[Federal Register Volume 81, Number 185 (Friday, September 23, 2016)]
[Notices]
[Pages 65656-65658]
[FR Doc No: 2016-22935]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-E-2360 and FDA-2014-E-2361]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for MYALEPT 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
November 22, 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 March 22,
2017. 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 Nos.
FDA-2014-E-2360 and FDA-2014-E-2361 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; MYALEPT.'' 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 MYALEPT
(metreleptin). MYALEPT is indicated as an adjunct to diet as
replacement therapy to treat the complications of leptin deficiency in
patients with congenital or acquired generalized lipodystrophy.
Subsequent to this approval, the USPTO received two patent term
restoration applications for MYALEPT (U.S. Patent No. 6,001,968 from
The Rockefeller University, and U.S. Patent No. 7,183,254 from Amgen,
Inc.; The Board of Regents, The University of Texas System; and the
Secretary, United States Department of Health and Human Services,
National Institutes of Health). The USPTO requested FDA's assistance in
determining these patents' eligibility for patent term restoration. The
USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated October 22,
2015, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of MYALEPT
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
MYALEPT is 6,509 days. Of this time, 6,174 days occurred during the
testing phase of the regulatory review period, while 335 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: May 2,
1996. The applicants claim June 19, 2008, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the first IND effective date was May 2, 1996,
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): March 27, 2013. FDA has verified the
applicants' claims that the biologics license application (BLA) for
MYALEPT (BLA 125-390) was initially submitted on March 27, 2013.
    3. The date the application was approved: February 24, 2014. FDA
has verified the applicant's claim that BLA 125-390 was approved on
February 24, 2014.
    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 the applications for patent extension,
the applicants each seek 1,206 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.

    Dated: September 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22935 Filed 9-22-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 107 (Tuesday, June 4, 2019)]
[Notices]
[Pages 25814-25815]
[FR Doc No: 2019-11603]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-2131]

Evaluating Alternate Curricula for the Standards for the Growing,
Harvesting, Packing, and Holding of Produce for Human Consumption;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry entitled ``Evaluating
Alternate Curricula for the Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption.'' The draft
guidance, when finalized, will provide recommendations on the factors
that covered farms should consider if they are selecting an alternate
curriculum training to meet the requirements of the ``Standards for the
Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption'' (Produce Safety Rule) and for educators when developing
or evaluating alternate curricula.

DATES: Submit either electronic or written comments on the draft
guidance by October 2, 2019 to ensure that the Agency considers your
comment on the draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-2131 for ``Evaluating Alternate Curricula for the Standards
for the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption: Guidance for Industry.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS

CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including
the claimed confidential information, in its consideration of comments.
The second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Fazila Shakir, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry
entitled ``Evaluating Alternate Curricula for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption: Guidance for
Industry.'' We are issuing the draft guidance consistent with our good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on this topic. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternate approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.
    The Produce Safety Rule established science-based minimum standards
for the safe growing, harvesting, packing, and holding of produce grown
for human consumption. Subpart C of the rule includes the specific
requirements for personnel qualifications and training, including the
requirement for at least one supervisor or responsible party from a
farm to successfully complete food safety training at least equivalent
to that received under the standardized curriculum recognized as
adequate by FDA (Sec.  112.22(c) (21 CFR 112.22(c))). For farms covered
by the Produce Safety Rule, version 1.1 of the standardized curriculum
developed by the Produce Safety Alliance is adequate as the
standardized curriculum in Sec.  112.22(c). The purpose of this draft
guidance is to provide recommendations on the factors that covered
farms should consider if they are using an alternate curriculum
training to satisfy the requirements of Sec.  112.22(c) and for
educators when developing or evaluating alternate curricula.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/guidance-documents-regulatory-information-topic-food-and-dietary-supplements or https://www.regulations.gov. Use the
FDA website listed in the previous sentence to find the most current
version of the guidance.

    Dated: May 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11603 Filed 6-3-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: November 19, 2009 (Volume 74, Number 222)]
[Notices]
[Page 60020]
[DOCID:fr19no09-90]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Noise Compatibility Program (NCP); 14 CFR Part 150; Notice of
Record of Approval (ROA); the Louisville International Airport,
Louisville, KY (SDF)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: The Federal Aviation Administration (FAA) announces its
findings on the noise compatibility program update submitted by the
Louisville Regional Airport Authority (LRAA).
    On October 29, 2008, the LRAA submitted to the FAA Air Traffic
Organization (ATO) a request with supporting documentation for an
offset approach to Runway 17R at Louisville International Airport
(SDF). This request was for a re-evaluation of noise abatement measure
NA-7, and associated measures NA-2 and NA-3, submitted to the FAA for
action in its 2003 NCP but were deferred.
    The FAA ATO evaluated the offset approach procedure provided by
LRAA. After considerable review and evaluation, the procedure was
disapproved. The FAA ATO notified LRAA of its determination on April 3,
2009. Subsequent to ATO's determination, the FAA issued its Record of
Approval (ROA) concerning the LRAA's NCP update on August 4, 2009, and
disapproved noise abatement measures NA-2, NA-3, and NA-7.
    In its evaluation, the FAA reviewed the proposal under 14 CFR Part
150 and the Aviation Safety and Noise Abatement Act of 1979. Section
150.35 of Part 150 includes language stating that programs will be
approved under this part if program measures relating to the use of
flight procedures for noise control can be implemented within the
period covered by the program and without reducing the level of
aviation safety provided or adversely affecting the efficient use and
management of the navigable airspace and air traffic control systems.

DATES: Effective Date: The effective date of the FAA's disapproval of
the request for an offset approach to Runway 17R at Louisville
International Airport is April 3, 2009. The effective date of FAA's ROA
of LRAA's NCP update is August 4, 2009.

FOR FURTHER INFORMATION CONTACT: Stephen Wilson, Community Planner,
Federal Aviation Administration, Memphis Airports District Office, 2862
Business Park Drive, Building G, Memphis, TN 38118. Documents
reflecting this FAA action can be reviewed in person at this same
location.

SUPPLEMENTARY INFORMATION: The FAA has reviewed Noise Abatement
Measures (NA-2), (NA-3) and (NA-7) in accordance with 14 CFR Part 150.
The ROA contains the FAA's decisions for 3 of the 7 NCP measures that
were previously deferred under LRAA's 2003 NCP. The FAA has given its
disapproval to the Runway 17R offset approach request at LRAA. All
other portions of the previously issued ROA remain in effect.
    The following is a brief overview of the request:
    On October 29, 2008, the LRAA provided the FAA Air Traffic
Organization with a letter and supporting documentation requesting an
offset approach to Runway 17R at Louisville International Airport
(SDF). This was additional information submitted for re-evaluation of
previously submitted but deferred noise abatement measures NA-2, NA-3,
and NA-7 in LRAA's 2003 NCP

    Issued in Memphis, TN, on November 3, 2009.
Tommy L. Dupree,
Acting Manager, Memphis Airports District Office, Southern Region.
[FR Doc. E9-27654 Filed 11-18-09; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 88, Number 140 (Monday, July 24, 2023)]
[Rules and Regulations]
[Pages 47355-47358]
[FR Doc No: 2023-15596]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-0931; Project Identifier MCAI-2022-00653-R;
Amendment 39-22493; AD 2023-13-08]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2021-05-03
for certain Airbus Helicopters Model EC225LP helicopters. AD 2021-05-03
required various inspections of a certain part-numbered left-hand (LH)
engine fuel supply (fuel supply) hose and depending on the inspection
results, reinstalling or removing the fuel supply hose from service. AD
2021-05-03 also required installing an improved part and prohibited
installing an affected fuel supply hose on any helicopter unless it was
installed by following certain procedures. Since the FAA issued AD
2021-05-03, there were reports of difficulties using an adjusting tool
to install the improved fuel supply hose. This AD continues to require
the actions of AD 2021-05-03, expands the applicability, expands the
parts installation limitations, and requires using an improved
adjusting tool and updated procedures. This AD also updates certain
compliance times and clarifies certain requirements. The FAA is issuing
this AD to address the unsafe condition on these products.

DATES: This AD is effective August 28, 2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 28,
2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of
January 27, 2022 (86 FR 72824, December 23, 2021).

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-0931; 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, 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.
    Material Incorporated by Reference:
     For Airbus Helicopters service information identified in
this final rule, contact Airbus Helicopters, 2701 North Forum Drive,
Grand Prairie, TX 75052; phone<PHONE_NUMBER> or<PHONE_NUMBER>; fax
(972) 641-3775; or at airbus.com/helicopters/services/technical-support.html.
     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>. It is also available at
regulations.gov under Docket No. FAA-2023-0931.
    Other Related Service Information: Other Airbus Helicopters service
information identified in this final rule is available at the Airbus
Helicopters contact information under Material Incorporated by
Reference above. You may also view this service information at the FAA
contact information under Material Incorporated by Reference above.

FOR FURTHER INFORMATION CONTACT: Hal Jensen, Aviation Safety Engineer,
FAA, 26805 E 68th Ave., Mail Stop: Room 214, Denver, CO 80249;
telephone<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2021-05-03, Amendment 39-21864 (86 FR
72824, December 23, 2021) (AD 2021-05-03). AD 2021-05-03 applied to
Airbus Helicopters Model EC225LP helicopters with an LH fuel supply
hose part number (P/N) 704A34416087 installed. AD 2021-05-03 required
visually inspecting the LH fuel supply hose for twisting, and if
needed, borescope inspecting the entire length of the inside of the
fuel supply hose for twisting. Depending on the inspection results, AD
2021-05-03 required reinstalling or removing the fuel supply hose from
service. Additionally, AD 2021-05-03 prohibited installing that part-
numbered LH fuel supply hose on any helicopter unless that LH fuel
supply hose was installed by following certain procedures described in
the manufacturer's service bulletin. Finally, AD 2021-05-03 required
modifying your helicopter by removing LH fuel supply hose P/N
704A34416087 from service and installing the improved LH fuel supply
hose P/N 704A34416101. The FAA issued AD 2021-05-03 to prevent
restricted fuel flow to the LH engine, which if not addressed, could
result in a decrease of the LH engine power when accelerating to a
power setting corresponding to One Engine Inoperative power and
subsequent reduced control of the helicopter.
    The NPRM published in the Federal Register on April 18, 2023 (88 FR
23586). The NPRM was prompted by European Union Aviation Safety Agency
(EASA) AD 2022-0087, dated May 16, 2022 (EASA AD 2022-0087) which
superseded EASA AD 2021-0156, dated July 2, 2021 (EASA AD 2021-0156),
issued by EASA, which is the Technical Agent for the Member States of
the European Union, to correct an unsafe condition for all Airbus
Helicopters Model EC 225 LP helicopters. EASA advises of difficulties
that were reported during installation of the improved LH fuel supply
hose due to using an inappropriately shaped adjusting tool.
Accordingly, EASA AD 2022-0087 retains the requirements of EASA AD
2021-0156 and requires replacing the affected part with the improved
part by following updated modification instructions and using an
improved adjusting tool. The updated modification instructions also
specify updated torque values for the junction nuts and re-tightening
instructions for helicopters modified with previous instructions. EASA
AD 2022-0087 requires a repetitive inspection for fuel leakage for
those helicopters modified with previous instructions and considers the
re-tightening of the junction nuts of the improved part as terminating
action for the repetitive inspection requirements. You may examine EASA
AD 2022-0087 in the AD docket at regulations.gov under Docket No. FAA-
2023-0931.
    In the NPRM, for helicopters with LH fuel supply hose P/N
704A34416087 installed, the FAA proposed to require visually inspecting
the LH fuel supply hose for twisting, and if needed, borescope
inspecting the entire length of the inside of the fuel supply hose for
twisting. Depending on the inspection results, the NPRM proposed to
require reinstalling or removing the fuel supply hose from service. The
NPRM also proposed to require modifying the helicopter by removing LH
fuel supply hose P/N 704A34416087 from service and installing improved
LH fuel supply hose P/N 704A34416101 using updated procedures.
Additionally, for helicopters modified with the improved LH fuel supply
hose P/N 704A34416101 using previous procedures or if the installation
procedures cannot be determined, the NPRM proposed to

require repetitive inspections for fuel leakage and, depending on the
results, tightening the junction nuts of this improved fuel supply hose
with the LH side engine removed. Tightening the junction nuts would
provide terminating action for the repetitive fuel leakage inspections.
Lastly, the NPRM proposed to require installation limitations for LH
fuel supply hose P/N 704A34416087 and LH fuel supply hose P/N
704A34416101.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the costs.

Conclusion

    These products have been approved by the aviation authority of
another country and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with this State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI referenced above. The FAA reviewed the relevant data 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 products.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Airbus Helicopters Alert Service Bulletin (ASB)
No. EC225-28A026, Revision 1, dated May 6, 2022 (ASB EC225-28A026 Rev
1), which specifies procedures for modifying the adjusting tool and
replacing the LH fuel supply hose by using the modified adjusting tool.
ASB EC225-28A026 Rev 1 also specifies updated allowable torque limits
for the junction nuts and, for helicopters that have previously
accomplished Airbus Helicopters ASB No. EC225-28A026, Revision 0, dated
May 21, 2021, ASB EC225-28A026 Rev 1 specifies procedures to
repetitively inspect the junction nuts for fuel leakage until the LH
engine is removed and the updated allowable torque limit is applied to
the junction nuts.
    This AD also requires Airbus Helicopters ASB No. EC225-71A019,
Revision 2, dated May 21, 2021, which the Director of the Federal
Register approved for incorporation by reference as of January 27, 2022
(86 FR 72824, December 23, 2021).
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES.

Other Related Service Information

    The FAA also reviewed Airbus Helicopters ASB No. EC225-71A019,
Revision 1, dated February 28, 2019. This service information specifies
procedures for removing the fuel supply hose from the LH power plant,
visually inspecting the fuel supply hose for twisting, and depending on
inspection results, performing an endoscope inspection on the inside of
the hose.

Differences Between This AD and EASA AD 2022-0087

    EASA AD 2022-0087 is applicable to all serial-numbered Model
EC225LP helicopters, whereas this AD applies to Model EC225LP
helicopters with certain part-numbered LH fuel supply hoses installed.
    For helicopters modified with LH fuel supply hose P/N 704A34416101
in accordance with previous instructions or by installation of AH
modification 0728745 prior to initial delivery of the helicopter from
the manufacturer, EASA AD 2022-0087 requires re-tightening the junction
nuts to the new torque values during the next (re)installation of the
LH engine or of the improved fuel supply hose, whereas this AD requires
that action within 110 hours time-in-service with the LH side engine
removed for helicopters with LH fuel supply hose P/N 704A34416101
installed with previous instructions, by installation of AH
modification 0728745 prior to initial delivery of the helicopter from
the manufacturer, or if the previously accomplished installation
procedures cannot be determined. Also, for those helicopters, depending
on the interim fuel leakage inspection results, EASA AD 2022-0087
requires corrective action in accordance with approved maintenance
instructions, whereas this AD requires tightening the junction nuts to
the new torque values with the LH engine removed.

Costs of Compliance

    The FAA estimates that this AD affects up to 28 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.
    Visually inspecting the LH fuel supply hose for twisting takes
about 1 work-hour for an estimated cost of $85 per helicopter and
$2,380 for the U.S. fleet. Borescope inspecting the LH fuel supply hose
takes about 8 work-hours for an estimated cost of $680 per helicopter.
    Replacing an LH fuel supply hose takes up to 11 work-hours and
parts cost about $2,363 for an estimated replacement cost of up to
$3,298 per replacement.
    Inspecting for fuel leakage takes about 1 work-hour for an
estimated cost of $85 per helicopter, per inspection cycle. Removing
the LH engine and tightening the LH fuel supply hose fittings takes 8
work-hours for an estimated cost of $680 per helicopter.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA has determined that 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:
0
a. Removing Airworthiness Directive 2021-05-03, Amendment 39-21864 (86
FR 72824, December 23, 2021); and
0
b. Adding the following new airworthiness directive:

2023-13-08 Airbus Helicopters: Amendment 39-22493; Docket No. FAA-
2023-0931; Project Identifier MCAI-2022-00653-R.

(a) Effective Date

    This airworthiness directive (AD) is effective August 28, 2023.

 (b) Affected ADs

    This AD replaces AD 2021-05-03, Amendment 39-21864 (86 FR 72824,
December 23, 2021).

 (c) Applicability

    This AD applies to Airbus Helicopters Model EC225LP helicopters,
certificated in any category, with a left-hand side (LH) engine fuel
supply (fuel supply) hose part number (P/N) 704A34416087 or P/N
704A34416101 installed.

 (d) Subject

    Joint Aircraft Service Component (JASC) Code: 2820, Aircraft
Fuel Distribution System.

 (e) Unsafe Condition

    This AD was prompted by a report of an incorrect installation of
the LH fuel supply hose P/N 704A34416087. The FAA is issuing this AD
to prevent restricted fuel flow to the LH engine. The unsafe
condition, if not addressed, could result in a decrease of the LH
engine power when accelerating to a power setting corresponding to
One Engine Inoperative power and subsequent reduced control of the
helicopter.

 (f) Compliance

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

 (g) Required Actions

    (1) For helicopters with LH fuel supply hose P/N 704A34416087
installed, within 110 hours time-in-service (TIS) or 6 months after
the effective date of this AD, whichever occurs first, visually
inspect the LH fuel supply hose for twisting as shown in Figures 1
and 2 of Airbus Helicopters Alert Service Bulletin (ASB) No. EC225-
71A019, Revision 2, dated May 21, 2021 (ASB EC225-71A019 Rev 2). If
the LH fuel supply hose has any twisting or if it cannot be
determined if the LH fuel supply hose has any twisting, before
further flight, borescope inspect the entire length of the inside of
the fuel supply hose for twisting as shown in Figures 3 through 5 of
ASB EC225-71A019 Rev 2.
    (i) If the inside of the LH fuel supply hose has any twisting,
before further flight, remove the LH fuel supply hose from service
and install an airworthy LH fuel supply hose in accordance with the
actions required by paragraphs (g)(2) or (4) of this AD.
    (ii) If the inside of the LH fuel supply hose does not have any
twisting, reinstall the LH fuel supply hose by following the
Accomplishment Instructions, paragraph 3.B.3.b., of ASB EC225-71A019
Rev 2.
    (2) For helicopters with LH fuel supply hose P/N 704A34416087
installed, within 1,200 hours TIS or 36 months after the effective
date of this AD, whichever occurs first, modify your helicopter by
removing from service LH fuel supply hose P/N 704A34416087 and
installing LH fuel supply hose P/N 704A34416101 in accordance with
the Accomplishment Instructions, paragraph 3.B.2.b., of Airbus
Helicopters ASB No. EC225-28A026, Revision 1, dated May 6, 2022 (ASB
EC225-28A026 Rev 1).
    (3) For helicopters with LH fuel supply hose P/N 704A34416101
previously installed by accomplishing Airbus Helicopters ASB No.
EC225-28A026, Revision 0, dated May 21, 2021, by installation of AH
modification 0728745 prior to initial delivery of the helicopter
from the manufacturer, or if the previously accomplished
installation procedures cannot be determined, accomplish the actions
required by paragraph (g)(3)(i) of this AD.
    (i) Within 15 hours TIS or 7 days after the effective date of
this AD, whichever occurs first, and thereafter at intervals not to
exceed 15 hours TIS or 7 days, whichever occurs first, inspect the
LH fuel supply hose for fuel leakage in the area of each junction
nut (items 1a and 1b) as depicted in Figure 1 of ASB EC225-28A026
Rev 1.
    (A) If there is any fuel leakage, before further flight, remove
the LH side engine and tighten each junction nut (items 1a and 1b)
of the LH fuel supply hose by applying the torque depicted in Figure
1 of ASB EC225-28A026 Rev 1.
    (B) If there is no fuel leakage, within 110 hours TIS after the
effective date of this AD, remove the LH side engine and tighten
each junction nut (items 1a and 1b) of the LH fuel supply hose by
applying the torque depicted in Figure 1 of ASB EC225-28A026 Rev 1.
    (ii) Tightening the junction nuts as required by paragraphs
(g)(3)(i)(A) and (B) of this AD constitutes terminating action for
the repetitive inspection required by paragraph (g)(3)(i) of this
AD.
    (4) For helicopters with LH fuel supply hose P/N 704A34416087
installed, as of the effective date of this AD, you may replace an
LH fuel supply hose P/N 704A34416087 with an LH fuel supply hose P/N
704A34416087 or reinstall an LH fuel supply hose P/N 704A34416087 on
any helicopter by following the Accomplishment Instructions,
paragraph 3.B.3.b., of ASB EC225-71A019 Rev 2, until required to
install LH fuel supply hose P/N 704A34416101 by paragraph (g)(2) of
this AD, provided one of the conditions in paragraphs (g)(4)(i)
through (iii) of this AD is met.
    (i) If installing, the LH fuel supply hose P/N 704A34416087 is
new (zero total hours TIS).
    (ii) If reinstalling, before reinstallation, the LH fuel supply
hose P/N 704A34416087 is inspected by accomplishing the actions
required by the introductory text of paragraph (g)(1) of this AD and
the inside of the LH fuel supply hose does not have any twisting.
    (iii) If reinstalling, the initial delivery of the helicopter
from the manufacturer was on or after November 30, 2018, and the LH
fuel supply hose P/N 704A34416087 has never been previously
reinstalled.
    (5) For helicopters with an LH fuel supply hose P/N 704A34416101
installed, as of the effective date of this AD, do not remove LH
fuel supply hose P/N 704A34416101 and replace it with LH fuel supply
hose P/N 704A34416087 and do not install an LH engine with an LH
fuel supply hose P/N 704A34416087 installed.

 (h) Credit for Previous Actions

    This paragraph provides credit for the actions specified in
paragraph (g)(1) of this AD, if those actions were performed before
the effective date of this AD using Airbus Helicopters ASB No.
EC225-71A019, Revision 1, dated February 28, 2019.

 (i) Special Flight Permits

    Special flight permits may be permitted provided that there are
no passengers on board and that helicopters identified in paragraph
(g)(3) of this AD have no fuel leakage.

 (j) 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 (k)(2) 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.

 (k) Additional Information

    (1) Refer to European Union Aviation Safety Agency (EASA) AD
2022-0087, dated May 16, 2022, for related information. This EASA AD
may be found in the AD docket at regulations.gov under Docket No.
FAA-2023-0931.
    (2) For more information about this AD, contact Hal Jensen,
Aerospace Engineer, FAA, 26805 E 68th Ave., Mail Stop: Room 214,
Denver, CO 80249; telephone<PHONE_NUMBER>; email
[email protected].
    (3) Service information identified in this AD that is not
incorporated by reference is available at the contact information
specified in paragraphs (l)(5) and (6) of this AD.

 (l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference

(IBR) of the service information listed in this paragraph under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (3) The following service information was approved for IBR on
August 28, 2023
    (i) Airbus Helicopters Alert Service Bulletin No. EC225-28A026,
Revision 1, dated May 6, 2022.
    (ii) [Reserved]
    (4) The following service information was approved for IBR on
January 27, 2022 (86 FR 72824, December 23, 2021).
    (i) Airbus Helicopters Alert Service Bulletin No. EC225-71A019,
Revision 2, dated May 21, 2021.
    (ii) [Reserved]
    (5) For Airbus Helicopters service information identified in
this AD, contact Airbus Helicopters, 2701 North Forum Drive, Grand
Prairie, TX 75052; phone<PHONE_NUMBER> or<PHONE_NUMBER>; fax (972)
641-3775; or at airbus.com/helicopters/services/technical-support.html.
    (6) 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>.
    (7) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on July 3, 2023.
Michael Linegang,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-15596 Filed 7-21-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 74, Number 110 (Wednesday, June 10, 2009)]
[Notices]
[Pages 27526-27527]
[FR Doc No: E9-13545]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12636-001]

Mohawk Hydro Corp.; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

June 3, 2009.
    On May 1, 2009, Mohawk Hydro Corporation filed an application,
pursuant to section 4(f) of the Federal Power Act, for a successive
preliminary permit to study the feasibility of the Middle Mohawk
Hydroelectric Project, to be located on the Mohawk River, in
Schenectady and Montgomery Counties, New York.
    The proposed Middle Mohawk Hydroelectric Project would be located
at existing facilities that are owned by the New York State Canal
Corporation. The proposed run-of-river project would consist of the
following eight Developments:

Lock 8 Development

    (1) An existing 530-foot-long, 14-foot-high bridge type dam
constructed primarily of steel, (2) an existing reservoir having a
surface area of 336 acres, with a storage capacity of 3,360 acre-feet
and a normal water surface elevation of 224 feet USGS, (3) a proposed
intake structure, (4) two proposed powerhouses containing 18 generating
units having a total installed capacity of 6 MW, (5) a proposed 1,800-
foot-long, 34.5 kV transmission line, and (6) appurtenant facilities.
    The development would have an annual generation of 16 gigawatt-
hours which would be sold to a local utility.

Lock 9 Development:

    (1) An existing 530-foot-long, 15-foot-high bridge type dam
constructed primarily of steel, (2) an existing reservoir having a
surface area of 428 acres, with a storage capacity of 4,280 acre-feet
and a normal water surface elevation of 239 feet USGS, (3) a proposed
intake structure, (4) two proposed powerhouses containing 18 generating
units having a total installed capacity of 6 MW, (5) a proposed 200-
foot-long, 13.2 kV transmission line, and (6) appurtenant facilities.
    The development would have an annual generation of 17.6 gigawatt-
hours which would be sold to a local utility.

Lock 10 Development

    (1) An existing 500-foot-long, 15-foot-high bridge type dam
constructed primarily of steel, (2) an existing reservoir having a
surface area of 414 acres, with a storage capacity of 4,140 acre-feet
and a normal water surface elevation of 254 feet USGS, (3) a proposed
intake structure, (4) two proposed powerhouses containing 18 generating
units having a total installed capacity of 6 MW, (5) a proposed 1,500-
foot-long, 115 kV transmission line, and (6) appurtenant facilities.
    The development would have an annual generation of 17.3 gigawatt-
hours which would be sold to a local utility.

Lock 11 Development

    (1) An existing 588-foot-long, 12-foot-high bridge type dam
constructed primarily of steel, (2) an existing reservoir having a
surface area of 414 acres, with a storage capacity of 4,140 acre-feet
and a normal water surface elevation of 266 feet USGS, (3) a proposed
intake structure, (4) two proposed powerhouses containing 18 generating
units having a total installed capacity of 6 MW, (5) a proposed 700-
foot-long, 34.5 kV transmission line, and (6) appurtenant facilities.
    The development would have an annual generation of 16.1 gigawatt-
hours which would be sold to a local utility.

Lock 12 Development

    (1) An existing 460-foot-long, 11-foot-high bridge type dam
constructed primarily of steel, (2) an existing reservoir having a
surface area of 737 acres, with a storage capacity of 7,370 acre-feet
and a normal water surface elevation of 277 feet USGS, (3) a proposed
intake structure, (4) two proposed powerhouses containing 18 generating
units having a total installed capacity of 6 MW, (5) a proposed 400-
foot-long, 13.2 kV transmission line, and (6) appurtenant facilities.
    The development would have an annual generation of 11.7 gigawatt-
hours which would be sold to a local utility.

Lock 13 Development

    (1) An existing 370-foot-long, 8-foot-high bridge type dam
constructed primarily of steel, (2) an existing reservoir having a
surface area of 464 acres, with a storage capacity of 4,640 acre-feet
and a normal water surface elevation of 285 feet USGS, (3) a proposed
intake structure, (4) a proposed powerhouse containing 9 generating
units having a total installed capacity of 3 MW, (5) a proposed 200-
foot-long, 13.2 kV transmission line, and (6) appurtenant facilities.
    The development would have an annual generation of 7.3 gigawatt-
hours which would be sold to a local utility.

Lock 14 Development

    (1) An existing 430-foot-long, 8-foot-high bridge type dam
constructed primarily of steel, (2) an existing reservoir having a
surface area of 219 acres, with a storage capacity of 2,190 acre-feet
and a normal water surface elevation of 293 feet USGS, (3) a proposed
intake structure, (4) a proposed powerhouse containing 9 generating
units having a total installed capacity of 3 MW, (5) a proposed 200-
foot-long, 13.2 kV transmission line, and (6) appurtenant facilities.
    The development would have an annual generation of 5.8 gigawatt-
hours which would be sold to a local utility.

Lock 15 Development:

    (1) An existing 430-foot-long, 8-foot-high bridge type dam
constructed primarily of steel, (2) an existing reservoir having a
surface area of 578 acres, with a storage capacity of 5,780 acre-feet
and a normal water surface

elevation of 293 feet USGS, (3) a proposed intake structure, (4) two
proposed powerhouses containing 18 generating units having a total
installed capacity of 6 MW, (5) a proposed 200-foot-long, 13.2 kV
transmission line, and (6) appurtenant facilities.
    The development would have an annual generation of 5.8 gigawatt-
hours which would be sold to a local utility. The total installed
capacity for all eight proposed developments is 41 MW and the total
annual generation is 97.6 gigawatt-hours.
    Applicant Contact: Mr. James A. Besha, P.E., President of Albany
Engineering Corporation, Agent for Mohawk Hydro Corp., 5 Washington
Square, Albany, NY 12205,<PHONE_NUMBER>.
    FERC Contact: John Ramer,<PHONE_NUMBER>.
    Deadline for filing motions to intervene, competing applications
(without notice of intent), or notices of intent to file competing
applications: 60 days from the issuance date of this notice. Comments,
motions to intervene, notices of intent, and competing applications may
be electronically filed via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be filed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filling-comments.asp. More information about this project can be viewed or
printed on the ``e-library'' link of the Commission's Web site at
http://www.ferc.gov/docs-filings/elibrary.asp. Enter the docket number
(P-12636-001) in the docket number field to access the document. For
assistance, call toll free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-13545 Filed 6-9-09; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 54 (Thursday, March 20, 2014)]
[Notices]
[Page 15602]
[FR Doc No: 2014-06095]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2014-0002]

Final Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final notice.

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

SUMMARY: Flood hazard determinations, which may include additions or
modifications of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where
applicable, in the supporting Flood Insurance Study (FIS) reports have
been made final for the communities listed in the table below.
    The FIRM and FIS report are the basis of the floodplain management
measures that a community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the Federal Emergency Management Agency's (FEMA's)
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report are used by insurance agents and others to calculate appropriate
flood insurance premium rates for buildings and the contents of those
buildings.

DATES: The effective date of June 16, 2014 which has been established
for the FIRM and, where applicable, the supporting FIS report showing
the new or modified flood hazard information for each community.

ADDRESSES: The FIRM, and if applicable, the FIS report containing the
final flood hazard information for each community is available for
inspection at the respective Community Map Repository address listed in
the tables below and will be available online through the FEMA Map
Service Center at www.msc.fema.gov by the effective date indicated
above.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the new or
modified flood hazard information for each community listed.
Notification of these changes has been published in newspapers of local
circulation and ninety (90) days have elapsed since that publication.
The Deputy Associate Adminstrator for Mitigation has resolved any
appeals resulting from this notification.
    This final notice is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the new or revised FIRM and FIS report available at the address
cited below for each community or online through the FEMA Map Service
Center at www.msc.fema.gov. The flood hazard determinations are made
final in the watersheds and/or communities listed in the table below.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
              Pinal County, Arizona, and Incorporated Areas
                         Docket No.: FEMA-B-1246
------------------------------------------------------------------------
City of Maricopa.......................  City Hall, 45145 West Madison
                                          Avenue, Maricopa, AZ 85139.
Unincorporated Areas of Pinal County...  Pinal County Engineering
                                          Department, 31 North Pinal
                                          Street, Building F, Florence,
                                          AZ 85132.
------------------------------------------------------------------------
             Starke County, Indiana, and Incorporated Areas
                         Docket No.: FEMA-B-1292
------------------------------------------------------------------------
City of Knox...........................  City Hall, 101 West Washington
                                          Street, Knox, IN 46534.
Town of North Judson...................  Town Office, 204 Keller Avenue,
                                          North Judson, IN 46366.
Unincorporated Areas of Starke County..  Starke County Annex Building,
                                          53 East Mound Street, Knox, IN
                                          46534.
------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: January 31, 2014.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2014-06095 Filed 3-19-14; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 87, Number 192 (Wednesday, October 5, 2022)]
[Rules and Regulations]
[Pages 60295-60298]
[FR Doc No: 2022-21580]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0184; FRL-10228-01-OCSPP]

IN-11460: 2-Propenoic Acid, Polymer With Ethene, Ethenyl Acetate
and Sodium Ethenesulfonate; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of 2-propenoic acid, polymer with ethene,
ethenyl acetate and sodium ethenesulfonate (CAS Reg. No. 429691-44-1)
when used as an inert ingredient in a pesticide chemical formulation.
Celanese Corporation submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of 2-propenoic acid,
polymer with ethene, ethenyl acetate and sodium ethenesulfonate on food
or feed commodities.

DATES: This regulation is effective October 5, 2022. Objections and
requests for hearings must be received on or before December 5, 2022
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2022-0188, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is<PHONE_NUMBER>. For the latest
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
https://www.ecfr.gov/current/title-40.

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2022-0188 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
December 5, 2022. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified

by docket ID number EPA-HQ-OPP-2022-0188, by one of the following
methods.
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of March 22, 2021 (86 FR 15162) (FRL-10021-
44), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (PP IN-11460)
filed by Celanese Corporation (9502 Bayport Blvd., Pasadena, TX 77507).
The petition requested that 40 CFR 180.960 be amended by establishing
an exemption from the requirement of a tolerance for residues of 2-
propenoic acid, polymer with ethene, ethenyl acetate and sodium
ethenesulfonate (CAS Reg. No. 429691-44-1), with a minimum number
average molecular weight of 5,600 Daltons. That document included a
summary of the petition prepared by the petitioner and solicited
comments on the petitioner's request. The Agency did not receive any
public comments.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and use in residential settings but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing an exemption from the
requirement of a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue . . .'' and
specifies factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. To
determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). 2-Propenoic acid, polymer with ethene,
ethenyl acetate and sodium ethenesulfonate, with a minimum number
average molecular weight 5,600 Daltons, conforms to the definition of a
polymer given in 40 CFR 723.250(b) and meets the following criteria
that are used to identify low-risk polymers.
    1. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
    2. The polymer does contain as an integral part of its composition
at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen,
silicon, and sulfur.
    3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize: An
adequate biodegradation study (MRID 51976001) demonstrates that 2-
propenoic acid, polymer with ethene, ethenyl acetate and sodium
ethenesulfonate, with a minimum number average molecular weight 5,600
Daltons, is not readily biodegradable.
    5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 Daltons.
    7. The polymer does not contain certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length as listed in 40
CFR 723.250(d)(6).
    Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
    The polymer's number average molecular weight (MW) of 5,600 Daltons
is greater than 1,000 Daltons and less than 10,000 Daltons. However,
the polymer contains less than 10% oligomeric material below MW 500 and
less than 25% oligomeric material below MW 1,000.
    Thus, 2-propenoic acid, polymer with ethene, ethenyl acetate and
sodium ethenesulfonate meets the criteria for a polymer to be
considered low risk under 40 CFR 723.250. Based on its conformance to
the criteria in this unit, no mammalian toxicity is anticipated from
dietary, inhalation, or dermal exposure to 2-propenoic acid, polymer
with ethene, ethenyl acetate and sodium ethenesulfonate.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this
exemption, EPA considered that 2-propenoic acid, polymer with ethene,
ethenyl acetate and sodium ethenesulfonate could be present in all raw
and processed agricultural commodities and drinking water, and that
non-occupational non-dietary exposure was possible. The minimum number
average MW of 2-propenoic acid, polymer with ethene, ethenyl acetate
and sodium ethenesulfonate is 5,600 Daltons. Generally, a polymer of

this size would be poorly absorbed through the intact gastrointestinal
tract or through intact human skin. Since 2-propenoic acid, polymer
with ethene, ethenyl acetate and sodium ethenesulfonate conforms to the
criteria that identify a low-risk polymer, there are no concerns for
risks associated with any potential exposure scenarios that are
reasonably foreseeable. The Agency has determined that a tolerance is
not necessary to protect the public health.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not found 2-propenoic acid, polymer with ethene, ethenyl
acetate and sodium ethenesulfonate to share a common mechanism of
toxicity with any other substances, and 2-propenoic acid, polymer with
ethene, ethenyl acetate and sodium ethenesulfonate does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that 2-
propenoic acid, polymer with ethene, ethenyl acetate and sodium
ethenesulfonate does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of 2-propenoic acid, polymer
with ethene, ethenyl acetate and sodium ethenesulfonate, EPA has not
used a safety factor analysis to assess the risk. For the same reasons
the additional tenfold safety factor is unnecessary.

VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of 2-propenoic acid, polymer with
ethene, ethenyl acetate and sodium ethenesulfonate.

VIII. Other Considerations

Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of 2-propenoic acid,
polymer with ethene, ethenyl acetate and sodium ethenesulfonate from
the requirement of a tolerance will be safe.

X. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

XI. Congressional Review Act (CRA)

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

List of Subjects in 40 CFR Part 180

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

    Dated: September 28, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

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

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

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

0
2. In Sec.  180.960, amend table 1 by adding, in alphabetical order,
the polymer ``2-Propenoic acid, polymer with ethene, ethenyl acetate
and sodium ethenesulfonate, minimum number average molecular weight (in
amu) 5,600'' to read as follows:

Sec.  180.960  Polymers; exemptions from the requirement of a
tolerance.

* * * * *

                        Table 1 to Sec.   180.960
------------------------------------------------------------------------
                         Polymer                              CAS No.
------------------------------------------------------------------------

                              * * * * * * *
2-Propenoic acid, polymer with ethene, ethenyl acetate       429691-44-1
 and sodium ethenesulfonate, minimum number average
 molecular weight (in amu) 5,600........................

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

[FR Doc. 2022-21580 Filed 10-4-22; 8:45 am]
BILLING CODE 6560-50-P


1000 to 1900. U.S. Government Printing Office, Washington D.C. August,
1996.

US EPA 1997: US EPA. 1997. The FIFRA and FFDCA as amended by the Food
Quality Protection Act (FQPA) of August 3, 1996. OPP, EPA. March, 1997.
Pamphlet 730L97001. 189 pp.

US EPA 2005: US EPA. 2005. Title 40-Protection of Environment Parts 150
to 189. Code of Federal Regulations. Office of the Federal Register.
U.S. Government Printing Office, Washington D.C. 707 pp. USDA 2005:
USDA Agricultural Statistics 2005: USDA Statistics 2005.
http://www.usda.gov/nass/

USDA AMS 1962:  USDA Agricultural Marketing Service. 1962. United States
Standards for Grades of Canned Mushrooms. http://www.ams.usda.gov/fv

USDA AMS 1997:  USDA Agricultural Marketing Service. 1997. United States
Standards for Grades of Mushrooms. http://www.ams.usda.gov/fv

USDA Crop Profiles. 2005: USDA Crop Profiles. 2005:

USDA Crop Profiles 1999. Mushrooms in California.   HYPERLINK
"http://ipmcenters.org/cropprofiles/docs/pamushrooms.html"
http://ipmcenters.org/cropprofiles/docs/camushrooms.html

USDA Crop Profiles 1999. Mushrooms in Pennsylvania.   HYPERLINK
"http://ipmcenters.org/cropprofiles/docs/pamushrooms.html"
http://ipmcenters.org/cropprofiles/docs/pamushrooms.html

USDA ERS. 2006.  USDA Food Availability Per Capita Data System. USDA
Economic Research Service.  (  HYPERLINK
"http://www.ers.usda.dov/data/food consumption/foodavailqheriable.aspx"
http://www.ers.usda.dov/data/food consumption/foodavailqheriable.aspx ).

USDA FAS 2006:  USDA Foreign Agricultural Service. Foreign Agriculture
Trade (FATUS) Imports and Exports. FAS Online (  HYPERLINK
"http://www.fas.usda.gov/ustrade/USTImFatus"
http://www.fas.usda.gov/ustrade/USTImFatus )

USDA GRIN 2005: USDA, GRIN 2005. USDA, ARS, National Genetic Resources
Program. Germplasm Resource Information Network – (GRIN) [online
database]. US National Germplasm Resources Laboratory, Beltsville, MD.
URL: http://www.ars-grin.gov

USDA ERS 2005. USDA ERS. 2005. Food Consumption Per Capita Data System.
Food Availability Custom Queries. Dec 23. (  HYPERLINK
"http://www.ers.usda.gov/data/food consumption/foodavailqueriable.aspx"
http://www.ers.usda.gov/data/food consumption/foodavailqueriable.aspx ).

USDA NASS: USDA. 2005. Mushrooms. USDA National Agricultural Statistics
Service. VG 2-1-2 (8-05).

USDA, NRCS 2004: USDA, NRCS 2004. The PLANTS Database, Version 3.5
(http://plants.usda.gov). National Plant Data Center, Baton Rouge, LA
70874-4490 USA.

USDA National Nutrient Database, 2004.
http://www.nal.usda.gov/fnic/foodcomp/search

WALDE: Walde, S.G., V. Velu, T. Jyothirmayi, and R.G. Math. 2006.
Effects of Pretreatments and Drying Methods on Dehydration of Mushroom.
Journal of Food Engineering. 74: (1): 108-115.

WOOD. Wood, M. and F. Stevens. 2001. Stropharia coronilla. The Fungi of
California.   HYPERLINK
"http://www.mykoweb.com/CAF/species/Stropharia_coronilla.html"
http://www.mykoweb.com/CAF/species/Stropharia_coronilla.html

WIKIPEDIA: Wikipedia, The Free Encyclopedia Online information.
HYPERLINK "http://en.wikipedia.org/wiki/Main_Page"
http://en.wikipedia.org/wiki/Main_Page

WU: Wu, B.K. 2000. Mushroom Processing. Pp 1678-1682. In Encyclopedia of
Food Science and Technology. Volume 3. Second Ed. F.J. Francis, Editor.
John Wiley & Sons, Inc. NY.

 For residues from environmental sources other than from pesticide use
on the commodities.

 For post-harvest treatment only.

 PAGE

 PAGE   56

 PAGE


[Federal Register Volume 85, Number 236 (Tuesday, December 8, 2020)]
[Notices]
[Pages 79010-79011]
[FR Doc No: 2020-26933]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP21-268-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Colonial
911723 eff 12-01-2020 to be effective 12/1/2020.
    Filed Date: 12/1/20.
    Accession Number: 20201201-5001.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-269-000.
    Applicants: Equitrans, L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Capacity
Release Agreements--12/1/2020 to be effective 12/1/2020.
    Filed Date: 12/1/20.
    Accession Number: 20201201-5053.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-270-000.
    Applicants: NEXUS Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Various
Releases eff 12-01-2020 to be effective 12/1/2020.
    Filed Date: 12/1/20.
    Accession Number: 20201201-5078.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-271-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Chevron
911109 Releases eff 12-01-2020 to be effective 12/1/2020.
    Filed Date: 12/1/20.
    Accession Number: 20201201-5090.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-272-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Gulfport
911377 to Eco eff 12-1-20 to be effective 12/1/2020.
    Filed Date: 12/1/20.
    Accession Number: 20201201-5127.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-273-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Dec 20 Neg Rate Agmts Amends
to be effective 12/1/2020.
    Filed Date: 12/1/20.
    Accession Number: 20201201-5150.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-274-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20201201 Remove Non-Conforming
Golden Spread to be effective 1/1/2021.
    Filed Date: 12/1/20.
    Accession Number: 20201201-5175.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-275-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmts
(Atlanta Gas 8438 to various shippers eff 12-1-2020) to be effective
12/1/2020.
    Filed Date: 12/1/20.
    Accession Number: 20201201-5220.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-276-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmts
(Marathon releases eff 12-1-2020) to be effective 12/1/2020.
    Filed Date: 12/1/20.
    Accession Number: 20201201-5222.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-277-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Remove Expired Agmts eff 12-1-
2020 to be effective 12/1/2020.
    Filed Date: 12/1/20.
    Accession Number: 20201201-5224.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-278-000.
    Applicants: MarkWest Pioneer, L.L.C.
    Description: Sec.  4(d) Rate Filing: Quarterly Fuel Adjustment
Filing to be effective 1/1/2021.
    Filed Date: 12/1/20.
    Accession Number: 20201201-5244.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-279-000.
    Applicants: Enable Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Filing--
December 1, 2020 CERC 1001019 to be effective 12/1/2020.
    Filed Date: 12/1/20.
    Accession Number: 20201201-5267.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-280-000.
    Applicants: Chandeleur Pipe Line, LLC.
    Description: Compliance filing Chandeleur Annual Fuel and Gas Loss
Retention Adjustment Filing to be effective N/A.
    Filed Date: 12/1/20.
    Accession Number: 20201201-5268.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-281-000.
    Applicants: Alliance Pipeline L.P.
    Description: Sec.  4(d) Rate Filing: Hess 2021 Tioga Usage Charge
Filing to be effective 1/1/2021.
    Filed Date: 12/1/20.
    Accession Number: 20201201-5277.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-282-000.
    Applicants: Alliance Pipeline L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Rate
Schedule PAL to be effective 12/1/2020.
    Filed Date: 12/1/20.
    Accession Number: 20201201-5297.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-283-000.
    Applicants: Dominion Energy Questar Pipeline, LLC.
    Description: Sec.  4(d) Rate Filing: Fuel Gas Reimbursement
Percentage for 2021 to be effective 1/1/2021.

    Filed Date: 12/1/20.
    Accession Number: 20201201-5302.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-284-000.
    Applicants: Columbia Gulf Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: CGT SWN Non-conforming NRA
#216577 to be effective 1/1/2021.
    Filed Date: 12/1/20.
    Accession Number: 20201201-5304.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-285-000.
    Applicants: Cameron Interstate Pipeline, LLC.
    Description: Sec.  4(d) Rate Filing: Cameron Interstate Pipeline,
LLC Annual Adjustment of Fuel Retainage Percentage to be effective 1/1/
2021.
    Filed Date: 12/1/20.
    Accession Number: 20201201-5310.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-286-000.
    Applicants: Dominion Energy Overthrust Pipeline, LLC.
    Description: Sec.  4(d) Rate Filing: Non-conforming TSAs--BP, WIC
TSAs to be effective 1/1/2021.
    Filed Date: 12/1/20.
    Accession Number: 20201201-5339.
    Comments Due: 5 p.m. ET 12/14/20.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 2, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-26933 Filed 12-7-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: September 11, 2009 (Volume 74, Number 175)]
[Notices]
[Page 46763-46764]
[DOCID:fr11se09-40]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 1

August 25, 2009.
    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC09-105-000.
    Applicants: MxEnergy Electric Inc.
    Description: MXenergy Electric Inc. Application for Authorization
for Disposition of Jurisdictional Facilities and Request for Expedited
Action.
    Filed Date: 08/20/2009.
    Accession Number: 20090820-5082.
    Comment Date: 5 p.m. Eastern Time on Monday, August 31, 2009.

    Docket Numbers: EC09-106-000.
    Applicants: Milford Wind Corridor Phase I, LLC, MWCI Holdings, LLC.
    Description: Application for Authorization of Disposition of
Jurisdictional Facilities and Request for Expedited Consideration and
Confidential Treatment of Milford Wind Corridor Phase I, LLC, and MWCI
Holdings, LLC.
    Filed Date: 08/25/2009.
    Accession Number: 20090825-5046.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 15, 2009.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG09-89-000.
    Applicants: Silver Sage Windpower, LLC.
    Description: Notice of Self-Certification as an Exempt Wholesale
Generator of Silver Sage Windpower, LLC.
    Filed Date: 08/25/2009.
    Accession Number: 20090825-5039.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 15, 2009.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER07-589-003; ER05-1389-003; ER06-1228-004; ER99-
3450-009; ER99-2769-010; ER00-2706-007; ER01-390-007; ER04-208-006.
    Applicants: Citigroup Energy Canada ULC, San Juan Mesa Wind
Project, LLC, Chandler Wind Partners, LLC, Foote Creek II, LLC, Foote
Creek IV, LLC, Ridge Crest Wind Partners, LLC, Citigroup Energy Inc.,
Phibro LLC, Foote Creek III, LLC.
    Description: Notice of Non-Material Change in Status.
    Filed Date: 08/24/2009.
    Accession Number: 20090824-5128.

    Comment Date: 5 p.m. Eastern Time on Monday, September 14, 2009.

    Docket Numbers: ER09-863-002.
    Applicants: SMART Papers Holdings, LLC.
    Description: SMART Papers Holdings, LLC's Substitute Original Sheet
1 to its FERC Electric Tariff, Original Volume 1.
    Filed Date: 08/24/2009.
    Accession Number: 20090825-0057.
    Comment Date: 5 p.m. Eastern Time on Monday, September 14, 2009.

    Docket Numbers: ER09-1306-001.
    Applicants: Kansas City Power & Light Company.
    Description: Kansas City Power & Light Company submits the amended
and Restated Interconnection Rights Assignment and Assumption Agreement
et al.
    Filed Date: 08/24/2009.
    Accession Number: 20090825-0054.
    Comment Date: 5 p.m. Eastern Time on Monday, September 14, 2009.

    Docket Numbers: ER09-1548-001.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits Notice of Succession of Certain Transmission Service Agreements
and Network Integration Transmission Service and Operating Agreements.
    Filed Date: 08/24/2009.
    Accession Number: 20090825-0056.
    Comment Date: 5 p.m. Eastern Time on Monday, September 14, 2009.

    Docket Numbers: ER09-1544-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits Average System Cost filing for
sales of electric power to the Bonneville Power Administration.
    Filed Date: 08/04/2009.
    Accession Number: 20090805-0021.
    Comment Date: 5 p.m. Eastern Time on Friday, September 04, 2009.

    Docket Numbers: ER09-1620-000.
    Applicants: Virginia Electric and Power Company.
    Description: Virginia Electric and Power Company submits revised
cover sheet to cancel a Standard Large Generator Interconnection
Agreement between Dominion Virginia Power and CPV Warren, LLC.
    Filed Date: 08/24/2009.
    Accession Number: 20090825-0018.
    Comment Date: 5 p.m. Eastern Time on Monday, September 14, 2009.

    Docket Numbers: ER09-1621-000.
    Applicants: Jersey Central Power & Light Co.
    Description: Jersey Central Power & Light Co submits an amended
Interconnection Agreement with RR Energy Mid-Atlantic Power Holdings,
LLC.
    Filed Date: 08/24/2009.
    Accession Number: 20090825-0058.
    Comment Date: 5 p.m. Eastern Time on Monday, September 14, 2009.

    Take notice that the Commission received the following electric
securities filings:
    Docket Numbers: ES09-48-000.
    Applicants: El Paso Electric Company.
    Description: Application of El Paso Electric Company for
Authorization under Section 204 of the Federal Power Act regarding a
Revolving Credit Facility.
    Filed Date: 08/25/2009.
    Accession Number: 20090825-5040.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 15, 2009.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5:00 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-21875 Filed 9-10-09; 8:45 am]

BILLING CODE 6717-01-P