‘‘Instructions.’’                                                                               ANPRM, FDA requested information
                                                                                                        fda.hhs.gov.
                                                   Instructions: All submissions received                                                                      related to the role that flavors play in
                                                must include the Docket No. FDA–                        SUPPLEMENTARY INFORMATION:     In the                  tobacco products. The Agency is taking
                                                2017–N–6107 for ‘‘Regulation of                         Federal Register of March 26, 2018,                    this action in response to requests for an
                                                Premium Cigars.’’ Received comments,                    FDA published an ANPRM with a 90-                      extension to allow interested persons
                                                those filed in a timely manner (see                     day comment period to obtain                           additional time to submit comments.
                                                ADDRESSES), will be placed in the docket                information related to the regulation of               DATES: FDA is extending the comment
                                                and, except for those submitted as                      premium cigars under the Federal Food,                 period on the ANPRM published on
                                                ‘‘Confidential Submissions,’’ publicly                  Drug, and Cosmetic Act, as amended by                  March 21, 2018 (83 FR 12294). Submit
                                                viewable at https://www.regulations.gov                 the Family Smoking Prevention and                      either electronic or written comments
                                                or at the Dockets Management Staff                      Tobacco Control Act, and regulations                   by July 19, 2018.
                                                between 9 a.m. and 4 p.m., Monday                       regarding the sale and distribution of                 ADDRESSES: You may submit comments
                                                through Friday.                                         tobacco products. FDA is seeking                       as follows. Please note that late,
                                                   • Confidential Submissions—To                        comments, data, research results, or                   untimely filed comments will not be
                                                submit a comment with confidential                      other information that may inform                      considered. Electronic comments must
                                                information that you do not wish to be                  regulatory actions FDA might take with                 be submitted on or before July 19, 2018.
                                                made publicly available, submit your                    respect to premium cigars. Specifically,               The https://www.regulations.gov
                                                comments only as a written/paper                        FDA is seeking information related to                  electronic filing system will accept
                                                submission. You should submit two                       the following topics: Definition of                    comments until midnight Eastern Time
                                                copies total. One copy will include the                 premium cigars, use patterns of                        at the end of July 19, 2018. Comments
                                                information you claim to be confidential                premium cigars, and public health                      received by mail/hand delivery/courier
                                                with a heading or cover note that states                considerations associated with premium                 (for written/paper submissions) will be
                                                ‘‘THIS DOCUMENT CONTAINS                                                                                       considered timely if they are
                                                                                                        cigars.
                                                CONFIDENTIAL INFORMATION.’’ The                                                                                postmarked or the delivery service
                                                Agency will review this copy, including                   The Agency has received requests for                 acceptance receipt is on or before that
                                                the claimed confidential information, in                a 90-day extension of the comment                      date.
                                                its consideration of comments. The                      period for the ANPRM. FDA has
                                                second copy, which will have the                        considered the requests and is                         Electronic Submissions
amozie on DSK3GDR082PROD with PROPOSALS1




                                                claimed confidential information                        extending the comment period for the                     Submit electronic comments in the
                                                redacted/blacked out, will be available                 ANPRM for 30 days, until July 25, 2018.                following way:
                                                for public viewing and posted on                        The Agency believes that a 30-day                        • Federal eRulemaking Portal:
                                                https://www.regulations.gov. Submit                     extension allows adequate time for                     https://www.regulations.gov. Follow the
                                                both copies to the Dockets Management                   interested persons to submit comments                  instructions for submitting comments.
                                                Staff. If you do not wish your name and                 without significantly delaying any                     Comments submitted electronically,
                                                contact information to be made publicly                 potential regulatory action on these                   including attachments, to https://
                                                available, you can provide this                         important issues.                                      www.regulations.gov will be posted to


                                           VerDate Sep<11>2014   16:24 Jun 07, 2018   Jkt 244001   PO 00000   Frm 00008   Fmt 4702   Sfmt 4702   E:\FR\FM\08JNP1.SGM   08JNP1


                                                                           Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Proposed Rules                                                 26619

                                                the docket unchanged. Because your                      https://www.regulations.gov. Submit                    is extending the comment period for the
                                                comment will be made public, you are                    both copies to the Dockets Management                  ANPRM for 30 days, until July 19, 2018.
                                                solely responsible for ensuring that your               Staff. If you do not wish your name and                   The Agency believes that a 30-day
                                                comment does not include any                            contact information to be made publicly                extension allows adequate time for
                                                confidential information that you or a                  available, you can provide this                        interested persons to submit comments
                                                third party may not wish to be posted,                  information on the cover sheet and not                 without significantly delaying any
                                                such as medical information, your or                    in the body of your comments and you                   potential regulatory action on these
                                                anyone else’s Social Security number, or                must identify this information as                      important issues.
                                                confidential business information, such                 ‘‘confidential.’’ Any information marked                 Dated: June 5, 2018.
                                                as a manufacturing process. Please note                 as ‘‘confidential’’ will not be disclosed
                                                                                                                                                               Leslie Kux,
                                                that if you include your name, contact                  except in accordance with 21 CFR 10.20
                                                information, or other information that                                                                         Associate Commissioner for Policy.
                                                                                                        and other applicable disclosure law. For
                                                identifies you in the body of your                      more information about FDA’s posting                   [FR Doc. 2018–12369 Filed 6–7–18; 8:45 am]
                                                comments, that information will be                      of comments to public dockets, see 80                  BILLING CODE 4164–01–P
                                                posted on https://www.regulations.gov.                  FR 56469, September 18, 2015, or access
                                                  • If you want to submit a comment                     the information at: https://www.gpo.gov/
                                                with confidential information that you                  fdsys/pkg/FR-2015-09-18/pdf/2015-                      DEPARTMENT OF HEALTH AND
                                                do not wish to be made available to the                 23389.pdf.                                             HUMAN SERVICES
                                                public, submit the comment as a                            Docket: For access to the docket to
                                                written/paper submission and in the                                                                            Food and Drug Administration
                                                                                                        read background documents or the
                                                manner detailed (see ‘‘Written/Paper                    electronic and written/paper comments
                                                Submissions’’ and ‘‘Instructions’’).                                                                           21 CFR Part 1130
                                                                                                        received, go to https://
                                                Written/Paper Submissions                               www.regulations.gov and insert the                     [Docket No. FDA–2017–N–6189]
                                                                                                        docket number, found in brackets in the
                                                   Submit written/paper submissions as                  heading of this document, into the                     RIN 0910–AH86
                                                follows:                                                ‘‘Search’’ box and follow the prompts
                                                   • Mail/Hand delivery/Courier (for                    and/or go to the Dockets Management
                                                                                                                                                               Tobacco Product Standard for Nicotine
                                                written/paper submissions): Dockets                                                                            Level of Combusted Cigarettes;
                                                                                                        Staff, 5630 Fishers Lane, Rm. 1061,                    Extension of Comment Period
                                                Management Staff (HFA–305), Food and                    Rockville, MD 20852.
                                                Drug Administration, 5630 Fishers                                                                              AGENCY:   Food and Drug Administration,
                                                                                                        FOR FURTHER INFORMATION CONTACT:
                                                Lane, Rm. 1061, Rockville, MD 20852.                                                                           HHS.
                                                   • For written/paper comments                         Laura Rich or Katherine Collins, Center
                                                submitted to the Dockets Management                     for Tobacco Products, Food and Drug                    ACTION: Advance notice of proposed
                                                Staff, FDA will post your comment, as                   Administration, Document Control                       rulemaking; extension of comment
                                                well as any attachments, except for                     Center, 10903 New Hampshire Ave.,                      period.
                                                information submitted, marked and                       Bldg. 71, Rm. G335, Silver Spring, MD
                                                                                                        20993, 1–877–287–1373, AskCTP@                         SUMMARY:   The Food and Drug
                                                identified, as confidential, if submitted                                                                      Administration (FDA or the Agency) is
                                                as detailed in ‘‘Instructions.’’                        fda.hhs.gov.
                                                                                                                                                               extending the comment period for the
                                                   Instructions: All submissions received               SUPPLEMENTARY INFORMATION: In the
                                                                                                                                                               advance notice of proposed rulemaking
                                                must include the Docket No. FDA–                        Federal Register of March 21, 2018,
                                                                                                                                                               (ANPRM) that appeared in the Federal
                                                2017–N–6565 for ‘‘Regulation of Flavors                 FDA published an ANPRM with a 90-
                                                                                                                                                               Register of March 16, 2018. In the
                                                in Tobacco Products.’’ Received                         day comment period to obtain
                                                                                                                                                               ANPRM, FDA requested information for
                                                comments, those filed in a timely                       information related to the role that
                                                                                                                                                               consideration in developing a tobacco
                                                manner (see ADDRESSES), will be placed                  flavors play in tobacco products.
                                                                                                                                                               product standard to set a maximum
                                                in the docket and, except for those                     Specifically, the ANPRM is seeking
                                                                                                                                                               nicotine level in combusted cigarettes so
                                                submitted as ‘‘Confidential                             comments, data, research results, or
                                                                                                                                                               that they are minimally addictive or
                                                Submissions,’’ publicly viewable at                     other information about, among other
                                                                                                                                                               nonaddictive. The Agency is taking this
                                                https://www.regulations.gov or at the                   things, how flavors attract youth to
                                                                                                                                                               action in response to requests for an
                                                Dockets Management Staff between 9                      initiate tobacco product use and about
                                                                                                                                                               extension to allow interested persons
                                                a.m. and 4 p.m., Monday through                         whether and how certain flavors may
                                                                                                                                                               additional time to submit comments.
                                                Friday.                                                 help adult cigarette smokers reduce
                                                   • Confidential Submissions—To                        cigarette use and switch to potentially                DATES: FDA is extending the comment
                                                submit a comment with confidential                      less harmful products. FDA is seeking                  period on the ANPRM published on
                                                information that you do not wish to be                  this information to inform regulatory                  March 16, 2018 (83 FR 11818). Submit
                                                made publicly available, submit your                    actions FDA might take with respect to                 either electronic or written comments
                                                comments only as a written/paper                        tobacco products with flavors, under the               by July 16, 2018.
                                                submission. You should submit two                       Federal Food, Drug, and Cosmetic Act,                  ADDRESSES: You may submit comments
                                                copies total. One copy will include the                 as amended by the Family Smoking                       as follows. Please note that late,
                                                information you claim to be confidential                Prevention and Tobacco Control Act.                    untimely filed comments will not be
                                                with a heading or cover note that states                Potential regulatory actions include, but              considered. Electronic comments must
                                                ‘‘THIS DOCUMENT CONTAINS                                are not limited to, tobacco product                    be submitted on or before July 16, 2018.
amozie on DSK3GDR082PROD with PROPOSALS1




                                                CONFIDENTIAL INFORMATION.’’ The                         standards and restrictions on sale and                 The https://www.regulations.gov
                                                Agency will review this copy, including                 distribution of tobacco products with                  electronic filing system will accept
                                                the claimed confidential information, in                flavors.                                               comments until midnight Eastern Time
                                                its consideration of comments. The                         The Agency has received a number of                 at the end of July 16, 2018. Comments
                                                second copy, which will have the                        requests for a 90-day extension of the                 received by mail/hand delivery/courier
                                                claimed confidential information                        comment period for the ANPRM and                       (for written/paper submissions) will be
                                                redacted/blacked out, will be available                 one request for a 105-day extension.                   considered timely if they are
                                                for public viewing and posted on                        FDA has considered these requests and                  postmarked or the delivery service


                                           VerDate Sep<11>2014   16:24 Jun 07, 2018   Jkt 244001   PO 00000   Frm 00009   Fmt 4702   Sfmt 4702   E:\FR\FM\08JNP1.SGM   08JNP1



Document Created: 2018-06-08 01:22:34
Document Modified: 2018-06-08 01:22:34
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionAdvance notice of proposed rulemaking; extension of comment period.
DatesFDA is extending the comment period on the ANPRM published on March 21, 2018 (83 FR 12294). Submit either electronic or written comments by July 19, 2018.
ContactLaura Rich or 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, 1-877-287-1373, [email protected]
FR Citation83 FR 26618 
RIN Number0910-AH60
CFR Citation21 CFR 1100
21 CFR 1140
21 CFR 1143

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