[Federal Register Volume 80, Number 75 (Monday, April 20, 2015)]
[Notices]
[Pages 21790-21792]
[FR Doc No: 2015-08940]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74724; File No. SR-BX-2015-017]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by NASDAQ OMX BX, Inc. Relating
to Member Application

April 14, 2015.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 8, 2015, NASDAQ OMX BX, Inc. (``BX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I, II, and III, below,
which Items have been prepared by the Exchange. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    BX proposes to amend Rule 1013 titled ``New Member Application'' to
include an expedited application process for firms that are already
approved members of NASDAQ OMX PHLX LLC (``PHLX'').
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxbx.cchwallstreet.com, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of

the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to amend BX Rule
1013(a)(5), entitled Applicants That Are Members of an Association or
Another Exchange, to permit an expedited review for new member
applications seeking BX membership provided those applicants are
approved members of PHLX.
    Specifically, Exchange Rule 1013(a)(5)(C) currently permits the
Exchange to accept applicants that gained membership at Financial
Industry Regulatory Authority (``FINRA'') or The NASDAQ Stock Market
LLC (``NASDAQ'') when considering a BX new member application.
Applicants who are approved members of FINRA or NASDAQ are eligible for
an abbreviated waive-in application eliminating the submission and
review of duplicative supplemental material that has already been
submitted and reviewed in connection with a FINRA or NASDAQ new member
application.
    At this time, the Exchange proposes to extend the abbreviated
application process already in place for approved FINRA and/or NASDAQ
members to PHLX members. The Exchange notes that the PHLX
qualifications are the same as those applicable to BX membership
requirements. PHLX approved members seeking BX membership will be
required to submit a fully executed Waive-In Membership Application and
Membership Agreement but will not be required to submit any duplicative
documentation that was previously provided as part of the PHLX
application. These PHLX members would still be required to provide
additional information if there has been a material change in status
from its original application with PHLX. Applicants will be required to
attest that the information provided as part of previously conducted
new membership review remains complete and accurate.
    The Exchange also proposes to amend language in section (C) of this
rule to further harmonize the application with the current NASDAQ
application by updating the title of the BX membership application from
``Short Form'' to ``Waive-in'' and deleting unnecessary language that
does not appear in the corresponding NASDAQ rule. The application is
attached as Exhibit 3.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with section
6(b) of the Act \3\ in general, and furthers the objectives of section
6(b)(5) of the Act \4\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system and, in general, to protect
investors and the public interest.
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    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(5).
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    Today, the BX Membership Department performs similar functions when
reviewing new member applications for BX, NASDAQ and PHLX.\5\ The
Membership Department reviews: Applicant business plans, clearing
arrangements, FOCUS reports, organizational charts, and written
supervisory procedures for applicants desiring membership in any of the
aforementioned markets. These membership requirements include, but are
not limited to, review of registration as a Broker Dealer with the
Commission, a net capital review, qualification of associated persons
and examining written supervisory procedures. The same material is
considered for each new member review conducted by FINRA on behalf of
BX.
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    \5\ Today, FINRA conducts the new member application reviews for
NASDAQ and BX pursuant to a 17d-2 and Regulatory Services Agreement.
These application reviews are administered by FINRA and subject to
BX's final review and decision. PHLX maintains a separate new member
application review that is conducted by NASDAQ and not FINRA.
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    This proposed amendment is consistent with its current practices
today when reviewing applications for members of NASDAQ and FINRA. BX
proposes this rule change to harmonize its affiliated exchanges' rules
to provide applicants similar application procedures for each of its
markets. The PHLX new member review process is consistent with the BX
new member review process. Applicants that are members of PHLX should
be eligible for the waive-in process when seeking membership on BX
similar to current waive-in opportunities available today for NASDAQ
and FINRA members.
    The proposed rule change would eliminate the duplicate review for
prospective BX applicants that were approved for membership by PHLX.
The waive-in process will promote efficiency with respect to the
Exchange's membership review process and reduce the burden on
applicants that have already been approved for membership on PHLX by
reducing the duplicative information and documentation required to be
provided to the Exchange for these members. As a result, Exchange staff
will be able to focus its regulatory efforts on reviewing any material
changes or new information that may affect the applicant's eligibility
for Exchange membership.
    This proposed rule change does not affect the protection of
investors as BX will maintain the vigorous membership review that is
conducted today when reviewing PHLX member applications.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed waive-in process
for approved PHLX members will not impose any burden on competition,
but rather it will remove unnecessary burdens that currently exist for
PHLX member applicants seeking BX membership. The proposal will
eliminate the redundant review process for PHLX members that currently
does not exist for FINRA and NASDAQ members applying to become BX
members.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not significantly
affect the protection of investors or the public interest; does not
impose any significant burden on competition; and by its terms does not
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to section 19(b)(3)(A) \6\ of the Act and Rule 19b-
4(f)(6) thereunder.\7\
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    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f)(6).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: Necessary
or appropriate in the public interest; for the protection of

investors; or otherwise in furtherance of the purposes of the Act. If
the Commission takes such action, the Commission shall institute
proceedings to determine whether the proposed rule should be approved
or 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-BX-2015-017 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2015-017. 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
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. 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-BX-2015-017 and should be
submitted on or before May 11, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2015-08940 Filed 4-17-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 102 (Friday, May 25, 2012)]
[Rules and Regulations]
[Pages 31186-31188]
[FR Doc No: 2012-12671]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2012-0333]
RIN 1625-AA87

Security Zone; USS MISSISSIPPI Commissioning; Pascagoula Harbor &
Pascagoula River; Pascagoula, MS

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary security zone for
the arrival, commissioning, and departure of the USS MISSISSIPPI. This
security zone is necessary to protect persons, vessels, and waterfront
facilities from destruction, loss, or injury from sabotage or other
subversive acts, accidents, or other causes of a similar nature during
the arrival, commissioning, and departure of the USS MISSISSIPPI. Entry
into this zone is prohibited to all vessels, mariners, and persons
unless specifically authorized by the Captain of the Port (COTP) Mobile
or a designated representative.

DATES: This rule is effective from May 23, 2012 to June 8, 2012.

ADDRESSES: Documents mentioned in this preamble are part of docket
USCG-2012-0333. 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
temporary rule, call or email LT Lenell J. Carson, Sector Mobile,
Waterways Division, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. 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 there is insufficient time to publish
a NPRM. Following a planning meeting on March 29, 2012 between the U.S
Navy, U.S Coast Guard, local agencies, and port stakeholders, the Coast
Guard determined that a temporary security zone is necessary during the
arrival, commissioning ceremony (to be held on June 2, 2012), and
departure of the USS MISSISSIPPI. Publishing a NPRM and delaying this
rule's effective date would be impracticable because it would
unnecessarily delay the USS MISSISSIPPI's schedule and commitments.
Delaying or foregoing this necessary security zone would also be
contrary to public interest. This is a scheduled public event
surrounding the commissioning of a U.S. Naval vessel and immediate
action is necessary to implement additional security measure to protect
persons, vessels, and waterfront facilities from destruction, loss, or
injury from sabotage or other subversive acts, accidents, or other
causes of a similar nature.
    For the same reasons, 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 because immediate
action is needed to protect persons, vessels, and waterfront facilities
from destruction, loss, or injury from sabotage or other subversive
acts, accidents, or other causes of a similar nature during the
arrival, commissioning, and departure of the USS MISSISSIPPI.

B. Basis and Purpose

    The USS MISSISSIPPI will be commissioned at the Port of Pascagoula,
Pascagoula, MS on June 2, 2012. Scheduled events surround the
commissioning ceremony will draw large crowds in or near the port.
Additional security measures are necessary to protect persons, vessels,
and waterfront facilities from destruction, loss, or injury from
sabotage or other subversive acts, accidents, or other causes of a
similar nature during the arrival, commissioning, and departure of the
USS MISSISSIPPI.
    The COTP anticipates some impact on vessel traffic due to this
regulation. However, this security zone is deemed necessary for the
protection of life and property within the COTP Mobile zone.

C. Discussion of the Final Rule

    The Coast Guard is establishing a temporary security zone for the
arrival, commissioning, and departure of the USS MISSISSIPPI. While the
USS MISSISSIPPI is underway in the Pascagoula Harbor shoreward of the
Horn Island Pass Lighted Buoy HI (RW ``HI'' Mo (A); Position 30-08-
30.049 N, 088-38-40.125 W), the temporary security zone includes all
waters within 100 yards of the USS MISSISSIPPI. When the USS
MISSISSIPPI is moored in the Port of Pascagoula, the temporary security
zone includes all waters within 25 yards of the USS MISSISSIPPI. Entry
into these zones is prohibited to all vessels, mariners, and persons
unless specifically authorized by the COTP Mobile or a designated
representative. The COTP may be contacted by telephone at<PHONE_NUMBER>.
    The COTP Mobile or a designated representative will inform the
public through broadcast notice to mariners of changes in the effective
period for the security zone. This rule is effective from May 23, 2012
to June 8, 2012.

D. 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 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 Executive Order 12866

or under section 1 of Executive Order 13563. The Office of Management
and Budget has not reviewed it under that Order.
    The security zone listed in this rule will only restrict vessel
traffic from transiting a small portion of the Pascagoula Harbor and
Pascagoula River while the USS MISSISSIPPI is transiting through the
harbor and when moored in the Port of Pascagoula. The effect of this
regulation will not be significant for several reasons: (1) This rule
will only affect vessel traffic for a short duration; (2) vessels may
request permission from the COTP to transit through the security zone;
and (3) the impacts on routine navigation are expected to be minimal.
Notifications to the marine community will be made through the Local
Notices to Mariners and via Safety Broadcast Notices to Mariners. These
notifications will allow the public to plan operations around the
affected areas.

2. 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 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 rule will affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to transit
or anchor in the affected areas during the arrival, commissioning, and
departure of the USS MISSISSIPPI. This security zone will not have a
significant economic impact on a substantial number of small entities
for the following reasons. The zone is limited in size, is of short
duration, and traffic will be allowed to pass through the zone with the
permission of the COTP.

3. Assistance for Small Entities

    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
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    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.

4. 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).

5. 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.

6. 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.

7. 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 expenditure, we do discuss the effects of this rule elsewhere in
this preamble.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. Technical Standards

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

14. 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 determined
that 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 involves security during the arrival,
commissioning, and departure of the USS MISSISSIPPI and is not expected
to result in any significant adverse environmental impact as described
in NEPA. This rule is categorically excluded from further review under
paragraph (34)(g) of Figure 2-1 of the Commandant Instruction. An
environmental analysis checklist supporting this determination and a
categorical exclusion determination will be made available in the
docket where indicated under ADDRESSES. We seek any comments or
information that may

lead to the discovery of a significant environmental impact from this
rule.

List of Subjects 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: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-
295, 116 Stat. 2064; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T08-0333 to read as follows:

Sec.  165.T08-0333  Security Zone; Pascagoula Harbor & Pascagoula
River, Pascagoula, MS.

    (a) Location. The following areas are temporary security zones: all
waters of the Pascagoula Harbor and Pascagoula River--
    (1) Within 100 yards of the USS MISSISSIPPI while underway
shoreward of the Horn Island Pass Lighted Buoy HI (RW ``HI'' Mo (A);
Position 30-08-30.049 N, 088-38-40.125 W).
    (2) Within 25 yards of the USS MISSISSIPPI while moored in the Port
of Pascagoula.
    (b) Effective Dates. This rule is effective from May 23 through
June 8, 2012.
    (c) Periods of enforcement. This section will only be enforced
while the USS MISSISSIPPI is underway shoreward of the Horn Island Pass
Lighted Buoy HI (RW ``HI'' Mo (A); Position 30-08-30.049 N, 088-38-
40.125 W) and while moored in the Port of Pascagoula.
    (d) Regulations. (1) In accordance with the general regulations in
Sec.  165.33 of this part, entry into the security zones is prohibited
unless authorized by the Captain of the Port (COTP) Mobile or a
designated representative.
    (2) Persons or vessels desiring to enter into or passage through
the security zones must request permission from the COTP Mobile or a
designated representative. They may be contacted on VHF-FM channels 16
or by telephone at<PHONE_NUMBER>.
    (3) If permission is granted, all persons and vessels shall comply
with the instructions of the COTP Mobile or designated representative.
    (e) Informational Broadcasts. The COTP Mobile or a designated
representative will inform the public through broadcast notices to
mariners of the enforcement period for the security zones as well as
any changes in the planned schedule.

    Dated: April 30, 2012.
D. J. Rose,
Captain, U.S. Coast Guard, Captain of the Port Mobile.
[FR Doc. 2012-12671 Filed 5-24-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: April 20, 2010 (Volume 75, Number 75)]
[Rules and Regulations]
[Page 20522-20523]
[DOCID:fr20ap10-6]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

[Docket No. FDA-2010-N-0002]

New Animal Drugs; Change of Sponsor's Name and Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor's name from Minrad,
Inc. to Piramal Critical Care, Inc. The sponsor's mailing address will
also be changed.

DATES: This rule is effective April 20, 2010.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Minrad, Inc., 836 Main St., 2d floor,
Buffalo, NY 14202 has informed FDA that it has changed its name and
address to Piramal Critical Care, Inc., 3950 Schelden Circle,
Bethlehem, PA 18017. Accordingly, the agency is amending the
regulations in 21 CFR 510.600(c) to reflect this change.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because

it is a rule of ``particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 510 is
amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry
for ``Minrad, Inc.'' and alphabetically add a new entry for ``Piramal
Critical Care, Inc.''; and in the table in paragraph (c)(2), revise the
entry for ``060307'' to read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------
Piramal Critical Care, Inc., 3950 Schelden    060307
 Circle, Bethlehem, PA 18017
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------
060307.....................  Piramal Critical Care, Inc., 3950 Schelden
                              Circle, Bethlehem, PA 18017
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

    Dated: April 15, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-9045 Filed 4-19-10; 8:45 am]
BILLING CODE 4160-01-S


1 SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY STANDARDS OF PERFORMANCE FOR NSPS SUBPART O SEWAGE TREATMENT PLANT INCINERATORS 1. Identification of the Information Collection 1( a) Title of the Information Collection ICR for NSPS subpart O  Sewage Treatment Plant Incinerators 1( b) Short Characterization/ Abstract The New Source Performance Standards ( NSPS) for Sewage Treatment Plant incinerators ( Subpart O) were promulgated on February 28, 1974 ( 39FR9312) and amended in 1977 and 1988. These standards apply to each incinerator which combusts wastes containing more than 10 percent sewage sludge ( dry basis) produced by municipal sewage treatment plants or each incinerator which charges more than 1000 kg ( 2205 lb) per day municipal sewage sludge ( dry basis) and which commenced construction or modification after June 11, 1973.

Particulate matter ( PM) is the pollutant regulated under this Subpart. The standard sets an emission limitation for PM. This information is being collected to assure compliance with 40 CFR § 60.154( d)

Owners or operators of the facilities regulated under this Subpart must make several one time only reports and maintain records.

This includes various notifications and records from monitoring devices and facility operations. In general, these notifications,

reports and records are required of all sources subject to NSPS. 2 Any owner or operator subject to the provisions of this part shall maintain a file of these records, and retain the file for data collected by the facility for a minimum of 2 years and make available for inspection by the Administrator. Also, owners or operators of sewage treatment plants shall submit semiannual reports to the Administrator.

Approximately 147 sources are currently subject to the standard,

and it is estimated that an additional 7 sources per year will become subject to the standard in the next three years. Therefore, a annualized total of 154 ( 147+ 7) respondents are anticipated.

2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection The EPA is charged under Section 111 of the Clean Air Act, as amended, to establish standards of performance for new stationary sources that reflect:

. . . application of the best technological system of continuous emissions reduction which ( taking into consideration the cost of achieving such emissions reduction, or any nonair quality health and environmental impact and energy requirements) the Administrator determines has been adequately demonstrated [ Section 111( a)( l)].

The Agency refers to this charge as selecting the best demonstrated technology ( BDT). Section 111 also requires that the Administrator review and, if appropriate, revise such standards every four years. In addition, Section 114( a) states that: 3 . . . the Administrator may require any owner or operator subject to any requirement of this Act to ( A) establish and maintain such records, ( B) make such reports, ( C)

install, use, and maintain such monitoring equipment or methods ( in accordance with such methods at such locations, at such intervals, and in such manner as the Administrator shall prescribe), and ( D) sample such emissions, ( E) Keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical, ( F)

submit compliance certifications, and ( G) provide such other information as he may reasonably require.

In the Administrator's judgment, particulate matter emissions from sewage treatment plant incinerators cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, NSPS were promulgated for this source category at 40 CFR Part 60, Subpart 0 .

2( b) PRACTICAL UTILITY/ USERS OF THE DATA The control of emissions of particulate matter from sewage treatment plant incinerators requires not only the installation of properly designed equipment, but also the operation and maintenance of that equipment. Particulate matter emissions from sewage treatment plant incinerators are the result of the physical and chemical characteristics of the sludge feed and fuel use, the excess air rate, the temperature profile within the incinerator, the pressure drop across the control device, and operating procedures.

These standards rely on the reduction of particulate matter emissions by wet scrubbers. 4 The required notifications are used to inform the Agency or delegated authority when a source becomes subject to the standard.

The reviewing authority may then inspect the source to check if the pollution control devices are properly installed and operated.

Performance test reports are needed as these are the Agency's record of a source's initial capability to comply with the emission standard, and note the operating conditions under which compliance was achieved. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations. The information generated by the monitoring, recordkeeping and reporting requirements described in this ICR is used by the Agency to ensure that facilities affected by the NSPS continue to operate the control equipment used to achieve compliance with the NSPS. Adequate monitoring, recordkeeping, and reporting is necessary to ensure compliance with these standards, as required by the Clean Air Act.

The information collected from recordkeeping and reporting requirements is also used for targeting inspections, and is of sufficient quality to be used as evidence in court.

3. Nonduplication, Consultations, and Other Collection Criteria 3( a) Nonduplication The recordkeeping and reporting requested is required under 40 CFR Part 60 Subpart O. If the standard has not been delegated the information is sent to the appropriate EPA Regional Office.

Otherwise, the information is sent directly to the delegated State or Local Agency. If a State or Local Agency has adopted their own similar regulation to implement NSPS Subpart O, a copy of the report submitted to the State or local agency can be sent to the 5 Administrator in lieu of the report required by the Federal Standard.

Therefore, no duplication exists.

All reports are sent to the delegated State or local authority.

3( b) Public Notice Required Prior to ICR Submission to OMB An announcement of a public comment period for the renewal of this ICR was published in the Federal Register on September 15, 2000,

( 65 FR 55955). No comments were received.

3( c) Consultations No consultations were undertaken.

No comments were received on the burden published in the Federal Register.

No questions or major problems related to the record keeping requirements for 40 CFR Subpart O were raised.

3( d) Effects of Less Frequent Collection If the information required by these standards was collected less frequently, the main consequence would be that the chances of detecting poor operation and maintenance of control equipment would decrease. Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the required standards. Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met.

3( e) General Guidelines 6 None of the reporting or recordkeeping requirements contained in 40 CFR Part 60 or otherwise pertinent to this request violate any of the regulations established by OMB in 5 CFR 1320.6.

3( f) Confidentiality The required information consists of emissions data and other information that have been determined not to be private. However,

any information submitted to the agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, Chapter 1, Part 2, Subpart B

Confidentiality of Business Information ( see 40 CFR 2; 41 FR 36902,

September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3( g) Sensitive Questions None of the reporting or recordkeeping requirements contained in 40 CFR Part 60 or otherwise pertinent to this request contain sensitive questions.

4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes The respondents of the recordkeeping and reporting requirements are sewage treatment plant incinerators ( SIC Code 4952) with a charging rate of more than 0.75 lb/ ton dry sludge, which commenced construction, modification, or reconstruction after June 11, 1973.

4( b) INFORMATION REQUESTED ( I) Data Items All data in this ICR that is recorded and reported is required by 40 CFR Part 60 Subpart O.

Provide notification of:

 construction/ reconstruction ( 60.7( a)( 1)) 7  anticipated startup ( 60.7( a)( 2))

 actual startup ( 60.7( a)( 3))

 initial performance test notification ( 60.8( d))

 demonstration of continuous monitoring system ( 60.7( a)( 5))

 physical or operational change which may increase the emission rate ( 60.7( a)( 4))

 date upon which demonstration of continuous monitoring system performance commences ( 60.7( a)( 5))

Report on:

 initial performance test ( 60.8 ( a))

 excess emissions ( 60. 7( c) and 60.155)

 the owner or operator of any multiple hearth,

fluidized bed, or electric sludge incinerator report in which contains the following: scrubber pressure drop measurements, oxygen content, temperatures, rate of sludge charged, moisture and volatile solids content of the daily grab sample of sludge charged to the incinerator, and a record of control device operation measurements for other than a wet scrubber.

( 60.155 ( a), 60.155( b), and 60.155 ( c))

Record:

 startups, shutdowns, malfunctions, periods where the continuous monitoring system is inoperative ( 60.7( b))

 maintain a file of all measurements including,

performance test measurements, and all other information required by this part/ subpart recorded in a permanent file suitable for inspection.( 60.7( e)) 8  recording of daily charging rates and hours of operation ( 60.153( a)( 1))

 install, calibrate , maintain, and operate weighing device for determination of the mass of any municipal solid waste charged to the incinerator ( 60.153 ( a)( 3))

 install, calibrate, maintain and operate a monitoring device that continuously measures and records the pressure drop of gas flow through the wet scrubbing device ( 60.153( b)( 1))

 install, calibrate, maintain and operate a monitoring device that continuously measures and records the oxygen content of the incinerator exhaust gas.( 60.153( b)( 2))

 install, calibrate, maintain and operate temperature measuring devices. The temperature monitoring devices shall be operated continuously and data recorded during all periods of operation of the incinerator. ( 60.153( b)( 3))

 install, calibrate, maintain and operate a device for measuring the fuel flow to the incinerator. The fuel flow measuring device shall be operated continuously and data recorded during all periods of operation of the incinerator. ( 60.153( b)( 4))

 collect and analyze a grab sample of the sludge fed to the incinerator once per day. ( 60.153( b)( 5))

 test methods and procedures for performance tests( 60.154) 9  install, calibrate, maintain, and operate continuous monitoring system ( 60.13)

 the owner or operator of any multiple hearth,

fluidized bed, or electric sludge incinerator subject to the provisions of this subpart shall retain the following information and make it available for inspection: the measured pressure drop of the gas flow through the wet scrubbing device, a record of the measured oxygen content of the incinerator exhaust gas, record of the rate of sludge charged to the incinerator, the measured temperatures of the incinerator, the fuel flow to the incinerator, and the total solids and volatile solids content of the sludge charged to the incinerator. ( 60.153( c)( 1)

through ( 60.153( c)( 3)))

 the owner or operator of any sludge incinerator other than a multiple hearth, fluidized bed, or electric incinerator or any sludge incinerator equipped with a control device other than a wet scrubber shall submit for approval a plan for monitoring and recording incinerator and control device operation parameters.

( 60.153( e))

Records are required to be retained for 2 years. Under the standard, the data collected by the affected industry is retained at the facility for a minimum of two ( 2) years and made available for inspection by the Administrator. 10 b. Respondent Activities  Read instructions  Install, calibrate, maintain, and operate CMS for opacity, or for pressure drop and liquid supply pressure for wet scrubber  perform initial performance test, using 40 CFR 60 Appendix A Methods 5 and 9  write the notifications and reports listed above  enter information required to be recorded above.

 submit the required reports developing, acquiring,

installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying information;

 developing, acquiring, installing, and utilizing technology and systems for the purpose of processing and maintaining information;

 developing, acquiring, installing, and utilizing technology and systems for the purpose of disclosing and providing information;

 adjusting the existing ways to comply with any previously applicable instructions and requirements;

 training personnel to be able to respond to a collection of information;

 transmitting, or otherwise disclosing the information The records required by this NSPS must be retained by the owner or operator for two years.

5. The Information Collected  Agency Activities, Collection Methodology, and Information Management 11 5( a) Agency Activities EPA conducts the following activities in connection with the acquisition, analysis, storage, and distribution of the information required under 40 CFR Part 60, Subpart O:

 Observes initial performance tests  Reviews notifications and reports required to be submitted by industry  Audits facility records  Compiles data in the AIRS database 5( b) Collection Methodology and Management Following notification of startup, the reviewing authority might inspect the source to check if the pollution control devices ( wet scrubbers) are properly installed and operated. The initial performance test report is used by the Agency to discern a source's initial capability to comply with the emission standard for PM. Data obtained during periodic visits by Agency personnel from records maintained by the respondents are tabulated and published for internal Agency use in compliance and enforcement programs. The semiannual and other reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.

Information contained in the reports is entered into the Aerometric Information Retrieval System ( AIRS) Facility Subsystem ( AFS) which is operated and maintained by EPA's Office of Air Quality Planning and Standards. The AFS is EPA's database for the collection, maintenance, and retrieval of compliance and annual emission inventory data for over 100,000 industrial and governmentowned facilities. EPA uses AFS for tracking air pollution compliance 12 and enforcement by local and State regulatory agencies, EPA Regional Offices and Headquarters. EPA can edit, store, retrieve and analyze the data via PC terminals.

The records required by this NSPS must be retained by the owner or operator for ( two) years.

5( c) Small Entity Flexibility The recordkeeping and reporting requirements were selected within the context of a small collection of process equipment and reflect the burden on small businesses. To the extent that larger businesses can use economies of scale to reduce their burden, the overall burden will be reduced. However, even though the recordkeeping and reporting requirements are the same for small and larger businesses, the Agency considers these requirements the minimum needed to ensure compliance and, therefore, cannot reduce them further for small businesses.

5( d) Collection Schedule The specific frequency for each information collection activity within this request is shown on Table 2.

6. Estimating the Burden and Cost of the Collection Table 2 documents the computation of individual respondent burdens for each of the recordkeeping and reporting requirements applicable to the industry. The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Where appropriate, specific tasks and major assumptions have been identified. The Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. 13 6( a) Estimating Respondent Burden The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated at 9,089 person hours. These hours are based on Agency studies and background documents from the development of the standards or test methods, Agency knowledge and experience with the NSPS program, the previously approved ICR, and any comments received about time to prepare reports.

6( b) Estimating Respondent Costs ( i) Estimating Labor Costs This ICR uses labor rates of from the United States Department of Commerce Bureau of Labor Statistics, March 2000, Table 2:

Employment Costs for Civilian Workers by Occupational and Industry Group.

 Executive, Administrative, and Managerial $ 56.64 ($ 26.97 per hour + 110% overhead)

 Technical $ 39.77 ($ 18.94 per hour + 110% overhead)

 Clerical $ 25.75 ($ 12.26 per hour + 110% overhead)

( ii) Estimating Capital and Operations and Maintenance Costs The type of industry costs associated with the information collection activity in the standards are labor and CEMs. The capital start up costs are one time costs when a facility becomes subject to the standard. The capital start up costs for this regulation are $ 700,000 dollars. This is based on 7 new sources per year multiplied by $ 100,000 average for all monitoring devices required by 40 CFR 60 Subpart O. The annual operations and maintenance costs are $ 5,145,000 dollars. This is based on 147 existing sources multiplied by $ 35,000 for upkeep of the monitoring devices. The 14 total respondent costs have been calculated on the addition of the capital start up costs and the annual operations and maintenance costs. The average annual burden for capital and operations and maintenance costs to industry over the next three years of the ICR is estimated to be $ 5,845,000.

( iii) Capital/ Start up vs. Operating and Maintenance ( O& M)

Costs Monitoring device start up cost ($) annual O& M costs ($)

All Devices $ 100,000 $ 35,000 6( c) Estimating Agency Burden and Cost The only Federal costs are user costs associated with analysis of the reported information. Publication and distribution of the information are part of the Aerometric Information Retrieval System ( AIRS) Facility Subsystem ( AFS) which is operated and maintained by the EPA's Office of Air Quality Planning and Standards. Examination of records to be maintained by the respondents will occur as part of the periodic inspection of sources, which is part of EPA's overall compliance and enforcement program.

The average annual Federal Government cost during the 3 years of the ICR is estimated to be $ 72,143. This cost is based on an average wage of; Executive, Administrative, and Managerial of $ 75.16 per hour ( GS14 01 rate: $ 35.79 per hour + 110% overhead); Technical of $ 40.61 ( GS10 01 rate: $ 19.34 per hour + 110% overhead); and Clerical $ 27.13 ( GS06 01 rate: $ 12.92 per hour + 110% overhead) and travel associated with compliance activities. Details upon which this estimate is based appear in Table 1: Agency Burden. 15 6( d) Estimating the Respondent Universe and Total Burden and Costs The number of existing sources subject to 40 CFR Part 60 SUBPART O is 147. The number of new sources subject to 40 CFR Part 60 SUBPART O is 7 per year. The total annual labor costs are $ 357,042 and total annual capital and O& M costs to the regulated entity are $ 5,845,000 dollars. Details upon which this estimate is based appear in Table 2: Industry Burden.

6( e) Bottom Line Burden Hours And Cost Tables 1 Costs are based on the following hourly rounded rates: technical at $ 41, management at $ 75, and clerical at $ 27.

2 EPA personnel would attend 10 percent ( or 0.1) of the 1 new facilities conducting performance tests.

3 Assumes 20 percent of initial performance tests must be repeated due to failure.

4 Assumes 10 percent of facilities would undergo physical or operational changes.

5 Assumes 20 percent of facilities would have exceedances to report each year.

16 Table 1: Annual Burden and Cost to the Federal Government Activity ( A) EPA hr./ Occurre nce ( B) Occurrenc es/ plant/ yr ( C) Technical Personhours Per Year ( C= AxB) ( D) Management Personhours Per Year ( D= Cx 0.05) ( E) Clerical Personhours Per Year ( E= Cx 0.1) ( F) Total Cost Per year 1 Initial Performance Test ( Observe Monitoring) 24 7 2 168 8.4 16.8 7972 Repeat Performance Test Retesti ng prep. 24 1.4 3 33.6 1.68 3.36 1594 Report Review Notification of Construction/ Reconstr uction 2 7 14 0.7 1.4 664 Notification of Physical or Operational Changes 2 7 4 14 0.7 1.4 664 Notification of Anticipated Startup 0.5 7 3.5 0.175 0.35 166 Notification of Actual Startup 0.5 7 3.5 0.175 0.35 166 Initial Test 0.5 8.4 4.2 0.21 0.42 199 Repeat Performance Test 8 8.4 67.2 3.36 6.72 3189 Semiannual Reports 48 22.8 5 1094.4 54.72 109.44 51929 TOTAL ANNUAL HOURS/ DIRECT PERSONNEL COST 1402.4 70.17 140.24 66543 TRAVEL EXPENSES ( 2 person x 7 sources/ yr x 3 days/ source x $ 50 per diem)+ ($ 500 RT/ source x 1 sources/ yr) = 5600 TOTAL ANNUAL COST 72143 17 6( f) Reasons for Change in Burden There is no increase in burden from the most recently approved ICR.

6( g) Burden Statement Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions;

develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, Office of Environmental Information ( OEI), U. S. Environmental Protection Agency, Mail code 2822, 1200 Pennsylvania Ave, N. W., Washington, D. C. 20460 0001; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number 1063.08 and OMB control number 2060 0035 in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information.


[Federal Register Volume 85, Number 191 (Thursday, October 1, 2020)]
[Notices]
[Page 62004]
[FR Doc No: 2020-21662]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90007; File No. SR-CBOE-2020-072]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change To Amend Rules Relating to the Processing of Auction Responses

September 25, 2020.
    On July 30, 2020, Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe
Options'') 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\ a
proposed rule change to amend its rules relating to the processing of
auction responses. The proposed rule change was published for comment
in the Federal Register on August 18, 2020.\3\ The Commission has
received no comment letters regarding the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 89528 (August 12,
2020), 85 FR 50855 (August 18, 2020).
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    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding, or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is October 2, 2020. The Commission is extending this 45-day time
period.
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    \4\ 15 U.S.C. 78s(b)(2).
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    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider the proposed rule change. Accordingly, the
Commission, pursuant to Section 19(b)(2) of the Act,\5\ designates
November 16, 2020, as the date by which the Commission shall either
approve or disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-CBOE-2020-072).
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    \5\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
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    \6\ 17 CFR 200.30-3(a)(31).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-21662 Filed 9-30-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Rules and Regulations]
[Pages 1170-1172]
[FR Doc No: 2016-31239]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9057; Directorate Identifier 2016-NM-055-AD;
Amendment 39-18763; AD 2016-26-05]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are superseding Airworthiness Directive (AD) 2014-26-08,
for all Airbus Model A330-200, -200F, and -300 series airplanes. AD
2014-26-08 required revising the maintenance or inspection program to
incorporate new maintenance requirements and airworthiness limitations.
This new AD requires revising the maintenance or inspection program, as
applicable, to incorporate new or revised airworthiness limitation
requirements. This new AD also removes certain airplanes from the
applicability. This AD was prompted by a determination that more
restrictive maintenance instructions and airworthiness limitations are
necessary. We are issuing this AD to address the unsafe condition on
these products.

DATES: This AD is effective February 9, 2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of February 9,
2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of March
2, 2015 (80 FR 3866, January 26, 2015).

ADDRESSES: For service information identified in this final rule,
contact Airbus SAS, Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax
+33 5 61 93 45 80; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at
the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9057.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9057; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (telephone 800-
647-5527) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2014-26-08, Amendment 39-18059 (80 FR 3866,
January 26, 2015) (``AD 2014-26-08''). AD 2014-26-08 applied to all
Airbus Model A330-200, -200F, and -300 series airplanes. The NPRM
published in the Federal Register on September 12, 2016 (81 FR 62676)
(``the NPRM''). The NPRM was prompted by a determination that more
restrictive maintenance instructions and airworthiness limitations are
necessary. The NPRM proposed to require revising the maintenance or
inspection program to incorporate new maintenance requirements and
airworthiness limitations. The NPRM also proposed to remove certain
airplanes from the applicability. We are issuing this AD to prevent
safety-significant latent failures that would, in combination with one
or more other specific failures or events, result in a hazardous or
catastrophic failure condition.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2016-0066, dated April 6, 2016 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Model A330-200, -
200F, and -300 series airplanes. The MCAI states:

    The airworthiness limitations are currently defined and
published in the Airbus A330 and A340 Airworthiness Limitations
Section (ALS) documents.
    The mandatory instructions and airworthiness limitations
applicable to the Certification Maintenance Requirements (CMR),
which are approved by EASA, are specified in Airbus A330 and A340
ALS Part 3. Failure to comply with these instructions could result
in an unsafe condition.
    EASA issued AD 2013-0245 (A330 aeroplanes) [which corresponds to
FAA AD 2014-26-08] and AD 2013-0021 (A340 aeroplanes) to require the
actions as specified in Airbus A330 and A340 ALS Part 3 at Revision
04 and Revision 02, respectively.
    Since those [EASA] ADs were issued, Airbus issued Revision 05
and Revision 03, respectively, of Airbus A330 and A340 ALS Part 3,
to introduce more restrictive maintenance requirements.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2013-0245 and [EASA] AD 2013-0021, which are
superseded, and requires accomplishment of the actions specified in
Airbus A330 ALS Part 3 Revision 05, or A340 ALS Part 3 Revision 03,
as applicable * * *.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9057.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting this AD as proposed, except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    We reviewed Airbus A330 Airworthiness Limitations Section ALS Part
3--Certification Maintenance Requirements, Revision 04, dated August
17, 2013; and Revision 05, dated October 19, 2015. The service
information describes updated inspections and intervals to be
incorporated into the maintenance or inspection program. These
documents are distinct because each revision contains unique changes to
be incorporated into the maintenance or inspection program.
    This service information is reasonably available because the
interested parties

have access to it through their normal course of business or by the
means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 104 airplanes of U.S. registry.
    The actions required by AD 2014-26-08, and retained in this AD take
about 1 work-hour per product, at an average labor rate of $85 per
work-hour. Based on these figures, the estimated cost of the actions
that are required by AD 2014-26-08 is $85 per product.
    We also estimate that it takes about 2 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Based on these figures, we estimate the cost of
this AD on U.S. operators to be $17,680, or $170 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2014-26-08, Amendment 39-18059 (80 FR 3866, January 26, 2015), and
adding the following new AD:

2016-26-05 Airbus: Amendment 39-18763; Docket No. FAA-2016-9057;
Directorate Identifier 2016-NM-055-AD.

(a) Effective Date

    This AD is effective February 9, 2017.

 (b) Affected ADs

    This AD replaces AD 2014-26-08, Amendment 39-18059 (80 FR 3866,
January 26, 2015) (``AD 2014-26-08'').

 (c) Applicability

    This AD applies to Airbus Model A330-201, -202, -203, -223, -
223F -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342,
and -343 airplanes, certificated in any category, with an original
certificate of airworthiness or original export certificate of
airworthiness issued on or before October 19, 2015.

 (d) Subject

    Air Transport Association (ATA) of America Code 05, Periodic
inspections.

(e) Reason

    This AD was prompted by a determination that more restrictive
maintenance instructions and airworthiness limitations are
necessary. We are issuing this AD to prevent safety-significant
latent failures that would, in combination with one or more other
specific failures or events, result in a hazardous or catastrophic
failure condition.

(f) Compliance

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

(g) Retained: Revision of the Maintenance or Inspection Program, With
No Changes

    This paragraph restates the requirements of paragraph (k) of AD
2014-26-08, with no changes.
    (1) Within 90 days after March 2, 2015 (the effective date of AD
2014-26-08): Revise the maintenance or inspection program, as
applicable, to incorporate Airbus A330 Airworthiness Limitations
Section ALS Part 3--Certification Maintenance Requirements, Revision
04, dated August 27, 2013. Within the applicable compliance time
defined in the ``Record of Revisions'' section of Airbus A330
Airworthiness Limitations Section ALS Part 3--Certification
Maintenance Requirements, Revision 04, dated August 27, 2013, except
as provided by paragraph (g)(2) of this AD, accomplish all
applicable maintenance tasks. Accomplishing the actions specified in
paragraph (i) of this AD terminates the requirements of this
paragraph.
    (2) Where paragraph 3 of the ``Record of Revisions'' section of
Airbus A330 Airworthiness Limitations Section ALS Part 3--
Certification Maintenance Requirements, Revision 04, dated August
27, 2013, specifies accomplishing the actions ``from 27 August
2013,'' this AD requires compliance within the specified compliance
time after March 2, 2015 (the effective date of AD 2014-26-08).

(h) Retained: No Alternative Inspections or Intervals, With No Changes

    This paragraph restates the requirements of paragraph (l) of AD
2014-26-08, with no changes. After accomplishment of the action
required by paragraph (g)(1) of this AD, no alternative inspections
or inspection intervals may be used, other than those specified in
Airbus A330 Airworthiness Limitations Section ALS Part 3--
Certification Maintenance Requirements, Revision 04, dated August
27, 2013, except as provided by paragraphs (g)(2) and (i) of this
AD, unless the inspections or intervals are approved as an AMOC in
accordance with the procedures specified in paragraph (k)(1) of this
AD.

(i) New: Revision of the Maintenance or Inspection Program

    Within 90 days after the effective date of this AD: Revise the
maintenance or inspection program, as applicable, to incorporate
Airbus A330 Airworthiness Limitations Section ALS Part 3--
Certification Maintenance Requirements, Revision 05, dated October
19, 2015. Accomplishing the actions specified in this paragraph
terminates the requirements of paragraph (g) of this AD.

(j) New: No Alternative Inspections or Intervals

    After the action required by paragraph (i) of this AD has been
done, no alternative inspections or inspection intervals may be
used, other than those specified in Airbus A330 Airworthiness
Limitations Section ALS Part 3--Certification Maintenance
Requirements, Revision 05, dated October 19, 2015, unless the
inspections or intervals are approved as an AMOC in accordance with
the procedures specified in paragraph (k)(1) of this AD.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane

Directorate, FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. In accordance
with 14 CFR 39.19, send your request to your principal inspector or
local Flight Standards District Office, as appropriate. If sending
information directly to the International Branch, send it to ATTN:
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain corrective actions
from a manufacturer, the action must be accomplished using a method
approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or the European Aviation Safety Agency
(EASA); or Airbus's EASA Design Organization Approval (DOA). If
approved by the DOA, the approval must include the DOA-authorized
signature.

(l) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI)
EASA Airworthiness Directive 2016-0066, dated April 6, 2016, for
related information. This MCAI may be found in the AD docket on the
Internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2016-9057.

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
February 9, 2017.
    (i) Airbus A330 Airworthiness Limitations Section ALS Part 3--
Certification Maintenance Requirements, Revision 05, dated October
19, 2015. The revision level of this document is identified on only
the title page and in the Revision Status and the Record of
Revisions.
    (ii) Reserved.
    (4) The following service information was approved for IBR on
March 2, 2015 (80 FR 3866, January 26, 2015).
    (i) Airbus A330 Airworthiness Limitations Section ALS Part 3--
Certification Maintenance Requirements, Revision 04, dated August
27, 2013. The revision level of this document is identified on only
the title page and in the Record of Revisions. The revision date is
not identified on the title page of this document.
    (ii) Reserved.
    (5) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 45 80; email<EMAIL_ADDRESS>Internet
http://www.airbus.com.
    (6) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (7) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on December 15, 2016.
Victor Wicklund,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-31239 Filed 1-4-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)]
[Rules and Regulations]
[Pages 62456-62457]
[FR Doc No: 2015-26358]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2015-0948]

Drawbridge Operation Regulations; James River, Isle of Wight and
Newport News, VA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulations.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the James River Bridge (US 17 and VA
258) across the James River, mile 5.0, between Isle of Wight and
Newport News, VA. This deviation allows the bridge to remain in the
closed-to-navigation position to facilitate work on electrical control
and power wiring systems on the bridge.

DATES: This deviation is effective from 8 a.m. on October 16, 2015,
until 8 p.m. on October 19, 2015.

ADDRESSES: The docket for this deviation, [USCG-2015-0948], is
available at http://www.regulations.gov. Type the docket number in the
``SEARCH'' box and click ``SEARCH''. Click on Open Docket Folder on the
line associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Hal R. Pitts, Bridge
Administration Branch Fifth District, Coast Guard; telephone (757) 398-
6222, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Virginia Department of Transportation,
who owns and operates the James River Bridge (US 17 and VA 258), has
requested a temporary deviation from the current operating regulations
to facilitate work on electrical control and power wiring systems on
the bridge. The bridge is a vertical lift draw bridge and has a
vertical clearance in the closed position of 60 feet above mean high
water.
    The current operating schedule is set out in 33 CFR 117.5. Under
this temporary deviation, the bridge will remain in the closed-to-
navigation position from 8 a.m. on October 16, 2015 until 8 p.m. on
October 19, 2015.

The James River is used by a variety of vessels including deep draft
ocean-going vessels, U. S. government vessels, small commercial fishing
vessels, recreational vessels and tug and barge traffic. The Coast
Guard has carefully coordinated the restrictions with U. S. government
and commercial waterway users.
    Vessels able to pass through the bridge in the closed position may
do so at anytime. The bridge will not be able to open for emergencies
and there is no alternate route for vessels unable to pass through the
bridge in the closed position. The Coast Guard will also inform the
users of the waterways through our Local and Broadcast Notice to
Mariners of the change in operating schedule for the bridge so that
vessels can arrange their transits to minimize any impacts caused by
this temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: October 13,2015.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2015-26358 Filed 10-15-15; 8:45 am]
BILLING CODE 9110-04-P