[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Notices]
[Page 24136]
[FR Doc No: 2019-10955]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9993-99-OAR]

Meeting of the Mobile Sources Technical Review Subcommittee

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

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SUMMARY: Pursuant to the Federal Advisory Committee Act, Public Law 92-
463, notice is hereby given that the Mobile Sources Technical Review
Subcommittee (MSTRS) will meet on September 17, 2019. The MSTRS is a
subcommittee under the Clean Air Act Advisory Committee. This is an
open meeting. The meeting will include discussion of current topics and
presentations about activities being conducted by EPA's Office of
Transportation and Air Quality. The preliminary agenda for the meeting
and any notices about change in venue will be posted on the
Subcommittee's website: http://www2.epa.gov/caaac/mobile-sources-technical-review-subcommittee-mstrs-caaac. MSTRS listserv subscribers
will receive notification when the agenda is available on the
Subcommittee website. To subscribe to the MSTRS listserv, send an email
to<EMAIL_ADDRESS>
DATES: Tuesday, September 17, 2019 from 9 a.m. to 4:30 p.m.
Registration begins at 8:30 a.m.

ADDRESSES: The meeting is currently scheduled to be held at the EPA's
National Vehicle and Fuel Emissions Laboratory, 2000 Traverwood Drive,
Ann Arbor, MI 48105. However, this date and location are subject to
change and interested parties should monitor the Subcommittee website
(above) for the latest logistical information.

FOR FURTHER INFORMATION CONTACT: Courtney McCubbin, Designated Federal
Officer, Transportation and Climate Division, Mailcode 6406A, U.S. EPA,
1200 Pennsylvania Ave. NW, Washington, DC 20460; Ph:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    Background on the work of the Subcommittee is available at: https://www.epa.gov/caaac/mobile-sources-technical-review-subcommittee-mstrs-caaac. Individuals or organizations wishing to provide comments to the
Subcommittee should submit them to Ms. McCubbin at the address above by
September 4, 2019. The Subcommittee expects that public statements
presented at its meetings will not be repetitive of previously
submitted oral or written statements.

SUPPLEMENTARY INFORMATION: During the meeting, the Subcommittee may
also hear progress reports from some of its workgroups as well as
updates and announcements on activities of general interest to
attendees.
    For Individuals with Disabilities: For information on access or
services for individuals with disabilities, please contact Ms. McCubbin
(see above). To request accommodation of a disability, please contact
Ms. McCubbin, preferably at least 10 days prior to the meeting, to give
EPA as much time as possible to process your request.

    Dated: May 13, 2019.
Christopher Grundler,
Director, Office of Transportation and Air Quality, Office of Air and
Radiation.
[FR Doc. 2019-10955 Filed 5-23-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: May 27, 2008 (Volume 73, Number 102)]
[Proposed Rules]
[Page 30345-30347]
[DOCID:fr27my08-21]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2008-0186; FRL-8571-6]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Section 110(a)(1) 8-Hour Ozone Maintenance Plan and 2002
Base-Year Inventory for the Northumberland County Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the Commonwealth of Pennsylvania. The
Pennsylvania Department of Environmental Protection (PADEP) submitted a
SIP revision consisting of a maintenance plan that provides for
continued attainment of the 8-hour ozone national ambient air quality
standard (NAAQS) for at least 10 years after the April 30, 2004
designations, as well as a 2002 base-year inventory for the
Northumberland County Area. EPA is proposing approval of the
maintenance plan and the 2002 base-year inventory in accordance with
the requirements of the Clean Air Act (CAA).

DATES: Written comments must be received on or before June 26, 2008.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2008-0186 by one of the following methods:
    A. http://www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. E-mail<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2008-0097, Cristina Fernandez, Chief, Air
Quality Planning Branch, Mailcode 3AP21, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2008-0186. 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 information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. 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 during normal business hours at the
Air Protection Division, U.S. Environmental Protection Agency, Region
III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the
State submittal are available at Pennsylvania Department of
Environmental Protection, Bureau of Air Quality Control, P.O. Box 8468,
400 Market Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Melissa Linden,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On December 17, 2007, PADEP formally
submitted for approval, under section 110(a)(1) of the CAA, a SIP
revision for the 8-hour ozone maintenance plan and the 2002 base-year
inventory for the Northumberland County Area.

I. Background

    Section 110(a)(1) of the CAA requires that states submit to EPA
plans to maintain the NAAQS promulgated by EPA. EPA interprets this
provision to require that areas that were maintenance areas for the 1-
hour ozone NAAQS, but attainment for the 8-hour ozone NAAQS, submit a
plan to demonstrate the continued maintenance of the 8-hour ozone
NAAQS.
    On May 20, 2005, EPA issued guidance that applies to areas that are
designated unclassifiable/attainment for the 8-hour ozone standard. The
purpose of this guidance is to address the maintenance requirements in
section 110(a)(1) of the CAA, and to assist the states in the
development of a SIP. The components from EPA's guidance include: (1)
An attainment emissions inventory, which is based on actual ``typical
summer day'' emissions of volatile organic compounds (VOCs) and
nitrogen oxides (NOX) for a 10-year maintenance period, from
a base-year chosen by the state; (2) a maintenance demonstration, which
demonstrates how the area will remain in compliance with the 8-hour
ozone standard for a period of 10 years following the

effective date of designation unclassifiable/attainment (June 15,
2004); (3) an ambient air monitoring network, which will be in
continuous operation in accordance with 40 CFR Part 58 to verify
maintenance of the 8-hour ozone standard; (4) a contingency plan that
will ensure that in the event of a violation of the 8-hour ozone NAAQS,
measures will be implemented as promptly as possible; (5) a
verification of continued attainment, indicating how the state intends
on tracking the progress of the maintenance plan.

II. Summary of SIP Revision

    The Commonwealth of Pennsylvania has requested approval of its 8-
hour ozone maintenance plan and 2002 base-year inventory for the
Northumberland County Area. The PADEP 8-hour ozone maintenance plan
addresses the five components of EPA's May 20, 2005 guidance, which
pertains to the maintenance requirements in section 110(a)(1) of the
CAA.
    Attainment Emission Inventory: An attainment emissions inventory
includes emissions during the time period associated with the
monitoring data showing attainment. PADEP has provided an emissions
inventory for VOCs and NOX, using 2002 as the base-year from
which to project emissions. The 2002 inventory is consistent with EPA
guidance, is based on actual ``typical summer day'' emissions of VOCs
and NOX, and consists of a list of sources and their
associated emissions. PADEP prepared comprehensive VOCs and
NOX emissions inventories for the Northumberland County
Area. In the maintenance plan, PADEP included information on the man-
made sources of ozone precursors, VOCs and NOX (e.g.,
``stationary sources,'' ``stationary area sources,'' ``highway
vehicles,'' and ``nonroad sources'').
    Pennsylvania projected emissions for beyond 10 years from the
effective date of the April 30, 2004, designations for the 8-hour ozone
standard. PADEP has developed an emissions inventory for ozone
precursors for the year 2002, 2009, and 2018. Tables 1 and 2 show the
VOCs and NOX emissions reduction summary for 2002, 2009, and
2018.

          Table 1.--VOC Emissions Summary: 2002, 2009 and 2018
                          [Tons per summer day]
------------------------------------------------------------------------
      Major source category            2002         2009         2018
------------------------------------------------------------------------
Stationary Point Sources.........         2.29         2.72         3.51
Stationary Area Sources..........         4.75         4.45         4.72
Highway Vehicles.................         4.72         2.66         1.44
Nonroad Sources..................         4.58         3.51         2.87
                                  --------------------------------------
    Total........................        16.34        13.34        12.54
------------------------------------------------------------------------

          Table 2.--NOX Emissions Summary: 2002, 2009 and 2018
                          [Tons per summer day]
------------------------------------------------------------------------
      Major source category            2002         2009         2018
------------------------------------------------------------------------
Stationary Point Sources.........         1.41         1.05         1.22
Stationary Area Sources..........         0.43         0.48         0.50
Highway Vehicles.................         7.89         4.38         1.83
Nonroad Sources..................         2.65         2.17         1.55
                                  --------------------------------------
    Total........................        12.38         8.08         5.10
------------------------------------------------------------------------

    EPA believes Pennsylvania has demonstrated that the VOCs and
NOX emissions in the Northumberland County Area will improve
due to permanent and enforceable reductions in emissions resulting from
implementation of the SIP, federal measures, and other state-adopted
measures.
    Maintenance demonstration: As Table 1 and 2 indicate, the
Northumberland County Attainment Area plan shows maintenance of the 8-
hour ozone NAAQS by demonstrating that future emissions of VOCs and
NOX remain at or below the 2002 base-year emissions levels
through the year 2018.
    Based upon the comparison of the projected emissions and the 2002
base-year inventory emissions, along federal and state measures, EPA
concludes that PADEP successfully demonstrates that the 8-hour ozone
standard will be maintained in the Northumberland County Area. Further
details of Northumberland County Attainment Area's 8-hour ozone
maintenance demonstration can be found in a Technical Support Document
(TSD) prepared for this rulemaking.
    Ambient Air Quality Monitoring: With regard to the ambient air
monitoring component of the maintenance plan, Pennsylvania commits to
continue operating its current air quality monitoring stations in
accordance with 40 CFR Part 58, to verify the attainment status of the
area, with no reductions in the number of sites from those in the
existing network unless pre-approved by EPA.
    Contingency Plan: Section 110(a)(1) of the CAA requires that the
state develop a contingency plan which will ensure that any violation
of a NAAQS is promptly corrected. The purpose of the contingency plan
is to adopt measures, outlined in the maintenance plan, in order to
assure continued attainment in the event of a violation of the 8-hour
ozone NAAQS. The maintenance plan should identify the events that would
``trigger'' the adoption and implementation of a contingency
measure(s), the contingency measure(s) that would be adopted and
implemented, and the schedule indicating the time frame by which the
state would adopt and implement the measure(s).
    Since the Northumberland County Area does not have a monitor,
contingency measures will be considered if for two consecutive years
the fourth highest 8-hour ozone concentrations at the design monitor
for the Harrisburg Area are above 84 parts per billion (ppb). If this
trigger point occurs, PADEP will evaluate whether

additional local emission control measures should be implemented in
Northumberland County in order to prevent a violation of the air
quality standard. PADEP will analyze the conditions leading to the
excessive ozone levels and evaluate what measures might be most
effective in correcting the excessive ozone levels. PADEP will also
analyze the potential emissions effect of federal, state, and local
measures that have been adopted but not yet implemented at the time the
excessive ozone levels occurred. PADEP will then begin the process of
implementing the contingency measures outlined in their maintenance
plan.
    Verification of continued attainment: PADEP will track the
attainment status of the 8-hour ozone NAAQS for Northumberland County
by reviewing air quality at the design monitor for the Harrisburg Area
and emissions data during the maintenance period. An annual evaluation
of vehicle miles traveled and emissions reported from stationary
sources will be performed and compared to the assumptions about the
factors used in the maintenance plan. PADEP will also evaluate the
periodic (every three years) emission inventories prepared under EPA's
Consolidated Emission Reporting Regulation (40 CFR part 51, subpart A)
for any unanticipated increases. Based on these evaluations, PADEP will
consider whether any further emission control measures should be
implemented.

III. Proposed Action

    EPA is proposing to approve the maintenance plan and the 2002 base-
year inventory for the Northumberland County Area, submitted on
December 17, 2007, as revisions to the Pennsylvania SIP. EPA is
proposing to approve the maintenance plan and 2002 base-year inventory
for the Northumberland County Area because it meets the requirements of
section 110(a)(1) of the CAA. EPA is soliciting public comments on the
issues discussed in this document. These comments will be considered
before taking final action.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     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);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule to approve the maintenance plan and
the 2002 base-year inventory for the Northumberland County Area in the
Commonwealth of Pennsylvania does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements, Volatile organic
compounds.

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

    Dated: May 14, 2008.
William T. Wisniewski,
Acting Regional Administrator, Region III.
 [FR Doc. E8-11754 Filed 5-23-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Notices]
[Pages 70139-70141]
[FR Doc No: 2021-26652]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0125]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Establishing That a Tobacco
Product Was Commercially Marketed in the United States as of February
15, 2007

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection aspects
of the Guidance for Industry on Establishing That a Tobacco Product Was
Commercially Marketed in the United States as of February 15, 2007.

DATES: Submit either electronic or written comments on the collection
of information by February 7, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 7, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 7, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-D-0125 for ``Guidance for Industry on Establishing That a
Tobacco Product Was Commercially Marketed in the United States as of
February 15, 2007.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential

Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     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 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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry on Establishing That a Tobacco Product Was
Commercially Marketed in the United States as of February 15, 2007

OMB Control Number 0910-0775--Extension

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (Tobacco Control Act) (Pub. L. 111-31) was signed into law. The
Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act
(FD&C Act) by adding, among other things, a chapter granting FDA
authority to regulate the manufacture, marketing, and distribution of
tobacco products to protect the public health generally and to reduce
tobacco use by minors.
    Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended,
defines a tobacco product as any product made or derived from tobacco
that is intended for human consumption, including any component, part,
or accessory of a tobacco product (except for raw materials other than
tobacco used in manufacturing a component, part, or accessory of a
tobacco product). Section 910 of the FD&C Act (21 U.S.C. 387j) sets out
premarket requirements for new tobacco products. The term new tobacco
product is defined as any tobacco product (including those products in
test markets) that was not commercially marketed in the United States
as of February 15, 2007, or any modification (including a change in
design, any component, any part, or any constituent, including a smoke
constituent, or in the content, delivery, or form of nicotine, or any
other additive or ingredient) of a tobacco product where the modified
product was commercially marketed in the United States after February
15, 2007 (section 910(a)(1) of the FD&C Act).
    The Tobacco Control Act also gave FDA the authority to issue a
regulation deeming all other products that meet the statutory
definition of a tobacco product to be subject to chapter IX of the FD&C
Act (section 901(b) (21 U.S.C. 387a(b)) of the FD&C Act). On May 10,
2016, FDA issued that rule, extending FDA's tobacco product authority
to all products that meet the definition of tobacco product in the law
(except for accessories of newly regulated tobacco products), including
electronic nicotine delivery systems, cigars, hookah, pipe tobacco,
nicotine gels, and dissolvables that were not already subject to the
FD&C Act, and other tobacco products that may be developed in the
future (81 FR 28974 at 28976).
    FDA refers to tobacco products that were commercially marketed
(including those products in test markets) in the United States as of
February 15, 2007, as Pre-Existing tobacco products.\1\ Pre-Existing
tobacco products are not considered new tobacco products and are not
subject to the premarket requirements of section 910 of the FD&C Act.
The guidance document associated with this information collection
entitled ``Establishing That a Tobacco Product Was Commercially
Marketed in the United States as of February 15, 2007 (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishing-tobacco-product-was-commercially-marketed-united-states-february-15-2007), provides information on how a manufacturer may
establish that a tobacco product was commercially marketed in the
United States as of February 15, 2007. A Pre-Existing tobacco product
(except such products exclusively in test markets) may also serve as
the predicate tobacco product in a section 905(j) report (intended to
be used toward demonstrating substantial

equivalence) for a new tobacco product (section 905(j)(1)A)(i) of the
FD&C Act (21 U.S.C. 387e(j)(1)(A)(i))).
---------------------------------------------------------------------------

    \1\ FDA changed the term from ``grandfathered tobacco product''
to ``Pre-Existing tobacco product'' in the recently published final
SE (86 FR 55224) and PMTA (86 FR 55300) rules because it more
appropriately describes these products by using the more precise
``Pre-Existing'' in place of ``grandfathered.''
---------------------------------------------------------------------------

    The guidance recommends that the manufacturer submit information
adequate to demonstrate that the tobacco product was commercially
marketed in the United States as of February 15, 2007. Examples of such
information may include, but are not limited to, the following: Dated
copies of advertisements, dated catalog pages, dated promotional
material, and dated bills of lading.
    FDA estimates the burden of this collection of information as
follows:

----------------------------------------------------------------------------------------------------------------
                                                      No. of                      Average burden
            Activity                  No. of       responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
Submit evidence of commercial              1,000               1           1,000               5           5,000
 marketing in the United States
 as of February 15, 2007........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's estimate of the number of respondents is based on the fact
that requesting an Agency determination of the Pre-Existing status of a
tobacco product under the guidance is not required and also on the
number of Pre-Existing tobacco product submissions received from 2011
to October 2021. For deemed products that met the definition of a new
tobacco product and were on the market as of August 8, 2016 (when the
deeming rule took effect), FDA issued a compliance policy; this, in
effect, provided more time for manufacturers of these products to
submit their applications for marketing authorization. The deadline for
the submission of applications for these products has now passed. As
the result of a court order (and a subsequent extension due to the
unique circumstances of the COVID-19 pandemic), applications for deemed
new tobacco products on the market at that time were due to FDA by
September 9, 2020.\2\ The court order also provided a 1-year period
during which products with timely filed applications might remain on
the market pending FDA review. The number of hours to gather the
evidence is FDA's estimate of how long it might take a manufacturer to
review, gather, and submit dated information if making a request for
Agency determination.
---------------------------------------------------------------------------

    \2\ On August 19, 2020, the U.S. District Court for the District
of Columbia issued a ruling, in part, to prohibit FDA enforcement of
the Tobacco Control Act's premarket authorization requirement for
premium cigars until after the agency considers developing a
streamlined substantial equivalence process specifically for premium
cigars. Accordingly, FDA will not enforce the premarket review
requirement against manufacturers of premium cigars that do not
submit premarket applications for these products by the September 9,
2020 deadline.
---------------------------------------------------------------------------

    FDA further estimates it would take a manufacturer approximately 5
hours to put together this collection of evidence and to submit the
package to FDA for review. FDA estimates that it would take
approximately 5,000 hours annually to respond to this collection of
information.
    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: December 2, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26652 Filed 12-8-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Rules and Regulations]
[Page 51911]
[FR Doc No: 2022-18206]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2022-0711]

Safety Zones; Fireworks Displays in the Fifth Coast Guard
District

AGENCY: Coast Guard, DHS.

ACTION: Notification of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the Delaware River, Philadelphia,
PA; Safety Zone from 8:15 p.m. through 9 p.m. on September 3, 2022 to
provide for the safety of life on navigable waterways during the
Delaware River Waterfront Corporation fireworks display. Our regulation
for fireworks displays in the Fifth Coast Guard District identifies the
regulated area for this event in Philadelphia, PA. During the
enforcement period, the operator of any vessel in the regulated area
must comply with directions from the Patrol Commander or any Official
Patrol displaying a Coast Guard ensign.

DATES: The regulation 33 CFR 165.506 will be enforced for the location
identified in entry 10 of table 1 to paragraph (h)(1) from 8:15 p.m.
through 9 p.m. on September 3, 2022.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of enforcement, call or email Petty Officer Dylan
Caikowski, U.S. Coast Guard, Sector Delaware Bay, Waterways Management
Division, telephone:<PHONE_NUMBER>, Email: [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
in table 1 to paragraph (h)(1) to 33 CFR 165.506, entry 10 for the
Delaware River Waterfront Corporation fireworks display from 8:15 p.m.
through 9 p.m. on September 3, 2022. This action is necessary to ensure
safety of life on the navigable waters of the United States immediately
prior to, during, and immediately after the fireworks display. Our
regulation for safety zones of fireworks displays in the Fifth Coast
Guard District, table 1 to paragraph (h)(1) to 33 CFR 165.506, entry 10
specifies the location of the regulated area as all waters of Delaware
River, adjacent to Penn's Landing, Philadelphia, PA, within a 500-yard
radius of the fireworks barge position. The approximate position for
the fireworks barge is latitude 39[deg]56'52'' N, longitude
075[deg]08'09'' W. During the enforcement period, as reflected in Sec.
165.506(d), vessels may not enter, remain in, or transit through the
safety zone unless authorized by the Captain of the Port or designated
Coast Guard patrol personnel on-scene.
    In addition to this notice of enforcement in the Federal Register,
the Coast Guard will provide notification of this enforcement period
via broadcast notice to mariners.

    Dated: August 18, 2022.
Kate F. Higgins-Bloom,
Captain, U.S. Coast Guard Acting Captain of the Port Delaware Bay.
[FR Doc. 2022-18206 Filed 8-23-22; 8:45 am]
BILLING CODE 9110-04-P