[Federal Register Volume 87, Number 43 (Friday, March 4, 2022)]
[Rules and Regulations]
[Pages 12401-12402]
[FR Doc No: 2022-04704]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 7

[Docket No. FDA-2018-D-2074]

Initiation of Voluntary Recalls; Guidance for Industry and Food
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a final guidance for industry and FDA
staff entitled ``Initiation of Voluntary Recalls Under 21 CFR part 7,
subpart C.'' The guidance for industry and FDA staff provides guidance
on timely initiation of voluntary recalls of FDA-regulated products. It
also discusses preparations that firms in a distribution chain should
consider making to ensure timely responses to a recall communication.
In addition, the guidance discusses how FDA assists firms with carrying
out their recall responsibilities to protect the public health from
distributed products in violation of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) and other laws administered by FDA. This
guidance finalizes the draft guidance of the same title issued on April
24, 2019.

DATES: The announcement of the guidance is published in the Federal
Register on March 4, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2018-D-2074 for ``Initiation of Voluntary Recalls Under 21 CFR part
7, subpart C.'' 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,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this

information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    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 guidance to the
Office of Strategic Planning and Operational Policy, Office of
Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr.,
Element Bldg., Rm. 4141, Rockville, MD 20857. Send two self-addressed
adhesive labels to assist that office in processing your request. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance.

FOR FURTHER INFORMATION CONTACT: Peter Fox, Office of Regulatory
Affairs, Office of Strategic Planning and Operational Policy, Food and
Drug Administration, 12420 Parklawn Dr., Element Bldg., Rm. 4146,
Rockville, MD 20857,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and
FDA staff entitled ``Initiation of Voluntary Recalls Under 21 CFR part
7, subpart C.'' The guidance for industry and FDA staff provides
guidance on timely initiation of voluntary recalls of FDA-regulated
products. The guidance discusses what preparations firms in a
distribution chain, including manufacturers and distributors, should
consider making to establish recall initiation procedures; to ensure
timely identification of, and response to, product problems that might
lead to a recall; and to promptly issue recall communications and press
releases or other public notices. It also discusses preparations that
firms in a distribution chain should consider making to ensure timely
responses to recall communications. In addition, the guidance discusses
how FDA assists firms with carrying out their recall responsibilities
to protect the public health from distributed products in violation of
the FD&C Act and other laws administered by FDA.
    This guidance finalizes the draft guidance of the same title issued
on April 24, 2019 (84 FR 17112). FDA considered comments received on
the draft guidance as the guidance was finalized. In addition to
editorial changes made to improve clarity, changes from the draft to
the final guidance include the addition of the terms correction and
market withdrawal to the terminology section, the addition of language
encouraging the use of electronic communications for conveying
voluntary recall communications about FDA-regulated products, and the
deletion of section IV (``References'').
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents 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
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR 7.46, 7.49, and 7.59 have been approved under
OMB control number 0910-0249; section 417 of the FD&C Act (21 U.S.C.
350f) has been approved under OMB control number 0910-0643; section 761
of the FD&C Act (21 U.S.C. 379aa-1) has been approved under OMB control
number 0910-0291; 21 CFR 107.240 has been approved under OMB control
number 0910-0188; 21 CFR part 117 has been approved under OMB control
number 0910-0751; and 21 CFR part 507 has been approved under OMB
control number 0910-0751.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.regulations.gov.

    Dated: February 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04704 Filed 3-3-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 56 (Thursday, March 25, 2021)]
[Notices]
[Pages 15983-15986]
[FR Doc No: 2021-06119]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91376; File No. SR-ICEEU-2021-002]

Self-Regulatory Organizations; ICE Clear Europe Limited; Order
Approving Proposed Rule Change Relating to Amendments to the ICE Clear
Europe Price Submission Disciplinary Framework

March 19, 2021.

I. Introduction

    On February 2, 2021, ICE Clear Europe Limited (``ICE Clear
Europe'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to modify certain provisions of its Price
Submission Disciplinary Framework and to rename it as the ``Price
Submission Disciplinary Procedure'' (hereinafter referred to as the
``Procedure'').\3\ The proposed rule change was published for comment
in the Federal Register on February 18, 2021.\4\ The Commission did not
receive comments regarding the proposed rule change. For the reasons
discussed below, the Commission is approving the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Self-Regulatory Organizations; ICE Clear Europe Limited;
Notice of Filing of Proposed Rule Change Relating to Amendments to
the ICE Clear Europe Price Submission Disciplinary Framework,
Exchange Act Release No. 91114 (February 11, 2021), 86 FR 10152
(February 18, 2021) (SR-ICEEU-2021-002) (``Notice'').
    \4\ See Notice, supra note 3, 86 FR 10152.
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II. Description of the Proposed Rule Change

    ICE Clear Europe proposes to make specific amendments to the
current Procedure for investigating and disciplining Clearing Members
for missed price submissions when a Clearing Member holds cleared open
interest in a single-name or index credit default swap (``CDS'')
product.\5\ The proposed amendments are summarized below.\6\
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    \5\ Capitalized terms used not defined herein have the meanings
specified in the Procedure or the ICE Clear Europe Clearing Rules
(the ``Rules''), as applicable.
    \6\ The following description is substantially excerpted from
the Notice.
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Cash Assessments for Missed Submissions and Waivers

    The proposed amendments in renumbered Section 2.2.3 (Fixed Cash
Assessments for Missed Submissions) would state that a Clearing Member
in receipt of a Notice of Investigation issued in respect of an alleged
Missed Submission will have five days to submit written comments. The
proposed amendments would also provide an additional five days for ICE
Clear Europe to review the relevant Clearing Member's comments before
sending a Letter of Mindedness to the Clearing Member under Rule
1002(f) at the conclusion of the investigation. ICE Clear Europe
represents that these proposed amendments would improve the current
process by affording the Clearing Member an opportunity to respond to
the initial notice and giving ICE Clear Europe time to assess the
Clearing Member's response before determining whether to take further
action under the Rules.\7\
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    \7\ See Notice, 86 FR at 10152.
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    The proposed rule change would also clarify when ICE Clear Europe
would issue a cash assessment notice to a Clearing Member, regardless
of whether ICE Clear Europe receives written comments from the Clearing
Member during the ten-day period from the date of a Letter of
Mindedness. Specifically, the proposed rule change would provide that
ICE Clear Europe will issue a cash assessment notice following the
expiry of such ten-day period where it determines that an assessment
amount is required to be collected. The proposed rule change would make
a drafting clarification to specify that the cash assessment notice
would be calculated according to the cash assessment calculation
details outlined in the Procedure.
    In addition, the proposed rule change would remove the current
investigation procedures for one or more Missed Submissions in a month
for the type of instrument (index or single-name) involved. Instead,
the proposed amendments would update and clarify the procedures by
which a Clearing Member may assert that one or more Missed Submissions
were due to extraordinary circumstances outside of its control. In such
circumstances, the proposed rule change would designate the Head of
Regulation and Compliance to determine whether such circumstances
apply, rather than the currently designated Head of Clearing
Compliance.
    ICE Clear Europe also proposes changes in renumbered Section 2.2.3
(Fixed Cash Assessments for Missed Submissions) to the process for
granting waivers of the applicable cash assessment amount for Missed
Submissions based on the CDS product type. The proposed rule change
would clarify that if a waiver is granted, no cash assessment amount
would be due for the Missed Submission. Further, the proposed rule
change would change the current eligibility provisions for such
waivers. ICE Clear Europe represents that, under the current waiver
process, a Clearing Member receives only one waiver over the course of
its clearing membership for a Missed Submission.\8\ The proposed rule
change would change that process by providing that a Clearing Member is
eligible for one waiver per calendar year for Missed Submissions for
single-name products and one waiver per calendar year for Missed
Submissions for index products.
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    \8\ Id.
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    The proposed rule change would also expressly limit such waivers to
Missed Submissions caused by technical failures. In addition, the
proposed rule change would require that Clearing Members must provide
an adequate written explanation of the technical failure and a summary
of planned remedial actions. The proposed rule change would also
specify that only the first instance of a Missed Submission in any
calendar year for both single-name and index products will be eligible
for a waiver. ICE Clear Europe represents that it believes the proposed
approach to waivers strikes a better balance than the current approach
between the need for robust submissions under the Policy and the goal
of not unnecessarily penalizing Clearing Members for technical
failures.\9\
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    \9\ See Notice, 86 FR at 10153.
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Changes Regarding Missed Submissions

    In the definition of the term ``Missed Submissions'' in Section
2.1.2, ICE Clear Europe would change the type of submissions that count
as Missed Submissions. Specifically, ICE Clear Europe would remove the
statement that spread submissions will be counted as

Missed Submissions, and replace it with a statement that submissions
not adhering to the format described in Section 2.2.3 of the Policy
will be counted as Missed Submissions. ICE Clear Europe represents that
such format requires index submissions to follow market convention in
terms of providing prices as spreads, and be either midpoint or bid-
offer.\10\
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    \10\ See Notice, 86 FR at 10152.
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    ICE Clear Europe also would make certain non-substantive drafting
clarifications to the provisions in this section on Obvious Error
submissions where the bid is higher than the high threshold, or the
offer is lower than the low threshold. Specifically, ICE Clear Europe
would clarify that references to ``Missed Submissions'' shall be deemed
to include Obvious Errors on CDX Indices submissions, as applicable.

Document Governance and Exception Handling

    The proposed amendments would add new provisions with respect to
the governance of the Procedure document and the handling of exception
approvals to this document. Specifically, the proposed amendments would
state that the document owner is responsible for ensuring that the
Procedure remains up-to-date and is reviewed in accordance with ICE
Clear Europe's governance processes. The proposed amendments would
further provide that the document owner will report material breaches
or unapproved deviations from the Procedure to the document owner's
Head of Department, the Chief Risk Officer and the Head of Compliance
(or their delegates) who together will determine if further escalation
is required. Lastly, the proposed amendments would state that
exceptions to the Procedure can be approved in accordance with ICE
Clear Europe's governance process for the Procedure. ICE Clear Europe
represents that the proposed approach to governance and exception
handling is consistent with that of other ICE Clear Europe
procedures.\11\
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    \11\ Id.
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General Drafting Clarifications and Improvements

    ICE Clear Europe would amend the current document title from
``Price Submission Disciplinary Framework'' to ``Price Submission
Disciplinary Procedure,'' and make a conforming word change in Section
2.1.1 (Purpose) from ``framework'' to ``procedure.'' ICE Clear Europe
would remove Section 2.2 (End of Day Price Discovery Process) and the
related Appendix A: End of Day Price Discovery Process, because these
matters are covered in the existing CDS End of Day Price Discovery
Policy (the ``Policy''). As a result of this proposed amendment and
deletion of this section, ICE Clear Europe would renumber current
Section 2.3 (Price Submission Incentives) as 2.2, add a cross-reference
to the Policy in Section 1.1 (Overview), and remove a parenthetical
cross-reference to such section in the renumbered Price Submission
Incentives section.
    To aid with readability, ICE Clear Europe would shorten the term
``CDS Clearing Member'' to ``CM'' throughout the Procedure, and also
shorten or rephrase certain sentences without changing their
substantive meanings. ICE Clear Europe would also replace references to
CDX products with references to CDX Indices as a more precise term. In
Section 1.1, ICE Clear Europe would update a reference to Markit Group
Limited to its current name, IHS Markit.
    In Section 2.1.1 (Purpose), ICE Clear Europe proposes to simplify
and clarify the stated purpose of the Procedure to provide that the
document outlines the procedure to be used internally by ICE Clear
Europe when taking disciplinary action in relation to price
submissions. In Section 2.1.3 (Legal Basis), ICE Clear Europe would
also include a cross-reference to Rule 503(g), rather than restate the
relevant text of Rule 503(g).

III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act directs the Commission to approve a
proposed rule change of a self-regulatory organization if it finds that
such proposed rule change is consistent with the requirements of the
Act and the rules and regulations thereunder applicable to such
organization.\12\ For the reasons given below, the Commission finds
that the proposed rule change is consistent with Section 17A(b)(3)(F)
of the Act, Section 17A(b)(3)(G) of the Act, Section 17A(b)(3)(H) of
the Act,\13\ Rule 17Ad-22(e)(2), and Rule 17Ad-22(e)(6)(iv)
thereunder.\14\
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    \12\ 15 U.S.C. 78s(b)(2)(C).
    \13\ 15 U.S.C. 78q-1(b)(3)(F), 15 U.S.C. 78q-1(b)(3)(G), and 15
U.S.C. 78q-1(b)(3)(H).
    \14\ 17 CFR 240.17Ad-22(e)(2) and 17 CFR 240.17Ad-22(e)(6)(iv).
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A. Consistency With Section 17A(b)(3)(F) of the Act

    Section 17A(b)(3)(F) of the Act requires, among other things, that
the rules of ICE Clear Europe be designed to promote the prompt and
accurate clearance and settlement of securities transactions and, to
the extent applicable, derivative agreements, contracts, and
transactions, as well as to assure the safeguarding of securities and
funds which are in the custody or control of ICE Clear Europe or for
which it is responsible.\15\ As discussed above, the proposed rule
change would make a number of updates and enhancements to the
Procedure.
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    \15\ 15 U.S.C. 78q-1(b)(3)(F).
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    First, the proposed rule change would amend the current processes
for investigating Missed Submissions for disciplinary action in the
form of cash assessment amounts, including by specifying the time
periods applicable to different aspects of the process, and for
granting waivers of cash assessment amounts for Missed Submissions.
During an investigation, the proposed rule change would update and
clarify the procedures by which a Clearing Member may assert that a
Missed Submission was caused by extraordinary circumstances outside of
its control, as determined by ICE Clear Europe's Head of Regulation and
Compliance. At the conclusion of an investigation, the proposed rule
change would clarify that ICE Clear Europe will issue a cash assessment
notice following the expiry of the ten-day period from the date of a
Letter of Mindedness issued to a Clearing Member under Rule 1002(f),
regardless of whether ICE Clear Europe receives written comments from
the Clearing Member during such period, where it determines that a cash
assessment is required to be collected. The proposed rule change would
also make a drafting clarification to specify how the cash assessment
amount will be calculated.
    With respect to the waiver process, the proposed rule change would
introduce new requirements that limit waivers to Missed Submissions
caused by technical failures, and would require the Clearing Member to
provide an adequate written explanation of the technical failure and a
remedial plan to ICE Clear Europe. The proposed rule change would also
specify that only the first instance of a Missed Submission in any
calendar year for both single-name and index products will be eligible
for a waiver.
    The Commission believes such proposed amendments to the current
processes for investigating Missed Submissions for disciplinary action
in the form of cash assessment amounts and for granting waivers of cash
assessment amounts for Missed Submissions should further incentivize
Clearing Members to avoid repeated Missed Submissions. These improved

processes should, in turn, enhance ICE Clear Europe's overall end-of-
day price submission process by helping to ensure that Clearing Members
perform their daily price submission obligations that, in turn, inform
the calculation and collection of margin requirements for CDS products
as part of ICE Clear Europe's overall risk-based margin system and risk
management processes. Consequently, the Commission believes that the
proposed changes would enhance ICE Clear Europe's ability to manage the
risks associated with clearing both single-name and index CDS products,
including the calculation of Mark-to-Market Prices under Rule 503(g),
and should help to ensure that ICE Clear Europe is able to promptly and
accurately clear and settle CDS transactions.
    Second, the proposed rule change would update and clarify which
submissions will count as Missed Submissions. Specifically, the
proposed rule change would remove spread submissions as Missed
Submissions and instead, would count submissions that do not adhere to
the designated format in the Policy as Missed Submissions. The proposed
rule change would also clarify that Obvious Errors on CDX Indices
submissions count as Missed Submissions. The Commission finds that
these proposed changes would update and clarify the scope of Missed
Submissions for Clearing Members and avoid any possible disputes or
discrepancies over which submissions will count as Missed Submissions,
which could hinder ICE Clear Europe's ability to conduct its end-of-day
price discovery process and, in turn, to promptly and accurately
calculate and collect margin requirements for CDS products and, in
turn, to promptly and accurately clear and settle CDS transactions.
Consequently, the Commission believes that these proposed changes
should also help promote the prompt and accurate clearance and
settlement of CDS transactions by ICE Clear Europe.
    Third, the proposed rule change would assign clear and direct
responsibilities to the document owner at ICE Clear Europe to review
and update the Procedure in accordance with ICE Clear Europe's
governance processes, report material breaches to designated officers
at ICE Clear Europe, and obtain approvals of any exceptions to the
Procedure by following ICE Clear Europe's governance process. The
Commission believes that the proposed governance and exception handling
changes should help ensure clarity regarding the persons at ICE Clear
Europe involved in the governance processes for the Procedure document.
The Commission believes that a lack of clarity could lead to potential
confusion regarding the proper persons to take action on behalf of ICE
Clear Europe, thereby potentially hindering ICE Clear Europe's ability
to efficiently administer and manage the Procedure and its end-of-day
price discovery process, and, in turn, to promptly and accurately clear
and settle CDS transactions.
    Fourth, the proposed rule change would remove redundant provisions
in the Procedure that are contained in the Policy or in the Rules, and
replace them with clear cross-references. The proposed rule change
would also shorten or rephrase certain sentences and defined terms, and
update certain terms and references. The Commission finds that these
proposed drafting clarifications and improvements would enhance the
clarity, transparency, and readability of the Procedure for ICE Clear
Europe management, employees, and Clearing Members that, in turn,
should help them understand their respective authorities, rights, and
obligations regarding ICE Clear Europe's clearance and settlement of
CDS transactions.
    The Commission further believes that the proposed amendments, taken
as a whole, would enhance ICE Clear Europe's ability to obtain complete
and reliable end-of-day prices that inform its calculation and
collection of margin requirements for such CDS products, and help to
manage its operational risks. Moreover, the Commission believes these
risks, if mismanaged, could threaten ICE Clear Europe's ability to
operate and therefore its ability to clear and settle transactions and
safeguard funds. As a result, the Commission believes that the proposed
changes should promote ICE Clear Europe's ability to assure the
safeguarding of securities and funds which are in the custody or
control of ICE Clear Europe or for which it is responsible.
    Therefore, the Commission believes that the proposed rule change is
consistent with Section 17A(b)(3)(F) of the Act.\16\
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    \16\ 15 U.S.C. 78q-1(b)(3)(F).
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B. Consistency With Section 17A(b)(3)(G) of the Act

    Section 17A(b)(3)(G) of the Act requires, among other things, that
ICE Clear Europe's rules provide that Clearing Members shall be
appropriately disciplined for violation of any provision of ICE Clear
Europe's rules by fine or other fitting sanction.\17\ As noted above,
the proposed rule change would amend the current Procedure for
investigating Missed Submissions for disciplinary action in the form of
cash assessment amounts, including by specifying the time periods
applicable to different aspects of the investigation process. The
proposed rule change would also clarify that ICE Clear Europe will
issue a cash assessment notice following the expiry of the ten-day
period from the date of a Letter of Mindedness issued to a Clearing
Member under Rule 1002(f), regardless of whether ICE Clear Europe
receives written comments from the Clearing Member during such period,
where it determines that a cash assessment is required to be collected.
In addition, the proposed rule change would update and clarify the
procedures by which a Clearing Member may assert that a Missed
Submission was caused by extraordinary circumstances outside of its
control. The proposed rule change would also make a drafting
clarification to specify how the cash assessment amount will be
calculated and would update and clarify which submissions will count as
Missed Submissions. The Commission believes these proposed improvements
and drafting clarifications, taken together, would help ICE Clear
Europe conduct more informed investigations of the facts and
circumstances surrounding an alleged Missed Submission before deciding
to impose cash assessments as appropriate and fitting sanctions for
violations of the Policy.
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    \17\ 15 U.S.C. 78q-1(b)(3)(G).
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    The proposed changes would also add waiver eligibility requirements
for Missed Submissions. Specifically, the proposed rule change would
limit waivers to Missed Submissions caused by technical failures, and
would require the Clearing Member to provide an adequate written
explanation of the technical failure and a remedial plan to ICE Clear
Europe. The Commission believes that these aspects of the proposed rule
change should help ICE Clear Europe decide whether to grant waivers
where individual circumstances warrant, or impose cash assessment
amounts as an appropriate and fitting sanction against Clearing Members
that violate the Policy by committing Missed Submissions for any reason
other than technical failures that meet the waiver eligibility
requirements.
    Therefore, the Commission believes that the proposed rule change is
consistent with Section 17A(b)(3)(G) of the Act.\18\
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    \18\ 15 U.S.C. 78q-1(b)(3)(G).

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C. Consistency With Section 17A(b)(3)(H) of the Act

    Section 17A(b)(3)(H) of the Act \19\ requires, among other things,
that ICE Clear Europe's rules, in general, provide a fair procedure
with respect to the disciplining of participants. As discussed above,
the proposed rule change would amend the current process for
investigating alleged Missed Submissions for disciplinary action in the
form of cash assessment amounts, including by specifying the time
periods applicable to different aspects of the process. The proposed
amendments would also update and clarify the investigative process for
Clearing Members to assert that one or more Missed Submissions were due
to extraordinary circumstances outside of its control and how ICE Clear
Europe's Head of Regulation & Compliance would assess and weigh such
circumstances in reaching a determination. The Commission believes
these proposed investigative process changes would promote the overall
fairness of the Procedure by formalizing the general time frames and
procedural steps that precede ICE Clear Europe's final determination of
whether to impose a disciplinary cash assessment amount.
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    \19\ 15 U.S.C. 78q-1(b)(3)(H).
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    The Commission believes that the proposed addition of waiver
eligibility requirements would also enhance the fairness of the
Procedure for either granting waivers or imposing cash assessment
amounts, depending on the particular facts and circumstances of the
Missed Submission. The Commission believes that these aspects of the
proposed rule change would formalize the process of granting waivers
for Missed Submissions caused by technical failures, and facilitate ICE
Clear Europe's ability to administer a fair procedure for disciplining
Clearing Members for any Missed Submission resulting from a non-
technical reason that would warrant a cash assessment amount as
calculated under the Procedure.
    As noted above, the proposed rule change would also make a number
of general drafting improvements to shorten and clarify certain
sentences and defined terms and to update references. In particular,
the proposed rule change would update and clarify the types of
submissions that count as Missed Submissions, including submissions
that do not adhere to the designated format in the Policy as Missed
Submissions and Obvious Errors on CDX Indices submissions, which the
Commission believes would further enhance the fairness of the Procedure
by increasing its clarity and readability for Clearing Members.
    For these reasons, the Commission believes that the proposed rule
change is consistent with Section 17A(b)(3)(H) of the Act.\20\
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    \20\ 15 U.S.C. 78q-1(b)(3)(H).
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D. Consistency With Rule 17Ad-22(e)(2) Under the Act

    Rule 17Ad-22(e)(2) \21\ requires each covered clearing agency to
establish, implement, maintain and enforce written policies and
procedures reasonably designed to, among other things, provide for
governance arrangements that are clear and transparent and specify
clear and direct lines of responsibility. As noted above, the proposed
amendments to renumbered Section 2.2.3 (Fixed Cash Assessments for
Missed Submissions) would assign clear and direct responsibility to ICE
Clear Europe's Head of Regulation & Compliance during investigations of
Missed Submissions to determine whether a Clearing Member's
circumstances are extraordinary and outside of the Clearing Member's
control. In addition, the proposed provisions on document governance
and exception handling would assign clear and direct responsibility to
the document owner at ICE Clear Europe to ensure that the Procedure
remains up-to-date and is reviewed in accordance with ICE Clear
Europe's governance processes. The proposed amendments would also
clarify the document owner's responsibility to report material breaches
or unapproved deviations from the Procedure to the document owner's
Head of Department, the Chief Risk Officer and the Head of Compliance
(or their delegates) who together will determine if such matters
require further escalation to ICE Clear Europe's senior executives.
Further, the proposed amendments would clarify how to handle approvals
of any exceptions to the Procedure by following ICE Clear Europe's
governance process for the Procedure document.
---------------------------------------------------------------------------

    \21\ 17 CFR 240.17Ad-22(e)(2).
---------------------------------------------------------------------------

    The Commission believes these aspects of the proposed rule change
would improve the clarity and transparency of the Procedure document
and its governance processes by specifying relevant roles and lines of
responsibility within ICE Clear Europe. The Commission believes that
the proposed rule change is therefore consistent with Rule 17Ad-
22(e)(2).\22\
---------------------------------------------------------------------------

    \22\ 17 CFR 240.17Ad-22(e)(2).
---------------------------------------------------------------------------

E. Consistency With Rule 17Ad-22(e)(6)(iv) Under the Act

    Rule 17Ad-22(e)(6)(iv) \23\ requires each covered clearing agency
to establish, implement, maintain and enforce written policies and
procedures reasonably designed to cover its credit exposures to its
participants by establishing a risk-based margin system that, at a
minimum, uses reliable sources of timely price data and uses procedures
and sound valuation models for addressing circumstances in which
pricing data are not readily available or reliable. The Commission
believes the proposed rule change is reasonably designed to deter the
occurrence of Missed Submissions for CDS instruments that would
undermine ICE Clear Europe's ability to maintain the integrity and
effectiveness of its end-of-day price discovery process for the
provision of reliable prices, which could, in turn, be used to enhance
ICE Clear Europe's ability to establish and maintain risk-based margin
requirements which rely, in part, on the end-of-day price submissions
of Clearing Members.
---------------------------------------------------------------------------

    \23\ 17 CFR 240.17Ad-22(e)(6)(iv).
---------------------------------------------------------------------------

    For these reasons, the Commission believes that the proposed rule
change is consistent with Rule 17Ad-22(e)(6)(iv).\24\
---------------------------------------------------------------------------

    \24\ 17 CFR 240.17Ad-22(e)(6)(iv).
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed rule change is consistent with the requirements of the Act,
and in particular, with the requirements of Section 17A(b)(3)(F) of the
Act, Section 17A(b)(3)(G) of the Act, Section 17A(b)(3)(H) of the Act
\25\ and Rules 17Ad-22(e)(2) and 17Ad-22(e)(6)(iv) thereunder.\26\
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78q-1(b)(3)(F), 15 U.S.C. 78q-1(b)(3)(G) and 15
U.S.C. 78q-1(b)(3)(H).
    \26\ 17 CFR 240.17Ad-22(e)(2) and 17 CFR 240.17Ad-22(e)(6)(iv).
---------------------------------------------------------------------------

    It is therefore ordered pursuant to Section 19(b)(2) of the Act
\27\ that the proposed rule change (SR-ICEEU-2021-002), be, and hereby
is, approved.\28\
---------------------------------------------------------------------------

    \27\ 15 U.S.C. 78s(b)(2).
    \28\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\29\
---------------------------------------------------------------------------

    \29\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2021-06119 Filed 3-24-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 230 (Tuesday, December 1, 2015)]
[Notices]
[Pages 75088-75091]
[FR Doc No: 2015-30472]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP15-115-001; CP15-115-000]

National Fuel Gas Supply Corporation Empire Pipeline, Inc.;
Supplemental Notice of Intent to Prepare an Environmental Assessment
for the Proposed Northern Access 2016 Project and Request for Comments
on Environmental Issues

    On October 22, 2014, the Federal Energy Regulatory Commission (FERC
or Commission) issued in Docket No. PF14-18-000 a Notice of Intent to
Prepare an Environmental Assessment for the Planned Northern Access
2016 Project, Request for Comments on Environmental Issues, and Notice
of Public Scoping Meetings (October 22, 2014 NOI). In their application
in Docket No. CP15-115-000, National Fuel Gas Supply Corporation
(Supply) and Empire Pipeline, Inc. (Empire) (collectively referred to
as National Fuel) filed proposed locations for one new compressor
station and one natural

gas dehydration facility in Niagara County, New York. To solicit
comments on the new proposed aboveground facilities, on April 29, 2015,
the Commission issued a Supplemental Notice of Intent to Prepare an
Environmental Assessment for the Proposed Northern Access 2016 Project,
Request for Comments on Environmental Issues, Notice of Environmental
Site Review, and Notice of Public Scoping Meeting (April 29, 2015 NOI).
Based on public input received throughout the scoping process, National
Fuel now proposes a new location for its new compressor station and has
made other modifications to its proposed facilities in an amendment
application in Docket No. CP15-115-001. This Supplemental Notice is
being issued to seek comments on these changes, and opens a new 30-day
scoping period for interested parties to file comments on environmental
issues specific to these facilities.
    The October 22, 2014 NOI announced that the FERC will prepare an
environmental assessment (EA) to address the environmental impacts of
the Northern Access 2016 Project (Project). Please refer to the NOI for
more information about the facilities proposed by National Fuel in
Pennsylvania and New York. The Commission will use the EA in its
decision-making process to determine whether to authorize the Project.
    You can make a difference by providing us with your specific
comments or concerns about the project. Your comments should focus on
the potential environmental effects, reasonable alternatives, and
measures to avoid or lessen environmental impacts. Your input will help
Commission staff determine what issues they need to evaluate in the EA.
To ensure your comments are timely and properly recorded, please send
your comments so that the Commission receives them in Washington, DC on
or before December 19, 2015.
    The Commission previously solicited input on the pipeline portion
of the project in Pennsylvania and New York in the fall of 2014. In
addition, the Commission solicited input on the aboveground facilities
in Niagara County in the spring of 2015. If you have previously
submitted comments during the pre-filing review in docket no. PF14-18-
000 or since the application filing in docket no. CP15-115-000, you do
not need to resubmit your comments at this time. We \1\ are
specifically seeking comments on the new proposed location of the
Pendleton Compressor Station and additional modifications associated
with National Fuel's amended application for the Project.
---------------------------------------------------------------------------

    \1\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
---------------------------------------------------------------------------

    This notice is being sent to the Commission's current environmental
mailing list for this project. State and local government
representatives should notify their constituents of this proposed
project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable agreement. However, if
the Commission approves the project, that approval conveys with it the
right of eminent domain. Therefore, if easement negotiations fail to
produce an agreement, the pipeline company could initiate condemnation
proceedings where compensation would be determined in accordance with
state law.
    National Fuel provided landowners with a fact sheet prepared by the
FERC entitled ``An Interstate Natural Gas Facility On My Land? What Do
I Need To Know?'' This fact sheet addresses a number of typically asked
questions, including the use of eminent domain and how to participate
in the Commission's proceedings. It is also available for viewing on
the FERC Web site (www.ferc.gov).

Public Participation

    For your convenience, there are three methods you can use to submit
your comments to the Commission. The Commission encourages electronic
filing of comments and has expert staff available to assist you at
(202) 502-8258 or<EMAIL_ADDRESS>Please carefully follow these
instructions so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for submitting brief,
text-only comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' If you are filing a comment on a particular project,
please select ``Comment on a Filing'' as the filing type; or
    (3) You can file a paper copy of your comments by mailing them to
the following address. Be sure to reference the project docket number
(CP15-115-000) with your submission: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Room 1A,
Washington, DC 20426.
    Please note this is not your only public input opportunity; please
refer to the review process flow chart in appendix 1.\2\
---------------------------------------------------------------------------

    \2\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of the appendices were sent to all
those receiving this notice in the mail and are available at
www.ferc.gov using the link called ``eLibrary'' or from the
Commission's Public Reference Room, 888 First Street NE.,
Washington, DC 20426, or call<PHONE_NUMBER>. For instructions on
connecting to eLibrary, refer to the last page of this notice.
---------------------------------------------------------------------------

Summary of the Newly Proposed Facilities

    The facilities that are the focus of this notice are the new
Pendleton Compressor Station (Killian Road Site) and an additional 2.07
miles of 16- and 14-inch diameter pipeline in the town of Pendleton,
New York to connect the new Pendleton Compressor Station to the
northward to the existing XM-10 pipeline and southward to the existing
X-North Pipeline.
    The tie-in between the southern end of Line XM-10 and National
Fuel's X-North pipeline in Wheatfield, New York is no longer necessary
due to the newly proposed Pendleton Compressor Station site. National
Fuel previously proposed to abandon all 3.09 miles of the XM-10
Pipeline system in Wheatfield, New York and Pendleton, New York via
sale to Empire. Based on the new location of the Pendleton Compressor
Station, Empire would only acquire 1.08 miles of the XM-10 Pipeline
system and associated facilities from National Fuel.
    The general location of the project facilities is shown in appendix
2.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
to discover and address concerns the public may have about proposals.
This process is referred to as ``scoping.'' The main goal of the
scoping process is to focus the analysis in the EA on the important
environmental issues. By this notice, the Commission requests public
comments on the scope of the issues to

address in the EA. We will consider all filed comments during the
preparation of the EA.
    In the EA we will discuss impacts that could occur as a result of
the construction and operation of the proposed project under these
general headings:
     Geology and soils;
     Water resources and wetlands;
     Vegetation and wildlife, including migratory birds;
     Fisheries and aquatic resources;
     Threatened, endangered, and other special-status species;
     Land use, recreation, special interest areas, and visual
resources;
     Socioeconomics;
     Cultural resources;
     Air quality and noise;
     Reliability and safety; and
     Cumulative environmental impacts.
    We will also evaluate reasonable alternatives to the proposed
project or portions of the project, and make recommendations on how to
lessen or avoid impacts on the various resource areas.
    Please note that since the amended application has been filed, an
additional docket number has been assigned (CP15-115-001) for the
amended Project facilities. As part of our pre-filing review, we
participated in public Open House meetings sponsored by National Fuel
in the project area in August 2014 to explain the environmental review
process to interested stakeholders. We also conducted public scoping
meetings of along the proposed pipeline route in November 2014 and in
Pendleton, New York in May 2015. We have also contacted federal and
state agencies to discuss their involvement in the scoping process and
the preparation of the EA.
    The EA will present our independent analysis of the issues. We will
publish and distribute the EA for public comment. We will consider all
comments on the EA before making our recommendations to the Commission.
To ensure we have the opportunity to consider and address your
comments, please carefully follow the instructions in the Public
Participation section, beginning on page 2 of this notice.
    With this notice, we are asking agencies with jurisdiction by law
and/or special expertise with respect to the environmental issues of
this project to formally cooperate with us in the preparation of the
EA.\3\ Agencies that would like to request cooperating agency status
should follow the instructions for filing comments provided under the
Public Participation section of this notice. Currently, the U.S. Army
Corps of Engineers and New York Department of Agriculture and Markets
have expressed their intention to participate as cooperating agencies
in the preparation of the EA to satisfy their NEPA responsibilities
related to this project.
---------------------------------------------------------------------------

    \3\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Part 1501.6.
---------------------------------------------------------------------------

Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, we are using this notice to initiate consultation
with the applicable State Historic Preservation Offices (SHPO), and to
solicit their views and those of other government agencies, interested
Indian tribes, and the public on the project's potential effects on
historic properties.\4\ We will define the project-specific Area of
Potential Effects (APE) in consultation with the SHPO as the project
develops. On natural gas facility projects, the APE at a minimum
encompasses all areas subject to ground disturbance (examples include
construction right-of-way, contractor/pipe storage yards, compressor
stations, and access roads). Our EA for this project will document our
findings on the impacts on historic properties and summarize the status
of consultations under section 106.
---------------------------------------------------------------------------

    \4\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
---------------------------------------------------------------------------

Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the project. We will update the environmental mailing list
as the analysis proceeds to ensure that we send the information related
to this environmental review to all individuals, organizations, and
government entities interested in and/or potentially affected by the
proposed project.
    Copies of the EA will be sent to the environmental mailing list for
public review and comment. If you would prefer to receive a paper copy
of the document instead of the CD version or would like to remove your
name from the mailing list, please return the attached Information
Request (appendix 3).

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an ``intervenor'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Instructions for becoming an intervenor are in
the ``Document-less Intervention Guide'' under the ``e-filing'' link on
the Commission's Web site. Motions to intervene are more fully
described at http://www.ferc.gov/resources/guides/how-to/intervene.asp.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site at www.ferc.gov using the ``eLibrary'' link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number,
excluding the last three digits in the Docket Number field (i.e., CP15-
115). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: November 19, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-30472 Filed 11-30-15; 8:45 am]
BILLING CODE 6717-01-P


" Ekholm, Mike R."

< ekholmmr@ usfilte To: Carey Johnston/ DC/ USEPA/ US@ EPA r. com> cc: " Watson, Mark E" < WatsonME@ usfilter. com>, " Shugrue, Brian F." < ShugrueBF@ usfilter. com> 06/ 22/ 2001 03: 45 Subject: Re: EPA/ Johnson Screen Meeting Notes PM The following are some quick responses to your e mail questions. I will try and provide additional detail on the key points of interest if required. Please feel free to contact me with any comments or questions.

From: Johnston. Carey@ epamail. epa. gov on 06/ 21/ 2001 03: 17 PM EDT To: Mark E Watson/ US/ USF@ MEMTEC cc: Mike R. Ekholm/ US/ USF@ MEMTEC, Connor. Timothy@ epamail. epa. gov@ SMTP@ Exchange Subject: EPA/ Johnson Screen Meeting Notes Dear Mark:

Thank you again for coming to EPA and sharing information related to your Z Alloy technology. Please see the attached draft meeting notes for your comments. Please send me your comments within the next two weeks.

Regarding your question below, we would like to have as much information submitted before the June 25th deadline as possible. We can and will use information received after the deadline. In particular, we are interested in know more about the specifics of the Z Alloy deployments ( Industry, Location, Month/ Year of Installation, Type of Water ( fresh, estuarine, marine), MGD, Air Scour ( Y/ N), Designed Through Screen Velocity, Functioning Properly ( Y/ N), etc.).

I have compiled a quick list from our older installations. It has several CuNi screen users, but should not be considered a complete list. As I mentioned in our meeting, we are in the process of consolidating all of our installation lists and contacts for these types of screens. This list will not be completed by the June 25th but hopefully the short list of what appears to be seawater intakes will be of some use. As far as I know, these screens have been functioning properly. Most of the screens we supply do have an integral air scour pipe. Designed screen velocity has always been .5 fps max unless otherwise requested by our customers.

<< CuNi Install List. xls>>

We are also interested if you or any one you know has designed a intake structure for an coastal or offshore oil/ gas extraction facility.

The last one on the list, Texaco Harvest, appears to be an offshore oil/ gas installation. I do not currently have any additional information on this installation but I will try and complete the contact details.

What would be the material costs, time of installation, and any O& M costs for a Z Alloy screen deployment for such an operation.

Typical lead time is 2 weeks for drawing submittal, 4 8+ weeks for intake manufacture depending on the size of the screen. The costs will depend on capacity, depth and slot ( screen opening size) but for example:

Johnson SWS Intake Model T33 63 wire with 0.039 circumferencial slot Installation at 10 Ft depth 5 MGD per assembly Thru Slot Velocities ( fps):. 435 Max .396 Avg End Fittings: plate one end, plate other end. Connected to 24PS inlet pipe Material: ZAL Estimated net wt: 1074 Lbs Budget Price: $ 16,780 each ($ US) This example is for an arbitrary 5 MGD capacity screen. I can quickly work up pricing on any specific flow values that are required. Please not that this is an order of magnitude price, and would be adjusted for current material costs at the time of bid.

Michael Ekholm Applications Engineer US Filter/ Johnson Screens 1950 Old Hwy 8 New Brighton, MN 55112 1 800 VEE WIRE ext 110 651 638 3110 651 638 3177 fax ekholmmr@ usfilter. com http:// www. johnsonscreens. com ( See attached file: CuNi Install List. xls)


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on October 27, 2005

   NOTICE OF ACTION TAKEN -- DOCKET OST-2005-22799

________________________________________________________________________
_________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Joint Application of UNITED AIR LINES, INC. (UNITED) filed 10/19/05 for:

XX  Exemption for United for two years under 49 U.S.C. 40109 to provide
the following service:

Scheduled foreign air transportation of persons, property, and mail
between Chicago, Illinois and St. Lucia.  United also seeks route
integration authority to combine this exemption authority with its
existing certificate and exemption authority.  United proposes initially
to operate weekly service beginning on or about February 5, 2006 on a
seasonal basis.

Applicant reps: Jeffrey A. Manley<PHONE_NUMBER>    DOT Analyst: Thuy H.
Cooper<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (subject to conditions, see attached)

The above action granting exemption authority was effective when taken:
October 27, 2005, through October 27, 2007.

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX  The authority granted is consistent with the aviation agreement
between the United States and the United Kingdom to which St. Lucia
acceded upon its independence.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

XX Holder’s certificates of public convenience and necessity

XX Standard exemption conditions (attached)

Conditions: The route integration authority granted is subject to the
following conditions:

The applicant is subject to the condition that any service provided
under this exemption shall be consistent with all applicable agreements
between the United States and the foreign countries involved.
Furthermore, (a) nothing in the award of the route integration authority
granted should be construed as conferring upon the applicant rights
(including fifth-freedom intermediate and/or beyond rights) to serve
markets where U.S. carrier entry is limited unless the applicant
notifies the Department of its intent to serve such a market and unless
and until the Department has completed any necessary carrier selection
procedures to determine which carrier(s) should be authorized to
exercise such rights; (b) should there be a request by any carrier to
use the limited-entry route rights that are included in the
applicant’s authority by virtue of the route integration exemption
granted here, but that are not then being used by the applicant, the
holding of such authority by route integration will not be considered as
providing any preference for the applicant in a competitive carrier
selection proceeding to determine which carrier(s) should be entitled to
use the authority at issue.

Remarks:  We acted on this application without awaiting expiration of
the 15-day answer period with the consent of all parties served.

________________________________________________________________________
____________

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicants qualified to provide
the exemption services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

05/2004

 United expressly requests expedited approval of this exemption
application so that marketing and sale of the new service may begin
without delay.  United also asks that the requested exemption authority
in the instant docket and United’s pending application for U.S.-St.
Lucia certificate authority (Docket OST-99-6385) be awarded pursuant to
the Department’s new streamlined regulatory procedures for licensing
U.S. carriers (see Docket OST-2005-22228).  In the interest of according
United the expedited treatment it seeks on the present application, we
have decided to grant United’s request for exemption authority to
serve the Chicago-St. Lucia market here, and to handle the carrier’s
pending application for U.S.-St. Lucia certificate authority separately.

 PAGE


[Federal Register Volume 80, Number 243 (Friday, December 18, 2015)]
[Rules and Regulations]
[Page 78978]
[FR Doc No: 2015-31856]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket Number USCG-2015-1087]

Drawbridge Operation Regulation; Upper Mississippi River, Rock
Island, IL

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Rock Island Railroad and Highway
Drawbridge across the Upper Mississippi River, mile 482.9, at Rock
Island, Illinois. The deviation is necessary to allow the bridge owner
time to perform preventive maintenance and critical repairs that are
essential to the continued safe operation of the drawbridge, and is
scheduled in the winter when there is less impact on navigation. This
deviation allows the bridge to be maintained in the closed-to-
navigation position for 21 days.

DATES: This deviation is effective from 8 a.m., February 8, 2016 until
5 p.m., February 28, 2016.

ADDRESSES: The docket for this deviation, [USCG-2015-1087] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Eric A. Washburn, Bridge
Administrator, Western Rivers, Coast Guard; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The U.S. Army Rock Island Arsenal requested
a temporary deviation for the Rock Island Railroad and Highway
Drawbridge, across the Upper Mississippi River, mile 482.9, at Rock
Island, Illinois to remain in the closed-to-navigation position for 21
days from 8 a.m., February 8, 2016 to 5 p.m., February 28, 2016, while
preventive maintenance and critical repairs that are essential to the
continued safe operation of the drawbridge are performed.
    The Rock Island Railroad and Highway Drawbridge currently operates
in accordance with 33 CFR 117.5, which states the general requirement
that the drawbridge shall open on signal.
    There are no alternate routes for vessels transiting this section
of the Upper Mississippi River. The bridge cannot open in case of
emergency.
    Winter conditions on the Upper Mississippi River coupled with the
closure of Army Corps of Engineer's Lock No. 13 (Mile 522.5 UMR) and
Lock No. 21 (Mile 324.9 UMR) from 7 a.m. January 4, 2016 until 12 p.m.,
March 4, 2016 will preclude any significant navigation demands for the
drawspan opening. In addition, Army Corps Lock No. 14 (Mile 493.3 UMR)
and Lock No. 17 (Mile 437.1 UMR) will be closed from 7 a.m. December
14, 2015 until 12 p.m. March 2, 2016.
    The Rock Island Railroad and Highway Drawbridge provides a vertical
clearance of 23.8 feet above normal pool in the closed-to-navigation
position. Navigation on the waterway consists primarily of commercial
tows and recreational watercraft and will not be significantly
impacted. This temporary deviation has been coordinated with waterway
users. No objections were received.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: December 15, 2015.
Eric A. Washburn,
Bridge Administrator, Western Rivers.
[FR Doc. 2015-31856 Filed 12-17-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Proposed Rules]
[Pages 64175-64178]
[FR Doc No: 2022-22399]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1302; Project Identifier MCAI-2022-00062-E]
RIN 2120-AA64

Airworthiness Directives; GE Aviation Czech s.r.o. (Type
Certificate Previously Held by WALTER Engines a.s., Walter a.s., and
MOTORLET a.s.) Turboprop Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all GE Aviation Czech s.r.o. (GEAC) H75-100, H75-200, H80, H80-100,
H80-200, H85-100, and H85-200 model turboprop engines. This proposed AD
was prompted by the manufacturer revising the airworthiness limitations
section (ALS) of the existing engine maintenance manual (EMM) to
introduce updated coefficients for the calculation of the cyclic life
and safe life for the main shaft. This proposed AD would require
revising the ALS of the existing EMM and the operator's existing
approved maintenance or inspection program, as applicable, to
incorporate the updated coefficients and recalculate the cycles
accumulated on critical parts. The FAA is proposing this AD to address
the unsafe condition on these products.

DATES: The FAA must receive comments on this NPRM by December 8, 2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-1302; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this NPRM, the mandatory

continuing airworthiness information (MCAI), any comments received, and
other information. The street address for Docket Operations is listed
above.

FOR FURTHER INFORMATION CONTACT: Barbara Caufield, Aviation Safety
Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803;
phone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-1302; Project Identifier
MCAI-2022-00062-E'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Barbara Caufield, Aviation Safety Engineer, ECO Branch, FAA, 1200
District Avenue, Burlington, MA 01803. Any commentary that the FAA
receives which is not specifically designated as CBI will be placed in
the public docket for this rulemaking.

Background

    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Union, has issued
EASA AD 2022-0008, dated January 19, 2022 (referred to after this as
``the MCAI''), to address an unsafe condition on all GEAC H75-100, H75-
200, H80, H80-100, H80-200, H85-100, and H85-200 engines, all build
configurations, all serial numbers. The MCAI states that the
airworthiness limitations for H series engine models, which are
approved by EASA, are currently defined and published in the ALS of the
GEAC EMM. These instructions have been identified as mandatory for
continued airworthiness. Failure to accomplish these instructions could
result in an unsafe condition. Recently, GEAC published the ALS, as
defined in the MCAI, introducing updated coefficients for the
calculation of the cyclic life and safe life for the main shaft. For
the reason described above, the MCAI specifies accomplishment of the
actions specified in the ALS.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2022-1302.

Related Service Information

    The FAA reviewed the ALS of the GEAC EMM, Part No: 0983402 Rev. 22,
dated December 18, 2020. This service information provides updated
coefficients for the calculation of the cyclic life and safe life for
the main shaft.

FAA's Determination

    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 and service information described above. The FAA is issuing
this NPRM after determining that the unsafe condition described
previously is likely to exist or develop on other products of these
same type designs.

Proposed AD Requirements in This NPRM

    This proposed AD would require revising the ALS of the existing EMM
and the operator's existing approved maintenance or inspection program,
as applicable, to incorporate the updated coefficients and recalculate
the cycles accumulated on critical parts. An owner/operator (pilot)
holding at least a private pilot certificate may revise the ALS of the
existing EMM, and the owner/operator must enter compliance with the
applicable paragraphs of the AD into the aircraft records in showing
compliance with this AD in accordance with 14 CFR 43.9(a) and 14 CFR
91.417(a)(2)(v). The record must be maintained as required by 14 CFR
91.417, 121.380, or 135.439. This is an exception to the FAA's standard
maintenance regulations.

Differences Between This Proposed AD and the MCAI

    The MCAI specifies replacing each component before exceeding the
applicable life limit and accomplishing all the applicable maintenance
tasks within the thresholds and intervals, as defined in the ALS, from
its effective date. The MCAI specifies that in case of finding
discrepancies during accomplishment of any task required by paragraph
(1) of the MCAI, before the next flight, accomplish the applicable
corrective actions in accordance with existing GEAC instructions. The
MCAI also specifies to contact GEAC for approved instructions if a
detected discrepancy cannot be corrected using existing GEAC
instructions. This proposed AD would not require performing corrective
actions in accordance with existing GEAC instructions or contacting
GEAC for approved instructions. The MCAI specifies revising the
aircraft maintenance program within 12 months from its effective date.
This proposed AD would require revising the ALS of the existing EMM and
the operator's existing approved maintenance or inspection program, as
applicable, to incorporate the updated coefficients and recalculate the
cycles accumulated on critical parts within 90 days after the effective
date of the proposed AD.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 33 engines installed on aircraft of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
               Action                         Labor cost            Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Revise the ALS of the EMM and the     1 work-hour x $85 per hour              $0             $85          $2,805
 operator's existing approved          = $85.
 maintenance or inspection program.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

GE Aviation Czech s.r.o (Type Certificate previously held by WALTER
Engines a.s., Walter a.s., and MOTORLET a.s.): Docket No. FAA-2022-
1302; Project Identifier MCAI-2022-00062-E.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by December 8, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to GE Aviation Czech s.r.o. (Type Certificate
previously held by WALTER Engines a.s., Walter a.s., and MOTORLET
a.s.) H75-100, H75-200, H80, H80-100, H80-200, H85-100, and H85-200
model turboprop engines.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7200, Engine
(Turbine/Turboprop).

(e) Unsafe Condition

    This AD was prompted by the manufacturer revising the
airworthiness limitations section (ALS) of the existing engine
maintenance manual (EMM) to introduce updated coefficients for the
calculation of the cyclic life and safe life for the main shaft. The
FAA is issuing this AD to prevent failure of the engine. The unsafe
condition, if not addressed, could result in uncontained release of
a critical part, damage to the engine, and damage to the airplane.

(f) Compliance

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

(g) Required Actions

    (1) Within 90 days after the effective date of this AD, revise
the ALS of the existing EMM to incorporate the information in Table
1 to paragraph (g)(1) of this AD and recalculate the cycles
accumulated on critical parts.

             Table 1 to Paragraph (g)(1)--Equivalent Cyclic Life (N) and Safe Life of Critical Parts
----------------------------------------------------------------------------------------------------------------
                                                                    Abbreviated   Flight mission    Equivalent
                                                                   flight cycle     coefficient     cyclic life
              Description                      Drawing No.          coefficient  ----------------      limit
                                                                 ----------------                ---------------
                                                                       AV AP             L               N
----------------------------------------------------------------------------------------------------------------
Main Shaft............................  M601-1017.75............            0.47            1.05          16,000
----------------------------------------------------------------------------------------------------------------

    (2) After performing the action required by paragraph (g)(1) of
this AD, except as provided in paragraph (h) of this AD, no
alternative life limits may be approved.
    (3) The action required by paragraph (g)(1) of this AD may be
performed by the owner/operator (pilot) holding at least a private
pilot certificate and must be entered into the aircraft records
showing compliance with this AD in accordance with 14 CFR 43.9(a)
and 14 CFR 91.417(a)(2)(v). The record must be maintained as
required by 14 CFR 91.417, 121.380, or 135.439.

(h) Alternative Methods of Compliance (AMOCs)

    The Manager, ECO Branch, FAA, has the authority to approve AMOCs
for this AD, if requested using the procedures found in Sec.  39.19.
In accordance with Sec.  39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the manager of the certification
office, send it to the attention of the person identified in
paragraph (i)(2) of this AD and email to: [email protected].
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.

(i) Additional Information

    (1) Refer to European Union Aviation Safety Agency (EASA) AD
2022-0008, dated January 19, 2022, for related information. This
EASA AD may be found in the AD docket at regulations.gov under
Docket No. FAA-2022-1302.
    (2) For more information about this AD, contact Barbara
Caufield, Aviation Safety Engineer, ECO Branch, FAA, 1200 District
Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>; email:
[email protected].

(j) Material Incorporated by Reference

    None.

    Issued on October 7, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-22399 Filed 10-21-22; 8:45 am]
BILLING CODE 4910-13-P