[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Proposed Rules]
[Pages 54259-54263]
[FR Doc No: 2023-16791]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2023-0341, FRL-11175-01-R10]

Air Plan Approval; Washington; Southwest Clean Air Agency;
Emission Standards and Controls for Sources Emitting Gasoline Vapors

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) proposes to approve
a revision to the Washington State Implementation Plan (SIP) for the
Southwest Clean Air Agency (SWCAA) jurisdiction as it relates to the
ozone National Ambient Air Quality Standard. This proposed revision
updates SWCAA's requirements in the SIP for Stage I and Stage II vapor
recovery systems at gasoline dispensing facilities including:
decommissioning existing Stage II systems incompatible with onboard
refueling vapor recovery systems on or before January 1, 2023; allowing
removal from service of Stage II vapor recovery equipment compatible
with onboard refueling vapor recovery on or after January 1, 2023; and
removing the requirement for Stage II vapor recovery at new
installations. The proposed revisions to the SIP also include, among
other changes, revised requirements for installation of enhanced
conventional nozzles, installation of low permeation hoses, and annual
testing based on facility throughput. SWCAA's submittal, in
coordination with the Washington Department of Ecology, incudes a
demonstration that such removal of Stage II requirements is consistent
with the Clean Air Act and EPA guidance.

DATES: Comments must be received on or before September 11, 2023.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2023-0341 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 submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure 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: Jeff Hunt, EPA Region 10, 1200 Sixth
Avenue--Suite 155, Seattle, WA 98101, at<PHONE_NUMBER>, or
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, it is intended to refer to the EPA.

I. Background

    Ozone is a gas composed of three oxygen atoms. Ground-level ozone
is generally not emitted directly from a vehicle's exhaust or an
industrial smokestack but is created by a chemical reaction between
nitrogen oxides (NOX) and volatile organic compounds (VOC)
in the presence of sunlight and high ambient temperatures. VOC and
NOX emissions often are referred to as ``precursors'' to
ozone formation. Thus, ozone is known primarily as a summertime air
pollutant. Motor vehicle exhaust and industrial emissions, gasoline
vapors, chemical solvents and natural sources can emit or contain
NOX and/or VOC. Urban areas tend to have high concentrations
of ground-level ozone, but areas without

significant industrial activity and with relatively low vehicular
traffic are also subject to increased ozone levels because wind carries
ozone and its precursors hundreds of miles from their sources. In 1979,
under section 109 of the Clean Air Act (CAA or the Act), the EPA
established the primary and secondary National Ambient Air Quality
Standards (NAAQS) for ozone at 0.12 parts per million (ppm) averaged
over a 1-hour period (44 FR 8202, February 8, 1979). In 1997, we
revised the primary and secondary NAAQS for ozone to set the acceptable
level of ozone in the ambient air at 0.08 ppm, averaged over an 8-hour
period (62 FR 38856, July 18, 1997). In 2008, we further revised the
primary and secondary ozone NAAQS to 0.075 ppm, averaged over an 8-hour
period (73 FR 16436, March 27, 2008). In 2015, we again revised the
primary and secondary ozone NAAQS to 0.070 ppm, averaged over an 8-hour
period (73 FR 16436, March 27, 2008). For additional information on
ozone, visit https://www.epa.gov/ozone-pollution.
    Stage II vapor recovery is an air pollution control technology for
automobiles and other on-road mobile sources. When an automobile or
other vehicle is brought into a gas station to be refueled, the empty
portion of the gas tank on the vehicle contains gasoline vapors, which
are VOCs. When liquid gasoline is pumped into the partially empty gas
tank in the vehicle the vapors are displaced out of the tank as the
tank fills with liquid gasoline. Where air pollution control technology
is not used, these vapors are emitted into the air. In the atmosphere,
these VOCs can, in the presence of sunlight, react with NOX
and VOCs from other sources to form ozone. The Stage II system consists
of special nozzles and coaxial hoses at each gas pump that capture
vapor from the vehicle's fuel tank and route them to underground or
above ground storage tanks during the refueling process. Stage II vapor
recovery systems are specifically installed at gasoline dispensing
facilities and capture the refueling fuel vapors at the gasoline pump
nozzle. The system directs the displaced vapors back to the underground
storage tank at the gasoline dispensing facility to prevent the vapors
from escaping to the atmosphere.
    Onboard refueling vapor recovery (ORVR) is another emission control
system that can capture fuel vapors from vehicle gas tanks during
refueling. ORVR systems are carbon canisters installed directly on
automobiles to capture the fuel vapors displaced from the gasoline tank
before they are released to the atmosphere. The fuel vapors captured in
the carbon canisters are then combusted in the engine when the
automobile is started and operated after refueling.
    Stage II vapor recovery systems and vehicle ORVR systems were
initially both required by the 1990 Amendments to the CAA, with Stage
II requirements applying to certain nonattainment areas. Under CAA
section 182(b)(3) ozone nonattainment areas classified as moderate and
above were required to adopt Stage II requirements. CAA section
202(a)(6), requires an onboard system of capturing vehicle refueling
emissions, commonly referred to as an ORVR system. In 1994, the EPA
promulgated ORVR standards (59 FR 16262, April 6, 1994). Section
202(a)(6) of the CAA required that the EPA's ORVR standards apply to
light-duty vehicles manufactured beginning in the fourth model year
after the model year in which the standards were promulgated, and that
ORVR systems provide a minimum evaporative emission capture efficiency
of 95 percent.\1\ ORVR equipment has been phased in for new light duty
vehicles (passenger vehicles) beginning with model year 1998 and
starting with model year 2001 for light-duty trucks and most heavy-duty
gasoline powered vehicles. Since 2006, ORVR has been a required
emissions control on nearly all new gasoline-powered highway vehicles
having less than 14,000 pounds gross vehicle weight rating. CAA section
202(a)(6) provides discretionary authority to the Administrator, by
rule, to revise or waive the application of the Stage II requirements
for areas classified as Serious, Severe, or Extreme for ozone, as
appropriate, after such time as the Administrator determines that
onboard emissions control systems are in widespread use throughout the
motor vehicle fleet.
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    \1\ Unlike Stage II, which is a requirement only in certain
ozone nonattainment areas, ORVR requirements apply to vehicles
everywhere.
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    On May 16, 2012, the EPA issued a national rulemaking making the
finding that ORVR systems are in ``widespread use'' and determined that
emission reductions from ORVR alone are essentially equal to and will
soon surpass the emission reductions achieved by Stage II alone (see 77
FR 28772 at 28772). In the May 16, 2012 action, we noted that each
year, non-ORVR-equipped vehicles continue to be replaced with ORVR-
equipped vehicles and Stage II and ORVR systems capture the same VOC
emissions and thus, are redundant. Id. The EPA also determined that
ORVR systems are in widespread use and waived the Stage II requirement
for gasoline dispensing facilities if doing so did not interfere with
attaining or maintaining the ozone standards. Id. at 28776-28779. The
EPA also noted that any state currently implementing Stage II vapor
recovery programs may submit SIP revisions that would allow for the
phase-out of Stage II vapor recovery systems including a CAA section
110(l) analysis showing that its removal did not interfere with
attaining or maintaining the ozone standards. Id.
    The Portland/Vancouver area was designated an interstate ozone
nonattainment area in 1978. On November 15, 1990, the CAA Amendments of
1990 were enacted. (Pub. L. 101-549, 104 Stat. 2399, codified at 42
U.S.C. 7401-7671q). Under section 181(a)(1) of the 1990 CAA, the area
was further classified as a ``Marginal'' ozone nonattainment area. This
interstate nonattainment area consisted of the southern portion of
Clark County, Washington, and portions of Multnomah, Clackamas, and
Washington Counties in Oregon. In 1997, the EPA redesignated the
Portland/Vancouver area to attainment (62 FR 27204, May 19, 1997). The
Portland/Vancouver area was designated as ``unclassifiable/attainment''
due to the data showing the area was below the new NAAQS for subsequent
updates, including the 1997 8-hour ozone NAAQS (69 FR 23857, April 30,
2004), the 2008 8-hour ozone NAAQS (77 FR 30088, May 21, 2012), and the
2015 8-hour ozone NAAQS (82 FR 54232, November 16, 2017).
    The Portland/Vancouver area was not subject to Stage II
requirements under the 1990 Clean Air Act Amendments as it was
classified as Marginal nonattainment for the 1-hour NAAQS for ozone,
rather than Moderate or above. However, SWCAA in coordination with the
Washington Department of Ecology submitted SWAPCA 491 ``Emission
Standards and Controls for Sources Emitting Gasoline Vapors'' (state
effective November 21, 1996, subsequently renamed to SWCAA 491) which
contained Stage II requirements as a SIP-strengthening measure approved
concurrently with redesignation of the Portland/Vancouver area to
attainment (see proposed rulemaking, 62 FR 10501, March 7, 1997, at
page 10507). On August 11, 2015 (80 FR 48033), the EPA approved SWCAA's
maintenance plan update for the Vancouver portion of the Portland/
Vancouver area that specifically anticipated and modeled widespread use
of ORVR and the full decommissioning of Stage II in the modeling
demonstration of continued attainment through 2015. The SWCAA
maintenance plan update and the

modeling demonstration are included in the docket for this action.

II. SWCAA's SIP Revision

    On June 22, 2023, SWCAA, in coordination with the Washington
Department of Ecology as the Governor's designee for revisions to the
SIP, submitted the current version of SWCAA 491 ``Emission Standards
and Controls for Sources Emitting Gasoline Vapors'' (state effective
February 7, 2020) for EPA approval. Since the EPA's last approval of
SWCAA 491, SWCAA revised the regulations four times. Effective June 24,
2000, SWCAA updated the regulations to revise applicability of the
Stage II vapor recovery program, which is now replaced by the
applicability provisions of the current SWCAA 491. Other changes to
SWCAA 491, effective June 24, 2000, are generally SIP-strengthening in
nature including the addition of gasoline marine vessel loading and
unloading vapor control requirements, which are now contained in the
current version of SWCAA 491. The exact revisions in 2000 are in
redline/strikeout format included in the docket for this action under
WSR 00-11-149. Effective March 18, 2001 (WSR 01-05-067), SWCAA made
minor changes to SWCAA 491 to reflect the name change from ``Southwest
Pollution Control Authority'' to ``Southwest Clean Air Agency.''
Effective June 18, 2017 (WSR 17-11-080), SWCAA consolidated all agency
fees into a single location and updated the cross reference in SWCAA
491-030 accordingly. We note that the 2000, 2001, and 2017 revisions to
SWCAA 491 were not previously submitted as updates to the SIP. However,
to the extent these revisions are retained in the current version of
SWCAA 491 submitted for approval, we are proposing to determine that
these relatively minor changes since our last update to the SIP in 1997
are approvable.
    The most substantive changes to SWCAA 491 since the EPA's last
approval are detailed in WSR 20-03-031, state effective February 7,
2020. Among other changes, this revision to SWCAA 491 included the
following: added a requirement to install enhanced conventional (ECO)
nozzles; added a requirement that low permeation hoses be installed on
higher volume gasoline dispensing facilities without balance type Stage
II vapor recovery equipment by no later than January 1, 2023; added a
requirement for annual testing of Stage I vapor recovery systems; \2\
added a requirement that new or upgraded gasoline storage tanks be
equipped with Stage I enhanced vapor recovery equipment; removed a
requirement that gasoline dispensing facilities install Stage II vapor
recovery equipment; allowed removal from service of Stage II vapor
recovery equipment compatible with ORVR on or after January 1, 2023;
allowed removal from service of Stage II vapor recovery equipment
incompatible with ORVR on or after January 3, 2020; required removal
from service of Stage II vapor recovery equipment incompatible with
ORVR no later than January 1, 2023; and revised the applicability
threshold for low flow nozzles to align SWCAA rules with Federal rules.
In the SIP submittal, SWCAA provided a demonstration that VOC emission
reductions from enhanced conventional nozzles and low permeation hoses
will outweigh the annual emissions impact of removing Stage II
requirements. Therefore, SWCAA requested removal of Stage II vapor
recovery system requirements in the SIP for SWCAA's jurisdiction.
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    \2\ Stage I vapor recovery is a system in which gasoline vapors
are forced from the storage tank into a vapor-tight gasoline tank
truck or vapor collection and control system through direct
displacement by the gasoline loaded into the storage tank.
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III. The EPA's Evaluation of the Revision

    The EPA's primary consideration for determining the approvability
of SWCAA's revisions to remove Stage II vapor control requirements and
provide for decommissioning of Stage II equipment within SWCAA's
jurisdiction is whether these revisions comply with section 110(l) of
the Act. Section 110(l) requires that a revision to the SIP not
interfere with any applicable requirement concerning attainment and
reasonable further progress (RFP), or any other applicable requirement
of the Act. The EPA can approve a SIP revision that removes or modifies
control measures in the SIP once the state or local agency makes a
``noninterference'' demonstration that such removal or modification
will not interfere with attainment of the NAAQS, RFP, or any other CAA
requirement.
    The EPA reviewed SWCAA's submittal with the revised SWCAA 491
regulatory text as well as the accompanying analysis of emissions
impacts. We propose to determine that SWCAA's June 22, 2023, SIP
revision addresses the EPA's Widespread Use for Onboard Refueling Vapor
Recovery and Stage II Waiver (77 FR 28772) and is consistent with the
EPA's ``Guidance on Removing Stage II Gasoline Vapor Control Programs
from State Implementation Plans and Assessing Comparable Measures''
(EPA-457/B-12-001, August 7, 2012).\3\ In accordance with the EPA 2012
Guidance on Removing Stage II, SWCAA submitted a demonstration that the
Stage II decommissioning will not interfere with attainment or
maintenance of the ozone NAAQS. This demonstration was based on an
analysis of precursor VOC emissions from removal of Stage II controls
at GDFs, as well as emission reduction benefits from other changes to
the regulations such as requirements for enhanced conventional nozzles
and low permeation hoses. SWCAA estimated emissions impacts using the
guidance methodologies from the EPA 2012 Guidance showing an overall
benefit to air quality and a reduction of VOC emissions upon full
implementation of the rule requirements in 2023. SWCAA estimated the
impact on emissions from decommissioning Stage II in its jurisdiction
by using EPA approved equations from the same 2012 guidance, to assess
compliance with CAA 110(l). A detailed spreadsheet with the equation
calculations and supporting inputs is included in the docket for this
action.
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    \3\ The guidance document is available at: https://www3.epa.gov/ttn/naaqs/aqmguide/collection/cp2/20120807_page_stage2_removal_guidance.pdf.
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    The demonstration indicates that the emissions benefit of retaining
Stage II requirements is rapidly diminishing with vehicle fleet
turnover and ORVR penetration. As discussed in the EPA 2012 Guidance,
the EPA has developed equations to assist states in evaluating the
emissions consequences of phasing out existing Stage II programs. These
equations may be used to calculate an ``increment,'' which identifies
the area-wide emission control gained from Stage II installations as
ORVR technology phases in. For example, using the equations in the EPA
2012 Guidance, SWCAA calculated the increment declining from 4.0% in
2020 to 1.1% in 2023 for Clark County, the most populous county in
SWCAA's jurisdiction. Projecting these increments to full
implementation of the rule in 2023, the removal of Stage II vapor
recovery systems would result in minimal increases in VOC emissions of
18.31 tons per year (tpy) for SWCAA's entire jurisdiction.
Additionally, SWCAA calculated the emission reduction benefits of
enhanced conventional nozzles and low permeation hoses. These emission
reduction benefits are estimated to be 33.84 tpy, outweighing the
emissions increase from decommissioning Stage II

requirements. Overall, the 2020 regulatory changes are projected to
result in a net reduction of 15.99 tpy VOC with full implementation of
the rule. In addition, the EPA expects that market saturation of ORVR-
equipped vehicles will remain static or increase in the years after
2023, meaning the air quality benefits of these changes will continue
into the future.
    Lastly, the removal of Stage II is consistent with the current
maintenance plan update for the Vancouver portion of the Portland/
Vancouver ozone area (80 FR 48033, August 11, 2015). As previously
discussed, this maintenance plan update was approved by the EPA in
2015. The associated modeling, included in the docket for this action,
anticipated the decommissioning of Stage II in the projection of
continued ozone attainment for the 1997 8-hour ozone NAAQS.\4\ For the
2008 and 2015 ozone NAAQS, all counties within SWCAA's jurisdiction are
designated attainment/unclassifiable. We believe that removal of Stage
II vapor recovery systems would have a negligible impact on ozone
levels which are offset by the emission reduction benefits of other
requirements in the revised SWCAA 491. Thus, we proposed to determine
that approval of the SIP revision would not interfere with any
applicable requirement concerning attainment and maintenance of any
ozone standard and is compliant with CAA section 110(l).
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    \4\ Consistent with EPA guidance, SWCAA evaluated compliance
with the 1997 8-hour ozone NAAQS because the former 1-hour ozone
NAAQS was replaced by the 1997 8-hour standard. See 62 FR 38856
(July 18, 1997) and 75 FR 24542 (May 5, 2010).
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IV. Proposed Action

    We are proposing to find that SWCAA's demonstration for removal of
Stage II equipment meets section 110(l) of the Act. Therefore, we are
proposing to approve and incorporate by reference SWCAA 491 ``Emission
Standards and Controls for Sources Emitting Gasoline Vapors'' state
effective February 7, 2020. This version of the regulation removes from
the Washington SIP the requirement for Stage II vapor recovery systems
in SWCAA's jurisdiction and adds additional VOC controls such as the
installation of enhanced conventional nozzles and low permeation hoses,
as well as other historic changes since the EPA's last approval as
discussed in section II of this preamble.

V. 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 SWCAA 491 discussed in section IV of this preamble. 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).

VI. 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 Clean Air Act
and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this 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 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 14094 (88 FR 21879, April 11, 2023);
     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 subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it approves a state program;
     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 those requirements would be inconsistent
with the Clean Air Act.
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the 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).
    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.
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.'' 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 Southwest Clean Air Agency did not evaluate environmental
justice considerations as part of its SIP submittal; the CAA and
applicable implementing regulations neither prohibit nor require such
an evaluation. EPA did not perform an EJ analysis and did not consider
EJ in this action. Due to the nature of the action being taken here,
this action is expected to have a neutral to positive impact on the air
quality of the affected area. Consideration of EJ is not required as
part of this action, and there is no information in the record
inconsistent with the stated goal of E.O. 12898 of achieving
environmental justice for people of color, low-income populations, and
Indigenous peoples.

List of Subjects in 40 CFR Part 52

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

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

    Dated: August 1, 2023.
Casey Sixkiller,
Regional Administrator, Region 10.
[FR Doc. 2023-16791 Filed 8-9-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Notices]
[Pages 21744-21748]
[FR Doc No: 2021-08474]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-0987, FDA-2020-D-1106, FDA-2020-D-1136, FDA-
2020-D-1137, FDA-2020-D-1825]

Guidance Documents Related to Coronavirus Disease 2019;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of FDA guidance documents related to the Coronavirus
Disease 2019 (COVID-19) public health emergency (PHE). This notice of
availability (NOA) is pursuant to the process that FDA announced, in
the Federal Register of March 25, 2020, for making available to the
public COVID-19-related guidances. The guidances identified in this
notice address issues related to the COVID-19 PHE and have been issued
in accordance with the process announced in the March 25, 2020, notice.
The guidances have been implemented without prior comment, but they
remain subject to comment in accordance with the Agency's good guidance
practices.

DATES: The announcement of the guidances is published in the Federal
Register on April 23, 2021.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as 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 name of the
guidance document that the comments address and the docket number for
the guidance (see table 1). Received comments will be placed in the
docket(s) and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
    Submit written requests for single copies of these guidances to the
address noted in table 1. Send two self-addressed adhesive labels to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911, Kimberly Thomas, Center for Drug Evaluation and Research
(CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6220, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, or Erica
Takai, Center for Devices and Radiological Health (CDRH), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, the
Secretary of Health and Human Services (HHS), pursuant to the authority
under section 319 of the Public Health Service Act (42 U.S.C. 247d),
determined that a PHE exists and has existed since January 27, 2020,
nationwide.\1\ On March 13, 2020, there was a Presidential declaration
that the COVID-19 outbreak in the United States constitutes a national
emergency, beginning March 1, 2020.\2\
---------------------------------------------------------------------------

    \1\ Secretary of Health and Human Services, ``Determination that
a Public Health Emergency Exists'' (originally issued on January 31,
2020, and subsequently renewed), available at: https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
    \2\ ``Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak'' (March 13,
2020), available at: https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. On February
24, 2021, there was a Presidential Declaration continuing the
national emergency concerning the COVID-19 pandemic beyond March 1,
2021. See ``Continuation of the National Emergency Concerning the
Coronavirus Disease 2019 (COVID-19) Pandemic'' (February 24, 2021),
available at https://www.federalregister.gov/documents/2021/02/26/2021-04173/continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic.
---------------------------------------------------------------------------

    In the Federal Register of March 25, 2020 (85 FR 16949) (the March
25, 2020, notice) (available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), FDA announced procedures for making
available FDA guidances related to the COVID-19 PHE. These procedures,
which operate within FDA's established good guidance practices
regulations, are intended to allow FDA to rapidly disseminate Agency
recommendations and policies related to COVID-19 to industry, FDA
staff, and other stakeholders. The March 25, 2020, notice stated that
due to the need to act quickly and efficiently to respond to the COVID-
19 PHE, FDA believes that prior public participation will not be
feasible or appropriate before FDA implements COVID-19-related
guidances. Therefore, FDA will issue COVID-19-related guidances for
immediate implementation without prior public comment (see section
701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
371(h)(1)(C)) and Sec.  10.115(g)(2)). The guidances are available on
FDA's web pages entitled ``COVID-19-Related Guidance Documents for
Industry, FDA Staff, and Other Stakeholders'' (available at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders)
and ``Search for FDA Guidance Documents'' (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents).
    The March 25, 2020, notice further stated that, in general, rather
than publishing a separate NOA for each COVID-19-related guidance, FDA
intends to publish periodically a consolidated NOA announcing the
availability of certain COVID-19-related guidances that FDA issued
during the relevant period, as included in table 1. This notice
announces COVID-19-related guidances that are posted on FDA's website.

II. Availability of COVID-19-Related Guidance Documents

    Pursuant to the process described in the March 25, 2020, notice,
FDA is announcing the availability of the following COVID-19-related
guidances:

                       Table 1--Guidances Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
                                                                                Contact information to
           Docket No.                    Center              Title of guidance          request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1825.................  CBER................  Investigational COVID-19     Office of Communication,
                                                         Convalescent Plasma          Outreach and Development,
                                                         (Updated February 2021).     10903 New Hampshire Ave.,
                                                                                Bldg. 71, Rm. 3128, Silver
                                                                                Spring, MD 20993-0002, 1-
<PHONE_NUMBER> or 240-402-
                                                                                8010; email
<EMAIL_ADDRESS>FDA-2020-D-1137.................  CBER................  Emergency Use Authorization  Office of Communication,
                                                         for Vaccines to Prevent      Outreach and Development,
                                                         COVID-19 (Updated February   10903 New Hampshire Ave.,
                                                         2021).                       Bldg. 71, Rm. 3128, Silver
                                                                                Spring, MD 20993-0002, 1-
<PHONE_NUMBER> or 240-402-
                                                                                8010; email
<EMAIL_ADDRESS>FDA-2020-D-1136.................  CDER................  COVID-19 Container Closure<EMAIL_ADDRESS>                                                         System and Component        Please include the docket
                                                         Changes: Glass Vials and     number FDA-2020-D-1136 and
                                                         Stoppers Guidance for        complete title of the
                                                         Industry (March 2021).       guidance in the request.
FDA-2020-D-1136.................  CDER................  Development of Monoclonal<EMAIL_ADDRESS>                                                         Antibody Products           Please include the docket
                                                         Targeting SARS-CoV-2,        number FDA-2020-D-1136 and
                                                         Including Addressing the     complete title of the
                                                         Impact of Emerging           guidance in the request.
                                                         Variants, During the COVID
                                                         19 Public Health Emergency
                                                         (February 2021).

FDA-2020-D-1106.................  CDER................  Temporary Policy for<EMAIL_ADDRESS>                                                         Manufacture of Alcohol for  Please include the docket
                                                         Incorporation Into Alcohol-  number FDA-2020-D-1106 and
                                                         Based Hand Sanitizer         complete title of the
                                                         Products During the Public   guidance in the request.
                                                         Health Emergency (COVID-
                                                         19) (Updated February
                                                         2021).
FDA-2020-D-1106.................  CDER................  Temporary Policy for<EMAIL_ADDRESS>                                                         Preparation of Certain      Please include the docket
                                                         Alcohol-Based Hand           number FDA-2020-D-1106 and
                                                         Sanitizer Products During    complete title of the
                                                         the Public Health            guidance in the request.
                                                         Emergency (COVID-19)
                                                         (Updated February 2021).
FDA-2020-D-0987.................  CDRH................  Policy for Evaluating<EMAIL_ADDRESS>                                                         Impact of Viral Mutations    Please include the
                                                         on COVID-19 Tests            document number 21104 and
                                                         (February 2021).             complete title of the
                                                                                guidance in the request.
----------------------------------------------------------------------------------------------------------------

    Although these guidances have been implemented immediately without
prior comment, FDA will consider all comments received and revise the
guidances as appropriate (see Sec.  10.115(g)(3)).
    These guidances are being issued consistent with FDA's good
guidance practices regulation (Sec.  10.115). The guidances represent
the current thinking of FDA. They do not establish any rights for any
person and are not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

III. Paperwork Reduction Act of 1995

A. CBER Guidances

    While these guidances contain no collection of information, they do
refer to previously approved FDA collections of information (listed in
table 2). Therefore, clearance by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521) is not required for these guidances. The previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in the following FDA regulations and
guidances have been approved by OMB as listed in the following table:

                                     Table 2--CBER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                                       Another guidance title
        COVID-19 guidance title           CFR cite referenced in       referenced in COVID-19       OMB control
                                            COVID-19 guidance                 guidance                No(s).
----------------------------------------------------------------------------------------------------------------
Emergency Use Authorization for         21 CFR 314.420...........                                      0910-0001
 Vaccines to Prevent COVID-19           21 CFR part 312..........  .............................       0910-0014
 (Updated: February 22, 2021).          21 CFR parts 210, 211,     .............................       0910-0139
                                         and 610.                  .............................       0910-0308
                                        21 CFR part 600..........  .............................       0910-0338
                                        21 CFR part 601..........
                                                                   Emergency Use Authorization         0910-0595
                                                                    of Medical Products and
                                                                    Related Authorities.
Investigational COVID-19 Convalescent   21 CFR part 312..........                                      0910-0014
 Plasma; Guidance for Industry          21 CFR parts 606 and 630.  .............................       0910-0116
 (Updated: February 11, 2021).
                                                                   Form FDA 3926................       0910-0814
----------------------------------------------------------------------------------------------------------------

B. CDER Guidances

    While these guidances contain no collection of information, they do
refer to previously approved FDA collections of information (listed in
table 3). Therefore, clearance by OMB under the PRA (44 U.S.C. 3501-
3521) is not required for these guidances. The previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in the following FDA regulations and
guidances have been approved by OMB as listed in the following table:

                                     Table 3--CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                                       Another guidance title
        COVID-19 guidance title           CFR cite referenced in       referenced in COVID-19       OMB control
                                            COVID-19 guidance                 guidance                No(s).
----------------------------------------------------------------------------------------------------------------
COVID-19 Container Closure System and   21 CFR 314.70............  Requests for Expedited Review       0910-0001
 Component Changes: Glass Vials and     21 CFR 314.97............   of New Drug Application and        0910-0338
 Stoppers Guidance for Industry (March  21 CFR 601.12............   Biologics License                  0910-0139
 2021).                                 21 CFR 314.420...........   Application Prior Approval
                                                                    Supplements Submitted for
                                                                    Chemistry, Manufacturing,
                                                                    and Controls Changes.
                                                                   Comparability Protocols for
                                                                    Human Drugs and Biologics:
                                                                    Chemistry, Manufacturing,
                                                                    and Controls Information
                                                                    (April 2016).
                                                                   Chemistry, Manufacturing, and
                                                                    Controls Changes to an
                                                                    Approved Application:
                                                                    Certain Biological Products
                                                                    (December 2017).
                                                                   Changes to an Approved
                                                                    Application for Specified
                                                                    Biotechnology and Specified
                                                                    Synthetic Biological
                                                                    Products (July 1997).
                                                                   Changes to an Approved NDA or
                                                                    ANDA (April 2004).
                                                                   Container Closure Systems for
                                                                    Packaging Human Drugs and
                                                                    Biologics; Chemistry,
                                                                    Manufacturing, and Controls
                                                                    Documentation (May 1999).
                                                                   CMC Postapproval
                                                                    Manufacturing Changes for
                                                                    Specified Biological
                                                                    Products To Be Documented in
                                                                    Annual Reports (August 2017).
                                                                   Comparability Protocols for
                                                                    Human Drugs and Biologics:
                                                                    Chemistry, Manufacturing,
                                                                    and Controls Information
                                                                    (April 2016).
                                                                   Drug Master Files (October
                                                                    2019).
                                                                   Harmonizing Compendial
                                                                    Standards With Drug
                                                                    Application Approval Using
                                                                    the USP Pending Monograph
                                                                    Process (July 2019).

                                                                   Manufacturing, Supply Chain,
                                                                    and Drug and Biological
                                                                    Product Inspections During
                                                                    COVID-19 Public Health
                                                                    Emergency; Questions and
                                                                    Answers (August 2020).
                                                                   PAC-ATLS: Postapproval
                                                                    Changes--Analytical Testing
                                                                    Laboratory Sites (April
                                                                    1998).
                                                                   Submission Documentation for
                                                                    Sterilization Process
                                                                    Validation in Applications
                                                                    for Human and Veterinary
                                                                    Drug Products (November
                                                                    1994).
                                                                   Immediate Release Solid Oral
                                                                    Dosage Forms; Scale-Up and
                                                                    Postapproval Changes:
                                                                    Chemistry, Manufacturing,
                                                                    and Controls, In Vitro
                                                                    Dissolution Testing, and In
                                                                    Vivo Bioequivalence
                                                                    Documentation (November
                                                                    1995).
                                                                   Nonsterile Semisolid Dosage
                                                                    Forms; Scale-Up and
                                                                    Postapproval Changes:
                                                                    Chemistry, Manufacturing,
                                                                    and Controls; In Vitro
                                                                    Release Testing and In Vivo
                                                                    Bioequivalence Documentation
                                                                    (May 1997).
                                                                   SUPAC: Manufacturing
                                                                    Equipment Addendum (December
                                                                    2014).
                                                                   SUPAC-IR: Questions and
                                                                    Answers about SUPAC-IR
                                                                    Guidance (February 1997).
                                                                   SUPAC-MR: Modified Release
                                                                    Solid Oral Dosage Forms;
                                                                    Scale-Up and Postapproval
                                                                    Changes: Chemistry,
                                                                    Manufacturing, and Controls;
                                                                    In Vitro Dissolution Testing
                                                                    and In Vivo Bioequivalence
                                                                    Documentation (September
                                                                    1997).
                                                                   Q6A Specifications: Test
                                                                    Procedures and Acceptance
                                                                    Criteria for New Drug
                                                                    Substances and New Drug
                                                                    Products: Chemical
                                                                    Substances (December 2000).
                                                                   Q6B Specifications: Test
                                                                    Procedures and Acceptance
                                                                    Criteria for
                                                                    Biotechnological/Biological
                                                                    Products (August 1999).
                                                                   Q9 Quality Risk Management
                                                                    (June 2006).
                                                                   Q10 Pharmaceutical Quality
                                                                    System (April 2009).
Development of Monoclonal Antibody      21 CFR 312...............  Emergency Use Authorization         0910-0014
 Products Targeting SARS-CoV-2,         21 CFR 601.20............   of Medical Products and            0910-0001
 Including Addressing the Impact of                                 Related Authorities (January       0910-0338
 Emerging Variants, During the COVID-                               2017).                             0910-0139
 19 Public Health Emergency (February
 2021).
                                                                   COVID-19: Potency Assay
                                                                    Considerations for
                                                                    Monoclonal Antibodies and
                                                                    Other Therapeutic Proteins
                                                                    Targeting SARS-CoV-2
                                                                    Infectivity (January 2021).
                                                                   S6(R1) Preclinical Safety
                                                                    Evaluation of Biotechnology-
                                                                    Delivered Pharmaceuticals
                                                                    (May 2012).
                                                                   CGMP for Phase 1
                                                                    Investigational Drugs (July
                                                                    2008)..
                                                                   COVID-19 Public Health
                                                                    Emergency: General
                                                                    Considerations for Pre-IND
                                                                    Meeting Requests for COVID-
                                                                    19 Related Drugs and
                                                                    Biological Products.
                                                                   Points to Consider in the
                                                                    Manufacture and Testing of
                                                                    Monoclonal Antibody Products
                                                                    for Human Use (February
                                                                    1997)..
                                                                   COVID-19: Developing Drugs
                                                                    and Biological Products for
                                                                    Treatment or Prevention
                                                                    (February 2021).
                                                                   Antiviral Product
                                                                    Development--Conducting and
                                                                    Submitting Virology Studies
                                                                    to the Agency (June 2006).
Temporary Policy for Preparation of                                Temporary Compounding of            0910-0045
 Certain Alcohol-Based Hand Sanitizer                               Certain Alcohol-Based Hand         0910-0139
 Products During the Public Health                                  Sanitizer Products During          0910-0230
 Emergency (COVID-19) (Updated                                      the Public Health Emergency        0910-0291
 February 10, 2021).                                                (COVID-19).                        0910-0340
                                                                                0910-0641
                                                                                0910-0645
                                                                                0910-0800
                                                                   Temporary Policy for
                                                                    Manufacture of Alcohol for
                                                                    Incorporation Into Alcohol-
                                                                    Based Hand Sanitizer
                                                                    Products During the Public
                                                                    Health Emergency (COVID-19).
                                                                   Adverse Event Reporting
                                                                    Requirements.
                                                                   Policy for Testing of Alcohol
                                                                    (Ethanol) and Isopropyl
                                                                    Alcohol for Methanol,
                                                                    Including During the Public
                                                                    Health Emergency (COVID-19).
                                                                   Q3C Guideline on Impurities:
                                                                    Guideline for Residual
                                                                    Solvents.
Temporary Policy for Manufacture of     21 CFR 207.17............  Temporary Policy for                0910-0045
 Alcohol for Incorporation Into         21 CFR 207.25............   Preparation of Certain             0910-0139
 Alcohol-Based Hand Sanitizer Products  21 CFR 207.41............   Alcohol-Based Hand Sanitizer       0910-0230
 During the Public Health Emergency                                 Products During the Public         0910-0291
 (COVID-19) (Updated February 10,                                   Health Emergency (COVID-19).       0910-0340
 2021).                                                                                0910-0641
                                                                   Policy for Testing of Alcohol
                                                                    (Ethanol) and Isopropyl
                                                                    Alcohol for Methanol,
                                                                    Including During the Public
                                                                    Health Emergency (COVID-19).
                                                                   Q3C Guideline on Impurities:
                                                                    Guideline for Residual
                                                                    Solvents.
----------------------------------------------------------------------------------------------------------------

C. CDRH Guidance

    While this guidance contains no collection of information, it does
refer to a previously approved FDA collection of information (listed in
table 4). Therefore, clearance by OMB under the PRA (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved
collection of information is subject to review by OMB under the PRA.
The collection of information in the following FDA guidance has been
approved by OMB as listed in the following table:

                                     Table 4--CDRH Guidance and Collections
----------------------------------------------------------------------------------------------------------------
                                                                       Another guidance title
        COVID-19 guidance title           CFR cite referenced in       referenced in COVID-19       OMB control
                                            COVID-19 guidance                 guidance                No(s).
----------------------------------------------------------------------------------------------------------------
Policy for Evaluating Impact of Viral                              Emergency Use Authorization         0910-0595
 Mutations on COVID-19 Tests (February                              of Medical Products and
 2021).                                                             Related Authorities;
                                                                    Guidance for Industry and
                                                                    Other Stakeholders.
----------------------------------------------------------------------------------------------------------------

IV. Electronic Access

    Persons with access to the internet may obtain COVID-19-related
guidances at:
     FDA web page entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,'' available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders;
     FDA web page entitled ``Search for FDA Guidance
Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
     https://www.regulations.gov.

    Dated: April 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08474 Filed 4-22-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 80 (Tuesday, April 26, 2016)]
[Notices]
[Page 24597]
[FR Doc No: 2016-09576]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL_9942-93-OEI]

Cross-Media Electronic Reporting: Authorized Program Revision
Approval, State of Louisiana

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces EPA's approval of the State of
Louisiana's request to revise its National Primary Drinking Water
Regulations Implementation EPA-authorized program to allow electronic
reporting.

DATES: EPA's approval is effective May 26, 2016 for the State of
Louisiana's National Primary Drinking Water Regulations Implementation
program, if no timely request for a public hearing is received and
accepted by the Agency.

FOR FURTHER INFORMATION CONTACT: Karen Seeh, U.S. Environmental
Protection Agency, Office of Environmental Information, Mail Stop
2823T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 566-
1175<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 13, 2005, the final Cross-Media
Electronic Reporting Rule (CROMERR) was published in the Federal
Register (70 FR 59848) and codified as part 3 of title 40 of the CFR.
CROMERR establishes electronic reporting as an acceptable regulatory
alternative to paper reporting and establishes requirements to assure
that electronic documents are as legally dependable as their paper
counterparts. Subpart D of CROMERR requires that state, tribal or local
government agencies that receive, or wish to begin receiving,
electronic reports under their EPA-authorized programs must apply to
EPA for a revision or modification of those programs and obtain EPA
approval. Subpart D provides standards for such approvals based on
consideration of the electronic document receiving systems that the
state, tribe, or local government will use to implement the electronic
reporting. Additionally, Sec.  3.1000(b) through (e) of 40 CFR part 3,
subpart D provides special procedures for program revisions and
modifications to allow electronic reporting, to be used at the option
of the state, tribe or local government in place of procedures
available under existing program-specific authorization regulations. An
application submitted under the subpart D procedures must show that the
state, tribe or local government has sufficient legal authority to
implement the electronic reporting components of the programs covered
by the application and will use electronic document receiving systems
that meet the applicable subpart D requirements.
    On February 8, 2016, the Louisiana Department of Health and
Hospitals (LDHH) submitted an application titled Compliance Monitoring
Data Portal for revision to its EPA-approved drinking water program
under title 40 CFR to allow new electronic reporting. EPA reviewed
LDHH's request to revise its EPA-authorized program and, based on this
review, EPA determined that the application met the standards for
approval of authorized program revision set out in 40 CFR part 3,
subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's
decision to approve Louisiana's request to revise its Part 142--
National Primary Drinking Water Regulations Implementation program to
allow electronic reporting under 40 CFR part 141 is being published in
the Federal Register.
    LDHH was notified of EPA's determination to approve its application
with respect to the authorized program listed above.
    Also, in today's notice, EPA is informing interested persons that
they may request a public hearing on EPA's action to approve the State
of Louisiana's request to revise its authorized public water system
program under 40 CFR part 142, in accordance with 40 CFR 3.1000(f).
Requests for a hearing must be submitted to EPA within 30 days of
publication of today's Federal Register notice. Such requests should
include the following information:
    (1) The name, address and telephone number of the individual,
organization or other entity requesting a hearing;
    (2) A brief statement of the requesting person's interest in EPA's
determination, a brief explanation as to why EPA should hold a hearing,
and any other information that the requesting person wants EPA to
consider when determining whether to grant the request;
    (3) The signature of the individual making the request, or, if the
request is made on behalf of an organization or other entity, the
signature of a responsible official of the organization or other
entity.
    In the event a hearing is requested and granted, EPA will provide
notice of the hearing in the Federal Register not less than 15 days
prior to the scheduled hearing date. Frivolous or insubstantial
requests for hearing may be denied by EPA. Following such a public
hearing, EPA will review the record of the hearing and issue an order
either affirming today's determination or rescinding such
determination. If no timely request for a hearing is received and
granted, EPA's approval of the State of Louisiana's request to revise
its part 142--National Primary Drinking Water Regulations
Implementation program to allow electronic reporting will become
effective 30 days after today's notice is published, pursuant to
CROMERR section 3.1000(f)(4).

Matthew Leopard,
Director, Office of Information Collection.
[FR Doc. 2016-09576 Filed 4-25-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 205 (Thursday, October 22, 2020)]
[Proposed Rules]
[Pages 67322-67324]
[FR Doc No: 2020-22913]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0878; Airspace Docket No. 20-AGL-35]
RIN 2120-AA66

Proposed Amendment of Class E Airspace; Warroad, MN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend the Class E airspace extending
upward from 700 feet above the surface at Warroad International
Memorial Airport, Warroad, MN. The FAA is proposing this action as the
result of an airspace review caused by the decommissioning of the
Baudette VHF omnidirectional range (VOR) navigation aid as part of the
VOR Minimum Operational Network (MON) Program. The name and geographic
coordinates of the airport would also be updated to coincide with the
FAA's aeronautical database.

DATES: Comments must be received on or before December 7, 2020.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2020-0878/Airspace Docket No. 20-AGL-35, at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order 7400.11E, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11E at NARA, email:
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    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
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 regulation is within the scope of that authority as it
would amend the Class E airspace extending upward from 700 feet above
the surface at Warroad International Memorial Airport, Warroad, MN, to
support instrument flight rule operations at this airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking 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 and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2020-0878/
Airspace Docket No. 20-AGL-35.'' 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 through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/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 the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11E, Airspace
Designations and Reporting Points, dated July 21, 2020, and effective
September 15, 2020. FAA Order 7400.11E is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11E lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by amending the Class E airspace extending
upward from 700 feet above the surface to within a 6.6-mile (decreased
from a 7-mile) radius of Warroad International Memorial Airport,
Warroad, MN; removing the exclusionary language from the airspace legal
description as it is no longer required; and updating the name
(previously Warroad International-Swede Carlson Field) and geographic
coordinates of the airport to coincide with the FAA's aeronautical
database.
    This action is the result of an airspace review caused by the
decommissioning of the Baudette VOR, which provided navigation
information for the instrument procedures this airport, as part of the
VOR MON Program.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11E, dated July 21, 2020, and effective September 15,
2020, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. 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 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.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, 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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

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

* * * * *

AGL MN E5 Warroad, MN [Amended]

Warroad International Memorial Airport, MN
    (Lat. 48[deg]56'29'' N, long. 95[deg]20'55'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of the Warroad International Memorial
Airport.

    Issued in Fort Worth, Texas, on October 13, 2020.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2020-22913 Filed 10-21-20; 8:45 am]
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[Federal Register Volume 78, Number 235 (Friday, December 6, 2013)]
[Notices]
[Pages 73520-73521]
[FR Doc No: 2013-29192]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2013-0715; FRL-9902-85]

Agency Information Collection Activities; Proposed Collection;
Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this
document announces that EPA is planning to submit an Information
Collection Request (ICR) to the Office of Management and Budget (OMB).
The ICR, entitled: ``Survey of the Public and Commercial Building
Industry'' and identified by EPA ICR No. 2494.01 and OMB Control No.
2070-NEW, represents a new request. Before submitting the ICR to OMB
for review and approval, EPA is soliciting comments on specific aspects
of the proposed information collection that is summarized in this
document. The ICR and accompanying material are available in the docket
for public review and comment.

DATES: Comments must be received on or before February 4, 2014.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2013-0715, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. ATTN:
Docket ID Number EPA-HQ-OPPT-2013-0715. The DCO is open from 8 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The telephone
number for the DCO is<PHONE_NUMBER>. Such deliveries are only accepted
during the DCO's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2013-0715. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. 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
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is<PHONE_NUMBER>, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Judith Brown, Economics, Exposure and Technology Division (7406M),
Office of Pollution Prevention and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What Information is EPA Particularly Interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)),
EPA specifically solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What Information Collection Activity or ICR Does this Action Apply
to?

    Title: Survey of the Public and Commercial Building Industry.
    ICR number: EPA ICR No. 2494.01.
    OMB control number: OMB Control No. 2070-NEW.

    ICR status: This ICR is for a new information collection activity.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the Code of Federal Regulations (CFR), after appearing
in the Federal Register when approved, are listed in 40 CFR part 9, are
displayed either by publication in the Federal Register or by other
appropriate means, such as on the related collection instrument or
form, if applicable. The display of OMB control numbers for certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: EPA has initiated a proceeding to investigate whether and
what type of regulatory action might be appropriate to control
exposures to lead dust resulting from renovation, repair, and painting
(RRP) activities in public and commercial buildings (PnCBs). These
proceedings have been described in previous Federal Register documents,
entitled ``Lead; Renovation, Repair, and Painting Program for Public
and Commercial Buildings'' (advance notice of proposed rulemaking) (75
FR 24848, May 6, 2010) (FRL-8823-6); ``Lead; Renovation, Repair, and
Painting Program for Public and Commercial Buildings; Request for
Information and Advance Notice of Public Meeting'' (77 FR 76996,
December 31, 2012) (FRL-9373-7); and ``Lead; Renovation, Repair, and
Painting Program for Public and Commercial Buildings; Notice of Public
Meeting and Reopening of Comment Period'' (78 FR 27906, May 13, 2013)
(FRL-9385-6).
    EPA plans to conduct a survey to collect information on: Building
and activity patterns that may affect exposures to lead dust from RRP
activities in PnCBs; the number of firms that perform RRP activities in
PnCBs; the types and numbers of RRP activities that are performed; the
extent to which various work practices are currently being used in RRP
jobs in PnCBs; and the extent to which various work practices that help
with the containment and cleanup of lead dust are currently being used
in RRP jobs performed in PnCBs.
    The information collected through the survey (along with
information submitted to EPA in response to the previous Federal
Register documents for this proceeding, as well as other data sources)
will allow EPA to predict a baseline for the incidence of different
types of RRP activities that disturb lead-based paint in PnCBs, the
methods that are used to conduct these activities, the work practices
that are used to contain and clean the resulting dust, and the
characteristics of the buildings where the work is performed. EPA will
use this information to estimate the resulting exposures to lead dust,
which will inform Agency decisionmaking about the need for and scope of
potential regulatory or other actions to reduce exposures to lead dust
from RRP activities in PnCBs. If EPA determines that a regulation is
needed, the Agency will use this data to assess the incremental
benefits and costs of potential options to reduce such exposures. The
information collected through the survey is necessary to inform Agency
decisionmakers about the need for and scope of regulatory or other
actions to protect against risks created by RRP activities disturbing
lead-based paint in PnCBs.
    The information collection will be a one-time data collection.
Participation will be voluntary. Establishments will be selected using
a stratified random sampling method. EPA plans to have a total of 402
respondents complete a questionnaire. The information collection will
utilize separate questionnaires for contractors that perform RRP
activities in PnCBs; lessors and managers of PnCBs that use their own
staff to perform RRP activities; and building owners and occupants of
PnCBs that use their own staff to perform RRP activities. The survey
asks for readily available information, e.g., information known or
easily accessible by respondents.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 3
minutes per response for the screening portion of the survey, 30
minutes for the contractor questionnaire, 5 minutes for the property
lessor/manager questionnaire, and 5 minutes for the building owner/
occupant questionnaire. Burden is defined in 5 CFR 1320.3(b).
    The ICR, which is available in the docket along with other related
materials, provides a detailed explanation of the collection activities
and the burden estimate that is only briefly summarized here:
    Respondents/Affected Entities: Entities potentially affected by
this ICR are RRP contractors that work in PnCBs, lessors and managers
of PnCBs, and owners and occupants of PnCBs.
    Estimated total number of potential respondents: 402.
    Frequency of response: One occasion (one time).
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 672 hours.
    Estimated total annual costs: $ 39,191. This includes an estimated
burden cost of $ 39,191 and an estimated cost of $ 0 for capital
investment or maintenance and operational costs.

 III. What is the Next Step in the Process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to
announce the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the technical person listed under
FOR FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: November 27, 2013.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2013-29192 Filed 12-5-13; 8:45 am]
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