83 FR 26619 - Tobacco Product Standard for Nicotine Level of Combusted Cigarettes; 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 | 26619-26620 | |
| FR Document | 2018-12368 |
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)] [Proposed Rules] [Pages 26619-26620] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12368] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1130 [Docket No. FDA-2017-N-6189] RIN 0910-AH86 Tobacco Product Standard for Nicotine Level of Combusted Cigarettes; 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 the Agency) is extending the comment period for the advance notice of proposed rulemaking (ANPRM) that appeared in the Federal Register of March 16, 2018. In the ANPRM, FDA requested information for consideration in developing a tobacco product standard to set a maximum nicotine level in combusted cigarettes so that they are minimally addictive or nonaddictive. 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 16, 2018 (83 FR 11818). Submit either electronic or written comments by July 16, 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 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 16, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service [[Page 26620]] 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 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-6189 for ``Tobacco Product Standard for Nicotine Level of Combusted Cigarettes.'' 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: Gerie Voss, 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- CTP-1373, [email protected]. SUPPLEMENTARY INFORMATION: In the Federal Register of March 16, 2018, FDA published an ANPRM with a 90-day comment period to obtain information for consideration in developing a tobacco product standard to set a maximum nicotine level in combusted cigarettes so that they are minimally addictive or nonaddictive. Comments on the scope of products to be covered, maximum nicotine level for a potential nicotine tobacco product standard, implementation methods, analytical testing methods, technical achievability, possible countervailing effects, and other topics will aid FDA in its consideration regarding development of a tobacco product standard to set a maximum nicotine level in combusted cigarettes. 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 120-day extension. FDA has considered the requests and is extending the comment period for the ANPRM for an additional 30 days, until July 16, 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. 2018-12368 Filed 6-7-18; 8:45 am] BILLING CODE 4164-01-P
![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_26730/page/1.svg)
![26620 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Proposed Rules
acceptance receipt is on or before that submission. You should submit two maximum nicotine level in combusted
date. copies total. One copy will include the cigarettes.
information you claim to be confidential The Agency has received a number of
Electronic Submissions
with a heading or cover note that states requests for a 90-day extension of the
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS comment period for the ANPRM and
following way: CONFIDENTIAL INFORMATION.’’ The one request for a 120-day extension.
• Federal eRulemaking Portal: Agency will review this copy, including FDA has considered the requests and is
https://www.regulations.gov. Follow the the claimed confidential information, in extending the comment period for the
instructions for submitting comments. its consideration of comments. The ANPRM for an additional 30 days, until
Comments submitted electronically, second copy, which will have the July 16, 2018. The Agency believes that
including attachments, to https:// claimed confidential information a 30-day extension allows adequate time
www.regulations.gov will be posted to redacted/blacked out, will be available for interested persons to submit
the docket unchanged. Because your for public viewing and posted on comments without significantly
comment will be made public, you are https://www.regulations.gov. Submit delaying any potential regulatory action
solely responsible for ensuring that your both copies to the Dockets Management on these important issues.
comment does not include any Staff. If you do not wish your name and
Dated: June 5, 2018.
confidential information that you or a contact information to be made publicly
third party may not wish to be posted, Leslie Kux,
available, you can provide this
such as medical information, your or information on the cover sheet and not Associate Commissioner for Policy.
anyone else’s Social Security number, or in the body of your comments and you [FR Doc. 2018–12368 Filed 6–7–18; 8:45 am]
confidential business information, such must identify this information as BILLING CODE 4164–01–P
as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
that if you include your name, contact as ‘‘confidential’’ will not be disclosed
information, or other information that except in accordance with 21 CFR 10.20 DEPARTMENT OF THE INTERIOR
identifies you in the body of your and other applicable disclosure law. For
comments, that information will be more information about FDA’s posting National Indian Gaming Commission
posted on https://www.regulations.gov. of comments to public dockets, see 80
• If you want to submit a comment FR 56469, September 18, 2015, or access 25 CFR Part 543
with confidential information that you the information at: https://www.gpo.gov/ RIN 3141–AA60
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
public, submit the comment as a 23389.pdf. Minimum Internal Control Standards
written/paper submission and in the Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper read background documents or the AGENCY: National Indian Gaming
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments Commission, Department of the Interior.
Written/Paper Submissions received, go to https:// ACTION: Notice of proposed rulemaking.
www.regulations.gov and insert the
Submit written/paper submissions as docket number, found in brackets in the SUMMARY: The National Indian Gaming
follows: heading of this document, into the Commission (NIGC) proposes to amend
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts its minimum internal control standards
written/paper submissions): Dockets and/or go to the Dockets Management for Class II gaming under the Indian
Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, Gaming Regulatory Act to correct an
Drug Administration, 5630 Fishers Rockville, MD 20852. erroneous deletion of the key control
Lane, Rm. 1061, Rockville, MD 20852. standards and to make other minor edits
FOR FURTHER INFORMATION CONTACT:
• For written/paper comments and additions for clarity.
Gerie Voss, Center for Tobacco
submitted to the Dockets Management DATES: Written comments on this
Products, Food and Drug
Staff, FDA will post your comment, as proposed rule must be received on or
Administration, Document Control
well as any attachments, except for before July 9, 2018.
Center, 10903 New Hampshire Ave.,
information submitted, marked and
Bldg. 71, Rm. G335, Silver Spring, MD ADDRESSES: You may submit comments
identified, as confidential, if submitted
20993, 1–877–CTP–1373, AskCTP@ by any one of the following methods,
as detailed in ‘‘Instructions.’’
Instructions: All submissions received fda.hhs.gov. however, please note that comments
must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: In the sent by electronic mail are strongly
2017–N–6189 for ‘‘Tobacco Product Federal Register of March 16, 2018, encouraged.
Standard for Nicotine Level of FDA published an ANPRM with a 90- D Email comments to: 543_
Combusted Cigarettes.’’ Received day comment period to obtain comments@nigc.gov.
comments, those filed in a timely information for consideration in D Mail comments to: National Indian
manner (see ADDRESSES), will be placed developing a tobacco product standard Gaming Commission, 1849 C Street NW,
in the docket and, except for those to set a maximum nicotine level in MS 1621, Washington, DC 20240.
submitted as ‘‘Confidential combusted cigarettes so that they are D Fax comments to: National Indian
Submissions,’’ publicly viewable at minimally addictive or nonaddictive. Gaming Commission at 202–632–0045.
https://www.regulations.gov or at the Comments on the scope of products to FOR FURTHER INFORMATION CONTACT:
amozie on DSK3GDR082PROD with PROPOSALS1
Dockets Management Staff between 9 be covered, maximum nicotine level for Jennifer Lawson at (202) 632–7003 or by
a.m. and 4 p.m., Monday through a potential nicotine tobacco product fax (202) 632–7066 (these numbers are
Friday. standard, implementation methods, not toll free).
• Confidential Submissions—To analytical testing methods, technical SUPPLEMENTARY INFORMATION:
submit a comment with confidential achievability, possible countervailing
information that you do not wish to be effects, and other topics will aid FDA in I. Background
made publicly available, submit your its consideration regarding development The Indian Gaming Regulatory Act
comments only as a written/paper of a tobacco product standard to set a (IGRA or Act), Public Law 100–497, 25
VerDate Sep<11>2014 16:24 Jun 07, 2018 Jkt 244001 PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 E:\FR\FM\08JNP1.SGM 08JNP1](https://thefederalregister.org/doc/83_FR_26730/page/2.svg)
Document Created: 2018-06-08 01:22:07
Document Modified: 2018-06-08 01:22:07
| 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 16, 2018 (83 FR 11818). Submit either electronic or written comments by July 16, 2018. | |
| Contact | Gerie Voss, 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- CTP-1373, [email protected] | |
| FR Citation | 83 FR 26619 | |
| RIN Number | 0910-AH86 |
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