accordance with Sec.  296.21(e)(5); the claimant closed the sale of a
home and wishes to present a claim for decrease in the value of the
real property under Sec.  296.21(c)(3); the claimant has incurred
additional losses under Sec.  296.21(c)(1) as part of a reconstruction
in excess of those previously awarded; or the Director of the Claims
Office otherwise determines that claimant has demonstrated good cause.

Sec.  296.36   Access to records.

    For purpose of audit and investigation, a claimant will grant the
DHS Office of the Inspector General and the Comptroller General of the
United States access to any property that is the subject of a claim and
to any and all books, documents, papers, and records (including any
relevant tax records) maintained by a claimant or under the claimant's
control pertaining or relevant to the claim.

Sec.  296.37   Confidentiality of information.

    Confidential information submitted by individual claimants is
protected from disclosure to the extent permitted by the Privacy Act.
These protections are described in the Privacy Act Notice provided with
the Notice of Loss. Other claimants should consult with FEMA concerning
the availability of confidentiality protection under exemptions to the
Freedom of Information Act and other applicable laws before submitting
confidential, proprietary or trade secret information.

Subpart E--Dispute Resolution

Sec.  296.40   Scope.

    This subpart describes a claimant's right to bring an
Administrative Appeal in response to the Authorized Official's
Determination. It also describes the claimant's right to pursue
arbitration or seek judicial review following an Administrative Appeal.

Sec.  296.41   Administrative appeal.

    (a) Notice of appeal. A claimant may request that the Director of
the Claims Office review the Authorized Official's determination by
written request to the Appeals Docket, Office of Hermit's Peak/Calf
Canyon Claims, postmarked or delivered within 120 days after the date
that appears on the Authorized Official's determination pursuant to
Sec.  296.32. The claimant will submit along with the notice of appeal
a statement explaining why the Authorized Official's determination was
incorrect. Information regarding where to file can be found at http://www.fema.gov/hermits-peak.
    (b) Acknowledgement of appeal. The Claims Office will acknowledge
receipt of an appeal. Following the receipt of a timely filed appeal,
the Director of the Claims Office will obtain the Administrative Record
from the

Authorized Official and transmit a copy to the claimant.
    (c) Supplemental filings. The claimant may supplement their
statement accompanying the appeal and provide any additional
documentary evidence supporting the appeal within 60 days after the
date when the appeal is filed. The Director of the Claims Office may
extend these timeframes or authorize additional filings either on their
own initiative or in response to a request by the claimant for good
cause shown.
    (d) Admissible evidence. The claimant may rely upon any relevant
evidence to support the appeal, regardless of whether the evidence was
previously submitted to the Claims Reviewer for consideration by the
Authorized Official.
    (e) Obtaining evidence. The Director of the Claims Office may
request from the claimant or from the Authorized Official any
additional information that is relevant to the issues posed by the
appeal in their discretion.
    (f) Conferences. The Director of the Claims Office may schedule a
conference to gain a better understanding of the issues or to explore
settlement or compromise possibilities. The claimant may also request a
conference. Conferences will generally be conducted virtually. In
limited circumstances, the Director may convene an in-person conference
at a location in New Mexico designated by the Director. A claimant may
request that the Director of the Claims Office appoint a mediator at
FEMA's expense to facilitate such conferences.
    (g) Hearings. The Director of the Claims Office may exercise the
discretion to convene an informal hearing to receive oral testimony
from witnesses or experts. The rules under which hearings will be
conducted will be established by the Director of the Claims Office and
provided to the claimant. Formal rules of evidence applicable to court
proceedings will not be used in hearings under this subsection.
Hearings will generally be conducted virtually, be transcribed, and the
transcript will be entered in the Administrative Record. In limited
circumstances, the Director may convene an in-person hearing at a
location in New Mexico designated by the Director.
    (h) Decision on appeal. After the allotted time for submission of
evidence has passed, the Director of the Claims Office will close the
Administrative Record and render a written decision on the
Administrative Appeal. The Director of the Claims Office's decision on
the Administrative Appeal will constitute the final decision of the
Administrator of FEMA under sections 104(d)(2)(B) and 104(i)(1) of the
Act.
    (i) Claimant's options following appeal. The claimant's concurrence
with the decision in the Administrative Appeal will be conclusively
presumed unless the claimant initiates arbitration in accordance with
Sec.  296.42 or seeks judicial review in accordance with Sec.  296.43.
If the claimant concurs with the Director's determination, payment of
any additional damages awarded by the Director will be made to the
claimant upon receipt of a properly executed Release and Certification
Form.

Sec.  296.42   Arbitration.

    (a) Initiating arbitration. A claimant who is dissatisfied with the
outcome of the Administrative Appeal may elect to submit the dispute to
a binding arbitration process. A claimant may initiate arbitration by
submitting a written request to the Arbitration Administrator for
Hermit's Peak/Calf Canyon Claims. Additional information regarding how
to submit a written arbitration request can be found at http://www.fema.gov/hermits-peak. The written request for arbitration must be
electronically stamped or postmarked no later than 60 days after the
date that appears on the Administrative Appeal decision.
    (b) Permissible claims. A claimant may not arbitrate an issue
unless it was raised and decided in the Administrative Appeal.
Arbitration will be conducted on the evidence in the Administrative
Record. Evidence not previously entered into the Administrative Record
will not be considered.
    (c) Selection of arbitrator. The Arbitration Administrator will
maintain a list of qualified arbitrators who have agreed to serve. The
arbitration will be decided by one arbitrator if the amount in dispute
is $500,000 or less and a panel of three arbitrators if the amount in
dispute exceeds $500,000. Arbitrators will be assigned by the
Arbitration Administrator through a random drawing.
    (d) Conduct of arbitration. Pursuant to guidelines from the
Arbitration Administrator, which will be provided directly to claimants
who have filed a request for arbitration, the arbitration process will
include an arbitration hearing with consideration of the claimant's
written request for arbitration, the Administrative Record, and oral
testimony. Hearings will generally be conducted virtually. In limited
circumstances, the arbitrator may convene an in-person hearing at a
location in New Mexico designated by the Arbitration Administrator.
    (e) Decision. After a hearing and reviewing the evidence, the
arbitrator(s) will render a written decision and will transmit the
decision to the Arbitration Administrator, the claimant, and the
Director of the Claims Office. If a panel of three arbitrators conducts
the arbitration, at least two of the three arbitrators must sign the
decision. The arbitrator(s) should render a decision no later than 10
Days after a hearing is concluded. The Arbitration Administrator may
extend the time for a decision with notice to the claimant and the
Director of the Claims Office. The decision will establish the
compensation due to the claimant, if any, and the reasons therefor.
    (f) Action on arbitration decision. The Arbitration Administrator
will forward the arbitration decision to the claimant and, if
additional compensation is awarded to the claimant, a Release and
Certification Form. Additional compensation awarded in the arbitration
will be paid to the claimant after the signed Release and Certification
Form is received by the Arbitration Administrator.
    (g) Final decision. The decision of the arbitrator(s) will be final
and binding on all parties and will not be subject to any
administrative or judicial review. The arbitrator(s) may correct
clerical, typographical or computational errors as requested by the
Arbitration Administrator.
    (h) Administration of arbitration. The Arbitration Administrator
oversees arbitration procedures and will resolve any procedural
disputes arising in the course of the arbitration.
    (i) Expenses. The Arbitration Administrator will pay all fees and
expenses of the arbitrator(s). The claimant is responsible for any
expenses they incur, including travel costs.

Sec.  296.43   Judicial review.

    As an alternative to arbitration, a claimant dissatisfied with the
outcome of an Administrative Appeal may seek judicial review of the
decision by bringing a civil lawsuit against FEMA in the United States
District Court for the District of New Mexico. This lawsuit must be
brought within 60 Days of the date that appears on the Administrative
Appeal decision. Pursuant to section 104(i) of the Act, the court may
only consider evidence in the Administrative Record. The court will
uphold FEMA's decision if it is supported by substantial

evidence on the record considered as a whole.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-24728 Filed 11-10-22; 8:45 am]
BILLING CODE 9111-68-P


[Federal Register: April 15, 2009 (Volume 74, Number 71)]
[Notices]
[Page 17547-17548]
[DOCID:fr15ap09-125]

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

[File No. 500-1]

VoIP, Inc.; Order of Suspension of Trading

 April 13, 2009.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
VoIP, Inc. (``VoIP'') because it has not filed an Annual Report on Form
10-K since December 31, 2006 or periodic or quarterly reports on Form
10-Q for any fiscal period subsequent to its fiscal quarter ending
September 30, 2007.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above listed company.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the

securities in the above listed company is suspended for the period from
9:30 a.m. EDT, April 13, 2009 through 11:59 p.m. EDT, on April 24,
2009.

    By the Commission.
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E9-8743 Filed 4-13-09; 4:15 pm]

BILLING CODE 8010-01-P


[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Proposed Rules]
[Pages 26887-26889]
[FR Doc No: 2018-12452]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0404; Product Identifier 2018-NE-15-AD]
RIN 2120-AA64

Airworthiness Directives; International Aero Engines (IAE)
Turbofan engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
International Aero Engines (IAE) PW1133G-JM, PW1133GA-JM, PW1130G-JM,
PW1127G-JM, PW1127GA-JM, PW1127G1-JM, PW1124G-JM, PW1124G1-JM, and
PW1122G-JM turbofan engines. This proposed AD was prompted by reports
of in-flight engine shutdowns and aborted take-offs as the result of
certain parts affecting the durability of the rear high-pressure
compressor (HPC) rotor hub knife edge seal. This proposed AD would
require replacing the diffuser case air seal assembly, the high-
pressure turbine (HPT) 2nd-stage vane assembly, and the HPT 2nd-stage
borescope stator vane assembly with parts eligible for installation. We
are proposing this AD to address the unsafe condition on these
products.

DATES: We must receive comments on this proposed AD by July 26, 2018.

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 http://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 service information identified in this NPRM, contact
International Aero Engines, 400 Main Street, East Hartford, CT 06118;
phone:<PHONE_NUMBER>; email: [email protected]; internet: http://fleetcare.pw.utc.com. You may view this service information at the FAA,
Engine and Propeller Standards Branch, 1200 District Avenue,
Burlington, MA 01803. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0404; 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 regulatory evaluation, any comments received, and other
information. The street address for Docket Operations (phone: 800-647-
5527) is listed above. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Kevin M. Clark, Aerospace Engineer,
ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone:
781-238-7088; fax:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2018-0404;
Product Identifier 2018-NE-15-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM because
of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this NPRM.

Discussion

    In-flight engine shutdowns and aborted take-offs have occurred on
certain IAE turbofan engines as the result of a failed knife edge seal
on engine serial numbers (ESNs) P770450 through P770614. In response to
these events, the European Aviation Safety Agency published AD 2018-
0041R1, dated March 23, 2018 (corrected on April 4, 2018).
Additionally, the FAA published AD 2018-04-01 (83 FR 6791,

February 15, 2018), for all Airbus Model A320-271N, A321-271N, and
A321-272N airplanes. Both ADs describe procedures to de-pair affected
airplanes and to discontinue extended operations (ETOPS) for airplanes
with at least one affected engine.
    An analysis by the manufacturer of these engine failures has shown
that production modifications to the diffuser case air seal assembly
and the 2nd-stage HPT vane assemblies, beginning with ESN P770450,
negatively affected the durability of the rear HPC rotor hub knife edge
seal. The modifications caused the knife edge seal on the rear HPC
rotor hub to experience high-cycle fatigue and failure. This condition,
if not addressed, could result in failure of one or more engines, loss
of thrust control, and loss of the airplane.

Related Service Information

    We reviewed Pratt & Whitney Alert Service Bulletin (ASB) PW1000G-C-
72-00-0099-00A-930A-D, Issue No. 002, dated March 15, 2018. The ASB
describes procedures for removing production modifications to the
diffuser case air seal assembly, HPT 2nd-stage vane assembly, and the
HPT 2nd-stage borescope stator vane assembly, beginning with ESN
P770450, which resulted in an unanticipated increase in stress at the
rear HPC rotor hub knife edge seal.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require removing from service and replacing
the diffuser case air seal assembly, P/N 30G4993-01; the HPT 2nd-stage
vane assembly, P/N 30G7572; and the HPT 2nd-stage borescope stator vane
assembly, P/N 30G7672, with parts eligible for installation.

Interim Action

    We consider this proposed AD interim action. The manufacturer is
currently developing a modification that will address the unsafe
condition identified in this AD. Once this modification is developed,
approved, and available, we might consider additional rulemaking.

Costs of Compliance

    We estimate that this proposed AD affects 16 engines installed on
airplanes of U.S. registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Removing modifications................  0 work-hours x $85 per           $44,000         $44,000        $704,000
                                         hour = $0.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to engines, propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation Division.

Regulatory Findings

    We 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) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

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 (AD):

International Aero Engines: Docket No. FAA-2018-0404; Product
Identifier 2018-NE-15-AD.

(a) Comments Due Date

    We must receive comments by July 26, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to International Aero Engines (IAE) PW1133G-JM,
PW1133GA-JM, PW1130G-JM, PW1127G-JM, PW1127GA-JM, PW1127G1-JM,
PW1124G-JM, PW1124G1-JM, and PW1122G-JM turbofan engines with engine
serial numbers (ESNs) P770450 through P770614.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7230, Turbine Engine
Compressor Section.

(e) Unsafe Condition

    This AD was prompted by reports of in-flight engine shutdowns
and aborted take-offs that were the result of a failed knife edge
seal on ESNs P770450 through P770614. We are issuing this AD to
prevent failure of the rear high-pressure compressor rotor hub knife
edge seal. The unsafe condition, if not addressed, could result in
failure of one or more engines, loss of thrust control, and loss of
the airplane.

(f) Compliance

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

(g) Required Actions

    At the next engine shop visit after the effective date of this
AD, do the following:
    (1) Remove from service the diffuser case air seal assembly,
part number (P/N) 30G4993-01, and replace with a part eligible for
installation.
    (2) Remove from service the high-pressure turbine (HPT) 2nd-
stage vane assembly, P/N 30G7572, and replace with a part eligible
for installation.
    (3) Remove from service HPT 2nd-stage borescope stator vane
assembly, P/N 30G7672, and replace with a part eligible for
installation.

(h) Definition

    For the purpose of this AD, an ``engine shop visit'' is the
induction of an engine into the shop for maintenance involving the
separation of pairs of major mating engine flanges (lettered
flanges). The separation of engine flanges solely for the purpose of
transportation of the engine without subsequent engine maintenance
does not constitute an engine shop visit.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO 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 local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in paragraph (j)(1) of this AD. You may email your
request to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    (1) For more information about this AD, contact Kevin M. Clark,
Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].
    (2) For service information identified in this AD, contact
International Aero Engines, 400 Main Street, East Hartford, CT
06118; phone:<PHONE_NUMBER>; email: [email protected]; internet:
http://fleetcare.pw.utc.com. You may view this referenced service
information at the FAA, Engine and Propeller Standards Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Burlington, MA, on June 6, 2018.
Robert J. Ganley,
Manager, Engine and Propeller Standards Branch, Aircraft Certification
Service.
[FR Doc. 2018-12452 Filed 6-8-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Page 53094]
[FR Doc No: 2021-20687]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4512-DR; Docket ID FEMA-2021-0001]

Virginia; Amendment No. 6 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Virginia (FEMA-4512-DR), dated April 2, 2020,
and related determinations.

DATES: This amendment was issued August 5, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
dated April 2, 2020 for the Commonwealth of Virginia is hereby amended
to include the Hazard Mitigation Grant Program.

    All areas within the Commonwealth of Virginia are eligible for
assistance under the Hazard Mitigation Grant Program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-20687 Filed 9-23-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 81, Number 5 (Friday, January 8, 2016)]
[Notices]
[Pages 937-938]
[FR Doc No: 2016-149]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-5073]

Use of Nucleic Acid Tests To Reduce the Risk of Transmission of
Hepatitis B Virus From Donors of Human Cells, Tissues, and Cellular and
Tissue-Based Products; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft document entitled ``Use of Nucleic Acid
Tests to Reduce the Risk of Transmission of Hepatitis B Virus from
Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products;
Draft Guidance for Industry.'' The draft guidance document provides
establishments that make donor eligibility determinations for donors of
human cells, tissues, and tissue-based products (HCT/Ps), with
recommendations concerning the use of FDA-licensed nucleic acid tests
(NAT) in donor testing for hepatitis B virus (HBV) deoxyribonucleic
acid (DNA). The draft guidance, when finalized, is intended to
supplement previous FDA recommendations to HCT/P establishments
concerning donor testing for hepatitis B surface antigen (HBsAg) and
total antibody to hepatitis B core antigen (anti-HBc), in the document
entitled ``Guidance for Industry: Eligibility Determination for Donors
of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/
Ps)'' dated August 2007 (2007 Donor Eligibility Guidance).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 7, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-5073 for ``Use of Nucleic Acid Tests to Reduce the Risk of
Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues,
and Cellular and Tissue Based Products; Draft Guidance for Industry.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the

claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Jessica T. Walker, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Use of Nucleic Acid Tests to Reduce the Risk of Transmission of
Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and
Tissue-Based Products; Draft Guidance for Industry.'' The draft
guidance document provides establishments that make donor eligibility
determinations for donors of HCT/Ps, with recommendations concerning
the use of FDA-licensed NAT in donor testing for HBV DNA. FDA considers
the use of FDA-licensed HBV NAT in testing HCT/Ps donors to be
necessary to adequately and appropriately reduce the risk of
transmission of HBV. The FDA-licensed HBV NAT can detect evidence of
the viral infection at an earlier stage than the HBsAg and total anti-
HBc tests. Therefore, FDA recommends the use of FDA-licensed HBV NAT
for testing donors of HCT/Ps for evidence of infection with HBV.
    HBV is a major global public health concern and has been
transmitted by blood transfusions and tissue transplantation. Available
literature has indicated possible transmissions of HBV by hematopoietic
stem cells and blood with HBV NAT positive/hepatitis B surface antigen
(anti-HBs) positive/HBsAg negative blood, irrespective of anti-HBc test
results. In blood donors, adding the HBV NAT testing for HBV reduces
the residual risk of transmission of HBV infection beyond that which
can be achieved by screening donors using only HBsAg and total anti-HBc
tests. In addition, it can detect breakthrough infections in previously
vaccinated individuals who are exposed to the virus, and HBV mutants
appear to be more likely detected by HBV NAT than by HBsAg assays.
    In the United States, there are currently FDA-licensed HBV NAT
assays with an indication for screening donor blood samples for Whole
Blood and Blood components, other living donors (individual organ
donors when specimens are obtained while the donor's heart is still
beating), and blood specimens from cadaveric (non-heart-beating)
donors. Some of these are multiplex assays that can simultaneously
detect HIV, HCV, and HBV in a single blood specimen, thus improving the
feasibility of routine NAT testing for HBV. By analogy to the
experience in the blood donor setting, it is reasonable to expect that
the residual risk of transmission of HBV infection would be reduced by
adding HBV NAT to the testing strategy for HCT/P donors. HBV NAT's
potential utility in further reducing risk of HBV transmission by
transplantation is mainly restricted to the early HBsAg-negative phase
of infection. In summary, the available scientific data and the
availability of FDA-licensed assays support a recommendation that all
HCT/Ps donors should be tested using an FDA-licensed HBV NAT. The draft
guidance, when finalized, is intended to supplement previous FDA
recommendations to HCT/P establishments concerning donor testing for
HBsAg and total anti-HBc, in the 2007 Donor Eligibility Guidance.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the ``Use of
Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B
Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-
Based Products.'' It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: January 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-149 Filed 1-7-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Notices]
[Pages 63916-63918]
[FR Doc No: 2018-26911]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84749; File No. SR-BX-2018-060]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Port Fees

December 7, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 27, 2018, Nasdaq BX, Inc. (``BX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III, below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to a proposal to amend port fees within
Options 7, Section 3, titled ``BX Options Market--Ports and Other
Services.''
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqbx.cchwallstreet.com/, at the principal office
of the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to define ``account
number'' and utilize that term within Options 7, Section 3. Each change
will be described in more detail below.
New Defined Term ``Account'' [sic]
    The Exchange proposes to adopt a new definition within Options 7,
Section 3 and apply this definition within the rule. The purpose of
this defined new term ``account number'' is to conform the Exchange's
use of certain terms within BX Rules. This term would be utilized in
Options 7, Section 3 to describe the manner in which pricing is
calculated. Recently, the Nasdaq affiliated exchanges filed rule
changes to conform the usage of various terms across its 6 affiliated
options markets within the various rulebooks.\3\ The Exchange believes
that utilizing the same defined terms, where possible, across its 6
affiliated options markets will avoid confusion for certain rules and
pricing purposes. The term ``account number'' can be defined
identically across Nasdaq's 6 affiliated options markets for purposes
of pricing ports. The Exchange is not amending the manner in which
pricing will be applied with respect to this particular change. The
Exchange proposes to utilize the defined term ``account number'' in
place of the term ``mnemonic,'' which was not defined in the pricing
rules. The insertion of the new defined term is intended to add more
specificity and clarity to the current pricing.
---------------------------------------------------------------------------

    \3\ BX filed to define the terms ``account number,'' ``badge''
and ``mnemonic'' at Chapter I, Section 1(a)(70), (71) and (72)
respectively. See Securities Exchange Act Release No. 84520
(November 1, 2018), 83 FR 55765 (November 7, 2018) (SR-BX-2018-050).
The Nasdaq Stock Market LLC filed to amend The Nasdaq Options Market
LLC rules to define the terms ``account number,'' ``badge'' and
``mnemonic'' at Chapter I, Section 1(a)(69), (70) and (71)
respectively. See Securities Exchange Act Release No. 84571
(November 9, 2018), 83 FR 57758 (November 16, 2018) (SR-NASDAQ-2018-
086). Nasdaq Phlx LLC has filed to define the terms ``account
number,'' ``badge'' and ``mnemonic'' at Rule 1000(b)(51), (52) and
(53) respectively. See Securities Exchange Act Release No. 84620
(November 19, 2018), 83 FR 60512 (November 6, 2018) (SR-Phlx-2018-
71). See also ISE Rule 100(a)(1), (5) and (34) which defines the
terms ``account number,'' ``badge'' and ``mnemonic,'' respectively.
See also GEMX Rule 100(a)(1), (5) and (35) which defines the terms
``account number,'' ``badge'' and ``mnemonic,'' respectively. See
also MRX Rule 100(a)(1), (5) and (36) which defines the terms
``account number,'' ``badge'' and ``mnemonic,'' respectively.
---------------------------------------------------------------------------

    At this time, the Exchange proposes to define an ``account number''
within Options 7, Section 3 to mean a number assigned to a Participant.
Participants may have more than one account number. The term
``mnemonic'' has been used frequently throughout Options 7 without
being defined. The Exchange proposes to remove the term ``mnemonic''
from Options 7, Section 3 and replace the term with the defined term
``account number'' for the FIX protocol. The Exchange notes that the
terms mnemonic and account number were being used interchangeably. The
Exchange recently defined both terms in its rules.\4\ The term account
number is appropriate to describe these fees. The Exchange is not
amending the manner in which it assesses the FIX port, rather the
Exchange simply proposes to utilize the new term to better describe its
current pricing.
---------------------------------------------------------------------------

    \4\ A ``mnemonic'' is defined as an acronym comprised of letters
and/or numbers assigned to Participants. A Participant account may
be associated with multiple mnemonics. See Securities Exchange Act
Release No. 84520 (November 1, 2018), 83 FR 55765 (November 7, 2018)
(SR-BX-2018-050). Mnemonics are issued to Participants to identify
associated persons of Participants.
---------------------------------------------------------------------------

    Also, the Exchange proposes to remove the term ``mnemonic'' from
the CTI Port Fee, FIX DROP Port Fee, BX Depth Port Fee and BX Top Port
Fee. Today, these ports are assessed only one fee per port, per month
and therefore adding the term ``per account number'' would be redundant
and unnecessary. These ports are associated with one account number.
The Exchange is not proposing to amend the manner in which these ports
are assessed, rather the Exchange proposes to eliminate the ``per
mnemonic'' description. The Exchange believes that the billing is
clearly defined as ``per port, per month.''
    The Exchange also proposes to amend current ``(c) Access and
Redistribution Fee'' as ``v'' to conform to the remainder of the rule.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\5\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\6\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility, and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

New Defined Term ``Account'' [sic]
    The Exchange's proposal to define the term ``account number''
within Options, Section 3 and apply that term within the rule in place
of the term ``mnemonic'' as to the manner in which FIX Port Fees are
priced is reasonable because the term is defined and will be utilized
consistently throughout Options 7, where applicable. The usage of the
defined term ``account number'' will

bring uniformity to the term and its usage across the 6 affiliated
options markets. The proposed change to utilize the defined term will
not amend the manner in which the ports are billed, rather it will also
bring greater clarity to pricing in Options 7, Section 3.
    The Exchange's proposal to define the term ``account number''
within Options 7, Section 3 and apply that term within Options 7,
Section 3, in place of the term ``mnemonic'' for the FIX Port Fee is
equitable and not unfairly discriminatory because the Exchange proposes
to apply that term uniformly in billing Participants utilizing those
ports.
    The Exchange's proposal to remove the term ``mnemonic'' for the
pricing of the CTI Port Fee, FIX DROP Port Fee, BX Depth Port Fee and
BX Top Port Fee is reasonable because, today, these ports are assessed
only one fee per port, per month and this change will bring greater
clarity to the manner in which these services are billed. The term
``mnemonic'' was undefined until the Exchange filed to define that term
within the BX Rules.\7\ The manner in which the term ``mnemonic'' was
defined for purposes of BX's Rules is not the manner that was intended
for pricing these ports. To that end, the Exchange proposes to remove
the term ``mnemonic'' and replace that term with ``account number,''
where applicable, to convey the intended manner in which the Exchange
prices ports. This proposal will conform the defined term across BX
Rules.\8\ Today, these ports are assessed only one fee per port, per
month and therefore adding the term ``per account number'' would be
redundant and unnecessary. These ports are associated with one account
number. This proposal will conform the defined term across BX Rules.
The Exchange is not proposing to amend the manner in which these ports
are assessed, rather the Exchange proposes to eliminate the ``per
mnemonic'' description and more clearly define the manner in which
these services are billed as ``per port, per month.''
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 84520 (November 1,
2018), 83 FR 55765 (November 7, 2018) (SR-BX-2018-050).
    \8\ See Chapter I, Section 1(a)(70).
---------------------------------------------------------------------------

    The Exchange's proposal to remove the term ``mnemonic'' for the
pricing of the CTI Port Fee, FIX DROP Port Fee, BX Depth Port Fee and
BX Top Port Fee is equitable and not unfairly discriminatory because
the Exchange will continue to uniformly assess all market participants
these services in a uniform manner. The proposed change does not amend
the manner in which these services are billed.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. In terms of inter-market
competition, the Exchange notes that this proposal does not amend
actual fees, rather the Exchange proposes to amend the name of a port
fee and define a new term to be used more accurately to describe the
manner in which certain services within Options 7, Section 3 are
billed.
New Defined Term ``Account'' [sic]
    The Exchange's proposal to define the term ``account number''
within Options 7, Section 3 and apply that term within that rule in
place of the term ``mnemonic'' with respect to the manner in which FIX
protocols are priced does not impose an undue burden on intra-market
competition because the Exchange proposes to apply that term uniformly
in billing Participants utilizing those ports. No changes are being
made to the manner in which the Exchange bills these ports.
    The Exchange's proposal to remove the term ``mnemonic'' for the
pricing of the CTI Port Fee, FIX DROP Port Fee, BX Depth Port Fee and
BX Top Port Fee does not impose an undue burden on intra-market
competition because the Exchange will continue to uniformly assess all
market participants these services in a uniform manner. The proposed
change does not amend the manner in which these services are billed.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\9\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BX-2018-060 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
    All submissions should refer to File Number SR-BX-2018-060. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-BX-2018-060 and should

be submitted on or before January 2, 2019.
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-26911 Filed 12-11-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Notices]
[Pages 49326-49327]
[FR Doc No: 2019-20284]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4459-DR; Docket ID FEMA-2019-0001]

Wisconsin; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Wisconsin (FEMA-4459-DR), dated August 27,
2019, and related determinations.

DATES: The declaration was issued August 27, 2019.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated August 27, 2019, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of Wisconsin resulting from severe storms, tornadoes, straight-line
winds, and flooding during the period of July 18 to July 20, 2019,
is of sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of Wisconsin.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Steven W. Johnson of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Wisconsin have been designated
as adversely affected by this major disaster:

    Barron, Clark, Forest, La Crosse, Langlade, Menominee, Monroe,
Oconto, Oneida, Outagamie, Polk, Portage, Rusk, Shawano, Vernon,
Waupaca, and Wood Counties and the Menominee Indian Tribe of
Wisconsin and the St. Croix Chippewa Indians of Wisconsin for Public
Assistance.
    All areas within the State of Wisconsin are eligible for
assistance under the Hazard Mitigation Grant Program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance

(Presidentially Declared Disasters); 97.039, Hazard Mitigation
Grant.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-20284 Filed 9-18-19; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Rules and Regulations]
[Pages 7290-7292]
[FR Doc No: 2019-03777]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0713]
RIN 1625-AA00

Safety Zone; Chicago Harbor, Navy Pier Southeast, Chicago, IL

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is modifying the Navy Pier Southeast Safety
Zone within the Chicago Harbor. This action is necessary to alleviate
congestion near the Chicago Lock during regularly scheduled fireworks
events. The current safety zone encompasses part of the lock
restricting vessels during events. This rule allows the lock to remain
in full operation during the fireworks display.

DATES: This rule is effective April 3, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2018-0713 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions about this rule,
call or email LT John Ramos, Waterways Management Division, Marine
Safety Unit Chicago, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Captain of the Port (COTP) Lake Michigan is modifying the size
of the established safety zone outlined in 33 CFR 165.931 (a) to allow
for the Chicago Lock to remain open during fireworks displays. The
current safety zone encompasses all waters of Lake Michigan within
Chicago Harbor bounded by coordinates beginning at 41[deg]53'26.5'' N,
087[deg]35'26.5'' W; then south to 41[deg]53'7.6'' N, 087[deg]35'26.3''
W; then west to 41[deg]53'7.6'' N, 087[deg]36'23.2'' W; then north to
41[deg]53'26.5'' N, 087[deg]36'24.6'' W; then east back to the point of
origin (NAD 83). The safety zone in this final rule still ensures a
safe distance for spectators while allowing the Chicago Lock to remain
open during the duration of the fireworks. The area in this final rule
encompasses all waters of Lake Michigan within Chicago Harbor bounded
by coordinates beginning at 41[deg]53'23.3'' N, 087[deg]36'04.5'' W;
then south to 41[deg]53'11.8'' N, 087[deg]36'04.1'' W; then west to
41[deg]53'12.1'' N, 087[deg]35'40.5'' W; then north to 41[deg]53'23.6''
N, 087[deg]35'40.07'' W; then east back to the point of origin (NAD
83).
    On September 13, 2018 the Coast Guard published a notice of
proposed rulemaking (NPRM) in the Federal Register titled Safety Zone;
Chicago Harbor, Navy Pier Southeast, Chicago, IL, 33 CFR part 165 (83
FR 46449).
    Included in the NPRM was an invitation to make comments on the
proposed regulatory action for the modification of the size of the Navy
Pier Southeast Safety Zone. The Coast Guard received 14 comments during
the comment period, which ended October 15, 2018.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The COTP Lake Michigan has determined that modifying the
preexisting safety zone will reduce congestion near the Chicago Lock.
This rule would not significantly change the regulatory language found
in 33 CFR 165.931. The change will only moderately reduce the size of
the safety zone with updated coordinates, found in 33 CFR 165.931 (a).
The purpose of this rule is to protect the safety of vessels and
persons in the safety zone before, during, and after scheduled events
while allowing the Chicago Lock to remain open for vessel traffic.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, The Coast Guard received fourteen (14) comments on
our NPRM published September 13, 2018. There were ten (10) comments
that supported modifying the size of the safety zone to allow the
Chicago Lock and Dam to remain open, allowing vessels to proceed during
the Fireworks Display. There were two (2) comments that were unrelated
to the modification of the Safety Zone and two (2) comments that
addressed congestion and the safety issues of modifying the size of the
Safety Zone.
    One of these comments misinterpreted the authority under which the
safety zone is issued. The commenter refers to 50 U.S.C. 191 but that
statute provides the authority for security zones. See, 33 CFR
165.9(c). As noted above in the ``Legal Authority and Need for Rule''
section, this rule is under authority in 33 U.S.C. 1231.
    The other comment failed to comprehend that the safety zone in this
final rule does allow vessel traffic to safely proceed through the
Chicago Lock without entering the safety zone. The safety zone in this
final rule was evaluated and we determined that the reduction in size
could be accomplished safely while allowing the Chicago Lock to remain
open for vessel traffic. Allowing the Lock to remain open alleviates
vessel congestion that is also a safety concern.
    After review, the Coast Guard amended this final rule by updating
the coordinates outlined in the NPRM to take into account applicable
comments and suggestions. The new safety zone will encompass all waters
of Lake Michigan within Chicago Harbor bounded by coordinates beginning
at 41[deg]53'23.3'' N, 087[deg]36'04.5'' W; then south to
41[deg]53'11.8'' N, 087[deg]36'04.1'' W; then west to 41[deg]53'12.1''
N, 087[deg]35'40.5'' W; then north to 41[deg]53'23.6'' N,
087[deg]35'40.07'' W; then east back to the point of origin (NAD 83).

    This rule does reduce the size of the safety zone outlined in 33
CFR 165.931 (a), but the size of the new safety zone still ensures a
safe distance for spectators as well as vessels entering and exiting
the locks. These new coordinates will allow vessels transiting to and
from the lock to proceed North or South, while still maintaining a safe
distance from the Fireworks Display. No vessel or person will be
permitted to enter the safety zone without obtaining permission from
the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 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. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and, pursuant to OMB guidance, it is
exempt from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. Vessel traffic
will be able to safely transit around this safety zone which would
impact a small designated area for less than 1 hour during the
scheduled events. Indeed, this action will allow for greater transit
than the pre-existing safety zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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. The Coast Guard received no comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), the Coast Guard wants to assist
small entities in understanding this rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). 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.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. The Coast Guard has analyzed this rule under that Order and
has determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does 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. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.

E. 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. Though this rule will not result in
such an expenditure, we discuss the effects of this rule elsewhere in
this preamble.

F. Environment

    The Coast Guard has analyzed this rule under Department of Homeland
Security Directive 023-01 and Commandant Instruction M16475.1D, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves a safety zone enforced intermittently, and for no longer
than the time necessary to protect vessels and persons during scheduled
Fireworks Displays. It is categorically excluded from further review
under L60 (a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-
001-01, Rev. 01. A Record of Environmental Consideration supporting
this reduction in size of a preexisting safety zone is available in the
docket where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Amend Sec.  165.931 by revising paragraph (a) to read as follows:

Sec.  165.931   Safety Zone, Chicago Harbor, Navy Pier Southeast,
Chicago, IL.

    (a) Location. The following area is a safety zone: The waters of
Lake Michigan within Chicago Harbor bounded by coordinates beginning at
41[deg]53'23.3'' N, 087[deg]36'04.5'' W; then south to 41[deg]53'11.8''
N, 087[deg]36'04.1'' W; then west to 41[deg]53'12.1'' N,
087[deg]35'40.5'' W; then north to 41[deg]53'23.6'' N,
087[deg]35'40.7'' W; then east back to the point of origin (NAD 83).
* * * * *

    Dated: February 26, 2019.
Thomas J. Stuhlreyer,
Captain, U.S. Coast Guard, Captain of the Port, Lake Michigan.
[FR Doc. 2019-03777 Filed 3-1-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: July 19, 2007 (Volume 72, Number 138)]
[Rules and Regulations]
[Page 39574-39576]
[DOCID:fr19jy07-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R05-OAR-2006-0459; FRL-8440-4]

Determination of Attainment, Approval and Promulgation of
Implementation Plans and Designation of Areas for Air Quality Planning
Purposes; Indiana; Redesignation of LaPorte County to Attainment for
Ozone

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: On May 30, 2006, the Indiana Department of Environmental
Management (IDEM) submitted a request for EPA approval of redesignation
of LaPorte County to attainment of the 8-hour ozone National Ambient
Air Quality Standard (NAAQS). In this submittal, IDEM also requested
EPA approval of an Indiana State Implementation Plan (SIP) revision
containing a plan to maintain the ozone standard in LaPorte County
through 2020 and established 2020 motor vehicle Volatile Organic
Compounds (VOC) and Nitrogen Oxides (NOX) emission budgets
for LaPorte County. EPA is making a determination that LaPorte County,
Indiana has attained the 8-hour ozone NAAQS. This determination is
based on three years of complete, quality assured ambient air quality
monitoring data for the 2003-2005 ozone seasons that demonstrate that
the 8-hour ozone NAAQS has been attained in LaPorte County. Quality
assured monitoring data for 2006 show that the area continues to attain
the ozone standard. EPA is approving, as a SIP revision, the State's
ozone maintenance plan for LaPorte County. As a result, Indiana has
satisfied the criteria for redesignation of LaPorte County to
attainment of the 8-hour ozone NAAQS, and EPA is approving Indiana's
ozone redesignation request for this area. Further, EPA is approving,
for purposes of transportation conformity, the motor vehicle emission
budgets (MVEBs) for VOC and NOX for the year 2020 that are
contained in the 8-hour ozone maintenance plan for this area.

DATES: This final rule is effective on July 19, 2007.

ADDRESSES: EPA has established a docket for this action under Docket ID
NO. EPA-R05-OAR-2006-0459. All documents in the docket are listed on
the http://www.regulations.gov Web site. Although listed in the index, some

information is not publicly available, i.e., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet, and will be publicly available only in hard
copy form. Publicly available docket materials are available either
electronically through http://www.regulations.gov or in hard copy at the

Environmental Protection Agency, Region 5, Air and Radiation Division,
77 West Jackson Boulevard, Chicago, Illinois 60604. This facility is
open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
Federal holidays. We recommend that you telephone Edward Doty,
Environmental Scientist, at<PHONE_NUMBER> before visiting the Region 5
office.

FOR FURTHER INFORMATION CONTACT: Edward Doty, Environmental Scientist,
Criteria Pollutant Section, Air Programs Branch (AR-18J), U.S.
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the following, whenever ``we,'' ``us,''
or ``our'' are used, we mean the United States Environmental Protection
Agency.

Table of Contents

I. What Is the Background for This Rule?
II. What Comments Did We Receive on the Proposed Action?
III. Impacts of Recent Court Decisions
IV. What Are Our Final Actions?
IV. Statutory and Executive Order Review

I. What Is the Background for This Rule?

    The Clean Air Act (CAA) requires EPA to designate as nonattainment
any area that is violating the 8-hour ozone NAAQS based on three
consecutive years of air quality monitoring data. EPA designated
LaPorte County, Indiana as a nonattainment area for the 8-hour ozone
NAAQS in a Federal Register notice published on April 30, 2004 (69 FR
23857). At the same time, EPA classified LaPorte County as a subpart 2
moderate 8-hour ozone nonattainment area, based on quality assured air
quality data for the period of 2001-2003.
    On May 30, 2006, Indiana submitted a request for redesignation of
LaPorte County to attainment of the 8-hour ozone NAAQS. Additional
supporting information was submitted on August 24, 2006. The
redesignation request included three years of complete, quality-assured
data for the period of 2003-2005, indicating attainment of the 8-hour
ozone NAAQS. The ozone data show attainment of the 8-hour ozone NAAQS
when the 3-year average of the annual fourth-highest daily maximum 8-
hour average ozone concentration is less than or equal to 0.08 parts
per million parts of air at all monitoring sites in an area. Under the
CAA, nonattainment areas may redesignated to attainment if sufficient
complete, quality-assured data are available for the Administrator to
determine that an area has attained the standard and if the area meets
other redesignation requirements in section 107(d)(3)(E) of the CAA. An
April 18, 2007, proposed rule (72 FR 19424) provides a discussion of
how LaPorte County and the State of Indiana met these requirements for
this area.

II. What Comments Did We Receive on the Proposed Action?

    EPA provided a 30-day review and comment period on the April 18,
2007, proposed rule. No comments were received by the EPA regarding
this proposed rule.

III. Impacts of Recent Court Decisions

    On December 22, 2006, the U.S. Court of Appeals for the District of
Columbia Circuit vacated EPA's Phase 1 implementation rule for the 8-
hour ozone standard (69 FR 23951, April 30, 2004). South Coast Air
Quality Management Dist. v. EPA, 472 F.3d 882 (D.C. Cir. 2006). On June
8, 2007, in South Coast Management Dist. v. EPA, Docket No. 04-1201, in
response to several petitions for rehearing, the D.C. Circuit clarified
that the Phase 1 rule was vacated only with regard to those parts of
the rule that had been successfully challenged. Therefore, the Phase 1
rule provisions related to classifications for areas currently
classified under subpart 2 of Title I, part D of the CAA as
nonattainment areas, the 8-hour attainment dates and the timing for
emissions reductions needed for attainment of the 8-hour ozone NAAQS
remain effective. The June 8th decision left intact the Court's
rejection of EPA's reasons for implementing the 8-hour ozone standard
in certain nonattainment areas under subpart 1 in lieu of subpart 2. By
limiting the vacatur, the Court let stand EPA's revocation of the 1-
hour ozone standard and anti-backsliding provisions of the Phase 1 rule
that had not been successfully challenged. The June 8th decision
reaffirmed the December 22, 2006, decision that EPA had improperly
failed to retain four measures required for 1-hour ozone nonattainment
areas under the anti-backsliding provisions of the regulations: (1)
Nonattainment area New Source Review (NSR) requirements based on an
area's 1-hour nonattainment

classification; (2) section 185 penalty fees for 1-hour severe or
extreme nonattainment areas; (3) measures to be implemented pursuant to
section 172(c)(9) or 182(c)(9) of the CAA, on the contingency of an
area not making reasonable further progress toward attainment of the 1-
hour ozone NAAQS, or for failure to attain that NAAQS; and, (4) certain
transportation conformity requirements for certain types of Federal
actions. The June 8th decision clarified that the Court's reference to
conformity requirements was limited to requiring the continued use of
1-hour motor vehicle emissions budget until 8-hour budgets were
available for 8-hour conformity determinations.
    For the reasons set forth in the proposal, EPA does not believe
that the Court's rulings alter any requirements relevant to this
redesignation action so as to preclude redesignation, and do not
prevent EPA from finalizing this redesignation. EPA believes that the
Court's December 22, 2006, and June 8, 2007, decisions impose no
impediment to moving forward with redesignation of this area to
attainment, because even in light of the Court's decisions,
redesignation is appropriate under the relevant redesignation
provisions of the CAA and longstanding policies regarding redesignation
requests.
    With respect to the 8-hour ozone standard, LaPorte County, which is
classified as a marginal nonattainment area under subpart 2, the June
8, 2007, opinion clarifies that the Court did not vacate the Phase 1
rule's provisions with respect to classifications for areas under
subpart 2. The Court's decision, therefore, upholds EPA's
classification for LaPorte County under subpart 2 for the 8-hour ozone
standard.

IV. What Are Our Final Actions?

    EPA is taking several related actions. EPA is making a
determination that LaPorte County, Indiana has attained the 8-hour
ozone standard. EPA is approving Indiana's ozone maintenance plan as a
SIP revision for LaPorte County (such approval being one of the CAA
criteria for redesignation to attainment). The maintenance plan is
designed to keep LaPorte County in attainment of the 8-hour ozone NAAQS
through 2020. Because Indiana has met these and other prerequisites for
redesignation to attainment, EPA is approving the State's request to
change the legal designation of LaPorte County from nonattainment to
attainment of the 8-hour ozone NAAQS. In addition, and supported by and
consistent with the ozone maintenance plan, EPA is approving the 2020
VOC and NOX MVEBs for LaPorte County for transportation
conformity purposes. The 2020 MVEBs for LaPorte County are 3.40 tons
per day for VOC and 6.50 tons per day for NOX.
    EPA finds that there is good cause for these actions to become
effective immediately upon publication because a delayed effective date
is unnecessary due to the nature of redesignation to attainment, which
relieves the area from certain CAA requirements that would otherwise
apply to it. The immediate effective date for this action is authorized
under both 5 U.S.C. 553(d)(1), which provides that rulemaking actions
may become effective less than 30 days after publication if the rule
``grants or recognizes an exemption or relieves a restriction'' and
section 553(d)(3), which allows an effective date less than 30 days
after publication ``as otherwise provided by the agency for good cause
found and published with the rule.'' The purpose of the 30-day waiting
period prescribed in 553(d) is to give affected parties a reasonable
time to adjust their behavior and prepare before the final rule takes
effect. Today's rule, however, does not create any new regulatory
requirements such that affected parties would need time to prepare
before the rule takes effect. Rather, today's rule relieves the State
of planning requirements for this 8-hour ozone nonattainment area. For
these reasons, EPA finds good cause under 5 U.S.C. 553(d)(3) for these
actions to become effective on the date of publication of these
actions.

IV. Statutory and Executive Order Review

Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and, therefore, is
not subject to review by the Office of Management and Budget.

Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    Because it is not a ``significant regulatory action'' under
Executive Order 12866 or a ``significant energy action,'' this action
is also not subject to Executive Order 13211, ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001).

Regulatory Flexibility Act

    This action merely approves state law as meeting Federal
requirements and imposes no additional requirements beyond those
imposed by state law. Redesignation of an area to attainment under
section 107(d)(3)(E) of the Clean Air Act does not impose any new
requirements on small entities. Redesignation is an action that affects
the status of a geographical area and does not impose any new
regulatory requirements on sources. Accordingly, the Administrator
certifies that this rule will not have a significant economic impact on
a substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.).

Unfunded Mandates Reform Act

    Because this rule approves pre-existing requirements under state
law and does not impose any additional enforceable duty beyond that
required by state law, it 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).

Executive Order 13175: Consultation and Coordination With Indian Tribal
Governments

    This rule also does not have tribal implications because it will
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, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000).

Executive Order 13132: Federalism

    This action also does not have Federalism implications because it
does not have substantial direct effects on the states, on the
relationship between the national government and the states, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132 (64 FR 43255, August
10, 1999). Redesignation is an action that merely affects the status of
a geographical area, and does not impose any new requirements on
sources, or allows a state to avoid adopting or implementing additional
requirements, and does not alter the relationship or distribution of
power and responsibilities established in the Clean Air Act.

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

    This rule also is not subject to Executive Order 13045 ``Protection
of Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), because it approves a state rule implementing a
Federal Standard.

National Technology Transfer Advancement Act

    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
state to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Redesignation is an
action that affects the status of a geographical area but does not
impose any new requirements on sources. Thus, the requirements of
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (15 U.S.C. 272 note) do not apply.

Paperwork Reduction Act

    This rule does not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).

Congressional Review Act

    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 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. 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 September 17, 2007. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review, nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to force its requirements. (See Section 307(b)(2).)

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Nitrogen dioxide, Ozone, Particulate matter, Volatile
organic compounds.

40 CFR Part 81

    Air pollution control, Environmental protection, National parks,
Wilderness areas.

    Dated: July 5, 2007.
Bharat Mathur,
Acting Regional Administrator, Region 5.

0
Parts 52 and 81, chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--[AMENDED]

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

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

Subpart P--Indiana

0
2. Section 52.777 is amended by adding paragraph (gg) to read as
follows:

Sec.  52.777  Control strategy: Photochemical oxidants (hydrocarbons).

* * * * *
    (gg) Approval--On May 30, 2006, Indiana submitted a request to
redesignate LaPorte County to attainment of the 8-hour ozone National
Ambient Air Quality Standard. As part of the redesignation request, the
State submitted a maintenance plan as required by section 175A of the
Clean Air Act. Elements of the section 175 maintenance plan include a
contingency plan and an obligation to submit a subsequent maintenance
plan revision in eight years as required by the Clean Air Act. The
maintenance plan establishes 2020 motor vehicle emission budgets for
LaPorte County of 3.40 tons per day for volatile organic compounds
(VOC) and 6.50 tons per day for oxides of nitrogen (NOX).

PART 81--[AMENDED]

0
1. The authority citation for part 81 continues to read as follows:

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

0
2. Section 81.315 is amended by revising the entries for LaPorte
County, Indiana: LaPorte County in the table entitled ``Indiana Ozone
(8-Hour Standard)'' to read as follows:

Sec.  81.315  Indiana.

* * * * *

                                                   Ohio Ozone
                                                [8-hour standard]
----------------------------------------------------------------------------------------------------------------
                                               Designation \a\                         Classification
         Designated area          ------------------------------------------------------------------------------
                                     Date \1\              Type              Date \1\             Type
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
LaPorte Co., IN:
    LaPorte County...............      8/20/07  Attainment...............

                                                 * * * * * * *
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as otherwise specified.
\1\ This date is June 15, 2004, unless otherwise noted.

[FR Doc. E7-13794 Filed 7-18-07; 8:45 am]

BILLING CODE 6560-50-P