[Federal Register: February 8, 2008 (Volume 73, Number 27)]
[Rules and Regulations]
[Page 7465-7468]
[DOCID:fr08fe08-5]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2007-1054; A-1-FRL-8524-9]

Approval and Promulgation of Air Quality Implementation Plans;
Maine; Transportation Conformity

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is approving a State Implementation Plan (SIP) revision
submitted by the State of Maine. This revision establishes
transportation conformity criteria and procedures related to
interagency consultation and enforceability of certain transportation-
related control measures and mitigation measures. The intended effect
of this action is to approve State criteria and procedures to govern
transportation conformity determinations. This action is being taken in
accordance with the Clean Air Act.

DATES: This direct final rule will be effective April 8, 2008, unless
EPA receives adverse comments by March 10, 2008. If adverse comments
are received, EPA will publish a timely withdrawal of the direct final
rule in the Federal Register informing the public that the rule will
not take effect.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R01-OAR-2007-1054 by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``Docket Identification Number EPA-R01-OAR-2007-1054'',
Anne Arnold, U.S. Environmental Protection Agency, EPA New England
Regional Office, One Congress Street, Suite 1100 (mail code CAQ),
Boston, MA 02114-2023.
    5. Hand Delivery or Courier. Deliver your comments to: Anne Arnold,
Manager, Air Quality Planning Unit, Office of Ecosystem Protection,
U.S. Environmental Protection Agency, EPA New England Regional Office,
One Congress Street, 11th floor, (CAQ), Boston, MA 02114-2023. Such
deliveries are only accepted during the Regional Office's normal hours
of operation. The Regional Office's official hours of business are
Monday through Friday, 8:30 to 4:30, excluding legal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R01-OAR-
2007-1054. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit through http://www.regulations.gov, or e-

mail, information that you consider to be CBI or otherwise protected.
The http://www.regulations.gov Web site is an ``anonymous access'' system,

which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov

your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you

submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://www.regulations.gov or

in hard copy at Office of Ecosystem Protection, U.S. Environmental
Protection Agency, EPA New England Regional Office, One Congress
Street, Suite 1100, Boston, MA. EPA requests that if at all possible,
you contact the contact listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 to 4:30, excluding
legal holidays.
    In addition, copies of the state submittal are also available for
public inspection during normal business hours, by appointment at the
State Air Agency; the Bureau of Air Quality Control, Department of
Environmental Protection, First Floor of the Tyson Building, Augusta
Mental Health Institute Complex, Augusta, ME 04333-0017.

FOR FURTHER INFORMATION CONTACT: Donald O. Cooke, Air Quality Unit,
U.S. Environmental Protection Agency, EPA New England Regional Office,
One Congress Street, Suite 1100 (CAQ), Boston, MA 02114-2023, telephone
number<PHONE_NUMBER>, fax number<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.
    Organization of this document. The following outline is provided to
aid in locating information in this preamble.

I. Background and Purpose
    A. What Is Transportation Conformity?
    B. Transportation Conformity Provisions of SAFETEA-LU
II. State Submittal
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background and Purpose

    On October 3, 2007, the State of Maine submitted a formal revision
to its State Implementation Plan (SIP). The SIP revision consists of a
new regulation ``Chapter 139 Transportation Conformity'' to implement
Section 176(c)(4)(E) of the Clean Air Act as amended (42 U.S.C. 7401,
et seq.), with respect to the conformity of transportation plans,
programs and projects which are developed, funded, or approved by the
United States Department of Transportation (U.S. DOT), and by
Metropolitan Planning Organizations (MPOs) or other recipients of funds
under Title 23 U.S.C. or the Federal Transit Laws (Title 49 U.S.C.
Chapter 53).

A. What Is Transportation Conformity?

    Transportation conformity is required under Section 176(c) of the
Clean Air Act to ensure that Federally supported highway, transit
projects, and other activities are consistent with (``conform to'') the
purpose of the SIP. Conformity currently applies to areas that are
designated nonattainment, and those redesignated to attainment after
1990 (maintenance areas) with plans developed under section 175A of the
Clean Air Act, for the following transportation related criteria
pollutants: Ozone, particulate matter (PM2.5 and
PM10), carbon monoxide (CO), and nitrogen dioxide
(NO2). Conformity to the purpose of the SIP means that
transportation activities will not cause new air quality violations,
worsen existing violations, or delay timely attainment of the relevant
national ambient air quality standards (NAAQS). The transportation
conformity regulation is found in 40 CFR part 93 and provisions related
to conformity SIPs are found in 40 CFR 51.390.

B. Transportation Conformity Provisions of SAFETEA-LU

    On August 10, 2005, the ``Safe, Accountable, Flexible, Efficient
Transportation Equity Act: A Legacy for Users'' (SAFETEA-LU) was signed
into law. SAFETEA-LU revised a number of aspects related to section
176(c) of the Clean Air Act's transportation conformity provisions. One
of the changes was to streamline the requirements for conformity SIPs.
Prior to SAFETEA-LU being signed into law, states were required to
address all of the Federal conformity rule's provisions in their
conformity SIPs. Most of the sections of the Federal rule were required
to be copied verbatim from the Federal rule into a state's SIP, as
previously required under 40 CFR 51.390(d).
    Under SAFETEA-LU, states are required to address and tailor only
three sections of the conformity rule in their conformity SIPs. These
three sections of the Federal rule which must meet a state's individual
circumstances are: 40 CFR 93.105, which addresses consultation
procedures; 40 CFR 93.122(a)(4)(ii), which requires that written
commitments be obtained for control measures that are not included in a
Metropolitan Planning Organization's transportation plan and
transportation improvement program prior to a conformity determination,
and that such commitments be fulfilled; and, 40 CFR 93.125(c) which
requires that written commitments be obtained for mitigation measures
prior to a project level conformity determination, and that project
sponsors must comply with such commitments. In general, states are no
longer required to submit conformity SIP revisions that address the
other sections of the conformity rule. This provision took effect on
August 10, 2005, when SAFETEA-LU was signed into law.

II. State Submittal

    Maine's ``Chapter 139: Transportation Conformity,'' includes
provisions addressing: applicability; definitions; priority of
projects; consultation roles, responsibilities, and procedures; public
notice; and project-level mitigation and control measures.
    We have reviewed Maine's submittal to assure consistency with the
current Clean Air Act, as amended by SAFETEA-LU, and EPA regulations
(40 CFR part 93 and 40 CFR 51.390) governing state procedures for
transportation conformity and interagency consultation and have
concluded that the submittal is approvable. Specifically, Maine's rule
adequately addresses the three sections of the Federal rule discussed
above.

IV. Final Action

    EPA is approving Maine's ``Chapter 139 Transportation Conformity,''
and incorporating this regulation into the Maine SIP.
    The EPA is publishing this action without prior proposal because
the Agency views this as a noncontroversial amendment and anticipates
no adverse comments. However, in the proposed rules section of this
Federal Register publication, EPA is publishing a separate document
that will serve as the proposal to approve the SIP revision

should relevant adverse comments be filed. This rule will be effective
April 8, 2008 without further notice unless the Agency receives
relevant adverse comments by March 10, 2008.
    If the EPA receives such comments, then EPA will publish a notice
withdrawing the final rule and informing the public that the rule will
not take effect. All public comments received will then be addressed in
a subsequent final rule based on the proposed rule. The EPA will not
institute a second comment period on the proposed rule. All parties
interested in commenting on the proposed rule should do so at this
time. If no such comments are received, the public is advised that this
rule will be effective on April 8, 2008 and no further action will be
taken on the proposed rule. Please note that if EPA receives adverse
comment on an amendment, paragraph, or section of this rule and if that
provision may be severed from the remainder of the rule, EPA may adopt
as final those provisions of the rule that are not the subject of an
adverse comment.

V. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601, et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999), because it merely approves a state rule
implementing a Federal standard, and does not alter the relationship or
the distribution of power and responsibilities established in the Clean
Air Act. This rule also is not subject to Executive Order 13045
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it approves a state rule
implementing a Federal standard.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq.)
    The Congressional Review Act, 5 U.S.C. 801, et seq., as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of the rule in the Federal Register. A major rule
cannot take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by April 8, 2008. Interested
parties should comment in response to the proposed rule rather than
petition for judicial review, unless the objection arises after the
comment period allowed for in the proposal. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action may not be challenged later in proceedings to enforce its
requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: January 24, 2008.
Ira W. Leighton,
 Acting Regional Administrator, EPA New England.

0
Part 52 of chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401, et seq.

Subpart U--Maine

0
2. Section 52.1020 is amended by adding paragraph (c)(64) to read as
follows:

Sec.  52.1020  Identification of plan.

* * * * *
    (c) * * *
    (64) Revisions to the State Implementation Plan submitted by the
Maine Department of Environmental Protection on October 3, 2007.
    (i) Incorporation by reference.
    (A) Maine Administrative Procedure Act (MAPA) 1 Form which provides
certification that the Attorney General approved Chapter 139
``Transportation Conformity,'' as to form and legality, dated September
10, 2007.
    (B) Chapter 139 of the Maine Department of Environmental Protection
Regulations, ``Transportation Conformity,'' effective in the State of
Maine on September 19, 2007.
    (ii) Additional materials.
    (A) Nonregulatory portions of the submittal.

0
3. In Sec.  52.1031, Table 52.1031 is amended by adding a new entry for
state citation Chapter 139 to read as follows:

Sec.  52.1031  EPA-approved Maine regulations.

* * * * *

                               Table 52.1031.--EPA-Approved Rules and Regulations
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                                          Date         Date
 State  citation     Title/subject     adopted by    approved    Federal Register    52.1020
                                         State        by EPA         citation
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                                                  * * * * * * *
139.............  Transportation          9/19/07      2/08/08  [Insert Federal        (c) 64
                   Conformity.                                   Register page
                                                                 number where the
                                                                 document begins].

                                                  * * * * * * *
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Note.--1. The regulations are effective statewide unless stated otherwise in comments section.

 [FR Doc. E8-2247 Filed 2-7-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27487-27489]
[FR Doc No: 2017-12369]

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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.

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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

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.gpo.gov/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:
<EMAIL_ADDRESS>
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;

     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