[Federal Register Volume 88, Number 100 (Wednesday, May 24, 2023)]
[Proposed Rules]
[Pages 33555-33560]
[FR Doc No: 2023-10955]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2022-0893; FRL-10419-01-R10]

Air Plan Approval; AK; Revisions to Ice Fog and Sulfur Dioxide
Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) proposes to approve
a revision to the Alaska State Implementation Plan (SIP) submitted on
May 16, 2022. In the submission, Alaska revised and repealed state
regulations originally put in place to limit water vapor emissions that
may contribute to ice fog and to address the use of high-sulfur marine
fuels near the communities of St. Paul Island and Unalaska. Alaska
determined that the regulations are now obsolete due to technology
improvements and regulatory changes, including Federal sulfur content
in fuel restrictions, and Alaska requested that the SIP be updated to
reflect the revised and repealed state regulations. We propose to find
that the submitted revision will not interfere with attainment of the
national ambient air quality standards or other applicable requirements
of the Clean Air Act.

DATES: Comments must be received on or before June 23, 2023.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2022-0893, at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from regulations.gov. The EPA may publish any
comment received to its public docket. Do not electronically submit any
information you consider to be Confidential Business Information (CBI)
or other information the disclosure of which is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Kristin Hall, EPA Region 10, 1200
Sixth Avenue, Suite 155, Seattle, WA 98101, at<PHONE_NUMBER> or
[email protected].

SUPPLEMENTARY INFORMATION: In this document, ``we'' and ``our'' mean
the EPA.

Table of Contents

I. Background
II. Evaluation of Submission
    A. Ice Fog Provisions
    B. Sulfur Dioxide Provisions
III. Proposed Action
IV. Environmental Justice Considerations
V. Tribal Consultation
VI. Incorporation by Reference
VII. Statutory and Executive Order Reviews

I. Background

    Each state has a State Implementation Plan (SIP) containing the air
pollution control measures and strategies used to meet the national
ambient air quality standards. These standards are established by the
EPA for the criteria pollutants: carbon monoxide, lead, nitrogen
dioxide, ozone, particulate matter, and sulfur dioxide
(SO2). The SIP contains elements such as emission limits,
pollution control technology requirements, monitoring networks, and
enforcement mechanisms, among other elements. The SIP is a living
compilation revised by the state over time to address changing air
quality conditions.

    As the primary government entity charged with controlling air
pollution in the state, the Alaska Department of Environmental
Conservation (DEC) generally establishes state air regulations in the
Alaska Administrative Code, Title 18, Chapter 50 (18 AAC 50). The
Alaska DEC then submits state regulations to the EPA for review and
approval. Through notice and comment rulemaking, the EPA approves and
incorporates the state regulations by reference into the Alaska SIP in
the Code of Federal Regulations (CFR) at 40 CFR part 52, subpart C. As
part of the SIP, the state regulations are enforceable by the EPA, and
by citizens in Federal district court.\1\
---------------------------------------------------------------------------

    \1\ See citizen suit provision at Clean Air Act section 304.
---------------------------------------------------------------------------

II. Evaluation of Submission

    On May 16, 2022, Alaska submitted a SIP revision to the EPA. In the
submission, the state revised and repealed certain air quality
regulations and requested to update the federally approved SIP.\2\
Alaska determined that the regulations, originally put in place to
limit water vapor emissions that may contribute to ice fog and to
address the use of high-sulfur marine fuels near the communities of St.
Paul Island and Unalaska are now obsolete due to technology
improvements and regulatory changes. Alaska requested that the SIP be
updated to reflect the revised and repealed state regulations. Alaska
provided background and supporting information in the submission. We
have included the full submission in the docket for this action. The
following paragraphs of this preamble summarize our evaluation.
---------------------------------------------------------------------------

    \2\ The submission also updated the state's adoption by
reference of Federal air quality standards and test methods codified
at 18 AAC 50.035 and 18 AAC 50.040. We approved these adoption
updates in a separate action on March 22, 2023 (88 FR 17159).
---------------------------------------------------------------------------

A. Ice Fog Provisions

    Ice fog is made up of tiny ice crystals that form in the air under
extremely cold conditions. The original 1972 Alaska SIP included a
chapter on ice fog because, at the time, water vapor from cooling
ponds, industrial processes, motor vehicles and other sources
contributed to regular ice fog events that caused dangerous road
conditions and other public safety hazards. The original Alaska SIP
also included a regulation \3\ to address industrial sources of water
vapor emissions. The regulation, currently codified at 18 AAC 50.080,
stated that the Alaska DEC may require a person who proposes to build
or operate an industrial process, fuel-burning equipment, or
incinerator in an area of potential ice fog to obtain a permit and to
reduce water vapor emissions.
---------------------------------------------------------------------------

    \3\ 18 AAC 50.090, state effective May 26, 1972. We note that
this regulation was renumbered from 18 AAC 50.090 to 18 AAC 50.080,
state effective January 18, 1997.
---------------------------------------------------------------------------

    The Alaska DEC determined that the ice fog chapter and regulation
are no longer needed. The submission, included in the docket for this
action, stated that, in the 50 years since establishing the ice fog
provisions, improved technologies have reduced water vapor emissions
from industrial processes and equipment. The submission further stated
that ice fog prevention measures are required in only a handful of
permits issued to older industrial turbines in interior Alaska that use
water injection as a nitrogen oxide control measure. To address these
limited situations, the Alaska DEC retains authority under a separate
regulation, 18 AAC 50.110,\4\ to limit water vapor emissions and
prevent ice fog events.
---------------------------------------------------------------------------

    \4\ 18 AAC 50.110 prohibits any emission injurious to health or
welfare, animal or plant life, or property, or which would
unreasonably interfere with the enjoyment of life or property. It is
also part of the federally approved Alaska SIP.
---------------------------------------------------------------------------

    The EPA may approve a state's request to revise or remove a
provision from the federally approved SIP as long as the SIP revision
would not interfere with any applicable requirement concerning
attainment of the national ambient air quality standards, reasonable
further progress toward achieving those standards, or other applicable
requirements of the Clean Air Act. We have reviewed the submission and
propose to approve the request to remove the ice fog chapter and
regulation from the SIP for two reasons. First, we propose to find that
the ice fog regulation at 18 AAC 50.090 is redundant. The submission
stated that the Alaska DEC may employ a different SIP-approved
regulation, 18 AAC 50.110, to prevent ice fog events. Second, the ice
fog chapter and regulation address water vapor emissions. Water vapor
is not a criteria pollutant, precursor to a criteria pollutant, or an
additional pollutant required to be regulated under the SIP and Clean
Air Act section 110 and part C of title I. Removal of this water vapor
provision will not impact air pollution control requirements for the
control of criteria pollutants. Therefore, we propose to find that
removing the ice fog chapter and regulation from the SIP will not
interfere with any applicable requirement concerning attainment of the
national ambient air quality standards, reasonable further progress
toward achieving those standards, or other applicable requirements of
the Clean Air Act.

B. Sulfur Dioxide Provisions

    In 1997, Alaska established two SO2 special protection
areas around the island fishing communities of Unalaska and St. Paul
Island.\5\ The submission, included in the docket for this action,
stated that marine vessels and on-shore industrial facilities in these
areas historically burned large quantities of high-sulfur fuel oil, as
high as 50,000 parts per million (ppm) sulfur content, or 5% sulfur by
weight. International treaty governs the sulfur content of commercial
marine fuel and, at the time Alaska established the SO2
special protection areas, allowed for the widespread burning of high-
sulfur fuel oil known as bunker fuel.
---------------------------------------------------------------------------

    \5\ Unalaska, population 4,254, is the largest community in the
Aleutian Islands chain. It is home to Dutch Harbor, main port to the
Bering Sea fishery. St. Paul Island, population 413, is the largest
of the Pribilof Islands, approximately 300 miles off the mainland in
the Bering Sea. Both communities are located in the Aleutians West
Census Area. See U.S. Census Bureau Data for Alaska, 2020. Available
at https://live.laborstats.alaska.gov/cen/hist.html. See also
Aleutians West Census Area map at https://live.laborstats.alaska.gov/cen/maps/bor/current/016.pdf.
---------------------------------------------------------------------------

    Lacking the authority to limit the sulfur content of commercial
marine fuel burned by vessels transiting near Alaska, the Alaska DEC
established SO2 special protection areas around Unalaska and
St. Paul Island. Within these special protection areas, Alaska imposed
additional minor source permitting requirements on certain sources.
Specifically, the Alaska DEC required each emissions unit with a rated
capacity of 10 million British thermal units (BTUs) or more per hour to
obtain a minor source permit prior to beginning actual construction.\6\
This requirement was in addition to the current state-wide requirement
for each new stationary source with the potential to emit (PTE)
SO2 greater than 40 tons per year to obtain a minor source
permit prior to beginning actual construction.\7\
---------------------------------------------------------------------------

    \6\ Previously 18 AAC 50.502(c)(2)(B).
    \7\ 18 AAC 50.502(c)(1)(C).
---------------------------------------------------------------------------

    Additionally, each applicant for a minor source permit in a special
protection area was required to provide

a demonstration that the proposed potential SO2 emissions
from the stationary source would not result in a violation of the
state-adopted SO2 national ambient air quality standard
(NAAQS).\8\ Finally, each source proposed to be constructed in a
special protection area was ineligible for the Alaska DEC's streamlined
minor source permitting process. This SIP-approved process provides the
public with notice and an opportunity to request a public comment
period, however, if no member of the public makes such a request, a
full comment period is not held.\9\
---------------------------------------------------------------------------

    \8\ Previously 18 AAC 50.540(c)(2)(C). This requirement was in
addition to the requirement that all applications include a
demonstration that the proposed source will not interfere with
attainment or maintenance of the NAAQS for each air pollutant for
which the source's PTE exceeded the minor source permitting
threshold in 18 AAC 50.502(c)(1), (3) or (4). The latter requirement
remains a part of Alaska's SIP.
    \9\ See 18 AAC 50.542.
---------------------------------------------------------------------------

    Since 1997, there have been significant restrictions on sulfur in
marine fuel. In 2010, the International Marine Organization (IMO)
established emission standards for vessels operating in designated
waters off the coast of North America.\10\ The North American Emissions
Control Area (ECA) covers most coastal areas of the United States,
including southeast Alaska and the Gulf of Alaska. Vessels operating in
the area must burn low sulfur marine fuel, 1,000 ppm sulfur content
(0.10% sulfur by weight). Notably, the North American ECA does not
extend to Unalaska and St. Paul Island, however, as of January 1, 2020,
the IMO limited sulfur in fuel for ships operating outside designated
ECAs to 5,000 ppm sulfur content (0.50% sulfur by weight).\11\ This
limit represents a substantial reduction from the prior IMO limit of
35,000 ppm sulfur content (3.5% sulfur by weight).
---------------------------------------------------------------------------

    \10\ MARPOL Annex VI is codified at 33 U.S.C. 1901 et seq.
Pursuant to 33 U.S.C. 1907 it is unlawful to act in violation of the
MARPOL Protocol.
    \11\ Fuel sulfur limits are codified at 40 CFR part 1043. See 84
FR 69335, 69336 (Dec. 18, 2019).
---------------------------------------------------------------------------

    As stated in the submission, the Alaska DEC's assessment is that
most vessels transiting shipping routes near Unalaska and St. Paul
Island are now burning 5,000 ppm sulfur content fuel or less, an
estimated seven-fold decrease from the prior IMO limit of 35,000 ppm
sulfur content fuel. Therefore, any associated emissions increase due
to removal of the SO2 special protection area permit process
requirements would be more than offset by the reduction in
SO2 emissions from this change in the Federal sulfur content
of fuel standards. The submission requested to remove the rule denoting
the two sulfur dioxide special protection areas, 18 AAC 50.025(c), and
associated cross-references to minor stationary source permitting
rules, from the Alaska SIP.\12\
---------------------------------------------------------------------------

    \12\ The rules that cross reference 18 AAC 50.025(c) are part of
the minor source permitting program in Article 5 of 18 AAC 50,
specifically: 18 AAC 50.502(c)(2)(B), 18 AAC 50.540(c)(2)(C), and 18
AAC 50.542(a)(1)(B).
---------------------------------------------------------------------------

    The EPA may approve a state's request to revise or remove a
provision from the federally approved SIP as long as the SIP revision
would not interfere with any applicable requirement concerning
attainment of the NAAQS, reasonable further progress toward achieving
those standards, or other applicable requirements of the Clean Air
Act.\13\ We propose to approve the submitted changes for the following
reasons. First, existing Federal sulfur content of fuel standards are
adequate substitutes for the additional minor source permitting
requirements in the SO2 special protection areas because the
existing Federal standards will achieve equivalent or greater emissions
reductions. The National Emissions Inventory (NEI) data presented in
Table 1 of this preamble confirms that the commercial marine vessel
sector is the largest sulfur dioxide-emitting sector in the census area
that encompasses Unalaska and St. Paul Island.
---------------------------------------------------------------------------

    \13\ Clean Air Act section 110(l), 42 U.S.C. 7410(l).
---------------------------------------------------------------------------

    Second, the data in Table 1 of this preamble suggests that sulfur
dioxide emissions from industrial fuel combustion in the census area is
low. It is reasonable to conclude that the EPA's regulations limiting
the sulfur content of marine diesel will greatly reduce emissions from
the largest source of SO2 pollution.\14\ Alaska does not
rely on these emission reductions for credit towards attainment,
maintenance, or reasonable further progress purposes in this geographic
area. We note, however, that it is difficult to evaluate NEI data for
potential trends from year to year because the protocols for estimating
emissions change over time. For example, between 2014 and 2017, the EPA
significantly changed its protocol for estimating marine vessel
emissions and as a result, commercial marine vessel emissions data for
2017 is not directly comparable to prior years.\15\
---------------------------------------------------------------------------

    \14\ See 84 FR 69335, 69336 (Dec. 18, 2019). 40 CFR 1043.60(b).
    \15\ See the EPA 2017 NEI technical support document at https://www.epa.gov/sites/default/files/2021-02/documents/nei2017_tsd_full_jan2021.pdf.
    \16\ Source: The EPA NEI website, downloaded November 14, 2022.
Available at https://www.epa.gov/air-emissions-inventories/national-emissions-inventory-nei. 2020 NEI data not released as of the EPA's
data pull.
    \17\ This table includes sectors with reported emissions greater
than zero tons per year for at least one NEI year between 2008 and
2017. For background on sectors, see page 2-1 of the EPA 2017 NEI
technical support document at https://www.epa.gov/sites/default/files/2021-02/documents/nei2017_tsd_full_jan2021.pdf.
    \18\ NEI marine vessel emissions data for 2017 are not directly
comparable to prior years because the EPA changed its protocol for
estimating marine vessel emissions. See the EPA 2017 NEI technical
support document at https://www.epa.gov/sites/default/files/2021-02/documents/nei2017_tsd_full_jan2021.pdf.

                         Table 1--Sulfur Dioxide Emissions in Aleutians West Census Area
                                              [Tons per year] \16\
----------------------------------------------------------------------------------------------------------------
                         Sector \17\                              2008         2011         2014         2017
----------------------------------------------------------------------------------------------------------------
Fuel Comb--Comm/Institutional--Oil..........................            4            4            3            1
Fuel Comb--Comm/Institutional--Other........................            0            1            1            0
Fuel Comb--Electric Generation--Oil.........................           51           15           11           15
Fuel Comb--Industrial Boilers, ICEs--Coal...................            0            0            0            1
Fuel Comb--Industrial Boilers, ICEs--Natural Gas............            0            0            0            1
Fuel Comb--Industrial Boilers, ICEs--Oil....................           36           14            1            1
Fuel Comb--Industrial Boilers, ICEs--Other..................            1            0            0            0
Fuel Comb--Residential--Oil.................................           24           17           12            0
Fuel Comb--Residential--Other...............................            0            1            0            0
Fuel Comb--Residential--Wood................................            0            0            0            1
Industrial Processes--Not Elsewhere Classified..............            2            0            0            0
Mobile--Aircraft............................................            1            1            3            3
Mobile--Commercial Marine Vessels...........................           41          116           71   \18\ 1,119
Mobile--Non-Road Equipment Diesel...........................            7            1            0            0

Mobile--On-Road Diesel Heavy Duty Vehicles..................            2            0            0            0
Mobile--On-Road non-Diesel Light Duty Vehicles..............            2            0            0            0
                                                             ---------------------------------------------------
    Total...................................................          171          170          102        1,142
----------------------------------------------------------------------------------------------------------------

    In addition, from 2007 through 2014, the EPA phased in ultra-low
sulfur diesel fuel standards. After 2014, the EPA mandated that all
nonroad locomotive and marine diesel fuel sold in the United States
must be ultra-low sulfur diesel and all nonroad, locomotive, and marine
engines and equipment in the United States must use this fuel.
    Lastly, Alaska's existing major and minor source permitting
programs will continue to enable the Alaska DEC to manage the
construction of new sources to ensure attainment and maintenance of the
NAAQS. New major stationary sources are subject to Alaska's SIP-
approved major new source review and prevention of significant
deterioration program.\19\ In 2010, the EPA established a new, more
stringent 1-hour sulfur dioxide NAAQS.\20\ Alaska adopted the standard
into the state air plan and therefore new and modified minor industrial
sources may not construct if it would interfere with attainment or
maintenance of the 2010 SO2 1-hour NAAQS, per 18 AAC 50.045
and 18 AAC 50.542.
---------------------------------------------------------------------------

    \19\ 18 AAC 50 Article 3. 18 AAC 50.040(h).
    \20\ The 2010 1-hour sulfur dioxide NAAQS is codified at 40 CFR
50.17.
---------------------------------------------------------------------------

    In addition, all new minor stationary sources with SO2
PTE greater than 40 tons per year must obtain a permit prior to
beginning actual construction.\21\ Similarly, portable oil and gas
operations must obtain a minor source permit prior to beginning actual
construction or relocation.\22\ Permit applicants for minor sources in
the former SO2 special protection areas are required to
include a demonstration that the proposed source will not interfere
with attainment or maintenance of the NAAQS for each air pollutant for
which the source's PTE exceeds the minor source permitting threshold in
18 AAC 50.502(c)(1), (3) or (4).\23\ Finally, minor stationary sources
are eligible for Alaska's fast track permitting procedures only if the
source's predicted ambient air concentration does not exceed 80 percent
of the adopted SO2 NAAQS based on a screening analysis.\24\
---------------------------------------------------------------------------

    \21\ 18 AAC 50.502(c)(1)(C).
    \22\ 18 AAC 50.502(c)(2).
    \23\ 18 AAC 50.540(c)(2)(C).
    \24\ 18 AAC 50.542(b)(4).
---------------------------------------------------------------------------

    In general, SIP changes of this nature must be evaluated for
potential impacts on other criteria pollutants and associated NAAQS.
However, this submitted change to the Alaska SIP addresses a provision
that is limited to changes in potential SO2 emissions only.
As specified in the SIP-approved Alaska minor source permitting
regulations at 18 AAC 50.540(c)(2), any modeling required to comply
with the SO2 special protection area provision in question
would have been required to address potential changes in SO2
emissions only. Therefore, we have not extended our non-interference
analysis to other criteria pollutants and NAAQS. We propose to find
that the repeal of the sulfur dioxide special protection areas will not
interfere with any applicable requirement concerning attainment and
reasonable further progress or any other applicable requirement of the
Clean Air Act.

III. Proposed Action

    The EPA is proposing to approve and incorporate by reference the
ice fog and SO2 related regulatory changes submitted by
Alaska on May 16, 2022.\25\ If finalized, the Alaska SIP will include
the following regulations, state effective April 16, 2022:
---------------------------------------------------------------------------

    \25\ The submission also updated the state's adoption by
reference of Federal air quality standards and test methods at 18
AAC 50.035 and 18 AAC 50.040. We are addressing these adoption
updates in a separate action.
---------------------------------------------------------------------------

     18 AAC 50.025 Visibility and other special protection
areas (establishing geographic areas that may need additional pollution
control because of special circumstances);
     18 AAC 50.502 Minor permits for air quality protection
(establishing which types of stationary sources must obtain minor
construction and/or operating permits);
     18 AAC 50.540 Minor permit: application (outlining the
required contents of an application for a minor construction and/or
operating permit); and
     18 AAC 50.542 Minor permit: review and issuance
(establishing the process the state uses to review permit applications
from sources, conduct public notice and comment, and issue permits).
    The EPA is also proposing to approve Alaska's request to remove the
following regulation from incorporation by reference:
     18 AAC 50.080 Ice fog, state effective January 18, 1997
(regulating water vapor emissions from industrial sources that may form
ice fog).

IV. Environmental Justice Considerations

    To provide additional context and information to the public on
potential environmental burdens and susceptible populations in
underserved communities in the Unalaska and St. Paul Island areas, we
conducted a screening-level analysis using the EPA's environmental
justice (EJ) screening and mapping tool, EJSCREEN.\26\ We note,
however, that this screening analysis does not serve as a basis for
this proposed action. As detailed in section II. of this preamble, the
EPA's proposed action is based on its determination that the SIP
revisions submitted by the Alaska DEC meet Clean Air Act requirements.
---------------------------------------------------------------------------

    \26\ EJSCREEN provides a nationally consistent dataset and
approach for combining environmental and demographic indicators.
EJSCREEN is available at https://www.epa.gov/ejscreen/what-ejscreen.
---------------------------------------------------------------------------

    EJSCREEN includes 12 EJ indices, each of which combines demographic
factors with a single environmental factor.\27\ EJSCREEN also includes
a

demographic index that combines low income, race and ethnicity data for
an area.\28\ Additionally, there are individual socioeconomic and
health indicators in EJSCREEN: unemployment; less than high school
education; limited English speaking; low life expectancy; under age 5;
over age 64; asthma; and medically underserved.\29\
---------------------------------------------------------------------------

    \27\ The 12 EJ indices in EJSCREEN are: fine particulate matter
(annual average of fine particulate matter in ambient air); ozone
(summer seasonal ozone averages); diesel particulate matter (diesel
particulate matter level in air); air toxics cancer risk (lifetime
cancer risk of inhalation of air toxics); air toxics respiratory
hazard index; traffic proximity (count of vehicles per day at major
roads divided by distance); lead paint (housing built before 1960,
as index of potential exposure to lead paint); superfund proximity
(count of proposed and listed Superfund national priority list sites
divided by distance); risk management plan facility proximity (count
of risk management plan facilities divided by distance); hazardous
waste proximity (count of waste transfer, storage and disposal
facilities and large quantity generators divided by distance);
underground storage tanks (count of leaking underground storage
tanks and tanks within a buffered block group); wastewater discharge
(risk screening environmental indicators modeled toxic
concentrations at stream segments divided by distance).
    \28\ The demographic index in EJSCREEN combines the average of
the number of individuals whose household income is less than twice
the poverty level and the number of individuals who list their
racial status as a race other than white alone and/or list their
ethnicity as Hispanic or Latino.
    \29\ The unemployment indicator is based on the number of
individuals who did not have a job at all during the reporting
period made at least one specific active effort to find a job during
the prior 4 weeks, and were available for work (unless temporarily
ill). The less than high school education indicator is based on the
number of individuals age 25 and older with less than a high school
degree. The limited English speaking indicator is based on the
percent of households in which all members age 14 years and over
speak a non-English language and also speak English less than `very
well'. The low life expectancy indicator is based on the average
life expectancy ranked as percentiles. The under age 5 indicator is
based on the percent of individuals under age 5. The over age 64
indicator is based on the percent of individuals over age 64. The
asthma indicator is based on the percent of individuals with asthma.
The medically underserved indicator is based on areas designated as
have too few primary care providers, high infant mortality, high
poverty or a high elderly population.
---------------------------------------------------------------------------

    We ran EJSCREEN reports for the Unalaska and St. Paul Island areas
and placed the reports in the docket for this action. The results of
these analyses, described in the following paragraphs, are being
provided for informational and transparency purposes, only. There are
important caveats and uncertainties that apply to these reports and
this screening-level information. Please see the EJSCREEN technical
documentation for more discussion on the limitations of this
information.\30\ We note that four of the EJ indices are not available
for the geographic areas addressed in this action (Unalaska and St.
Paul Island) and therefore, we reviewed the eight remaining EJ
indices.\31\
---------------------------------------------------------------------------

    \30\ U.S. Environmental Protection Agency (EPA), 2022. EJSCREEN
Technical Documentation.
    \31\ The four EJ indices not available for Unalaska and St. Paul
Island are: fine particulate matter, ozone, traffic proximity, and
wastewater discharge. The eight EJ indices available for Unalaska
and St. Paul Island are: diesel particulate matter, air toxics
cancer risk, air toxics respiratory hazard index, lead paint,
superfund proximity, risk management plan facility proximity,
hazardous waste proximity, and underground storage tanks.
---------------------------------------------------------------------------

    The EPA has determined that the use of an initial data filter in
EJSCREEN promotes consistency and provides a pragmatic first step for
EPA programs and regions when interpreting screening results. For early
applications of EJSCREEN, the EPA has identified the 80th percentile
filter as that initial starting point. For more information on
percentiles, please see the EJSCREEN technical documentation.\32\ For
the Unalaska area, there are two EJ indices above the 80th percentile:
lead paint (90th state percentile); and risk management plan facility
proximity (92nd state percentile and 84th U.S. percentile). The
demographic index for Unalaska is also at the 80th state percentile.
Most of Alaska, including Unalaska and St. Paul Island, is considered
medically underserved.\33\ For the St. Paul Island area, there are
three EJ indices above the 80th percentile: lead paint (92nd state
percentile); superfund proximity (94th state percentile and 86th U.S.
percentile); and risk management plan facility proximity (91st state
percentile and 80th U.S. percentile). The demographic index for St.
Paul Island is also above the 80th percentile (86th state percentile
and 79th U.S. percentile). Other indicators above the 80th percentile
for St. Paul Island include: people of color (87th state percentile and
81st U.S. percentile); and limited English speaking (86th state
percentile).
---------------------------------------------------------------------------

    \32\ U.S. Environmental Protection Agency (EPA), 2022. EJSCREEN
Technical Documentation.
    \33\ The medically underserved indicator is based on areas
designated as having too few primary care providers, high infant
mortality, high poverty or a high elderly population.
---------------------------------------------------------------------------

    The Clean Air Act requires action on this Alaska SIP submission,
including the submitted regulatory changes related to sulfur dioxide
emissions. The EPA expects that any changes in emissions resulting from
this action will be neutral or reduced. Additionally, the EPA expects
that this proposed action will contribute to neutral or reduced
environmental and health impacts on all populations in Unalaska and St.
Paul Island, including people of color and lower income populations. At
a minimum, this action is not expected to worsen existing air quality
nor contribute to potential violations of the SO2 NAAQS.
More information on sulfur dioxide and its relationship to negative
health impacts can be found at https://www.epa.gov/so2-pollution.

V. Tribal Consultation

    The Qawalangin Tribe of Unalaska is located in the Unalaska area
and the Pribilof Islands Aleut Community of St. Paul is located on the
Island of St. Paul. Consistent with EPA policy, the EPA offered the
Qawalangin Tribe of Unalaska and the Aleut Community of St. Paul Island
the opportunity to consult on a government to government basis prior to
this proposed action in letters dated March 14, 2023. We received no
consultation or coordination requests prior to this proposed action.

VI. Incorporation by Reference

    In this document, the EPA is proposing to include in a final rule,
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the provisions described in section III. of this preamble.
The EPA is also proposing to remove from incorporation by reference 18
AAC 50.080 Ice fog (regulating water vapor emissions that may form ice
fog), state effective January 18, 1997.
    The EPA has made, and will continue to make, these documents
generally available through https://www.regulations.gov and at the EPA
Region 10 Office (please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section of this preamble for more
information).

VII. Statutory and Executive Order Reviews

    Under the Clean Air Act, the EPA Administrator is required to
approve a SIP submission that complies with the provisions of the Clean
Air Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR
52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to
approve state choices, provided that they meet the criteria of the
Clean Air act. Accordingly, this proposed action merely approves 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 Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     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); and
     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 the requirements would be inconsistent
with the Clean Air Act.
    Executive Order 12898 (Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations, 59 FR 7629,
February 16, 1994) directs Federal agencies to identify and address
``disproportionately high and adverse human health or environmental
effects'' of their actions on minority populations and low-income
populations to the greatest extent practicable and permitted by law.
The EPA defines environmental justice (EJ) as ``the fair treatment and
meaningful involvement of all people regardless of race, color,
national origin, or income with respect to the development,
implementation, and enforcement of environmental laws, regulations, and
policies.'' The EPA further defines the term fair treatment to mean
that ``no group of people should bear a disproportionate burden of
environmental harms and risks, including those resulting from the
negative environmental consequences of industrial, governmental, and
commercial operations or programs and policies.''
    The air agency did not evaluate environmental justice
considerations as part of its SIP submittal; the Clean Air Act and
applicable implementing regulations neither prohibit nor require such
an evaluation. The EPA performed an environmental justice analysis, as
is described in section IV. of this preamble titled, ``Environmental
Justice Considerations.'' The analysis was done for the purpose of
providing additional context and information about this rulemaking to
the public, not as a basis of the action. This action is expected to
have a neutral to positive impact on the air quality of the affected
area. In addition, there is no information in the record upon which
this decision is based inconsistent with the stated goal of Executive
Order 12898 of achieving environmental justice for people of color,
low-income populations, and Indigenous peoples.
    This proposed rulemaking would not apply on any Indian reservation
land or in any other area where the EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the proposed rulemaking does not have Tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Consistent with EPA policy, the EPA provided an opportunity to request
consultation. Please see section V. of this preamble titled, ``Tribal
Consultation.''

List of Subjects in 40 CFR Part 52

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

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

    Dated: May 17, 2023.
Casey Sixkiller,
Regional Administrator, Region 10.
[FR Doc. 2023-10955 Filed 5-23-23; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7192-7194]
[FR Doc No: 2018-03342]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-1888]

Determination of Regulatory Review Period for Purposes of Patent
Extension; DARZALEX

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for DARZALEX and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
23, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 20, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

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 April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 23, 2018. 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-2016-E-1888 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; DARZALEX.'' 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.
     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 Sec.  10.20 (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 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.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave, Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product DARZALEX
(daratumumab). DARZALEX is indicated for the treatment of patients with
multiple myeloma who have received at least three prior lines of
therapy, including a proteasome inhibitor and an immunomodulatory
agent, or who are double-refractory to a proteasome inhibitor and an
immunomodulatory agent. This indication is approved under accelerated
approval based on response rate. Continued approval for this indication
may be contingent upon verification and description of clinical benefit
in confirmatory trials. Subsequent to this approval, the USPTO received
a patent term restoration application for DARZALEX (U.S. Patent No.
7,829,673) from Genmab A/S, and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated August 25, 2016, FDA advised the USPTO that this human
biological product had undergone a regulatory review period and that
the approval of DARZALEX represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
DARZALEX is 1,939 days. Of this time, 1,808 days occurred during the
testing phase of the regulatory review period, while 131 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: July 28,
2010. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on July 28,
2010.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): July 9, 2015. FDA has verified the
applicant's claim that the

biologics license application (BLA) for DARZALEX (BLA 761,036) was
initially submitted on July 9, 2015.
    3. The date the application was approved: November 16, 2015. FDA
has verified the applicant's claim that BLA 761,036 was approved on
November 16, 2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,000 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03342 Filed 2-16-18; 8:45 am]
 BILLING CODE 4164-01-P


subpart A. Under this rule, metropolitan planning organizations (MPO)
in nonattainment and maintenance areas coordinate with state and local
air quality and transportation agencies, the EPA, the FHWA, and the FTA
to demonstrate that an area's regional transportation plans and
transportation improvement programs conform to the applicable SIP. This
demonstration is typically done by showing that estimated emissions
from existing and planned highway and transit systems are less than or
equal to the motor vehicle emissions budgets (MVEBs or ``budgets'')
contained in all control strategy SIPs. Budgets are generally
established for specific years and specific pollutants or precursors.
Ozone plans should identify budgets for on-road emissions of ozone
precursors (NOX and VOC) in the area for each RFP milestone
year and, if the plan demonstrates attainment, the attainment
year.\132\
---------------------------------------------------------------------------

    \132\ 40 CFR 93.102(b)(2)(i).
---------------------------------------------------------------------------

    For motor vehicle emissions budgets to be approvable, they must
meet, at a minimum, the EPA's adequacy criteria (40 CFR 93.118(e)(4)
and (5)) and be approvable under all pertinent SIP requirements. To
meet these requirements, the MVEBs must be consistent with the
approvable attainment and RFP demonstrations and reflect all of the
motor vehicle control measures contained in the attainment and RFP
demonstrations.\133\ Budgets may include a safety margin representing
the difference between projected emissions and the total amount of
emissions estimated to satisfy any requirements for attainment or RFP.
---------------------------------------------------------------------------

    \133\ 40 CFR 93.118(e)(4)(iii), (iv) and (v). For more
information on the transportation conformity requirements and
applicable policies on MVEBs, please visit our transportation
conformity website at: http://www.epa.gov/otaq/stateresources/transconf/index.htm.
---------------------------------------------------------------------------

    The EPA's process for determining adequacy of a MVEB consists of
three basic steps: (1) Providing public notification of a SIP
submission; (2) providing the public the opportunity to comment on the
MVEB during a public comment period; and, (3) making a finding of
adequacy or inadequacy.\134\
---------------------------------------------------------------------------

    \134\ 40 CFR 93.118.
---------------------------------------------------------------------------

2. Summary of the State's Submission
    The 2016 WMD Attainment Plan includes budgets for the 2018, 2021,
and 2024 RFP milestone years, and a 2026 attainment year. The budgets
for 2018, 2021, and 2024 were derived from the 2012 RFP baseline year
and the associated RFP milestone years. These budgets are affected by
the South Coast II decision vacating the alternative baseline year
provision, and therefore, the EPA has not previously acted on the
budgets.
    The 2018 SIP Update revised the RFP demonstration consistent with
the South Coast II decision (i.e., by using a 2011 RFP baseline year)
and identifies new budgets for the WMD for VOC and NOX for
each updated RFP milestone year through 2026. The budgets in the 2018
SIP Update replace the budgets contained in the 2016 WMD Attainment
Plan. Like the budgets in the 2016 WMD Attainment Plan, the budgets in
the 2018 SIP Update were calculated using EMFAC2014, the version of
CARB's EMFAC model approved by the EPA for estimating emissions from
on-road vehicles operating in California at the time the 2016 WMD
Attainment Plan and 2018 SIP Update were developed. The budgets in the
2018 SIP Update reflect updated VMT estimates from SCAG's 2016-2040
Regional Transportation Plan/Sustainable Communities Strategy,
Amendment 2, adopted in July 2017, and align with the emissions
inventory, RFP and attainment demonstrations in the 2016 WMD Attainment
Plan. Additionally, the budgets in the 2018 SIP Update are more precise
because they are rounded up to the nearest tenth of a tpd, instead of
the nearest whole number.\135\
---------------------------------------------------------------------------

    \135\ For instance, the 2016 WMD Attainment Plan estimates that
2026 on-road vehicle emissions (summer planning inventory) would be
7 tpd for VOC and 11 tpd for NOX. See Appendix A, A-23
through A-26. The corresponding budgets from the 2018 SIP Update are
6.2 tpd for VOC and 10.2 tpd for NOX. See Table VI-3 and
surrounding discussion in Section V of the TSD for this action for
additional detail.
---------------------------------------------------------------------------

    The conformity budgets for NOX and VOC in the 2018 SIP
Update for the WMD are provided in Table 4 below.

                                   Table 4--West Mojave Desert Motor Vehicle Emissions Budgets in the 2018 SIP Update
                                                             [tpd, average summer weekday] a
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       2020                            2023                            2026
                                                         -----------------------------------------------------------------------------------------------
                                                                VOC             NOX             VOC             NOX             VOC             NOX
--------------------------------------------------------------------------------------------------------------------------------------------------------
On-Road Inventory.......................................            7.87           17.57            6.73           10.98            5.98            9.79
Safety Margin...........................................  ..............  ..............  ..............  ..............             0.2             0.4
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................            7.87           17.57            6.73           10.98            6.18           10.19

MVEBs \b\...............................................             7.9            17.6             6.8            11.0             6.2            10.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Source: Table VI-3 from the 2018 SIP Update.
\b\ Rounded up to the next tenth of a ton.

    The submittal letters for both the 2016 WMD Attainment Plan and the
2018 SIP Update include a request from CARB that the EPA limit the
duration of our approval of the budgets to last only until the
effective date of future EPA adequacy findings for replacement
budgets.\136\
---------------------------------------------------------------------------

    \136\ Letter dated April 9, 2021, from Michael Benjamin, Chief,
Air Quality Planning and Science Division, CARB, to Deborah Jordan,
Acting Regional Administrator, EPA Region IX, and letter dated
December 5, 2018, from Richard Corey, Executive Officer, CARB, to
Mike Stoker, Regional Administrator, EPA Region IX.
---------------------------------------------------------------------------

3. The EPA's Review of the State's Submission
    As part of our review of the approvability of the budgets in the
2018 SIP Update, we have evaluated the budgets using our adequacy
criteria in 40 CFR 93.118(e)(4) and (5). We will complete the adequacy
review concurrently with our final action on the 2016 WMD Attainment
Plan. The EPA is not required under its transportation conformity rule
to find budgets adequate prior to proposing approval of them.\137\
Today, the EPA is announcing that the adequacy process for these
budgets begins and the public has 30 days to comment on their adequacy,
per the transportation conformity regulation at 40 CFR 93.118(f)(2)(i)
and (ii).
---------------------------------------------------------------------------

    \137\ Under the transportation conformity regulations, the EPA
may review the adequacy of submitted motor vehicle emission budgets
simultaneously with the EPA's approval or disapproval of the
submitted implementation plan. 40 CFR 93.118(f)(2).
---------------------------------------------------------------------------

    As documented in Table 5 of section V of the EPA's TSD for this
proposal, we preliminarily conclude that the budgets in the 2018 SIP
Update for the West Mojave Desert meet each adequacy criterion. While
adequacy and approval are two separate actions, reviewing the budgets
in terms of the adequacy criteria informs the EPA's decision to propose
to approve the budgets. We have completed our detailed review of the
2016 WMD Attainment Plan and the 2018 SIP Update, and we are proposing
herein to approve the attainment and RFP demonstrations. We have also
reviewed the budgets in the 2018 SIP Update and found that they are
consistent with the attainment and RFP demonstrations for which we are
proposing approval, are based on control measures that have already
been adopted and implemented, and meet all other applicable statutory
and regulatory requirements, including the adequacy criteria in 40 CFR
93.1118(e)(4) and (5). Therefore, we are proposing to approve the 2023
and 2026 budgets in the 2018 SIP Update. At the point when we finalize
our adequacy process or approve the budgets for the 2008 ozone NAAQS in
the 2018 SIP Update as proposed (whichever occurs first; note that they
could also occur concurrently per 40 CFR 93.118(f)(2)(iii)), then these
budgets will replace the budgets that we previously found adequate for
use in transportation conformity determinations.\138\
---------------------------------------------------------------------------

    \138\ We found adequate the budgets from the Antelope Valley-
Western Mojave Desert 8-hour Ozone Early Progress Plan (February
2008) for the 1997 ozone NAAQS at 73 FR 24594 (May 5, 2008). The
budgets in Table VI-3 of the 2018 SIP Update for the 2008 ozone
NAAQS are lower than the corresponding budgets approved for the 1997
ozone NAAQS. The current budgets of 22 tpd for VOC and 77 tpd for
NOX for all years, would be replaced by budgets of 6.8
tpd for VOC and 11.0 tpd for NOX in 2023 and 6.2 tpd for
VOC and 10.2 tpd for NOX in 2026.
---------------------------------------------------------------------------

    Under our transportation conformity rule, as a general matter, once
budgets are approved, they cannot be superseded by revised budgets
submitted for the same CAA purpose and the same year(s) addressed by
the previously approved SIP submittal until the EPA approves the
revised budgets as a SIP revision. In other words, as a general matter,
such approved budgets cannot be superseded by revised budgets found
adequate, but rather only through approval of the revised budgets,
unless the EPA specifies otherwise in its approval of a SIP by limiting
the duration of the approval to last only until subsequently submitted
budgets are found adequate.\139\
---------------------------------------------------------------------------

    \139\ 40 CFR 93.118(e)(1).
---------------------------------------------------------------------------

    In this instance, CARB's submittal letters transmitting the 2016
WMD Attainment Plan and 2018 SIP Update requested that we limit the
duration of our approval to the effective date of an EPA adequacy
finding for subsequently submitted budgets, and on April 9, 2021, CARB
provided further explanation for its request. Generally, we will
consider a state's request to limit an approval of a budget only if the
request includes the following elements: \140\
---------------------------------------------------------------------------

    \140\ 67 FR 69139 (November 15, 2002) (final action limiting our
prior approval of budgets in certain California SIPs).
---------------------------------------------------------------------------

     An acknowledgement and explanation as to why the budgets
under consideration have become outdated or deficient;
     A commitment to update the budgets as part of a
comprehensive SIP update; and
     A request that the EPA limit the duration of its approval
to the time when new budgets have been found to be adequate for
transportation conformity purposes.
    CARB's request includes an explanation for why the budgets have
become, or will become, outdated or deficient. In short, CARB requested
that we limit the duration of the approval of the budgets in light of
the EPA's recent approval of EMFAC2017, an updated version of the
EMFAC2014 model used for the budgets in the 2018 SIP Update. EMFAC2017
updates vehicle mix and emissions data of the previously approved
version of the model, EMFAC2014.
    In light of the approval of EMFAC2017, CARB requests that the
budgets from the 2016 WMD Attainment Plan, for which we are proposing
approval in this action, will be revised using EMFAC2017 in 2022.
CARB's request also states, ``without the ability to replace the
applicable transportation conformity emissions budgets with submitted
budgets found adequate using the budget adequacy process, the benefits
of using the updated data may not be realized for a year or more after
the SIPs are submitted, due to the SIP approval process.''
    We note that CARB has not committed to update the budgets as part
of a comprehensive SIP update, but as a practical matter, CARB must
submit a SIP revision that includes updated demonstrations as well as
the updated budgets to meet the adequacy criteria in

40 CFR 93.118(e)(4) for the 2015 ozone NAAQS in 2022,\141\ and thus, we
do not need a specific commitment for such a plan at this time. For the
reasons provided above, and in light of CARB's explanation for why the
budgets will become outdated and should be replaced upon an adequacy
finding for updated budgets, we propose to limit the duration of our
approval of the budgets in the 2018 SIP Update until we find revised
budgets based on EMFAC2017 to be adequate.
---------------------------------------------------------------------------

    \141\ Under 40 CFR 93.118(e)(4), the EPA will not find a budget
in a submitted SIP to be adequate unless, among other criteria, the
budgets, when considered together with all other emissions sources,
are consistent with applicable requirements for RFP and attainment.
40 CFR 93.118(e)(4)(iv).
---------------------------------------------------------------------------

I. Other Clean Air Act Requirements Applicable to Severe Ozone
Nonattainment Areas

    In addition to the requirements discussed above, title 1, subpart D
of the CAA includes other provisions applicable to Severe ozone
nonattainment areas, such as the WMD. We describe these provisions and
their current status below for informational purposes only.
1. Enhanced Vehicle Inspection and Maintenance Programs
    Section 182(c)(3) of the CAA requires states with ozone
nonattainment areas classified under subpart 2 as Serious or above to
implement an enhanced motor vehicle I/M program in each urbanized area
within the nonattainment area. As discussed in Section III.G.3 of this
document, Section 182(c)(3) further explains that urbanized areas are
``defined by the Bureau of the Census, with a 1980 population of
200,000 or more.'' Because parts of the MDAQMD within the WMD were not
considered urbanized areas in 1980, only part of the WMD is subject to
enhanced I/M.\142\
---------------------------------------------------------------------------

    \142\ As described in section III.G.2 of this document, the
State has committed to adopt a contingency measure to implement
enhanced I/M throughout the portion of the WMD that is currently
subject to basic I/M, in the event that the area fails to meet an
RFP milestone or to attain the 2008 NAAQS by the attainment date.
---------------------------------------------------------------------------

    Consistent with the 2008 Ozone SRR, no new I/M programs are
currently required for nonattainment areas for the 2008 ozone
NAAQS.\143\ The EPA previously approved the California I/M program in
the West Mojave Desert as meeting the requirements of the CAA and
applicable EPA regulations for enhanced I/M programs.\144\
---------------------------------------------------------------------------

    \143\ 2008 Ozone SRR, 80 FR 12264, at 12283 (March 6, 2015).
    \144\ 75 FR 38023 (July 1, 2010).
---------------------------------------------------------------------------

2. New Source Review Rules
    Section 182(a)(2)(C) of the CAA requires states to develop SIP
revisions containing permit programs for each of its ozone
nonattainment areas. The SIP revisions are to include requirements for
permits in accordance with CAA sections 172(c)(5) and 173 for the
construction and operation of each new or modified major stationary
source for VOC and NOX anywhere in the nonattainment
area.\145\ The 2008 Ozone SRR includes provisions and guidance for
nonattainment new source review (NSR) programs.\146\ We will address
the NSR requirements for the 2008 ozone NAAQS in the WMD in a separate
action.
---------------------------------------------------------------------------

    \145\ See also CAA sections 182(e).
    \146\ 80 FR 12264 (March 6, 2015).
---------------------------------------------------------------------------

3. Clean Fuels Fleet Program
    Sections 182(c)(4)(A) and 246 of the CAA require California to
submit to the EPA for approval into the SIP measures to implement a
Clean Fuels Fleet Program. Section 182(c)(4)(B) of the CAA allows
states to opt out of the federal clean-fuel vehicle fleet program by
submitting a SIP revision consisting of a program or programs that will
result in at least equivalent long-term reductions in ozone precursors
and toxic air emissions.
    In 1994, CARB submitted a SIP revision to the EPA to opt out of the
federal clean-fuel fleet program and included a demonstration that
California's low-emissions vehicle program achieved emissions
reductions at least as large as would be achieved by the federal
program. The EPA approved the SIP revision to opt out of the federal
program on August 27, 1999.\147\ There have been no changes to the
federal Clean Fuels Fleet program since the EPA approved the California
SIP revision to opt out of the federal program, and thus, no
corresponding changes to the SIP are required. Thus, we find that the
California SIP revision to opt out of the federal program, as approved
in 1999, meets the requirements of CAA sections 182(c)(4)(A) and 246
for the WMD for the 2008 ozone standards.
---------------------------------------------------------------------------

    \147\ 64 FR 46849 (August 27, 1999).
---------------------------------------------------------------------------

4. Gasoline Vapor Recovery
    Section 182(b)(3) of the CAA requires states to submit a SIP
revision by November 15, 1992, that requires owners or operators of
gasoline dispensing systems to install and operate gasoline vehicle
refueling vapor recovery (``Stage II'') systems in ozone nonattainment
areas classified as Moderate and above. California's ozone
nonattainment areas implemented Stage II vapor recovery well before the
passage of the CAA Amendments of 1990.\148\
---------------------------------------------------------------------------

    \148\ General Preamble, 57 FR 13498 at 13514 (April 16, 1992).
---------------------------------------------------------------------------

    Section 202(a)(6) of the CAA requires the EPA to promulgate
standards requiring motor vehicles to be equipped with onboard
refueling vapor recovery (ORVR) systems. The EPA promulgated the first
set of ORVR system regulations in 1994 for phased implementation on
vehicle manufacturers, and since the end of 2006, essentially all new
gasoline-powered light- and medium-duty vehicles are ORVR-
equipped.\149\ Section 202(a)(6) also authorizes the EPA to waive the
SIP requirement under CAA section 182(b)(3) for installation of Stage
II vapor recovery systems after such time as the EPA determines that
ORVR systems are in widespread use throughout the motor vehicle fleet.
Effective May 16, 2012, the EPA waived the requirement of CAA section
182(b)(3) for Stage II vapor recovery systems in ozone nonattainment
areas regardless of classification.\150\ Thus, a SIP submittal meeting
CAA section 182(b)(3) is not required for the 2008 ozone NAAQS.
---------------------------------------------------------------------------

    \149\ 77 FR 28772, at 28774 (May 16, 2012).
    \150\ 40 CFR 51.126(b).
---------------------------------------------------------------------------

    While a SIP submittal meeting CAA section 182(b)(3) is not required
for the 2008 ozone NAAQS, under California state law (i.e., Health and
Safety Code section 41954), CARB is required to adopt procedures and
performance standards for controlling gasoline emissions from gasoline
marketing operations, including transfer and storage operations. State
law also authorizes CARB, in cooperation with local air districts, to
certify vapor recovery systems, to identify defective equipment and to
develop test methods. CARB has adopted numerous revisions to its vapor
recovery program regulations and continues to rely on its vapor
recovery program to achieve emissions reductions in ozone nonattainment
areas in California.
    In the WMD, the installation and operation of CARB-certified vapor
recovery equipment is required and enforced through AVAQMD Rule 461,
``Gasoline Transfer and Dispensing,'' approved into the SIP on October
21, 2008, and MDAQMD Rule 461, ``Gasoline Transfer and Dispensing,''
approved into the SIP on May 1, 2020.\151\
---------------------------------------------------------------------------

    \151\ 76 FR 5277 (January 31, 2011) and 85 FR 25293 (May 1,
2020).
---------------------------------------------------------------------------

5. Enhanced Ambient Air Monitoring
    Section 182(c)(1) of the CAA requires that all ozone nonattainment
areas

classified as Serious or above implement measures to enhance and
improve monitoring for ambient concentrations of ozone, NOX,
and VOC, and to improve monitoring of emissions of NOX and
VOC. The enhanced monitoring network for ozone is referred to as the
photochemical assessment monitoring station (PAMS) network. The EPA
promulgated final PAMS regulations on February 12, 1993.\152\
---------------------------------------------------------------------------

    \152\ 58 FR 8452 (February 12, 1993).
---------------------------------------------------------------------------

    On November 10, 1993, CARB submitted to the EPA a SIP revision
addressing the PAMS network for six ozone nonattainment areas in
California, including the WMD, to meet the enhanced monitoring
requirements of CAA section 182(c)(1). The EPA determined that the PAMS
SIP revision met all applicable requirements for enhanced monitoring
and the EPA PAMS regulations and approved the PAMS submittal into the
California SIP.\153\
---------------------------------------------------------------------------

    \153\ 82 FR 45191 (September 28, 2017). This action addressed 1-
hour ozone nonattainment areas. The area identified as Southeast
Desert Modified Air Quality Management Area for the 1-hour ozone
NAAQS has been split into two separate nonattainment areas for the
1997 and 2008 ozone NAAQS, the WMD and Riverside County (Coachella
Valley).
---------------------------------------------------------------------------

    Prior to 2006, the EPA's ambient air monitoring regulations in 40
CFR part 58, ``Ambient Air Quality Surveillance,'' set forth specific
SIP requirements (see former 40 CFR 52.20). In 2006, the EPA
significantly revised and reorganized 40 CFR part 58.\154\ Under
revised 40 CFR part 58, SIP revisions are no longer required; rather,
compliance with EPA monitoring regulations is established through
review of required annual monitoring network plans.\155\ The 2008 Ozone
SRR made no changes to these requirements.\156\
---------------------------------------------------------------------------

    \154\ 71 FR 61236 (October 17, 2006).
    \155\ 40 CFR 58.2(b) now provides that, ``The requirements
pertaining to provisions for an air quality surveillance system in
the SIP are contained in this part.''
    \156\ The 2008 ozone SRR addresses PAMS-related requirements at
80 FR 12264, 12291 (March 6, 2015).
---------------------------------------------------------------------------

    The 2016 WMD Attainment Plan does not specifically address the
enhanced ambient air monitoring requirement in CAA section 182(c)(1).
However, we note that CARB includes the ambient monitoring network
within the WMD in its annual monitoring network plan that is submitted
to the EPA, and that we have approved the most recent annual monitoring
network plan (``Annual Network Plan Covering Monitoring Operations in
25 California Air Districts, July 2020'' or ``2018 ANP''), which
includes the enhanced ambient air monitoring element for the WMD.\157\
Based on our review and approval of the 2020 ANP with respect to the
WMD and our earlier approval of the PAMS SIP revision, we propose to
find that CARB, AVAQMD and MDAQMD meet the enhanced monitoring
requirements under CAA section 182(c)(1) for the WMD with respect to
the 2008 ozone NAAQS.
---------------------------------------------------------------------------

    \157\ The EPA approved the 2020 ANP in a letter dated November
5, 2020, from Gwen Yoshimura, Manager, Air Quality Analysis Office,
EPA Region IX, to Ravi Ramalingam, Chief, Consumer Products and Air
Quality Assessment Branch, Air Quality Planning and Science
Division, CARB.
---------------------------------------------------------------------------

6. CAA Section 185 Fee Program
    Section 185 of the CAA requires that the SIP for each Severe and
Extreme ozone nonattainment area provide that, if the area fails to
attain by its applicable attainment date, each major stationary source
of VOC and NOX located in the area shall pay a fee to the
state as a penalty for such failure for each calendar year beginning
after the attainment date, until the area is redesignated as an
attainment area for ozone. States are not yet required to submit a SIP
revision that meets the requirements of CAA section 185 for the 2008
ozone NAAQS.\158\
---------------------------------------------------------------------------

    \158\ See 40 CFR 51.1117. For the WMD, a section 185 SIP
revision for the 2008 ozone standards will be due on July 20, 2022.
---------------------------------------------------------------------------

IV. Proposed Action

    For the reasons discussed in this notice, under CAA section
110(k)(3), the EPA is proposing to approve as a revision to the
California SIP the following portions of the 2016 WMD Attainment Plan
for the 2008 ozone NAAQS, submitted by CARB on June 2, 2017, and the
2018 SIP Update, submitted on December 11, 2018:
     Base year emissions inventory element in the 2016 WMD
Attainment Plan as meeting the requirements of CAA sections 172(c)(3)
and 182(a)(1) and 40 CFR 51.1115;
     Emissions statement element in the 2016 WMD Attainment
Plan as meeting the requirements of CAA section 182(a)(3)(B) and 40 CFR
51.1102;
     RACM demonstration element in the 2016 WMD Attainment
Plan, as meeting the requirements of CAA section 172(c)(1) and 40 CFR
51.1112(c);
     Attainment demonstration element in the 2016 WMD
Attainment Plan as meeting the requirements of CAA section 182(c)(2)(A)
and 40 CFR 51.1108;
     RFP demonstration element in the 2018 SIP Update as
meeting the requirements of CAA sections 172(c)(2), 182(b)(1), and
182(c)(2)(B), and 40 CFR 51.1110(a)(2)(ii);
     VMT emissions offset demonstration element in the 2016 WMD
Attainment Plan as meeting the requirements of CAA section 182(d)(1)(A)
and 40 CFR 51.1102; and
     Motor vehicle emissions budgets in the 2018 SIP Update for
the 2023 RFP milestone year and the 2026 attainment year (see Table 4
of this notice) because they are consistent with the RFP and attainment
demonstrations proposed for approval herein and meet the other criteria
in 40 CFR 93.118(e).
    We are also proposing to find that the:
     California SIP revision to opt out of the federal Clean
Fuels Fleet Program meets the requirements of CAA sections 182(c)(4)(A)
and 246 and 40 CFR 51.1102 with respect to the WMD;
     Enhanced monitoring in the WMD meets the requirements of
CAA section 182(c)(1) and 40 CFR 51.1102; and
     Enhanced vehicle inspection and maintenance program
element in the WMD meets the requirements of CAA section 182(c)(3) and
40 CFR 51.1102.
    Lastly, we are proposing, under CAA section 110(k)(4), to
conditionally approve the contingency measure element of the 2016 WMD
Attainment Plan as meeting the requirements of CAA sections 172(c)(9)
and 182(c)(9) for RFP contingency measures. Our proposed approval is
based on commitments by the District and CARB to supplement the element
through submission, as a SIP revision (within one year of final
conditional approval action), a MDAQMD Board resolution detailing the
circumstances, timing, and procedure for implementing enhanced vehicle
inspection and maintenance for areas within WMD currently subject to
basic I/M, if an RFP milestone is not met or the area fails to attain
the 2008 ozone NAAQS by the attainment date.
    The EPA is soliciting public comments on the issues discussed in
this document. We will accept comments from the public on this proposal
for the next 30 days and will consider comments before taking final
action.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, 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, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed action merely proposes to approve state
plans 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 Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     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 Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the proposed rule does not have tribal implications and
will not impose substantial direct costs on tribal governments or
preempt tribal law as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

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

    Dated: May 4, 2021.
Deborah Jordan,
Acting Regional Administrator, Region IX.
[FR Doc. 2021-09842 Filed 5-7-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Notices]
[Pages 18032-18033]
[FR Doc No: 2014-06997]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2002-D-0094]

Guidance for the Public, Food and Drug Administration Advisory
Committee Members, and Food and Drug Administration Staff: Public
Availability of Advisory Committee Members' Financial Interest
Information and Waivers; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for the public, FDA advisory committee
members, and

FDA staff, entitled ``Guidance for the Public, Food and Drug
Administration Advisory Committee Members, and Food and Drug
Administration Staff: Public Availability of Advisory Committee
Members' Financial Interest Information and Waivers.'' We are issuing
the guidance to help the public, FDA advisory committee members, and
FDA staff to understand and implement FDA procedures regarding public
availability of information regarding certain financial interests and
waivers granted by FDA to permit individuals to participate in an
advisory committee meeting. This guidance replaces the guidance of the
same title dated March 2012.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to Advisory Committee Oversight and Management Staff, Office of Special
Medical Programs, Office of Medical Products and Tobacco, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Michael Ortwerth, Office of Special
Medical Programs, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for the public,
FDA advisory committee members, and FDA staff, entitled ``Guidance for
the Public, Food and Drug Administration Advisory Committee Members,
and Food and Drug Administration Staff: Public Availability of Advisory
Committee Members' Financial Interest Information and Waivers.''
    FDA's advisory committees provide independent expert advice and
recommendations to the Agency on scientific, technical, and policy
matters related to FDA-regulated products. In March 2012, FDA published
a guidance for the public, FDA advisory committee members, and FDA
staff concerning the implementation of Agency-wide procedures regarding
disclosure of financial interest information that apply to all special
Government employees and regular Government employees invited to
participate in FDA advisory committee meetings subject to the Federal
Advisory Committee Act.
    Effective October 1, 2012, the Food and Drug Administration Safety
and Innovation Act amended the statutory provision related to this
guidance. The amendments were relatively minor. FDA is revising the
March 2012 guidance to reflect these amendments and to make other non-
substantive editorial changes.
    This level 2 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the Agency's thinking on the public availability of waivers relating to
the disclosure of conflicts of interest for advisory committee members
participating in FDA advisory committee meetings. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/RegulatoryInformation/Guidances/ucm122045.htm
or http://www.regulations.gov.

    Dated: March 25, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-06997 Filed 3-28-14; 8:45 am]
BILLING CODE 4160-01-P