[Federal Register Volume 79, Number 126 (Tuesday, July 1, 2014)]
[Notices]
[Pages 37371-37372]
[FR Doc No: 2014-15324]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72465; File No. SR-CME-2014-26]

Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Regarding Modifications to Its OTC IRS Fee Schedule

June 25, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Exchange Act'' or ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on June 18, 2014, Chicago Mercantile Exchange Inc.
(``CME'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change described in Items I and II
below, which Items have been prepared primarily by CME. CME filed the
proposal pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(2) \4\ thereunder, so that the proposal was effective upon filing
with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b--4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CME is filing the proposed rule change that is limited to its
business as a derivatives clearing organization. More specifically, the
proposed rule change would modify the fee schedule applicable to its
over-the-counter (``OTC'') interest rate swap (``IRS'') clearing
offering.

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

    In its filing with the Commission, CME included statements
concerning the purpose 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. CME 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

    CME is registered as a derivatives clearing organization with the
Commodity Futures Trading Commission (``CFTC'') and currently offers
clearing services for many different futures and swaps products. With
this filing, CME proposes to modify the fee schedule (the ``Fee
Schedule'') that applies to over-the-counter (``OTC'') Interest Rate
Swaps (``IRS'') cleared at CME.
    The proposed fee change relates to the charges for customer back-
loaded trades. The proposed change applies to the OTC IRS Customer Fee
Schedule. The proposed modification would specify that certain
qualifying back-loaded trades would be eligible for rebated clearing
fees provided that certain conditions and criteria are met. In order to
be eligible for the clearing fee rebate, the following criteria would
have to be satisfied: The entire back-loaded portfolio must have an
aggregate gross notional equal to or greater than $500 billion (or U.S.
Dollar equivalent); the customer notifies CME at least five (5) days in
advance by contacting<EMAIL_ADDRESS>the participating back-
loaded trades are back-loaded within a period of twenty (20) business
days or less; and, finally,

the back-loaded trades result in a net increase in customer open
interest during the specified back-loading period.
    In addition, the proposed modification to the OTC IRS Fee Schedule
also includes certain corrections to the current Fee Schedule for IRS
Clearing Members dealing with end of day offsets for currencies. These
corrections are intended to adjust the standard day offsets that are
used to coincide more closely with market standard settlement
conventions.
    The change that is described in this filing impacts fees that are
limited to CME's business as a derivatives clearing organization
clearing products under the exclusive jurisdiction of the CFTC and does
not materially impact CME's security-based swap clearing business in
any way. The fee change would become effective immediately but would be
operationalized on July 1, 2014. CME notes that it has already
submitted the proposed rule changes that is the subject of this filing
to its primary regulator, the CFTC, in CME Submission 14-239.
    CME believes the proposed rule change is consistent with the
requirements of the Exchange Act including Section 17A of the Exchange
Act.\5\ More specifically, the proposed rule changes establish or
change a member due, fee or other charge imposed by CME under Section
19(b)(3)(A)(ii) \6\ of the Exchange Act and Rule 19b-4(f)(2) \7\
thereunder. CME believes that the proposed fee change is consistent
with the requirements of the Exchange Act and the rules and regulations
thereunder and, in particular, to Section 17A(b)(3)(D) of the Exchange
Act,\8\ because the proposed fee changes apply equally to all OTC IRS
customers clearing IRS at CME and therefore the proposed changes
provide for the equitable allocation of reasonable dues, fees and other
charges among participants. CME also notes that it operates in a highly
competitive market in which market participants can readily direct
business to competing venues. As such, the proposed change is
appropriately filed pursuant to Section 19(b)(3)(A)\9\ of the Act and
Rule 19b-4(f)(2) \10\ thereunder.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78q-1.
    \6\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \7\ 17 CFR 240.19b-4(f)(2).
    \8\ 15 U.S.C. 78q-1(b)(3)(D).
    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    CME does not believe that the proposed rule change will have any
impact, or impose any burden, on competition. The fee change provides a
waiver of fees for certain large qualifying back-loaded IRS legacy
portfolios. Back-loaded transactions are defined as where the trade
date for the transaction is prior to the cleared date and, thus, by
definition, are transactions which have already occurred well before
clearing. Back-loaded transactions promote the general goal of
increasing central clearing of OTC derivatives products. Further, OTC
IRS are swaps under the exclusive jurisdiction of the CFTC, and, as
such, these proposed fee change does not affect the security-based swap
clearing activities of CME in any way and therefore does not impose any
burden on competition that is inappropriate in furtherance of the
purposes of the Act.

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

    CME has not solicited, and does not intend to solicit, comments
regarding this proposed rule change. CME has not received any
unsolicited written comments from interested parties.

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

    The foregoing rule change has become effective upon filing pursuant
to Section 19(b)(3)(A) \11\ of the Act and Rule 19b-4(f)(2) \12\
thereunder. 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.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comment

    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 No. SR-CME-2014-26 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-CME-2014-26. 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 CME and on CME's
Web site at http://www.cmegroup.com/market-regulation/rule-filings.html.
    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-CME-2014-26 and
should be submitted on or before July 22, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
Kevin M. O'Neill,
Deputy Secretary.
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

[FR Doc. 2014-15324 Filed 6-30-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 15 (Tuesday, January 24, 2023)]
[Proposed Rules]
[Pages 4114-4117]
[FR Doc No: 2023-01166]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-0023; Project Identifier MCAI-2022-01030-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2021-08-08, which applies to all Airbus SAS Model A350-941 and -1041
airplanes. AD 2021-08-08 requires replacing affected bleed duct
assemblies and bleed gimbals at the wing-to-pylon interface, and
prohibits the installation of affected parts. This AD was prompted by a
report of a welding quality issue in the gimbal joint of the air bleed
duct at each wing-to-pylon interface and the consequent deformation of
the gimbal inner ring, and by new findings that affected bleed gimbals
were found on certain airplanes that did not have any maintenance
record of affected part replacement. This proposed AD would continue to
require the actions in AD 2021-08-08 and, for certain airplanes, would
require inspection of the bleed gimbals to determine the part number
and replacement if necessary, as specified in a European Union Aviation
Safety Agency (EASA) AD, which is proposed for incorporation by
reference. The FAA is proposing this AD to address the unsafe condition
on these products.

DATES: The FAA must receive comments on this proposed AD by March 10,
2023.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-0023; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this NPRM, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For material that will be incorporated by reference (IBR)
in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne,
Germany; telephone +49 221 8999 000; email [email protected]; website
easa.europa.eu. You may find this material on the EASA website at
ad.easa.europa.eu.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Dat Le, Aerospace Engineer, Large
Aircraft Section, FAA, International Validation Branch, 2200 South
216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2023-0023; Project Identifier
MCAI-2022-01030-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Dat
Le, Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone<PHONE_NUMBER>; email [email protected]. Any commentary that the
FAA receives which is not specifically designated as CBI will be

placed in the public docket for this rulemaking.

Background

    The FAA issued AD 2021-08-08, Amendment 39-21502 (86 FR 20453,
April 20, 2021) (AD 2021-08-08), for all Airbus SAS Model A350-941 and
-1041 airplanes. AD 2021-08-08 was prompted by MCAI originated by EASA,
which is the Technical Agent for the Member States of the European
Union. EASA issued EASA AD 2020-0169R1, dated August 19, 2020 (EASA AD
2020-0169R1), to correct an unsafe condition.
    AD 2021-08-08 requires replacing affected bleed duct assemblies and
bleed gimbals at the wing-to-pylon interface with serviceable parts.
The FAA issued AD 2021-08-08 to address a welding quality issue in the
gimbal joint of the air bleed duct located at each wing-to-pylon
interface; the inner ring of a gimbal had deformed to an oval shape,
which could cause cracking by direct contact between metal parts, and
could lead to hot bleed air leakage in the pylon area, and possibly
result in loss of the pneumatic system and exposure of the wing
structure to high temperatures, and lead to reduced structural
integrity of the airplane.

Actions Since AD 2021-08-08 Was Issued

    Since the FAA issued AD 2021-08-08, EASA superseded EASA AD 2020-
0169R1 and issued EASA AD 2022-0156, dated August 2, 2022 (EASA AD
2022-0156) (also referred to as the MCAI), to correct an unsafe
condition for all Airbus SAS Model A350-941 and -1041 airplanes. Since
EASA AD 2020-0169R1 was issued, affected bleed gimbals at the wing-to-
pylon interface have been found installed on certain airplanes without
having any maintenance record of affected part replacement.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2023-0023.

Explanation of Retained Requirements

    Although this proposed AD does not explicitly restate the
requirements of AD 2021-08-08, this proposed AD would retain all of the
requirements of AD 2021-08-08. Those requirements are referenced in
EASA AD 2022-0156, which, in turn, is referenced in paragraph (g) of
this proposed AD.

Related Service Information Under 1 CFR Part 51

    EASA AD 2022-0156 specifies procedures, for certain airplanes, for
replacing affected bleed duct assemblies and bleed gimbals at the wing-
to-pylon interface with serviceable parts, and, for certain other
airplanes, inspecting each bleed gimbal at the wing-to-pylon interface
to determine if it is an affected part and replacing affected parts.
EASA AD 2022-0156 also prohibits the installation of an affected part
on any airplane. This material 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.

FAA's Determination

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with the State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA is issuing this NPRM after determining that
the unsafe condition described previously is likely to exist or develop
in other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in EASA AD 2022-0156 described previously, except for any differences
identified as exceptions in the regulatory text of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2022-0156 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2022-0156 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in EASA AD 2022-0156 does not mean that
operators need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2022-
0156. Service information required by EASA AD 2022-0156 for compliance
will be available at regulations.gov under Docket No. FAA-2023-0023
after the FAA final rule is published.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 31 airplanes of U.S. registry. The FAA estimates the following
costs to comply with this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                     Labor cost            Parts cost       Cost per  product     operators
----------------------------------------------------------------------------------------------------------------
Retained actions (Group 1        Up to 25 work-hours x    Up to $48,800.....  Up to $50,925.....            * $0
 airplanes in the MCAI).          $85 per hour = $2,125.
New proposed actions (Group 2    2 work-hours x $85 per   0.................  170...............           5,270
 airplanes in the MCAI).          hour = $170.
----------------------------------------------------------------------------------------------------------------
\*\ The retained replacement from AD 2021-08-08 applies to Group 1 airplanes specified in the MCAI. There are no
  affected U.S.-registered airplanes in Group 1.

    The FAA estimates the following costs to do any necessary on-
condition action that would be required based on the results of any
required actions. The FAA has no way of determining the number of
aircraft that might need this on-condition action:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
           Labor cost                 Parts cost       Cost per product
------------------------------------------------------------------------
Up to 25 work-hours x $85 per     Up to $48,800.....  Up to $50,925.
 hour = $2,125.
------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. The FAA does not control warranty
coverage for affected individuals. As a result, the FAA has included
all known costs in the cost estimate.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) 2021-08-08, Amendment 39-21502
(86 FR 20453, April 20, 2021); and
    b. Adding the following new AD:

Airbus SAS: Docket No. FAA-2023-0023; Project Identifier MCAI-2022-
01030-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by March 10, 2023.

(b) Affected ADs

    This AD replaces AD 2021-08-08, Amendment 39-21502 (86 FR 20453,
April 20, 2021) (AD 2021-08-08).

(c) Applicability

    This AD applies to all Airbus SAS Model A350-941 and -1041
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 36, Pneumatic.

(e) Unsafe Condition

    This AD was prompted by a report that a welding quality issue
has been identified in the gimbal joint of the air bleed duct
located at each wing-to-pylon interface; the inner ring of a gimbal
had deformed to an oval shape, which could lead to cracking caused
by direct contact between metal parts, and by new findings that
affected bleed gimbals were found on certain airplanes that did not
have any maintenance record of affected part replacement. The unsafe
condition, if not addressed, could result in hot bleed air leakage
in the pylon area, and possibly result in loss of the pneumatic
system and exposure of the wing structure to high temperatures, and
lead to reduced structural integrity of the airplane.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraphs (h) and (i) of this AD: Comply
with all required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2022-0156, dated August 2, 2022 (EASA AD 2022-0156).

(h) Exceptions to EASA AD 2022-0156

    (1) Where EASA AD 2022-0156 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where paragraph (6) of EASA AD 2022-0156 refers to August
26, 2020 (the effective date of EASA AD 2020-0169R1), this AD
requires using May 25, 2021 (the effective date of AD 2021-08-08).
    (3) Where the definition of ``Groups'' in EASA AD 2022-0156
specifies Group 1 airplanes are those manufacturer serial numbers
(MSN) listed in certain service information, replace the text
``Airbus Service Bulletin (SB) A350-36-P021 and SB A350-36-P022''
with ``Airbus Service Bulletin A350-36-P021, dated January 17, 2020;
and Airbus Service Bulletin A350-36-P022, dated January 17, 2020.''
    (4) Where the definition of ``Groups'' in EASA AD 2022-0156
specifies Group 2 airplanes are those MSN listed in certain service
information, replace the text ``Airbus SB A350-36-P029'' with
``Airbus Service Bulletin A350-36-P029, Revision 01, dated February
3, 2022.''
    (5) This AD does not adopt the Remarks paragraph of EASA AD
2022-0156.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2022-0156
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Additional FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Validation Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or responsible Flight Standards Office, as
appropriate. If sending information directly to the International
Validation Branch the attention of the person identified in
paragraph (k) of this AD. Information may be emailed to: [email protected]. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must

be accomplished using a method approved by the Manager,
International Validation Branch, FAA; or EASA; or Airbus SAS's EASA
Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraph (j)(2) of this AD, if any service information contains
procedures or tests that are identified as RC, those procedures and
tests must be done to comply with this AD; any procedures or tests
that are not identified as RC are recommended. Those procedures and
tests that are not identified as RC may be deviated from using
accepted methods in accordance with the operator's maintenance or
inspection program without obtaining approval of an AMOC, provided
the procedures and tests identified as RC can be done and the
airplane can be put back in an airworthy condition. Any
substitutions or changes to procedures or tests identified as RC
require approval of an AMOC.

(k) Additional Information

    For more information about this AD, contact Dat Le, Aerospace
Engineer, Large Aircraft Section, FAA, International Validation
Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 516-
228-7317; email [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2022-0156,
dated August 2, 2022.
    (ii) [Reserved]
    (3) For EASA AD 2022-0256, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; website easa.europa.eu. You may find this EASA
AD on the EASA website at ad.easa.europa.eu.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on January 18, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-01166 Filed 1-23-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 180 (Monday, September 19, 2022)]
[Rules and Regulations]
[Pages 57139-57142]
[FR Doc No: 2022-20146]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 87, No. 180 / Monday, September 19, 2022 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1156; Project Identifier MCAI-2021-01024-T;
Amendment 39-22175; AD 2022-19-06]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Airbus SAS Model A310 series airplanes. This AD was prompted by a
determination that new or more restrictive airworthiness tasks are
necessary. This AD requires revising the existing maintenance or
inspection program, as applicable, to incorporate new or more
restrictive airworthiness tasks, as specified in a European Union
Aviation Safety Agency (EASA) AD, which is incorporated by reference.
The FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD is effective October 4, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of October 4,
2022.
    The FAA must receive comments on this AD by November 3, 2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

AD Docket

    You may examine the AD docket at regulations.gov under Docket No.
FAA-2022-1156; or in person at Docket Operations between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.

Material Incorporated by Reference

     For material incorporated by reference (IBR) in this AD,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone
+49 221 8999 000; email [email protected]; website easa.europa.eu. You
may find this material on the EASA website at ad.easa.europa.eu.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, Large
Aircraft Section, International Validation Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2022-1156; Project Identifier MCAI-
2021-01024-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this final rule, it is important that you clearly designate the
submitted comments as CBI. Please mark each page of your submission
containing CBI as ``PROPIN.'' The FAA will treat such marked
submissions as confidential under the FOIA, and they will not be placed
in the public docket of this final rule. Submissions containing CBI
should be sent to Dan Rodina, Aerospace Engineer, Large Aircraft
Section, International Validation Branch, FAA, 2200 South 216th St.,
Des Moines, WA 98198; telephone<PHONE_NUMBER>; email [email protected].
Any commentary that the FAA receives which is not specifically
designated as CBI will be placed in the public docket for this
rulemaking.

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0205, dated September 14, 2021
(EASA AD 2021-0205) (referred to after this as the MCAI), to correct an
unsafe condition on all Airbus SAS Model A310-203, -204, -221, -222, -
304, -322, -324, and -325 airplanes. The MCAI states that new or more
restrictive airworthiness limitation tasks related to nose and center
fuselage and engine mount maintenance are necessary. The MCAI also
states that not accomplishing the tasks could result in fatigue
cracking, damage, or corrosion in principal structural elements.
    EASA AD 2021-0205 specifies that it requires tasks (limitations)
already in Airbus A310 Airworthiness Limitations

Section (ALS), Part 2, Damage Tolerant Airworthiness Limitation Items
(DT-ALI), Revision 03, dated December 14, 2018, that is required by
EASA AD 2019-0091 (which corresponds to FAA AD 2019-20-06, Amendment
39-19759 (84 FR 55859, October 18, 2019) (AD 2019-20-06)), and that
incorporation of EASA AD 2021-0205 invalidates (terminates) prior
instructions for those tasks. This AD therefore terminates the
limitations for the corresponding tasks, as required by paragraph (g)
of AD 2019-20-06.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2022-1156.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed EASA AD 2021-0205. This service information
specifies new or more restrictive airworthiness tasks for airplane
structures (nose and center fuselage, and engine mount). This material
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.

FAA's Determination

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
described above. The FAA is issuing this AD after determining that the
unsafe condition described previously is likely to exist or develop on
other products of the same type design.

AD Requirements

    This AD requires revising the existing maintenance or inspection
program, as applicable, to incorporate new or more restrictive
airworthiness tasks, which are specified in EASA AD 2021-0205 described
previously, as incorporated by reference. Any differences with EASA AD
2021-0205 are identified as exceptions in the regulatory text of this
AD.
    This AD requires revisions to certain operator maintenance
documents to include new actions (e.g., inspections). Compliance with
these actions is required by 14 CFR 91.403(c). For airplanes that have
been previously modified, altered, or repaired in the areas addressed
by this AD, the operator may not be able to accomplish the actions
described in the revisions. In this situation, to comply with 14 CFR
91.403(c), the operator must request approval for an alternative method
of compliance (AMOC) according to paragraph (k)(1) of this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result,
EASA AD 2021-0205 is incorporated by reference in this AD. This AD
requires compliance with EASA AD 2021-0205 through that incorporation,
except for any differences identified as exceptions in the regulatory
text of this AD. Using common terms that are the same as the heading of
a particular section in EASA AD 2021-0205 does not mean that operators
need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2021-
0205. Service information required by EASA AD 2021-0205 for compliance
will be available at regulations.gov by searching for and locating
Docket No. FAA-2022-1156 after this final rule is published.

Airworthiness Limitation ADs Using the New Process

    The FAA's process of incorporating by reference MCAI ADs as the
primary source of information for compliance with corresponding FAA ADs
has been limited to certain MCAI ADs (primarily those with service
bulletins as the primary source of information for accomplishing the
actions required by the FAA AD). However, the FAA is now expanding the
process to include MCAI ADs that require a change to airworthiness
limitation documents, such as airworthiness limitation sections.
    For these ADs that incorporate by reference an MCAI AD that changes
airworthiness limitations, the FAA requirements are unchanged.
Operators must revise the existing maintenance or inspection program,
as applicable, to incorporate the information specified in the new
airworthiness limitation document. The airworthiness limitations must
be followed according to 14 CFR 91.403(c) and 91.409(e).
    The previous format of the airworthiness limitation ADs included a
paragraph that specified that no alternative actions (e.g.,
inspections) or intervals may be used unless the actions and intervals
are approved as an AMOC in accordance with the procedures specified in
the AMOCs paragraph under ``Additional AD Provisions.'' This new format
includes a ``New Provisions for Alternative Actions and Intervals''
paragraph that does not specifically refer to AMOCs, but operators may
still request an AMOC to use an alternative action or interval.

Justification for Immediate Adoption and Determination of the Effective
Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    There are currently no domestic operators of these products.
Accordingly, notice and opportunity for prior public comment are
unnecessary, pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for the
foregoing reason(s), the FAA finds that good cause exists pursuant to 5
U.S.C. 553(d) for making this amendment effective in less than 30 days.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because the FAA has determined
that it has good cause to adopt this rule without notice and comment,
RFA analysis is not required.

Costs of Compliance

    Currently, there are no affected U.S.-registered airplanes. For any
affected airplane that may be imported and placed on the U.S. Register
in the future, the FAA provides the following cost estimates to comply
with this AD:
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the agency recognizes that this number may vary from operator
to operator. Since operators incorporate maintenance or inspection
program changes for their affected fleet(s), the FAA has

determined that a per-operator estimate is more accurate than a per-
airplane estimate.
    The FAA estimates the total cost per operator for the new actions
to be $7,650 (90 work-hours x $85 per work-hour).

Authority for This Rulemaking

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

Regulatory Findings

    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, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2022-19-06 Airbus SAS: Amendment 39-22175; Docket No. FAA-2022-1156;
Project Identifier MCAI-2021-01024-T.

(a) Effective Date

    This airworthiness directive (AD) is effective October 4, 2022.

(b) Affected ADs

    This AD affects AD 2019-20-06, Amendment 39-19759 (84 FR 55859,
October 18, 2019) (AD 2019-20-06).

(c) Applicability

    This AD applies to all Airbus SAS Model A310-203, -204, -221, -
222, -304, -322, -324, and -325 airplanes, certificated in any
category.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Unsafe Condition

    This AD was prompted by a determination that new or more
restrictive airworthiness tasks are necessary. The FAA is issuing
this AD to address fatigue cracking, damage, or corrosion in
principal structural elements. The unsafe condition, if not
addressed, could result in reduced structural integrity of the
fuselage.

(f) Compliance

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

(g) Revision of the Existing Maintenance or Inspection Program

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2021-0205, dated September 14, 2021 (EASA AD 2021-0205).

(h) Exceptions to EASA AD 2021-0205

    (1) The requirements specified in paragraphs (1) and (2) of EASA
AD 2021-0205 do not apply to this AD.
    (2) Paragraph (3) of EASA AD 2021-0205 specifies revising ``the
approved AMP'' within 12 months after its effective date, but this
AD requires revising the existing maintenance or inspection program,
as applicable, within 90 days after the effective date of this AD.
    (3) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA 2021-0205 is at the applicable ``associated
thresholds'' as incorporated by the requirements of paragraph (3) of
EASA AD 2021-0205, or within 90 days after the effective date of
this AD, whichever occurs later.
    (4) The provisions specified in paragraph (4) of EASA AD 2021-
0205 do not apply to this AD.
    (5) The ``Remarks'' section of EASA AD 2021-0205 does not apply
to this AD.

(i) New Provisions for Alternative Actions and Intervals

    After the existing maintenance or inspection program has been
revised as required by paragraph (g) of this AD, no alternative
actions (e.g., inspections) and intervals are allowed unless they
are approved as specified in the provisions of the ``Ref.
Publications'' section of EASA AD 2021-0205.

(j) Terminating Action for AD 2019-20-06

    Accomplishing the actions required by this AD terminates the
corresponding requirements of AD 2019-20-06, for the tasks
identified in the service information referenced in EASA AD 2021-
0205 only.

(k) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Validation Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or responsible Flight Standards Office, as
appropriate. If sending information directly to the International
Validation Branch, send it to the attention of the person identified
in paragraph (l) of this AD. Information may be emailed to: [email protected]. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Validation Branch, FAA; or EASA; or Airbus SAS's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(l) Additional Information

    For more information about this AD, contact Dan Rodina,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
206-231-3225; email [email protected].

(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.
    (i) European Union Aviation Safety Agency (EASA) AD 2021-0205,
dated September 14, 2021.
    (ii) [Reserved]
    (3) For EASA AD 2021-0205, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; website easa.europa.eu. You may find this EASA
AD on the EASA website at ad.easa.europa.eu.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational

Safety Branch, 2200 South 216th St., Des Moines, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on September 2, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-20146 Filed 9-16-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 33 (Tuesday, February 21, 2017)]
[Notices]
[Pages 11227-11228]
[FR Doc No: 2017-03365]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0595]

Pediatric Postmarketing Pharmacovigilance and Drug Utilization
Reviews; Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is
establishing a public docket to collect comments related to the
pediatric postmarketing pharmacovigilance and drug utilization reviews
of products posted between September 17, 2016, and February 24, 2017,
on the FDA Web site, but will not be presented at the March 6-7, 2017,
Pediatric Advisory Committee (PAC) meeting. These reviews are intended
to be available for review and comment by members of the PAC,
interested parties (such as academic researchers, regulated industries,
consortia, and patient groups), and the general public.

DATES: Submit either electronic or written comments by March 10, 2017.
The docket will open on February 27, 2017, and remain open until March
10, 2017.

ADDRESSES: You may submit your comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submission as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-0595 for ``Pediatric Postmarketing Pharmacovigilance and
Drug Utilization Reviews'' that have been posted on the FDA Web site at
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm between September 17, 2016,
and February 24, 2017, but will not be presented at the March 6-7, 2017
PAC meeting (82 FR 1345, January 5, 2017). Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential''

will not be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenneth Quinto, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5145, Silver Spring, MD 20993,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is responsible for protecting the public
health by assuring the safety, efficacy, and security of human and
veterinary drugs, biological products, medical devices, our Nation's
food supply, cosmetics, and products that emit radiation.
    FDA is establishing a public docket FDA-2017-N-0595 to receive
input on pediatric postmarketing pharmacovigilance and drug utilization
reviews posted between September 17, 2016, and February 24, 2017, on
the FDA Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm,
but will not be presented at the March 6-7, 2017, PAC meeting (82 FR
1345, January 5, 2017). FDA welcomes comments by members of the PAC, as
mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109)
and the Pediatric Research Equity Act (Pub. L. 108-155), interested
parties (such as academic researchers, regulated industries, consortia,
and patient groups), and the general public. The docket will open on
February 27, 2017, and remain open until March 10, 2017. These
pediatric postmarketing pharmacovigilance and drug utilization reviews
are for the following products:

 ALEVE PM (diphenhydramine hydrochloride/naproxen sodium)
 ASTEPRO (azelastine hydrochloride)
 ECOZA (econazole nitrate)
 JETREA (ocriplasmin)
 QUARTETTE (levonorgestrel/ethinyl estradiol and ethinyl
estradiol)
 TRUVADA (emtricitabine/tenofovir disoproxil fumarate)
 XERESE (acyclovir/hydrocortisone)

    Dated: February 15, 2017.
Janice M. Soreth,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2017-03365 Filed 2-17-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: December 1, 2006 (Volume 71, Number 231)]
[Rules and Regulations]
[Page 69486-69488]
[DOCID:fr01de06-14]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2006-0728; FRL-8249-7]

Approval and Promulgation of Air Quality Implementation Plans;
West Virginia; Emission Reductions to Meet Phase II of the Nitrogen
Oxides (NOX) SIP Call; Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule; correcting amendment.

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

SUMMARY: This document corrects an error in the rule language of a
final rule pertaining to EPA's direct final action to

convert a conditional approval in the West Virginia State
Implementation Plan (SIP) to a full approval. The SIP revision pertains
to nitrogen oxides (NOX) emission reductions required in
West Virginia to meet Phase II of the NOX SIP Call.

EFFECTIVE DATE: December 1, 2006.

FOR FURTHER INFORMATION CONTACT: Marilyn Powers,<PHONE_NUMBER> or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we,''
``us,'' or ``our'' are used we mean EPA. On September 28, 2006 (71 FR
56881), we published a final rulemaking action announcing our action to
approve nitrogen oxides (NOX) emission reductions required
in West Virginia to meet Phase II of the NOX SIP Call. In
that document, we inadvertently omitted information describing the
Federal Register publication date and page citation of the approval
date for West Virginia Regulation 45 CSR 1. This action adds the
omitted language.
    In rule document E6-15981 published in the Federal Register on
September 28, 2006 (71 FR 56881), on pages 56883 (bottom) and 56884
(top), the revised rule language described in Amendatory Instruction
Number 2 is corrected to add a Federal Register publication date and
page citation for each revised entry in 40 CFR 52.2520(c) for West
Virginia Regulation 45 CSR 1.
    Section 553 of the Administrative Procedure Act, 5 U.S.C.
553(b)(B), provides that, when an agency for good cause finds that
notice and public procedure are impracticable, unnecessary or contrary
to the public interest, the agency may issue a rule without providing
notice and an opportunity for public comment. We have determined that
there is good cause for making today's rule final without prior
proposal and opportunity for comment because we are merely correcting
an incorrect citation in a previous action. Thus, notice and public
procedure are unnecessary. We find that this constitutes good cause
under 5 U.S.C. 553(b)(B).

Statutory and Executive Order Reviews

    Under Executive Order (E.O.) 12866 (58 FR 51735, October 4, 1993),
this action is not a ``significant regulatory action'' and is therefore
not subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355 (May 22, 2001)). Because
the agency has made a ``good cause'' finding that this action is not
subject to notice-and-comment requirements under the Administrative
Procedures Act or any other statute as indicated in the SUPPLEMENTARY
INFORMATION section above, it is not subject to the regulatory
flexibility provisions of the Regulatory Flexibility Act (5 U.S.C 601
et seq.), or to sections 202 and 205 of the Unfunded Mandates Reform
Act of 1995 (UMRA) (Pub. L. 104-4). In addition, this action does not
significantly or uniquely affect small governments or impose a
significant intergovernmental mandate, as described in sections 203 and
204 of UMRA. This rule also 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, as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor
will it have substantial direct effects 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
governments, as specified by Executive Order 13132 (64 FR 43255, August
10, 1999). This rule also is not subject to Executive Order 13045 (62
FR 19885, April 23, 1997), because it is not economically significant.
    This technical correction action does not involve technical
standards; thus the requirements of section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do
not apply. The rule also does not involve special consideration of
environmental justice related issues as required by Executive Order
12898 (59 FR 7629, February 16, 1994). In issuing this rule, EPA has
taken the necessary steps to eliminate drafting errors and ambiguity,
minimize potential litigation, and provide a clear legal standard for
affected conduct, as required by section 3 of Executive Order 12988 (61
FR 4729, February 7, 1996). EPA has complied with Executive Order 12630
(53 FR 8859, March 15, 1998) by examining the takings implications of
the rule in accordance with the ``Attorney General's Supplemental
Guidelines for the Evaluation of Risk and Avoidance of Unanticipated
Takings'' issued under the executive order. This rule does not impose
an information collection burden under the Paperwork Reduction Act of
1995. (44 U.S.C. 3501 et seq.)
    The Congressional Review Act (5 U.S.C. 801 et seq.), as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. Section 808 allows the issuing agency to
make a rule effective sooner than otherwise provided by the CRA if the
agency makes a good cause finding that notice and public procedure is
impracticable, unnecessary or contrary to the public interest. This
determination must be supported by a brief statement. 5 U.S.C. 808(2).
As stated previously, EPA had made such a good cause finding, including
the reasons therefore, and established an effective date of December 1,
2006. EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This correction to 40 CFR Sec.
52.2520(c) for West Virginia is not a ``major rule'' as defined by 5
U.S.C. 804(2).

    Dated: November 21, 2006
William T. Wisniewski,
Acting Regional Administrator, Regional Administrator, Region III.

0
40 CFR Part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for 40 CFR part 52 continues to read as
follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart XX--West Virginia

0
2. In Sec.  52.2520, the table in paragraph (c) is amended by revising
entries for [45CSR] Series 1, Sections 1-5, 22, 70-72, 74, 89, 90, and
100 to read as follows:

Sec.  52.2520  Identification of plan.

* * * * *
    (c) EPA-Approved Regulations.

                                                    EPA-Approved Regulations in the West Virginia SIP
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           State                                               Additional explanation/
 State citation [Chapter 16-20 or 45            Title/subject            effective              EPA approval date              citation at 40 CFR Sec.
                CSR]                                                        date                                                       52.2565
--------------------------------------------------------------------------------------------------------------------------------------------------------
[45 CSR] Series 1...................    Control and Reduction of Nitrogen Oxides From Non-Electric Generating Units As a means to Mitigate Transport of
                                                                                Ozone Precursors
Section 45-1-1......................  General.........................       5/1/06  9/28/06, 71 FR 58661
Section 45-1-2......................  Definitions.....................       5/1/06  9/28/06, 71 FR 58661
Section 45-1-3......................  Acronyms........................       5/1/06  9/28/06, 71 FR 58661
Section 45-1-4......................  NOX Budget Trading Program             5/1/06  9/28/06, 71 FR 58661
                                       Applicability.
Section 45-1-5......................  Retired Unit Exemption..........       5/1/06  9/28/06, 71 FR 58661

                                                                      * * * * * * *
Section 45-1-22.....................  Information Requirements for NOX       5/1/06  9/28/06, 71 FR 58661
                                       Budget Permit Applications.

                                                                      * * * * * * *
Section 45-1-70.....................  General Monitoring Requirements.       5/1/06  9/28/06, 71 FR 58661
Section 45-1-71.....................  Initial Certification and              5/1/06  9/28/06, 71 FR 58661
                                       Recertification Procedures.
Section 45-1-72.....................  Out of Control Periods..........       5/1/06  9/28/06, 71 FR 58661

                                                                      * * * * * * *
Section 45-1-74.....................  Recordkeeping and Reporting.....       5/1/06  9/28/06, 71 FR 58661

                                                                      * * * * * * *
Section 45-1-89.....................  Appeal Procedures...............       5/1/06  9/28/06, 71 FR 58661                    New Section
Section 45-1-90.....................  Requirements for Stationary            5/1/06  9/28/06, 71 FR 58661                    New Section.
                                       Internal Combustion Engines.
Section 45-1-100....................  Requirements for Emissions of          5/1/06  9/28/06, 71 FR 58661
                                       NOX from Cement Manufacturing
                                       Kilns.

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

* * * * *
 [FR Doc. E6-20291 Filed 11-30-06; 8:45 am]

BILLING CODE 6560-50-P