82 FR 55616 - Modified Risk Tobacco Product Applications: Applications for IQOS System With Marlboro Heatsticks, IQOS System With Marlboro Smooth Menthol Heatsticks, and IQOS System With Marlboro Fresh Menthol Heatsticks Submitted by Philip Morris Products S.A.; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 224 (November 22, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 224 (November 22, 2017)
| Page Range | 55616-55617 | |
| FR Document | 2017-25224 |
[Federal Register Volume 82, Number 224 (Wednesday, November 22, 2017)] [Notices] [Pages 55616-55617] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25224] [[Page 55616]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-3001] Modified Risk Tobacco Product Applications: Applications for IQOS System With Marlboro Heatsticks, IQOS System With Marlboro Smooth Menthol Heatsticks, and IQOS System With Marlboro Fresh Menthol Heatsticks Submitted by Philip Morris Products S.A.; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is extending the period for public comment on modified risk tobacco product applications (MRTPAs) submitted by Philip Morris Products S.A. for its IQOS system with Marlboro Heatsticks, IQOS system with Marlboro Smooth Menthol Heatsticks, and IQOS system with Marlboro Fresh Menthol Heatsticks. DATES: FDA is extending the comment period on the MRTPAs made available for public comment through the notice of availability that appeared in the Federal Register of June 15, 2017 (82 FR 27487). 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): 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-D-3001 for ``Modified Risk Tobacco Product Applications: Applications for IQOS system with Marlboro Heatsticks, IQOS system with Marlboro Smooth Menthol Heatsticks, and IQOS system with Marlboro Fresh Menthol Heatsticks submitted by Philip Morris Products S.A.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Please note that FDA intends to establish a date on which the comment period will close by publishing a notice in the Federal Register (see SUPPLEMENTARY INFORMATION). 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: Paul Hart, 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: I. Background In the Federal Register of June 15, 2017 (82 FR 27487), FDA published a notice of availability of the first batch of documents from modified risk tobacco product applications (MRTPAs) submitted by Philip Morris Products S.A. and gave the public 180 days to comment on the applications. In that notice, FDA announced that it would post the remaining MRTPA documents on a rolling basis as they were redacted in accordance with applicable laws and that it would extend the comment period if fewer than 30 days remained when the last batch of application documents was posted. In this notice, FDA is extending the period for public comment. Once all documents from the MRTPAs, including amendments, are posted, FDA intends to issue a notice in the Federal Register announcing when the comment period will close, which will be no earlier than 30 days from the date the last batch of application documents is posted. As stated in the Federal Register notice of June 15, 2017, FDA believes that this comment period is appropriate given the volume and complexity of the applications being posted. FDA is required by section 911(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387k(e)) to make an MRTPA available to the public (except for matters in the application that are trade secrets or otherwise confidential commercial information) and to request comments by interested persons on the information contained in the application and on the [[Page 55617]] label, labeling, and advertising accompanying the application. The determination of whether an order is appropriate under section 911(g) of the FD&C Act is based on the scientific information submitted by the applicant as well as the scientific evidence and other information that is made available to the Agency, including through public comments. II. Electronic Access Persons with access to the Internet may access the application documents at: http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm546281.htm. Dated: November 16, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-25224 Filed 11-21-17; 8:45 am] BILLING CODE 4164-01-P
![55616 Federal Register / Vol. 82, No. 224 / Wednesday, November 22, 2017 / Notices
DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper and other applicable disclosure law. For
HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). more information about FDA’s posting
of comments to public dockets, see 80
Food and Drug Administration Written/Paper Submissions
FR 56469, September 18, 2015, or access
Submit written/paper submissions as the information at: https://www.gpo.gov/
[Docket No. FDA–2017–D–3001]
follows: fdsys/pkg/FR-2015-09-18/pdf/2015-
Modified Risk Tobacco Product • Mail/Hand delivery/Courier (for 23389.pdf.
Applications: Applications for IQOS written/paper submissions): Dockets Docket: For access to the docket to
System With Marlboro Heatsticks, Management Staff (HFA–305), Food and read background documents or the
IQOS System With Marlboro Smooth Drug Administration, 5630 Fishers electronic and written/paper comments
Menthol Heatsticks, and IQOS System Lane, Rm. 1061, Rockville, MD 20852. received, go to https://
• For written/paper comments www.regulations.gov and insert the
With Marlboro Fresh Menthol
submitted to the Dockets Management docket number, found in brackets in the
Heatsticks Submitted by Philip Morris
Staff, FDA will post your comment, as heading of this document, into the
Products S.A.; Extension of Comment
well as any attachments, except for ‘‘Search’’ box and follow the prompts
Period
information submitted, marked and and/or go to the Dockets Management
AGENCY: Food and Drug Administration, identified, as confidential, if submitted Staff, 5630 Fishers Lane, Rm. 1061,
HHS. as detailed in ‘‘Instructions.’’ Rockville, MD 20852.
ACTION: Notice; extension of comment Instructions: All submissions received
must include the Docket No. FDA– FOR FURTHER INFORMATION CONTACT: Paul
period. Hart, Center for Tobacco Products, Food
2017–D–3001 for ‘‘Modified Risk
SUMMARY: The Food and Drug Tobacco Product Applications: and Drug Administration, Document
Administration (FDA) is extending the Applications for IQOS system with Control Center, 10903 New Hampshire
period for public comment on modified Marlboro Heatsticks, IQOS system with Ave., Bldg. 71, Rm. G335, Silver Spring,
risk tobacco product applications Marlboro Smooth Menthol Heatsticks, MD 20993, 1–877–CTP–1373,
(MRTPAs) submitted by Philip Morris and IQOS system with Marlboro Fresh AskCTP@fda.hhs.gov.
Products S.A. for its IQOS system with Menthol Heatsticks submitted by Philip SUPPLEMENTARY INFORMATION:
Marlboro Heatsticks, IQOS system with Morris Products S.A.’’ Received
Marlboro Smooth Menthol Heatsticks, comments will be placed in the docket I. Background
and IQOS system with Marlboro Fresh and, except for those submitted as In the Federal Register of June 15,
Menthol Heatsticks. ‘‘Confidential Submissions,’’ publicly 2017 (82 FR 27487), FDA published a
DATES: FDA is extending the comment viewable at https://www.regulations.gov notice of availability of the first batch of
period on the MRTPAs made available or at the Dockets Management Staff documents from modified risk tobacco
for public comment through the notice between 9 a.m. and 4 p.m., Monday product applications (MRTPAs)
of availability that appeared in the through Friday. Please note that FDA submitted by Philip Morris Products
Federal Register of June 15, 2017 (82 FR intends to establish a date on which the S.A. and gave the public 180 days to
27487). comment period will close by comment on the applications. In that
ADDRESSES: You may submit comments publishing a notice in the Federal notice, FDA announced that it would
as follows: Register (see SUPPLEMENTARY post the remaining MRTPA documents
INFORMATION). on a rolling basis as they were redacted
Electronic Submissions • Confidential Submissions—To in accordance with applicable laws and
Submit electronic comments in the submit a comment with confidential that it would extend the comment
following way: information that you do not wish to be period if fewer than 30 days remained
• Federal eRulemaking Portal: made publicly available, submit your when the last batch of application
https://www.regulations.gov. Follow the comments only as a written/paper documents was posted. In this notice,
instructions for submitting comments. submission. You should submit two FDA is extending the period for public
Comments submitted electronically, copies total. One copy will include the comment. Once all documents from the
including attachments, to https:// information you claim to be confidential MRTPAs, including amendments, are
www.regulations.gov will be posted to with a heading or cover note that states posted, FDA intends to issue a notice in
the docket unchanged. Because your ‘‘THIS DOCUMENT CONTAINS the Federal Register announcing when
comment will be made public, you are CONFIDENTIAL INFORMATION.’’ The the comment period will close, which
solely responsible for ensuring that your Agency will review this copy, including will be no earlier than 30 days from the
comment does not include any the claimed confidential information, in date the last batch of application
confidential information that you or a its consideration of comments. The documents is posted. As stated in the
third party may not wish to be posted, second copy, which will have the Federal Register notice of June 15, 2017,
such as medical information, your or claimed confidential information FDA believes that this comment period
anyone else’s Social Security number, or redacted/blacked out, will be available is appropriate given the volume and
confidential business information, such for public viewing and posted on complexity of the applications being
as a manufacturing process. Please note https://www.regulations.gov. Submit posted.
that if you include your name, contact both copies to the Dockets Management FDA is required by section 911(e) of
asabaliauskas on DSKBBXCHB2PROD with NOTICES
information, or other information that Staff. If you do not wish your name and the Federal Food, Drug, and Cosmetic
identifies you in the body of your contact information to be made publicly Act (the FD&C Act) (21 U.S.C. 387k(e))
comments, that information will be available, you can provide this to make an MRTPA available to the
posted on https://www.regulations.gov. information on the cover sheet and not public (except for matters in the
• If you want to submit a comment in the body of your comments and you application that are trade secrets or
with confidential information that you must identify this information as otherwise confidential commercial
do not wish to be made available to the ‘‘confidential.’’ Any information marked information) and to request comments
public, submit the comment as a as ‘‘confidential’’ will not be disclosed by interested persons on the information
written/paper submission and in the except in accordance with 21 CFR 10.20 contained in the application and on the
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![Federal Register / Vol. 82, No. 224 / Wednesday, November 22, 2017 / Notices 55617
label, labeling, and advertising ADDRESSES: You may submit comments submission. You should submit two
accompanying the application. The as follows: copies total. One copy will include the
determination of whether an order is information you claim to be confidential
Electronic Submissions
appropriate under section 911(g) of the with a heading or cover note that states
FD&C Act is based on the scientific Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
information submitted by the applicant following way: CONFIDENTIAL INFORMATION.’’ The
as well as the scientific evidence and • Federal eRulemaking Portal: Agency will review this copy, including
other information that is made available https://www.regulations.gov. Follow the the claimed confidential information, in
to the Agency, including through public instructions for submitting comments. its consideration of comments. The
comments. Comments submitted electronically, second copy, which will have the
including attachments, to https:// claimed confidential information
II. Electronic Access www.regulations.gov will be posted to redacted/blacked out, will be available
Persons with access to the Internet the docket unchanged. Because your for public viewing and posted on
may access the application documents comment will be made public, you are https://www.regulations.gov. Submit
at: http://www.fda.gov/ solely responsible for ensuring that your both copies to the Dockets Management
TobaccoProducts/Labeling/ comment does not include any Staff. If you do not wish your name and
MarketingandAdvertising/ confidential information that you or a contact information to be made publicly
ucm546281.htm. third party may not wish to be posted, available, you can provide this
such as medical information, your or information on the cover sheet and not
Dated: November 16, 2017.
anyone else’s Social Security number, or in the body of your comments and you
Leslie Kux, confidential business information, such
Associate Commissioner for Policy.
must identify this information as
as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
[FR Doc. 2017–25224 Filed 11–21–17; 8:45 am] that if you include your name, contact as ‘‘confidential’’ will not be disclosed
BILLING CODE 4164–01–P information, or other information that except in accordance with 21 CFR 10.20
identifies you in the body of your and other applicable disclosure law. For
comments, that information will be more information about FDA’s posting
DEPARTMENT OF HEALTH AND posted on https://www.regulations.gov. of comments to public dockets, see 80
HUMAN SERVICES • If you want to submit a comment FR 56469, September 18, 2015, or access
with confidential information that you the information at: https://www.gpo.gov/
Food and Drug Administration 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.
[Docket No. FDA–2016–D–0785] written/paper submission and in the Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper read background documents or the
General Principles for Evaluating the Submissions’’ and ‘‘Instructions’’).
Abuse Deterrence of Generic Solid electronic and written/paper comments
Oral Opioid Drug Products; Guidance Written/Paper Submissions received, go to https://
for Industry; Availability www.regulations.gov and insert the
Submit written/paper submissions as
docket number, found in brackets in the
follows:
AGENCY: Food and Drug Administration, heading of this document, into the
• Mail/Hand delivery/Courier (for
HHS. ‘‘Search’’ box and follow the prompts
written/paper submissions): Dockets
ACTION: Notice of availability. and/or go to the Dockets Management
Management Staff (HFA–305), Food and
Staff, 5630 Fishers Lane, Rm. 1061,
Drug Administration, 5630 Fishers
SUMMARY: The Food and Drug Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852.
Administration (FDA or Agency) is Submit written requests for single
• For written/paper comments
announcing the availability of a copies of this guidance to the Division
submitted to the Dockets Management
guidance for industry entitled ‘‘General of Drug Information, Center for Drug
Staff, FDA will post your comment, as
Principles for Evaluating the Abuse Evaluation and Research, Food and
well as any attachments, except for
Deterrence of Generic Solid Oral Opioid Drug Administration, 10001 New
information submitted, marked and
Drug Products.’’ This guidance is Hampshire Ave., Hillandale Building,
identified, as confidential, if submitted
intended to assist a person who plans to 4th Floor, Silver Spring, MD 20993–
as detailed in ‘‘Instructions.’’
develop and submit an abbreviated new Instructions: All submissions received 0002. Send one self-addressed adhesive
drug application (ANDA) to seek must include the Docket No. FDA– label to assist that office in processing
approval of a generic version of a solid 2016–D–0785 for ‘‘General Principles your requests. See the SUPPLEMENTARY
oral opioid drug product that references INFORMATION section for electronic
for Evaluating the Abuse Deterrence of
an opioid drug product with abuse- Generic Solid Oral Opioid Drugs; access to the guidance document.
deterrent properties described in its Guidance for Industry; Availability.’’ FOR FURTHER INFORMATION CONTACT: Gail
labeling. The guidance recommends Received comments will be placed in Schmerfeld, Office of Generic Drugs,
studies, including comparative in vitro the docket and, except for those Center for Drug Evaluation and
and pharmacokinetic (PK) studies, that submitted as ‘‘Confidential Research, Food and Drug
a potential ANDA applicant should Submissions,’’ publicly viewable at Administration, 10903 New Hampshire
conduct and submit to FDA to Ave., Silver Spring, MD 20993–0002,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
https://www.regulations.gov or at the
demonstrate that a generic solid oral Dockets Management Staff between 9 301–796–9291, email: gail.schmerfeld@
opioid drug product is no less abuse a.m. and 4 p.m., Monday through fda.hhs.gov.
deterrent than its reference listed drug Friday. SUPPLEMENTARY INFORMATION:
(RLD) with respect to all potential • Confidential Submissions—To
routes of abuse. submit a comment with confidential I. Background
DATES: Submit either electronic or information that you do not wish to be FDA is announcing the availability of
written comments on Agency guidances made publicly available, submit your a guidance for industry entitled
at any time. comments only as a written/paper ‘‘General Principles for Evaluating the
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Document Created: 2017-11-22 00:48:51
Document Modified: 2017-11-22 00:48:51
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; extension of comment period. | |
| Dates | FDA is extending the comment period on the MRTPAs made available for public comment through the notice of availability that appeared in the Federal Register of June 15, 2017 (82 FR 27487). | |
| Contact | Paul Hart, 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 | 82 FR 55616 |
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