designated credit risk officer or credit risk committee. See
proposed FINRA Rule 4210(e)(2)(H)(ii)b. and Rule 4210.05 in Exhibit
5.
    \141\ To clarify the rule's structure, FINRA is revising
paragraphs (e)(2)(F) and (e)(2)(G) so that the risk analysis
language that appears under current, pre-revision paragraph
(e)(2)(H), and which currently by its terms applies to both
paragraphs (e)(2)(F) and (e)(2)(G), would be placed in each of those
paragraphs and deleted from its current location. Accordingly, FINRA
proposes to move to paragraphs (e)(2)(F) and (e)(2)(G): ``Members
shall maintain a written risk analysis methodology for assessing the
amount of credit extended to exempt accounts pursuant to [this
paragraph], which shall be made available to FINRA upon request.''
FINRA proposes to further add to each: ``The risk limit
determination shall be made by a designated credit risk officer or
credit risk committee in accordance with the member's written
policies and procedures.'' FINRA believes this is logical as it
makes the risk limit language more congruent with the language
proposed for paragraph (e)(2)(H) of the rule.
---------------------------------------------------------------------------

    Separately, not in response to comment, as noted earlier \142\
FINRA has revised the opening sentence of proposed Rule
4210(e)(2)(H)(ii)b. to provide that a member that engages in Covered
Agency Transactions with any counterparty shall make a determination in
writing of a risk limit for each such counterparty that the member
shall enforce. FINRA believes that this is appropriate to clarify that
the member must make, and enforce, a written risk limit determination
for each counterparty with which the member engages in Covered Agency
Transactions. Further, FINRA is adding to Supplementary Material .05 a
provision that, for purposes of any risk limit determination pursuant
to paragraphs (e)(2)(F) through (H), a member must consider whether the
margin required pursuant to the rule is adequate with respect to a
particular counterparty account or all its counterparty accounts and,
where appropriate, increase such requirements. FINRA believes that this
requirement is consistent with the purpose of a risk limit
determination to ensure that the member is properly monitoring its risk
and that it is logical for a member to increase the required margin
where it appears the risk is greater.
---------------------------------------------------------------------------

    \142\ See note 40 supra.
---------------------------------------------------------------------------

5. Determination of Exempt Accounts
    As proposed in the Notice, the rule change provides that the
determination of whether an account qualifies as an exempt account must
be based on the beneficial ownership of the account. The rule change
provides that sub-accounts managed by an investment adviser, where the
beneficial owner is other than the investment adviser, must be margined
individually.
    Commenters expressed concern that exempt account determination and
margining at the sub-account level would be onerous, especially for
managers advising large numbers of clients.\143\ In response, FINRA, as
discussed above, is revising the proposed rule change so that risk
limit determinations may be made at the investment adviser level,
subject to specified conditions. FINRA believes that the proposed risk
limit determination language, in combination with the proposed $2.5
million per counterparty exception as discussed above, should reduce
potential burdens on members. Individual margining of sub-accounts,
however, would still be required given that individual margining is
required in numerous other settings and is fundamental to sound
practice. FINRA notes that, among other things, an investment adviser
cannot use one advised client's money and securities to meet the margin
obligations of another without that other client's consent and that
current FINRA Rule 4210(f)(4) sets forth the conditions under which one
account's money and securities may be used to margin another's debit.
---------------------------------------------------------------------------

    \143\ Baird, BB&T, BDA, Clarke, FIF, Mischler, Sandler, Shearman
and SIFMA AMG.
---------------------------------------------------------------------------

6. Concentration Limits
    Under current (pre-revision) paragraph (e)(2)(H) of Rule 4210, a
member must provide written notification to FINRA and is prohibited
from entering into any new transactions that could increase credit
exposure if net capital deductions, over a five day business period,
exceed: (1) For a single account or group of commonly controlled
accounts, five percent of the member's tentative net capital; or (2)
for all accounts combined, 25 percent of the member's tentative net
capital. As proposed in the Notice, the proposed rule change would
expressly include Covered Agency Transactions, within the calculus of
the five percent and 25 percent thresholds.
    Several commenters said that the five percent and 25 percent
thresholds are too restrictive, that they would be easily reached in
volatile markets, that they would have the effect of reducing market
access by smaller firms, and that the limits should be raised.\144\
---------------------------------------------------------------------------

    \144\ BB&T, BDA, FirstSouthwest, Mischler, Sandler, SIFMA and
SIFMA AMG.
---------------------------------------------------------------------------

    In response, FINRA notes that the five percent and 25 percent
thresholds are not new requirements. The thresholds are currently in
use and are designed to address aggregate risk in this area. FINRA
believes that the suggestion that the thresholds are easily reached in
volatile markets, if anything, confirms that they serve an important
purpose in monitoring risk. Accordingly, FINRA proposes to retain the
thresholds, with non-substantive edits to further clarify that the
provisions are meant to include Covered Agency Transactions. In
addition, the proposed rule change would clarify that de minimis
transfer amounts must be included toward the concentration thresholds,
as well as all amounts pursuant to the $2.5 million per counterparty
exception as discussed earlier.\145\
---------------------------------------------------------------------------

    \145\ See proposed FINRA Rule 4210(e)(2)(I) in Exhibit 5.
---------------------------------------------------------------------------

7. Central Banks
    As proposed in the Notice, the proposed rule change would not apply
to Covered Agency Transactions with central banks. As explained in the
Notice, FINRA would interpret ``central bank'' to include, in addition
to government central banks and central banking authorities,
sovereigns, multilateral development banks and the Bank for
International Settlements. One commenter proffered language to expand
the proposed exemption for central banks to include sovereign wealth
funds.\146\ The Federal Home Loan Banks (FHLB) requested exemption from
the requirements on grounds of the low counterparty risk that they
believe they present.\147\ Two commenters suggested that in the
interest of clarity the interpretive language in the Notice as to
``central banks'' should be integrated into the rule text.\148\
---------------------------------------------------------------------------

    \146\ SIFMA.
    \147\ FHLB.
    \148\ SIFMA and SIFMA AMG.
---------------------------------------------------------------------------

    In response, as noted earlier \149\ FINRA has revised the proposed
rule language as to central banks and similar entities to make the
rule's scope more clear and to provide members flexibility to manage
their risk vis-[agrave]-vis such entities. Specifically, proposed Rule
4210(e)(2)(H)(ii)a.1. provides that, with respect to Covered Agency
Transactions with any counterparty that is a Federal banking agency, as
defined in 12 U.S.C. 1813(z),\150\ central bank, multinational central
bank, foreign sovereign, multilateral development bank, or the Bank for
International Settlements, a member may elect not to apply the margin
requirements specified in paragraph (e)(2)(H) of the rule provided the
member makes a written risk limit determination for each such
counterparty that the member shall enforce pursuant to paragraph
(e)(2)(H)(ii)b. FINRA believes that, in addition to providing members
flexibility from the standpoint of managing their risk, the proposal as
revised is more clear as to the types of entities that are included
within the scope of the election that paragraph (e)(2)(H)(ii)a.1. makes
available to members. Specifically, the terms Federal banking agency,
central bank, multinational central bank, and foreign sovereign are
consistent with usage in

the ``Volcker Rules'' as adopted in January, 2014.\151\ As explained in
the Notice, the inclusion of multilateral development banks and the
Bank for International Settlements is consistent with usage by the
Basel Committee on Banking Supervision (``BCBS'') and the Board of the
International Organization of Securities Commissioners
(``IOSCO'').\152\ FINRA does not propose to include sovereign wealth
funds, as such entities engage in market activity as commercial
participants. Informed by discussions with the FRBNY staff, FINRA does
not propose to include other specific entities, other than the Bank for
International Settlements on account of its role vis-[agrave]-vis
central banks, given that FINRA has been advised that doing so would
create perverse incentives for regulatory arbitrage. Further, absent a
showing that an entity is expressly backed by the full faith and credit
of a sovereign power or powers and is expressly limited by its
organizing charter as to any speculative activity in which it may
engage, including such an entity within the scope of the election made
available under paragraph (e)(2)(H)(ii)a.1. would cut against the
overall purpose of the rule amendments.
---------------------------------------------------------------------------

    \149\ See note 39 supra.
    \150\ See note 38 supra.
    \151\ See OCC, Federal Reserve, FDIC and SEC, 79 FR 5536
(January 31, 2014) (Final Rule: Prohibitions and Restrictions on
Proprietary Trading and Certain Interests in, and Relationships
With, Hedge Funds and Private Equity Funds).
    \152\ See BCBS and IOSCO, Margin Requirements for Non-Centrally
Cleared Derivatives, September 2013, available at: <http://www.bis.org/publ/bcbs261.pdf>.
---------------------------------------------------------------------------

8. Timing of Margin Collection and Transaction Liquidation
    The proposed rule change, with minor revision vis-[agrave]-vis the
version as set forth in the Notice, provides that, unless FINRA has
specifically granted the member additional time, the member would be
required to liquidate positions if, with respect to exempt accounts, a
mark to market loss is not satisfied within five business days, or,
with respect to non-exempt accounts, a deficiency is not satisfied
within such period.
    Commenters suggested that the proposed five-day timeframe is too
short, that the appropriate timeframe is 15 days, as set forth in
current Rule 4210(f)(6), that firms may not be able to collect the
margin within the specified timeframe, and that firms should be
permitted to negotiate the timeframe with their customers.\153\ One
commenter sought clarification as to whether a member would be required
to take a capital charge on deficiencies on the day such deficiencies
are cured.\154\
---------------------------------------------------------------------------

    \153\ AII, BB&T, BDA, Credit Suisse, Duncan-Williams, ICI,
MetLife, Pershing, Sandler, Shearman, SIFMA and SIFMA AMG.
    \154\ SIFMA.
---------------------------------------------------------------------------

    In response, FINRA believes that the five-day period as proposed is
appropriate in view of the potential counterparty risk in the TBA
market.\155\ Accordingly, the proposed requirement is largely as set
forth in the Notice, with minor revision as noted earlier to better
align the language with corresponding provisions under FINRA Rule
4210(g)(10)(A) in the context of portfolio margining.\156\ Further,
consistent with longstanding practice under current Rule 4210(f)(6),
FINRA notes that the proposed rule makes allowance for FINRA to
specifically grant the member additional time.\157\ FINRA maintains,
and regularly updates, the online Regulatory Extension System for this
purpose. With respect to the curing of deficiencies, FINRA notes that
the margin rules have consistently been interpreted so that a capital
charge, once created, is removed when the deficiency is cured.
---------------------------------------------------------------------------

    \155\ In the interest of clarity, FINRA is revising paragraph
(f)(6) of Rule 4210 so as to except paragraph (e)(2)(H) of the rule
from the 15-day timeframe set forth in paragraph (f)(6).
    \156\ See notes 52, 53 and 56 supra.
    \157\ See proposed FINRA Rule 4210(e)(2)(H)(ii)d.
---------------------------------------------------------------------------

9. Miscellaneous Issues
(a) Cleared TBA Market Products
    One commenter suggested that the proposed amendments should apply
to Covered Agency Transactions cleared through a registered clearing
agency.\158\ FINRA does not propose to apply the requirements to
cleared transactions at this time given that such requirements would
appear to duplicate the efforts of the registered clearing agencies and
increase burdens on members.
---------------------------------------------------------------------------

    \158\ Brevan.
---------------------------------------------------------------------------

(b) Introducing and Carrying/Clearing Firms
    One commenter sought clarification as to whether introducing firms
or carrying/clearing firms would be responsible for calculating,
collecting and holding custody of the customer's margin under the
proposed amendments.\159\ In response, FINRA notes that Rule 4311
permits firms to allocate responsibilities under carrying agreements so
that, for instance, an introducing firm could calculate margin and make
margin calls, provided, however, that the carrying firm is responsible
for the safeguarding of funds and securities for the purposes of SEA
Rule 15c3-3.\160\
---------------------------------------------------------------------------

    \159\ Sandler.
    \160\ With respect to any customer funds and securities, an
introducing firm is subject to the obligation of prompt transmission
or delivery.
---------------------------------------------------------------------------

(c) Margining of Fails
    Three commenters sought clarification as to whether members would
be required to margin fails to deliver.\161\ In response, FINRA notes
that currently Rule 4210 does not require the margining of fails to
deliver. However, FINRA notes that members need to consider the
relevant capital requirements under SEA Rule 15c3-1, in particular the
treatment of unsecured receivables under Rule 15c3-1(c)(2)(iv). FINRA
does not propose to address fails to deliver as part of the proposed
rule change.
---------------------------------------------------------------------------

    \161\ Pershing, Sandler and SIFMA.
---------------------------------------------------------------------------

(d) Eligible Collateral
    Several commenters suggested that FINRA should clarify that the
proposal is not specifying what type of collateral a firm should accept
and that there should be flexibility for parties to negotiate
collateral via the terms of the Master Securities Forward Transaction
Agreement (MSFTA).\162\ Some commenters suggested the proposal should
impose limits with respect to types of collateral.\163\ In response,
FINRA believes that all margin eligible securities, with the
appropriate margin requirement, should be permissible as collateral
under Rule 4210 to satisfy required margin.
---------------------------------------------------------------------------

    \162\ AII, Clarke, FIF and SIFMA.
    \163\ BB&T and Duncan-Williams.
---------------------------------------------------------------------------

(e) Protection of Customer Margin; Two-Way Margining
    One commenter suggested that, in light of the Bankruptcy Court
decision concerning TBA products in the Lehman case,\164\ FINRA should
enhance protection of the margin that customers post by requiring that
members hold the margin through tri-party custodial arrangements.\165\
One commenter suggested that, as a way to manage the risk of Covered
Agency Transactions, FINRA should implement two-way margining that
would require members to post the same mark to market margin that would
be required of counterparties, and that FINRA should, as part of the
rule change, permit the

use of tri-party custodial arrangements.\166\
---------------------------------------------------------------------------

    \164\ See Memorandum Decision Confirming the Trustee's
Determination of Claims Relating to TBA Contracts, In re Lehman
Brothers, Inc., Debtor, 462 B.R. 53, 2011 Bankr. LEXIS 4753
(S.D.N.Y. December 8, 2011).
    \165\ Brevan.
    \166\ ICI.
---------------------------------------------------------------------------

    In response, though FINRA is supportive of enhanced customer
protection wherever possible, implementation of such requirements at
this time could impose substantial additional burdens on members, or
otherwise raise issues that are beyond the scope of the proposed rule
change. FINRA is considering the issue of tri-party arrangements but
does not propose to address it as part of the proposed rule change.
Further, FINRA supports the use of two-way margining as a means of
managing risk but does not propose to address such a requirement as
part of the rule change.
(f) Unrealized Profits; Standbys
    The proposed rule change, with minor revision vis-[agrave]-vis the
version as set forth in the Notice, provides that unrealized profits in
one Covered Agency Transaction may offset losses from other Covered
Agency Transaction positions in the same counterparty's account and the
amount of net unrealized profits may be used to reduce margin
requirements. Further, the rule provides that, with respect to
standbys, only profits (in-the-money amounts), if any, on long standbys
shall be recognized.
    One commenter sought clarification as to whether for long standbys
only profits, not losses, may be factored into the setoff.\167\ In
response, FINRA notes that this is correct.
---------------------------------------------------------------------------

    \167\ SIFMA.
---------------------------------------------------------------------------

(g) Definition of Exempt Account
    One commenter suggested FINRA should revise the definition of
``exempt'' account under Rule 4210 to include the non-US equivalents of
the types of entities set forth under the definition.\168\ In response,
FINRA notes that the definition of exempt account plays an important
role under Rule 4210 and believes that issue is better addressed as
part of a future, separate rulemaking effort.
---------------------------------------------------------------------------

    \168\ Shearman.
---------------------------------------------------------------------------

(h) Standardized Pricing
    One commenter suggested FINRA should suggest standardized sources
for pricing and a calculation methodology for the TBA market.\169\ In
response, though FINRA agrees that market transparency is important,
FINRA does not propose at this time to suggest or mandate sources for
valuation, as this currently is a market function. FINRA notes that the
FINRA Web site makes available extensive TRACE data and other market
data for use by the public.\170\
---------------------------------------------------------------------------

    \169\ BB&T.
    \170\ See for instance bond data available on the FINRA Web site
at: <http://finra-markets.morningstar.com/BondCenter/Default.jsp>.
---------------------------------------------------------------------------

(i) MSFTA
    One commenter sought clarification as to whether FINRA would
require a member to have an executed MSFTA in place prior to engaging
in any Covered Agency Transactions.\171\ In response, FINRA does not
propose to mandate the use of MSFTAs. FINRA notes, however, that
members are obligated under, among other things, the books and records
rules to maintain and preserve proper records as to their trading.
---------------------------------------------------------------------------

    \171\ Vining Sparks.
---------------------------------------------------------------------------

(j) Implementation
    Commenters suggested implementation periods ranging from six to 24
months for the proposed rule change once adopted.\172\ In response,
FINRA supports in general the suggestion of an implementation period
that permits members adequate time to prepare for the rule change and
welcomes further comment on this issue.\173\
---------------------------------------------------------------------------

    \172\ AII, BB&T, Credit Suisse, FIF, ICI and Pershing.
    \173\ FINRA understands that firms that are following the TMPG
recommendations have been doing so since the recommendations took
effect in December 2013.
---------------------------------------------------------------------------

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2015-036 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-FINRA-2015-036. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-FINRA-2015-036 and should be
submitted on or before November 10, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\174\
---------------------------------------------------------------------------

    \174\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-26518 Filed 10-19-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 147 (Thursday, July 31, 2014)]
[Rules and Regulations]
[Pages 44286-44288]
[FR Doc No: 2014-18079]

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

Coast Guard

33 CFR Part 117

[Docket No. USCG-2013-0319]
RIN 1625-AA09

Drawbridge Operation Regulation; Gulf Intracoastal Waterway,
Treasure Island, FL

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is modifying the operating schedule that
governs the Treasure Island Causeway Bridge, mile 119.0, Treasure
Island, Florida. Changing the schedule from on signal to three times an
hour during the week and twice an hour on the weekends will reduce
vehicle traffic issues caused by the bridge openings while providing
for the reasonable needs of navigation.

DATES: This rule is effective September 2, 2014.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2013-0319]. To view documents mentioned in this preamble as being
available in the docket, go to 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 rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 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 email, Mr. Gene Stratton, Chief Operations Section, Seventh
Coast Guard District Bridge Branch at<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Cheryl Collins, Program Manager, Docket Operations, telephone 202-
366-9826.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
Sec.  Section Symbol

A. Regulatory History and Information

    On November 13, 2013, we published a notice of proposed rulemaking
(NPRM) entitled, ``Drawbridge Operation Regulation; Gulf Intracoastal
Waterway, Treasure Island, FL'' in the Federal Register (78 FR 67999).
We received no comments on the proposed rule. No public meeting was
requested, and none was held.

B. Basis and Purpose

    The Treasure Island Causeway Bridge crosses the Gulf Intracoastal
Waterway at mile 119.0, Treasure Island, Pinellas County, Florida. This
change would reduce the vehicle traffic back-ups caused by the opening
of the bridge while providing for the reasonable needs of navigation.
    The Treasure Island Bridge is a double-leaf bascule bridge that
provides a vertical clearance of 21 feet in the closed position.
    The City of Treasure Island requested a change to the Treasure
Island Causeway Bridge regulation due to an increase in vehicle traffic
in this area. Based on the bridge logs, this bridge opens on average
less than twice an hour on signal. Fewer scheduled openings at regular
intervals between 7

a.m. and 7 p.m. would reduce the vehicle traffic back-ups caused by the
opening of the bridge.

C. Discussion of Comments and Changes

    The Coast Guard provided a comment period of 90 days and no
comments were received. No changes have been made to the proposed rule.

D. Discussion of Final Rule

    The current operating regulation governing the Treasure Island
Causeway Bridge at 33 CFR 117.267(g) was for the old bridge which
required the bridge to open four times per hour on the quarters between
7 a.m. and 7 p.m. and to open on signal if at least ten minutes advance
notice was given between 11 p.m. and 7 a.m. However, since the old
bridge was replaced, the new bridge has been operating under 33 CFR
117.5 which requires the bride to open on signal. This final rule
allows the bridge to open three times an hour during the week and twice
an hour on the weekends which will reduce vehicle traffic congestion
through this area by requiring less frequent openings. The Coast Guard
does not anticipate longer bridge opening periods due to an
accumulation of vessels, since the bridge currently opens less than
twice an hour on average.

E. Regulatory Analyses

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

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Order 12866 or under
section 1 of Executive Order 13563. The Office of Management and Budget
has not reviewed it under those Orders.
    This action will have a minor impact on vessels transiting the Gulf
Intracoastal Waterway in the vicinity of Treasure Island, Florida as
vessels will still be able to transit the bridge on specific intervals
and this action will still meet the reasonable needs of navigation.
This action is designed to improve vehicle traffic flow in downtown
Treasure Island.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rule. 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 action will not have a significant economic impact on a
substantial number of small entities for the following reasons: This
bridge generally does not open but two to three times an hour on a
regular basis. Placing a regulation on this bridge, reducing these
openings, will not unreasonably disrupt vessels transiting the Gulf
Intracoastal Waterway in this area.

3. 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).

4. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it does not have implications for federalism.

5. Protest Activities

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

6. Unfunded Mandates Reform Act

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

7. Taking of Private Property

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

8. 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.

9. 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 might
disproportionately affect children.

10. 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.

11. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

12. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

13. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guides the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
that this action is one of a category of actions that do not
individually or cumulatively have a

significant effect on the human environment. This rule involves
changing the open on demand bridge operating schedule to three times an
hour Monday through Friday and twice an hour on Saturday, Sunday and
Federal holidays and will meet the reasonable needs of navigation. This
rule is categorically excluded, under figure 2-1, paragraph (32)(e), of
the Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule.

List of Subjects in 33 CFR Part 117

    Bridges.

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

PART 117--DRAWBRIDGE OPERATION REGULATIONS

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

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

0
2. In Sec.  117.287, revise paragraph (g) to read as follows:

Sec.  117.287  Gulf Intracoastal Waterway.

* * * * *
    (g) The draw of the Treasure Island Causeway bridge, mile 119.0
shall open on signal except that from 7 a.m. to 7 p.m. the draw need
open on the hour, 20 minutes after the hour and 40 minutes after the
hour Monday through Friday and on the quarter hour and three quarter
hour on Saturday, Sunday and Federal holidays.
* * * * *

    Dated: June 18, 2014.
J. H. Korn,
Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard
District.
[FR Doc. 2014-18079 Filed 7-30-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)]
[Notices]
[Pages 28220-28221]
[FR Doc No: 2017-12796]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2017-0040]

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System

    Under part 235 of Title 49 of the Code of Federal Regulations and
49 U.S.C. 20502(a), this document provides the public notice that on
April 24, 2017, the National Railroad Passenger Corporation (Amtrak)
petitioned the Federal Railroad Administration (FRA) seeking approval
for the discontinuance or modification of a signal system. FRA assigned
the petition Docket Number FRA-2017-0040.
    Applicant: National Railroad Passenger Corporation, Mr. Nicholas J.
Croce III, PE, Deputy Chief Engineer C&S, Acting, 2995 Market Street,
Philadelphia, PA 19104.
    Amtrak seeks to remove the wayside automatic signals' Numbers 532-
2, 532-3, 533-2 and 533-3, milepost (MP) 53.3, and automatic signals'
Numbers 552-2, 552-3, 553-2 and 553-3, MP 55.2, between interlockings
Prince and Bacon, on Amtrak's Northeast Corridor, Mid-Atlantic
Division, Perryville, MD.
    The reason for removal of the signals is that Amtrak is installing
new clear block signals at Prince and Bacon interlockings to establish
Northeast Operating Rules Advisory Committee Rule 562 territory, cab
signals without fixed automatic block signals, on Amtrak's Northeast
Corridor, Mid-Atlantic Division, Main Line Philadelphia to Washington.
With the proposed addition of the clear block signals at Prince and
Bacon the automatic block signals are not necessary and require
additional maintenance. The changes proposed are to remove the wayside
signals on both Track No. 2 and No. 3 at automatic block points 553 and
552. Both locations will remain in service as block points without
wayside signals.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    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 parties
desire 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 by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by August 4, 2017 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), 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/privacyNotice for the
privacy notice of regulations.gov.

Robert C. Lauby,
Associate Administrator for Railroad Safety Chief Safety Officer.
[FR Doc. 2017-12796 Filed 6-19-17; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register: May 21, 2009 (Volume 74, Number 97)]
[Notices]
[Page 23849-23850]
[DOCID:fr21my09-30]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13334-000]

FFP Project 31, LLC; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comment, Motions To Intervene, and
Competing Applications

May 14, 2009.
    On November 24, 2008, FFP Project 31, LLC filed an application,
pursuant to section 4(f) of the Federal Power Act, proposing to study
the feasibility of the Mississippi River Lock and Dam No. 3 Water Power
Project (Lock & Dam 3 Project), to be located at River Mile 796.9 on
the Mississippi River in Goodhue County, Minnesota, and Pierce County,
Wisconsin, six miles north of Red Wing, Minnesota.
    The proposed Lock & Dam 3 Project would be integral with: (1) The
existing

U.S. Army Corps of Engineers Lock & Dam No. 3 comprised of a 365-foot-
long gated dam section and a 600-foot-long lock; and (2) an existing
8.3-mile long reservoir with a normal pool elevation of 675 feet mean
sea level and 31,200 acre-feet of storage.
    The proposed project would consist of: (1) 20 Very Low Head (VHL)
generating units and 60 hydrokinetic generating units with a total
installed capacity of 11.0 megawatts (MW); (2) a new 69-kilovolt
transmission line connected to an existing above ground local
distribution system; and (3) appurtenant facilities. The project would
have an estimated average annual generation of 56,300 megawatt-hours.
    Applicant Contact: Mr. Daniel R. Irvin, Free Flow Power
Corporation, 33 Commercial Street, Gloucester, MA 01930, phone (978)
252-7631.
    FERC Contact: Patrick Murphy,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of Commission's Web site at http://
www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
13334) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-11799 Filed 5-20-09; 8:45 am]

BILLING CODE 6717-01-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

Issued by the Department of Transportation on October 13, 2005

NOTICE OF ACTION TAKEN -- DOCKET OST-2003-15123

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).

Applicant:  LONDON AIR SERVICES LIMITED				 Date Filed:  August 22, 2005

Relief requested:  Renewal of exemption from 49 USC § 41301 to permit
the applicant to conduct passenger and cargo charter operations between:
1) Canada and the United States; 2) third countries and the United
States, via Canada, that make a stopover in Canada for at least two
consecutive nights; and 3) other charters to/from the United States in
accordance with 14 CFR Part 212.  The applicant requests that the
authority be granted for a two-year term.

If renewal, date and citation of last action:  September 7, 2004, in
this Docket.

Applicant representative:  Victor H. Smith,<PHONE_NUMBER>         DOT
analyst:  Robert J. Finamore,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved, in part, remainder dismissed.  (See below).
   Action date:  October 13, 2005

Effective dates of authority granted:  October 13, 2005, through,
October 13, 2006.

Basis for approval (bilateral agreement/reciprocity):  United
States-Canada Air Transport Agreement (“Agreement”).

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations of our standard exemption conditions
(attached).

Special conditions/Remarks:  In the conduct of these operations, the
carrier must adhere to all applicable provisions of

the U.S.-Canada Agreement, and may only use aircraft designed to have a
maximum passenger capacity of not more

than 60 seats or a maximum payload capacity of not more than 18,000
pounds.  Moreover, under this authority the

carrier may conduct charter operations between: 1) Canada and the United
States; and 2) third countries and the

United States, via Canada, with a stopover in Canada for at least two
consecutive nights.  Other charters to be

conducted under this authority, however, are subject to prior approval
under 14 CFR Part 212.  The one-year duration of the authority we
granted is consistent with our usual policy of granting exemption
authority in the circumstances presented.  We, therefore, dismissed the
application to the extent that it sought authority for a longer period.

Action taken by:   Paul L. Gretch, Director,

	                    Office of International Aviation

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) the applicant was qualified to perform its proposed
operations; (3) grant of the authority was consistent with the public
interest; and (4) 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/deferred/dismissed, 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:

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

FOREIGN CARRIER EXEMPTION CONDITIONS
                              ATTACHMENT

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

1) Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

2) Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
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;

3) Comply with the requirements for minimum insurance coverage contained
in 14 CFR Part 205, and, prior to the commencement of any operations
under this authority, file evidence of such coverage, in the form of a
completed OST Form 6411, with the Federal Aviation Administration’s
Program Management Branch (AFS-260), Flight Standards Service (any
changes to, or termination of, insurance also shall be filed with that
office);

4) Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

5) Conform to the airworthiness and airman competency requirements of
its Government for international air services;

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

7) Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: a) based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or b) based on
a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term “international air transportation” means “international
transportation” as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

8) Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

9) Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department’s
rules governing charters (including 14 CFR Parts 212 and 380); and

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

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

 05/2004


[Federal Register Volume 86, Number 204 (Tuesday, October 26, 2021)]
[Rules and Regulations]
[Pages 59031-59033]
[FR Doc No: 2021-23333]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0811]
RIN 1625-AA00

Safety Zone; Ohio River, Friendly, WV

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters of the Ohio River from mile marker 145-151 for safety
concerns regarding an unknown, possibly explosive device found on a
barge. The safety zone is needed to protect personnel, vessels, and the
marine environment from potential hazards associated with the reported
device. Entry of vessels or persons into this zone is prohibited unless
specifically authorized by the Captain of the Port Ohio Valley.

DATES: This rule is effective without actual notice from October 26,
2021, through October 28, 2021. For purposes of enforcement, actual
notice will be used from October 21, 2021, until October 26, 2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2021-0811 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email MST3 Wesley Cornelius, MSU Huntington, U.S. Coast Guard;
304-733-0198, [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary 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 the reported device requires
immediate action to respond to the potential safety hazards. It is
impracticable and contrary to the public interest to publish an NPRM
because we must establish this safety zone by October 21, 2021.
    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. Delaying the effective date of
this rule would be impracticable and contrary to public interest
because it would create significant safety hazards to the public.
Immediate action is needed to respond to the potential safety hazards
associated with the reported device.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Ohio Valley
(COTP) has determined that potential hazards associated with the
unknown, possibly explosive device reported October 21, 2021, will be a
safety concern for anyone on the Ohio River from mile marker 145 to
mile marker 151. This rule is needed to protect personnel, vessels, and
the marine environment in the navigable waters within the safety zone
while emergency responders and law enforcement officers assess the
device.

IV. Discussion of the Rule

    This rule establishes a safety zone from October 21, 2021 through
October 28, 2021. The safety zone will cover all navigable waters on
the Ohio River from mile marker 145 to mile marker 151. The duration of
the zone is intended to protect personnel, vessels, and the marine
environment in these navigable waters for the duration of emergency
response and law enforcement operations. No vessel or person will be
permitted to enter the safety zone

without obtaining permission from the COTP or a designated
representative. If the need for the zone ends before October 28, the
COTP will use a broadcast notice to mariners to inform the public that
the zone is terminated.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the limited size
and duration of the zone, and potential impact to the safety of
mariners and waterway users on the Ohio River between mile marker 145
and mile marker 151.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, the economic impact on any vessel owner or operator will be
limited by the temporary duration of the zone.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 01, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule a safety zone
lasting seven days that will prohibit vessel operations on the Ohio
River from mile marker 145 through mile marker 151. It is categorically
excluded from further review under paragraph L[60c] of Appendix A,
Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T08-0811 to read as follows:

Sec.  165.T08-0811   Safety Zone; Ohio River, Friendly, WV.

    (a) Location. The following area is a safety zone: all navigable
waters of the Ohio River from mile marker 145 to mile marker 151.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a
Federal, State, and local officer

designated by or assisting the Captain of the Port Ohio Valley (COTP)
in the enforcement of the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by<PHONE_NUMBER>. Those in the safety zone must comply
with all lawful orders or directions given to them by the COTP or the
COTP's designated representative.

    Dated: October 21, 2021.
A.M. Beach,
Captain, U.S. Coast Guard, Captain of the Port Ohio Valley.
[FR Doc. 2021-23333 Filed 10-25-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: March 6, 2009 (Volume 74, Number 43)]
[Notices]
[Page 9820-9822]
[DOCID:fr06mr09-43]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0097]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Request for Samples and Protocols

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,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements relating to the regulations which state that protocols for
samples of biological products must be submitted to the agency.

DATES: Submit written or electronic comments on the collection of
information by May 5, 2009.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

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, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (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.

Request for Samples and Protocols (OMB Control Number 0910-0206)--
Extension

    Under section 351 of the Public Health Service Act (42 U.S.C. 262),
FDA has the responsibility to issue regulations that prescribe
standards designed to ensure the safety, purity, and potency of
biological products and to ensure that the biologics licenses for such
products are only issued when a product meets the prescribed standards.
Under Sec.  610.2 (21 CFR 610.2), the Center for Biologics Evaluation
and Research (CBER) or the Center for Drug Evaluation and Research may
at any time require manufacturers of licensed biological products to
submit to FDA samples of any lot along with the protocols showing the
results of applicable tests prior to distributing the lot of the
product. In addition to Sec.  610.2, there are other regulations that
require the submission of samples and protocols for specific licensed
biological products: Sec. Sec.  660.6 (21 CFR 660.6) (Antibody to
Hepatitis B Surface Antigen); 660.36 (21 CFR 660.36) (Reagent Red Blood
Cells); and 660.46 (21 CFR 660.46) (Hepatitis B Surface Antigen).
    Section 660.6(a) provides requirements for the frequency of
submission of samples from each lot of Antibody to Hepatitis B Surface
Antigen product, and Sec.  660.6(b) provides the requirements for the
submission of a protocol containing specific information along with
each required sample. For Sec.  660.6 products subject to official
release by FDA, one sample from each filling of each lot is required to
be submitted along with a protocol consisting of a summary of the
history of manufacture of the product, including all results of each
test for which test results are requested by CBER. After official
release is no longer required, one sample along with a protocol is
required to be submitted at 90-day intervals. In addition, samples,
which must be accompanied by a protocol, may at any time be required to
be submitted to CBER if continued evaluation is deemed necessary.
    Section 660.36(a) requires, after each routine establishment
inspection by FDA, the submission of samples from a lot of final
Reagent Red Blood Cell product along with a protocol containing
specific information. Section 660.36(a)(2) requires that a protocol
contain information including, but not limited to, manufacturing
records, certain test records, and identity test results. Section
660.36(b) requires a copy of the antigenic constitution matrix
specifying the antigens present or absent to be submitted to the CBER
Director at the time of initial distribution of each lot.
    Section 660.46(a) contains requirements as to the frequency of
submission of samples from each lot of Hepatitis B Surface Antigen
product, and Sec.  660.46(b) contains the requirements as to the
submission of a protocol containing specific information along with
each required sample. For Sec.  660.46 products subject to official
release by FDA, one sample from each filling of each lot is required to
be submitted along with a protocol consisting of a summary of the
history of manufacture of the product, including all results of each
test for which test results are requested by CBER. After notification
of official release is received, one sample along with a protocol is
required to be submitted at 90-day intervals. In addition, samples,
which must be accompanied by a protocol, may at any time be required to
be submitted to CBER if continued evaluation is deemed necessary.
    Samples and protocols are required by FDA to help ensure the
safety, purity, or potency of a product because of the potential lot-
to-lot variability of a product produced from living organisms. In
cases of certain biological products (e.g., Albumin, Plasma Protein
Fraction, and therapeutic biological products) that are known to have
lot-to-lot consistency, official lot release is not normally required.
However, submissions of samples and protocols of these products may
still be required for surveillance, licensing, and export purposes, or
in the event that FDA obtains information that the manufacturing
process may not result in consistent quality of the product.
    The following burden estimate is for the protocols required to be
submitted with each sample. The collection of samples is not a
collection of information under 5 CFR 1320.3(h)(2). Respondents to the
collection of information under Sec.  610.2 are manufacturers of
licensed biological products. Respondents to the collection of
information under Sec. Sec.  660.6(b), 660.36(a)(2) and (b), and
660.46(b) are manufacturers of the specific products referenced
previously in this document. The estimated number of respondents for
each regulation is based on the annual number of manufacturers that
submitted samples and protocols for biological products including
submissions for lot release, surveillance, licensing, or export. Based
on information obtained from FDA's database system, approximately 69
manufacturers submitted samples and protocols in fiscal year (FY) 2008,
under the regulations cited previously in this document. FDA estimates
that approximately 65 manufacturers submitted protocols under Sec.
610.2 and 3 manufacturers submitted protocols under the regulations
(Sec. Sec.  660.6 and 660.46) for the other specific products.

FDA received no submissions under Sec.  660.36, however FDA is using
the estimate of one protocol submission in the event one is submitted
in the future.
    The estimated total annual responses are based on FDA's final
actions completed in FY 2008, which totaled 6,314, for the various
submission requirements of samples and protocols for the licensed
biological products. The rate of final actions is not expected to
change significantly in the next few years. The hours per response are
based on information provided by industry. The burden estimates
provided by industry ranged from 1 to 5.5 hours. Under Sec.  610.2, the
hours per response are based on the average of these estimates and
rounded to 3 hours. Under the remaining regulations, the hours per
response are based on the higher end of the estimate (rounded to 5 or 6
hours) since more information is generally required to be submitted in
the other protocols than under Sec.  610.2.
    FDA estimates the burden of this information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
610.2                             65               95.5              6,208                  3             18,624
----------------------------------------------------------------------------------------------------------------
660.6(b)                           2                 44                 88                  5                440
----------------------------------------------------------------------------------------------------------------
660.36(a)(2) and                   1                  1                  1                  6                  6
 (b)
----------------------------------------------------------------------------------------------------------------
660.46(b)                          1                 17                 17                  5                 85
----------------------------------------------------------------------------------------------------------------
Total                             69  .................              6,314  .................             19,155
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: February 24, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4750 Filed 3-5-09; 8:45 am]

BILLING CODE 4160-01-S


AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

August 16-17, 2007

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ-OPP-2007-0388

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202

Assessing Approaches for the Development of PBPK Models of Pyrethroid
Pesticides

Thursday, August 16, 2007

  8:30 A.M.	Introduction and Identification of Panel Members –

		Steven G. Heeringa, Ph.D. (FIFRA SAP Chair)

  8:40 A.M.	Administrative Procedures by Designated Federal Official –

		Steven Knott, Office of Science Coordination and Policy, EPA

  8:45 A.M.	Welcome and Opening Remarks – Tina Levine, Ph.D.,
Director, Health Effects Division, Office of Pesticide Programs, EPA

  8:50 A.M.	Introduction – Anna Lowit, Ph.D., Health Effects Division,
Office of Pesticide Programs, Health Effects Division, EPA

  9:10 A.M.	Disposition and Dose Metrics of Pyrethroid Pesticides –
Michael F. Hughes, Ph.D., D.A.B.T., National Health and Environmental
Effects Research Laboratory, Office of Research and Development, EPA

  9:35 A.M.	In Vitro Metabolism of Pyrethroids in Rats and Humans –
Edward Scollon, Ph.D., National Health and Environmental Effects
Research Laboratory, Office of Research and Development, EPA

10:00 A.M.	Physiologically-Based Pharmacokinetic Modeling Approaches:
Pyrethroid Pesticides – Rogelio Tornero-Velez, Ph.D., National
Exposure Research Laboratory, Office of Research and Development,  EPA

10:30 A.M.	Statistical Analysis of Pyrethroid PBPK Models – R. Woodrow
Setzer, Ph.D., National Center for Computational Toxicology, Office of
Research and Development, EPA

10:40 A.M.	Break

10:55 A.M.	Public Comments

12:00 P.M.	Lunch

  1:15 P.M.	Charge to Panel:

Question 1:

The Agency’s issue paper describes different aspects of the
pharmacokinetic (PK) properties of pyrethroid pesticides. The Agency
believes that the important PK properties relevant for PBPK modeling are
common among all or most members of this class, such that a
‘generic’ or family model structure with chemical specific
adjustments, as needed, can be used.

Please comment on the evidence which does and does not support the
concept of using a generic model structure for the pyrethroid
pesticides.

3:00 P.M.	Break

3:15 P.M.	Charge to Panel:

Question 2:

In the development of PBPK models in vivo and in vitro data are acquired
and used to calibrate and optimize the model. The predictions of the
PBPK model are then evaluated against additional in vivo data sets. In
the case of pyrethroids, there are limited human data available to
calibrate and assess the human PBPK models. The Agency plans to develop
a family modeling approach to address this issue. This approach assumes
that because pyrethroids share many physical chemical and biological
properties, a common model structure can be used for all pyrethroids.
The family model approach allows for the assessment of the overall model
structure with each iteration. The more iterations through this process,
the more confidence is gained in the model’s predictive abilities.
Thus, the rat deltamethrin model is not only assessed by data from
deltamethrin, but is assessed by model fits to data for every other
pyrethroid. As our confidence in the rodent family model increases
across pyrethroids, our confidence in the use of this modeling approach
for rodent to human extrapolation also increases. The Agency is planning
to develop equivalent rodent and human in vitro databases for metabolic
and physiological parameters. The rodent in vitro parameters will be
assessed by comparing model predictions to in vivo data. It is likely
that scaling factors will be used in order to incorporate these in vitro
parameters into the rodent model. When calibrating the human data, the
scaling factors used in the rodent models will be used in the human
models.

Please comment on this approach and other approaches that could be taken
to calibrate and assess these models for use in human risk assessment.

5:00 P.M. 	Adjournment

AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

August 16-17, 2007

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ-OPP-2007-0388

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202

Assessing Approaches for the Development of PBPK Models of Pyrethroid
Pesticides

Friday, August 17, 2007

8:30 A.M.	Introduction and Identification of Panel Members -

		Steven G. Heeringa, Ph.D. (FIFRA SAP Chair)

8:40 A.M.	Administrative Procedures by Designated Federal Official -

		Steven Knott, Office of Science Coordination and Policy, EPA

8:45 A.M.	Follow-up from Previous Day’s Discussion

9:00 A.M.	Charge to Panel:

Question 3:

The Agency’s issue paper and data provided in Appendix C show that
blood and brain concentrations of parent compound in the rat correlate
with pyrethroid toxicity as measured by motor activity. At the present
time, the Agency plans to evaluate additional metrics (e.g., area under
the curve) with additional pyrethroids. Moreover, the Agency plans to
test other behavioral measures (e.g., startle response).

Please comment on the available database to assess the dose metric for
pyrethroids. Please also comment on what additional experiments, if any,
that could further inform the dose metric.

10:15 A.M.	Break

10:30 A.M.	Charge to Panel – Question 3 continued

11:00 A.M.	Charge to Panel:

Question 4:

Pyrethroids may have one or more chiral centers resulting in potentially
multiple stereoisomers. Some products, such as deltamethrin, are
relatively pure single stereoisomers. Others such as cypermethrin may
contain as many as eight stereoisomers. There is limited information on
the toxicity and pharmacokinetics of the different stereoisomers. The
Agency is proposing to evaluate three modeling assumptions. The first
approach combines all stereoisomers as one chemical. The second approach
includes modeling all the diastereomers and ignores the enantiomers; the
third approach includes only the toxic stereoisomers. To evaluate these
approaches, the Agency is using permethrin as a model chemical.

Please comment on these three approaches. Are there additional modeling
assumptions or approaches that the Agency should consider or that could
simplify the modeling?

12:00 P.M.	Lunch

  1:15 P.M.	Charge to Panel – Question 4 continued

  2:00 P.M.	Adjournment

Please be advised that agenda times are approximate; when the discussion
for one topic is completed, discussions for the next topic will begin.
For further information, please contact the Designated Federal Official
for this meeting, Mr. Steven Knott, via telephone:<PHONE_NUMBER>; fax:
<PHONE_NUMBER>; or email<EMAIL_ADDRESS>