[Federal Register Volume 87, Number 28 (Thursday, February 10, 2022)]
[Rules and Regulations]
[Pages 7687-7690]
[FR Doc No: 2022-02747]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0964; Project Identifier 2018-SW-051-AD; Amendment
39-21909; AD 2022-02-12]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.a. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Leonardo S.p.a. Model AB139 and AW139 helicopters. This AD was prompted
by the identification of certain parts needing maintenance actions,
including life limits and maintenance tasks. This AD requires
incorporating into maintenance records requirements (airworthiness
limitations), as specified in a European Aviation Safety Agency (now
European Union Aviation Safety Agency) (EASA)

AD, which is incorporated by reference. The FAA is issuing this AD to
address the unsafe condition on these products.

DATES: This AD is effective March 17, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of March 17,
2022.

ADDRESSES: For EASA material 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 the EASA material on the EASA website
at https://ad.easa.europa.eu. You may view this material at the FAA,
Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy.,
Room 6N-321, Fort Worth, TX 76177. 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-2021-0964.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0964; 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 final rule, the
EASA AD, any comments received, and other information. The address for
Docket Operations is U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Kristi Bradley, Program Manager, COS
Program Management Section, Operational Safety Branch, Compliance &
Airworthiness Division, FAA, 10101 Hillwood Pkwy., Fort Worth, TX
76177; telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2018-0132, dated June 21, 2018 (EASA
AD 2018-0132) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for all Leonardo S.p.A. Model AB139 and AW139 helicopters.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all Leonardo S.p.A.
Model AB139 and AW139 helicopters. The NPRM published in the Federal
Register on November 12, 2021 (86 FR 62744). The NPRM was prompted by
the identification of certain parts needing maintenance actions,
including life limits and maintenance tasks. The parts include a
certain part-numbered main rotor damper, tail gear box center housing,
and tail assembly, the fuselage structure assembly (station (STA) 5700,
right-hand (RH)/left-hand (LH) side), and tail structure assembly
(tail/rear fuselage attachment fittings). The NPRM proposed to require
incorporating into maintenance records requirements (airworthiness
limitations), as specified in EASA AD 2018-0132.
    The FAA is issuing this AD to address the failure of certain parts,
which could result in the loss of control of the helicopter. See EASA
AD 2018-0132 for additional background information.

Discussion of Final Airworthiness Directive

Comments

    The FAA received a comment from one commenter, Bristow Group, who
commented on the service information. The following presents the
comment received on the NPRM and the FAA's response to the comment.

Request To Consider Service Information

    The commenter stated it would take into consideration that the
service information identified in EASA AD 2018-0132 (Leonardo AB139 and
AW139 Maintenance Manual (MM), 39-A-AMPI-00-P, Chapter IV,
Airworthiness Limitations, Issue 9, dated March 6, 2018, as well as
Issue 8) has already been added. The commenter noted the EASA AMPI
(i.e., the airworthiness limitations section (ALS) document) is already
on Issue 14 and the FAA AMPI is on Issue 13. The FAA infers the
commenter is requesting the FAA consider the effect of later revisions
of the ALS document on the proposed AD.
    The FAA agrees to clarify the effect of later revisions of the ALS
document on this AD. This AD mandates a specific revision of the ALS
document. Later revisions of the ALS document are not required to be
incorporated into maintenance records requirements (airworthiness
limitations) for that helicopter unless an AD mandates those revisions.
However, this AD also allows operators to incorporate later approved
revisions of the ALS document as specified in the Ref. Publications
section of EASA AD 2018-0132 without the need for an alternative method
of compliance (AMOC). Historically, operators needed an AMOC to use
later revisions of an ALS. The FAA has not changed this AD in this
regard.

Conclusion

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA reviewed the relevant
data, considered the comment received, and determined that air safety
requires adopting this AD as proposed. Accordingly, the FAA is issuing
this AD to address the unsafe condition on these helicopters. Except
for minor editorial changes, this AD is adopted as proposed in the
NPRM. None of the changes will increase the economic burden on any
operator.

Related Service Information Under 1 CFR Part 51

    EASA AD 2018-0132 requires certain actions and associated
thresholds and intervals, including life limits and maintenance tasks.
These requirements (airworthiness limitations) include new life limits
for a certain part-numbered main rotor damper, tail gear box center
housing, and tail assembly; and new maintenance tasks (e.g.,
inspections for cracking) for the fuselage structure assembly (STA
5700, RH/LH side), and tail structure assembly (tail/rear fuselage
attachment fittings).
    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.

ADs Mandating Airworthiness Limitations

    The FAA has previously mandated airworthiness limitations by
mandating each airworthiness limitation task (e.g., inspections and
replacements (life limits)) as an AD requirement or issuing ADs that
require revising the ALS of the existing maintenance manual or
instructions for continued airworthiness to incorporate new or revised
inspections and life limits. This AD, however, requires operators to
incorporate into maintenance records required by 14 CFR 91.417(a)(2) or
135.439(a)(2), as applicable for your rotorcraft, the requirements
(airworthiness limitations) specified in an MCAI AD. The FAA does not
intend this as a substantive change. For these ADs, the ALS
requirements for operators are the same but are complied with
differently. Requiring the incorporation

of the new ALS requirements into the maintenance records, rather than
requiring individual ALS tasks (e.g., repetitive inspections and
replacements), requires operators to record AD compliance once after
updating the maintenance records, rather than after every time the ALS
task is completed.
    In addition, paragraph (h) of this AD allows operators to
incorporate later approved revisions of the ALS document as specified
in the Ref. Publications section of EASA AD 2018-0132 without the need
for an AMOC.

Differences Between This AD and the EASA AD

    Paragraph (1) of EASA AD 2018-0132 requires compliance with actions
and associated thresholds and intervals, including life limits and
maintenance tasks, from the effective date of EASA AD 2018-0132.
Paragraph (3) of EASA AD 2018-0132 requires incorporating the actions
and associated thresholds and intervals, including life limits and
maintenance tasks, into the approved maintenance program within 12
months after the effective date of EASA AD 2018-0132. This AD requires
incorporating into maintenance records requirements (airworthiness
limitations) within 30 days after the effective date of this AD.

Costs of Compliance

    The FAA estimates that this AD affects 130 helicopters of U.S.
Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates the following costs to comply with
this AD. Incorporating requirements (airworthiness limitations) into
maintenance records would require about 2 work-hours for a cost of $170
per helicopter and a cost of $22,100 for the U.S. fleet.

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

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) 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 Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

2022-02-12 Leonardo S.p.a.: Amendment 39-21909; Docket No. FAA-2021-
0964; Project Identifier 2018-SW-051-AD.

(a) Effective Date

    This airworthiness directive (AD) is effective March 17, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Leonardo S.p.a. Model AB139 and AW139
helicopters, certificated in any category.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 5101, Aircraft
Structures; and 6300, Main Rotor Drive Systems.

(e) Unsafe Condition

    This AD was prompted by the identification of certain parts
needing maintenance actions, including life limits and maintenance
tasks. The FAA is issuing this AD to address the failure of certain
parts, which could result in the loss of control of the helicopter.

(f) Compliance

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

(g) Required Action

    Within 30 days after the effective date of this AD, incorporate
into maintenance records required by 14 CFR 91.417(a)(2) or
135.439(a)(2), as applicable for your rotorcraft, the requirements
(airworthiness limitations) specified in paragraph (1) of European
Aviation Safety Agency (now European Union Aviation Safety Agency)
(EASA) AD 2018-0132, dated June 21, 2018 (EASA AD 2018-0132).

(h) Provisions for Alternative Requirements (Airworthiness Limitations)

    After the action required by paragraph (g) of this AD has been
done, no alternative requirements (airworthiness limitations) are
allowed unless they are approved as specified in the provisions of
the ``Ref. Publications'' section of EASA AD 2018-0132.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, 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 local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (j) of
this AD. Information may be emailed 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

    For more information about this AD, contact Kristi Bradley,
Program Manager, COS Program Management Section, Operational Safety
Branch, Compliance & Airworthiness Division, FAA, 10101 Hillwood
Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
[email protected].

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.

    (i) European Aviation Safety Agency (EASA) AD 2018-0132, dated
June 21, 2018.
    (ii) [Reserved]
    (3) For EASA AD 2018-0132, 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 the
EASA material on EASA website at https://ad.easa.europa.eu.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket at https://www.regulations.gov by searching
for and locating Docket No. FAA-2021-0964.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on January 11, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-02747 Filed 2-9-22; 8:45 am]
BILLING CODE 4910-13-P


Triadimefon Reader =

s Guide 1 Reader =

s Guide to Triadimefon Docket # EPA HQ OPP 2005 0258 EPA has created this document to provide an organizational structure to the Triadimefon Docket. The docket index groups related documents. The first group contains the Federal Register and Docket Organizational Documents; the second group contains Human Health Risk Assessment Documents for Phase 3 Public Comments, and the third group contains the Environmental Risk Assessment documents. The Agency is providing the A Reader =

s Guide @

to allow the reader to more easily access and navigate the various items contained in the Triadimefon docket.

Federal Register and Docket Organizational Documents:

Docket Item 1. Federal Register Notice: Triadimefon Risk Assessment; Notice of Availability, and Risk Reduction Options ( Phase 3 of 4 Phase Process)

This document formally and publicly announces that the triadimefon risk assessments are available for review on the internet or at the EPA =

s Office of Pesticides Programs =

Public Docket and solicits comments and suggestions on the risk assessment and how to mitigate or address potential risks of concern.

Docket Item 2. Reader =

s Guide to the Triadimefon Docket # EPA HQ OPP 2005 0258 This document is designed to annotate all the documents in the Triadimefon Docket.

Human Health Risk Assessment Documents for Phase 3 Public Comments Docket Item 3. Triadimefon. Preliminary Human Health Risk Assessment ( Revised) Griffin 2/ 9/ 06 This document describes all the human health risks from the use of triadimefon including erroronly revisions based on registrant comments.

Docket Item 4. Triadimefon. Acute and Chronic Dietary Exposure Assessments for the Reregistration Eligibility Decision ( RED) Document 11/ 23/ 05 Ary This document describes the potential risk to the US general population and population subgroups from food and drinking water containing triadimefon residues in/ on them. Triadimefon Reader =

s Guide 2 Docket Item 5. Triadimefon. Preliminary Human Health Risk Assessment 11/ 23/ 05 Griffin This is the preliminary human health risk assessment document ( prior to error correction) that describes all the human health risks from the use of triadimefon.

Docket Item 6. Triadimefon: Summary of Product Chemistry Data for Reregistration Eligibility Decision ( RED) Document 11/ 22/ 05 Barnes This document describes physical and chemical characteristics of the technical product that contain triadimefon.

Docket Item 7. Triadimefon. Summary of Analytical Chemistry and Residue Data for the Reregistration Eligibility Decision ( RED) Document 11/ 23/ 05 Ary This document reports on the fate and metabolic pathways of the active ingredient, triadimefon. It describes how much triadimefon is likely to remain in food after use over time.

Docket Item 8. Review of Triadimefon Incident Reports ( includes 127201, triadimenol) 8/ 24/ 2005 Hawkins This document reports on the documented poisoning incident data involving triadimefon and triadimenol.

Docket Item 9. Triadimefon: Occupational and Residential Exposure Assessment for the Reregistration Eligibility Decision Document 11/ 17/ 05 Recore This document describes the potential risks to workers and homeowners who come in contact with triadimefon residues.

Docket Item 10. Note to Reader memo ( Triazoles) 2/ 8/ 06 Special Review and Reregistration Division This document describes the Agency's current process for reviewing the registration of three fungicide pesticides ( triadimefon, triadimenol, and propiconazole) who share the common metabolites 1,2,4 triazole, triazole alanine, and triazole acetic acid. Triadimefon Reader =

s Guide 3 Docket Item 11. Occupational and Residential Exposure/ Risk Assessment of 1,2,4 Triazole 12/ 9/ 05 Arthur This document describes the potential risks to workers and homeowners who come in contact with 1,2,4 Triazole residues.

Docket Item 12. 1,2,4 Triazole. Acute and Chronic Dietary Exposure Assessments to Support Reregistration and Registration Actions for Triazole derivative Fungicides 11/ 1/ 05 Doherty This document describes the acute and chronic dietary risks ( 1,2,4 triazole as a terminal residue) associated with food consumption through the conjugated metabolites triazole alanine and triazole acetic acid.

Docket Item 13. Triazole Alanine and Triazole Acetic Acid. Acute and Chronic Dietary Exposure Assessments to Support Reregistration and Registration Actions for Triazole derivative Fungicides 12/ 20/ 05 Doherty This document describes the acute and chronic dietary risks ( 1,2,4 triazole as a terminal residue) associated with food consumption through the conjugated metabolites triazole alanine and triazole acetic acid.

Docket Item 14. 1,2,4 Triazole, Triazole Alanine, Triazole Acetic Acid: Human Health Aggregate Risk Assessment in Support of Reregistration and Registration Actions for Triazole derivative Fungicide Compounds 2/ 7/ 06 Doherty This document describes the evaluation of risks for various population subgroups, including those comprised of infants and children.

Environmental Fate and Effects Documents for Phase 3 Public Comment Docket Item 15. Environmental Fate and Effects Chapter ( Revised) 1/ 19/ 06 Embry This document describes the toxicity of triadimefon to animals and plants in the environment. It also describes the breakdown and fate of triadimefon and its metabolites in the environment including error only revisions based on registrant comments. Triadimefon Reader =

s Guide 4 Docket Item 16. Memorandum. Environmental Fate and Effects Division Error only Corrections and revised Triadimefon RED 1/ 19/ 06 Embry This document is the cover memo to the revised Environmental Fate and Effects Chapter that describes the Agency's response to error only comments submitted by the registrant.

Docket Item 17. Ecological Risk Assessment in Support of the Reregistration Eligibility Decision on Triadimefon 8/ 30/ 05 Embry This document describes the toxicity of triadimefon to animals and plants in the environment. It also describes the breakdown and fate of triadimefon and its metabolites in the environment.

Docket Item 18. Memorandum. Environmental Fate and Effects Chapter. Environmental Fate and Ecological Risk Assessment for Triadimefon 8/ 30/ 05 Embry This document is the cover memo to the Agency's ecological risk assessment for triadimefon.

Docket Item 19. Tier 2 Drinking Water Assessment for Triadimefon and its Major Degradate Triadimenol 8/ 31/ 05 Angier This document describes how much triadimefon and other metabolites may be found in drinking water after application.


[Federal Register: September 3, 2008 (Volume 73, Number 171)]
[Rules and Regulations]
[Page 51361-51362]
[DOCID:fr03se08-8]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2008-0850]
RIN 1625-AA09

Drawbridge Operation Regulation; Plaquemine Brule Bayou, Midland,
LA

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is removing the published drawbridge operation
regulation for the draw of the Union Pacific railroad bridge across
Plaquemine Brule Bayou, mile 5.1, at Midland, LA. It has been
determined that this bridge no longer exists. Since the bridge no
longer exists, the regulation controlling the opening and closing of
the bridge is no longer necessary.

DATES: This rule is effective September 3, 2008.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2008-0850 and are available online
at http:// www.regulations.gov. This material is also available for
inspection or copying at two locations: The Docket Management Facility
(M-30), U.S. Department of Transportation, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays, and the office of the Commander, Eighth Coast Guard District,
Bridge Administration Branch, 500 Poydras Street, Room 1313, New
Orleans, LA 70130-3310 between 7 a.m. and 3 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call David M. Frank, Bridge Administration Branch, telephone (504) 671-
2128. If you have questions on viewing the docket, call Renee V.
Wright, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this final rule without prior notice and
opportunity to comment pursuant to authority under section 4(a) of the
Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it has been determined that the
bridge no longer exists and mariners do not have to request an opening
of the draw.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds good cause exists
for making this rule effective in less than 30 days after publication
in the Federal Register. There is no need to delay the implementation
of this rule because the bridge it governs is already out of service
and mariners are no longer required to request an opening.

Background and Purpose

    A recent survey of the waterways within the District has determined
that the Union Pacific railroad bridge across Plaquemine Brule Bayou,
mile 5.1, at Midland, no longer exists. It is unclear when the bridge
was removed from the waterway; however, mariners are no longer
restricted from passing through the area because of a requirement to
have the draw of the bridge opened. The regulation governing the
operation of the bridge is found in 33 CFR 117.489(a). The purpose of
this rule is to remove 33 CFR 117.489(a) from the Code of Federal
Regulations since it governs a bridge that is no longer in existence.

Discussion of Rule

    The Coast Guard is changing the regulation in 33 CFR 117 without
publishing an NPRM. The change removes the regulation governing the
bridge since the bridge no longer exists. This change does not affect
vessel operators using the waterway. Thus, it is not necessary to
publish an NPRM.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a ``significant regulatory action'' under section
3(f) of Executive Order 12866, Regulatory Planning and Review, and does
not require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. The Coast Guard does not consider this
rule to be ``significant'' under that Order because it does not affect
the way vessels operate on the waterway.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
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.

    The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule will not have a significant economic impact on a substantial
number of small entities. This proposed rule will not significantly
impact any small entities because the bridge no longer exists and no
longer affects vessel operators that would have required an opening of
the draw.

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).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

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 or more in any
one year. Though this rule will not result in such expenditure, we do
discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

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

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.

Protection of Children

    We have 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.

Indian Tribal Governments

    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.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that 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. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, 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, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 5100.1 and Commandant Instruction M16475.lD, which
guides the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
that there are no factors in this case that would limit the use of a
categorical exclusion under section 2.B.2 of the Instruction.
Therefore, this rule is categorically excluded, under figure 2-1,
paragraph (32)(e) of the Instruction, from further environmental
documentation. Under figure 2-1, paragraph (32)(e), of the Instruction,
an environmental analysis checklist and a categorical exclusion
determination are not required for this rule.

List of Subjects in 33 CFR Part 117

    Bridges.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. Sec.  117.489 is revised to read as follows:

Sec.  117.489  Plaquemine Brule Bayou.

    The draw of the S91 bridge, mile 8.0 at Estherwood, shall open on
signal from 5 a.m. to 9 p.m. if at least four hours notice is given.
From 9 p.m. to 5 a.m., the draw shall open on signal if at least 12
hours notice is given.

    Dated: August 25, 2008.
J.H. Korn,
Captain, U.S. Coast Guard, Commander, 8th Coast Guard District, Acting.
[FR Doc. E8-20362 Filed 9-2-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 86, Number 230 (Friday, December 3, 2021)]
[Notices]
[Pages 68719-68720]
[FR Doc No: 2021-25936]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Airport Compliance Program

AGENCY: Federal Aviation Administration, Department of Transportation.

ACTION: Notice of availability of FAA Order 5190.6B, Change 1, Airport
Compliance Manual.

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

    This notice announces the availability of revisions to five
chapters of FAA Order 5190.6B, Airport Compliance Manual, originally
issued in September 2009. Order 5190.6B provides guidance to FAA
employees on the implementation of the FAA's airport compliance
program. Under the program, the FAA has the responsibility to assure
airport sponsors comply with certain obligations that arise from FAA
grant agreements and from deeds of property conveyance for airport use.
The FAA is undertaking this update to ensure Order 5190.6B is accurate
and consistent with current law and practice. As FAA updates Order
5190.6B, revised chapters will be available electronically at: https://www.faa.gov/airports/resources/publications/orders/compliance_5190_6/.
    The FAA will identify the date of the update on each page of the
Order.
    The updated Order will be identified as FAA Order 5190.6B, Change
1. Each change will be numbered until the entire Order is updated. When
this is complete, the new Order will be 5190.6C.
    At this time, the FAA has completed revisions to five chapters. The
revised chapters can be found at: https://www.faa.gov/airports/resources/publications/orders/compliance_5190_6/.
    The updated chapters include: Chapter 1, Scope and Authority;
Chapter 9, Unjust Discrimination between Aeronautical Users; Chapter
10, Reasonable Commercial Minimum Standards; Chapter 11, Self-Service;
and Chapter 23, Reversions of Airport Property. Each of the five
chapters has been updated to remain current with Federal statutes,
correct or update references to regulations, orders or other
authorities, and make editorial changes. The FAA will revise the
remaining chapters in the Order to reflect statutory changes, update or
correct references to authorities, or make editorial changes. The FAA
will provide electronic notice on its website, a summary of the changes
to each chapter, and electronically update the Order.

DATES: Revisions to Chapters 1, 9, 10, 11, and 23 of FAA Order 5190.6
are effective upon the date of publication of this notice. Subsequent
revisions to chapters will be posted electronically at: https://www.faa.gov/airports/resources/publications/orders/compliance_5190_6/.

FOR FURTHER INFORMATION CONTACT: Lorraine Herson-Jones, Manager,
Airport Compliance Division, ACO-100, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591, telephone (202) 267-
3085; facsimile:<PHONE_NUMBER>.
    Availability of Documents: FAA Order 5190.6BB, Change 1 is
available on the FAA website at: https://www.faa.gov/airports/resources/publications/orders/compliance_5190_6/.
    You can get an electronic copy of the Order and all other documents
in this docket using the internet by:
    (1) Visiting FAA's Regulations and Policies web page: https://www.faa.gov/regulations_policies

--or--

    (2) Accessing the Government Printing Office's web page: http://www.govinfo.gov/index.html.
    You can also get a copy by sending a request to the Federal
Aviation Administration, Office of Airport Compliance and Management
Analysis, 800 Independence Avenue SW, Washington, DC 20591, or by
calling<PHONE_NUMBER>. Make sure to identify the FAA Order number
being requested.

SUPPLEMENTARY INFORMATION:

Background

    The FAA administers several grant programs for airports, including
the Airport Improvement Program (AIP), established by the Airport and
Airway Improvement Act of 1982 as amended, 49 U.S.C. 47101 et seq.,
(AAIA).\1\ Section 47107 requires the Secretary of Transportation to
obtain certain assurances from an airport operator as a condition of
receiving a grant under the AIP. The FAA implements this requirement
with a standard set of grant assurances for airport sponsors which can
be viewed on the FAA Airports website at: https://www.faa.gov/airports/aip/grant_assurances/.
---------------------------------------------------------------------------

    \1\ FAA also administers CARES, CRSSA and ARPA grants. These new
grant programs are beyond the scope of this guidance. For more
information, see https://www.faa.gov/airports/airport_rescue_grants/.
---------------------------------------------------------------------------

    The FAA has issued a series of compliance manuals for the
administration of the AIP and its predecessor grant programs. Order
5190.6, Airport Compliance Requirements, was issued on August 24, 1973.
Order 5190.6 was canceled and replaced by Order 5190.6A, Airport
Compliance Requirements, on October 2, 1989. Order 5190.6A was replaced
by Order 5190.6B on September 30, 2009. Each of these orders
respectively, while in effect, has served as the handbook or manual for
FAA employees responsible for monitoring and enforcing the compliance
of airport sponsors with obligations to the Federal government. Those
obligations most commonly arise from conditions or assurances contained
in agreements with the FAA for grants in aid to airports. In addition
to grant obligations, an airport sponsor may also have Federal
obligations under a deed of property transferred under the Surplus
Property Act of 1944, as amended, 49 U.S.C. 47151-47153, or the Federal
Airports Act of 1946, as amended, 49 U.S.C. 47125, or property acquired
with Federal funds.
    Since 2009, there have been changes to the laws and policies
relating to the Federal obligations of airport sponsors and revisions
to the procedures for investigating and resolving complaints that
allege noncompliance. The Office of Airport Compliance and Management
Analysis has worked closely with industry stakeholders since the Order
was last updated in 2009 to gain the best understanding of issues of
concern. Where applicable, the changes in this updated Order reflect
feedback from industry stakeholders. Stakeholders may contact the
Office of Airport Compliance and Management Analysis with additional
concerns so that they may be considered for future updates to the
Order. To incorporate any changes and provide the most useful and
current program guidance to FAA employees, the Office of Airport
Compliance and Management Analysis is undertaking a review of the Order
and will publish updates as the chapter reviews are completed. The
updated FAA Order 5190.6B will be located on the FAA website.
Concurrent with this notice, the FAA has uploaded the first revised
chapters to the Order, referred to as Order 5190.6B, Change 1. These
are: Chapter 1, Scope and Authority; Chapter 9, Unjust Discrimination
between Aeronautical Users; Chapter 10, Reasonable Commercial Minimum
Standards; Chapter 11, Self-Service; and Chapter 23, Reversions of
Airport Property.
    The FAA considered comments received to Order 5190.6B and updates
to Chapters 1, 9, 10, 11, and 23 reflect the major issues raised.
Updates to the Order's appendices also are included with this update.

Summary of Changes to Order 5190.6B

     After review of public comments and experience since 2009
with using Order 5190.B, the FAA is updating the Order starting with
Chapters 1, 9, 10, 11, and 23 of the Order.
     Many of these changes are editorial and intended to
clarify language based on suggestions received in public comments or
recommendations from FAA employees.
     In other cases, the Order has been updated to align with
new or revisions to Federal statutes, regulations, or orders which have
been enacted or revised since 2009.
     Edits and additions to the revised chapters are intended
to provide accurate and useful guidance on airport compliance policy
for FAA employees and not to adopt significant changes in compliance
policy. A summary of the changes will be posted on the FAA website as
future chapters are revised.
    In addition to updating these five chapters listed above, the
agency has revised several of the appendices to Order 5190.6B. The
changes update citations and documents to provide current versions,
delete obsolete references, and include more recent sample documents.
As part of the updates, Appendices E-1, F-3, G-1, and S have been
removed.

Future Updates to Order

    The FAA is continuing its review of all chapters of Order 5190.6B
and will publish updates to the Order as it completes each review.
Chapters may be updated individually or in related groups. These
updates will reflect statutory, administrative, or clerical changes. It
is intended that the Order will continue to be updated periodically as
changes in statutes, regulations, or orders occur.
    The most current version of the updated chapters will be maintained
at: https://www.faa.gov/airports/resources/publications/orders/compliance_5190_6/.
    Each chapter will contain the date of its most recent update.

Notice of Availability

    FAA Order 5190.6B.1, Airport Compliance Manual, with the updated
Chapters 1, 9, 10, 11 and 23, is available at the locations listed in
the ``Availability of Documents'' section of this notice.

    Issued in Washington, DC.
Kevin C. Willis,
Director, FAA, Office of Airport Compliance and Management Analysis.
[FR Doc. 2021-25936 Filed 12-2-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 121 (Wednesday, June 24, 2015)]
[Notices]
[Pages 36333-36334]
[FR Doc No: 2015-15489]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL15-68-000]

Midcontinent Independent System Operator, Inc.; Notice of
Institution of Section 206 Proceeding and Refund Effective Date

    On June 18, 2015, the Commission issued an order in Docket No.
EL15-68-000, pursuant to section 206 of the Federal Power Act (FPA), 16
U.S.C. 824e (2012), instituting an investigation into the justness and
reasonableness of Midcontinent Independent System Operator Inc.'s pro
forma Facilities Construction Agreement, Generator Interconnection
Agreement, and Multi-Party Facilities Construction Agreement.
Midcontinent Indep. Sys. Operator, Inc., 151 FERC ] 61,220 (2015).

    The refund effective date in Docket No. EL15-68-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.

    Dated: June 18, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-15489 Filed 6-23-15; 8:45 am]
 BILLING CODE 6717-01P


[Federal Register: July 24, 2007 (Volume 72, Number 141)]
[
Notices]
[Page 40295-40296]
[DOCID:fr24jy07-60]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-R04-OAR-2006-0584; FRL-8444-4]

Adequacy Status of the Bi-State Louisville 8-Hour Ozone Motor
Vehicle Emission Budgets for Transportation Conformity Purposes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of adequacy.

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

SUMMARY: In this notice, EPA is notifying the public that we have found
that the Motor Vehicle Emissions Budgets (MVEBs) in Kentucky's bi-state
Louisville 8-Hour Ozone Maintenance State Implementation Plan (SIP),
submitted on September 29, 2006, by the Kentucky Division of Air
Quality (KDAQ), are adequate for transportation conformity purposes. As
a result of EPA's finding, the bi-state Louisville area must use the
MVEBs from the September 29, 2006, bi-state Louisville 8-Hour Ozone
Maintenance SIP for future conformity determinations for the 8-hour
ozone standard. In a separate rulemaking, EPA has already approved
these MVEBs. These MVEBs are identical to the MVEBs established for
this area in the Indiana SIP.

DATES: These MVEBs were effective the date of publication (July 5,
2007) for the final rulemaking.

FOR FURTHER INFORMATION CONTACT: Lynorae Benjamin, Environmental

Engineer, U.S. Environmental Protection Agency, Region 4, Air Planning
Branch, Air Quality Modeling and Transportation Section, 61 Forsyth
Street, SW, Atlanta, Georgia 30303. Ms. Benjamin can also be reached by
telephone at<PHONE_NUMBER>, or via electronic mail at

<EMAIL_ADDRESS>The finding is available at EPA's conformity

Web site: http://www.epa.gov/otaq/stateresources/transconf/
currsips.htm
.

SUPPLEMENTARY INFORMATION:

Background

    This notice is simply an announcement of a finding that EPA has
already made. EPA Region 4 sent a letter to KDAQ on June 18, 2007,
stating that the MVEBs in Kentucky's SIP, submitted on September 29,
2006, are adequate. The bi-state Louisville 8-hour ozone nonattainment
area is comprised of the following five counties: Bullitt, Oldham and
Jefferson counties in Kentucky and Clark and Floyd counties in Indiana.
EPA's adequacy comment period for Kentucky's SIP ran from April 27,
2007, through May 29, 2007. During EPA's adequacy comment period no
comments regarding the adequacy of the MVEBs were received. This
finding has also been announced on EPA's conformity Web site: http://
www.epa.gov/otaq/stateresources/transconf/pastsips.htm.
 The adequate

MVEBs are provided in the following table:

                 Bi-State Louisville 8-Hour Ozone MVEBs
                             [Tons per day]
------------------------------------------------------------------------
                                                    2003         2020
------------------------------------------------------------------------
VOC...........................................        40.97        22.92
NOX...........................................        95.51        29.46
------------------------------------------------------------------------

EPA has already approved these MVEBs in a separate rulemaking (72 FR
36601, July 5, 2007), and is providing this notice for informational
purposes.

    Transportation conformity is required by section 176 (c) of the
Clean Air Act, as amended in 1990. EPA's conformity rule requires that
transportation plans, programs and projects conform to state air
quality implementation plans and establishes the criteria and
procedures for determining whether or not they do. Conformity to a SIP
means that transportation activities will not produce new air quality
violations, worsen existing violations, or delay timely attainment of
the national ambient air quality standards.
    The criteria by which EPA determines whether a SIP's MVEBs are
adequate for transportation conformity purposes are outlined in 40 Code
of Federal Regulations 93.118(e)(4). We have described the process for
determining the adequacy of submitted SIP budgets in our July 1, 2004,
final rulemaking entitled, `` Transportation Conformity Rule Amendments
for the New 8-hour Ozone and PM2.5 National Ambient Air
Quality Standards and Miscellaneous Revisions for Existing Areas;
Transportation Conformity Rule Amendments: Response to Court Decision
and Additional Rule Changes'' (69 FR 40004). Please note that an
adequacy review is separate from EPA's completeness review, and it also
should not be used to prejudge EPA's ultimate approval of the SIP. Even
if EPA finds the MVEBs adequate, the Agency may later determine that
the SIP itself is not approvable.

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

    Dated: June 25, 2007.
Russell L. Wright, Jr.,
Acting Regional Administrator, Region 4.
 [FR Doc. E7-14316 Filed 7-23-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)]
[Notices]
[Pages 77643-77645]
[FR Doc No: 2015-31400]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-1575]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 16, 2016. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by June 13,
2016. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

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-2013-E-1575 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; RAXIBACUMAB''. 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.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
biological product will include all of the testing phase and approval
phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biologic product
RAXIBACUMAB (raxibacumab). RAXIBACUMAB is indicated for treatment of
adult and pediatric patients with inhalational anthrax due to Bacillus
anthracis in combination with appropriate antibacterial drugs, and for
prophylaxis of inhalational anthrax when alternative therapies are not
available or are not appropriate. Subsequent to this approval, the
USPTO received a patent term restoration application for RAXIBACUMAB
(U.S. Patent No. 7,906,119) from Human Genome Sciences, and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated January 31, 2014, FDA
advised the USPTO that this human biological product had undergone a
regulatory review period and that the approval of RAXIBACUMAB
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
RAXIBACUMAB is 3,465 days. Of this time, 2,154 days occurred during the
testing phase of the regulatory review period, while 1,311 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i))

became effective: June 22, 2003. The applicant claims July 18, 2003, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was June 22, 2003, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): May 14, 2009. The applicant claims June
15, 2012, as the date the biologics license application (BLA) for
RAXIBACUMAB (BLA 125349/0) was initially submitted. However, FDA
records indicate that BLA 125349/0 was submitted on May 14, 2009.
    3. The date the application was approved: December 14, 2012. FDA
has verified the applicant's claim that BLA 125349/0 was approved on
December 14, 2012.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 412 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31400 Filed 12-14-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: June 10, 2008 (Volume 73, Number 112)]
[Notices]
[Page 32782]
[DOCID:fr10jn08-98]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Request To Release Airport Property
at the Scappoose Industrial Airpark, Scappoose, OR

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Request to Release Airport Property.

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

SUMMARY: The FAA proposes to rule and invite public comment on the
release of land at Scappoose Industrial Airpark under the provisions of
Section 125 of the Wendell H. Ford Aviation Investment Reform Act for
the 21st Century (AIR 21), now 49 U.S.C. 47107(h)(2).

DATES: Comments must be received on or before July 10, 2008.

ADDRESSES: Comments on this application may be mailed or delivered to
the FAA at the following address: Ms. Carol Key, Manager, Federal
Aviation Administration, Northwest Mountain Region, Airports Division,
Seattle Airports District Office, 1601 Lind Avenue, SW., Suite 250,
Renton, Washington 98057-3356.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to Ms. Kim Shade, Operations Manager of the Port of
St. Helens, at the following address: Ms. Kim Shade, Port of St.
Helens, 100 E. Street, Columbia City, Oregon 97018.

FOR FURTHER INFORMATION CONTACT: Mr. Dave Roberts, Civil Engineer,
Federal Aviation Administration, Northwest Mountain Region, Seattle
Airports District Office, 1601 Lind Avenue, SW., Suite 250, Renton,
Washington 98057-3356.
    The request to release property may be reviewed, by appointment, in
person at this same location.

SUPPLEMENTARY INFORMATION: The FAA invites public comment on the
request to release property at the Scappoose Industrial Airpark under
the provisions of the AIR 21 (49 U.S.C. 47107(h)(2)).
    On May 27, 2008, the FAA determined that the request to release
property at Scappoose Industrial Airpark submitted by the airport meets
the procedural requirements of the Federal Aviation Administration. The
FAA may approve the request, in whole or in part, no later than July
10, 2008.
    The following is a brief overview of the request:
    The Port of St. Helens is proposing the release, through fee
acquisition and permanent easements for slopes, of approximately 21,967
square feet of Scappoose Industrial Airpark property to Columbia
County. The land would be used for road curvature improvements at the
Westlane/Honeyman Road intersection to Skyway Drive to increase traffic
safety. The revenue made from this sale will be used toward Airport
capital improvement.
    Any person may inspect, by appointment, the request in person at
the FAA office listed above under FOR FURTHER INFORMATION CONTACT.
    In addition, any person may, upon appointment and request, inspect
the application, notice and other documents germane to the application
in person at Scappoose Industrial Airpark.

    Issued in Renton, Washington on May 28, 2008.
Carol Key,
Manager, Seattle Airports District Office.
 [FR Doc. E8-12776 Filed 6-9-08; 8:45 am]

BILLING CODE 4910-13-M