[Federal Register: September 10, 2009 (Volume 74, Number 174)]
[Rules and Regulations]
[Page 46491-46493]
[DOCID:fr10se09-3]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2009-0752]
RIN 1625-AA00

Safety Zones: Fireworks Displays Within the Captain of the Port
Puget Sound Zone

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The U.S. Coast Guard is establishing safety zones on the
waters of the Puget Sound located in the Captain of the Port Puget
Sound Zone during multiple fireworks displays. This action is necessary
to provide for the safety of life and avoidance of injury resulting
from these displays. Entry into, transit through, mooring, or anchoring
within these zones is prohibited unless authorized by the Captain of
the Port, Puget Sound or Designated Representative.

DATES: The effective date of this temporary final rule is September 10,
2009 through 8 a.m. on September 13, 2009 unless canceled sooner by the
Captain of the Port. This temporary final rule was enforced with actual
notice by Coast Guard personnel beginning at 8 a.m. on August 22, 2009.
Rules enforced through actual notice are superseded by this rule as of
September 10, 2009.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2009-0752 and are available online
by going to http://www.regulations.gov, inserting USCG-2009-0752 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail ENS Ashley M. Wanzer, Waterways Management, Sector
Seattle, Coast Guard; telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because immediate action is necessary to
ensure public safety due to inherent hazards that may exist in
conjunction with these fireworks events.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Immediate action is necessary to
ensure public safety since these events encompass the launching of
projectiles over a marine environment with the fallout of hot debris
and flammable materials in a vicinity of public marine traffic and
spectators.

Background and Purpose

    The U.S. Coast Guard is establishing temporary safety zones to
allow for safe fireworks displays. The effective time is from 8 a.m. on
August 22, 2009 through 8 a.m. on September 13, 2009 unless canceled
sooner by the Captain of the Port. All events occur within the Captain
of the Port, Puget Sound, WA, Area of Responsibility (AOR). The
following areas are designated safety zones:
    (1) John Eddy Wedding, Magnolia Bluff, WA.
    (i) Location. All water of Magnolia Bluff, WA extending to a 500'
radius from the launch site at 49[deg]38'59.25'' N 122[deg]25'21.34''
W.
    (ii) Enforcement time and date. 9 p.m. to 11:30 p.m. on August 22,
2009.
    (2) True Colors Event, Blaine, WA.
    (i) Location. All water of Blaine, WA extending to a 300' radius
from the launch site at 48[deg]59'29.25'' N 122[deg]46'20.36'' W.
    (ii) Enforcement time and date. 9 p.m. to 11:30 p.m. on September
6, 2009.
    (3) Kirkland Concours D'Elegence, Kirkland, WA.
    (i) Location. All water of Kirkland, Lake Washington, WA extending
out to a 400' radius from the launch site at 47[deg]39'31.27'' N
122[deg]12'26.35'' W.
    (ii) Enforcement time and date. 9 p.m. to 11:30 p.m. on September
12, 2009.
    (4) Mikilteo Lighthouse Festival, Possession Sound, WA.
    (i) Location. All water of Possession Sound, WA extending out to a
800' radius from the launch site at 47[deg]56'54'' N 122[deg]18'36'' W.
    (ii) Enforcement time and date. 8:30 p.m. to 11:30 p.m. on
September 12, 2009.
    These events may result in a number of vessels congregating near
fireworks launching barges and sites. The safety zones are needed to
protect watercraft and their occupants from safety hazards associated
with fireworks displays. The Captain of the Port Puget Sound may be
assisted by other Federal and local agencies in the enforcement of this
safety zone.

Discussion of Rule

    This rule will control the movement of all vessels and persons in a
regulated area surrounding the fireworks events indicated in this
Temporary Final Rule. The safety zones do not extend on land.
    The U.S. Coast Guard through this action intends to promote the
safety of vessels and spectators during fireworks displays and
activities associated with these events. Entry into this zone by all
vessels or persons will be prohibited unless authorized by the Captain
of the Port or Designated Representative. The Captain of the Port may
be assisted by other Federal, State, or local agencies as needed.

Regulatory Analyses

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

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. This rule is not a significant regulatory
action because it is short in duration and does not affect a large area
or a critical waterway.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently

owned and operated and are not dominant in their fields, and
governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This temporary rule will affect the following entities, some of
which may be small entities: The owners or operators of vessels
intending to transit a portion of the Puget Sound while this rule is
enforced. These safety zones will not have significant economic impact
on a substantial number of small entities for the following reasons.
This temporary rule will be in effect for minimal times when vessel
traffic volume is low and are limited in size. If safe to do so,
traffic will be allowed to pass through the zone with the permission of
the Captain of the Port or Designated Representative.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

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

Federalism

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

Unfunded Mandates Reform Act

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

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

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

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

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

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction. This rule involves multiple safety zones
on the waters of Puget Sound established for one week or longer to deal
with an emergency situation.
    An ``Environmental Analysis Check List'' and a ``Categorical
Exclusion Determination'' will be available in the docket.

List of Subjects in 33 CFR Part 165

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

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165, as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapters 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;

Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add temporary Sec.  165.T13-107 to read as follows:

Sec.  165.T13-107  Safety Zones: Fireworks displays within the Captain
of the Port, Puget Sound Zone.

    (a) Safety Zones. The following areas are designated safety zones:
    (1) John Eddy Wedding, Magnolia Bluff, WA.
    (i) Location. All water of Magnolia Bluff, WA extending to a 500'
radius from the launch site at 49[deg]38'59.25'' N 122[deg]25'21.34''
W.
    (ii) Enforcement time and date. 9 p.m. to 11:30 p.m. on August 22,
2009.
    (2) True Colors Event, Blaine, WA.
    (i) Location. All water of Blaine, WA extending to a 300' radius
from the launch site at 48[deg]59'29.25'' N 122[deg]46'20.36'' W.
    (ii) Enforcement time and date. 9 p.m. to 11:30 p.m. on September
6, 2009.
    (3) Kirkland Concours D'Elegence, Kirkland, WA.
    (i) Location. All water of Kirkland, Lake Washington, WA extending
out to a 400' radius from the launch site at 47[deg]39'31.27'' N
122[deg]12'26.35'' W.
    (ii) Enforcement time and date. 9 p.m. to 11:30 p.m. on September
12, 2009.
    (4) Mikilteo Lighthouse Festival, Possession Sound, WA.
    (i) Location. All water of Possession Sound, WA extending out to an
800' radius from the launch site at 47[deg]56'54'' N 122[deg]18'36'' W.
    (ii) Enforcement time and date. 8:30 p.m. to 11:30 p.m. on
September 12, 2009.
    (b) Regulations. In accordance with the general regulations in 33
CFR Part 165, Subpart C, no vessel may enter, transit, moor, or anchor
within this safety zone, except for vessels authorized by the Captain
of the Port or Designated Representative.
    (c) Authorization. All vessel operators who desire to enter the
safety zone must obtain permission from the Captain of the Port or
Designated Representative by contacting either the on-scene patrol
craft on VHF Ch 13 or Ch 16 or the Coast Guard Sector Seattle Joint
Harbor Operations Center (JHOC) via telephone at<PHONE_NUMBER>.
    (d) Effective Period. This rule is effective from 8 a.m. on August
22, 2009 through 8 a.m. on September 13, 2009 unless canceled sooner by
the Captain of the Port.

    Dated: August 20, 2009.
Suzanne E. Englebert,
Captain, U.S. Coast Guard, Captain of the Port, Puget Sound.
[FR Doc. E9-21757 Filed 9-9-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 83, Number 31 (Wednesday, February 14, 2018)]
[Notices]
[Pages 6646-6650]
[FR Doc No: 2018-02973]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82658; File No. SR-OCC-2017-007]

Self-Regulatory Organizations; the Options Clearing Corporation;
Order Approving Proposed Rule Change Related to the Options Clearing
Corporation's Margin Policy

February 7, 2018.

I. Introduction

    On December 11, 2017, the Options Clearing Corporation (``OCC'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ proposed rule change SR-
OCC-2017-007. On December 18, 2017, OCC filed Amendment No. 1 to the
proposed rule change.\3\ The proposed rule change, as modified by
Amendment No. 1, was published for comment in the Federal Register on
December 26, 2017.\4\ The Commission did not receive any comments on
the proposed rule change. This order approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ In Amendment No. 1, OCC modified a portion of its Margin
Policy to: (i) State that OCC's Board of Directors (``Board'') is
ultimately responsible for annual review and approval of the Policy,
and (ii) correctly cite provisions in OCC's Rules governing its
stock loan program. OCC did not propose any other changes in
Amendment No. 1.
    \4\ Securities Exchange Act Release No. 82355 (Dec. 19, 2017),
82 FR 61060 (Dec. 26, 2017) (SR-OCC-2017-007) (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

A. Background

    As stated in the Notice, OCC filed the proposed rule change to
formalize and update its Margin Policy, which describes OCC's approach
for collecting margin and managing the credit exposure presented by its
Clearing Members to ensure that the manner in which its margin
methodologies are governed and implemented complies with Section 17A of
the Act \5\ and Rule 17Ad-22(e)(6) thereunder.\6\ OCC stated that the
Margin Policy is part of a broader framework used by OCC to promote
compliance with Rule 17Ad-22(e)(6), including OCC's By-Laws, Rules, and
other policies that are designed to support the resiliency of

OCC by ensuring that it appropriately sizes margin to market risks.\7\
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78q-1.
    \6\ See Notice at 61061 (citing 17 CFR 240.17Ad-22(e)(6)).
    \7\ See id. at 61061 (citing CCA Adopting Release, 81 FR 70786,
70812 (Oct. 13, 2016)), (explaining that the requirements of Rule
17Ad-22(e)(6) ``further support the resiliency of a covered clearing
agency by requiring the covered clearing agency to have policies and
procedures that are designed to appropriately size . . . margin to
market risks'').
---------------------------------------------------------------------------

    The Margin Policy describes: (1) The treatment of the various types
of positions held by Clearing Members in connection with margin
calculations, (2) OCC's cross-margin programs with other clearing
agencies, (3) the treatment of collateral included in margin
calculations, (4) the model assumptions and market data OCC uses as
inputs for its margin calculation methodologies, (5) OCC's margin
calculation methodologies, (6) protocols surrounding OCC's exercise of
margin calls and adjustments, and (7) daily backtesting and model
validation that OCC conducts to measure performance of its margin
methodologies. Each aspect of the Margin Policy is summarized below.

B. The Proposed Change to OCC's Margin Policy

1. Treatment of Various Types of Positions
    The Margin Policy describes how OCC treats the various types of
positions it accepts from different types of market participants. OCC
utilizes multiple types of Clearing Member accounts in order to comply
with the relevant customer protection and segregation requirements of
the Commission and the Commodity Futures Trading Commission. For
example, OCC segregates and excludes long securities options positions
from its margin requirement calculation under the assumption that such
positions are fully paid and pose no additional risk to OCC. According
to OCC, accounting for different types of products in different types
of accounts allows OCC to set margin requirements commensurate with the
actual risks presented by these positions.
2. Cross-Margining
    OCC maintains cross-margin programs with other clearinghouses and
treats positions in index options, options on centrally cleared fund
shares, and futures and options on futures held as part of one of the
programs as if they were held within a single account at OCC.\8\
According to OCC, its Margin Policy allows OCC to take these cross-
margining agreements into consideration to establish a risk-based
margin system that appropriately measures its credit exposure and
portfolio effects across products.
---------------------------------------------------------------------------

    \8\ See id.
---------------------------------------------------------------------------

3. Collateral
    To mitigate its credit risk exposure, OCC generally requires
Clearing Members to deposit collateral as margin with respect to each
account type on the morning following the trade date. The Margin Policy
provides a general description of how the use of deposits in lieu of
margin and collateral in margins may affect margin calculations.\9\ For
example, the Margin Policy states that OCC permits Clearing Members to
make deposits in lieu of margin, which enables them to meet their
margin requirements for securities options by posting escrow deposits
of acceptable collateral or specific deposits of the underlying
security.\10\
---------------------------------------------------------------------------

    \9\ See id. at 61061-62.
    \10\ See Notice at 61061-62.
---------------------------------------------------------------------------

    OCC's Margin Policy also describes OCC's ``collateral in margins''
program.\11\ Under this program, OCC computes margin requirements based
on a combination of a Clearing Member's open positions in cleared
contracts and any deposits of eligible collateral, while also
incorporating scenarios that could exacerbate or mitigate risk exposure
based upon the collateral type deposited. OCC states that the Margin
Policy's recognition of risk interactions between open positions and
clearing member collateral takes into account portfolio effects across
products for the measurement of credit risk.\12\
---------------------------------------------------------------------------

    \11\ See id. at 61062.
    \12\ See id.
---------------------------------------------------------------------------

4. Model Assumptions, Sensitivity Analyses and Market Data
    The Margin Policy states that all of OCC's critical margin model
assumptions should be consistent with OCC's default management
assumptions. To ensure that OCC complies with this requirement, the
Margin Policy provides for a monthly sensitivity analysis and review of
its parameters and assumptions for business backtesting, the results of
which are reported to OCC's Model Risk Working Group, and may be
escalated to OCC's Management Committee.
    The Margin Policy also requires OCC to take measures to ensure the
quality and completeness of its market data, including the use of
redundant sources for market data and pricing system infrastructure.
The Margin Policy requires OCC to prioritize the quality and
reliability of data when selecting vendors, and to protect its ability
to obtain data in a variety of market conditions. OCC states that it
protects the integrity of the data it receives by monitoring for
delays, errors, or interruptions in the receipt or availability of
price data. Further, the Margin Policy prescribes procedures for using
alternative data, including settlement prices provided by a primary
exchange or other data sources where final settlement values are not
available from the listing exchange. The Margin Policy also states that
OCC utilizes sound valuation models, system edit checks, and automated
and manual controls with any price data it obtains.\13\ Where OCC does
not receive pricing information on a daily basis for a product, the
Margin Policy states that OCC relies on modeled prices as a substitute
for the daily price.\14\
---------------------------------------------------------------------------

    \13\ See Notice at 61062.
    \14\ See id. at 61062-63.
---------------------------------------------------------------------------

5. Margin Methodology
    OCC's Margin Policy includes a description of OCC's System for
Theoretical Analysis and Numerical Simulations (``STANS''), which is
its margin methodology for all positions it margins on a net basis.\15\
STANS is a risk-based methodology that is designed to produce a margin
requirement that exceeds OCC's minimum regulatory obligations through
the use of an Expected Shortfall methodology (``ES''), which is
effectively a weighted average of tail losses beyond the 99% Value-at-
Risk (``VaR'') level. OCC states that STANS may produce significant
variations in the ES in Clearing Member Accounts. Under its current
approach, OCC relies upon the expert judgment of its staff to identify
whether the variation demonstrates that STANS is not functioning as
expected, but has no set variance level which would trigger further
review. Under the proposed change, OCC would implement a new 5%
tolerance for standard error in STANS, such that if the five percent
threshold is reached, OCC must investigate further whether STANS is
appropriately measuring the risk presented by a Clearing Member's
account.
---------------------------------------------------------------------------

    \15\ See id. at 61063.
---------------------------------------------------------------------------

    The Margin Policy also explains how STANS calculates margin by
utilizing Monte Carlo simulations of portfolio values at a two-day risk
horizon based on the behavior of various risk factors affecting: (i)
Values at a two-day risk horizon, and (ii) values of Clearing Member
accounts, including implied volatility surfaces of options for all
equity and index risk factors.\16\ OCC states that this two-day risk
horizon is consistent with the STANS assumption

of a two-day liquidation period for all positions margined on a net
basis and is based on a thorough analysis of market conditions and the
risks associated with the products OCC clears.\17\
---------------------------------------------------------------------------

    \16\ See Notice at 61063.
    \17\ See id.
---------------------------------------------------------------------------

    The Margin Policy also provides for the daily evaluation of the
market data that supports STANS and a monthly recalibration to ensure
that it accounts for market conditions over the past month. This
includes the use of ``scale factors'' to account for daily changes in
market volatility between monthly recalibrations. Further, the Margin
Policy has the ability to use alternatives to STANS for certain product
accounts, including the ability to apply add-on charges and surcharges
for certain Clearing Members who present higher risk levels, as well as
the use of Standard Portfolio Analysis of Risk margin methodology
(``SPAN'') for certain segregated futures accounts. According to OCC,
these procedures are designed to ensure that OCC complies with the
requirement that its risk based margin system calculates margin on a
portfolio level and sets initial margin requirements that meet ``an
established single-tail confidence level of at least 99 percent'' with
respect to each portfolio's distribution of future exposure.
6. Margin Calls and Adjustments
    The Margin Policy describes OCC's process for daily calculation and
collection of margin requirements, as well as making intraday margin
calls and adjustments. Pursuant to the Margin Policy, OCC issues margin
calls during standard trading hours when unrealized losses exceeding
50% of an account's total risk charges are observed for that account
based on start-of-day positions. The Margin Policy specifies the timing
of such calls, price minimums, exceptions, and the necessary approvals
that must be obtained. The Margin Policy also states that additional
margin adjustments may be performed as the need arises following
approval by an officer of OCC.\18\
---------------------------------------------------------------------------

    \18\ See Notice at 61064.
---------------------------------------------------------------------------

7. Backtesting and Model Validation
    The Margin Policy requires OCC to conduct daily backtesting for
each margin account and to analyze in detail all accounts exhibiting
losses in excess of calculated margin requirements. OCC states that any
exceedances under the Margin Policy are required to be reported at
least monthly and evaluated through OCC's governance process for model
risk management, as well as an annual evaluation by OCC's independent
Model Validation Group (``MVG'') of the overall performance of STANS
and its associated models. The results of this annual MVG evaluation
and any recommendations would then be presented to the OCC Board's Risk
Committee.

III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act \19\ 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 rules and regulations thereunder applicable
to such organization. The Commission finds that the proposal is
consistent with Section 17A(b)(3)(F) of the Act \20\ and Rule 17Ad-
22(e)(6) \21\ thereunder, as described in detail below.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(2)(C).
    \20\ 15 U.S.C. 78q-1(b)(3)(F).
    \21\ 17 CFR 240.17Ad-22(e)(6).
---------------------------------------------------------------------------

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

    Section 17A(b)(3)(F) of the Act \22\ requires, among other things,
that the rules of a clearing agency be designed to assure the
safeguarding of securities and funds which are in its custody or
control or for which it is responsible, and, in general, to protect
investors and the public interest. As described above, the Margin
Policy provides a framework for managing the credit exposure presented
to OCC by its Clearing Members through the calculation and collection
of margin. That framework includes: (1) The treatment of the various
types of positions held by Clearing Members in connection with margin
calculations, (2) OCC's cross-margin programs with other clearing
agencies, (3) the treatment of collateral included in margin
calculations, (4) the model assumptions and market data OCC uses as
inputs for its margin calculation methodologies, (5) OCC's margin
calculation methodologies, (6) protocols surrounding OCC's exercise of
margin calls and adjustments, and (7) daily backtesting and model
validation that OCC conducts to measure performance of its margin
methodologies. These matters, in turn, directly relate to OCC's ability
to accurately risk manage Clearing Member portfolios by calculating and
collecting an appropriate amount of collateral. The Commission believes
that the proposed Margin Policy is designed to help ensure that OCC's
margin methodology calculates and collects margin sufficient to
mitigate OCC's credit exposure to a Clearing Member default. The
Commission also believes that accurate calculation of margin is
necessary to help ensure that OCC is able to risk manage the default of
a Clearing Member without recourse to the assets of non-defaulting
Clearing Members, which supports the safeguarding of securities and
funds in OCC's custody or control. The Commission further believes that
calculating and collecting sufficient margin would permit OCC to
continue to perform its duties as a clearing agency after a default
without disruption to non-defaulting market participants, thereby
protecting investors and the public interest. Accordingly, the
Commission finds that the proposed Margin Policy is designed to promote
the accurate clearance and settlement of securities transactions, and
is therefore consistent with Section 17A(b)(3)(F) of the Act.\23\
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78q-1(b)(3)(F).
    \23\ Id.
---------------------------------------------------------------------------

B. Consistency With Rule 17Ad-22(e)(6)

    Rule 17Ad-22(e)(6) generally requires each covered clearing agency
that provides central counterparty services to establish, implement,
maintain, and enforce policies and procedures reasonably designed to,
among other things, cover its credit exposures to its participants
through the establishment of a risk-based margin system that meets
certain standards.\24\
---------------------------------------------------------------------------

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

1. Rule 17Ad-22(e)(6)(i)
    Rule 17Ad-22(e)(6)(i) generally requires a covered clearing agency
to establish a risk-based margin system that considers and produces
margin levels commensurate with the risks and particular attributes of
each relevant product, portfolio, and market.\25\ The Commission
believes that the Margin Policy describes and formalizes OCC's approach
for collecting margin and managing the credit exposures of each of its
Clearing Members to set margin requirements commensurate with the
actual risks presented. The Margin Policy allows OCC to take into
account the different types of products across different types of
accounts, including the use of its existing STANS methodology to
address the particular attributes and risk factors of the products
being margined, using cross-margining agreements with other
clearinghouses, excluding fully collateralized positions from its
margin requirement, and permitting the use of deposits in lieu of
margin and collateral in margins to incentivize Clearing Members to
post collateral that reduces

OCC's exposures in cleared contracts. Therefore, the Commission
believes that the Margin Policy is consistent with Rule 17Ad-
22(e)(6)(i).
---------------------------------------------------------------------------

    \25\ 17 CFR 240.17Ad-22(e)(6)(i).
---------------------------------------------------------------------------

2. Rule 17Ad-22(e)(6)(ii)
    Rule 17Ad-22(e)(6)(ii) generally requires a covered clearing agency
to establish a risk-based margin system that collects margin at least
daily and have the operational capacity to make intraday margin
calls.\26\ The Margin Policy describes the process for calculating and
collecting margin on a daily basis, and for making intraday margin
calls and adjustments, as needed. The Margin Policy further specifies
the timing of such calls, price minimums that must be collected, the
process for allowing exceptions, and the necessary approvals that must
be obtained. Therefore, the Commission believes that the Margin Policy
establishes a process to collect margin daily and make intraday margin
calls, and finds, therefore, that it is consistent with Rule 17Ad-
22(e)(6)(ii).
---------------------------------------------------------------------------

    \26\ 17 CFR 240.17Ad-22(e)(6)(ii).
---------------------------------------------------------------------------

3. Rule 17Ad-22(e)(6)(iii)
    Rule 17Ad-22(e)(6)(iii) generally requires a covered clearing
agency to establish a risk-based margin system that calculates margin
sufficient to cover its potential future exposure to participants,\27\
which the Commission defines as the maximum exposure estimated to occur
at a future point in time with an established single-tailed confidence
level of at least 99%.\28\ The Margin Policy states that OCC uses STANS
to estimate ES, the weighted average of tail losses beyond the 99% VaR
level, with a 5% tolerance to calculate margin with respect to each
portfolio's distribution of future exposure. The Margin Policy further
describes OCC's assumptions with respect to a two-day liquidation
period that covers potential future exposure between the last margin
collection and close-out of a position should there be Clearing Member
default. Therefore, the Commission believes that the Margin Policy is
intended to facilitate OCC's calculation of margin amounts sufficient
to cover potential future exposure to participants, and, therefore,
that the Margin Policy is consistent with Rule 17Ad-22(e)(6)(iii).
---------------------------------------------------------------------------

    \27\ 17 CFR 240.17Ad-22(e)(6)(iii).
    \28\ See Standards for Covered Clearing Agencies, 81 FR 70786,
70817 (Oct. 13, 2016) (citing 17 CFR 240.17Ad-22(a)(14)).
---------------------------------------------------------------------------

4. Rule 17Ad-22(e)(6)(iv)
    Rule 17Ad-22(e)(6)(iv) generally requires a covered clearing agency
to establish a risk-based margin system that uses ``reliable sources of
timely price data'' and use ``procedures and sound valuation models for
addressing circumstances in which pricing data are not readily
available or reliable.'' \29\ The Margin Policy describes the measures
OCC is required to take to ensure the quality and completeness of
market data it acquires, including the use of redundant sources of
market data, prioritizing the quality and reliability of data, and to
prioritize the ability of vendors to provide data during market stress.
The Margin Policy also requires OCC to use sound valuation models,
system checks, and automated and manual controls for data it obtains,
and to use primary exchange prices and alternatives, including
modeling, in instances when data is not available or reliable. The
Commission finds that the Margin Policy requires OCC to use reliable
sources of timely price data, and describes procedures to address
circumstances where such data is not readily available or reliable.
Therefore, the Commission finds that the Margin Policy is consistent
with Rule 17Ad-22(e)(6)(iv).
---------------------------------------------------------------------------

    \29\ 17 CFR 240.17Ad-22(e)(6)(iv).
---------------------------------------------------------------------------

5. Rule 17Ad-22(e)(6)(v)
    Rule 17Ad-22(e)(6)(v) generally requires a covered clearing agency
to establish a risk-based margin system that uses an appropriate method
for measuring credit exposure that accounts for relevant product risk
factors and portfolio effects across products.\30\ The Commission
believes that the Margin Policy takes into account the risks and
particular attributes of different products in different accounts and
portfolios to permit OCC to set margin commensurate with the actual
risks that the product presents to OCC. The Commission also believes
that the use of cross-margining agreements, as described in the Margin
Policy, allows OCC to set margins based upon the particular credit
exposure and portfolio effects across products. The Commission further
believes that the Margin Policy's allowance for offsets and exclusions
for deposits in lieu of margin and collateral in margins permits OCC to
set margin based upon the actual credit exposure to its Clearing
Members. Accordingly, the Commission finds that the Margin Policy
allows OCC to measure credit exposure in a manner that accounts for
product risk factors and portfolio effects across products, and finds,
therefore, that it is consistent with Rule 17Ad-22(e)(6)(v).
---------------------------------------------------------------------------

    \30\ 17 CFR 240.17Ad-22(e)(6)(v).
---------------------------------------------------------------------------

6. Rule 17Ad-22(e)(6)(vi)
    Rule 17Ad-22(e)(6)(vi) generally requires a covered clearing agency
to establish a risk-based margin system that is monitored by management
on an ongoing basis and is regularly reviewed, tested, and
verified.\31\ The Commission finds that the Margin Policy requires the
MVG to perform an independent evaluation of the overall performance of
OCC's margin model, and present its findings and recommendations to
OCC's Board on at least an annual basis. The Margin Policy further
requires OCC to conduct daily backtesting for each margin account and
to analyze in detail all accounts that exhibit losses in excess of
calculated margin. The Margin Policy also requires that any such
exceedances be reported at least monthly and be evaluated through OCC's
governance processes. The Commission believes that the Margin Policy
establishes a process for ongoing monitoring, review, testing, and
verification, and finds, therefore, that it is consistent with Rule
17Ad-22(e)(6)(vi).
---------------------------------------------------------------------------

    \31\ 17 CFR 240.17Ad-22(e)(6)(vi).
---------------------------------------------------------------------------

7. Rule 17Ad-22(e)(6)(vii)
    Rule 17Ad-22(e)(6)(vii) generally requires a covered clearing
agency to establish policies and procedures designed to perform model
validation for its credit risk models not less than annually or more
frequently as may be contemplated by the covered clearing agency's risk
management framework.\32\ The Commission finds that the Margin Policy
requires an independent review of OCC's risk model be conducted at
least annually by MVG, who then presents its findings and
recommendations to the Risk Committee of OCC's Board. The Commission
believes that the Margin Policy establishes policies and procedures to
perform model validation not less than annually, and finds, therefore,
that it is consistent with Rule 17Ad-22(e)(6)(vii).
---------------------------------------------------------------------------

    \32\ 17 CFR 240.17Ad-22(e)(6)(vii).
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the Margin
Policy is consistent with the requirements of the Act, and in
particular, with the requirements of Section 17A of the Act \33\ and
Rule 17Ad-22(e)(6) thereunder.
---------------------------------------------------------------------------

    \33\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\34\ that the

proposed rule change (SR-OCC-2017-007) be, and it hereby is, approved.
---------------------------------------------------------------------------

    \34\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated Authority.\35\
---------------------------------------------------------------------------

    \35\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-02973 Filed 2-13-18; 8:45 am]
 BILLING CODE 8011-01-P


MEMORANDUM TO: 3848.141 file FROM: Craig Simons, DPRA DATE: September 10, 1999 SUBJ: Record of communication with Jerry Oldenwelder, Horseheads. (610 826 2111)

I called regarding some of our assumptions in the F006 analysis. He was somewhat abrupt– not making for a long conversation. Not unfriendly, but...

Regarding our assumptions on minimum loads, he said they did not deal with small loads. The material they get is primarily from preprocessors– and they do deal in supersacks– only bulk. Consequently he really could not address our assumption regarding the minimum load costs. (On the other hand when I asked him about recycling charges, he said they were very competitive with landfills– and since our minimum charge assumption is based on landfill charges, it may not be inappropriate– my conclusion, not his.)

I noted that we assumed a charge for recycling of about $200 to $400 per ton. He said this was too high– they were more in line with landfill charges. They do not, however pay for metal values. He thought a charge of $100 to $200 per ton may be more in line.


[Federal Register Volume 81, Number 2 (Tuesday, January 5, 2016)]
[Notices]
[Pages 240-242]
[FR Doc No: 2015-33127]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0256 (Formerly 2007D-0089)]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Draft Guidance for Industry and Review Staff on Target
Product Profile--A Strategic Development Process Tool

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the reporting requirements contained in the
draft guidance for industry and review staff entitled ``Target Product
Profile--A Strategic Development Process Tool.''

DATES: Submit either electronic or written comments on the collection
of information by March 7, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2007-D-0256 (formerly 2007D-0089) for ``Agency Information
Collection Activities: Proposed Collection; Comment Request; Draft
Guidance for Industry and Review Staff on Target Product Profile--A
Strategic Development Process Tool.'' 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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520) Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, in the Federal Register of March 30, 2007 (72 FR 15141),
FDA published a notice of availability of the draft guidance document
with a 60-day notice requesting public comment on the collection of
information. In response to a request by OMB, FDA is republishing a
notice of the proposed collection of information set forth in this
document.
    With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
    The draft guidance is intended to provide sponsors and FDA review
staff with information regarding target product profiles (TPPs). A TPP
can be prepared by a sponsor and then shared voluntarily with the
appropriate FDA review staff to facilitate communication regarding a
particular drug development program. A Clinical Development Working
Group recommended use of a template that provides a summary of drug
labeling concepts to focus discussions and aid in the understanding
between sponsors and FDA. The resulting TPP is a format for a summary
of a drug development program described in terms of labeling concepts.
With the TPP, a sponsor specifies the labeling concepts that are the
goals of the drug development program, documents the specific studies
that are intended to support the labeling concepts, and then uses the
TPP to assist in a constructive dialogue with FDA. The draft guidance
describes the purpose of a TPP, its advantages, and its optimal use. It
also provides information on how to complete a TPP and relates case
studies that demonstrate a TPP's usefulness.
    Sponsors are not required to submit a TPP. The TPP does not
represent an implicit or explicit obligation on the sponsor's part to
pursue all stated goals. Submission of a TPP summary does not constrain
the sponsor to submit draft labeling in a new drug application (NDA) or
biologics license application (BLA) that is identical to the TPP. The
TPP is part of the proprietary investigational new drug application
(IND) file.
    The TPP is organized according to the key sections of the drug
labeling and links drug development activities to specific concepts
intended for inclusion in the drug labeling. The TPP is not a long
summary. Generally, the TPP is shorter than the ultimate annotated
draft labeling because it captures only a summary of the drug
development activities and labeling concepts. Early TPPs can be brief
depending on the status of the drug's development process.
    The Target Product Profile Template in Appendix C of the draft
guidance details the suggested information to be included in each
section of the TPP. The TPP includes information from each discipline
comprising an NDA/BLA. Within each discipline, the TPP briefly
summarizes the specific studies that will supply the evidence for each
conclusion that is a labeling concept. A TPP is organized according to
key sections in the drug's labeling. Typical key sections are:

 Indications and Usage
 Dosage and Administration
 Dosage Forms and Strengths
 Contraindications
 Warnings and Precautions
 Adverse Reactions
 Drug Interactions
 Use in Specific Populations
 Drug Abuse and Dependence
 Overdosage
 Description
 Clinical Pharmacology
 Nonclinical Toxicology
 Clinical Studies
 References
 How Supplied/Storage and Handling
 Patient Counseling Information

    Description of Respondents: Sponsors of applications seeking FDA
approval to perform clinical investigations of a human drug before
applying for marketing approval of the drug from FDA.
    Burden Estimate: FDA estimates that sponsors of approximately 10
percent of the number of active INDs submitted to FDA annually would
prepare and submit TPPs. This would equal

approximately 132 TPPs per year. Based on data received from the
Pharmaceutical Research and Manufacturers of America, we estimate that
approximately 20 sponsors would submit TPPs and that each TPP would
take approximately 20 hours to prepare and submit to FDA. Based on the
previous methodology and assumptions, the following table provides an
estimate of the annual reporting burden for the voluntary submission of
TPPs under the draft guidance. FDA requests comments on this analysis
of information collection burdens.

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                                                                     Number of      responses per     Total annual    Average burden      Total hours
                                                                    respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Target Product Profiles (TPPs)..................................              20              6.6              132               20               2,640
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: December 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-33127 Filed 1-4-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 162 (Wednesday, August 25, 2021)]
[Notices]
[Page 47535]
[FR Doc No: 2021-18243]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2021-0076]

Petition for Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on July 8, 2021, the Long
Island Rail Road Company (LIRR) petitioned the Federal Railroad
Administration (FRA) for a waiver of compliance from certain provisions
of the Federal railroad safety regulations contained at 49 CFR parts
239 (Passenger Train Emergency Preparedness); 240 (Qualification and
Certification of Locomotive Engineers); and 242 (Qualification and
Certification of Conductors). FRA assigned the petition Docket Number
FRA-2021-0076.
    LIRR requests an extension of the relief that was granted to the
American Public Transportation Association (APTA), on behalf of its
member railroads, by letter dated September 18, 2020, from certain
regulations pertaining to training.\1\ Specifically, LIRR refers to
pages 10-11 of the FRA decision letter in Docket Number FRA-2020-0060,
regarding relief from recurrent/refresher training requirements for
parts 239, 240, and 242.
---------------------------------------------------------------------------

    \1\ See https://www.regulations.gov/document/FRA-2020-0060-0005.
---------------------------------------------------------------------------

    LIRR requests relief for approximately 30 ``higher level
Transportation Department employees.'' LIRR states that it has had to
limit classroom capacity for its training sessions because of the
coronavirus disease 2019 (COVID-19) pandemic and states that it has a
training backlog. Although LIRR expects to eliminate this backlog for
some groups of employees by September 18, 2021, when the APTA relief
expires, LIRR asserts that it does not have the necessary classroom or
instructor availability to catch up on training its Transportation
Department higher-level employees by that date. Instead, LIRR seeks an
extension to permit recurrent/refresher training of such employees to
occur by December 31, 2021.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted at http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Communications received by September 9, 2021 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable. Anyone can search the electronic
form of any written communications and comments received into any of
our dockets by the name of the individual submitting the comment (or
signing the document, if submitted on behalf of an association,
business, labor union, etc.). Under 5 U.S.C. 553(c), the U.S.
Department of Transportation (DOT) solicits comments from the public to
better inform its processes. DOT posts these comments, without edit,
including any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacy-notice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2021-18243 Filed 8-24-21; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 83, Number 120 (Thursday, June 21, 2018)]
[Notices]
[Pages 28851-28853]
[FR Doc No: 2018-13297]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1919]

Major Depressive Disorder: Developing Drugs for Treatment; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Major
Depressive Disorder: Developing Drugs for Treatment.'' The purpose of
this draft guidance is to assist sponsors in the clinical development
of drugs for the monotherapeutic, combination, and adjunctive treatment
of major depressive disorder (MDD). Specifically, this draft guidance
addresses FDA's current thinking regarding the overall development
program and clinical trial designs for antidepressant drug products.
This draft guidance is intended to serve as a focus for continued
discussions among FDA, pharmaceutical sponsors, the academic community,
and the public. This draft

guidance revises the guidance for industry entitled ``Guidelines for
the Clinical Evaluation of Antidepressant Drugs'' issued in September
1977.

DATES: Submit either electronic or written comments on the draft
guidance by August 20, 2018 to ensure that the Agency considers your
comment on this 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-2018-D-1919 for ``Major Depressive Disorder: Developing Drugs for
Treatment; Draft 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 Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Juliette Tour[eacute], Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4120, Silver Spring, MD 20993-0002, 301-
796-2260.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Major Depressive Disorder: Developing Drugs for Treatment.''
The purpose of this draft guidance is to assist sponsors in the
clinical development of drugs for the monotherapeutic, combination, and
adjunctive treatment of MDD. Specifically, this draft guidance
addresses FDA's current thinking regarding the overall development
program and clinical trial designs for antidepressant drug products.
This draft guidance is intended to serve as a focus for continued
discussions among FDA, pharmaceutical sponsors, the academic community,
and the public.
    This draft guidance revises the guidance for industry entitled
``Guidelines for the Clinical Evaluation of Antidepressant Drugs''
issued in September 1977. Major revisions were made to the 1977
guidance to align it with the FDA's current thinking on this topic.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on developing
drugs for the treatment of MDD. 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. This guidance is not subject to Executive
Order 12866.

II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: June 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-13297 Filed 6-20-18; 8:45 am]
 BILLING CODE 4164-01-P


Southeast Regional Office 9721 Executive Center Drive N. St. Petersburg, Florida 33702 February 23, 2004 Magalie R. Salas, Secretary Federal Energy Regulatory Commission 888 First Street, N. E., Room 1A Washington, D. C. 20426 Dear Secretary Salas:

The National Marine Fisheries Service ( NOAA Fisheries) has reviewed the " NOTICE OF ENVIRONMENTAL REVIEW AND SCOPING FOR THE GOLDEN PASS LNG TERMINAL AND PIPELINE PROJECT AND REQUEST FOR COMMENTS ON ENVIRONMENTAL ISSUES" ( Docket No. PF04 1 000) dated January 23, 2004. Golden Pass LNG Terminal LP and Golden Pass Pipeline LP, both affiliates of ExxonMobil Corporation ( ExxonMobil) propose to construct a liquefied natural gas ( LNG) receiving terminal, regasification facility, and associated pipeline near Sabine Pass, Texas. ExxonMobil proposes to use approximately 100 million gallons of seawater per day ( mgd) as a heating medium in an open rack vaporizing system for LNG regasification. The seawater intake will be located at the head of the berth area for the LNG tanker ships. An aquatic filter barrier system engineered by Gunderboom would be placed as a curtain in front of the intake in an attempt to exclude eggs and larval fish from entrainment in the heating water intake.

The proposed project site includes and is adjacent to areas identified as essential fish habitat ( EFH) for postlarval, juvenile, and adult red drum ( Sciaenops ocellatus), adult and subadult Spanish mackerel ( Scomberomorus maculatus), and juvenile and subadult white ( Litopenaeus setiferus) and brown shrimp ( Farfantepenaeus aztecus). The estuarine water column, unvegetated benthic habitats, and intertidal wetlands are categories of EFH that could be impacted by the proposed project. The designations by the Gulf of Mexico Fishery Management Council ( GMFMC) in its EFH amendment, as approved by NOAA Fisheries, were specified consistent with the requirements of the Magnuson Stevens Fishery Conservation and Management Act ( Magnuson Stevens Act) ( P. L. 104 297) and implementing regulations. As the proposed facilities would have an adverse impact on EFH and associated managed species, Federal Energy Regulatory Commission ( FERC) will be required to consult with NOAA Fisheries prior to any final federal action on the proposed LNG project. The GMFMC also is provided an opportunity for comment on EFH related issues under provisions of the Magnuson Stevens Act.

NOAA Fisheries is very concerned that ExxonMobil proposes to construct this facility in an estuarine tidal pass. It has been estimated that approximately 95 percent of all Gulf coast fishery landings are of estuarine dependent species ( U. S. EPA, 1999). Natural mortality of fish eggs and larvae is already high, and stock success can depend on survival and transport of relatively few recruits to their estuarine nursery habitats ( Houde 1987, 1989). NOAA Fisheries views mortality caused by the proposed LNG facility as a significant additional mortality factor to the natural conditions that affect the sustainability of these fisheries. If it is determined that the proposed LNG facility kills the few recruits destined for survival, the facility may have a dramatic negative effect on economically important fish stocks. Information which should be provided to complete a traditional stock assessment to determine impacts from impingement and entrainment includes:

a) Numbers of eggs, larvae, and juveniles that are expected to be entrained or impinged ( and killed) by species.

b) Daily natural mortality estimates by life stage during the first year of life by species, including hatching success. This allows an estimation of survival from viable egg to age of entrainment.

c) Age structured population model ( e. g., VPA or forward projection model) estimates of recruits to age 1 and population fecundity ( need maturity schedule and fecundity relationship). This allows stock level estimates of egg production ( viable eggs) and overall survival from viable egg to recruitment at age 1.

In addition to direct fish and crustacean impacts, all zooplankton passing through the proposed LNG facility are likely to be killed. Zooplankton are microscopic drifting animals that are important components of the marine and estuarine food webs, consuming phytoplankton and smaller zooplankton and providing food for higher level predators, such as larvae of fish and crustaceans. A rough estimate from Minello ( 1980) indicates that average annual densities of larger zooplankton ( mostly copepods) are around 2000 per m3 in coastal waters off Texas and Louisiana. Therefore, the environmental impact statement should provide and evaluate information on zooplankton mortality from the proposed LNG facility.

NOAA Fisheries also questions whether the Gunderboom Marine Life Exclusion System © will adequately address the potential problem of impingement and entrainment of larval fish and eggs. From internet searches, it appears that this technology has been used mainly in riverine systems and is unproven in eutrophic and often turbid estuarine systems such as those found on the Gulf coast. Studies conducted by P. A. Henderson et al. ( 2001) found that the Gunderboom systems became bio fouled very quickly and resulted in organisms becoming impinged on the curtain. The air jets were found to injure impinged organisms and actually increased the amount of colonization by other organisms within the curtain's mesh. Seaby et al. ( 2002) concluded that fouling was likely to cause a failure of the system and result in entrainment of organisms. Fouling may be even greater in the Gulf estuaries such as Sabine Lake. Even if a small mesh size were used and filtration efficiency could be maintained ( i. e., no clogging), planktonic eggs and larvae would be impinged on the mesh surface and likely suffer mortality due to predation, starvation, or physical damage. Aggregating predators are likely to feed upon impinged organisms, and air burst cleaning may damage any survivors. Therefore, to allow an adequate evaluation of alternative screening devices, ExxonMobil or FERC should conduct a scientifically based demonstration project in the Sabine Pass area to test the efficacy of the proposed Gunderboom system. Any such demonstration design first should be reviewed and approved by the NOAA Fisheries Southeast Science Center.

We also are concerned that the proposed LNG facility would add significantly to the cumulative loss of living marine resources from existing once through seawater cooling systems. For example, Palafox and Wolford ( 1993) conducted a study to gauge the relative importance of impingement from five power plants in Galveston Bay, Texas, on commercially and recreationally important species. They reported that from 1978 1979, the time period with the most extensive data set, the weight of impinged shrimp and crabs on power plant intake screens was nearly 11 and 17 percent respectively of the commercial bay landings. Impingement of red drum, sand seatrout ( Cynoscion arenarius) and spotted seatrout also accounted for almost three percent of the recreational landings. The Environmental Protection Agency ( EPA) also conducted several case study analyses of the impact of cooling water intakes for power plants on fisheries as part of their proposed Section 316( b) Phase II Existing Facilities rulemaking process. In their study of Tampa Bay, Florida, the only Gulf coast estuary studied, EPA found that the economic impacts from entrainment and impingement ranged between $ 20.39 million to $ 21.75 million dollars annually in year 2000 dollars ( EPA 2002). To adequately address such issues, the FERC should undertake a detailed cumulative impacts assessment of the proposed project which takes into account project impacts in conjunction with past, present and reasonably foreseeable future projects, as required by the National Environmental Policy Act ( NEPA).

The FERC also should provide a detailed alternatives analysis, as required by NEPA, of regasification systems. Alternative systems are proposed for use at other LNG facilities which we believe avoid and minimize impacts to EFH and associated managed species. It is noteworthy that a closed loop system utilizing a water/ glycol solution and a natural gas boiler to vaporize LNG is proposed for use at the Sabine Pass facility during the late fall to late winter months when seawater temperatures are not suitable for efficient regasification. Since the system would already be in place, one alternative would be to run the closed loop system year round and not construct the once through seawater system. We believe this technology should be considered a best available technology.

EPA is considering revising the Clean Water Act Section 316( b) regulations concerning entrainment and impingement impacts from once through water systems. Although EPA has not made a decision whether LNG facilities will be covered under the proposed Phase III Regulations, we believe that the FERC should hold new LNG facilities to the same standards as new power plants, since the impacts on fisheries from the once through seawater systems with similar intake volumes would be the same. Therefore, we believe that the Tract I standards set in section 125.84 ( b)( 1) of the Section 316( b) Phase I Regulations for new electric generation facilities that withdraw greater than 10 mgd should be the required standard for this LNG facility. The cited standard requires that intake flows, at a minimum, be reduced to a level commensurate with that which can be attained by a closed cycle recirculating cooling water system.

We are also concerned about the potential impacts of the proposed pipeline construction. Installation of pipelines and other transmission lines by current trenching and push/ pull methods historically has caused significant emergent marsh loss in coastal environments. Both documented and undocumented evidence demonstrates that restoration of temporary pipeline work corridors to pre project conditions is often unsuccessful, that restoration requirements are not being enforced and that permanent wetlands impacts are occurring. A review of aerial photography of the upper Texas Coast along pipeline corridors clearly depicts extensive permanent marsh loss for permitted pipelines, although the amount of marsh loss is largely undocumented and unmitigated.

To address pipeline impacts, we recommend that the FERC consider the following issues during its evaluation of mitigation needs for the proposed pipeline construction in EFH:

a) The need for pre construction surveys and aerial photography of pipeline rights of way in wetlands to determine pre project contours, elevations, vegetation types and vegetative cover.

b) The need for post construction pipeline surveys using aerial photography and other techniques, which would include all vehicle tracks both inside and outside the identified work corridor. The surveys should be designed to evaluate restoration success, remedial measures and mitigation needs.

Finally, the project area may be within the known distribution limits of federally listed threatened species that are under purview of NOAA Fisheries. In accordance with the Endangered Species Act of 1973, as amended, it is the responsibility of FERC to identify actions that may affect endangered or threatened species or their habitat. Determinations involving species under NOAA Fisheries' jurisdiction should be reported to our Protected Resources Division ( PRD) at the letterhead address. If it is determined that the activities may adversely affect any species listed as endangered or threatened and under PRD purview, then formal consultation must be initiated.

Thank you for the opportunity to provide comments on environmental issues concerning the proposed permitting of the Golden Pass LNG Terminal and Pipeline. While we strongly urge FERC to require the use of a closed loop heating system on a year round basis, we are including a list of scoping information needs, in addition to the preceding, to allow a full assessment of the impacts of the project as currently proposed. If we may be of further assistance, please contact Mr. Rusty Swafford in our Galveston, Texas, facility at ( 409) 766 3699. For information concerning threatened and endangered species please contact Mr. David Bernhart of our PRD at ( 727) 570 5312.

Sincerely,

Miles M. Croom Assistant Regional Administrator Habitat Conservation Division cc: PRD SER 42 SER 43 SER 44 SEFSC Minello Enclosure References Cited Hartman, R. D., C. F. Bryan, and J. W. Korth 1987. Community structure and dynamics of fishes in a Southeast Texas estuary. U. S. Fish and Wildlife Service, Albuquerque. 116 p.

Houde, E. D. 1987. Fish early life dynamics and recruitment variability. p. 17 29 In Hoyt, R. D.( ed.). Proceedings of the10th Annul Larval Fish Conference held in Miami, FL May 18 23, 1986. American Fisheries Society Symposium 2. American Fisheries Society, Bethesda, MD.

Houde, E. 1989. Subtleties and episodes in the early life of fishes. J. Fish. Biol. 35 Supplement A: 29 38.

P. A. Henderson, R. M. Seaby, C. Cailes, and J. R. Somes, 2001. Gunderboom Fouling Studies in Bowline Pond, July 2001. Pisces Conservation Ltd. IRC House, Pennington, Lymington, England.

Minello, T. J. 1980. The neritic zooplankton of the northwestern Gulf of Mexico. Texas A& M University, College Station, 240 p.

Palafox, S. D., and E. D. Wolford. 1993. Non fishing/ human induced mortality in fisheries. Galveston bay National Estuary Program. Pub. GBNEP 29. Webster, TX Riverkeeper, Inc. 2003. Comprehensive survey and investigation of dry cooling systems to reduce impingement and entrainment. Riverkeeper, Inc. ( http:// riverkeeper. org/ campaign. php/ fishkills/ we_ are_ doing/ 622),

Seaby, R. M., P. A. Henderson, C. Cailes, and J. R. Somes 2002. Gunderboom fouling studies. ( http:// riverkeeper. org/ document. php/ 138/ Appendix_ C__ Pis. pdf). Pices Conservation Ltd ( www. irchouse. demon. co. uk), England.

U. S. Environmental Protection Agency. 1999. Ecological considerations of estuaries in the Gulf of Mexico. EPA 620 R 98 004. U. S. Environmental Protection Agency, Office of Research and Development, National Health and Environmental Effects Research Laboratory, Gulf Ecology Division, Gulf Breeze, FL.

U. S. Environmental Protection Agency. 2002. Case study analysis for the proposed Section 316( b) Phase II Existing Facilities rule. EPA 821 R 02 002. U. S. Environmental Protection Agency, Office of Water.

U. S. Department of the Army Corps of Engineers, Galveston District. Permit 20376 to Liquid Carbonics monitoring report.

U. S. Department of the Army Corps of Engineers, Galveston District. Permit 20838 to Air Liquide monitoring report. INFORMATION REQUIREMENTS FOR NOAA REVIEW OF GOLDEN PASS LNG PROJECT, DOCKET NO. PF 04 1 000 General project details:

1. Project Location a. Associated state, county/ parish, city b. Habitat types impacted c. Surrounding features ( natural, created, other industry, etc.) d. Alternate sites i. Location of less damaging sites ( particularly important if proposed terminal to be sited in a wetland, estuarine pass, or shallow water) ii. Justification for not siting terminal in less damaging location 2. Project Features a. Type of terminal structure b. Associated pipelines i. Size ii. Location iii. Installation procedures iv. Associated wetlands impacts v. Restoration/ monitoring protocols vi. Wetlands impact mitigation plan vii. Reporting requirements c. Overall project footprint d. Construction and/ or installation procedures e. Regasification system i. Closed loop or other Best Available Technology ( BAT) vs. ii. Open loop ( 1) Justification for not using BAT ( a) Economic ( i. e., comparison of cost associated with using BAT vs. open loop; open loop cost estimate should include cost of additional necessary features such as exclusion systems, cleaning, monitoring, mitigation, fisheries impacts, etc.,) ( b) Safety ( i. e., combustion hazard) ( c) Environmental ( i. e., air emissions) ( i) Quantification of existing air quality regime in the project area ( ii) Comparison of emissions in BAT vs. open loop systems ( 2) Impacts ( see next section for greater detail) ( a) Entrainment ( b) Impingement ( c) Anti biofouling agents ( d) Thermal discharge ( e) Cumulative impacts f. Terminal operation schedule ( i. e., number of days per year LNG expected to be regasified at terminal)

3. Essential fish habitat ( EFH) a. Description of EFH to be impacted b. Description of life stages of managed species to be impacted c. Proposed measures to avoid and minimize EFH impact d. Proposed EFH mitigation measures Issues associated with regasification in open loop mode:

4. Seawater intakes e. Depth of intake b. Configuration i. Type of intake ii. Number of intakes c. Intake volume ( i. e., number of gallons of seawater utilized per day and year) d. Intake velocity i. Maximum allowed velocity ii. Method for monitoring velocity iii. Operational protocol if intake velocity is found to exceed maximum allowed by license e. Marine life exclusion features i. Type ( mesh screens, Gunderboom, etc.) 1. Provide information on efficiency of exclusion feature ( e. g., literature review, data from demonstration projects, etc.,) ii. Size range of organisms excluded by system iii. Operational procedures 1. Cleaning procedures 2. Frequency of cleaning 3. Potential effects to intake velocity as exclusion system becomes increasingly fouled 4. Quantify impacts to organisms that will be impinged on screen f. Estimation of entrainment i. Species present ii. Density of eggs and larvae in the project area iii. Vertical distribution of organisms iv. Any known seasonality of organism distribution v. Entrainment mortality 1. contact with structural components of system ( e. g., impeller blades) 2. sudden changes in ambient pressure 3. drop in water temperature 4. exposure to anti biofouling agents vi. Impacts to managed species from loss of food source ( e. g., entrainment of zooplankton) g. Fisheries stock impact assessment i. Describe approach and provide rationale ii. Provide data and information on data source h. Analysis of economic impact to commercial and recreation fishers i. Describe approach and provide rationale ii. Provide data and information on data source 5. Seawater discharge a. Depth of discharge b. Configuration i. Type of discharge ( diffuser, vertical, angular, etc.) ii. Number of discharge points c. Discharge velocity d. Anti biofouling agents i. Type of agent used ii. Concentration of agent 1. In system 2. In discharge 3. Area required for dilution of agent 4. Potential for accumulation in the project area iii. Potential impacts to organisms exposed to anti biofouling agent 1. Tolerance of relevant species to chronic and acute levels of agent ( in egg, larval, juvenile, and adult forms) 2. Lethal impacts 3. Sublethal impacts 4. Potential for bioaccumulation e. Thermal discharge i. Temperature of discharge ii. Difference between ambient temperature and thermal discharge iii. Area required for dilution of thermal discharge back to ambient temperature ( given that ) iv. Potential impacts to organisms exposed to thermal discharge 1. Tolerance of relevant species to predicted temperatures ( in egg, larval, juvenile, and adult forms) 2. Lethal impacts 3. Sublethal impacts 6. Cumulative Impacts ( past, present and reasonably foreseeable future) a. Other LNGs b. Other industry ( e. g., petroleum, fishing, power generation, etc.) c. Natural processes i. Environmental conditions ii. Starvation iii. Predation iv. Transport out of area ( i. e., currents)

7. Monitoring ( If terminal will be permitted to operate in open loop mode, NOAA Fisheries will require a monitoring plan; it would be helpful if license applications/ NEPA documents indicated the applicant's intent to implement monitoring and indicate the general components of the plan) a. Baseline ( pre project) conditions at the site b. Protocol for monitoring impacts of terminal i. Entrainment ii. Impingement iii. Anti biofouling agents iv. Thermal discharge c. Timeline i. Coordination of monitoring plan with NOAA Fisheries ii. Implementation of monitoring plan prior to construction and operation of terminal d. Reporting procedures e. Proposed remedial actions for marine life exclusion system failure 8. Identify mitigation measures for impacts and direct loss to fisheries