[Federal Register Volume 87, Number 74 (Monday, April 18, 2022)]
[Proposed Rules]
[Pages 22816-22818]
[FR Doc No: 2022-08219]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0464; Project Identifier MCAI-2021-01290-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Airbus SAS Model A350-941 and -1041 airplanes. This proposed AD
was prompted by a report of inadvertent auto flight system (AFS)
altitude changes on the flight control unit (FCU). This proposed AD
would require revising the existing airplane flight manual (AFM) to
include a procedure on the use of the AFS control panel ALT knob and
replacing any affected FCU with a serviceable FCU, as specified in a
European Union Aviation Safety Agency (EASA), which is proposed for
incorporation by reference. This proposed AD would also prohibit the
installation of affected parts. The FAA is proposing this AD to address
the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by June 2,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material that will be incorporated by reference (IBR) in this
AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find this material on the EASA website at
https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket at https://www.regulations.gov by searching for and locating
Docket No. FAA-2022-0464.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0464; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, the
mandatory continuing airworthiness information (MCAI), any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, Large
Aircraft Section, International Validation Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-0464; Project Identifier
MCAI-2021-01290-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Dan
Rodina, Aerospace Engineer, Large Aircraft Section, International
Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email [email protected]. Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0260, dated November 18, 2021
(EASA AD 2021-0260) (also referred to as the MCAI), to correct an
unsafe condition for all Airbus SAS Model A350-941 and -1041 airplanes.
This proposed AD was prompted by a report of inadvertent AFS altitude
changes on the FCU; an investigation revealed that, depending on the
ring selection, failure of the ALT knob on the FCU could change the
target altitude, by either by 100 or 1,000 feet. The erroneous altitude
shows in the AFS cockpit panel display and in the primary flight
display of the FCU, but the flightcrew might not notice. Further
investigation revealed that the cause was an incorrect manufacturing

process of the ALT knob encoder. The FAA is proposing this AD to
address erroneous target altitude during descent, climb, or go-around,
which could result in an unexpected vertical trajectory deviation and
loss of correct situational awareness that could potentially result in
uncontrolled impact with the ground. See the MCAI for additional
background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0260 describes procedures for revising the existing
AFM to include a procedure on the use of the AFS control panel ALT knob
and replacing any affected FCU having part numbers (P/N) C31006AC01 or
C31006AB01 with a serviceable FCU having P/N C31006AD01. This material
is reasonably available because the interested parties have access to
it through their normal course of business or by the means identified
in the ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with the State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA is issuing this NPRM after determining that
the unsafe condition described previously is likely to exist or develop
in other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in EASA AD 2021-0260 described previously, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
This proposed AD would also prohibit the installation of affected
parts.
    EASA AD 2021-0260 requires operators to ``inform all flight crews''
of revisions to the AFM, and thereafter to ``operate the aeroplane
accordingly.'' However, this proposed AD would not specifically require
those actions as those actions are already required by FAA regulations.
FAA regulations require operators furnish to pilots any changes to the
AFM (for example, 14 CFR 121.137), and to ensure the pilots are
familiar with the AFM (for example, 14 CFR 91.505). As with any other
flightcrew training requirement, training on the updated AFM content is
tracked by the operators and recorded in each pilot's training record,
which is available for the FAA to review. FAA regulations also require
pilots to follow the procedures in the existing AFM including all
updates. 14 CFR 91.9 requires that any person operating a civil
aircraft must comply with the operating limitations specified in the
AFM. Therefore, including a requirement in this proposed AD to operate
the airplane according to the revised AFM would be redundant and
unnecessary.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2021-0260 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2021-0260 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in EASA AD 2021-0260 does not mean that
operators need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2021-
0260. Service information required by EASA AD 2021-0260 for compliance
will be available at https://www.regulations.gov by searching for and
locating Docket No. FAA-2022-0464 after the FAA final rule is
published.

Costs of Compliance

    The FAA estimates that this proposed AD would affect 27 airplanes
of U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
            Labor cost                Parts cost           Cost per product            Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Up to 6 work-hours x $85 per hour          $27,000  Up to $27,510................  Up to $742,770.
 = $510.
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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.
    The FAA is 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 products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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:

Airbus SAS: Docket No. FAA-2022-0464; Project Identifier MCAI-2021-
01290-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by June 2, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus SAS Model A350-941 and -1041
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 22, Auto Flight.

(e) Unsafe Condition

    This AD was prompted by a report of inadvertent auto flight
system (AFS) altitude changes on the flight control unit (FCU); an
investigation revealed that, depending on the ring selection,
failure of the ALT knob on the FCU could change the target altitude.
The FAA is issuing this AD to address erroneous target altitude
during descent, climb, or go-around, which could result in an
unexpected vertical trajectory deviation and loss of correct
situational awareness that could potentially result in uncontrolled
impact with the ground.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2021-0260, dated November 18, 2021 (EASA AD 2021-0260).

(h) Exceptions to EASA AD 2021-0260

    (1) Where EASA AD 2021-0260 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where paragraph (1) of EASA AD 2021-0260 specifies to
``inform all flight crews, and thereafter, operate the aeroplane
accordingly,'' this AD does not require those actions as those
actions are already required by existing FAA operating regulations.
    (3) The ``Remarks'' section of EASA AD 2021-0260 does not apply
to this AD.

(i) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (j)(2) of
this AD. Information may be emailed to: [email protected].
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.

(j) Related Information

    (1) For information about EASA AD 2021-0260, contact EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email [email protected]; internet www.easa.europa.eu. You
may find this EASA AD on the EASA website at https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2022-0464.
    (2) For more information about this AD, contact Dan Rodina,
Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email [email protected].

    Issued on April 11, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-08219 Filed 4-15-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Proposed Rules]
[Pages 47094-47095]
[FR Doc No: 2011-19393]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2011-0462; FRL-9437-7]

Revisions to the California State Implementation Plan; South
Coast Air Quality Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve a revision to the South Coast Air
Quality Management District portion of the California State
Implementation Plan (SIP). This revision concerns volatile organic
compound (VOC) emissions from polymeric cellular foam product
manufacturing operations. We are proposing to approve a local rule to
regulate these emission sources under the Clean Air Act as amended in
1990 (CAA).

DATES: Any comments on this proposal must arrive by September 6, 2011.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2011-0462, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.

    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through http://www.regulations.gov or e-mail. http://www.regulations.gov is an
``anonymous access'' system, and EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send e-mail directly to EPA, your e-mail address will be
automatically captured and included as part of the public comment. 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: Generally, documents in the docket for this action are
available electronically at http://www.regulations.gov and in hard copy
at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While
all documents in the docket are listed at http://www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps), and some may not be
publicly available in either location (e.g., CBI). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: Mae Wang, EPA Region IX, (415) 947-
4124<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposal addresses the following local
rule: South Coast Air Quality Management District Rule 1175, Control of
Emissions from the Manufacturing of Polymeric Cellular (Foam) Products.
In the Rules and Regulations section of this Federal Register, we are
approving this local rule in a direct final action without prior
proposal because we believe these SIP revisions are not controversial.
If we receive adverse comments, however, we will publish a timely
withdrawal of the direct final rule and address the comments in
subsequent action based on this proposed rule. Please note that if we
receive adverse comment on an amendment, paragraph, or section of this
rule and if that provision may be severed from the remainder of the
rule, we may adopt as final those provisions of the rule that are not
the subject of an adverse comment.
    We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is

planned. For further information, please see the direct final action.

    Dated: June 21, 2011.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2011-19393 Filed 8-3-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Rules and Regulations]
[Pages 63045-63047]
[FR Doc No: 2014-24996]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2014-0173; FRL-9918-21-Region 8]

Approval and Promulgation of Implementation Plans; North Dakota;
Revisions to the Air Pollution Control Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is approving changes to North Dakota's State
Implementation Plan (SIP). On January 23, 2013, the Governor of North
Dakota submitted to EPA revisions to several chapters of the North
Dakota SIP. These revisions included the removal of subsections 33-15-
03-04.4 and 33-15-05-01.2.a(l) of the North Dakota Administrative Code
(NDAC). In this action, EPA is approving the removal of these
subsections from the SIP because it is consistent with Clean Air Act
(CAA) requirements. The State's submission corrects certain
deficiencies related to the treatment of excess emissions from sources.
EPA will address the remaining revisions from North Dakota's January
23, 2013 submission in other actions.

DATES: This final rule is effective November 21, 2014.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R08-OAR-2014-0173. All documents in the docket
are listed in the www.regulations.gov index. Although listed in the
index, some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available either
electronically in www.regulations.gov or in hard copy at the Air
Program, Environmental Protection Agency (EPA), Region 8, 1595 Wynkoop
St., Denver, Colorado 80202-1129. EPA requests that if at all possible,
you contact the individual listed in the FOR FURTHER INFORMATION
CONTACT section to view the hard copy of the docket. You may view the
hard copy of the docket Monday through Friday, 8:00 a.m. to 4:00 p.m.,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Adam Clark, U.S. Environmental
Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595 Wynkoop Street,
Denver, Colorado 80202-1129,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Definitions

    For the purpose of this document, we are giving meaning to
certain words or initials as follows:
    (i) The words or initials Act or CAA mean or refer to the Clean
Air Act, unless the context indicates otherwise.
    (ii) The words EPA, we, us or our mean or refer to the United
States Environmental Protection Agency.

    (iii) The initials NDAC mean or refer to the North Dakota
Administrative Code.
    (iv) The initials SIP mean or refer to state implementation
plan.
    (v) The initials SSM mean or refer to startup, shutdown, and
malfunction.
    (vi) The words State or North Dakota mean the State of North
Dakota, unless the context indicates otherwise.

I. Background

    On January 23, 2013, the Governor of North Dakota submitted to EPA
SIP revisions that would remove both NDAC 33-15-03-04.4 and NDAC 33-15-
05-01.2.a(l) from the North Dakota SIP; the submission also contained
other revisions to the North Dakota SIP. On July 16, 2014 (79 FR
41473), we proposed approval of the removal of subsections NDAC 33-15-
03-04.4 and NDAC 33-15-05-01.2.a(l) from the North Dakota SIP, but we
did not propose to take any action on the remaining revisions from the
January 23, 2013 submittal.
    In our proposed rule, we explained that, in accordance with the
requirements of CAA section 110(a)(2)(A), SIPs must contain enforceable
emission limitations and, in accordance with the definition of
``emission limitations'' in CAA section 302(k), such emission
limitations must be continuous. In addition, under CAA section 304(a),
any person may bring a civil action against any person alleged to have
violated (if there is evidence that the alleged violation has been
repeated) or to be in violation of an ``emission standard or
limitation'' under the CAA. For the purposes of section 304, ``emission
standard or limitation'' is defined in section 304(f) and includes SIP
emission limitations. Thus, SIP emission limitations can be enforced in
a section 304 action and so must be capable of enforcement. SIP
provisions that create exemptions such that excess emissions during
startup, shutdown, malfunctions (SSM) and other conditions are not
violations of the applicable emission limitations are inconsistent with
these fundamental requirements of the CAA with respect to emission
limitations in SIPs.
    For these reasons, we proposed to approve the State's removal of
subsections NDAC 33-15-03-04.4 and NDAC 33-15-05-01.2.a(l) from the
North Dakota SIP. In particular, NDAC 33-15-03-04.4 created exemptions
from a number of cross-referenced opacity limits ``where the limits
specified in this article cannot be met because of operations and
processes such as, but not limited to, oil field service and drilling
operations, but only so long as it is not technically feasible to meet
said specifications.'' NDAC 33-15-05-01.2a(1) created an implicit
exemption from particulate matter emissions limits for ``temporary
operational breakdowns or cleaning of air pollution equipment'' if the
source met certain conditions. Because these provisions contemplated
outright exemptions from the otherwise applicable SIP emission limits,
they were inconsistent with CAA requirements. In addition, NDAC 33-15-
03-04.4 had inherent ambiguities that called into question its
enforceability.
    The State's removal of these provisions is sufficient to correct
the inadequacies the provisions created and is consistent with the
requirements of the CAA. As a result of their removal from the SIP, the
improper exemptions from emissions limitations contained within these
provisions will no longer be available to sources. Therefore, the
emissions limitations will become continuous and more enforceable.

II. Response to Comments

    The comment period for our June 16, 2014 proposal was open for 30
days. We received three brief comments on the proposed action. The
Sierra Club submitted a comment in support of the proposed action, and
two individuals submitted comments regarding other matters that are
entirely unrelated to the proposed action. We acknowledge the
supportive comment. We are not responding to the other comments on
subjects unrelated to our proposal.

III. EPA's Final Action

    We are approving the State's removal of NDAC 33-15-03-04.4 and NDAC
33-15-05-01.2.a(l) from the North Dakota SIP, as reflected in the
State's January 23, 2013 SIP submission. This approval corrects the
deficiencies contained in these provisions, as noted above, in our June
16, 2014 proposed rule, and in EPA's February 22, 2013 proposed SSM SIP
Call (78 FR 12531). Based on this final approval, EPA notes that these
two deficiencies in the North Dakota SIP identified in the proposed SSM
SIP call have now been correctly resolved. Thus, EPA's final action on
the SSM SIP call should not need to address these two deficiencies. We
also note that a third deficient provision, NDAC 33-15-03-04.3, was
identified in the February 22, 2013 proposed SSM SIP call; however, the
January 23, 2013 submission did not revise NDAC 33-15-03-04.3. Finally,
we are not taking action today on the remaining portions of the January
23, 2013 submission.

IV. Statutory and Executive Orders Review

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
final 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 Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999); is not an
economically significant regulatory action based on health or safety
risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and,
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small

Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    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 December 22, 2014. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action 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, Air pollution control, Carbon monoxide,
Greenhouse gases, 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: October 2, 2014.
Debra H. Thomas,
Acting Regional Administrator, Region 8.
    40 CFR part 52 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 JJ--North Dakota

0
2. In Sec.  52.1820, the table in paragraph (c) is amended by revising
the entries for ``33-15-03-04'' and ``33-15-05-01'' to read as follows:

Sec.  52.1820  Identification of plan.

* * * * *
    (c) * * *

                                        State of North Dakota Regulations
----------------------------------------------------------------------------------------------------------------
                                                        State      EPA Approval date and
      State citation            Title/Subject      effective date       citation \1\           Explanations
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                33-15-03 Restrictions of Visible Air Contaminants
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
33-15-03-04...............  Exceptions...........          1/1/13  10/22/14, [Insert
                                                                    Federal Register
                                                                    citation].
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                               33-15-05 Emissions of Particulate Matter Restricted
----------------------------------------------------------------------------------------------------------------
33-15-05-01...............  Restrictions of                1/1/13  10/22/14 [Insert
                             emissions of                           Federal Register
                             particulate matter                     citation].
                             from industrial
                             processes.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ In order to determine the EPA effective date for a specific provision listed in this table, consult the
  Federal Register notice cited in this column for the particular provision.

* * * * *
[FR Doc. 2014-24996 Filed 10-21-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Rules and Regulations]
[Pages 68342-68343]
[FR Doc No: 2019-26996]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 52

[Docket No. USCG-2019-0929]

Board for Correction of Military Records; Technical Amendment

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Board for Correction of Military Records of the Coast
Guard (BCMR) is updating its mailing address in the Code of Federal
Regulations. On April 29, 2019 the BCMR moved from 245 Murray Lane,
Washington, DC 20528 to 2707 Martin Luther King Jr. Avenue SE,
Washington, DC 20528. This rule only updates the BCMR's mailing address
for submitting an application for correction of a Coast Guard record
and does not create or change any substantive requirements.

DATES: This final rule is effective on December 16, 2019.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket number USCG-2019-0929, which is available
at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For information about this document
call or email Julia Andrews, Chair, BCMR, telephone<PHONE_NUMBER>, email
at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Discussion of the Rule

    On April 29, 2019 the Board for Correction of Military Records of
the Coast Guard (BCMR) mailing address changed from 245 Murray Lane,
Washington, DC 20528 to 2707 Martin Luther King Jr. Avenue SE, Stop
0485, Washington, DC 20528-0485. Through this technical amendment, the
BCMR is making a corresponding change to the BCMR's mailing address in
the Code of Federal Regulations (CFR) in 33 CFR 52.21(a). Section
52.21(a) provides the BCMR mailing address for submitting an
application for correction of a Coast Guard record on DD Form 149
(Application for Correction of Military or Naval Record). The BCMR has
already updated the mailing address on the DD Form 149 and the BCMR's
website to reflect the change in address.
    This rule is issued under the authority of 5 U.S.C. 552; 14 U.S.C.
501 and 503; and Department of Homeland Security Delegation Nos. 0160.1
and 0170.1.

II. Regulatory History

    The Coast Guard did not publish a notice of proposed rulemaking for
this rule. Under Title 5 of the United States Code (U.S.C.), Section
553(b)(A), this final rule is exempt from notice and public comment
rulemaking requirements because the change involves rules of agency
organization, procedure, or practice. In addition, under 5 U.S.C.
553(b)(B), an agency may waive the notice and comment requirements if
it finds, for good cause, that notice and comment is impracticable,
unnecessary, or contrary to the public interest. The Coast Guard finds
that notice and comment is unnecessary under 5 U.S.C. 553(b)(B) because
the mailing address change is an agency procedural correction that will
have no substantive effect on the public. For the same reasons, the
Coast Guard finds that good cause exists under 5 U.S.C. 553(d) for
making this final rule effective immediately upon publication.

III. Regulatory Analyses

    The Coast Guard developed this rule after considering numerous
statutes and executive orders related to rulemaking. Below are
summarized analyses based on these statutes or executive orders.

A. Regulatory Planning and Review

    Executive Orders 12866 (Regulatory Planning and Review) and 13563
(Improving Regulation and Regulatory Review) direct agencies to assess
the costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. Executive Order 13771 (Reducing Regulation and Controlling
Regulatory Costs) directs agencies to reduce regulation and control
regulatory costs and provides that ``for every one new regulation
issued, at least two prior regulations be identified for elimination,
and that the cost of planned regulations be prudently managed and
controlled through a budgeting process.''
    The Office of Management and Budget (OMB) has not designated this
rule a significant regulatory action under section 3(f) of Executive
Order 12866. Accordingly, OMB has not reviewed it. Because this rule is
not a significant regulatory action, this rule is exempt from the
requirements of Executive Order 13771. See the OMB Memorandum titled
``Guidance Implementing Executive Order 13771, titled `Reducing
Regulation and Controlling Regulatory Costs''' (April 5, 2017). This
rule involves non-substantive changes and internal agency practices and
procedures; it will not impose any additional costs on the public. The
benefit of the non-substantive change that updates a mailing address is
increased clarity and accuracy of regulations for the public.

B. Small Entities

    Under the Regulatory Flexibility Act, 5 U.S.C. 601-612, the Coast
Guard has considered whether this rule would have a significant
economic impact on a substantial number of small entities. The term
``small entities'' comprises small businesses, not-for-profit
organizations that are independently owned and operated and are not
dominant in their fields, and governmental jurisdictions with
populations of less than 50,000.
    This rule is not preceded by a notice of proposed rulemaking.
Therefore, it is exempt from the requirements of the Regulatory
Flexibility Act (5 U.S.C. 601-612). The Regulatory Flexibility Act does
not apply when notice and comment rulemaking is not required. This rule
consists of a technical amendment to a mailing address and does not
have any substantive effect on the regulated industry or small
businesses.

C. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996, Public Law 104-121, the Coast Guard offers to
assist small entities in understanding this rule so that they can
better evaluate its effects on them and participate in the rulemaking.
The Coast Guard will not retaliate against small entities that question
or complain about this rule or any policy or action of the Coast Guard.

D. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520.

E. Federalism

    A rule has implications for federalism under Executive Order 13132
(Federalism) if it has a substantial direct effect on 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. The Coast Guard has analyzed this rule under Executive
Order 13132 and has determined that it is consistent with the
fundamental federalism principles and preemption requirements described
in Executive Order 13132.

F. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531-1538,
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Although this rule will not result
in such expenditure, the Coast Guard does discuss the effects of this
rule elsewhere in this preamble.

G. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630 (Governmental
Actions and Interference with Constitutionally Protected Property
Rights).

H. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988 (Civil Justice Reform) to minimize litigation,
eliminate ambiguity, and reduce burden.

I. Protection of Children

    The Coast Guard has analyzed this rule under Executive Order 13045
(Protection of Children from Environmental Health Risks and Safety
Risks). This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

J. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175 (Consultation and Coordination with Indian Tribal Governments),
because it would not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

K. Energy Effects

    The Coast Guard has analyzed this rule under Executive Order 13211
(Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use). It is not a ``significant energy
action'' under that order because it is not a ``significant regulatory
action'' under Executive Order 12866 and is not likely to have a
significant adverse effect on the supply, distribution, or use of
energy.

L. Technical Standards

    The National Technology Transfer and Advancement Act, codified as a
note to 15 U.S.C. 272, directs agencies to use voluntary consensus
standards in their regulatory activities unless the agency provides
Congress, through OMB, with an explanation of why using these standards
would be inconsistent with applicable law or otherwise impractical.
Voluntary consensus standards are technical standards (e.g.,
specifications of materials, performance, design, or operation; test
methods; sampling procedures; and related management systems practices)
that are developed or adopted by voluntary consensus standards bodies.
    This rule does not use technical standards. Therefore, the Coast
Guard did not consider the use of voluntary consensus standards.

M. Environment

    The Coast Guard has analyzed this rule under Department of Homeland
Security Instruction Manual 023-01-001-01, Rev. 1, and U.S. Coast Guard
Environmental Planning Policy (COMDTINST 5090.1), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and concluded that this action is one of a
category of actions that do not individually or cumulatively have a
significant effect on the human environment. A final Record of
Environmental Consideration supporting this determination is available
in the docket where indicated in the ADDRESSES section of this
preamble. This final rule involves a non-substantive technical
amendment that updates a mailing address in existing Coast Guard
regulations. Therefore, this rule is categorically excluded under
paragraphs A3 and L54 in Appendix A, Table 1, of DHS Instruction Manual
023-01-001-01, Rev. 1. Paragraphs A3 and L54 pertain to regulations
which are editorial or procedural.

List of Subjects in 33 CFR Part 52

    Administrative practice and procedure, Archives and records,
Military personnel.

    For the reason stated in the preamble, the Coast Guard amends 33
CFR part 52 as follows:

PART 52--BOARD FOR CORRECTION OF MILITARY RECORDS OF THE COAST
GUARD

0
1. Revise the authority citation for part 52 to read as follows:

    Authority: 10 U.S.C. 1552; 14 U.S.C. 501, 633; Department of
Homeland Security Delegations No. 0160.1(II)(B)(1), 0170.1(II)(23).

Sec.  52.21  [Amended]

0
2. In Sec.  52.21(a), remove the text, ``Mailstop 485, 245 Murray Lane,
Washington, DC 20528'' and add, in its place, the text ``2707 Martin
Luther King Jr. Avenue SE, Stop 0485, Washington, DC 20528-0485''.

    Dated: December 10, 2019.
M.W. Mumbach,
Chief, Office of Regulations and Administrative Law, U.S. Coast Guard.
[FR Doc. 2019-26996 Filed 12-13-19; 8:45 am]
BILLING CODE 9110-04-P


PART 571--FEDERAL MOTOR VEHICLE SAFETY STANDARDS

0
1. The authority citation for Part 571 continues to read as follows:

    Authority: 49 U.S.C. 322, 30111, 30115, 30117 and 30166;
delegation of authority at 49 CFR 1.50.

0
2. Section 571.214 is amended by:
0
a. Revising S5(b)(3), S6.1.2, S6.1.3, S6.2.2, S6.2.3;
0
b. Adding S7.2.4(a)(3); and
0
c. Revising S7.2.5(b), S8.2, S9.2.1(b), S<IP_ADDRESS>, S10.5, S11.1(b),
S11.5(b)(1),

S12.1, S12.2.1, S12.3.2(a)(1) and (9), S12.3.2(b)(6), S12.3.3(a)(1) and
(9); and S12.3.3(b)(3), S12.3.4(h), and S12.3.4(k).
    The revisions and addition read as follows:

Sec.  571.214  Standard No. 214; Side impact protection.

* * * * *
    S5 * * *
    (b) * * *
    (3) Passenger cars, multipurpose passenger vehicles, trucks and
buses need not meet the requirements of S7 (moving deformable barrier
test) as applied to the rear seat for side-facing rear seats and for
rear seating areas that are so small that a Part 572 Subpart V dummy
representing a 5th percentile adult female cannot be accommodated
according to the positioning procedure specified in S12.3.4 of this
standard. Vehicles that are manufactured before September 1, 2010, and
vehicles that manufactured on or after September 1, 2010, that are not
part of the percentage of a manufacturer's production meeting the
moving deformable barrier test requirements with advanced test dummies
(S7.2 of this section) or are otherwise excluded from the phase-in
requirements of S7.2, need not meet the requirements of the moving
deformable barrier test as applied to the rear seat for rear seating
areas that are so small that a Subpart F dummy (SID) cannot be
accommodated according to the positioning procedure specified in S12.1
of this standard.
* * * * *
    S6 * * *
    S6.1.2 Intermediate crush resistance. The intermediate crush
resistance shall not be less than 15,569 N (3,500 lb).
    S6.1.3 Peak crush resistance. The peak crush resistance shall not
be less than two times the curb weight of the vehicle or 31,138 N
(7,000 lb), whichever is less.
* * * * *
    S6.2.2 Intermediate crush resistance. The intermediate crush
resistance shall not be less than 19,460 N (4,375 lb).
    S6.2.3 Peak crush resistance. The peak crush resistance shall not
be less than three and one half times the curb weight of the vehicle or
53,378 N (12,000 lb), whichever is less.
* * * * *
    S7.2.4 * * *
    (a) * * *
    (3) Convertibles manufactured before September 1, 2015, are not
subject to S7.2.1 or S7.2.2 of this section. These vehicles may be
voluntarily certified to meet the MDB test requirements prior to
September 1, 2015. Vehicles manufactured on or after September 1, 2015
are subject to S7 and S7.2.2.
    S7.2.5 * * *
* * * * *
    (b) Thorax. The deflection of any of the upper, middle, and lower
ribs, shall not exceed 44 mm (1.73 inches).
* * * * *
    S8.2 Vehicle test attitude. Determine the distance between a level
surface and a standard reference point on the test vehicle's body,
directly above each wheel opening, when the vehicle is in its fully
loaded condition at the test site, with all tires inflated to the
manufacturer's specifications listed on the vehicle's tire placard, and
with the vehicle filled to 100 percent of all fluid capacities. The
``fully loaded condition'' is the test vehicle loaded in accordance
with S8.1 of this standard (49 CFR 571.214). The load placed in the
cargo area is centered over the longitudinal centerline of the vehicle.
The pretest vehicle attitude is equal to the fully loaded attitude
 10 mm.
* * * * *
    S9.2.1 * * * *
    (b) Thorax. The deflection of any of the upper, middle, and lower
ribs, shall not exceed 44 mm (1.73 inches).
* * * * *
    S<IP_ADDRESS> Other seat adjustments. Position any adjustable parts of
the seat that provide additional support so that they are in the lowest
or non-deployed adjustment position. Position any adjustable head
restraint in the lowest and most forward position. If it is possible to
achieve a position lower than the effective detent range, the head
restraint should be set to its lowest possible position. Place
adjustable seat backs in the manufacturer's nominal design riding
position in the manner specified by the manufacturer. If the position
is not specified, set the seat back at the first detent rearward of
25[deg] from the vertical.
* * * * *
    S10.5 Adjustable steering wheel. Adjustable steering controls are
adjusted so that the steering wheel hub is at the geometric center of
the locus it describes when it is moved through its full range of
driving positions. If there is no setting detent in the mid-position,
lower the steering wheel to the detent just below the mid-position. If
the steering column is telescoping, place the steering column in the
mid-position. If there is no mid-position, move the steering wheel
rearward one position from the mid-position.
* * * * *
    S11.1 * * *
* * * * *
    (b) 5th percentile female. The 49 CFR part 572 subpart V test dummy
representing a 5th percentile female is clothed in formfitting cotton
stretch garments with short sleeves and about the knee length pants.
Each foot has on a size 7.5W shoe that meets the configuration and size
specifications of MIL-S-21711E or its equivalent.
* * * * *
    S11.5 * * *
* * * * *
    (b) Subpart U (Es-2re 50th percentile male) test dummy.
    (1) The rib deflection data are filtered at channel frequency class
180 Hz. Abdominal and pubic force data are filtered at channel
frequency class of 600 Hz.
* * * * *
    S12.1 50th percentile male test dummy--49 CFR part 572 subpart F
(SID). Position a correctly configured test dummy, conforming to the
applicable requirements of part 572 Subpart F of this chapter, in the
front outboard seating position on the side of the test vehicle to be
struck by the moving deformable barrier and, if the vehicle has a
second seat, position another conforming test dummy in the second seat
outboard position on the same side of the vehicle, as specified in
S12.1.3. Each test dummy is restrained using all available belt systems
in all seating positions where such belt restraints are provided. Place
any adjustable anchorages at the manufacturer's nominal design position
for a 50th percentile adult male occupant. In addition, any folding
armrest is retracted. Additional positioning procedures are specified
below.
* * * * *
    S12.2.1 Positioning an ES-2re dummy in all seating positions.
Position a correctly configured ES-2re test dummy, conforming to the
applicable requirements of part 572 of this chapter, in the front
outboard seating position on the side of the test vehicle to be struck
by the moving deformable barrier or pole. Restrain the test dummy using
all available belt systems in the seating positions where the belt
restraints are provided. Place any adjustable anchorages at the
manufacturer's nominal design position for a 50th percentile adult male
occupant. Retract any folding armrest.
* * * * *
    S12.3.2 * * *
    (a) * * *
    (1) With the seat in the position determined in S10.3.2, use only
the control that moves the seat fore and aft to place the seat in the
rearmost position. If the seat cushion reference line angle
automatically changes as the

seat is moved from the full forward position, maintain, as closely as
possible, the seat cushion reference line angle determined in
S<IP_ADDRESS>.3, for the final forward position when measuring the pelvic
angle as specified in S12.3.2(a)(11). The seat cushion reference line
angle position may be achieved through the use of any seat or seat
cushion adjustments other than that which primarily moves the seat or
seat cushion fore-aft.
* * * * *
    (9) For vehicles without adjustable seat backs, adjust the lower
neck bracket to level the head as much as possible. For vehicles with
adjustable seat backs, while holding the thighs in place, rotate the
seat back forward until the transverse instrumentation platform of the
head is level to within  0.5 degree, making sure that the
pelvis does not interfere with the seat bight. If the torso contacts
the steering wheel, adjust the steering wheel in the following order
until there is no contact: telescoping adjustment, lowering adjustment,
raising adjustment. If the vehicle has no adjustments or contact with
the steering wheel cannot be eliminated by adjustment, position the
seat at the next detent where there is no contact with the steering
wheel as adjusted in S10.5. If the seat is a power seat, position the
seat to avoid contact while assuring that there is a maximum of 5 mm
(0.2 in) distance between the steering wheel as adjusted in S10.5 and
the point of contact on the dummy. Adjust the lower neck bracket to
level the head as much as possible.
* * * * *
    (b) * * *
    (6) If the left foot does not contact the floor pan, place the foot
parallel to the floor and place the leg as perpendicular to the thigh
as possible. If necessary to avoid contact with the vehicle's brake
pedal, clutch pedal, wheel-well, or foot rest, use the three foot
position adjustments listed in S12.3.2(b)(6)(i) through (iii). The
adjustment options are listed in priority order, with each subsequent
option incorporating the previous. In making each adjustment, move the
foot the minimum distance necessary to avoid contact. If it is not
possible to avoid all prohibited foot contact, priority is given to
avoiding brake or clutch pedal contact:
* * * * *
    S12.3.3 * * *
    (a) * * *
    (1) With the seat at the mid-height in the full-forward position
determined in S10.3.2, use only the control that primarily moves the
seat fore and aft to place the seat in the rearmost position, without
adjusting independent height controls. If the seat cushion reference
line angle automatically changes as the seat is moved from the full
forward position, maintain, as closely as possible, the seat cushion
reference line angle determined in S<IP_ADDRESS>.3, for the final forward
position when measuring the pelvic angle as specified in
S12.3.3(a)(11). The seat cushion reference line angle position may be
achieved through the use of any seat or seat cushion adjustments other
than that which primarily moves the seat or seat cushion fore-aft.
* * * * *
    (9) For vehicles without adjustable seat backs, adjust the lower
neck bracket to level the head as much as possible. For vehicles with
adjustable seat backs, while holding the thighs in place, rotate the
seat back forward until the transverse instrumentation platform of the
head is level to within  0.5 degree, making sure that the
pelvis does not interfere with the seat bight.
* * * * *
    (b) * * *
    (3) If either foot does not contact the floor pan, place the foot
parallel to the floor pan and place the lower leg as perpendicular to
the thigh as possible.
* * * * *
    S12.3.4 * * *
* * * * *
    (h) For vehicles without adjustable seat backs, adjust the lower
neck bracket to level the head as much as possible. For vehicles with
adjustable seat backs, while holding the thighs in place, rotate the
seat back forward until the transverse instrumentation platform of the
head is level to within  0.5 degrees, making sure that the
pelvis does not interfere with the seat bight.
* * * * *
    (k) Passenger foot positioning.
    (1) Place the rear seat passenger's feet flat on the floor pan and
beneath the front seat as far as possible without front seat
interference.
    (2) If either foot does not contact the floor pan, place the foot
parallel to the floor and place the leg as perpendicular to the thigh
as possible.
* * * * *

0
3. Section 571.301 is amended by revising S6.3(b), to read as follows:

Sec.  571.301  Standard No. 301; Fuel system integrity.

* * * * *
    S6.3 * * *
* * * * *
    (b) Vehicles manufactured on or after September 1, 2004. When the
vehicle is impacted laterally on either side by a moving deformable
barrier at 53  1.0 km/h with the appropriate 49
CFR part 572 test dummies specified in 571.214 at positions required
for testing by S7.1.1, S7.2.1, or S7.2.2 of Standard 214, under the
applicable conditions of S7 of this standard, fuel spillage shall not
exceed the limits of S5.5 of this standard.
* * * * *

0
4. Section 571.305 is amended by revising S6.3 and S7.5, to read as
follows:

Sec.  571.305  Standard No. 305; Electric-powered vehicles: electrolyte
spillage and electrical shock protection.

* * * * *
    S6.3 Side moving deformable barrier impact. The vehicle must meet
the requirements of S5.1, S5.2 and S5.3 when it is impacted from the
side by a barrier that conforms to part 587 of this chapter that is
moving at any speed up to and including 54 km/h, with the appropriate
49 CFR part 572 test dummies specified in 571.214 of this chapter.
* * * * *
    S7.5 Side moving deformable barrier impact test conditions. In
addition to the conditions of S7.1 and S7.2, the conditions of S8.9,
S8.10, and S8.11 of 571.214 of this chapter apply to the conduct of the
side moving deformable barrier impact test specified in S6.3.
* * * * *

    Issued: March 9, 2010.
David L. Strickland,
Administrator.
[FR Doc. 2010-5575 Filed 3-12-10; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: November 6, 2008 (Volume 73, Number 216)]
[Notices]
[Page 66079-66082]
[DOCID:fr06no08-78]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-28481]

Notice of Applications for Deregistration Under Section 8(f) of
the Investment Company Act of 1940

October 31, 2008.
    The following is a notice of applications for deregistration under
section 8(f) of the Investment Company Act of 1940 for the month of
October, 2008. A copy of each application may be obtained for a fee at
the Commission's Public Reference Room, 100 F Street, NE., Washington,
DC 20549-1520 (tel.<PHONE_NUMBER>). An order granting each application
will be issued unless the SEC orders a hearing. Interested persons may
request a hearing on any application by writing to the SEC's Secretary
at the address below and serving the relevant applicant with a copy of
the request, personally or by mail. Hearing requests should be received
by the SEC by 5:30 p.m. on November 20, 2008, and should be accompanied
by proof of service on the applicant, in the form of an affidavit or,
for lawyers, a certificate of service. Hearing requests should state
the nature of the writer's interest, the reason for the request, and
the issues contested. Persons who wish to be notified of a hearing may
request notification by writing to the Secretary, U.S. Securities and
Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.

FOR FURTHER INFORMATION CONTACT: Diane L. Titus at<PHONE_NUMBER>, SEC,
Division of Investment Management, Office of Investment Company
Regulation, 100 F Street, NE., Washington, DC 20549-4041.

Eaton Vance Municipal Bond Fund L.P. [File No. 811-2778]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On December 31, 1997, applicant transferred
its assets to Eaton Vance Municipal Bond Fund, a series of Eaton Vance
Mutual Funds Trust, based on net asset value. Expenses of $15,000
incurred in

connection with the reorganization were paid by applicant.
    Filing Dates: The application was filed on August 11, 2008, and
amended on September 29, 2008.
    Applicant's Address: The Eaton Vance Building, 255 State St.,
Boston, MA 02109.

Scudder Global RREEF Real Estate Fund, Inc. [File No. 811-21550]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant has
never made a public offering of its securities and does not propose to
make a public offering or engage in business of any kind.
    Filing Dates: The application was filed on August 4, 2008, and
amended on October 14, 2008.
    Applicant's Address: 280 Park Ave., New York, NY 10017.

Delaware Investments Minnesota Municipal Income Fund, Inc. [File No.
811-6568]

Delaware Investments Minnesota Municipal Income Fund III, Inc. [File
No. 811-7938]

    Summary: Each applicant, a closed-end investment company, seeks an
order declaring that it has ceased to be an investment company. On
February 24, 2006, each applicant transferred its assets to Delaware
Investments Minnesota Municipal Income Fund II, Inc., based on net
asset value. Total expenses of approximately $396,650 incurred in
connection with the reorganizations were paid by the applicants, the
acquiring fund and Delaware Management Company, investment adviser to
the applicants.
    Filing Dates: The applications were filed on August 13, 2008, and
amended on October 20, 2008.
    Applicants' Address: 2005 Market St., Philadelphia, PA 19103.

Phoenix Multi-Series Trust [File No. 811-6566]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company.
    On December 22, 2005, applicant liquidated one series. On June 27,
2007, applicant's two remaining series transferred their assets to
corresponding series of Phoenix Opportunities Trust, based on net asset
value. Expenses of approximately $152,211 incurred in connection with
the reorganization were paid by the acquiring fund.
    Filing Date: The application was filed on September 26, 2008.
    Applicant's Address: 56 Prospect St., PO Box 150480, Hartford, CT
06115-0480.

Phoenix PHOLIOs [File No. 811-7643]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On December 22 and 27, 2006, applicant
liquidated three series. On September 24, 2007, applicant's four
remaining series transferred their assets to corresponding series of
Phoenix Opportunities Trust, based on net asset value. Expenses of
approximately $62,358 incurred in connection with the reorganization
were paid by the surviving series.
    Filing Date: The application was filed on September 26, 2008.
    Applicant's Address: 56 Prospect St., PO Box 150480, Hartford, CT
06115-0480.

Phoenix CA Tax-Exempt Bond Fund [File No. 811-3714]

Phoenix Portfolios [File No. 811-8631]

    Summary: Each applicant seeks an order declaring that it has ceased
to be an investment company. On June 27, 2007, each applicant
transferred its assets to a corresponding series of Phoenix
Opportunities Trust, based on net asset value. Expenses of
approximately $9,263 and $10,023, respectively, incurred in connection
with the reorganizations were paid by the acquiring fund.
    Filing Date: The applications were filed on September 26, 2008.
    Applicants' Address: 56 Prospect St., PO Box 150480, Hartford, CT
06115-0480.

Legg Mason Partners Equity Funds [File No. 811-4551]

Legg Mason Partners Sector Series, Inc. [File No. 811-4757]

    Summary: Each applicant seeks an order declaring that it has ceased
to be an investment company. On April 16, 2007, each applicant
transferred its assets to corresponding series of Legg Mason Partners
Equity Trust, based on net asset value. Expenses of approximately
$197,148 and $47,850, respectively, incurred in connection with the
reorganizations were paid by applicants and Legg Mason, Inc., the
parent company of applicants' investment adviser.
    Filing Date: The applications were filed on September 26, 2008.
    Applicants' Address: 55 Water St., New York, NY 10041.

Legg Mason Partners Massachusetts Municipals Fund [File No. 811-4994]

Legg Mason Partners Oregon Municipals Fund [File No. 811-7149]

    Summary: Each applicant seeks an order declaring that it has ceased
to be an investment company. On April 16, 2007, each applicant
transferred its assets to a corresponding series of Legg Mason Partners
Income Trust, based on net asset value. Expenses of approximately
$8,190 and $6,526, respectively, incurred in connection with the
reorganizations were paid by applicants and Legg Mason, Inc., parent
company of applicants' investment adviser.
    Filing Date: The applications were filed on September 26, 2008.
    Applicants' Address: 55 Water St., New York, NY 10041.

Legg Mason Partners Investors Value Fund, Inc. [File No. 811-805]

Legg Mason Partners Equity Fund, Inc. [File No. 811-2733]

Legg Mason Partners Fundamental Value Fund, Inc. [File No. 811-3158]

    Summary: Each applicant seeks an order declaring that it has ceased
to be an investment company. On April 16, 2007, each applicant
transferred its assets to a corresponding series of Legg Mason Partners
Equity Trust, based on net asset value. Expenses of approximately
$223,156, $235,396 and $2,749,910, respectively, incurred in connection
with the reorganizations were paid by applicants and Legg Mason, Inc.,
the parent company of applicants' investment adviser.
    Filing Date: The applications were filed on September 17, 2008.
    Applicants' Address: 55 Water St., New York, NY 10041.

Legg Mason Partners Investment Series [File No. 811-5018]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On April 16, 2007, applicant transferred its
assets to corresponding series of Legg Mason Partners Equity Trust,
Legg Mason Partners Variable Equity Trust and Legg Mason Partners
Variable Income Trust, based on net asset value. Expenses of
approximately $2,003,049 incurred in connection with the reorganization
were paid by applicant and Legg Mason, Inc., the parent company of
applicant's investment adviser.
    Filing Date: The application was filed on September 26, 2008.
    Applicant's Address: 55 Water St., New York, NY 10041.

Legg Mason Partners Series Funds, Inc. [File No. 811-6087]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On April 16, 2007, applicant transferred its
assets to corresponding series of Legg Mason Partners Equity Trust and
Legg Mason Partners Income Trust, based on net asset value. Expenses of
approximately $453,367 incurred in connection with the reorganization
were paid by applicant and Legg Mason, Inc., the parent company of
applicant's investment adviser.
    Filing Date: The application was filed on September 26, 2008.
    Applicant's Address: 55 Water St., New York, NY 10041.

Legg Mason Partners Municipal Funds [File No. 811-4395]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On April 16, 2007, applicant transferred its
assets to corresponding series of Legg Mason Partners Income Trust and
Legg Mason Partners Money Market Trust, based on net asset value.
Expenses of approximately $599,641 incurred in connection with the
reorganization were paid by applicant and Legg Mason, Inc., the parent
company of applicant's investment adviser.
    Filing Date: The application was filed on September 26, 2008.
    Applicant's Address: 55 Water St., New York, NY 10041.

Legg Mason Partners Funds, Inc. [File No. 811-1464]

Legg Mason Partners Managed Municipals Fund, Inc. [File No. 811-3097]

Legg Mason Partners Core Plus Bond Fund, Inc. [File No. 811-4061]

Legg Mason Partners New Jersey Municipals Fund, Inc. [File No. 811-
5406]

    Summary: Each applicant seeks an order declaring that it has ceased
to be an investment company. On April 16, 2007, each applicant
transferred its assets to a corresponding series of Legg Mason Partners
Income Trust, based on net asset value. Expenses of approximately
$31,993, $360,606, $87,298 and $25,533, respectively, incurred in
connection with the reorganizations were paid by applicants and Legg
Mason, Inc., the parent company of applicants' investment adviser.
    Filing Date: The applications were filed on September 17, 2008.
    Applicants' Address: 55 Water St., New York, NY 10041.

The Blue Fund Group [File No. 811-21908]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On June 24, 2008, applicant made a final
liquidating distribution to its shareholders, based on net asset value.
Expenses of $29,567 incurred in connection with the liquidation were
paid by Blue Investment Management, LLC, applicant's investment
adviser.
    Filing Date: The application was filed on September 23, 2008.
    Applicant's Address: 888 16th St., NW., Suite 800, Washington, DC
20006.

Cash Equivalent Fund [File No. 811-2899]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On July 8, 2005, applicant made a liquidating
distribution to its shareholders, based on net asset value. Expenses of
$72,039 incurred in connection with the liquidation were paid by
Deutsche Investment Management Americas Inc., applicant's investment
adviser.
    Filing Date: The application was filed on September 30, 2008.
    Applicant's Address: 345 Park Ave., New York, NY 10154.

AIM Summit Investors Plans I [File No. 811-3444]

AIM Summit Investors Plans II [File No. 811-9311]

    Summary: Each applicant, a unit investment trust, seeks an order
declaring that it has ceased to be an investment company. On December
8, 2006, each applicant made a liquidating distribution to its
unitholders, based on net asset value. Expenses of $251,861 and
$76,978, respectively, incurred in connection with the liquidations
were paid by Invesco Aim Distributors, Inc., applicants' distributor.
    Filing Date: The applications were filed on September 26, 2008.
    Applicants' Address: 11 Greenway Plaza, Suite 100, Houston, TX
77046-1173.

Oppenheimer Tremont Opportunity Fund, LLC [File No. 811-10541]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On March 31,
2008, June 30, 2008, and August 31, 2008, applicant made liquidating
distributions to its shareholders, based on net asset value. Applicant
incurred no expenses in connection with the liquidation.
    Filing Date: The application was filed on October 3, 2008.
    Applicant's Address: 6803 S. Tucson Way, Centennial, CO 80112.

Evergreen Latin America Fund [File No. 811-7914]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On or about February 27, 1998, applicant
transferred its assets to a corresponding series of Evergreen
International Trust, based on net asset value. Applicant paid the
expenses incurred in connection with the reorganization.
    Filing Date: The application was filed on October 6, 2008.
    Applicant's Address: 200 Berkeley St., Boston, MA 02116.

Evergreen Limited Market Fund Inc. [File No. 811-3653]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On or about December 22, 1997, applicant
transferred its assets to a corresponding series of Evergreen Equity
Trust, based on net asset value. Applicant paid the expenses incurred
in connection with the reorganization.
    Filing Date: The application was filed on October 7, 2008.
    Applicant's Address: 200 Berkeley St., Boston, MA 02116.

Evergreen Lexicon Trust [File No. 811-6368]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On or about December 22, 1997, applicant
transferred its assets to a corresponding series of Evergreen Fixed
Income Trust, based on net asset value. Applicant paid the expenses
incurred in connection with the reorganization.
    Filing Date: The application was filed on October 6, 2008.
    Applicant's Address: 200 Berkeley St., Boston, MA 02116.

XTF Advisors Trust [File No. 811-21971]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On June 20, 2008, applicant made a
liquidating distribution to its shareholders, on the basis of net
assets. Expenses of $7,916 incurred in connection with the liquidation
were paid by the applicant and CLS Investment Firm, LLC, applicant's
investment adviser.
    Filing Dates: The application was filed on August 29, 2008, and
amended on September 30, 2008.
    Applicant's Address: c/o Gemini Fund Services, LLC, 450 Wireless
Boulevard, Hauppauge, NY 11788.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-26441 Filed 11-5-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: September 13, 2010 (Volume 75, Number 176)]
[Notices]
[Page 55589-55591]
[DOCID:fr13se10-47]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0463]

Fee for Using a Priority Review Voucher in Fiscal Year 2011

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates for using a tropical disease priority review voucher for fiscal
year (FY) 2011. The Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as amended by title XI of the Food and Drug Administration
Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect
priority review user fees for certain applications for approval of drug
or biological products when those applications use a priority review
voucher awarded by the Secretary of Health and Human Services. These
vouchers are awarded to the sponsor of certain tropical disease product
applications, submitted after September 27, 2007, upon FDA approval of
such applications. The amount of the fee to be submitted to FDA with
applications using a priority review voucher is determined each fiscal
year (FY) based on the average cost incurred by FDA in the review of a
human drug application subject to priority review in the previous FY.
    This notice establishes the priority review fee rate for FY 2011.

FOR FURTHER INFORMATION CONTACT: David Miller, Office of Financial
Management (HFA-100), Food and Drug Administration, 1350 Piccard Dr.,
Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 1102 of FDAAA added new section 524 to the FD&C Act (21
U.S.C. 360n). In section 524, Congress encouraged development of new
drug and biological products for prevention and treatment of certain
tropical diseases by offering additional incentives for obtaining FDA
approval of such products. Under section 524, the sponsor of an
eligible human drug application submitted after September 27, 2007, for
a qualified tropical disease (as defined in section 524(a)(3)), shall
receive a priority review voucher upon approval of the tropical disease
product application. The recipient of a priority review voucher may
either use the voucher with a future submission to FDA under section
505(b)(1) of the FD&C Act (21 U.S.C. 355(b)(1)) or section 351 of the
Public Health Service Act (21 U.S.C. 262), or transfer (including by
sale) the voucher to another party that may then use it. A priority
review is a review conducted with a Prescription Drug User Fee Act
(PDUFA) goal date of 6 months.
    The applicant that uses a priority review voucher is entitled to a
priority review but must pay FDA a priority review user fee in addition
to any other fee required by PDUFA. FDA has published a draft guidance
on its Web site about how this priority review voucher program will
operate (available at: http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/ucm080599.pdf).
    This notice establishes the priority review fee rate for 2011 of
$4,582,000, and outlines FDA's process for implementing the collection
of the priority review user fees. This rate is effective on October 1,
2010, and will remain in effect through September 30, 2011, for
applications submitted with a priority review voucher, and the payment
of this priority review user fee is required in addition to the payment
of any other fee that would normally apply to such an application under
PDUFA before FDA considers the application complete and acceptable for
filing.

II. Priority Review User Fee for FY 2011

    Under section 524(c)(2) of the FD&C Act, the amount of the priority
review user fee is to be determined each FY based on the average cost
incurred by FDA in the review of a human drug application subject to
priority review in the previous FY.
    A priority review is a review conducted with a PDUFA goal date of 6
months. Normally, an application for a Center for Drug Evaluation and
Research (CDER) product will qualify for a priority review if FDA
determines that the product, if approved, would provide safe and
effective therapy where no satisfactory alternative therapy exists or
would be a significant improvement compared to marketed products,
including non-drug products and/or therapies, in the treatment,
diagnosis, or prevention of a disease. A Center for Biologics
Evaluation and Research (CBER) product will qualify for a priority
review if FDA determines that the product, if approved, would be a
significant improvement in the safety or effectiveness of the
treatment, diagnosis, or prevention of a serious or life-threatening
disease. FDA has committed to a goal to review and act on 90 percent of
the applications that have been granted priority review status no later
than 6 months after receipt. An application that does not receive a
priority designation will receive a ``standard'' review. Under the
goals identified in the letters referenced in section 101(c) of FDAAA,
FDA commits to a goal to review and act on 90 percent of ``standard''
applications within 10 months of the date of receipt. A priority review
involves a more intensive level of effort and a higher level of
resources than a standard review.
    Section 524 of the FD&C Act specifies that the fee amount should be
based on the average cost incurred by the Agency for a priority review
in the previous FY. Because FDA has never tracked the cost of reviewing
applications that get priority review as a separate cost subset, FDA
estimated this cost based on other data that the Agency has tracked and
kept. FDA started by using data that the Agency estimates and publishes
on its Web site each year--standard costs for review. FDA does not
publish a standard cost for ``the review of a human drug application
subject to priority review in the previous fiscal year.'' However, we
expect all such applications would contain clinical data. The standard
cost application

categories with clinical data that FDA does publish each year are as
follows:
    (1) New drug applications (NDAs) for a new molecular entity (NME)
with clinical data and
    (2) Biologic license applications (BLAs).
    The worksheets for standard costs for FY 2009, the latest year for
which standard cost data are available, show a standard cost of
$4,021,000 (rounded to the nearest thousand dollars) for an NDA with
clinical data and $3,530,000 (rounded to the nearest thousand dollars)
for a BLA. Based on these standard costs, the total cost to review the
55 applications in these 2 categories in FY 2009 (24 BLAs and 31 NDAs
with clinical data) was $209,371,000. (Note: no investigational new
drug (IND) review costs are included in this amount; they will be
calculated separately and added in the next paragraph.) Records
acquired from CDER and CBER by the Office of Policy, Planning and
Budget (OPPB), Economics Staff, indicate that a total of 17 of these
applications (8 NDAs [excluding the President's Emergency Plan for Aids
Relief NDAs] and 9 BLAs) received priority review, which would mean
that the remaining 38 received standard reviews. Because a priority
review compresses a review that ordinarily takes 10 months into 6
months, OPPB estimates that a multiplier of 1.67 (10 months divided by
6 months) should be applied to non-priority review costs in estimating
the effort and cost of a priority review as compared to a standard
review. This multiplier is consistent with published research on this
subject. In the article ``Developing Drugs for Developing Countries,''
published in Health Affairs, vol. 25, Number 2, in 2006, the analysis
by David B. Ridley, Henry G. Grabowski, and Jeffrey L. Moe supports a
priority review multiplier in the range of 1.48 to 2.35. The multiplier
derived by FDA falls well below the midpoint of this range. Using FY
2009 figures, the costs of a priority and standard review are estimated
using the following formula:
    (17a x 1.67) + (38a) = $209,371,000
where ``a'' is the cost of a standard review and ``a'' times 1.67 is
the cost of a priority review. Using this formula, the cost of a
standard review for NMEs is calculated to be $3,154,000 (rounded to the
nearest thousand dollars) and the cost of a priority review for NMEs is
1.67 times that amount, or $5,267,000 (rounded to the nearest thousand
dollars).
    Next, the cost of the IND review phase for these applications is
calculated. The standard lifetime cost of reviewing a drug IND in FY
2009 was $291,000 (rounded to the nearest thousand dollars). The
standard lifetime cost of a biologic IND review in FY 2009 was $860,000
(rounded to the nearest thousand dollars). Because there were 8
priority NDAs and 9 priority BLAs received in FY 2009, the following
formula estimates the average cost of the IND review phase of an
application:
    (8 NDAs x $291,000) + (9 BLAs x $860,000) = $10,068,000
    This is the full cost of the IND review associated with the 17
priority review applications received in FY 2009. Dividing $10,068,000
by 17 (the total number of priority review applications received in FY
2009), yields an average IND review phase cost of $592,000 (rounded to
the nearest thousand dollars) per priority review application.
    Adding the cost of the NDA/BLA priority review calculated
previously, $5,267,000, to the cost of the IND review phase of
$592,000, results in an estimated average cost for priority review for
an application received in FY 2009 of $5,859,000.
    Section 524 of the FD&C Act specifies that the fee amount should be
based on the average cost incurred by the Agency for a priority review
in the previous FY. FDA is setting fees for FY 2011, and the previous
FY is FY 2010. However, the FY 2010 submission cohort has not been
closed out yet, and the cost data for FY 2010 are not complete. The
latest year for which FDA has data is FY 2009. Accordingly, FDA will
adjust the previously mentioned FY 2009 cost figure by the average
amount by which FDA's average salary and benefit costs increased in the
5 years prior to FY 2011, to adjust the FY 2009 amount for cost
increases in FY 2010. That figure, published in the Federal Register of
August 4, 2010 (75 FR 46952 at 46954), which set Prescription Drug User
Fees for FY 2011, is 4.53 percent. Increasing the FY 2009 average
priority review cost figure of $5,859,000 by 4.53 percent results in an
estimated cost of $6,124,000 (rounded to the nearest thousand dollars).
    FDA will deduct from this amount the PDUFA fee that must also be
paid in addition to the priority review fee when an NDA or BLA with
clinical data is submitted in FY 2011. That amount, also published in
the Federal Register of August 4, 2010 (75 FR 46952 at 46957), which
set PDUFA fees for FY 2011, is $1,542,000. The difference, rounded to
the nearest thousand dollars, is $4,582,000. This is the priority
review user fee amount for FY 2011 that must be submitted with a
priority review voucher in FY 2011, in addition to any PDUFA fee that
is required for such an application.

III. Priority Review Fee Schedule for FY 2011

    The fee rate for FY 2011 is set out in table 1 of this document.

                                Table 1.
------------------------------------------------------------------------
               FEE CATEGORY                     FEE RATE FOR FY 2011
------------------------------------------------------------------------
APPLICATIONS SUBMITTED WITH A PRIORITY REVIEW VOUCHER
------------------------------------------------------------------------
  In addition to the normal PDUFA Fee      $4,582,000
------------------------------------------------------------------------

IV. Implementation of Priority Review Fee

    Under section 524(c)(4)(A) of the FD&C Act, the priority review
user fee is due upon submission of the application for which the
priority review voucher is used. Section 524(c)(4)(B) specifies that
the application will be considered incomplete if the priority review
user fee and all other applicable user fees are not paid in accordance
with FDA payment procedures. FDA may not grant a waiver, exemption,
reduction, or refund of any fees due and payable under this section of
the FD&C Act, and FDA may not collect priority review voucher fees
prior to a relevant appropriation for fees for that FY. Beginning with
FDA's appropriation for FY 2009, the annual appropriation language
states specifically that ``priority review user fees authorized by 21
U.S.C. 360n (section 524 of the FD&C Act) may be credited to this
account, to remain available until expended.'' (Public Law 111-8,
Section 5, Division A, Title VI).
    The priority review fee established in the new fee schedule must be
paid for any application that is received after September 30, 2010, and
submitted with a priority review voucher. This fee must be paid in
addition to any other fee due under PDUFA. Payment must be made in U.S.
currency by check, bank draft, or U.S. postal money order payable to
the order of the Food and Drug Administration. The user fee
identification (ID) number should be included on the check, followed by
the words ``Priority Review''. Payments can be mailed to: Food and Drug
Administration, P.O. Box 70963, Charlotte, NC 28272-0963.
    If checks are sent by a courier that requests a street address, the
courier can deliver the checks to: Wells Fargo QLP Lockbox D1113-022,
Attn: Food and Drug Administration Lockbox 70963, 1525 West WT Harris
Blvd., Charlotte,

NC 28262. (Note: This Wells Fargo address is for courier delivery
only.) The FDA post office box number (P.O. Box 70963) must be written
on the check. The tax identification number of the Food and Drug
Administration is 53-0196965.
    Wire transfer payments may also be used. Please reference your
unique user fee ID number when completing your transfer. The
originating financial institution may charge a wire transfer fee.
Please ask your financial institution about the fee and include it with
your payment to ensure that your fee is fully paid. The account
information is as follows: New York Federal Reserve Bank, U.S. Dept. of
Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.:
75060099, Routing No.: 021030004, SWIFT: FRNYUS33, Beneficiary: FDA,
1350 Piccard Dr., Rockville, MD 20850.
    Application fees can also be paid online with an electronic check
(ACH). FDA has partnered with the U.S. Department of Treasury to
utilize Pay.gov, a Web-based payment application, for online electronic
payment. The Pay.gov feature is available on FDA's Web site after the
user fee ID number is generated.

    Dated: September 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-22760 Filed 9-10-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 185 (Tuesday, September 28, 2021)]
[Rules and Regulations]
[Pages 53557-53558]
[FR Doc No: 2021-20357]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0385; FRL-8400-02-OCSPP]

Metaflumizone; Pesticide Tolerances; Technical Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Correcting amendment.

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SUMMARY: EPA issued a final rule in the Federal Register of April 19,
2021, establishing tolerances for residues of the insecticide
metaflumizone in or on multiple commodities requested by BASF
Corporation under the Federal Food, Drug, and Cosmetic Act (FFDCA).
That document inadvertently requested removal of tolerances for the
crop group fruit, stone, group 12-12. This document corrects the final
regulation.

DATES: This correction is effective September 28, 2021.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0385, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    The Agency included in the April 19, 2021 final rule a list of
those who may be potentially affected by this action.

II. What does this technical correction do?

    EPA issued a final rule in the Federal Register of April 19, 2021
(86 FR 20290) (FRL-10018-60) that established tolerances for residues
of the insecticide metaflumizone in or on multiple commodities. While
establishing tolerances in response to a petition requesting these
tolerances, EPA included erroneous language in its instructions to the
Federal Register, by directing the removal of the existing tolerance
established in Sec.  180.657 for ``Fruit, stone, group 12-12''. Instead
of instructing the Federal Register to Remove the entries for ``Fruit,
citrus, group 10-10''; ``Fruit, pome, group 11-10''; and ``Fruit,
stone, group 12-12'' the instructions should have only directed the
removal of entries for ``Fruit, citrus, group 10-10'' and ``Fruit,
pome, group 11-10''. EPA's instructions to remove the tolerances for
``Fruit, stone, group 12-12'' were not consistent with its authority
under FFDCA section 408(d)(4)(A). Therefore, EPA is rescinding its
instruction to remove ``Fruit, stone, group 12-12'' and reinstating the
tolerance level at 0.04 parts per million.

III. Why is this correction issued as a final rule?

    Section 553 of the Administrative Procedure Act (APA) (5 U.S.C.
553(b)(3)(B)) provides that, when an agency for good cause finds that
notice and public procedure are impracticable, unnecessary, or contrary
to the public interest, the agency may issue a final rule without
providing notice and an opportunity for public comment. EPA has
determined that there is good cause for making this technical
correction final without prior proposal and opportunity for comment,
because EPA inadvertently deleted the existing tolerance established
for ``Fruit, stone, group 12-12''. EPA finds that this constitutes good
cause under 5 U.S.C. 553(b)(3)(B).

IV. Do any of the statutory and executive order reviews apply to this
action?

    No. For a detailed discussion concerning the statutory and
Executive order review, refer to Unit VI. of the April 19, 2021 final
rule.

V. Congressional review act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: September 14, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is
correcting 40 CFR part 180 as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.657, amend the table in paragraph (a)(1) by adding in
alphabetical order the entry ``Fruit, stone, group 12-12'' to read as
follows:

Sec.  180.657  Metaflumizone; tolerances for residues.

    (a) * * *
    (1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Fruit, stone, group 12-12...............................            0.04

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

* * * * *
[FR Doc. 2021-20357 Filed 9-27-21; 8:45 am]
BILLING CODE 6560-50-P