Modified Risk Tobacco Product Application: Application for the IQOS 3 System Holder and Charger Submitted by Philip Morris Products S.A., 26530-26532 [2021-10177]

Download as PDF 26530 Federal Register / Vol. 86, No. 92 / Friday, May 14, 2021 / Notices visit our website at: https:// www.fda.gov/federal-state-local-tribaland-territorial-officials/nationalintegrated-food-safety-system-ifssprograms-and-initiatives. In the United States, Federal and State governments work cooperatively to ensure the safety of food intended for both human and animal consumption. Part of this effort includes developing and maintaining uniform review criteria by which to assess food safety. FDA has established and maintains a number of program standards aimed at improving the safety evaluation for certain food products including manufactured foods and animal feed. Similarly, we are establishing regulatory program standards for eggs and have developed the ‘‘Eggs Regulatory Program Standards’’ (ERPS). The ERPS is intended for use by State and local regulatory officials and identifies ten elements we believe are essential to the effective regulatory assessment of egg safety. States are encouraged to build systems that are sustainable and implement plans corresponding to the IFSS. In the course of their normal duties, State, local, Territorial, and Tribal governments collect information pertaining to compliance with the respective State, local, Territorial, and tribal food safety requirements within their jurisdictions. Although content and format of the information collected may vary, these activities are a usual and customary part of routine regulatory oversight. Respondents to the information collection are State, local, Territorial, Tribal, and Federal regulatory agencies participating in FDA’s Voluntary National Retail Food Regulatory Program Standards (information collection currently approved under OMB control number 0910–0621). Consistent with the ERPS, respondents will submit the following information to FDA: (1) Program selfassessment; (2) risk factor study of the regulated industry; and (3) independent outside audit (verification audit). The ERPS offers forms, worksheets, and templates to help respondents assess and meet the program elements identified and discussed. Respondents are not required to use the sample collection instruments included in the ERPS, however all data elements should be submitted to FDA and supporting documentation retained. The ERPS is not intended to address any performance appraisal processes that any State, local, Territorial, or tribal agency may use to evaluate its employees’ performance. Funding opportunities are available to respondents who choose to implement the ERPS, however these opportunities are limited and contingent upon the availability of funds, and to those respondents who currently have an egg inspection contract with FDA and thus subject to auditing. A copy of the ERPS has been posted to FDA–2021–N–0341 and is available at https:// www.regulations.gov. We estimate the burden of the information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Respondents; information collection activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours State, Local, Territorial, and/or Tribal Governments; submission of data elements to FDA consistent with ERPS 10 10 100 500 500,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on our experience with similar information collection, we estimate an initial 10 respondents will participate in the ERPS, and assume an average of 500 hours is necessary for the attendant recordkeeping and submission of data elements to FDA. We expect participation in the ERPS to increase. Dated: May 7, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–10180 Filed 5–13–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES khammond on DSKJM1Z7X2PROD with NOTICES [Docket No. FDA–2021–N–0408] Modified Risk Tobacco Product Application: Application for the IQOS 3 System Holder and Charger Submitted by Philip Morris Products S.A. Food and Drug Administration, HHS. VerDate Sep<11>2014 19:58 May 13, 2021 Jkt 253001 Notice of availability. The Food and Drug Administration (FDA) is announcing the availability for public comment of a modified risk tobacco product application (MRTPA) for the IQOS 3 System Holder and Charger submitted by Philip Morris Products S.A. DATES: Electronic or written comments on the application may be submitted beginning May 14, 2021. FDA will establish a closing date for the comment period as described in section I. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions Food and Drug Administration AGENCY: ACTION: 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 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 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 E:\FR\FM\14MYN1.SGM 14MYN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 86, No. 92 / Friday, May 14, 2021 / Notices 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– 2021–N–0408 for ‘‘Modified Risk Tobacco Product Application: Application for the IQOS 3 System Holder and Charger 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, 240–402–7500. • 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.govinfo.gov/content/pkg/FR-201509-18/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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Samantha Loh Collado, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire VerDate Sep<11>2014 19:58 May 13, 2021 Jkt 253001 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 pursuant to 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 a 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 a 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 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 (2). The applicant, Philip Morris Products S.A., is seeking an order under section 911(g)(2) of the FD&C Act. 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 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 26531 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) of the FD&C Act; • 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; • 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 benefits the health of individuals and the population as a whole. FDA is issuing this notice to inform the public that an MRTPA for the IQOS 3 System Holder and Charger submitted by Philip Morris Products S.A. has been filed and is being made available for public comment. The applicant is seeking authorization to market a modified version of the IQOS system holder and charger that previously E:\FR\FM\14MYN1.SGM 14MYN1 26532 Federal Register / Vol. 86, No. 92 / Friday, May 14, 2021 / Notices khammond on DSKJM1Z7X2PROD with NOTICES received an order under section 911(g)(2) of the FD&C Act 1 as an MRTP and is including information from the authorized MRTPA by cross-reference. FDA will post the application documents, including those crossreferenced from prior submissions previously authorized and those contained in any amendments, for public comment 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 for public comment. FDA intends to establish a closing date for the comment period that is both at least 45 days after the date this notice publishes and at least 30 days after the final documents from the application are made available for public comment. FDA will announce the closing date at least 30 days in advance. FDA believes that this comment period is appropriate given the relatively low volume of information in the MRTPA that has not already been available for public comment as part of the previously authorized MRTPAs for the IQOS system. FDA will notify the public about the availability of application documents and comment period closing date via the Agency’s web page for the MRTPA (see section II) and by other means of public communication, such as by email to individuals who have signed up to receive email alerts. FDA does not intend to issue additional notices in the Federal Register regarding the availability of additional application documents, including amendments, or the comment period for this MRTPA. To receive email alerts, visit FDA’s email subscription service management website (https://www.fda.gov/about-fda/ contact-fda/get-email-updates), provide an email address, scroll down to the ‘‘Tobacco’’ heading, select ‘‘Modified Risk Tobacco Product Application Update’’, and click ‘‘Submit’’. To encourage public participation consistent with section 911(e) of the FD&C Act, FDA is making the redacted MRTPA that is the subject of this notice available electronically (see section II). II. Electronic Access Persons with access to the internet may obtain the application documents at either https://www.fda.gov/tobaccoproducts/advertising-and-promotion/ philip-morris-products-sa-modified-risk1 The notice of availability for the IQOS MRTPAs that received a modified risk granted order appeared in the Federal Register of June 15, 2017 (82 FR 27487), and the docket containing notices and public comments, FDA–2017–D–3001, is accessible at: https://www.regulations.gov/docket/ FDA-2017-D-3001/. VerDate Sep<11>2014 19:58 May 13, 2021 Jkt 253001 tobacco-product-mrtp-applications or https://www.regulations.gov. Dated: May 10, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–10177 Filed 5–13–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0155] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA). SUMMARY: Submit written comments (including recommendations) on the collection of information by June 14, 2021. DATES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0363. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 Veterinary Feed Directive OMB Control Number 0910–0363— Extension Section 504 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 354) establishes a regulatory category for certain new animal drugs called veterinary feed directive (VFD) drugs. The VFD regulation is set forth at § 558.6 (21 CFR 558.6). VFD drugs are new animal drugs, intended for use in or on animal feed, which are limited to use under the professional supervision of a licensed veterinarian in the course of the veterinarian’s professional practice (§ 558.6(b)(6)). An animal feed containing a VFD drug or a combination VFD drug may be fed to animals only by or upon a lawful VFD issued by a licensed veterinarian (§ 558.6(a)(1)). Veterinarians issue three copies of the VFD: One for their own records, one for their client, and one to the client’s VFD feed distributor (§ 558.6(a)(4) and (b)(8) and (9)). The VFD includes information about the number and species of animals to receive feed containing one or more of the VFD drugs (§ 558.6(b)(3)), along with other information required under § 558.6. All distributors of medicated feed containing VFD drugs must notify FDA of their intent to distribute such feed and must maintain records of the receipt and distribution of all medicated feeds containing VFD drugs. The VFD regulation ensures the protection of public health while enabling animal producers to obtain and use needed drugs as efficiently and cost effectively as possible. The VFD regulation is tailored to the unique circumstances relating to the distribution and use of animal feeds containing a VFD drug. We will use the information collected to assess compliance with the VFD regulation. The required recordkeeping and third-party disclosures provide assurance that the medicated feeds will be safe and effective for their labeled conditions of use and that edible products from treated animals will be free of unsafe drug residues. In the Federal Register of December 23, 2020 (85 FR 83968), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: A. Reporting Requirements Description of Respondents: VFD Feed Distributors and VFD Drug Sponsors. E:\FR\FM\14MYN1.SGM 14MYN1

Agencies

[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Notices]
[Pages 26530-26532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10177]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0408]


Modified Risk Tobacco Product Application: Application for the 
IQOS 3 System Holder and Charger Submitted by Philip Morris Products 
S.A.

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for public comment of a modified risk tobacco product 
application (MRTPA) for the IQOS 3 System Holder and Charger submitted 
by Philip Morris Products S.A.

DATES: Electronic or written comments on the application may be 
submitted beginning May 14, 2021. FDA will establish a closing date for 
the comment period as described in section I.

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

[[Page 26531]]

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-2021-N-0408 for ``Modified Risk Tobacco Product Application: 
Application for the IQOS 3 System Holder and Charger 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, 240-
402-7500.
     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.govinfo.gov/content/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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Samantha Loh Collado, 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].

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 pursuant to 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 a 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 a 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 
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 (2). The applicant, Philip Morris Products S.A., is 
seeking an order under section 911(g)(2) of the FD&C Act.
    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) of the 
FD&C Act;
     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;
     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 benefits the 
health of individuals and the population as a whole.
    FDA is issuing this notice to inform the public that an MRTPA for 
the IQOS 3 System Holder and Charger submitted by Philip Morris 
Products S.A. has been filed and is being made available for public 
comment. The applicant is seeking authorization to market a modified 
version of the IQOS system holder and charger that previously

[[Page 26532]]

received an order under section 911(g)(2) of the FD&C Act \1\ as an 
MRTP and is including information from the authorized MRTPA by cross-
reference.
---------------------------------------------------------------------------

    \1\ The notice of availability for the IQOS MRTPAs that received 
a modified risk granted order appeared in the Federal Register of 
June 15, 2017 (82 FR 27487), and the docket containing notices and 
public comments, FDA-2017-D-3001, is accessible at: https://www.regulations.gov/docket/FDA-2017-D-3001/.
---------------------------------------------------------------------------

    FDA will post the application documents, including those cross-
referenced from prior submissions previously authorized and those 
contained in any amendments, for public comment 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 for public comment. FDA intends to establish a 
closing date for the comment period that is both at least 45 days after 
the date this notice publishes and at least 30 days after the final 
documents from the application are made available for public comment. 
FDA will announce the closing date at least 30 days in advance. FDA 
believes that this comment period is appropriate given the relatively 
low volume of information in the MRTPA that has not already been 
available for public comment as part of the previously authorized 
MRTPAs for the IQOS system. FDA will notify the public about the 
availability of application documents and comment period closing date 
via the Agency's web page for the MRTPA (see section II) and by other 
means of public communication, such as by email to individuals who have 
signed up to receive email alerts. FDA does not intend to issue 
additional notices in the Federal Register regarding the availability 
of additional application documents, including amendments, or the 
comment period for this MRTPA. To receive email alerts, visit FDA's 
email subscription service management website (https://www.fda.gov/about-fda/contact-fda/get-email-updates), provide an email address, 
scroll down to the ``Tobacco'' heading, select ``Modified Risk Tobacco 
Product Application Update'', and click ``Submit''. To encourage public 
participation consistent with section 911(e) of the FD&C Act, FDA is 
making the redacted MRTPA that is the subject of this notice available 
electronically (see section II).

II. Electronic Access

    Persons with access to the internet may obtain the application 
documents at either https://www.fda.gov/tobacco-products/advertising-and-promotion/philip-morris-products-sa-modified-risk-tobacco-product-mrtp-applications or https://www.regulations.gov.

    Dated: May 10, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10177 Filed 5-13-21; 8:45 am]
BILLING CODE 4164-01-P

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