82 FR 27487 - 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.; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 114 (June 15, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 114 (June 15, 2017)
| Page Range | 27487-27489 | |
| FR Document | 2017-12369 |
[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)] [Notices] [Pages 27487-27489] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12369] ----------------------------------------------------------------------- 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.; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability for public comment of modified risk tobacco product applications (MRTPAs) 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. DATES: Submit either electronic or written comments on the application by December 12, 2017. 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 [[Page 27488]] manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Paul Hart, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 1-877-287-1373, email: AskCTP@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387k) addresses the marketing and distribution of modified risk tobacco products (MRTPs). MRTPs are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. Section 911(a) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any MRTP unless an order issued by FDA under section 911(g) of the FD&C Act is effective with respect to such product. Section 911(d) of the FD&C Act describes the information that must be included in an MRTPA, which must be filed and evaluated by FDA before an applicant can receive an order from FDA. FDA is required by section 911(e) of the FD&C Act 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 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. Section 911(g) of the FD&C Act describes the demonstrations applicants must make to obtain an order from FDA under either section 911(g)(1) or (g)(2). A person seeking an order under section 911(g)(1) of the FD&C Act must show that the tobacco product, as it is actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and will benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products. Section 911(g)(4) of the FD&C Act describes factors that FDA must take into account in evaluating whether a tobacco product benefits the health of individuals and the population as a whole. FDA may issue an order under section 911(g)(2) of the FD&C Act with respect to a tobacco product that does not satisfy the section 911(g)(1) standard. A person seeking an order under section 911(g)(2) of the FD&C Act must show that: Such an order would be appropriate to promote the public health; Any aspect of the label, labeling, and advertising for the product that would cause the product to be an MRTP is limited to an explicit or implicit representation that the tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke; Scientific evidence is not available and, using the best available scientific methods, cannot be made available without conducting long-term epidemiological studies for an application to meet the standards for obtaining an order under section 911(g)(1); The scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in subsequent studies; The magnitude of overall reductions in exposure to the substance or substances which are the subject of the application is substantial, such substance or substances are harmful, and the product as actually used exposes consumers to the specified reduced level of the substance or substances; The product as actually used by consumers will not expose them to higher levels of other harmful substances compared to the similar types of tobacco products then on the market unless such increases are minimal and the reasonably likely overall impact of use of the product remains a substantial and measurable reduction in overall morbidity and mortality among individual tobacco users; [[Page 27489]] Testing of actual consumer perception shows that, as the applicant proposes to label and market the product, consumers will not be misled into believing that the product is or has been demonstrated to be less harmful or presents or has been demonstrated to present less of a risk of disease than one or more other commercially marketed tobacco products; and Issuance of the exposure modification order is expected to benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products. Section 911(g)(4) of the FD&C Act describes factors that FDA must take into account in evaluating whether a tobacco product satisfies the requirements in section 911(g)(2). FDA is issuing this notice to inform the public that the following MRTPAs submitted by Philip Morris Products S.A. have been filed and are being made available for public comment: MR0000059: IQOS system with Marlboro Heatsticks MR0000060: IQOS system with Marlboro Smooth Menthol Heatsticks MR0000061: IQOS system with Marlboro Fresh Menthol Heatsticks Due to the large size of these applications, FDA will post the application documents in batches on a rolling basis as they are redacted in accordance with applicable laws. In this document, FDA is announcing the availability of the first batch of application documents. FDA is making the applications available for public comment for 180 days from the posting of the first batch of application documents. In the event that fewer than 30 days remain in the comment period when the final batch is posted, FDA will issue a notice in the Federal Register extending the comment period to allow for at least 30 days of public comment from the day the final batch is posted. FDA believes that this comment period is appropriate given the volume and complexity of the applications being posted. To encourage public participation consistent with section 911(e) of the FD&C Act, FDA is making the redacted MRTPAs that are the subject of this notice available electronically (see section II). II. Electronic Access Persons with access to the Internet may obtain the documents at http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm546281.htm. Dated: June 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-12369 Filed 6-14-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices 27487
manufacturing plant; (5) name, published on our Web site. The purpose information as is currently collected via
telephone number, and email address of of the lists is to help foreign the existing paper-based process. Draft
the contact person; (6) list of products governments in their determinations of screenshots of Form FDA 3972 and
divided into three categories: Presently which U.S. milk product manufacturers instructions are available at http://
shipped, ready to ship, and available for and processors are eligible to export to www.fda.gov/Food/
shipment in the next 3 years; (7) their respective countries. GuidanceRegulation/ImportsExports/
identities of agencies that inspected the FDA has recently developed an Exporting/ucm496929.htm and is
plant; (8) date of last inspection, plant electronic registry system (Form FDA entitled ‘‘Dairy Listing Module.’’
number, and copy of last inspection 3972) that allows milk product Description of Respondents:
notice; and (9) if other than an FDA manufacturers and processors to Respondents to this collection of
inspection, copy of last inspection electronically send a request to FDA to information include U.S. milk product
report. be included on the export lists. manufacturers/processors subject to
We request that this information be Manufacturers and processors that FDA jurisdiction that wish to export to
updated every 2 years. prefer to submit a paper request in a certain foreign countries that require
We use the information submitted by format of their own choosing will still inclusion on export lists.
firms to determine their eligibility for have the option to do so. Electronic FDA estimates the burden of this
placement on the export lists, which are Form FDA 3972 collects the same collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
Activity responses per Total hours
respondents responses per response
respondent
New requests to be placed on the lists ................... 2,000 1 2,000 1 ................................ 2,000
Biennial update ........................................................ 2,000 1 2,000 0.5 (30 minutes) ........ 1,000
Occasional updates ................................................. 200 1 200 0.5 (30 minutes) ........ 100
Total .................................................................. ........................ ........................ ........................ .................................... 3,100
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate on the number is 3,100 hours ((2,000 × 1) plus (2,000 submitted by Philip Morris Products
of manufacturers/processors that have × 0.5) plus (200 × 0.5)). S.A.
submitted new written requests, Dated: June 9, 2017. DATES: Submit either electronic or
biennial updates, and occasional Anna K. Abram, written comments on the application by
updates over the past 10 years. The Deputy Commissioner for Policy, Planning, December 12, 2017.
estimate of the number of burden hours Legislation, and Analysis. ADDRESSES: You may submit comments
it will take a manufacturer/processor to [FR Doc. 2017–12356 Filed 6–14–17; 8:45 am] as follows:
gather the information needed to be BILLING CODE 4164–01–P
placed on the list or update its Electronic Submissions
information is based on FDA’s Submit electronic comments in the
experience with manufacturers/ DEPARTMENT OF HEALTH AND following way:
processors submitting similar requests. HUMAN SERVICES • Federal eRulemaking Portal:
FDA believes that the information to be https://www.regulations.gov. Follow the
submitted will be readily available to Food and Drug Administration instructions for submitting comments.
manufacturers/processors. This [Docket No. FDA–2017–D–3001] Comments submitted electronically,
collection is also incorporating including attachments, to https://
information collected to maintain lists Modified Risk Tobacco Product www.regulations.gov will be posted to
of eligible exporters of dairy products Applications: Applications for IQOS the docket unchanged. Because your
who wish to export to the EU from OMB System With Marlboro Heatsticks, comment will be made public, you are
control number 0910–0320, ‘‘Request for IQOS System With Marlboro Smooth solely responsible for ensuring that your
Information from U.S. Processors that Menthol Heatsticks, and IQOS System comment does not include any
Export to the European Community.’’ With Marlboro Fresh Menthol confidential information that you or a
FDA estimates that 2,000 firms will Heatsticks Submitted by Philip Morris third party may not wish to be posted,
average 60 minutes (1 hour) to submit Products S.A.; Availability such as medical information, your or
new requests for inclusion on the list, AGENCY: Food and Drug Administration, anyone else’s Social Security number, or
2,000 firms will average 30 minutes (0.5 HHS. confidential business information, such
hour) to update their information every ACTION: Notice. as a manufacturing process. Please note
2 years, and 200 firms will average 30 that if you include your name, contact
minutes (0.5 hour) to occasionally SUMMARY: The Food and Drug information, or other information that
pmangrum on DSK3GDR082PROD with NOTICES
update their information in this system. Administration (FDA or Agency) is identifies you in the body of your
We also believe that submission via the announcing the availability for public comments, that information will be
electronic registry system will not affect comment of modified risk tobacco posted on https://www.regulations.gov.
the burden estimates. An electronic product applications (MRTPAs) for • If you want to submit a comment
registry will enhance the ability of firms IQOS system with Marlboro Heatsticks, with confidential information that you
to more efficiently request inclusion on IQOS system with Marlboro Smooth do not wish to be made available to the
export lists. FDA calculates, therefore, Menthol Heatsticks, and IQOS system public, submit the comment as a
that the total burden for this collection with Marlboro Fresh Menthol Heatsticks written/paper submission and in the
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![Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices 27489
• Testing of actual consumer Dated: June 9, 2017. electronically, including attachments, to
perception shows that, as the applicant Anna K. Abram, https://www.regulations.gov/ will be
proposes to label and market the Deputy Commissioner for Policy, Planning, posted to the docket unchanged.
product, consumers will not be misled Legislation, and Analysis. Because your comment will be made
into believing that the product is or has [FR Doc. 2017–12369 Filed 6–14–17; 8:45 am] public, you are solely responsible for
been demonstrated to be less harmful or BILLING CODE 4164–01–P ensuring that your comment does not
presents or has been demonstrated to include any confidential information
present less of a risk of disease than one that you or a third party may not wish
or more other commercially marketed DEPARTMENT OF HEALTH AND to be posted, such as medical
tobacco products; and HUMAN SERVICES information, your or anyone else’s
• Issuance of the exposure Social Security number, or confidential
Food and Drug Administration business information, such as a
modification order is expected to benefit
the health of the population as a whole manufacturing process. Please note that
[Docket No. FDA–2011–N–0424]
taking into account both users of if you include your name, contact
tobacco products and persons who do Agency Information Collection information, or other information that
not currently use tobacco products. Activities; Proposed Collection; identifies you in the body of your
Comment Request; Temporary comments, that information will be
Section 911(g)(4) of the FD&C Act posted on https://www.regulations.gov/.
Marketing Permit Applications
describes factors that FDA must take • If you want to submit a comment
into account in evaluating whether a AGENCY: Food and Drug Administration, with confidential information that you
tobacco product satisfies the HHS. do not wish to be made available to the
requirements in section 911(g)(2). ACTION: Notice. public, submit the comment as a
FDA is issuing this notice to inform written/paper submission and in the
the public that the following MRTPAs SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper
submitted by Philip Morris Products Administration (FDA or Agency) is Submissions’’ and ‘‘Instructions’’).
S.A. have been filed and are being made announcing an opportunity for public
Written/Paper Submissions
available for public comment: comment on the proposed collection of
certain information by the Agency. Submit written/paper submissions as
• MR0000059: IQOS system with follows:
Under the Paperwork Reduction Act of
Marlboro Heatsticks • Mail/Hand delivery/Courier (for
1995 (PRA), Federal Agencies are
• MR0000060: IQOS system with required to publish notice in the written/paper submissions): Dockets
Marlboro Smooth Menthol Heatsticks Federal Register concerning each Management Staff (HFA–305), Food and
• MR0000061: IQOS system with proposed collection of information, Drug Administration, 5630 Fishers
Marlboro Fresh Menthol Heatsticks including each proposed extension/ Lane, Rm. 1061, Rockville, MD 20852.
reinstatement of an existing collection • For written/paper comments
Due to the large size of these submitted to the Dockets Management
applications, FDA will post the of information, and to allow 60 days for
public comment in response to the Staff, FDA will post your comment, as
application documents in batches on a well as any attachments, except for
rolling basis as they are redacted in notice. This notice solicits comments on
reporting requirements contained in information submitted, marked and
accordance with applicable laws. In this identified, as confidential, if submitted
document, FDA is announcing the existing FDA regulations governing
temporary marketing permit as detailed in ‘‘Instructions.’’
availability of the first batch of Instructions: All submissions received
application documents. FDA is making applications.
must include the Docket No. FDA–
the applications available for public DATES: Submit either electronic or 2011–N–0424 for ‘‘Temporary
comment for 180 days from the posting written comments on the collection of Marketing Permit Applications.’’
of the first batch of application information by August 14, 2017. Received comments, those filed in a
documents. In the event that fewer than ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be
30 days remain in the comment period as follows. Please note that late, placed in the docket and, except for
when the final batch is posted, FDA will untimely filed comments will not be those submitted as ‘‘Confidential
issue a notice in the Federal Register considered. Electronic comments must Submissions,’’ publicly viewable at
extending the comment period to allow be submitted on or before August 14, https://www.regulations.gov/ or at the
for at least 30 days of public comment 2017. The https://www.regulations.gov Dockets Management Staff between 9
from the day the final batch is posted. electronic filing system will accept a.m. and 4 p.m., Monday through
FDA believes that this comment period comments until midnight Eastern Time Friday.
is appropriate given the volume and at the end of August 14, 2017. • Confidential Submissions—To
complexity of the applications being Comments received by mail/hand submit a comment with confidential
posted. To encourage public delivery/courier (for written/paper information that you do not wish to be
participation consistent with section submissions) will be considered timely made publicly available, submit your
911(e) of the FD&C Act, FDA is making if they are postmarked or the delivery comments only as a written/paper
the redacted MRTPAs that are the service acceptance receipt is on or submission. You should submit two
subject of this notice available before that date. copies total. One copy will include the
electronically (see section II).
pmangrum on DSK3GDR082PROD with NOTICES
information you claim to be confidential
Electronic Submissions with a heading or cover note that states
II. Electronic Access
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Persons with access to the Internet following way: CONFIDENTIAL INFORMATION.’’ The
may obtain the documents at http:// • Federal eRulemaking Portal: Agency will review this copy, including
www.fda.gov/TobaccoProducts/ https://www.regulations.gov/. Follow the claimed confidential information, in
Labeling/MarketingandAdvertising/ the instructions for submitting its consideration of comments. The
ucm546281.htm. comments. Comments submitted second copy, which will have the
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Document Created: 2017-06-15 01:03:48
Document Modified: 2017-06-15 01:03:48
| 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. | |
| Dates | Submit either electronic or written comments on the application by December 12, 2017. | |
| Contact | Paul Hart, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 1-877-287-1373, email: [email protected] | |
| FR Citation | 82 FR 27487 |
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