[Federal Register Volume 76, Number 25 (Monday, February 7, 2011)]
[Rules and Regulations]
[Pages 6551-6553]
[FR Doc No: 2011-2552]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2010-D-0645]

Medical Devices; General and Plastic Surgery Devices;
Classification of Contact Cooling System for Aesthetic Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the
contact cooling system for aesthetic use into class II (special
controls). The special control that will apply to the device is the
guidance document entitled ``Guidance for Industry and FDA Staff; Class
II Special Controls Guidance Document: Contact Cooling System for
Aesthetic Use.'' The Agency is classifying the device into class II
(special controls) in order to provide reasonable assurance of safety
and effectiveness of the device. Elsewhere in this issue of the Federal
Register, FDA is announcing the availability of a guidance document
that will serve as the special control for this device type.

DATES: Effective Date: March 9, 2011.

FOR FURTHER INFORMATION CONTACT: Richard Felten, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1436, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. What is the background of this rulemaking?

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
301 et seq.) as amended by the Medical Device Amendments of 1976 (the
1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990
(Pub. L. 101-629), and the Food and Drug Administration Modernization
Act (Pub. L. 107-250) established a comprehensive system for regulation
of medical devices intended for human use. Section 513 of the FD&C Act
(21 U.S.C. 360c) established three categories (classes) of devices,
depending on the regulatory controls needed to provide reasonable
assurance of their safety and effectiveness. The three categories of
devices are class I (general controls), class II (special controls),
and class III (premarket approval).
    FDA refers to devices that were not in commercial distribution
before May 28, 1976 (the date of enactment of the 1976 amendments), as
postamendments devices. Postamendments devices are classified
automatically by statute (section 513(f) of the FD&C Act) into class
III without any FDA rulemaking process. These devices remain in class
III and require premarket approval unless: (1) FDA reclassifies the
device into class I or II; (2) FDA issues an order classifying the
device into class I or class II in accordance with section 513(f)(2) of
the FD&C Act; or FDA issues an order finding the device to be
substantially equivalent, under section 513(i) to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of FD&C Act (21
U.S.C. 360(k)) and 21 CFR part 807 of the regulations.
    Section 513(f)(2) of the FD&C Act provides that any person who
submits a premarket notification under section 510(k) of the FD&C Act
for a device that has not previously been classified may, within 30
days after receiving an order classifying the device that has not
previously been classified into class III under section 513(f)(1),
request FDA to classify the device under the criteria set forth in
section 513(a)(1). FDA will, within 60 days of receiving this request,
classify the device by written order. This classification shall be the
initial classification of the device. Within 30 days after the issuance
of an order classifying the device, FDA must publish a notice in the
Federal Register announcing this classification.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an
order on October 7, 2009, classifying the Zeltiq Lipolysis System for
Aesthetic Use into class III, because it was not substantially
equivalent to a device that was introduced or delivered for
introduction into interstate commerce for commercial distribution
before May 28, 1976, or a device which was subsequently reclassified
into class I or class II. On October 13, 2009, Zeltiq\TM\ Aesthetic,
Inc., submitted a petition requesting classification of the lipolysis
system for aesthetic use under section 513(f)(2) of the FD&C Act. The
manufacturer recommended that the device be classified into class II
(Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the petition in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies devices
into class II if general controls by themselves are insufficient
information to establish special controls to provide reasonable
assurance of the safety and effectiveness of the device for its
intended use. After review of the information submitted in the
petition, FDA determined that the contact cooling system for aesthetic
use can be classified into class II with the establishment of special
controls. FDA believes these special controls will provide assurance of
the safety and effectiveness of the device.
    The device was assigned the generic name ``Cooling System for
Aesthetic Use'' and it is identified as a cooling system for aesthetic
use. FDA has identified the following risks to health associated
specifically with this type of device and the recommended measures to
mitigate these risks.
     Discomfort and pain during and following treatment are
possible due to the application of mechanical or vacuum massage at
levels in excess of those recommended in the labeling. These effects
and tenderness at the treatment site may also occur following
treatment. Prevention of these effects are addressed by adequate bench
testing demonstrating that the feedback controls for temperature/
cooling are functional and do maintain target temperature within the
stated value. Proper function of mechanical controls to insure use of
the mechanical or vacuum massager within safe limits

should be confirmed as part of bench testing.
     Electrical shock is addressed by recommended testing of
the device according to recognized U.S. and International Standards
specifically designed to determine and measure potential electrical
safety. Again, the recommended device labeling also includes specific
warnings for the user in terms of device placement, appropriate
electrical wiring needs, reminders to periodically check device wiring
and accessories for damage, and avoidance of use of the device in
environments where electrical shock is possible.
     Use error represents those risks to the patient that can
occur from improper use of the device. In order to address this
potential risk, we recommend the manufacturer provide a detailed
operator manual which contains information on possible risks and
hazards and how these should be avoided and clear recommended safe
treatment procedures that include information on device settings for
treatment, clear information on how the device is to be used during
treatment, and recommended post treatment care.
     Tissue damage from uncontrolled cooling is a risk which is
addressed by the above stated bench testing of the temperature control
system. In addition the labeling provided shall give recommended safe
use parameters in terms of temperature setting and duration of
treatment with these parameters supported by animal or clinical data.
     Systemic response to cold is a potential hazard for
individuals who may have underlying cold sensitive health conditions or
reduced skin sensitivity due to other medical conditions. This risk is
addressed through the device labeling which provides appropriate
cautions, warnings and contradictions for such cold sensitive
conditions.
     Skin inflammation or foreign body responses can be an
issue for individuals based on the skin contact nature of this device.
This type of skin irritation is prevented by appropriate testing for
biocompatibility of the contact materials when in contact with skin.

            Table 1--Risks to Health and Mitigation Measures
------------------------------------------------------------------------
            Identified risk              Recommended mitigation measures
------------------------------------------------------------------------
Discomfort, Pain, Tenderness...........  Section 6. Bench Testing
                                         Section 9. Clinical Testing
                                         Section 13. Labeling
Thermal Injury (Tissue Damage from       Section 6. Bench Testing
 Uncontrolled Cooling).                  Section 7. Software Validation
                                         Section 8. Animal Testing
                                         Section 9. Clinical Testing
                                         Section 11. Electromagnetic
                                          Compatibility (IEC 60601-1-2)
                                         Section 13. Labeling
Systemic Response to Cold..............  Section 9. Clinical Testing
                                         Section 13. Labeling
Electrical Shock.......................  Section 12. Electrical and
                                          Mechanical Safety (IEC 60601-
                                          1)
Inflammation/Foreign Body Response.....  Section 10. Biocompatibility
                                          (ISO 10993)
Use Error..............................  Section 13. Labeling
------------------------------------------------------------------------

    FDA believes that the special controls, in addition to general
controls, address the risks to health identified in table 1 of this
document and provide reasonable assurance of the safety and
effectiveness of the device type. Therefore, on August 24, 2010, FDA
issued an order to the petitioner classifying the device into class II.
FDA is codifying this device classification by adding 21 CFR 878.4340.
    Following the effective date of the final classification rule, any
firm submitting a 510(k) premarket notification for cooling system for
aesthetic use device intended for the disruption of adipocyte cells
intended for non-invasive aesthetic use will need to address the issues
covered in the special controls guidance. However, the firm need only
show that its device meets the recommendations of the guidance or in
some other way provides equivalent assurance of safety and
effectiveness.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirement under section
510(k), if FDA determines that premarket notification is not necessary
to provide reasonable assurance of the safety and effectiveness of the
device. For this type of device, FDA has determined that premarket
notification is necessary to provide reasonable assurance of the safety
and effectiveness of the device and, therefore, the type of device is
not exempt from premarket notification requirements. Persons who intend
to market this type of device must submit to FDA a premarket
notification, prior to marketing the device, which contains information
about the cooling system for aesthetic use that they intend to market.

II. What is the environmental impact of this rule?

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. What is the analysis of impacts of this rule?

    FDA has examined the impacts of the final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order
12866 directs agencies to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The Agency believes that
this final rule is not a significant regulatory action as defined by
the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because reclassification of this device from class
III to class II will relieve manufacturers of the cost of complying
with the premarket approval requirements of section 515 of the FD&C

Act (21 U.S.C. 360e), and may permit small potential competitors to
enter the marketplace by lowering their costs, the Agency certifies
that the final rule will not have a significant economic impact on a
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

IV. Does this final rule have federalism implications?

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires agencies to ``construe * * * a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Federal law includes an express preemption provision
that preempts certain State requirements ``different from or in
addition to'' certain Federal requirements applicable to devices. 21
U.S.C. 360k; See Medtronic v. Lohr 518 U.S. 470 (1996); Riegel v.
Medtronic, 552 U.S. 312 (2008). The special controls established by
this final rule create ``requirements'' to address each identified risk
to health presented by these specific medical devices under 21 U.S.C.
360k, even though product sponsors have flexibility in how they meet
those requirements. Cf. Papike v. Tambrands, Inc., 107 F. 3d 737, 740-
42 (9th Cir. 1997).

V. How does this rule comply with the paperwork reduction act of 1995?

    This final rule contains no collections of new information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 is not required. Elsewhere in this
issue of the Federal Register, FDA is issuing a notice announcing
availability of the guidance for the final rule. This guidance entitled
``Class II Special Controls Guidance Document: Contact Cooling System
for Aesthetic Use'' references previously approved collections of
information found in FDA regulations.

VI. What references are on display?

    The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Petition from Zeltiq Aesthetics, October 13, 2009.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Section 878.4340 is added to subpart E to read as follows:

Sec.  878.4340  Contact cooling system for aesthetic use.

    (a) Identification. A contact cooling system for aesthetic use is a
device that is a combination of a cooling pad associated with a vacuum
or mechanical massager intended for the disruption of adipocyte cells
intended for non-invasive aesthetic use.
    (b) Classification. Class II (special controls). The special
controls for this device is FDA's ``Guidance for Industry and FDA
Staff; Class II Special Controls Guidance Document: Contact Cooling
System for Aesthetic Use.'' See Sec.  878.1(e) for the availability of
this guidance document.

    Dated: February 1, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-2552 Filed 2-4-11; 8:45 am]
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[Federal Register: October 13, 2010 (Volume 75, Number 197)]
[Notices]
[Page 62808-62809]
[DOCID:fr13oc10-47]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER10-3242-000]

Eagle Power Authority, Inc; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

October 5, 2010.
    This is a supplemental notice in the above-referenced proceeding of
Eagle Power Authority, Inc.'s application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 25, 2010.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed

dockets(s). For assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-25673 Filed 10-12-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 162 (Monday, August 22, 2011)]
[Proposed Rules]
[Pages 52290-52291]
[FR Doc No: 2011-21287]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0627; Airspace Docket No. 11-ASO-27]

Proposed Amendment of Class E Airspace; Pelion, SC

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E Airspace at Pelion, SC,
as new Standard Instrument Approach Procedures have been developed at
Lexington County Airport at Pelion. This action would enhance the
safety and airspace management of Instrument Flight Rules (IFR)
operations at the airport. This action also would recognize the airport
name change to Lexington County Airport at Pelion.

DATES: Comments must be received on or before October 6, 2011. The
Director of the Federal Register approves this incorporation by
reference action under title 1, Code of Federal Regulations, part 51,
subject to the annual revision of FAA, Order 7400.9 and publication of
conforming amendments.

ADDRESSES: Send comments on this rule to: U. S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Ave., SE., Washington, DC 20590-0001;
Telephone: 1-800-647-5527; Fax:<PHONE_NUMBER>. You must identify the
Docket Number FAA-2011-0627; Airspace Docket No. 11-ASO-27, at the
beginning of your comments. You may also submit and review received
comments through the Internet at http:[sol][sol]www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested persons are invited to comment on this rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2011-0627; Airspace Docket No. 11-ASO-27) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http:[sol][sol]www.regulations.gov.
    Annotators wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2011-0627; Airspace Docket No. 11-ASO-27.'' The postcard will
be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http:[sol][sol]www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http:[sol][sol]www.faa.gov/airports--airtraffic/air--
traffic/publications/airspace--amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays. An
informal docket may also be examined during normal business hours at
the office of the Eastern Service Center, Federal Aviation
Administration, Room 210, 1701 Columbia Avenue, College Park, Georgia
30337.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>, to
request a copy of Advisory circular No. 11-2A, Notice of Proposed
Rulemaking distribution System, which describes the application
procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to amend Class E airspace extending upward
from 700 feet above the surface to support new standard instrument
approach procedures developed at Lexington County Airport at Pelion,
Pelion, SC. Airspace reconfiguration is necessary due to the design of
new arrival procedures, and for continued safety and management of IFR
operations at the airport. Also, the airport name would be changed from
Corporate Airport to Lexington County Airport at Pelion.
    Class E airspace designations are published in Paragraph 6005 of
FAA Order 7400.9U, dated August 18, 2010,

and effective September 15, 2010, which is incorporated by reference in
14 CFR 71.1. The Class E airspace designation listed in this document
will be published subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This proposed rulemaking is promulgated under the authority
described in subtitle VII, part, A, subpart I, section 40103. Under
that section, the FAA is charged with prescribing regulations to assign
the use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This proposed regulation is within the scope
of that authority as it would amend Class E airspace at Lexington
County Airport at Pelion, Pelion, SC.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for Part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9U, Airspace Designations and
Reporting Points, dated August 18, 2010, effective September 15, 2010,
is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward from 700
feet or More Above the Surface of the Earth.

* * * * *

ASO SC E5 Pelion, SC [AMENDED]

Lexington County Airport at Pelion, Pelion, SC
    (Lat. 33[deg]47'41'' N., long. 81[deg]14'45'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of the Lexington County Airport at Pelion.

    Issued in College Park, Georgia, on August 12, 2011.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2011-21287 Filed 8-19-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 164 (Friday, August 25, 2023)]
[Notices]
[Pages 58264-58265]
[FR Doc No: 2023-18335]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2023-0435; FRL-11277-01-ORD]

Call for Information on the Integrated Science Assessment for
Ozone and Related Photochemical Oxidants

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; call for information.

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SUMMARY: The Environmental Protection Agency (EPA) is preparing an
Integrated Science Assessment (ISA) as part of the review of the air
quality criteria and the primary (health-based) and secondary (welfare-
based) National Ambient Air Quality Standards (NAAQS) for Ozone
(O3) and related photochemical oxidants. The ISA will be
developed by the Center for Public Health and Environmental Assessment
(CPHEA) within EPA's Office of Research and Development. When final,
the ISA is intended to update the previous ISA for O3 and
related photochemical oxidants (EPA/600/R-20/012), published in 2020.
Interested parties are invited to assist EPA in developing and refining
the scientific information base for the review of the O3
NAAQS by submitting research studies and data that have been published
or accepted for publication since January 1, 2018.

DATES: All communications and information should be received by EPA by
October 24, 2023.

ADDRESSES: Information may be submitted electronically, by mail, by
facsimile, or by hand delivery/courier. Please follow the detailed
instructions as provided in the section of this notice entitled
SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the ORD Docket at the EPA Headquarters Docket Center;
phone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or email:
[email protected]. For technical information, contact Qingyu Meng;
phone:<PHONE_NUMBER>; or email: [email protected]; or Jeffrey Herrick;
phone:<PHONE_NUMBER>; or email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Information About the Document

    Section 108(a) of the Clean Air Act (the Act) directs the
Administrator to identify and list certain air pollutants which, among
other things, ``cause or contribute to air pollution which may
reasonably be anticipated to endanger public health or welfare;'' \1\
and then to issue air quality criteria for them. The air quality
criteria are to ``accurately reflect the latest scientific knowledge
useful in indicating the kind and extent of all identifiable effects on
public health or welfare which may be expected from the presence of
[the] pollutant in the ambient air . . . .''.
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    \1\ Under Clean Air Act section 302(h), welfare effects include,
but are not limited to, ``effects on soils, water, crops,
vegetation, manmade materials, animals, wildlife, weather,
visibility, and climate, damage and deterioration of property, and
hazards to transportation, as well as effects on economic values and
on personal comfort and well-being.''
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    Under section 109 of the Act, EPA is then to establish NAAQS for
each pollutant for which EPA has issued criteria. Section 109(d)(1) of
the Act additionally requires periodic review and, if appropriate,
revision of existing air quality criteria to reflect advances in
scientific knowledge on the effects of the pollutant on public health
and welfare. Under the same provision, EPA is also to periodically
review and, if appropriate, revise the NAAQS, based on the revised air
quality criteria. Documents and technical materials associated with
NAAQS reviews are available at https://www.epa.gov/naaqs.
    Photochemical oxidants, including O3, are one of six
``criteria'' pollutants for which EPA has established NAAQS, and
O3 is the current indicator for that NAAQS. In its periodic
review of the air quality criteria for these pollutants, EPA reviews
the currently available science and prepares an ISA. The ISA provides
the scientific foundation for EPA's NAAQS reviews, in conjunction with
additional technical and policy assessments, and for the
Administrator's decisions on the adequacy of the current NAAQS and the
appropriateness of possible alternative standards. Early steps in this
review process include announcing the initiation of the review of the
air quality criteria and the NAAQS and the intention of the EPA to
develop an ISA, and requesting that the public submit scientific
literature that they want to bring to the attention of the Agency as it
begins this process. The Clean Air Scientific Advisory Committee
(CASAC), whose review and advisory functions are mandated by section
109(d)(2) of the Clean Air Act, is charged, among other things, with
the independent scientific review of the air quality criteria. In
conjunction with the CASAC review, the public will have an opportunity
to review and comment on the draft ISA. The ISA developed in this
review of the air quality criteria and O3 NAAQS will build
on the scientific assessment from the last review,\2\ focusing on
assessing and integrating the information newly available since that
considered in the 2020 ISA. With regard to development of the ISA, the
public is encouraged to assist in identifying relevant scientific
information for the review by submitting research studies that were

not part of the prior review, and that have been published or accepted
for publication in a peer-reviewed journal. The Agency is interested in
obtaining newly available information, particularly concerning
toxicological studies of effects of controlled exposure to
O3 in laboratory animals, humans, and in vitro systems;
epidemiologic (observational) studies of health effects associated with
ambient O3 exposures in human populations; studies examining
populations and life stages that may be at increased risk of
O3-related health effects.. For studies examining
effects on welfare or the environment, studies that address or provide
new information on terrestrial biota are of particular interest,
including effects of O3 on vegetation; communities and
populations of plants and associated biota, as well as exposure-
response relationships between O3 in ambient air and
specific welfare effects. The EPA also seeks recent information in
other areas of O3 research such as atmospheric chemistry and
physics, sources and emissions, analytical methodology, transport and
transformation in the environment, and ambient concentrations.
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    \2\ The scientific assessment for the last review is documented
in the Integrated Science Assessment (ISA) for Ozone and Related
Photochemical Oxidants (Final Report, April 2020). U.S.
Environmental Protection Agency, Washington, DC, EPA/600/R-20/012,
2020; 85 FR 21849, April 20, 2020.
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    The Agency also seeks information regarding the design and scope of
the review of the air quality criteria to ensure that it addresses key
policy-relevant issues and considers the new science that is relevant
to informing our understanding of these issues. The Agency seeks new
scientific information that may address key uncertainties identified in
the last O3 NAAQS review, which are provided in section 3.6
of the 2020 Policy Assessment (EPA-452/R-20-001, May 2020).\3\ The
Agency also seeks new scientific information or data that may address
scientific and technical issues raised in two more recent letters from
CASAC: one dated November 22, 2022 (EPA-CASAC-23-001) \4\ and the other
dated June 9, 2023 (EPA-CASAC-23-002).\5\ Other opportunities for
submission of new peer-reviewed, published (or in-press) papers will be
possible as part of public comment on the draft ISA that will be
reviewed by the CASAC.
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    \3\ The 2020 Policy Assessment for the Review of the Ozone
National Ambient Air Quality Standards is available at: https://www.epa.gov/sites/default/files/2020-05/documents/o3-final_pa-05-29-20compressed.pdf.
    \4\ Letter from Elizabeth A. Sheppard, Chair, Clean Air
Scientific Advisory Committee, to Administrator Michael S. Regan.
Re: CASAC Review of the EPA's Integrated Science Assessment (ISA)
for Ozone and Related Photochemical Oxidants (Final Report--April
2020). November 22, 2022. EPA-CASAC-23-001. Available at: https://casac.epa.gov/ords/sab/f?p=105:18:8476900499267:::RP,18:P18_ID:2614.
    \5\ Letter from Elizabeth A. Sheppard, Chair, Clean Air
Scientific Advisory Committee, to Administrator Michael S. Regan.
Re: CASAC Review of the EPA's Policy Assessment (PA) for the
Reconsideration of the Ozone National Ambient Air Quality Standards
(External Review Draft Version 2) (June 9, 2023) (EPA-CASAC-23-002).
Available at https://casac.epa.gov/ords/sab/f?p=113:18:7093179574667:::RP,18:P18_ID:2636#meeting.
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II. How To Submit Technical Comments to the Docket at
www.regulations.gov

    Submit your materials identified by Docket ID No. EPA-HQ-ORD-2023-
0435 by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email: [email protected].
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center, Office of Research and Development Docket, Mail Code 28221T,
1200 Pennsylvania Avenue NW, Washington, DC 20460. The phone number is
202-566-1752.
     Hand Delivery or Courier: EPA Docket Center, WJC West
Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004.
The Docket Center's hours of operation are 8:30 a.m. to 4:30 p.m.,
Monday through Friday (except Federal holidays). If you provide
materials by mail or hand delivery, please submit three copies of these
materials. For attachments, provide an index, number pages
consecutively with the materials, and submit an unbound original and
three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2023-0435. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all materials it receives in the public docket
without change and to make the materials available online at
www.regulations.gov, including any personal information provided,
unless materials include 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 www.regulations.gov or email. The
www.regulations.gov website 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 email directly
to EPA without going through www.regulations.gov, your email address
will be automatically captured and included as part of the materials
that are placed in the public docket and made available on the
internet. If you submit electronic materials, EPA recommends that you
include your name and other contact information in the body of your
materials and with any disk or CD-ROM you submit. If EPA cannot read
your materials due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider the materials you
submit. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses. For
additional information about EPA's public docket visit EPA's Docket
Center homepage at https://www.epa.gov/dockets.
    Docket: Documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the ORD Docket in EPA's
Headquarters Docket Center.

Wayne Cascio,
Director, Center for Public Health and Environmental Assessment.
[FR Doc. 2023-18335 Filed 8-24-23; 8:45 am]
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