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)
Food and Drug Administration
Federal Register Volume 83, Issue 111 (June 8, 2018)
| Page Range | 26618-26619 | |
| FR Document | 2018-12369 |
[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] ----------------------------------------------------------------------- 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](https://thefederalregister.org/doc/83_FR_26729/page/1.svg)
![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](https://thefederalregister.org/doc/83_FR_26729/page/2.svg)
Document Created: 2018-06-08 01:22:34
Document Modified: 2018-06-08 01:22:34
| 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 | Proposed Rules | |
| Action | Advance notice of proposed rulemaking; extension of comment period. | |
| 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. | |
| 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] | |
| FR Citation | 83 FR 26618 | |
| RIN Number | 0910-AH60 | |
| CFR Citation | 21
CFR
1100 21 CFR 1140 21 CFR 1143 |
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