[Federal Register Volume 81, Number 144 (Wednesday, July 27, 2016)]
[Notices]
[Page 49309]
[FR Doc No: 2016-17665]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78379; File No. SR-DTC-2016-003]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Designation of a Longer Period for Commission Action on
Proposed Rule Change Pursuant to Which DTC Would Impose Deposit Chills
and Global Locks and Provide Fair Procedures to Issuers

July 21, 2016.
    On May 27, 2016, The Depository Trust Company (``DTC'') filed with
the Securities and Exchange Commission (``Commission'') proposed rule
change SR-DTC-2016-003 pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4 thereunder,\2\ to
establish (i) the circumstances under which DTC would impose and
release a restriction on Deposits of an Eligible Security (a ``Deposit
Chill'') or on book-entry services for an Eligible Security (a ``Global
Lock''); and (ii) the fair procedures for notice and an opportunity for
the issuer of the Eligible Security (the ``Issuer'') to challenge the
Deposit Chill or Global Lock (each, a ``Restriction''). The proposed
rule change was published for comment in the Federal Register on June
9, 2016.\3\ The Commission received three comment letters to the
Proposed Rule Change.\4\
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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. 77991 (June 3,
2016), 81 FR 37232 (June 9, 2016) (SR-DTC-2016-003).
    \4\ See letters from Charles V. Rossi, Chairman, The Securities
Transfer Association, Inc. Board Advisory Committee, dated June 30,
2016, to Brent J. Fields, Secretary, Commission; Dorian Deyet, dated
June 30, 2016 (two submissions).
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \5\ 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 July 24, 2016. The Commission is extending this 45-day time period.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds that it is 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 comments received on the
proposed rule change. Accordingly, the Commission, pursuant to Section
19(b)(2) of the Act,\6\ designates September 7, 2016 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-DTC-2016-003).
---------------------------------------------------------------------------

    \6\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-17665 Filed 7-26-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Notices]
[Pages 77471-77472]
[FR Doc No: 2014-30043]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EF15-2-000]

Western Area Power Administration; Notice of Filing

    Take notice that on November 26, 2014, the Western Area Power
Administration submitted a tariff filing per 10 CFR 903.23: UGP_PSMBP-
ED_WAPA<PHONE_NUMBER>7, to be effective 1/1/2015. (Extension of the Pick-
Sloan Missouri Basin Program--Eastern Division Transmission and
Ancillary Services Rates-Western Area Power Administration-Rate Order
No. WAPA-168).
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on December 26, 2014.

    Dated: December 17, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-30043 Filed 12-23-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: December 31, 2009 (Volume 74, Number 250)]
[Rules and Regulations]
[Page 69286-69287]
[DOCID:fr31de09-15]

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

Pipeline and Hazardous Materials Safety Administration

49 CFR Part 192

[Docket No. PHMSA-RSPA-2004-19854; Amdt. 192-113]
RIN 2137-AE15

Pipeline Safety: Integrity Management Program for Gas
Distribution Pipelines

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Final rule; extension of comment period.

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

SUMMARY: PHMSA is extending for 30 days, until February 4, 2010, the
period for filing comments to the requirement adopted in the final
rule, ``Pipeline Safety: Integrity Management Program for Gas
Distribution Pipelines'' to require the reporting of failures of
compression couplings used in metal pipe. PHMSA had invited public
comment on the extension of this requirement to include reporting of
failure of compression couplings used in metal pipe until January 4,
2010. The American Gas Association (AGA) requested that PHMSA extend
the comment period for thirty days.

DATES: Comment Date: Interested persons are invited to submit comments
on the provisions for reporting failures of compression couplings by
February 4,

2010. At the end of the comment period, we will publish a document
modifying these provisions or a document stating that the provisions
will remain unchanged.

ADDRESSES: Comments limited to the provisions on reporting failures of
mechanical couplings should reference Docket No. PHMSA-RSPA-2004-19854
and may be submitted in the following ways:
     E-Gov Web Site: http://www.regulations.gov. This site
allows the public to enter comments on any Federal Register notice
issued by any agency.
     Fax: 1-202-493-2251.
     Mail: DOT Docket Operations Facility (M-30), U.S.
Department of Transportation, West Building, 1200 New Jersey Avenue,
SE., Washington, DC 20590.
     Hand Delivery: DOT Docket Operations Facility, U.S.
Department of Transportation, West Building, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590 between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    Instructions: In the E-Gov Web site: http://www.regulations.gov,
under ``Search Documents'' select ``Pipeline and Hazardous Materials
Safety Administration.'' Next, select ``Notices,'' and then click
``Submit.'' Select this rulemaking by clicking on the docket number
listed above. Submit your comment by clicking the yellow bubble in the
right column then following the instructions.
    Identify docket number PHMSA-RSPA-2004-19854 at the beginning of
your comments. For comments by mail, please provide two copies. To
receive PHMSA's confirmation receipt, include a self-addressed stamped
postcard. Internet users may access all comments at http://
www.regulations.gov, by following the steps above.

    Note: PHMSA will post all comments without changes or edits to
http://www.regulations.gov including any personal information
provided.

FOR FURTHER INFORMATION CONTACT: Mike Israni by phone at<PHONE_NUMBER>
or by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On December 4, 2009, PHMSA published a final
rule (74 FR 63905) under Docket No. PHMSA-RSPA-2004-19854 amending the
Pipeline Safety Regulations (49 CFR Parts 190-199) to require operators
of gas distribution pipelines to develop and implement integrity
management programs. In that final rule, PHMSA adopted a requirement
that operators report failures of all compression couplings, both
plastic and metallic. PHMSA also invited public comment on the
requirement to report failure of compression couplings used in metal
pipe. Public comments were due by January 4, 2010.
    On December 18, 2009, AGA petitioned PHMSA to extend the comment
period by thirty days. AGA stated that it is in the public interest to
extend the comment period so that gas utilities have the opportunity to
thoroughly review the regulation and draft annual report. AGA went on
to say that extending the comment period is the only way to provide
PHMSA with the necessary information to establish clear and consistent
data. PHMSA agrees that additional time should be allowed and is
extending the comment period from January 4, 2010 to February 4, 2010.

    Issued in Washington, DC, on December 28, 2009.
Jeffrey D. Wiese,
Associate Administrator for Pipeline Safety.
[FR Doc. E9-31078 Filed 12-30-09; 8:45 am]

BILLING CODE 4910-60-P


[Federal Register Volume 82, Number 134 (Friday, July 14, 2017)]
[Rules and Regulations]
[Pages 32464-32465]
[FR Doc No: 2017-14799]

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

Coast Guard

33 CFR Part 117

[Docket No. USCG-2017-0649]

Drawbridge Operation Regulation; New Jersey Intracoastal Waterway
(NJICW), Inside Thorofare, Atlantic City, NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the US40-322 (Albany Avenue) Bridge
which carries US 40 and US 322 across the NJICW (Inside Thorofare),
mile 70.0, at Atlantic City, NJ. The deviation is necessary to
facilitate the 7th Annual Atlantic City Triathlon. This deviation
allows the bridge to remain in the closed-to-navigation position.

DATES: The deviation is effective from 6 a.m. to 1 p.m. on Saturday,
August 5, 2017.

ADDRESSES: The docket for this deviation, [USCG-2017-0649] 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. Michael Thorogood, Bridge
Administration Branch Fifth District, Coast Guard, telephone 757-398-
6557, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The DelMoSports, LLC, on behalf of the New
Jersey Department of Transportation, owner and operator of the US40-322
(Albany Avenue) Bridge that carries US 40 and US 322 across the NJICW
(Inside Thorofare), mile 70.0, at Atlantic City, NJ, has requested a
temporary deviation from the current operating regulations to ensure
the safety of the increased volumes of cyclists and spectators that
will be participating in the 7th Annual Atlantic City Triathlon on
Saturday August 5, 2017. The bridge is a double bascule drawbridge. The
bridge has a vertical clearance of 10 feet above mean high water in the
closed position and unlimited vertical clearance in the open position.
    The current operating regulation is set out in 33 CFR 117.733(f).
Under this temporary deviation, the bridge will be maintained in the
closed-to-navigation position from 6 a.m. to 1 p.m. on Saturday, August
5, 2017.
    The NJICW (Inside Thorofare) is used by recreational vessels. The
Coast Guard has carefully considered the nature and volume of vessel
traffic on the waterway in publishing this temporary deviation.

    Vessels able to pass through the bridge in the closed-to-navigation
position may do so at any time. The bridge will be able to open for
emergencies, if at least 10 minutes notice is given, and there is no
immediate alternative route for vessels unable to pass through the
bridge in the closed position. The Coast Guard will also inform the
users of the waterway through our Local and Broadcast Notices to
Mariners of the change in operating schedule for the bridge so that
vessel operators can arrange their transits to minimize any impact
caused by the 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: July 11, 2017.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2017-14799 Filed 7-13-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 152 (Thursday, August 6, 2020)]
[Proposed Rules]
[Pages 47712-47714]
[FR Doc No: 2020-17044]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0746; Product Identifier 2019-CE-012-AD]
RIN 2120-AA64

Airworthiness Directives; Pilatus Aircraft Ltd. Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for Pilatus Aircraft Ltd. Model PC-12/47E airplanes. This proposed AD
results from mandatory continuing airworthiness information (MCAI)
originated by an aviation authority of another country to identify and
correct an unsafe condition on an aviation product. The MCAI describes
the unsafe condition as seizing of a main landing gear (MLG) spring
pack assembly. 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 September
21, 2020.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Pilatus Aircraft Ltd., Customer Technical Support (MCC), P.O. Box 992,
CH-6371 Stans, Switzerland; telephone: +41 (0)41 619 67 74; fax: +41
exception occurred on : 2020-17044.htm
exception occurred on : 2020-17044.htm
(0)41 619 67 73; email: aircraft.com">[email protected]aircraft.com; internet:
https://www.pilatus-aircraft.com/en. You may review this referenced
service information at the FAA, Airworthiness Products Section,
Operational Safety Branch, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call (816)
329-4148.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0746; 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 proposed AD, the regulatory evaluation, any comments received, and
other information. The street address for Docket Operations is listed
above. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Doug Rudolph, Aerospace Engineer, FAA,
General Aviation & Rotorcraft Section, International Validation Branch,
901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816)
329-4059; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2020-0746;
Product Identifier 2019-CE-012-AD'' at the beginning of your comments.
The FAA will consider all comments received by the closing date and may
amend this proposed AD because of those comments.
    Except for Confidential Business Information 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
https://regulations.gov, including any personal information you
provide. The FAA will also post a report summarizing each substantive
verbal contact it receives about this proposed AD.

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 Doug
Rudolph, Aerospace Engineer, FAA, General Aviation & Rotorcraft
Section, International Validation Branch, 901 Locust, Room 301, Kansas
City, Missouri 64106. Any commentary that the FAA receives which is not
specifically designated as CBI will be placed in the public docket for
this rulemaking.

Discussion

    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Community, has
issued AD No. 2019-0032, dated February 15, 2019 (referred to after
this as ``the MCAI''), to correct an unsafe condition for Pilatus
Aircraft Ltd. Model PC-12/47E airplanes. The MCAI states:

    An occurrence was reported of an unlocked main landing gear
(MLG) during landing of a PC-12/47E, equipped with electro-
mechanical landing gear. Subsequent investigation identified that
the aeroplane was equipped with an affected part [spring pack
assemblies having part number (P/N) 5<IP_ADDRESS>], which had
completely seized. Serviceable parts [spring pack assemblies having
P/N 5<IP_ADDRESS>] have a special surface treatment on the inner and
outer tube, which would have prevented the seizure.
    This condition, if not corrected, could lead to failure of an
MLG spring pack assembly, possibly resulting in inability to safely
extend the MLG and consequent loss of control of the aeroplane after
landing.
    To address this potential unsafe condition, Pilatus issued the
[service bulletin] SB to provide inspection and modification
instructions.
    For the reason described above, this [EASA] AD requires
replacement of affected parts with serviceable parts, and prohibits
(re)installation of affected parts.

    Forty-two airplanes were built that may have this version of the
spring pack assembly installed. An improved spring pack assembly with a
hard chrome plated inner tube was introduced in 2014. You may examine
the MCAI on the internet at https://www.regulations.gov by searching
for and locating Docket No. FAA-2020-0746.

Related Service Information Under 1 CFR Part 51

    Pilatus Aircraft Ltd. has issued PC-12 Service Bulletin No. 32-027,
dated January 7, 2019. The service information contains procedures for
inspecting the MLG spring pack assembly to determine the part number,
removing and discarding any affected spring pack assemblies, and
installing the improved design spring pack assemblies. 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.

FAA's Determination and Requirements of This Proposed AD

    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
had notified the FAA of the unsafe condition described in the MCAI and
service information referenced above. The FAA is proposing this AD
because it evaluated all information and determined the unsafe
condition exists and is likely to exist or develop on other products of
the same type design.

Costs of Compliance

    The FAA estimates that this proposed AD would affect 29 products of
U.S. registry. The FAA also estimates that it would take about 3 work-
hours per product to comply with the replacement requirements of this
proposed AD. The average labor rate is $85 per work-hour. Required
parts would cost about $5,000 per product.
    Based on these figures, the FAA estimates the cost of this proposed
AD on U.S. operators to be $152,395, or $5,255 per product.
    According to the manufacturer, some 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 costs in
this 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) Will not affect intrastate aviation in Alaska, and
    (3) 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.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Pilatus Aircraft Ltd.: Docket No. FAA-2020-0746; Product Identifier
2019-CE-012-AD.

(a) Comments Due Date

    The FAA must receive comments by September 21, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This airworthiness directive (AD) applies to Pilatus Aircraft
Ltd. Model PC-12/47E airplanes, serial numbers 1300 and 1451 thru
1944 (except serial number 1720), certificated in any category, with
a main landing gear (MLG) spring pack assembly part number (P/N)
5<IP_ADDRESS> installed.

(d) Subject

    Air Transport Association of America (ATA) Code 32: Landing
Gear.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as seizing of an
MLG spring pack assembly. The FAA is issuing this AD to prevent
failure of the MLG spring pack assembly, which could result in the
inability to extend the MLG with consequent loss of control of the
airplane after landing.

(f) Actions and Compliance

    (1) Within 2 months after the effective date of this AD, remove
from service MLG spring pack assembly P/N 5<IP_ADDRESS> and install
MLG spring pack assembly P/N 5<IP_ADDRESS> by following the
Accomplishment Instructions-Part A-Aircraft, section 3.B., in
Pilatus PC-12 Service Bulletin No. 32-027, dated January 7, 2019.
    (2) As of the effective date of this AD, do not install an MLG
spring pack assembly P/N 5<IP_ADDRESS> on any airplane.

(g) 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. Send information to ATTN: Doug
Rudolph, Aerospace Engineer, FAA, General Aviation & Rotorcraft
Section, International Validation Branch, 901 Locust, Room 301,
Kansas City, Missouri 64106; telephone:<PHONE_NUMBER>; fax: (816)
329-4090; email<EMAIL_ADDRESS>Before using any approved
AMOC, notify your appropriate principal inspector (PI), or lacking a
PI, your local Flight Standards District Office.

(h) Related Information

    Refer to MCAI European Aviation Safety Agency AD No. 2019-0032,
dated February 15, 2019, for related information. You may examine
the MCAI on the internet at https://www.regulations.gov by searching
for and locating Docket No. FAA-2020-0746. For service information
related to this AD, contact Pilatus Aircraft Ltd., Customer
Technical Support (MCC), P.O. Box 992, CH-6371 Stans, Switzerland;
phone: +41 (0)41 619 67 74; fax: +41 (0)41 619 67 73; email:
exception occurred on : 2020-17044.htm
exception occurred on : 2020-17044.htm
aircraft.com">[email protected]aircraft.com; internet: https://www.pilatus-aircraft.com/en. You may review this referenced service information
at the FAA, Airworthiness Products Section, Operational Safety
Branch, 901 Locust, Kansas City, Missouri 64106. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued on July 30, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-17044 Filed 8-5-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Proposed Rules]
[Pages 17000-17003]
[FR Doc No: 2015-07172]

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

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0675; Directorate Identifier 2014-NM-213-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Airbus Model A330-200, -200 Freighter, and -300 series
airplanes; and all Airbus Model A340-200, -300, -500, and -600 series
airplanes. This proposed AD was prompted by reports of cracks at
certain frames of the forward cargo door. This proposed AD would
require a detailed inspection for cracking of certain forward cargo
doors, and repair if necessary. We are proposing this AD to detect and
correct cracking at certain frames, which could result in the loss of
structural integrity of the forward cargo door.

DATES: We must receive comments on this proposed AD by May 15, 2015.

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 http://www.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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed 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. 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
425-227-1221.

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-2015-
0675; 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 proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

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:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2015-0675;
Directorate Identifier 2014-NM-213-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2014-0228, dated October 20, 2014 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for certain Airbus Model
A330-200, -200 Freighter, and -300 series airplanes; and all Airbus
Model A340-200, -300, -500, and -600 series airplanes. The MCAI states:

    An A330 aeroplane operator reported recently cases of crack
findings on two different aeroplanes, at frame 20A and at frame 20B
close to beam 3 of the forward cargo door. The first finding was
detected during scheduled maintenance, while the second one was
found during an inspection prompted by the first finding. Subsequent
analyses of these cracks identified that the first crack initiated
at frame 20B, which is the first primary load path, leading to
excessive loads at frame 20A and consequent cracking. Nevertheless,
on the other aeroplane, a crack was detected on frame 20A only.
Rupture of both frames 20A and 20B could lead to frame 21 failure
after a limited number of flight cycles (FC).
    This condition, if not detected and corrected, may potentially
result in the loss of structural integrity of the forward cargo
door, which could ultimately jeopardise the aeroplane's safe flight.
    Prompted by these findings, Airbus issued Alert Operators
Transmission (AOT) A52L010-14 to provide instructions for a one-time
inspection of frames 20A, 20B and 21 in the area of beam 3, until
the half pitch between beam 2 and beam 3.
    For the reasons described above, this [EASA] AD requires
identification of the Part Number (P/N) of the affected forward
cargo doors, a one-time detailed inspection (DET) of each affected
door and, depending on findings, accomplishment of applicable
corrective action(s) [contacting Airbus].
    This [EASA] AD is considered to be an interim action and further
AD action may follow.

    Required actions also include sending inspection results to Airbus.
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-2015-
0675.

Related Service Information Under 1 CFR Part 51

    Airbus has issued Alert Operators Transmission (AOT) A52L010-14,
dated September 30, 2014. The service information describes procedures
for an inspection for cracking of certain forward cargo doors, and
repair if necessary. The actions described in this AOT are intended to
correct the unsafe condition identified in the MCAI. This service
information is reasonably available; see ADDRESSES for ways to access
this service information.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.

Costs of Compliance

    We estimate that this proposed AD affects 89 airplanes of U.S.
registry.
    We also estimate that it would take about 1 work-hour per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Required parts would cost $0 per
product. Based on these figures, we estimate the cost of this proposed
AD on U.S. operators to be $7,565, or $85 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 32 work-hours and require parts costing $654,850, for a cost
of $657,570 per product. We have no way of determining the number of
aircraft that might need this action.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this proposed AD
is 2120-0056. The paperwork cost associated with this proposed AD has
been detailed in the Costs of Compliance section of this document and
includes time for reviewing instructions, as well as completing and
reviewing the collection of information. Therefore, all reporting
associated with this proposed AD is mandatory. Comments concerning the
accuracy of this burden and suggestions for reducing the burden should
be directed to the FAA at 800 Independence Ave. SW., Washington, DC
20591, ATTN: Information Collection Clearance Officer, AES-200.

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 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. 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.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Airbus: Docket No. FAA-2015-0675; Directorate Identifier 2014-NM-
213-AD.

(a) Comments Due Date

    We must receive comments by May 15, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the airplanes identified in paragraphs (c)(1)
and (c)(2) of this AD, certificated in any category.
    (1) Airbus Model A330-201, -202, -203, -223, -223F, -243, -243F,
-301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes,
all manufacturer serial numbers, except those on which Airbus
Modification 202702 has been embodied in production.
    (2) Airbus Model A340-211, -212, -213, -311, -312, -313, -541,
and -642 airplanes, all manufacturer serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

(e) Reason

    This AD was prompted by reports of cracks at certain frames of
the forward cargo door. We are issuing this AD to detect and correct
cracking at certain frames, which could result in the loss of
structural integrity of the forward cargo door.

(f) Compliance

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

(g) Inspection and Repair

    (1) Within 200 flight cycles after the effective date of this
AD, do a detailed inspection for cracking of an affected forward
cargo door, having a part number identified in paragraphs (g)(1)(i)
through (g)(1)(xii) of this AD, at frames 20A, 20B, and 21 areas
located above beam 3, from outside and inside, in accordance with
Airbus Alert Operators Transmission (AOT) A52L010-14, dated
September 30, 2014.
    (i) F523-70500-000.
    (ii) F523-70550-004.
    (iii) F523-70500-006.
    (iv) F523-70500-008.
    (v) F523-70500-010.
    (vi) F523-70500-012.
    (vii) F523-70500-014.
    (viii) F523-70550-000.
    (ix) F523-70550-002.
    (x) F523-70500-004.
    (xi) F523-70550-008.
    (xii) F523-70550-050.
    (2) If any crack is found during the inspection required by
paragraph (g)(1) of this AD, before further flight, repair 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).

(h) Definition of Detailed Inspection

    For the purposes of this AD, a detailed inspection is an
intensive examination of a specific item, installation, or assembly
to detect damage, failure, or irregularity. Available lighting is
normally supplemented with a direct source of good lighting at an
intensity deemed appropriate. Inspection aids such as a mirror,
magnifying lenses, etc., may be necessary. Surface cleaning and
elaborate procedures may be required.

(i) Reporting Requirement

    Submit a report of the findings (both positive and negative) of
the inspection required by paragraph (g)(1) of this AD to Serge
KIYMAZ, Structure Engineer, Structure Engineering--SEES1 CUSTOMER
SERVICES, Phone: +33(0)5 82 05 10 33, Fax: +33(0)5 61 93 36 14,
email<EMAIL_ADDRESS>at the applicable time specified in
paragraph (i)(1) or (i)(2) of this AD. The report must include the
information identified in Airbus AOT A52L010-14, dated September 30,
2014.
    (1) If the inspection was done on or after the effective date of
this AD: Submit the report within 30 days after the inspection.
    (2) If the inspection was done before the effective date of this
AD: Submit the report within 30 days after the effective date of
this AD.

(j) Parts Installation Limitation

    As of the effective date of this AD, installing a forward cargo
door having any part number specified in paragraphs (g)(1)(i)
through (g)(1)(xii) of this AD is permitted on any airplane,
provided that prior to installation, the door is inspected and,
depending on the findings, corrected, in accordance with Airbus AOT
A52L010-14, dated September 30, 2014.

(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. The AMOC approval letter must specifically reference this
AD.
    (2) Contacting the Manufacturer: 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 EASA;
or Airbus's EASA DOA. If approved by the DOA, the approval must
include the DOA-authorized signature.
    (3) Reporting Requirements: A federal agency may not conduct or
sponsor, and a person is not required to respond to, nor shall a
person be subject to a penalty for failure to comply with a
collection of information subject to the requirements of the
Paperwork Reduction Act unless that collection of information
displays a current valid OMB Control Number. The OMB Control Number
for this information collection is 2120-0056. Public reporting for
this collection of information is estimated to be approximately 5
minutes per response, including the time for reviewing instructions,
completing and reviewing the collection of information. All
responses to this collection of information are mandatory. Comments
concerning the accuracy of this burden and suggestions for reducing
the burden should be directed to the FAA at: 800 Independence Ave.
SW., Washington, DC 20591, Attn: Information Collection Clearance
Officer, AES-200.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2014-0228, dated October 20,
2014, 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-2015-0675.
    (2) 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. 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<PHONE_NUMBER>.

    Issued in Renton, Washington, on March 19, 2015.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-07172 Filed 3-30-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 36 (Monday, February 24, 2014)]
[Notices]
[Pages 10225-10226]
[FR Doc No: 2014-03851]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2014-0011-N-3]

Information Collection Requirements

AGENCY: Federal Railroad Administration (FRA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this
notice announces that the Information Collection Requirements (ICRs)
abstracted below have been forwarded to the Office of Management and
Budget (OMB) for review and comment. The ICRs describe the nature of
the information collections and their expected burdens. The Federal
Register notice with a 60-day comment period soliciting comments on the
following collections of information was published on December 23, 2013
(78 FR 246).

DATES: Comments must be submitted on or before March 26, 2014.

FOR FURTHER INFORMATION CONTACT: Ms. Janet Wylie, Office of Information
Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey
Ave. SE., Mail Stop 35, Washington, DC 20590 (telephone: (202) 493-
6353), or Ms. Kimberly Toone, Office of Information Technology, RAD-20,
Federal Railroad Administration, 1200 New Jersey Ave. SE., Mail Stop
35, Washington, DC 20590 (telephone:<PHONE_NUMBER>). (These telephone
numbers are not toll-free.).

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA),
Public Law 104-13, sec. 2, 109 Stat. 163 (1995) (codified as revised at
44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR part
1320, require Federal agencies to issue two notices seeking public
comment on information collection activities before OMB may approve
paperwork packages. 44 U.S.C. 3506, 3507; 5 CFR 1320.5, 1320.8(d)(1),
1320.12. On December 23, 2013, FRA published a 60-day notice in the
Federal Register soliciting comments on ICR that the agency was seeking
OMB approval. 78 FR 246. FRA received no comments after issuing this
60-day notice. Accordingly, DOT announces that these information
collection activities have been re-evaluated and certified under 5 CFR
1320.5(a) and forwarded to OMB for review and approval pursuant to 5
CFR 1320.12(c).
    Before OMB decides whether to approve these proposed collections of
information, it must provide 30 days for public comment. 44 U.S.C.
3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or
disapprove paperwork packages between 30 and 60 days after the 30 day
notice is published. 44 U.S.C. 3507 (b)-(c); 5 CFR 1320.12(d); see also
60 FR 44978, 44983, Aug. 29, 1995. OMB believes that the 30 day notice
informs the regulated community to file relevant comments and affords
the agency adequate time to digest public comments before it renders a
decision. 60 FR 44983, Aug. 29, 1995. Therefore, respondents should
submit their respective comments to OMB within 30 days of publication
to best ensure having their full effect. 5 CFR 1320.12(c); see also 60
FR 44983, Aug. 29, 1995.
    The summaries below describe the nature of the ICRs and the
expected burden. The revised requirements are being submitted for
clearance by OMB as required by the PRA.
    Title: Railroad Rehabilitation and Improvement Financing Program
    OMB Control Number: 2130-0580
    Type of Request: Revision of a currently approved collection.
    Affected Public: State and local governments, government sponsored
authorities and corporations, railroads, and joint ventures that
include at least one railroad.
    Abstract: The Consolidated Security, Disaster Assistance, and
Continuing Appropriations Act, 2009 (Pub. L. 110-329; September 30,
2008), established the Railroad Rehabilitation and Repair Program,
making Federal funds available directly to States. This Program allowed
grant to fund up to 80 percent of the cost of rehabilitation and
repairs to Class II and Class III railroad infrastructure damaged by
hurricanes, floods, and other natural disasters in areas that are
located in counties that have been identified in a Disaster Declaration
for Public Assistance by the President under title IV of the Robert T.
Stafford Disaster Relief and Emergency Assistance Act of 1974. Funding
was made available on a reimbursement basis for costs incurred after a
major disaster declaration that was made between January 1, 2008, and
the date of the publication of the notice of funding availability in
the counties covered by such a declaration. Rehabilitation and repairs
include rights-of-way, bridges, signals, and other infrastructure which
is part of the general railroad system of transportation and primarily
used by railroads to move freight traffic.
    FRA recently revised this ICR to allow for the submission of
additional grants under this program based on the Notice of Funding
Availability published by FRA on October 13, 2013, and the emergency
clearance request approved by OMB on November 5, 2013. Any grants
submitted as part of this previous information collection request were
due by December 9, 2013. Therefore, this revision no longer includes
any burden hours for the application process, as no new applications
are being accepted at this time.
    Due to the nature of these disaster assistance funds, current
economic conditions, and the various States need for immediate
assistance to vital freight transportation pathways and the important
role these sectors of transportation play in the overall national
economy, FRA is requesting OMB to extend this ICR in order to manage
the current grants obligated under this program until the remaining
grants have properly closed-out and are completed.
    Form Number(s): SF-425, SF271, SF-270.
    Annual Estimated Burden Hours: 504 hours
    Addressee: Send comments regarding these information collections to
the

Office of Information and Regulatory Affairs, Office of Management and
Budget, 725 Seventeenth Street NW., Washington, DC 20503, Attention:
FRA Desk Officer. Alternatively, comments may be sent via email to the
Office of Information and Regulatory Affairs (OIRA), Office of
Management and Budget, at the following address<EMAIL_ADDRESS>    Comments are invited on the following: Whether the proposed
collections of information are necessary for the proper performance of
the functions of the Department, including whether the information will
have practical utility; the accuracy of the Department's estimates of
the burden of the proposed information collections; ways to enhance the
quality, utility, and clarity of the information to be collected; and
ways to minimize the burden of the collections of information on
respondents, including the use of automated collection techniques or
other forms of information technology.
    A comment to OMB is best assured of having its full effect if OMB
receives it within 30 days of publication of this notice in the Federal
Register.

    Authority: 44 U.S.C. 3501-3520.

    Issued in Washington, DC on February 19, 2014.
Rebecca Pennington,
Chief Financial Officer.
[FR Doc. 2014-03851 Filed 2-21-14; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
[Notices]
[Pages 14272-14273]
[FR Doc No: 2022-05324]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-P-0959]

Determination That MPI DMSA KIDNEY REAGENT (Technetium Tc-99m
Succimer Kit), Injectable, Was Not Withdrawn From Sale for Reasons of
Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) has
determined that MPI DMSA KIDNEY REAGENT (Technetium Tc-99m Succimer
Kit), Injectable, was not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for Technetium Tc-99m Succimer Kit,
Injectable, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Michelle Weiner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 240
402-0374, [email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) Has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    MPI DMSA KIDNEY REAGENT (Technetium Tc-99m Succimer Kit),
Injectable, is the subject of NDA N017944, held by GE Healthcare, and
initially approved on May 18, 1982. MPI DMSA KIDNEY REAGENT is
indicated to be used as an aid in the scintigraphic evaluation of renal
parenchymal disorders. MPI DMSA KIDNEY REAGENT (Technetium Tc-99m
Succimer Kit), Injectable, is currently listed in the ``Discontinued
Drug Product List'' section of the Orange Book.
    Hyman, Phelps, & McNamara, P.C. submitted a citizen petition dated
August 27, 2021 (Docket No. FDA-

2021-P-0959), under 21 CFR 10.30, requesting that the Agency determine
whether MPI DMSA KIDNEY REAGENT (Technetium Tc-99m Succimer Kit),
Injectable, was withdrawn from sale for reasons of safety or
effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that MPI DMSA KIDNEY REAGENT (Technetium Tc-99m
Succimer Kit), Injectable, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that MPI DMSA KIDNEY REAGENT (Technetium Tc-99m
Succimer Kit), Injectable, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of MPI DMSA KIDNEY REAGENT (Technetium Tc-99m
Succimer Kit), Injectable, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have reviewed the available evidence and determined
that this drug product was not withdrawn from sale for reasons of
safety or effectiveness.
    Accordingly, the Agency will continue to list MPI DMSA KIDNEY
REAGENT ((Technetium Tc-99m Succimer Kit), Injectable, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to MPI DMSA KIDNEY
REAGENT ((Technetium Tc-99m Succimer Kit), Injectable, may be approved
by the Agency as long as they meet all other legal and regulatory
requirements for the approval of ANDAs. If FDA determines that labeling
for this drug product should be revised to meet current standards, the
Agency will advise ANDA applicants to submit such labeling.

    Dated: March 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05324 Filed 3-11-22; 8:45 am]
BILLING CODE 4164-01-P


Ron Evans/RTP/USEPA/US

03/11/2008 08:36 AM

To

"King, Heidi R."<EMAIL_ADDRESS> cc

Lydia Wegman, Janet Cakir/RTP/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA

Subject

RE: Ron - did you get Margo fax on ES-8 and Chap 7 # 17 & 18?

Heidi, here is the characterization of the alternative baseline in the ES.   It appears in ES.3 Caveats and Conclusions

	This analysis shows the costs and benefits of a standard of 0.075 ppm and other alternate standards of 0.079, 0.070, and 0.065.  The costs and benefits are incremental to a baseline that assumes some additional technology changes in the onroad technology sector.  If these changes do not occur, then cost for all standards would increase by $1.8 billion and benefits for all standards would increase by $360 million to $3.1 billion using 2006$ and a 3% discount rate, and $330 million to $2.8 billion when using a 7% discount rate. Details about costs and benefits using an alternate baseline can be found in appendix 9a.

footnotes to paragraph

 This cost could be offset in states that choose to replace existing periodic physical inspection of vehicles with remote onboard diagnostic device inspection in I/M programs.  As explained in later in this appendix, Remote OBD eliminates the need for periodic inspections of OBD-equipped vehicles by car owners.  EPA estimates that the nationwide installation of Remote OBD would save the nation’s motorists about $16 to $22 billion in inspection and convenience costs over a 10 year period.

㜀$␸䠀$葝ᚠ葞ᆘ摧䧕&฀Š

ory impact analyses.  Furthermore, the benefits only reflect a partial accounting of the total benefits associated with emission reductions related to the mobile controls included in this sensitivity analysis.

Ron Evans

Leader, Air Benefit & Cost Group

HEID/OAQPS/OAR/EPA

Mail Drop C-439-02

919-541-5488

919-541-0839 fax

We do one thing: overwhelm people's impossible expectations.


[Federal Register: July 17, 2008 (Volume 73, Number 138)]
[Notices]
[Page 41064]
[DOCID:fr17jy08-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. DI08-10-000]

John Werner; Notice of Declaration of Intention and Soliciting
Comments, Protests, and/or Motions To Intervene

July 10, 2008.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Declaration of Intention.
    b. Docket No.: DI08-10-000.
    c. Date Filed: June 22, 2008.
    d. Applicant: John Werner.
    e. Name of Project: Jordan Mill Hydroelectric Project.
    f. Location: The proposed Jordan Mill Hydroelectric Project will be
located on the Royal River, near the town of New Gloucester, in
Cumberland County, Maine.
    g. Filed Pursuant to: Section 23(b)(1) of the Federal Power Act, 16
U.S.C. 817(b).
    h. Applicant Contact: John Werner, 17 Sawyer Road, New Gloucester,
Maine 04260; telephone:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>    i. FERC Contact: Any questions on this notice should be addressed
to Henry Ecton,<PHONE_NUMBER>, or e-mail address:
<EMAIL_ADDRESS>    j. Deadline for filing comments, protests, and/or motions: August
11, 2008.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments, protests, and/or
interventions may be filed electronically via the Internet in lieu of
paper. Any questions, please contact the Secretary's Office. See, 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site at http://www.ferc.gov under the ``e-Filing'' link.
    Please include the docket number (DI08-10-000) on any comments,
protests, and/or motions filed.
    k. Description of Project: The proposed Jordan Mill Hydropower
Project will include: (1) An existing 10-foot-high, 25-foot-long
concrete-and-cut-stone gravity dam impounding a 38.25-acre-foot
reservoir; (2) a proposed 450-foot-long, 12-inch-diameter plastic
penstock; (3) a proposed 8-foot-wide by 12-foot-long powerhouse
containing a 10-kW generator; (4) a 390-foot-long transmission line;
and (5) appurtenant facilities. The proposed project will not be
connected to an interstate grid, and will not occupy any tribal or
federal lands. Power generated will be used on-site.
    When a Declaration of Intention is filed with the Federal Energy
Regulatory Commission, the Federal Power Act requires the Commission to
investigate and determine if the interests of interstate or foreign
commerce would be affected by the project. The Commission also
determines whether or not the project: (1) Would be located on a
navigable waterway; (2) would occupy or affect public lands or
reservations of the United States; (3) would utilize surplus water or
water power from a government dam; or (4) if applicable, has involved
or would involve any construction subsequent to 1935 that may have
increased or would increase the project's head or generating capacity,
or have otherwise significantly modified the project's pre-1935 design
or operation.
    l. Locations of the Application: Copies of this filing are on file
with the Commission and are available for public inspection. This
filing may be viewed on the Web at http://www.ferc.gov using the
``eLibrary'' link, select ``Docket'' and follow the
instructions. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``PROTESTS'', AND/
OR ``MOTIONS TO INTERVENE'', as applicable, and the Docket Number of
the particular application to which the filing refers. A copy of any
motion to intervene must also be served upon each representative of the
Applicant specified in the particular application.
    p. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-16302 Filed 7-16-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Rules and Regulations]
[Pages 12520-12524]
[FR Doc No: 2019-06333]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0665; FRL-9987-27]

Zoxamide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
zoxamide in or on Pepper/Eggplant Subgroup 8-10B. Gowan Company
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective April 2, 2019. Objections and
requests for hearings must be received on or before June 3, 2019, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID)

number EPA-HQ-OPP-2017-0665, is available at http://www.regulations.gov
or at the Office of Pesticide Programs Regulatory Public Docket (OPP
Docket) in the Environmental Protection Agency Docket Center (EPA/DC),
West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave.
NW, Washington, DC 20460-0001. The Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0665 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
June 3, 2019. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0665, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 27, 2018 (83 FR 8408) (FRL-
9972-17), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7F8615) by Gowan Company, 370 South Main Street, P.O. Box 5569, Yuma,
AZ 85364. The petition requested that 40 CFR 180.567 be amended by
establishing tolerances for residues of the fungicide zoxamide (3,5-
dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide)
in or on Pepper/Eggplant Subgroup 8-10B at 1.0 parts per million (ppm).
That document referenced a summary of the petition prepared by Gowan
Company, the registrant, which is available in the docket, http://www.regulations.gov. That notice of filing document relied on the
tolerance level referred to in the referenced summary, which requested
a tolerance level as 0.9 ppm; however, the full submitted petition
requested a tolerance level of 1.0 ppm, which the Agency used for the
tolerance level and its safety assessment. One comment was received on
the notice of filing; EPA's response is discussed in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for zoxamide including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with zoxamide follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The toxicity data of zoxamide indicate that the primary target
organ is the liver. Following zoxamide exposures, liver and thyroid
weights increased along with liver histopathological changes and

increases in alkaline phosphatase. Systemic toxicity was not seen in
the 28-day rat dermal toxicity study up to the limit dose. There are no
concerns for neurotoxicity, immunotoxicity, developmental toxicity, or
reproductive toxicity. There was no evidence of increased
susceptibility (qualitative or quantitative) for the offspring in the
reproduction studies or for fetuses following in utero exposure in the
developmental studies. Zoxamide is classified as ``not likely to be
carcinogenic to humans'' based on results from carcinogenicity studies
in rats and mice.
    Specific information on the studies received and the nature of the
adverse effects caused by zoxamide as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Zoxamide. Human Health Aggregate Risk
Assessment for the Proposed New Uses on Pepper/Eggplant Subgroup 8-10B
at page 19 in docket ID number EPA-HQ-OPP-2017-0665.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for zoxamide used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of 18 July 2014 (79 FR 41911) (FRL-
9913-35).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to zoxamide, EPA considered exposure under the petitioned-for
tolerances as well as all existing zoxamide tolerances in 40 CFR
180.567. EPA assessed dietary exposures from zoxamide in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for zoxamide; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA National
Health and Nutrition Examination Survey, What We Eat in America
(NHANES/WWEIA) database. As to residue levels in food, EPA assumed
tolerance level residues, 100% crop treated (CT), and default
processing factors for all established and proposed commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that zoxamide does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for zoxamide. Tolerance level residues and/or 100%
CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for zoxamide in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of zoxamide. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM
GW), the estimated drinking water concentrations (EDWCs) of zoxamide
for chronic exposures are estimated to be 22.84 parts per billion (ppb)
for surface water and 65.8 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 65.8 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Zoxamide is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found zoxamide to share a common mechanism of toxicity
with any other substances, and zoxamide does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that zoxamide does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this

provision, EPA either retains the default value of 10X, or uses a
different additional safety factor when reliable data available to EPA
support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There was no evidence for
increased susceptibility following prenatal exposure in developmental
toxicity studies in rats and rabbits. Additionally, there was no
evidence for increased susceptibility following pre- or postnatal
exposure in the reproduction and fertility effects study in rats.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for zoxamide is complete.
    ii. There is no indication that zoxamide is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. There is no evidence that zoxamide results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to zoxamide in drinking water. These assessments
will not underestimate the exposure and risks posed by zoxamide.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
zoxamide is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
zoxamide from food and water will utilize 6.4% of the cPAD for children
1-2 years old, the population group receiving the greatest exposure.
There are no residential uses for zoxamide.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposures take into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). A short- and
intermediate-term adverse effect was identified; however, zoxamide is
not registered for any use patterns that would result in short- and
intermediate-term residential exposure. Because there is no short- and
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess short- and
intermediate-term risks), no further assessment of short- and
intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating short- and intermediate-term
risk for zoxamide.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, zoxamide is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to zoxamide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Gas chromatography with electron
capture detection (GC/ECD) and GC with mass selective detection (GC/
MSD)) is available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established MRLs for zoxamide for Pepper/Eggplant
Subgroup 8-10B.

C. Response to Comments

    In response to the notice of filing for this action, the Agency
received the following from an anonymous citizen: ``DENY APPROVAL [sic]
OF THIS PRODUCT. IT SHOULD NOT BE USED ANYWHERE ON EARTH. IT IS HIGHLY
TOXIC TO FISH AND IT PERSISTS IN THE ENVIRONMENT FOR LONG PERIODS OF
TIME. DENY APPROVAL.'' The concerns raised in this comment are outside
the scope of the human health safety assessment conducted for this
tolerance action. Section 408 of the FFDCA authorizes EPA to establish
tolerances that it determines to be safe and instructs EPA when making
that determination to consider information related to human health, not
the environment. See 21 U.S.C. 346a(b)(2)(A), (C), (D).

V. Conclusion

    Therefore, tolerances are established for residues of zoxamide,
zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-
methylbenzamide), in or on Pepper/Eggplant Subgroup 8-10B at 1.0 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211,

entitled ``Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001);
Executive Order 13045, entitled ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997); or Executive Order 13771, entitled ``Reducing Regulations and
Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). This
action does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et
seq.), nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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 action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: March 15, 2019.
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

     Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.567, add alphabetically the commodity ``Pepper/Eggplant
Subgroup 8-10B'' to the table in paragraph (a)(1) to read as follows:

Sec.  180.567  Zoxamide; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Pepper/Eggplant Subgroup 8-10B..........................             1.0

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

* * * * *
[FR Doc. 2019-06333 Filed 4-1-19; 8:45 am]
BILLING CODE 6560-50-P