[Federal Register Volume 79, Number 21 (Friday, January 31, 2014)]
[Rules and Regulations]
[Pages 5251-5254]
[FR Doc No: 2014-01467]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0679; Directorate Identifier 2009-SW-015-AD;
Amendment 39-17733; AD 2014-02-05]
RIN 2120-AA64

Airworthiness Directives; Eurocopter France (Eurocopter)
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for
Eurocopter Model AS350B, AS350BA, AS350B1, AS350B2, AS350B3, AS350C,
AS350D, and AS350D1 helicopters. This AD requires measuring the
distance between the end of the main rotor collective pitch lever
(collective) locking stud (locking stud) and the locking strip and
repairing the locking stud if the clearance is insufficient. This

AD was prompted by a report that insufficient distance between the
locking stud and the locking strip may cause the collective to become
inadvertently locked in the low pitch (low) position. The actions of
this AD are intended to prevent the collective from becoming
inadvertently locked in the low position and subsequent loss of control
of the helicopter.

DATES: This AD is effective March 7, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain document listed in this AD as of March 7, 2014.

ADDRESSES: For service information identified in this AD, contact
American Eurocopter Corporation, 2701 N. Forum Drive, Grand Prairie, TX
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>;
or at http://www.eurocopter.com/techpub. You may review the referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas
76137.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the foreign authority's AD,
any incorporated-by-reference service information, the economic
evaluation, any comments received, and other information. The street
address for the Docket Operations Office (phone:<PHONE_NUMBER>) is U.S.
Department of Transportation, Docket Operations Office, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Robert Grant, Aviation Safety
Engineer, Safety Management Group, FAA, 2601 Meacham Blvd., Fort Worth,
Texas 76137; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On August 5, 2013, at 78 FR 47230, the Federal Register published
our notice of proposed rulemaking (NPRM), which proposed to amend 14
CFR part 39 by adding an AD that would apply to Eurocopter Model
AS350B, AS350BA, AS350B1, AS350B2, AS350B3, AS350C, AS350D, and AS350D1
helicopters. The NPRM proposed to require measuring the distance
between the end of the collective locking stud and the locking strip
and repairing the locking stud if the clearance is insufficient. The
proposed requirements were intended to prevent the collective from
becoming inadvertently locked in the low position and subsequent loss
of control of the helicopter.
    The NPRM was prompted by AD No. 2009-0019, dated February 3, 2009,
issued by the European Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Union, to correct
an unsafe condition for the Eurocopter Model AS350 helicopters. EASA
advises that the clearance between the collective locking stud and the
locking strip may be insufficient when the collective is positioned in
the low pitch stop. During an autorotation test flight, the collective
rubbed against the locking strip in the low pitch position. The rubbing
was due to inadequate clearance and could result in the collective
being inadvertently locked in the low pitch position.

Comments

    We gave the public the opportunity to participate in developing
this AD, but we did not receive any comments on the NPRM (78 FR 47230,
August 5, 2013).

FAA's Determination

    These helicopters have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, its technical
representative, has notified us of the unsafe condition described in
the EASA AD. We are issuing this AD because we evaluated all
information provided by EASA and determined the unsafe condition exists
and is likely to exist or develop on other helicopters of these same
type designs and that air safety and the public interest require
adopting the AD requirements as proposed.

Differences Between This AD and the EASA AD

    The EASA AD does not apply to Model AS350C or AS350D1 helicopters,
and this AD applies to these models because they have a similarly-
designed collective pitch lock. The EASA AD applies to the Model
AS350BB, and this AD does not because that model does not have a U.S.
type certificate. This AD requires an initial inspection within 100
hours time-in-service, while the EASA AD requires this inspection
``after the last flight of the day.''

Related Service Information

    Eurocopter issued Service Bulletin No. 67.00.37, Revision 2, dated
December 2, 2008, originally issued on September 27, 2007, and also
identified as modification (MOD) 073237, which contains procedures for
replacing the locking stud on the collective levers with a new locking
stud with higher wear resistance. The new locking stud is longer than
the previous one and has reduced the distance between the locking stud
and the locking strip. In some cases, the reduced distance is
insufficient when the collective is positioned in the low pitch
position causing the collective to lock in that position. As a result,
Eurocopter has issued one Emergency Alert Service Bulletin (EASB),
Revision 0, dated January 12, 2008, with two numbers. EASB No. 05.00.58
is for civil Model AS350B, BA, BB, B1, B2, B3, and D helicopters and
military Model AS350L1 helicopters. EASB No. 05.00.35 is for military
Model AS550A2, C2, C3, and U2 helicopters. The EASB specifies measuring
to ensure a required minimum distance between the locking stud and the
locking strip and specifies a repair solution in case the distance is
insufficient. As a precaution, Eurocopter extended the measure and
repair to helicopters with locking studs before MOD 073237. Eurocopter
also revised Service Bulletin No. 67.00.37 to include these procedures.

Costs of Compliance

    We estimate that this AD will affect 651 helicopters of U.S.
Registry. We estimate that operators may incur the following costs to
comply with this AD. We estimate 1 work hour to measure the clearance
and repair the locking stud and locking strip at $85 per work hour.
Required parts will cost $95 per helicopter. Based on these estimates,
the total cost per helicopter will be $180, and the total cost for the
fleet will be $117,180.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority

because it addresses an unsafe condition that is likely to exist or
develop on helicopters identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (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);
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction; and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2014-02-05 Eurocopter France Helicopters: Amendment 39-17733; Docket
No. FAA-2013-0679; Directorate Identifier 2009-SW-015-AD.

(a) Applicability

    This AD applies to Eurocopter Model AS350B, AS350BA, AS350B1,
AS350B2, AS350B3, AS350C, AS350D, and AS350D1 helicopters,
certificated in any category, without modification (MOD) 073175
installed; with MOD 073237 installed in accordance with Eurocopter
Service Bulletin No. 67.00.37, Revision 0, dated September 27, 2007,
or Revision 1, dated February 6, 2008; or with one of the following
serial numbers: 3972, 3973, 3982, 3987, 4003, 4023, 4046, 4050,
4086, 4120, 4122, 4132, 4143, 4152, 4172, 4194, 4259, 4314, 4324,
4378, 4392, 4447, 4452, 4477, 4489, 4490, 4501, 4523, 4546, 4560,
4589, 4594, 4599, 4632, 4659, 4666, or 4671.

(b) Unsafe Condition

    This AD defines the unsafe condition as the main rotor
collective pitch lever (collective) locking stud (locking stud)
inadvertently locking in the low pitch (low) position, which could
result in subsequent loss of control of the helicopter.

(c) Effective Date

    This AD becomes effective March 7, 2014.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    (1) For helicopters with MOD 073237 installed, within 100 hours
time-in-service (TIS):
    (i) With the collective (item b) in the low position but not
locked on the locking strip (item a), measure the distance between
the end of the locking stud (item c) and the locking strip as
indicated by dimension ``J'' in Figure 2 of Eurocopter Emergency
Alert Service Bulletin No. 05.00.58, Revision 0, dated January 12,
2008 (EASB 05.00.58).
    (ii) If the distance between the end of the locking stud and the
locking strip is equal to or more than 3 millimeters (mm), no
further action is required.
    (iii) If the distance between the end of the locking stud and
the locking strip is less than 3 mm and MOD 073175 is not installed,
inspect to determine whether the grommet in the locking strip is
seated against the console as shown in Figure 2 of EASB 05.00.58.
    (A) If the grommet is not seated against the console, restore
the original profile of the locking strip by doing the following:
    (1) Clamp the locking strip in a vice with soft jaws and apply
load progressively to the locking strip to restore the original
profile of the locking strip.
    (2) With the collective in the low position but not locked on
the locking strip, measure the distance between the end of the
locking stud and the locking strip as indicated by dimension ``J''
in Figure 2 of EASB 05.00.58.
    (3) If the distance between the end of the locking stud and the
locking strip is equal to or more than 3 mm, no further action is
required.
    (4) If the distance between the end of the locking stud and the
locking strip is less than 3 mm, adjust the length of the locking
stud and re-identify the locking stud by following the
Accomplishment Instructions, paragraph 2.B.2.c., of EASB 05.00.58,
except you are not required to comply with paragraph 2.B.4 of EASB
05.00.58.
    (B) If the grommet is seated against the console, adjust the
length of the locking stud and re-identify the locking stud by
following the Accomplishment Instructions, paragraph 2.B.2.c, of
EASB 05.00.58, except you are not required to comply with paragraph
2.B.4 of EASB 05.00.58.
    (iv) If the distance between the end of the locking stud and the
locking strip is less than 3 mm and MOD 073175 is installed, adjust
the length of the locking stud and re-identify the locking stud by
following the Accomplishment Instructions, paragraph 2.B.2.c., of
EASB 05.00.58, except you are not required to comply with paragraph
2.B.4 of EASB 05.00.58.
    (v) After adjusting the length of the locking stud in accordance
with paragraph 2.B.2.c of the EASB, determine whether the distance
between the end of the locking stud and the locking strip is equal
to or more than 3 mm.
    (A) If the distance between the end of the locking stud and the
locking strip is equal to or more than 3 mm, no further action is
required.
    (B) If the distance between the end of the locking stud and the
locking strip is less than 3 mm, do not approve the helicopter for
return to service until the distance between the end of the locking
stud and the locking strip is equal to or more than 3 mm.
    (2) For helicopters without MOD 073237 installed, within 100
hours TIS:
    (i) With the collective in the low position but not locked on
the locking strip, measure the distance between the end of the
locking stud and the locking strip as indicated by dimension ``J' in
Figure 2 of EASB 05.00.58.
    (ii) If the distance between the end of the locking stud and the
locking strip is equal to or more than 3 mm, no further action is
needed.
    (iii) If the distance between the end of the locking stud and
the locking strip is less than 3 mm and MOD 073175 is not installed,
inspect to determine whether the grommet in the locking strip is
seated against the console as shown in Figure 2 of EASB 05.00.58.
    (A) If the grommet is not seated against the console, restore
the original profile of the locking strip by doing the following:
    (1) Clamp the locking strip in a vice with soft jaws and apply
load progressively to the locking strip.
    (2) With the collective in the low position but not locked on
the locking strip, measure the distance between the end of the
locking stud and the locking strip as indicated by dimension ``J''
in Figure 2 of the EASB 05.00.58.
    (3) If the distance between the end of the locking stud and the
locking strip is equal to or more than 3 mm, no further action is
required.
    (4) If the distance between the end of the locking stud and the
locking strip is less than 3 mm, do not approve the helicopter for
return to service until the distance between the end of the locking
stud and the locking strip is equal to or more than 3 mm.
    (B) If the grommet is seated against the console, do not approve
the helicopter for return to service until the distance between the
end of the locking stud and the locking strip is equal to or more
than 3 mm.
    (iv) If the distance between the end of the locking stud and the
locking strip is less than 3 mm and MOD 073175 is installed, do not
approve the helicopter for return to service until the distance
between the end of the locking stud and the locking strip is equal
to or more than 3 mm.

    (3) Repeat the measurement requirement in paragraphs (e)(1) or
(e)(2) of this AD as applicable to your helicopter each time the
collective, locking stud, or locking strip is replaced; each time
the locking strip setting is readjusted; or at intervals not
exceeding 660 hours TIS or 2 years, whichever occurs first.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Robert Grant, Aviation Safety
Engineer, Safety Management Group, FAA, 2601 Meacham Blvd., Fort
Worth, Texas 76137; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (2) For operations conducted under 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    (1) Eurocopter Service Bulletin (SB) No. 67.00.21, Revision 1,
dated June 21, 2006, and SB No. 67.00.37, Revision 2, dated December
2, 2008, which are not incorporated by reference, contain additional
information about the subject of this AD. For service information
identified in this AD, contact American Eurocopter Corporation, 2701
N. Forum Drive, Grand Prairie, TX 75052; telephone<PHONE_NUMBER> or
(800) 232-0323; fax<PHONE_NUMBER>; or at http://www.eurocopter.com/techpub. You may review the referenced service information at the
FAA, Office of the Regional Counsel, Southwest Region, 2601 Meacham
Blvd., Room 663, Fort Worth, Texas 76137.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency (EASA) AD No. 2009-0019, dated February 3, 2009. You
may view the EASA AD on the Internet at http://www.regulations.gov
in Docket No. FAA-2013-0679.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6710 Main Rotor
Control.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Eurocopter Emergency Alert Service Bulletin No. 05.00.58,
Revision 0, dated January 12, 2008.
    (ii) Reserved.

    Note 1 to paragraph (i)(2):  Eurocopter Emergency Alert Service
Bulletin (EASB) No. 05.00.58, Revision 0, dated January 12, 2008, is
co-published in one document with Eurocopter EASB No. 05.00.35,
Revision 0, dated January 12, 2008, which is not incorporated by
reference in this AD.

    (3) For Eurocopter service information identified in this AD,
contact American Eurocopter Corporation, 2701 N. Forum Drive, Grand
Prairie, TX 75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax
(972) 641-3775.
    (4) You may view this service information at FAA, Office of the
Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663,
Fort Worth, Texas 76137. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Fort Worth, Texas, on January 16, 2014.
Lance T. Gant,
Acting Directorate Manager, Rotorcraft Directorate, Aircraft
Certification Service.
[FR Doc. 2014-01467 Filed 1-30-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Pages 10515-10517]
[FR Doc No: 2023-03515]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0343]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice for Blood and
Blood Components and Reducing the Risk of Transfusion-Transmitted
Infections

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with current good manufacturing practice (CGMP) for blood
and blood components, including information collection recommendations
found in Agency guidance related to reducing the risk of transfusion-
transmitted infection (TTI).

DATES: Either electronic or written comments on the collection of
information must be submitted by April 24, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 24, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-N-0343 for ``Current Good Manufacturing Practice for Blood and
Blood Components and Reducing the Risk of Transfusion-Transmitted
Infections.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

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

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal

Agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information including each proposed
extension of an existing collection of information, before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Current Good Manufacturing Practice for Blood and Blood Components and
Reducing the Risk of Transfusion-Transmitted Infections

OMB Control Number 0910-0116--Revision

    The FDA's Center for Biologics Evaluation and Research (CBER) is
responsible for regulatory oversight of the U.S. blood supply. FDA
issues and enforces requirements for blood collection and for the
manufacturing of blood products, including both blood components
intended for transfusion or for further manufacturing use. To implement
applicable statutory provisions, regulations have been codified at 21
CFR part 606--Current Good Manufacturing Practice for Blood and Blood
Components; 21 CFR part 610--General Biological Products Standards; 21
CFR part 630--Requirements for Blood and Blood Components Intended For
Transfusion or For Further Manufacturing Use; and 21 CFR part 640--
Additional Standards for Human Blood and Blood Products. The
regulations establish quality standard requirements applicable to blood
and blood products including information collection provisions.
    CBER works closely with other parts of the Department of Health and
Human Services to identify and respond to potential threats to blood
safety and to monitor the availability of the blood supply. FDA has
progressively strengthened the overlapping safeguards that help to
ensure donor health and the safety of the blood supply for recipients
of blood and blood products. For example:
     Blood donors answer donor history questions to identify
risk factors that could indicate possible infection with a relevant-
transfusion transmitted infection.
     FDA requires blood establishments to maintain a record of
deferred donors to prevent collections ineligible donors.
     Blood donations are tested for several relevant
transfusion-transmitted infections, include HIV, hepatitis B virus, and
hepatitis C virus.
    FDA also inspects blood establishments and monitors reports of
errors, accidents, and adverse events associated with blood donation or
transfusion.
    Description of Respondents: Respondents to the collection of
information are establishments that collect blood and blood components
intended for transfusion or further manufacturing use.
    For operational efficiency, we are revising the information
collection to account for burden that may be attributable to
recommendations found in associated FDA guidance documents, as listed
below. FDA regulations in Sec.  630.3(h) (21 CFR 630.3(h)) set forth a
list of relevant transfusion-transmitted infections (RTTIs) (Sec.
630.3(h)(1)) and the conditions under which a TTI would meet the
definition of an RTTI (Sec.  630.3(h)(2)). We have developed the
following guidance documents, consistent with our Good Guidance
Practice regulations in 21 CFR 10.115, that provide for comment at any
time. The guidance documents include recommendations specific to
certain RTTI or TTI regarding the collection of blood and blood
components and discuss corresponding recordkeeping and/or notification
activities.
Guidances Recommending Notification Based on Reactive Test Results
    The following guidance documents provide recommendations for
consignee and physician notification relating to donations that test
reactive for RTTIs:
     Guidance for Industry: Use of Nucleic Acid Tests to Reduce
the Risk of Transmission of West Nile Virus from Donors of Whole Blood
and Blood Components Intended for Transfusion (November 2009);
     Use of Serological Tests to Reduce the Risk of
Transmission of Trypanosoma cruzi Infection in Blood and Blood
Components; Guidance for Industry (December 2017);
     Recommendations for Reducing the Risk of Transfusion-
Transmitted Babesiosis; Guidance for Industry (May 2019); and
     Use of Serological Tests to Reduce the Risk of
Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II
(HTLV-I/II); Guidance for Industry (February 2020).
Guidances Recommending Notification Based on Post Donation Information
Regarding a Risk Factor
    The following guidance documents provide recommendations for
consignee and physician notification under circumstances where a blood
establishment may receive information following collection that reveals
the donor had a risk factor for a RTTI or TTI at the time of collection
and should have been deferred for the risk factor:
     Recommendations for Assessment of Blood Donor Eligibility,
Donor Deferral and Blood Product Management in Response to Ebola Virus;
Guidance for Industry (January 2017);
     Revised Recommendations for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products--
Guidance for Industry (August 2020);
     Recommendations to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob
Disease by Blood and Blood Components; Guidance for Industry (May
2022); and
     Recommendations to Reduce the Risk of Transfusion-
Transmitted Malaria; Guidance for Industry (December 2022).
    These guidance documents are available for download from our
website at https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/blood-guidances.
    We believe such notifications are rare and that these notification
practices would be part of the usual and customary business practice
for blood establishments and consignees in addressing the RTTIs or TTIs
under the regulations. We also believe respondents would have already
developed standard operating procedures for notifying consignees and
the recipient's physician of record regarding distributed blood
components potentially at risk for a RTTI or TTI. However, to account
for burden among respondents that may be attributable to this activity
we allot one response and 1 hour annually. As additional guidance is
developed by FDA addressing other RTTIs under Sec.  630.3(h)(2), we
will modify the information collection accordingly.

    Dated: February 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03515 Filed 2-17-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 94 (Wednesday, May 15, 2019)]
[Notices]
[Pages 21770-21771]
[FR Doc No: 2019-10043]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1855-000]

Great River Hydro, LLC; Notice of Authorization for Continued
Project Operation

    On October 31, 2012 Great River Hydro, LLC, licensee for the
Bellows Falls Hydroelectric Project, filed an Application for a New
License pursuant to the Federal Power Act (FPA) and the Commission's
regulations thereunder. The Bellows Falls Hydroelectric Project is
located on the Connecticut River in Windham County, VT and Cheshire
County, NH.
    The license for Project No. 1855 was issued for a period ending
April 30, 2019. Section 15(a) (1) of the FPA, 16 U.S.C. 808(a) (1),
requires the Commission, at the expiration of a license term, to issue
from year-to-year an annual license to the then licensee under the
terms and conditions of the prior license until a new license is
issued, or the project is otherwise disposed of as provided in section
15 or any other applicable section of the FPA. If the project's prior
license waived the applicability of section 15 of the FPA, then, based
on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c),
and as set forth at 18 CFR 16.21(a), if the licensee of such project
has filed an application for a subsequent license, the licensee may
continue to operate the project in accordance with the terms and
conditions of the license after the minor or minor part license
expires, until the Commission acts on its application. If the licensee
of such a project has not filed an application for a subsequent
license, then it may be required, pursuant to 18 CFR 16.21(b), to
continue project operations until the

Commission issues someone else a license for the project or otherwise
orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 1855 is issued to
the licensee for a period effective May1, 2019 through April 30, 2020,
or until the issuance of a new license for the project or other
disposition under the FPA, whichever comes first. If issuance of a new
license (or other disposition) does not take place on or before April
30, 2020, notice is hereby given that, pursuant to 18 CFR 16.18(c), an
annual license under section 15(a)(1) of the FPA is renewed
automatically without further order or notice by the Commission, unless
the Commission orders otherwise.
    If the project is not subject to section 15 of the FPA, notice is
hereby given that the licensee, Great River Hydro, LLC, is authorized
to continue operation of the Bellows Falls Hydroelectric Project until
such time as the Commission acts on its application for a subsequent
license.

    Dated: May 9, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-10043 Filed 5-14-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 248 (Thursday, December 30, 2021)]
[Notices]
[Page 74412]
[FR Doc No: 2021-28344]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9060-1]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS)
Filed December 17, 2021 10 a.m. EST Through December 23, 2021 10 a.m.
EST
Pursuant to 40 CFR 1506.9

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

Amended Notice

EIS No. 20210140, Draft, BLM, UT, WITHDRAWN--Pine Valley Water Supply
Project, Contact: Brooklynn Cox<PHONE_NUMBER>.

    Revision to FR Notice Published 09/20/2021; Officially Withdrawn
per request of the submitting agency.

    Dated: December 23, 2021.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2021-28344 Filed 12-29-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 97 (Friday, May 19, 2023)]
[Rules and Regulations]
[Pages 32120-32125]
[FR Doc No: 2023-10657]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2022-0957; FRL-10543-02-R9]

Partial Approval, Conditional Approval, and Partial Disapproval
of Air Quality State Implementation Plans; Nevada; Infrastructure
Requirements for Ozone

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving in
part, conditionally approving in part, and disapproving in part a state
implementation plan (SIP) revision submitted by the State of Nevada
pursuant to the requirements of the Clean Air Act (CAA or ``Act'') for
the implementation, maintenance, and enforcement of the 2015 national
ambient air quality standards (NAAQS) for ozone. As part of this
action, we are reclassifying a region of the State for emergency
episode planning purposes with respect to ozone. Finally, we are
approving a regulatory revision into the Nevada SIP.

DATES: This rule is effective June 20, 2023.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R09-OAR-2022-0957. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available through https://www.regulations.gov, or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional availability information. If you need assistance
in a language other than English or if you are a person with
disabilities who needs a reasonable accommodation at no cost to you,
please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section.

FOR FURTHER INFORMATION CONTACT: Nicole Law, Planning Section (AIR-2-
1), U.S. Environmental Protection Agency, Region IX,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' refer to the EPA.

Table of Contents

I. Background
II. Public Comments and EPA Responses
III. Final Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Background

A. Statutory Requirements

    Section 110(a)(1) of the CAA requires each state to submit to the
EPA, within three years after the promulgation of a primary or
secondary NAAQS or any revision thereof, a SIP revision that provides
for the implementation, maintenance, and enforcement of such NAAQS.
    Section 110(a)(2) of the CAA contains the infrastructure SIP
requirements, which generally relate to the information, authorities,
compliance assurances, procedural requirements, and control measures
that constitute the

``infrastructure'' of a state's air quality management program. These
infrastructure SIP requirements (or ``elements'') required by section
110(a)(2) are as follows:
     Section 110(a)(2)(A): Emission limits and other control
measures.
     Section 110(a)(2)(B): Ambient air quality monitoring/data
system.
     Section 110(a)(2)(C): Program for enforcement of control
measures and regulation of new and modified stationary sources.
     Section 110(a)(2)(D)(i): Interstate pollution transport.
     Section 110(a)(2)(D)(ii): Interstate pollution abatement
and international air pollution.
     Section 110(a)(2)(E): Adequate resources and authority,
conflict of interest, and oversight of local and regional government
agencies.
     Section 110(a)(2)(F): Stationary source monitoring and
reporting.
     Section 110(a)(2)(G): Emergency episodes.
     Section 110(a)(2)(H): SIP revisions.
     Section 110(a)(2)(J): Consultation with government
officials, public notification, prevention of significant deterioration
(PSD), and visibility protection.
     Section 110(a)(2)(K): Air quality modeling and submittal
of modeling data.
     Section 110(a)(2)(L): Permitting fees.
     Section 110(a)(2)(M): Consultation/participation by
affected local entities.
    Two elements identified in section 110(a)(2) are not governed by
the three-year submittal deadline of section 110(a)(1) and are
therefore not addressed in this action. These two elements are: (i)
section 110(a)(2)(C), to the extent it refers to permit programs
required under part D (nonattainment new source review (NSR)), and (ii)
section 110(a)(2)(I), pertaining to the nonattainment planning
requirements of part D. As a result, this action does not address
requirements for the nonattainment NSR portion of section 110(a)(2)(C)
or the whole of section 110(a)(2)(I).

B. NAAQS Addressed by This Final Rule

    On October 26, 2015, the EPA promulgated a revised NAAQS for ozone
(``the 2015 ozone NAAQS''), triggering a requirement for states to
submit infrastructure SIPs within three years of promulgation of the
revised NAAQS. The 2015 ozone NAAQS revised the 2008 8-hour ozone NAAQS
by lowering the primary and secondary 8-hour ozone standards from 75
parts per billion (ppb) to 70 ppb.\1\
---------------------------------------------------------------------------

    \1\ 80 FR 65292 (October 26, 2015).
---------------------------------------------------------------------------

    The Nevada Department of Environmental Protection (NDEP) made a
submittal addressing the infrastructure SIP requirements for the 2015
ozone NAAQS on September 28, 2018 (``Nevada's Infrastructure SIP
Submittal'').\2\ It included separate sections for Clark County \3\ and
Washoe County.\4\ We refer to each individual section as that agency's
or County's portion of the submittal. In accordance with CAA section
110(k)(1)(B), the infrastructure SIP became complete by operation of
law on March 28, 2019.
---------------------------------------------------------------------------

    \2\ Although NDEP submitted Nevada's Infrastructure SIP
Submittal electronically on September 28, 2018, the submittal letter
is dated October 1, 2018, from Greg Lovato, Administrator, Nevada
Division of Environmental Protection, to Mike Stoker, Regional
Administrator, U.S. EPA Region IX, RE: ``The Nevada State
Implementation Plan for the 2015 Primary and Secondary Ozone
NAAQS.''
    \3\ Letter dated September 12, 2018, from Marci Henson,
Director, Clark County Department of Air Quality, to Greg Lovato,
Administrator, Nevada Division of Environmental Protection, RE:
``Clark County Portion of the Nevada Infrastructure State
Implementation Plan for the 2015 Ozone NAAQS.''
    \4\ Letter dated August 28, 2018, from Charlene Albee, Director,
Washoe County Health District Air Quality Management Division, to
Greg Lovato, Administrator, Nevada Division of Environmental
Protection, Subject: ``2015 Ozone National Ambient Air Quality
Standard Infrastructure State Implementation Plan (SIP).''
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C. EPA's Proposal

1. Approvals and Partial Approvals
(a) Infrastructure SIP Requirements
    On January 11, 2023, we proposed to approve and partially approve
Nevada's Infrastructure SIP Submittal for the requirements of the
following sections of the CAA: 5 6
---------------------------------------------------------------------------

    \5\ 88 FR 1537 (January 11, 2023).
    \6\ All approvals are full approvals for NDEP, Clark County, and
Washoe County except where noted otherwise.
---------------------------------------------------------------------------

     110(a)(2)(A): Emission limits and other control measures.
     110(a)(2)(B): Ambient air quality monitoring/data system.
     110(a)(2)(C) (in part): Program for enforcement of control
measures (full approval), and regulation of new stationary sources
(approval for Clark County only) and minor sources (full approval).
     110(a)(2)(D) (in part, see below): Interstate Pollution
Transport.
    [cir] 110(a)(2)(D)(i)(II) (in part)--interference with PSD (prong
3) (approval for Clark County only).
    [cir] 110(a)(2)(D)(ii) (in part)--interstate pollution abatement
(approval for Clark County only) and international air pollution (full
approval).
     110(a)(2)(E): Adequate resources and authority, conflict
of interest, and oversight of local governments and regional agencies.
     110(a)(2)(F): Stationary source monitoring and reporting.
     110(a)(2)(G): Emergency episodes.
     110(a)(2)(H): SIP revisions.
     110(a)(2)(J) (in part): Consultation with government
officials, public notification (conditional approval for NDEP and
Washoe County, full approval for Clark County), and PSD and visibility
protection (full approval for Clark County only).
     110(a)(2)(K): Air quality modeling and submission of
modeling data.
     110(a)(2)(L): Permitting fees.
     110(a)(2)(M): Consultation/participation by affected local
entities.
(b) Proposed Approval of a State Provision Into the Nevada SIP
    As part of our proposed action on Nevada's Infrastructure SIP
Submittal, we proposed to approve a state regulation into the Nevada
SIP. Specifically, we proposed to approve into the SIP a new version of
Nevada Administrative Code (NAC) 445B.22097, which revises the 8-hour
ozone standard in the Nevada standards table from 0.075 to 0.070 parts
per million (ppm) to be consistent with the 2015 ozone NAAQS and
deletes the ``National Standards'' and ``Method'' columns because both
are for reference only and are often out-of-date compared to the
referenced federal regulations.
2. Conditional Approvals
    The EPA proposed to conditionally approve portions of the NDEP and
Washoe County Infrastructure SIP Submittals addressing the public
notification requirements of CAA section 110(a)(2)(J) for the 2015
ozone NAAQS based on commitments from NDEP and Washoe County to adopt
and submit specific enforceable measures to address the deficiencies
identified in our proposed rulemaking.\7\
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    \7\ Letter dated September 9, 2022, from Greg Lovato,
Administrator, Nevada Division of Environmental Protection, to
Martha Guzman, Regional Administrator, U.S. EPA Region IX, Re:
``Request for Conditional Approval of Nevada's Infrastructure State
Implementation Plan for the 2012 PM2.5 and 2015 Ozone
National Ambient Air Quality Standards.'' and Letter dated September
2, 2022, from Greg Lovato, Administrator, Nevada Division of
Environmental Protection to Martha Guzman, Regional Admin, Re:
Nevada's Infrastructure State Implementation Plan for the 2012
PM2.5 National Ambient Air Quality Standard dated
September 9, 2022 that enclosed the letter from Francisco Vega,
Director, Air Quality Management Division, Washoe County Health
Division to Greg Lovato, Administrator, Nevada Division of
Environmental Protection and Martha Guzman, EPA, Re: ``Request for
Conditional Approval of Nevada's Infrastructure State Implementation
Plan for the 2012 PM2.5 and 2015 Ozone National Ambient
Air Quality Standards.''

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3. Partial Disapprovals
    The EPA proposed to partially disapprove Nevada's Infrastructure
SIP Submittal with respect to the following infrastructure SIP
requirements:
     110(a)(2)(C) (in part): Regulation of new and modified
stationary sources (disapproval for NDEP and Washoe County).
     110(a)(2)(D)(i)(II) (in part): interference with PSD
(prong 3) (disapproval for NDEP and Washoe County).
     110(a)(2)(D)(ii) (in part): interstate pollution abatement
(disapproval for NDEP and Washoe County).
     110(a)(2)(J) (in part): PSD (disapproval for NDEP and
Washoe County).
    Although the NDEP and Washoe County portions of the SIP remain
deficient with respect to PSD requirements, the EPA noted that the
proposed disapproval, if finalized, would have no Federal
Implementation Plan (FIP) consequences, as both agencies already
implement the Federal PSD program at 40 CFR 52.21 for all regulated NSR
pollutants, pursuant to delegation agreements with the EPA.
4. Reclassification
    We proposed to retain the Priority I classification for the Las
Vegas Intrastate Air Quality Control Regions (AQCR) and Priority III
classification for the Nevada Intrastate AQCR. We proposed to
reclassify the Northwest Nevada Intrastate AQCR from Priority III to
Priority I for ozone. Priority I regions are required to have SIP-
approved emergency episode plans, which are also called ``contingency
plans.''
5. Deferred Action
    The EPA did not propose action on the interstate transport
visibility requirements of 110(a)(2)(D)(i)(II), which is also called
Prong 4 of the interstate transport requirements. On August 12, 2022,
NDEP withdrew the Prong 4 element in the Nevada's Infrastructure SIP
Submittal and submitted a revised Prong 4 element with the State's
Regional Haze Plan for the 2nd Planning Period.\8\ The EPA intends to
act on the revised Prong 4 element when we act on Nevada's Regional
Haze Plan for the 2nd Planning Period and is therefore not acting on
the requirement as part of this action.
---------------------------------------------------------------------------

    \8\ See letter dated August 12, 2022, from Greg Lovato,
Administrator, Nevada Department of Environmental Protection, to
Martha Guzman, Regional Administrator, EPA Region IX, Subject: ``The
Nevada State Implementation Plan for the Regional Haze Rule for the
Second Planning Period; Withdrawal and Replacement of Elements of
the 2012 PM2.5 NAAQS and 2015 Ozone NAAQS Infrastructure
SIPs.''
---------------------------------------------------------------------------

    Additionally, the EPA did not propose action on the following CAA
requirements because they are addressed in separate rulemakings: \9\
---------------------------------------------------------------------------

    \9\ 88 FR 9336 (February 13, 2023).
---------------------------------------------------------------------------

     110(a)(2)(D) (in part, see below): Interstate Pollution
Transport.
    [cir] 110(a)(2)(D)(i)(I)--significant contribution to a
nonattainment area (prong 1).
    [cir] 110(a)(2)(D)(i)(I)--significant contribution to a maintenance
area (prong 2).

II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period
that ended on February 10, 2023. During this period, the EPA received
one anonymous comment. The full text of the comment is available in the
docket for this rulemaking.
    The comment recommended that the federal government take immediate
action to clean the air and suggested that the state of Utah has failed
to clean the air in valley areas like Salt Lake and the Uinta Basin.
Additionally, the comment states there is a water crisis and the
federal government needs to take leadership. After reviewing the
comment, the EPA has determined that the comment fails to raise issues
germane to our proposed finding that the State of Nevada largely meets
the infrastructure SIP requirements of section 110(a)(2) of the Act,
which only evaluated the State's ability to implement, maintain, and
enforce the 2015 Ozone NAAQS. Therefore, we have determined that this
comment does not necessitate a response, and the EPA will not provide a
specific response to the comment in this document.

III. Final Action

A. Partial Approvals, Conditional Approvals, and Partial Disapprovals

    Under CAA section 110(a), we are partially approving and partially
disapproving Nevada's Infrastructure SIP submittal for the 2015 Ozone
NAAQS. Specifically, we are fully approving the submittal for the
requirements of CAA sections:
     110(a)(2)(A): Emission limits and other control measures.
     110(a)(2)(B): Ambient air quality monitoring/data system.
     110(a)(2)(C) (in part): Program for enforcement of control
measures (full approval), and regulation of new stationary sources
(approval for Clark County only) and minor sources (full approval).
     110(a)(2)(D) (in part, see below): Interstate Pollution
Transport.
    [cir] 110(a)(2)(D)(i)(II) (in part)--interference with PSD (prong
3) (approval for Clark County only).
    [cir] 110(a)(2)(D)(ii) (in part)--interstate pollution abatement
(approval for Clark County only) and international air pollution (full
approval).
     110(a)(2)(E): Adequate resources and authority, conflict
of interest, and oversight of local governments and regional agencies.
     110(a)(2)(F): Stationary source monitoring and reporting.
     110(a)(2)(G): Emergency episodes.
     110(a)(2)(H): SIP revisions.
     110(a)(2)(J) (in part): Consultation with government
officials, public notification (conditional approval for NDEP and
Washoe County, full approval for Clark County), and PSD and visibility
protection (full approval for Clark County only).
     110(a)(2)(K): Air quality modeling and submission of
modeling data.
     110(a)(2)(L): Permitting fees.
     110(a)(2)(M): Consultation/participation by affected local
entities.
    The EPA is taking final action to conditionally approve the NDEP
and Washoe County portions of Nevada's Infrastructure SIP Submittal
addressing the public notification requirements of CAA section
110(a)(2)(J) for the 2015 Ozone NAAQS.
    We are taking final action to disapprove Nevada's Infrastructure
SIP Submittal with respect to the following infrastructure SIP
requirements:
     110(a)(2)(C) (in part): Regulation of new and modified
stationary sources (disapproval for NDEP and Washoe County).
     110(a)(2)(D)(i)(II) (in part): interference with PSD
(prong 3) (disapproval for NDEP and Washoe County).
     110(a)(2)(D)(ii) (in part): interstate pollution abatement
(disapproval for NDEP and Washoe County).
     110(a)(2)(J) (in part): PSD (disapproval for NDEP and
Washoe County).
    Although the NDEP and Washoe County portions of the SIP remain
deficient with respect to PSD requirements, this final disapproval
action has no FIP consequences, as both agencies implement the Federal
PSD program at 40 CFR 52.21 for all regulated NSR pollutants, pursuant
to delegation agreements with the EPA.

B. Approval of an Updated Nevada State-Wide Provision

    In this final action, the EPA is also approving into the Nevada SIP
revisions

to the Nevada Administrative Code (NAC). The EPA is approving a new
version of NAC 445B.22097, which revises the 8-hour ozone standard in
the Nevada standards table from 0.075 to 0.070 parts per million (ppm)
to be consistent with the 2015 ozone NAAQS. The updated provisions
strengthen the SIP or clarify certain terms in the SIP, as discussed in
our proposed rulemaking, and meet the requirements of CAA sections
110(a)(2), 110(l), and 193. Therefore, the EPA is approving the
submitted revised rule into the Nevada SIP as proposed.

C. Reclassification and Exemption of AQCRs for Emergency Episode
Planning

    This final rule retains the classification of the Las Vegas
Intrastate AQCRs as Priority I and the classification of the Nevada
Intrastate AQCR as Priority III for emergency episodes. This rule
reclassifies the Northwest Nevada Intrastate AQCR to Priority I.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference as described in Section III.B. and set forth
below in the amendments to 40 CFR part 52. The EPA has made, and will
continue to make, these documents available through https://www.regulations.gov and at the EPA Region IX Office (please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information).

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review, Executive
Order 13563: Improving Regulation and Regulatory Review, and Executive
Order 14094: Modernizing Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA because this action does not impose additional requirements
beyond those imposed by state law.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities beyond those
imposed by state law.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action does not impose additional requirements
beyond those imposed by state law. Accordingly, no additional costs to
State, local, or tribal governments, or to the private sector, will
result from this action.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the National Government and the states, or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175: Coordination With Indian Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175, because the SIP is not approved to apply on any
Indian reservation land or in any other area where the EPA or an Indian
tribe has demonstrated that a tribe has jurisdiction and will not
impose substantial direct costs on tribal governments or preempt tribal
law. Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive order. This action is not subject to
Executive Order 13045 because it does not impose additional
requirements beyond those imposed by state law.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of the NTTAA directs the EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or otherwise impractical. The EPA
believes that this action is not subject to the requirements of section
12(d) of the NTTAA because application of those requirements would be
inconsistent with the CAA.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations, 59 FR 7629,
Feb. 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.''
    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to review state choices,
and approve those choices if they meet the minimum criteria of the Act.
Accordingly, this final action is approving in part, conditionally
approving in part, and disapproving in part a state implementation plan
as meeting federal requirements and does not impose additional
requirements beyond those imposed by state law.
    The State 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.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

L. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by July 18, 2023. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Administrative practice and procedure,
Air pollution control, Incorporation by reference, Intergovernmental
relations, Reporting and recordkeeping requirements.

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

    Dated: May 15, 2023.
Martha Guzman Aceves,
Regional Administrator, Region IX.

    Chapter I, title 40 of the Code of Federal Regulations is amended
as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart DD--Nevada

0
2. Amend Sec.  52.1470 as follows:
0
a. In paragraph (c), amend table 1 by:
0
i. Under the table heading ``Nevada Administrative Code, Chapter 445B,
Air Controls, Air Pollution; Nevada Administrative Code, Chapter 445,
Air Controls, Air Pollution; Nevada Air Quality Regulations--General
Provisions'', revise the entry for ``445B.22097''.
0
b. In paragraph (e), in the table under the heading ``AIR QUALITY
IMPLEMENTATION PLAN FOR THE STATE OF NEVADA'', add the entries ``The
Nevada Division of Environmental Protection Portion of the Nevada State
Implementation Plan for the 2015 Ozone NAAQS: Demonstration of
Adequacy, excluding the cover letter; the part addressing the
requirements of CAA 110(a)(2)(D)(i)(I); and Appendices'', ``The Clark
County Portion of the State Implementation Plan to meet the Ozone
Infrastructure SIP Requirement of Clean Air Act Section 110(a)(2),
excluding the cover letter to NDEP; the part of the submittal
addressing the requirements of CAA 110(a)(2)(D)(i)(I); and Attachment
A'', and ``The Washoe County Portion of the Nevada State Implementation
Plan to Meet the Ozone Infrastructure SIP Requirements of Clean Air Act
Section 110(a)(2), excluding the cover letter to NDEP, the part of the
submittal addressing the requirements of CAA 110(a)(2)(D)(i)(I), and
all Attachments and Appendices.'' after the entry ``The Washoe County
Portion of the Nevada State Implementation Plan to Meet the
PM2.5 Infrastructure SIP Requirements of Clean Air Act
Section 110(a)(2), excluding the cover letter to NDEP and all
Attachments and Appendices''.
    The revisions and additions read as follows:

Sec.  52.1470  Identification of plan.

* * * * *
    (c) * * *

                              Table 1--EPA-Approved Nevada Regulations and Statutes
----------------------------------------------------------------------------------------------------------------
                                                        State effective                           Additional
         State citation              Title/subject           date          EPA approval date      explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
 Nevada Administrative Code, Chapter 445B, Air Controls, Air Pollution; Nevada Administrative Code, Chapter 445,
                 Air Controls, Air Pollution; Nevada Air Quality Regulations--General Provisions

                                                  * * * * * * *
445B.22097......................  Standards of        05/16/2018........  [INSERT Federal     Most recently
                                   quality for                             Register            approved version
                                   ambient air.                            CITATION], 05/19/   was submitted on
                                                                           2023.               12/11/15.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
    (e) * * *

                   EPA-Approved Nevada Nonregulatory Provisions and Quasi-Regulatory Measures
----------------------------------------------------------------------------------------------------------------
                                      Applicable
      Name of SIP provision          geographic or      State submittal    EPA approval date      Additional
                                  nonattainment area         date                                 explanation
----------------------------------------------------------------------------------------------------------------
                           AIR QUALITY IMPLEMENTATION PLAN FOR THE STATE OF NEVADA \1\

                                                  * * * * * * *
The Nevada Division of            State-wide within   9/28/18...........  [INSERT Federal     NDEP
 Environmental Protection          NDEP jurisdiction.                      Register            ``Infrastructure'
 Portion of the Nevada State                                               CITATION], 05/19/   ' SIP for the
 Implementation Plan for the                                               2023.               2015 Ozone NAAQS.
 2015 Ozone NAAQS: Demonstration
 of Adequacy, excluding the
 cover letter; the part
 addressing the requirements of
 CAA 110(a)(2)(D)(i)(I); and
 Appendices.
The Clark County Portion of the   Clark County......  9/28/18...........  [INSERT Federal     Clark County
 State Implementation Plan to                                              Register            ``Infrastructure'
 meet the Ozone Infrastructure                                             CITATION], 05/19/   ' SIP for the
 SIP Requirement of Clean Air                                              2023.               2015 Ozone NAAQS.
 Act Section 110(a)(2),
 excluding the cover letter to
 NDEP; the part of the submittal
 addressing the requirements of
 CAA 110(a)(2)(D)(i)(I); and
 Attachment A.
The Washoe County Portion of the  Washoe County.....  9/28/18...........  [INSERT Federal     Washoe County
 Nevada State Implementation                                               Register            ``Infrastructure'
 Plan to Meet the Ozone                                                    CITATION], 05/19/   ' SIP for the
 Infrastructure SIP Requirements                                           2023.               2015 Ozone NAAQS.
 of Clean Air Act Section
 110(a)(2), excluding the cover
 letter to NDEP the part of the
 submittal addressing the
 requirements of CAA
 110(a)(2)(D)(i)(I), and all
 Attachments and Appendices.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

0
3. Section 52.1472 is amended by revising paragraph (k) to read as
follows:

Sec.  52.1472  Approval status.

* * * * *
    (k) 2015 8-hour ozone NAAQS. The SIP submittal from October 1,
2018, is disapproved for Clean Air Act (CAA) section 110(a)(2)(D)(i)(I)
(prongs 1 and 2) for the NDEP, Clark County, and Washoe County portions
of the Nevada SIP submission. The Nevada state implementation plan
(SIP) submittal on October 1, 2018 is partially disapproved for the
prevention of significant deterioration-related portions of Clean Air
Act (CAA) elements 110(a)(2)(C), (D)(i)(II), (D)(ii), and (J) for the
NDEP and Washoe County portions of the Nevada SIP. CAA element
110(a)(2)(J) for public notification is conditionally approved for NDEP
and Washoe County.
* * * * *
[FR Doc. 2023-10657 Filed 5-18-23; 8:45 am]
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