[Federal Register Volume 79, Number 101 (Tuesday, May 27, 2014)]
[Notices]
[Pages 30232-30234]
[FR Doc No: 2014-12130]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Petition for Exemption From the Federal Vehicle Theft Prevention
Standard; Jaguar Land Rover North America LLC

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Grant of petition for exemption.

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SUMMARY: This document grants in full the Jaguar Land Rover North
America LLC's, (Jaguar Land Rover) petition for an exemption of the
Discovery Sport vehicle line in accordance with 49 CFR part 543,
Exemption from Vehicle Theft Prevention Standard. This petition is
granted because the agency has determined that the antitheft device to
be placed on the line as standard equipment is likely to be as
effective in reducing and deterring motor vehicle theft as compliance
with the parts-marking requirements of 49 CFR part 541, Federal Motor
Vehicle Theft Prevention Standard (Theft Prevention Standard). Jaguar
Land Rover also requested confidential treatment of specific
information in its petition. The agency will address Jaguar Land
Rover's request for confidential treatment by separate letter.

DATES: The exemption granted by this notice is effective beginning with
the 2015 model year (MY).

FOR FURTHER INFORMATION CONTACT: Ms. Deborah Mazyck, Office of
International Policy, Fuel Economy and Consumer Programs, NHTSA, W43-
443, 1200 New Jersey Avenue SE., Washington, DC 20590. Ms. Mazyck's
phone number is<PHONE_NUMBER>. Her fax number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a petition dated February 19, 2014,
Jaguar Land Rover requested an exemption from the parts-marking
requirements of the Theft Prevention Standard for the Jaguar Land Rover
Discovery Sport vehicle line beginning with MY 2015. The petition
requested an exemption from parts-marking pursuant to 49 CFR part 543,
Exemption from Vehicle Theft Prevention Standard, based on the
installation of an antitheft device as standard equipment for the
entire vehicle line.
    Under 49 CFR 543.5(a), a manufacturer may petition NHTSA to grant
an exemption for one vehicle line per model year. In its petition,
Jaguar Land Rover provided a detailed description and diagram of the
identity, design, and location of the components of the antitheft
device for the Discovery Sport vehicle line. Jaguar Land Rover stated
that the MY 2015 Discovery Sport vehicle line will be equipped with a
passive, transponder based, electronic engine immobilizer antitheft
device as standard equipment. Key components of its antitheft device
will include a power train control module (PCM), instrument cluster,
body control module (BCM), keyless vehicle module (KVM), remote
frequency receiver (RFA), Immobilizer Antenna Unit, Smart Key and door
control units. Jaguar Land Rover stated that its antitheft device will
also be installed with an audible and visual perimeter alarm system as
standard equipment. Jaguar Land Rover stated that the perimeter alarm
system can be armed with the Smart Key or programmed to be passively
armed. The alarm will sound and the vehicle's exterior lights will
flash if unauthorized entry is attempted by opening the hood, doors or
luggage compartment. Jaguar Land Rover's submission is considered a
complete petition as required by 49 CFR 543.7, in that it meets the
general requirements contained in Sec.  543.5 and the specific content
requirements of Sec.  543.6.
    The immobilizer device is automatically armed when the Smart Key is
removed from the vehicle. Jaguar Land Rover stated that the Smart key
is programmed and synchronized to the vehicle through the means of a
unique identification key code for each key and a randomly generated
secret code that is unique to each vehicle.
    Jaguar Land Rover stated that there will be three methods for
unlocking the doors and starting the engine of the Discovery Sport
vehicle line. The three methods of system operation will either be
through the vehicle's automatic detection of the Smart Key, unlocking
the vehicle with the Smart key unlock button or by using the emergency
key blade. Jaguar Land Rover stated that automatic detection of the
Smart key method occurs when authentication of the correct Smart Key
via a low frequency to remote frequency challenge response sequence
occurs. Specifically, when the driver approaches the vehicle and pulls
the driver's door handle, the doors will unlock. When the driver

presses the ignition start button, a search begins to find and
authenticate the Smart Key within the vehicle interior. If successful,
this information is passed through a coded data transfer to the BCM via
the RFA. Jaguar Land Rover stated that the BCM will then pass the valid
key status to the instrument cluster, send the ``key valid'' message to
the PCM, initiate a coded data transfer and authorize the engine to
start. Method two of unlocking the vehicle with the Smart Key unlock
button occurs when the driver approaches the vehicle, presses the Smart
Key unlock button and unlocks the doors. Jaguar Land Rover stated that
once the driver presses the ignition start button, the operation
process is the same as method one. Method three involves using the
emergency key blade. Jaguar Land Rover stated that if the Smart Key has
a discharged or damaged battery, there is an emergency key blade that
can be removed from the Smart Key and used to unlock the doors. Once
the driver presses the ignition start button, a search begins to find
and authenticate the Smart Key within the vehicle interior. If this is
unsuccessful, the Smart Key needs to be docked in the lower steering
column cowl. Once the Smart Key is placed in the correct position and
the ignition start button is pressed again, the BCM and Smart key enter
a coded data exchange via the immobilizer antenna unit. The BCM passes
the valid key status to the instrument cluster, via the immobilizer
antenna unit and then sends the ``key valid'' message to the PCM
initiating a coded data transfer. If successful, the engine will start
the vehicle.
    In addressing the specific content requirements of Sec.  543.6,
Jaguar Land Rover provided information on the reliability and
durability of its proposed device. To ensure reliability and durability
of the device, Jaguar Land Rover conducted tests based on its own
specified standards. Jaguar Land Rover provided a detailed list of the
tests conducted (i.e., temperature and humidity cycling, high and low
temperature cycling, mechanical shock, random vibration, thermal
stress/shock tests, material resistance tests, dry heat, dust and fluid
ingress tests). Jaguar Land Rover stated that it believes that its
device is reliable and durable because it has complied with specified
requirements for each test. Additionally, Jaguar Land Rover stated that
the key recognition sequence includes in excess of a billion code
combinations which include encrypted data that are secure against
copying. Jaguar Land Rover also stated that the coded data transfer
between modules use a unique secure identifier, a random number and a
secure public algorithm. Furthermore, Jaguar Land Rover stated that
since the Discovery Sport vehicle line will utilize push button vehicle
ignition, it does not have a conventional mechanical key barrel.
Therefore, there will be no means of forcibly bypassing the key-locking
system.
    Jaguar Land Rover stated that the Discovery Sport is a new vehicle
line and therefore no theft data is available. Jaguar Land Rover
further stated that its immobilizer antitheft device is substantially
similar to the antitheft device installed on the Jaguar F-Type, Jaguar
XK, Jaguar XJ, Land Rover LR2 and Land Rover Range Rover Evoque vehicle
lines and have all been granted parts-marking exemptions by the agency.
Jaguar Land Rover stated that based on MY 2011 theft information
published by NHTSA, the Jaguar Land Rover vehicles equipped with
immobilizers had a combined theft rate of 0.79 per thousand vehicles,
which is below NHTSA's overall theft rate of 0.99 thefts per thousand.
The theft rates for the Jaguar XK, XJ and Land Rover LR2 are 0.8192,
1.4025 and 0.9001, respectively. Theft rate data is not available for
the Jaguar F-Type and Land Rover Evoque. Jaguar Land Rover believes
these low theft rates demonstrate the effectiveness of the immobilizer
device. Additionally, Jaguar Land Rover notes a Highway Loss Data
Institute news release (July 19, 2000) showing approximately a 50%
reduction in theft for vehicles installed with an immobilizer device.
    The agency agrees that the device is substantially similar to
devices installed on other vehicle lines for which the agency has
already granted exemptions
    Based on the supporting evidence submitted by Jaguar Land Rover on
its device, the agency believes that the antitheft device for the
Discovery Sport vehicle line is likely to be as effective in reducing
and deterring motor vehicle theft as compliance with the parts-marking
requirements of the Theft Prevention Standard (49 CFR part 541). The
agency concludes that the device will provide the five types of
performance listed in Sec.  543.6(a)(3): promoting activation; attract
attention to the efforts of an unauthorized person to enter or move a
vehicle by means other than a key; preventing defeat or circumvention
of the device by unauthorized persons; preventing operation of the
vehicle by unauthorized entrants; and ensuring the reliability and
durability of the device.
    Pursuant to 49 U.S.C. 33106 and 49 CFR 543.7 (b), the agency grants
a petition for exemption from the parts-marking requirements of Part
541 either in whole or in part, if it determines that, based upon
substantial evidence, the standard equipment antitheft device is likely
to be as effective in reducing and deterring motor vehicle theft as
compliance with the parts-marking requirements of Part 541. The agency
finds that Jaguar Land Rover has provided adequate reasons for its
belief that the antitheft device for the Jaguar Land Rover Discovery
Sport vehicle line is likely to be as effective in reducing and
deterring motor vehicle theft as compliance with the parts-marking
requirements of the Theft Prevention Standard (49 CFR Part 541). This
conclusion is based on the information Jaguar Land Rover submitted on
its device.
    For the foregoing reasons, the agency hereby grants in full Jaguar
Land Rover's petition for exemption for the Jaguar Land Rover Discovery
Sport vehicle line from the parts-marking requirements of 49 CFR Part
541. The agency notes that 49 CFR Part 541, Appendix A-1, identifies
those lines that are exempted from the Theft Prevention Standard for a
given model year. 49 CFR Part 543.7(f) requires NHTSA to publish a
notice of its decision to grant or deny an exemption petition in the
Federal Register. Advanced listing, including the release of future
product nameplates, the beginning model year for which the petition is
granted and a general description of the antitheft device is necessary
in order to notify law enforcement agencies of new vehicle lines
exempted from the parts-marking requirements of the Theft Prevention
Standard.
    If Jaguar Land Rover decides not to use the exemption for this
line, it must formally notify the agency. If such a decision is made,
the line must be fully marked according to the requirements under 49
CFR Parts 541.5 and 541.6 (marking of major component parts and
replacement parts).
    NHTSA notes that if Jaguar Land Rover wishes in the future to
modify the device on which this exemption is based, the company may
have to submit a petition to modify the exemption. Part 543.7(d) states
that a Part 543 exemption applies only to vehicles that belong to a
line exempted under this part and equipped with the antitheft device on
which the line's exemption is based. Further, Part 543.9(c)(2) provides
for the submission of petitions ``to modify an exemption to permit the
use of an antitheft device similar to but differing from the one
specified in that exemption.''

    The agency wishes to minimize the administrative burden that Part
543.9(c)(2) could place on exempted vehicle manufacturers and itself.
The agency did not intend in drafting Part 543 to require the
submission of a modification petition for every change to the
components or design of an antitheft device. The significance of many
such changes could be de minimis. Therefore, NHTSA suggests that if the
manufacturer contemplates making any changes, the effects of which
might be characterized as de minimis, it should consult the agency
before preparing and submitting a petition to modify.

    Authority: 49 U.S.C. 33106; delegation of authority at 49 CFR
1.50.

Claude H. Harris,
Acting Associate Administrator for Rulemaking.
[FR Doc. 2014-12130 Filed 5-23-14; 8:45 am]
BILLING CODE 4910-59-P


	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-R03-OAR-2007-1139; FRL-         ]

	Approval and Promulgation of Air Quality Implementation Plans;
Virginia;  Control of Volatile Organic Compound (VOCs) Emissions from
the Kraft Foods Global, Inc.— Bakery located in Henrico County,
Virginia

AGENCY:	Environmental Protection Agency (EPA).

ACTION:	Final rule.

SUMMARY:  EPA is approving a State Implementation Plan (SIP) revision
submitted by the Commonwealth of Virginia.  This revision pertains to a
federally enforceable State operating permit containing terms and
conditions for the control of emissions of volatile organic compounds
(VOCs) from the Kraft Foods Global, Inc.—Richmond Bakery located in
Henrico County, Virginia.  The submittal is for the purpose of meeting
the requirements for reasonably available control technology (RACT) in
order to implement the maintenance plan for the Richmond 8-hour ozone
maintenance area.  EPA is approving the revision to the Virginia SIP in
accordance with the requirements of the Clean Air Act (CAA).

EFFECTIVE DATE:  This final rule is effective on [insert date 30 days
from date of publication].

ADDRESSES:  EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2007-1139.  All documents in the docket are listed in
the www.regulations.gov website.   Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute.  Certain other material, such as copyrighted
material, is not placed on the Internet and

by statute.  Certain other material, such as copyrighted material, is
not placed on the Internet and

will be publicly available only in hard copy form.  Publicly available
docket materials are available either electronically through
www.regulations.gov or in hard copy for public inspection during normal
business hours at the Air Protection Division, U.S. Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania 19103. Copies of the State submittal are available at the
Virginia Department of Environmental Quality, 629 East Main Street,
Richmond, Virginia, 23219.

FOR FURTHER INFORMATION CONTACT:  Irene Shandruk,<PHONE_NUMBER>, or by
e-mail at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

SUPPLEMENTARY INFORMATION:

I.  Background

On January 31, 2008 (73 FR 5781), EPA published a notice of proposed
rulemaking (NPR) for the Commonwealth of Virginia.  The NPR proposed
approval of Virginia’s SIP revision for the purpose of meeting RACT
requirements in order to implement the maintenance plan for the Richmond
8-hour ozone maintenance area.  The formal SIP revision was submitted by
the Virginia Department of Environmental Quality on October 29, 2007.
Other specific requirements of RACT and the rationale for EPA’s
proposed action are explained in the NPR and will not be restated here.
No comments were received on the NPR.

II.  Summary of SIP Revision

The Virginia Department of Environmental Quality is requesting that a
revision to the Commonwealth’s SIP concerning a federally enforceable
State operating permit containing terms

and conditions for the control of emissions of VOCs from the Kraft Foods
Global, Inc. – Richmond Bakery located in Henrico County, Virginia be
approved.  The purpose of this revision is for meeting the requirements
for RACT in order to implement the maintenance plan for the Richmond
8-hour ozone maintenance area.

III.  General Information Pertaining to SIP Submittals From the
Commonwealth of Virgina

In 1995, Virginia adopted legislation that provides, subject to certain
conditions, for an environmental assessment (audit) “privilege” for
voluntary compliance evaluations performed by a regulated entity.  The
legislation further addresses the relative burden of proof for parties
either asserting the privilege or seeking disclosure of documents for
which the privilege is claimed.  Virginia's legislation also provides,
subject to certain conditions, for a penalty waiver for violations of
environmental laws when a regulated entity discovers such violations
pursuant to a voluntary compliance evaluation and voluntarily discloses
such violations to the Commonwealth and takes prompt and appropriate
measures to remedy the violations.  Virginia's Voluntary Environmental
Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege
that protects from disclosure documents and information about the
content of those documents that are the product of a voluntary
environmental assessment. The Privilege Law does not extend to documents
or information (1) that are generated or developed before the
commencement of a voluntary environmental assessment; (2) that are
prepared independently of the assessment process; (3) that demonstrate a
clear, imminent and substantial danger to the public health or
environment; or (4) that are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the Attorney
General provided a legal opinion that states that the Privilege law, Va.
Code Sec. 10.1-1198,  precludes granting a privilege to documents and
information “required by law,” including documents and information
“required by Federal law to maintain program delegation, authorization
or approval,” since Virginia must (enforce Federally authorized
environmental programs in a manner that is no less stringent than their
Federal counterparts. . . .”   The opinion concludes that
“[r]egarding ( 10.1-1198, therefore, documents or other information
needed for civil or criminal enforcement under one of these programs
could not be privileged because such documents and information are
essential to pursuing enforcement in a manner required by Federal law to
maintain program delegation, authorization or approval.”

Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o
the extent consistent with requirements imposed by Federal law,”  any
person making a voluntary disclosure of information to a state agency
regarding a violation of an environmental statute, regulation, permit,
or administrative order is granted immunity from administrative or civil
penalty.  The Attorney General's January 12, 1998 opinion states that
the quoted language renders this statute inapplicable to enforcement of
any Federally authorized programs, since “no immunity could be
afforded from administrative, civil, or criminal penalties because
granting such immunity would not be consistent with Federal law, which
is one of the criteria for immunity.”

Therefore, EPA has determined that Virginia's Privilege and Immunity
statutes will not preclude the Commonwealth from enforcing its program
consistent with the Federal requirements.  In any event, because EPA has
also determined that a state audit privilege and immunity law can affect
only state enforcement and cannot have any impact on Federal enforcement
authorities, EPA may at any time invoke its authority under the CAA,
including, for example, sections 113, 167, 205, 211 or 213, to enforce
the requirements or prohibitions of the state plan, independently of any
state enforcement effort.  In addition, citizen enforcement under
section 304 of the Clean Air Act is likewise unaffected by this, or any,
state audit privilege or immunity law.

Other specific requirements of the SIP revision and the rationale for
EPA's proposed action are explained in the NPR and will not be restated
here.  No public comments were received on the NPR.

IV.  Final Action

Virginia has met the requirements concerning a federally enforceable
State operating permit containing terms and conditions for the control
of emissions of VOCs from the Kraft Foods Global, Inc. – Richmond
Bakery located in Henrico County, Virginia, and EPA is therefore
approving Virginia’s revision for the purpose of this revision is for
meeting the requirements for RACT in order to implement the maintenance
plan for the Richmond 8-hour ozone maintenance area.

IV.   Statutory and Executive Order Reviews

A.   General Requirements

Under the Clean Air Act, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations.  42 U.S.C. 7410(k); 40 CFR 52.02(a).  Thus, in
reviewing SIP submissions, EPA’s role is to approve state choices,
provided that they meet the criteria of the Clean Air Act.  Accordingly,
this action merely approves state law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
state law.  For that reason, this action:

is not a "significant regulatory action” subject to review by the
Office of Management and Budget under Executive Order 12866 (58 FR
51735, October 4, 1993);

does not impose an information collection burden under the provisions of
the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

is certified as not having a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.);

does not contain any unfunded mandate or significantly or uniquely
affect small governments, as described in the Unfunded Mandates Reform
Act of 1995 (Public Law 104-4);

does not have Federalism implications as specified in Executive Order
13132 (64 FR 43255, August 10, 1999);

is not an economically significant regulatory action based on health or
safety risks subject to Executive Order 13045 (62 FR 19885, April 23,
1997);

is not a significant regulatory action subject to Executive Order 13211
(66 FR 28355, May 22, 2001);

is not subject to requirements of Section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note)
because application of those requirements would be inconsistent with the
Clean Air Act; and

does not provide EPA with the discretionary authority to address, as
appropriate, disproportionate human health or environmental effects,
using practicable and legally permissible methods, under Executive Order
12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP
is not approved to apply in Indian country located in the state, and EPA
notes that it will not impose substantial direct costs on tribal
governments or preempt tribal law.

B.   Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating the
rule must submit a rule report, which includes a copy of the rule, to
each House of the Congress and to the Comptroller General of the United
States.  EPA will submit a report containing this action 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.  A major rule cannot
take effect until 60 days after it is published in the Federal Register.
 This action is not a “major rule” as defined by 5 U.S.C. 804(2).

 The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating the
rule must submit a rule report, which includes a copy of the rule, to
each House of the Congress and to the Comptroller General of the United
States.  Section 804, however, exempts from section 801 the following
types of rules: rules of particular applicability; rules relating to
agency management or personnel; and rules of agency organization,
procedure, or practice that do not substantially affect the rights or
obligations of non-agency parties.  5 .S.C. 804(3).  Because this is a
rule of particular applicability, EPA is not required to submit a rule
report regarding this action under section 801.

C.  Petitions for Judicial Review

Under section 307(b)(1) of the Clean Air Act, petitions for judicial
review of this action must be filed in the United States Court of
Appeals for the appropriate circuit by [Insert date 60 days from date of
publication of this document in the Federal Register].  Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action.

This action approving Virginia’s SIP revision pertaining to a
federally enforceable State operating permit containing terms and
conditions for the control of emissions of volatile organic compounds
(VOCs) from the Kraft Foods Global, Inc.—Richmond Bakery located in
Henrico County, Virginia may not be challenged later in proceedings to
enforce its requirements.  (See section 307(b)(2).)

List of Subjects in 40 CFR part 52

Environmental protection, Air pollution control, Incorporation by
reference, Ozone, Reporting and recordkeeping requirements, Volatile
organic compounds.

                                 /s/

__April 3, 2008_______________    			__________________________

Dated:                            				William T. Wisniewski, Acting
                         							Regional Administrator,

                                  					Region III.

40 CFR Part 52 is amended as follows:

PART 52 - [AMENDED]

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

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

Subpart VV ( Virginia

2. In ( 52.2420, the table in paragraph (d) is amended by adding the
entry for Kraft Food Global, Inc. – Richmond Bakery at the end of the
table to read as follows:

( 52.2420  	Identification of plan.

*   *  *   *  *

(d) * * *

	EPA-APPROVED SOURCE-SPECIFIC REQUIREMENTS

Source Name	Permit/order or registration number	State effective date	EPA
approval date	40 CFR part 52 citation

*     *     *     *     *    *     *

Kraft Foods Global, Inc. – Richmond Bakery	Registration No. 50703
9/19/07	[Insert Federal Register publication date] [Insert page number
where the document begins]	52.2420(d)(8)

*    *     *     *      *

 PAGE

 PAGE  9


[Federal Register Volume 84, Number 141 (Tuesday, July 23, 2019)]
[Notices]
[Pages 35384-35385]
[FR Doc No: 2019-15579]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IN14-4-000]

Vitol Inc. and Federico Corteggiano; Updated Notice of
Designation of Commission Staff as Non-Decisional

    With respect to an order issued by the Commission on July 10, 2019,
in the above-captioned docket, with the exceptions noted below, the
staff of the Office of Enforcement are designated as non-decisional in
deliberations by the Commission in this docket.\1\ Accordingly,
pursuant to 18 CFR 385.2202 (2018), they will not serve as advisors to
the Commission or take part in the Commission's review of any offer of
settlement. Likewise, as non-decisional staff, pursuant to 18 CFR
385.2201 (2018), they are prohibited from communicating with advisory
staff concerning any deliberations in this docket.
---------------------------------------------------------------------------

    \1\ Vitol Inc. and Federico Corteggiano, 168 FERC 61,013 (2019).
---------------------------------------------------------------------------

    Exceptions to this designation as non-decisional are:

Jeremy Medovoy

Mark Nagle
Jessica Wack
Ambrea Watts
Benjamin Jarrett
Alfred Jasins
Darice Xue
Joel Douglas
Michelle Norman

    Dated: July 17, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-15579 Filed 7-22-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 248 (Friday, December 28, 2018)]
[Notices]
[Pages 67289-67290]
[FR Doc No: 2018-28219]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4662]

International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products;
Stability Testing of New Veterinary Drug Substances and Medicinal
Products in Climatic Zones III and IV; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry (GFI) #259 entitled
``Stability Testing of New Veterinary Drug Substances and Medicinal
Products in Climatic Zones III and IV'' (VICH GL58). This draft
guidance has been developed for veterinary use by the International
Cooperation on Harmonisation of Technical Requirements for Registration
of Veterinary Medicinal Products (VICH). This VICH draft guidance
document is an annex to the VICH parent stability guidance, GFI #73/
VICH GL3(R), ``Stability Testing of New Veterinary Drug Substances and
Medicinal Products (Revision),'' and provides guidance regarding the
stability data package for a new veterinary drug substance and
medicinal product to be included in a registration or application
submitted within the regions in climatic zones III and IV.

DATES: Submit either electronic or written comments on the draft
guidance by February 26, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-4662 for ``Stability Testing of New Veterinary Drug
Substances and Medicinal Products in Climatic Zones III and IV.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Mai Huynh, Center for Veterinary
Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft GFI #259 entitled
``Stability Testing of New Veterinary Drug Substances and Medicinal
Products in Climatic Zones III and IV'' (VICH GL58). In recent years,
many important initiatives have been undertaken by regulatory
authorities and industry associations to promote the international
harmonization of regulatory requirements. FDA has participated in
efforts to enhance harmonization and has expressed its commitment to
seek scientifically based, harmonized technical procedures for the
development of pharmaceutical products. One of the goals of
harmonization is to identify, and then reduce, differences in technical
requirements for drug development among regulatory agencies in
different

countries. FDA has actively participated in the International Council
for Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use to develop harmonized technical requirements for the approval
of human pharmaceutical and biological products among the European
Union, Japan, and the United States. The VICH is a parallel initiative
for veterinary medicinal products. The VICH is concerned with
developing harmonized technical requirements for the approval of
veterinary medicinal products in the European Union, Japan, and the
United States, and includes input from both regulatory and industry
representatives.
    The VICH Steering Committee is composed of member representatives
from the European Commission and European Medicines Agency,
International Federation for Animal Health--Europe; FDA; the U.S.
Department of Agriculture; the U.S. Animal Health Institute; the
Japanese Ministry of Agriculture, Forestry, and Fisheries; and the
Japanese Veterinary Products Association. Six observers are eligible to
participate in the VICH Steering Committee: One representative from the
government of Australia/New Zealand, one representative from the
industry in Australia/New Zealand, one representative from the
government of Canada, one representative from the industry in Canada,
one representative from the government of South Africa, and one
representative from the industry in South Africa. The VICH Secretariat,
which coordinates the preparation of documentation, is provided by the
International Federation for Animal Health.

II. Draft Guidance for Industry on Stability Testing of New Veterinary
Drug Substances and Medicinal Products in Climatic Zones III and IV

    The VICH Steering Committee held a meeting in June 2018 and agreed
that the draft guidance document entitled ``Stability Testing of New
Veterinary Drug Substances and Medicinal Products in Climatic Zones III
and IV'' (VICH GL58) should be made available for public comment. This
draft guidance document is an annex to the VICH parent stability
guidance, GFI #73/VICH GL3(R), ``Stability Testing of New Veterinary
Drug Substances and Medicinal Products (Revision),'' \1\ and provides
guidance regarding the stability data package for a new veterinary drug
substance and medicinal product to be included in a registration or
application submitted within the regions in climatic zones III and IV.
This guidance provides additional guidance on the storage conditions
for stability testing in countries located in Climatic Zones III (hot
and dry) and IVB (hot and very humid), which are not covered by GFI
#73/VICH GL3(R). This draft guidance document seeks to exemplify the
core stability data package for new veterinary drug substances and
medicinal products, but leaves flexibility to encompass the variety of
different practical situations that may be encountered due to specific
scientific considerations and characteristics of the materials being
evaluated.
---------------------------------------------------------------------------

    \1\ https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052387.pdf.
---------------------------------------------------------------------------

    FDA and the VICH Expert Working Group will consider comments about
the draft guidance document.

III. Significance of Guidance

    This level 1 draft guidance, developed under the VICH process, is
being issued consistent with FDA's good guidance practices regulation
(21 CFR 10.115). For example, the document has been designated
``guidance'' rather than ``guideline.'' In addition, guidance documents
do not include mandatory language such as ``shall,'' ``must,''
``require,'' or ``requirement,'' unless FDA is using these words to
describe a statutory or regulatory requirement.
    The draft guidance, when finalized, will represent the current
thinking of FDA on this topic. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 514 have been approved under
OMB control number 0910-0032.

V. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or
https://www.regulations.gov.

    Dated: December 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-28219 Filed 12-27-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 134 (Wednesday, July 13, 2011)]
[Notices]
[Page 41264]
[FR Doc No: 2011-17570]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0120]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Cosmetic Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Cosmetic Labeling Regulations''
has been approved by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 28, 2010 (75
FR 30035), the Agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0599.
The approval expires on June 13, 2014. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: July 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17570 Filed 7-12-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Rules and Regulations]
[Pages 72836-72838]
[FR Doc No: 2021-27774]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0716; Project Identifier 2019-CE-023-AD; Amendment
39-21799; AD 2021-23-01]
RIN 2120-AA64

Airworthiness Directives; Stemme AG Gliders

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Stemme AG Model Stemme S 12 gliders. This AD was prompted by mandatory
continuing airworthiness information (MCAI) issued by the aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as an airspeed indicator (ASI) with speed markings
inconsistent with the approved and published values. This AD requires
inspecting the ASI markings and, depending on findings, either
replacing the ASI or amending the existing aircraft flight manual (AFM)
until the ASI is replaced. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective January 27, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 27,
2022.

ADDRESSES: For service information identified in this final rule,
contact STEMME AG, Flugplatzstrasse F2, Nr. 6-7, D-15344 Strausberg,
Germany; phone: +49 (0) 3341 3612-0; fax: +49 (0) 3341 3612-30; email:
[email protected]; website: https://www.stemme.com. You may view
this service information at the FAA, Airworthiness Products Section,
Operational Safety Branch, 901 Locust, Kansas City, MO 64106. For
information on the availability of this material at the FAA, call (816)
329-4148. It is also available at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0716.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0716; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal

holidays. The AD docket contains this final rule, the MCAI, any
comments received, and other information. The address for Docket
Operations is U.S. Department of Transportation, Docket Operations, M-
30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue
SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aviation Safety
Engineer, General Aviation & Rotorcraft Section, International
Validation Branch, FAA, 901 Locust, Room 301, Kansas City, MO 64106;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all Stemme AG Model
Stemme S 12 gliders. The NPRM published in the Federal Register on
August 27, 2021 (86 FR 48065). The NPRM was prompted by MCAI originated
by the European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Union. EASA
issued EASA AD 2019-0082, dated April 12, 2019 (referred to after this
as ``the MCAI''), to address an unsafe condition on Stemme AG Model
Stemme S 12 gliders. The MCAI states:

    During a production inspection of a new powered sailplane, an
ASI was found with speed markings inconsistent with the approved and
published values (begin[ning] of the white and green arc).
Subsequent investigation of the production records for delivered
Stemme S 12 powered sailplanes does not exclude that a similar, non-
conforming ASI was installed during production.
    This condition, if not corrected, could lead to erroneous
information being provided to the pilot, particularly at the lower
speed operation limits, possibly resulting in reduced control of the
powered sailplane.
    To address this unsafe condition, Stemme AG issued the SB
[service bulletin] to provide inspections instructions.
    For the reason described above, this [EASA] AD requires a one-
time inspection of the markings of the affected part and, depending
on findings, amending the Aircraft Flight Manual (AFM) and replacing
the affected part. This [EASA] AD also prohibits installation of
affected parts.

    You may examine the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0716.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the costs.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI and
service information referenced above. The FAA reviewed the relevant
data and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these products. This AD is adopted as proposed in the
NPRM.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Stemme Service Bulletin No. P062-980027, Revision
00, dated December 17, 2018. The service information specifies checking
the ASI markings and provides illustrations of correct markings. The
service information specifies the procedure to replace an affected ASI
with an ASI with correct markings. The service information also
includes a temporary page to insert into the AFM until the ASI is
replaced. 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 ADDRESSES.[FEDREG][VOL]*[/
VOL][NO]*[/NO][DATE]*[/DATE][RULES][RULE][PREAMB][AGENCY]*[/
AGENCY][SUBJECT]*[/SUBJECT][/PREAMB][SUPLINF][HED]*[/HED]

Costs of Compliance

    The FAA estimates that this AD affects 20 gliders of U.S. registry.
The FAA estimates it would take about 0.5 work-hour per glider to
comply with the inspection requirements of this AD. The average labor
rate is $85 per work-hour.
    Based on these figures, the FAA estimates the cost of this AD on
U.S. operators to be $850 or $42.50 per glider.
    The FAA estimates that amending the AFM to insert and then remove
the temporary page as a result of the inspection would take about 1
work-hour per glider for a total cost of $85 per glider. The FAA
estimates that replacing the ASI would take about 3.5 work-hours and
require parts costing $603, for a total cost of $900.50 per glider. The
FAA has no way of determining the number of gliders that may need these
actions.
    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected operators.

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government. For the reasons discussed above, I certify that
this AD. For the reasons discussed above, I certify this AD:
    (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 Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

2021-23-01 Stemme AG: Amendment 39-21799; Docket No. FAA-2021-0716;
Project Identifier 2019-CE-023-AD.

(a) Effective Date

    This airworthiness directive (AD) is effective January 27, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Stemme AG Model Stemme S 12 gliders, all
serial numbers, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 3414, Airspeed/Mach
Indicator.

(e) Unsafe Condition

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) issued by the aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as an airspeed
indicator (ASI) with speed markings inconsistent with the approved
and published values (beginning of the white and green arc). The FAA
is issuing this AD to prevent erroneous information being provided
to the pilot, particularly at the lower speed operation limits. The
unsafe condition, if not addressed, could result in reduced control
of the glider.

(f) Compliance

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

(g) Required Actions

    (1) Within 30 days after the effective date of this AD, inspect
ASI part number (P/N) IF-W230 or IF-W190 for incorrect markings in
accordance with the table in the Appendix, ``2.3. Airspeed Indicator
Markings,'' of Stemme Service Bulletin No. P062-980027, Revision 00,
dated December 17, 2018 (the SB). If an ASI marking is incorrect,
before further flight, perform one of the following:
    (i) Replace the ASI by following the Actions, Action 2, of the
SB; or
    (ii) Amend the existing aircraft flight manual (AFM) for your
glider by inserting the Appendix, temporary page 2-3 SB, ``2.3.
Airspeed Indicator Markings,'' of the SB. Within 3 months after
amending the AFM, replace the ASI by following the Actions, Action
2, of the SB and remove temporary page 2-3 SB, ``2.3. Airspeed
Indicator Markings,'' from the AFM.[FEDREG][VOL]*[/VOL][NO]*[/
NO][DATE]*[/DATE][RULES][RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/
SUBJECT][/PREAMB][SUPLINF][HED]*[/HED]
    (2) As of the effective date of this AD, do not install ASI P/N
IF-W230 or IF-W190 on any glider unless it has passed the inspection
required by this AD.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the certification office, send it to the
attention of the person identified in paragraph (i)(1) of this AD or
email: [email protected].
    (2) 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.

(i) Related Information

    (1) For more information about this AD, contact Jim Rutherford,
Aviation Safety Engineer, General Aviation & Rotorcraft Section,
International Validation Branch, FAA, 901 Locust, Room 301, Kansas
City, MO 64106; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].
    (2) Refer to European Union Aviation Safety Agency (EASA) AD
2019-0082, dated April 12, 2019, for more information. You may
examine the EASA AD in the AD docket at https://www.regulations.gov
by searching for and locating it in Docket No. FAA-2021-0716.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Stemme Service Bulletin No. P062-980027, Revision 00, dated
December 17, 2018.
    Note 1 to paragraph (j)(2)(i): This service information has Feb-
29 and July 14, 2017, in the footer of every page on the document.
Feb-29 refers to the form number and July 14, 2017, is the revision
date of the form used to write the service information. The
signature block on the bottom of page 1 contains a release date and
an approval date. For enforceability purposes, the FAA will cite the
Stemme AG service information using the release date of December 17,
2018, that is used in EASA AD 2019-0082, dated April 12, 2019.
    Note 2 to paragraph (j)(2)(i): This service information contains
German to English translation. EASA used the English translation in
referencing the document from Stemme AG. For enforceability
purposes, the FAA will cite the Stemme AG service information in
English as it appears on the document.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
STEMME AG, Flugplatzstrasse F2, Nr. 6-7, D-15344 Strausberg,
Germany; phone: +49 (0) 3341 3612-0; fax: +49 (0) 3341 3612-30;
email: [email protected]; website: https://www.stemme.com.
    (4) You may view this service information at FAA, Airworthiness
Products Section, Operational Safety Branch, 901 Locust, Kansas
City, MO 64106. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on October 25, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-27774 Filed 12-22-21; 8:45 am]
BILLING CODE 4910-13-P[FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/
DATE][RULES]


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER

Interregional Research Project No. 4 (IR-4) in cooperation with Syngenta
Crop Protection, LLC

PP #6E8492

	EPA has received a pesticide petition (6E8492) from Interregional
Research Project No. 4 (IR-4) IR-4 Project Headquarters, Rutgers, The
State University of NJ, 500 College Road East, Suite 201 W, Princeton,
NJ 08540 in cooperation with Syngenta Crop Protection, LLC, P.O. Box
18300, Greensboro NC 27419 requesting, pursuant to section 408(d) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to
amend 40 CFR part 180 by establishing a tolerance for residues of
prometryn in or on the raw agricultural commodity sesame, seed at 0.05
parts per million (ppm); sesame, oil at 0.12 ppm; leaf petiole vegetable
subgroup 22B at 0.5 ppm; fennel, Florence at 0.5 ppm; celtuce at 0.5
ppm; Swiss chard at 0.5 ppm; and cottonseed subgroup 20C at 0.25 ppm.
Upon the approval of the aforementioned tolerances, IR-4 proposes to
remove the established tolerances for residues of prometryn, including
its metabolites and degradates in or on the leaf petioles subgroup 4B at
0.5 ppm and cotton, undelinted seed at 0.25 ppm.  EPA has determined
that the petition contains data or information regarding the elements
set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully
evaluated the sufficiency of the submitted data at this time or whether
the data supports granting of the petition. Additional data may be
needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. The qualitative nature of prometryn residues in
plants has been characterized based upon EPA approved cotton, celery and
carrot metabolism studies.  The major metabolic pathway involves
oxidative elimination, N-dealkylation and oxidative deamination, leading
to multiple minor products.  Characterization of the residues indicates
the biotransformation of prometryn is qualitatively similar in all three
crops.

	2. Analytical method. Syngenta has developed and validated a gas
chromatography analytical method for enforcement purposes.  The method
determines residues of prometryn in/on plants using a microcoulometric
sulfur detection system.  This method has been submitted to the EPA and
is in the Pesticide Analytical Manual (PAM).

	3. Magnitude of residues. Complete residue data to support the
requested tolerances have been submitted with this petition.

B. Toxicological Profile

	1. Acute toxicity.  The database for acute toxicity of prometryn is
considered complete.  Prometryn technical is slightly to practically
non-toxic (Toxicity Category III) by the oral, dermal and inhalation
routes.  It causes mild eye irritation (Toxicity Category III) and
slight dermal irritation (Toxicity Category IV).  Prometryn is not
considered a skin sensitizer.

	2. Genotoxicity. In four mutagenicity studies (Ames salmonella test,
chromosomal aberration, bacterial DNA repair, and unscheduled DNA
synthesis test) prometryn was found to be negative.  There is no
evidence of a mutagenic or cytogenetic effect in vivo or in vitro with
prometryn.

	3. Reproductive and developmental toxicity. In developmental toxicity
studies with rats and rabbits, maternal and developmental toxicity was
observed only at the highest doses tested (rats 250 mg/kg/day, rabbits
72 mg/kg/day).  The developmental NOEL was 50 mg/kg/day in rats and 12
mg/kg/day in rabbits.  A 2-generation reproduction study with rats
showed effects at the highest dose (1500 ppm; 105.6 mg/kg/day), with a
reproductive NOEL of 750 ppm or approximately 50 mg/kg/day.  The results
indicate that prometryn is not embryotoxic or teratogenic in the species
tested at maternally toxic doses.

	4. Subchronic toxicity. In a subchronic 28-day feeding study in mice at
the highest dose tested (4500 mg/kg/day), there were pathological
findings limited to the G.I. tract along with decreased body weights.
The NOAEL was 450 mg/kg/day.  In a 21-day dermal toxicity study in
rabbits, no local or systemic toxicity was observed at all dose levels
with a NOAEL of >1,000 mg/kg/day.

	5. Chronic toxicity. Studies with prometryn have shown no significant
chronic toxicity in either rats, mice or dogs.  In a chronic toxicity
study/oncogenicity study in mice the NOAEL in females was 1,000 ppm and
the LOAEL was 3,000 ppm based upon decreased body weight gain.  There
were no effects observed in males.  Prometryn was not oncogenic under
the conditions of the study.  The lowest chronic toxicity endpoints were
observed in the chronic toxicity study in dogs, with a NOAEL of 3.75
mg/kg/day and a LOAEL of 37.5 mg/kg/day.  The EPA has determined that,
for prometryn, there is no evidence of human carcinogenic potential.

	6. Animal metabolism. The metabolism of prometryn in rats is adequately
understood.  Data indicate that the distribution of prometryn is
greatest in the blood, followed by the spleen and the lungs.  Prometryn
is predominantly excreted in the urine and feces with slightly higher
concentrations in the urine.

	7. Metabolite toxicology. For risk assessment and enforcement purposes,
EPA has determined that residues of concern include parent prometryn
only.

	8. Endocrine disruption. There is no indication from the mammalian
toxicology database for any endocrine disrupting effect of prometryn.

C. Aggregate Exposure

	1. Dietary exposure. Tier I acute and chronic dietary exposure
evaluations were made for prometryn using the Dietary Exposure
Evaluation Model (DEEM-FCID™ Version 4.02) from EPA and consumption
data from the USDA NHANES “What We Eat in America” survey,
2005-2010.  In addition to current uses, these aggregate assessments
included estimated prometryn tolerances for a proposed IR-4 use on
sesame as well as a proposed regrouping on Crop Group 22B. The Tier I
assessments incorporated tolerance values for all crops.  All processing
factors used DEEMTM Version 7.87 defaults.  Percent of crop treated
(%CT) values were conservatively estimated to be 100% for all registered
and proposed uses.  Drinking water estimates were incorporated directly
into the dietary exposure assessment using the higher of the estimated
drinking water concentrations (EDWCs) for surface and ground water.

	i. Food. Acute Exposure:  An acute reference dose of 0.12 mg/kg/day for
females 13-49 years old was based on a no observed adverse effect level
(NOAEL) of 12 mg/kg/day from a developmental toxicity study in rabbits
and an uncertainly factor of 100X.  No additional FQPA safety factor was
applied.  For the purpose of the aggregate risk assessment, the exposure
value was expressed in terms of margin of exposure (MOE), which was
calculated by dividing the NOAEL by the exposure for each subpopulation.
 In addition, exposure was expressed as a percent of the acute reference
dose (aRfD).  Acute (food only) exposure to females 13-49 years old
resulted in an MOE of 26,284 or 0.4% of the aRfD (Benchmark MOE = 100;
aRfD = 0.12 mg/kg/day).

Chronic Exposure.  The prometryn chronic dietary (food only) risk
assessment was performed for all subpopulations with a chronic reference
dose of 0.04 mg/kg/day based on a chronic feeding study in dogs with a
NOAEL of 3.75 mg/kg/day and an uncertainty factor of 100X.  The 100X
safety factor includes intra- and inter-species variations.  No
additional FQPA safety factor was applied.  For the purpose of aggregate
risk assessment, the exposure values were expressed in terms of margin
of exposure (MOE), which was calculated by dividing the NOAEL by the
exposure for each subpopulation.  In addition, exposure was expressed as
a percent of the chronic reference dose (cRfD).  Chronic (food only)
exposure to the U.S. population resulted in an MOE of 30,392 or 0.3% of
the cRfD (Benchmark MOE = 100; cRfD = 0.04 mg/kg/day).  The most exposed
subpopulation was infants <1 year old, with an MOE of 7,191 or 1.3% of
the cRfD (Benchmark MOE = 100; cRfD = 0.04 mg/kg/day).

Cancer.  Prometryn has been classified as a Group E chemical (no
evidence of human carcinogenic potential).  Therefore, a cancer risk
assessment was not performed for prometryn.

	ii. Drinking water. The Estimated Drinking Water Concentrations (EDWCs)
of prometryn were determined using Tier l screening models, SCI-GROW
which estimates pesticide concentration in ground water and FIRST which
estimates pesticide concentration in surface water.  EDWCs of prometryn
from the currently registered uses plus the proposed sesame use were
determined.   Based on the SCI-GROW modeling, the highest groundwater
EDWC for prometryn is 21.8 ppb (acute and chronic) based on the
currently registered use on cotton.  Based on the FIRST modeling, the
cotton use provided the highest surface water EDWCs of 486.0 ppb for
acute and 183.7 ppb for chronic.  No Percent Cropped Area (PCA)
adjustments were applied to surface water EDWCs. Since the surface water
EDWCs exceed the ground water EDWC, the surface water values were used
for risk assessment purposes and will be considered protective for any
ground water exposure concerns.

Acute Exposure from Drinking Water.  The acute surface water EDWC of
486.0 ppb was input directly into the DEEM-FCID™ software as “water,
direct and indirect, all sources” to model the acute drinking water
exposures.  Exposure contributions at the 95.0%-ile of exposures were
determined by taking the difference between the aggregate (food +
drinking water) exposures and the food (alone) exposures for each
population subgroup.  Acute drinking water exposure to females 13-49
years old resulted in an MOE of 474 (21.1% of the acute RfD of 0.12
mg/kg-bw/day).

Chronic Exposure from Drinking Water.  The chronic surface water EDWC of
183.7 ppb was input directly into the DEEM-FCID™ software as “water,
direct and indirect, all sources” to model the chronic drinking water
exposures.  Chronic drinking water exposure to the U.S. population
resulted in a MOE of 1,010 (9.3% of the chronic RfD of 0.04
mg/kg-bw/day).  Chronic drinking water exposure to the most exposed
sub-population (infants, <1 year old) resulted in a MOE of 270 (34.7% of
the chronic RfD of 0.04 mg/kg-bw/day).

	2. Non-dietary exposure. Residential exposure assessments were
performed for prometryn to evaluate exposures resulting from off-site
drift of agricultural products into residential areas.  Incidental
exposure to consumers from spray drift from non-residential uses were
not included in the aggregate consumer risk; this approach agrees with
the EPA’s current policy and practice.

D. Cumulative Effects

	Cumulative Exposure to Substances with a Common Mechanism of Toxicity.
Prometryn is a member of the triazine class of pesticides.  Other
members of this class include atrazine, simazine, cyanazine, prometron,
propazine, metribuzin, hexazinone, ametryn, terbutryn, dipropetryn and
ethiozin.  Section 408(b)(2)(D)(v) 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 does not have, at this time,
available data to determine whether prometryn has a common mechanism of
toxicity with other substances or how to include this pesticide in a
cumulative risk assessment.  For the purposes of this tolerance action,
the EPA has not assumed that prometryn has a common mechanism of
toxicity with other substances.

E. Safety Determination

	1. U.S. population. An acute dietary exposure analysis was not required
for the general U.S. population, however exposure from all current and
proposed prometryn uses would result in an MOE of 465 or 21.5% of the
aRfD for females 13-49 years old (Benchmark MOE = 100; aRfD = 0.12
mg/kg/day).  The chronic dietary exposure analysis (food plus water)
showed that exposure from all current and proposed prometryn uses for
the general U.S. population would result in an MOE of 978 or 9.6% of the
cRfD (Benchmark MOE = 100; cRfD = 0.04 mg/kg/day).

	2. Infants and children. There are no acute dietary exposure concerns
from prometryn for infants and children.  The chronic dietary exposure
analysis (food plus water) showed that exposure from all current and
proposed prometryn uses for all infants <1 year old would result in a
MOE of 260 or 36.0% of the cRfD (Benchmark MOE = 100; cRfD = 0.04
mg/kg/day).

F. International Tolerances

	There are no Codex MRLs established for residues of prometryn in plant
or animal commodities.

 PAGE

 PAGE   5


[Federal Register Volume 82, Number 181 (Wednesday, September 20, 2017)]
[Rules and Regulations]
[Page 43864]
[FR Doc No: C1-2017-18411]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

46 CFR Parts 401, 403, and 404

[USCG-2016-0268]
RIN 1625-AC34

Great Lakes Pilotage Rates--2017 Annual Review

Correction

    In rule document 2017-18411 beginning on page 41466 in the issue of
Thursday, August 31, 2017, make the following corrections:
    1. On page 41466, in the first column, in the first line below
Table E-1, remove the words SUPPLEMENTARY INFORMATION:.
    2. On the same page, in the second column, after the second line,
insert the words SUPPLEMENTARY INFORMATION: on their own line.

Sec.  401.405  [Corrected]

0
3. On page 41495, in the second column, in the 22nd line from the
bottom, ``Revise Sec.  401.405 to read as follows:'' should read ``In
Sec.  401.405, revise paragraph (a) to read as follows:''.

Sec.  401.420  [Corrected]

0
4. On the same page, in the same column, in the eighth line from the
bottom, ``Revise Sec.  401.420 to read as follows:'' should read ``In
Sec.  401.420, revise paragraph (b) to read as follows:''.

Sec.  401.450  [Corrected]

0
5. On the same page, in the third column, in the ninth through
fourteenth lines,
0
5. Revise Sec.  401.450 as follows:
0
a. Redesignate paragraphs (b) through (j) as paragraphs (c) through
(k), respectively; and
0
b. Add new paragraph (b) to read as follows:
    Should read:
0
5. In Sec.  401.450, redesignate paragraphs (b) through (j) as
paragraphs (c) through (k), respectively, and add new paragraph (b) to
read as follows:
0
6. In part 401, in section 401.405, on the same page, in the same
column, after the 20th line, add the following line:
* * * * *

Sec.  404.100  [Corrected]

0
7. On the same page, in the same column, in the 28th line, ``Amend
Sec.  404.101(a) as follows:'' should read ``In Sec.  404.100, revise
paragraph (a) to read as follows:''.

0
8. In part 404, in section 404.100, on the same page, in the same
column, after the 39th line, add the following line:
* * * * *

Sec.  404.103  [Corrected]

0
9. In the same page, in the same column, in the 41st through 46th
lines,
0
a. In paragraph (a), following the words ``dividing each area's''
remove the word ``peak'' and add, in its place, the word ``seasonal'';
and
0
b. Revise paragraph (b) to read as follows:
    should read:
0
a. In paragraph (a) introductory text, following the words ``dividing
each area's'' remove the word ``peak'' and add in its place the word
``seasonal''; and
0
b. Revise paragraph (b).
    The revision reads as follows:

Sec.  404.105  [Corrected]

    10. On page 41496, in the first column, in the 22nd and 23rd line,
``and add, in their place, the words ``working capital fund.'' ''
should read ``and add in their place the words ``working capital
fund''.''.

[FR Doc. C1-2017-18411 Filed 9-19-17; 8:45 am]
 BILLING CODE 13010-00-D


[Federal Register: March 14, 2008 (Volume 73, Number 51)]
[Notices]
[Page 13888-13889]
[DOCID:fr14mr08-62]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. P-2244-022]

Energy Northwest; Notice of Application Tendered for Filing With
the Commission and Establishing Procedural Schedule for Licensing and
Deadline for Submission of Final Amendments

March 7, 2008.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: P-2244-022.
    c. Date Filed: February 25, 2008.
    d. Applicant: Energy Northwest.
    e. Name of Project: Packwood Lake Hydroelectric Project.
    f. Location: The existing project is on Lake Creek, a tributary to
Cowlitz River, in Lewis County in southwestern Washington near the
unincorporated town of Packwood. The upper portion of the lake lies
within the Goat Rocks Wilderness Area. The project occupies 503.25
acres of United States Forest Service land, 20.94 acres of Energy
Northwest-owned land, and 15.04 acres of Washington State lands.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Jack W. Baker, Vice President, Energy
Northwest, Mail Drop 1035, P.O. Box 968, Richland, WA 99352-0968;
telephone<PHONE_NUMBER>, or e-mail at<EMAIL_ADDRESS>    i. FERC Contact: Kenneth Hogan, telephone<PHONE_NUMBER>, or e-mail
at<EMAIL_ADDRESS>    j. This application is not ready for environmental analysis at this
time.
    k. Project Description: The existing project consists of the
following: (1) an intake canal, a concrete drop structure (dam) and
intake building on Lake Creek located about 424 feet downstream from
the outlet of Packwood Lake, a 21,691-foot system of concrete pipe and
tunnels, a 5,621-foot penstock, a surge tank, and a powerhouse with a
26.1-megawatt turbine generator; (2) a 452-acre reservoir (Packwood
Lake) at a normal full pool elevation of 2,857 feet above mean sea
level with approximately 4,162 acre-feet of usable storage; and (3)
appurtenant facilities. The average annual generation at the project is
about 90,998 megawatt-hours. The applicant proposes a slightly modified
reservoir operational regime and higher instream flow releases to the
bypassed reach on Lake Creek.
    l. Locations of the Application: A copy of the application is
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's website at http://www.ferc.gov using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC Online Support at<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or for TTY,<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. You may also register online at http://www.ferc.gov/
esubscribenow.htm to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. Procedural Schedule: The application will be processed according
to the following Hydro Licensing Schedule. Note that revisions to this
schedule are unlikely due to the strict deadlines associated with a
project that is filed under the Integrated Licensing Process.

------------------------------------------------------------------------
                  Milestone                               Date
------------------------------------------------------------------------
Application Deficiency Determination Letter    March 26, 2008.
 and Issuance of Additional Information
 Requests (AIRs).
Notice of Acceptance/Notice of Ready for       May 2008.
 Environmental Analysis.
Filing of Interventions, Recommendations,      July 2008.
 Preliminary Terms and Conditions, and
 Fishway Prescriptions.
Reply Comments Due...........................  August 2008.
Issuance of Draft EA.........................  January 2009.
Comments on Draft EA Due (30 days)...........  February 2009.
Filing of Final Terms and Conditions (90       April 2009.
 days).
Issuance of Final EA.........................  July 2009.
------------------------------------------------------------------------

    o. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

Kimberly D. Bose,
 Secretary.
 [FR Doc. E8-5108 Filed 3-13-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 69 (Wednesday, April 10, 2013)]
[Notices]
[Pages 21385-21386]
[FR Doc No: 2013-08279]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2013-0008; OMB No. 1660-0080]

Agency Information Collection Activities; Proposed Collection;
Comment Request: Application for Surplus Federal Real Property Public
Benefit Conveyance and BRAC Program for Emergency Management Use

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on an extension, without change, of a currently approved
information collection. In accordance with the Paperwork Reduction Act
of 1995, this notice seeks comments concerning the application process
for the conveyance of Federal real property for public benefit. The
purpose of this application is to implement the processes and
procedures for the successful, lawful, and expeditious conveyance of
real property from the Federal Government to public entities such as
State, local, city, town, or other like government bodies as it relates
to emergency management response purposes, including Fire and Rescue
services. Compliance will ensure that properties will be fully
positioned to use at their highest and best potentials as required by
General Services Administration and Department of Defense regulations,
Federal law, Executive Orders, and the Code of Federal Regulations.

DATES: Comments must be submitted on or before June 10, 2013.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2013-XXXX. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW.,

Room 835, Washington, DC 20472-3100.
    (3) Facsimile. Submit comments to<PHONE_NUMBER>.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Adrian Austin, Building Management
Specialist, FEMA, Support Services and Facilities Management Division,
202-212-2099. You may contact the Records Management Division for
copies of the proposed collection of information at facsimile number
(202) 646-3347 or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Excess Federal real property is defined as
property that is no longer mission critical to the needs of the Federal
Government. The conveyance and disposal of excess real property is
governed by the Federal Property and Administrative Services Act of
1949 (Property Act) as amended, 40 U.S.C. 541, et seq., 40 U.S.C. 553,
and applicable regulations (41 CFR 102-75.750 through 102.75.815).
    Under the sponsorship of Federal Emergency Management Agency (FEMA)
the Property Act gives the Administrator of the General Services
Administration (GSA) authority to convey Federal real and related
surplus property (without monetary consideration) to units of State and
local government for emergency management response purposes, including
fire rescue services. The scope and philosophy of GSA's real property
policies are contained in 41 CFR part 102-71.

Collection of Information

    Title: Application for Surplus Federal Real Property Public Benefit
Conveyance and BRAC Program for Emergency Management Use.
    Type of Information Collection: Extension, without change, of a
currently approved information collection.
    FEMA Forms: FEMA Form 119-0-1, Surplus Federal Real Property
Application for Public Benefit Conveyance.
    Abstract: Use of the Application for Surplus Federal Real Property
Public Benefit Conveyance and Base Realignment and Closure (BRAC)
Program for Emergency Management Use is necessary to implement the
processes and procedures for the successful, lawful, and expeditious
conveyance of real property from the Federal Government to public
entities such as State, local, county, city, town, or other like
government bodies, as it relates to emergency management response
purposes, including fire and rescue services. Utilization of this
application will ensure that properties will be fully positioned for
use at their highest and best potentials as required by GSA and
Department of Defense regulations, public law, Executive Orders, and
the Code of Federal Regulations.
    Affected Public: State, local, or Tribal Government.
    Number of Respondents: 100.
    Number of Responses: 100.
    Estimated Total Annual Burden Hours: 250 hours.

                                                                           Estimated Annualized Burden Hours and Costs
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                    Average burden   Total annual                    Total annual
              Type of  respondent                    Form  name/form  number         Number of    responses  per   Total number     per response    burden  (in   Average hourly    respondent
                                                                                respondents      respondent    of responses     (in hours)        hours)         wage rate         cost
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 State, Local, or Tribal Government...........  Surplus Federal Real Property                 50               1              50           4 hrs             200          $65.30         $13,060
                                                 Application for Public Benefit
                                                 Conveyances/FEMA Form 119-0-1.
 State Local or Tribal Government.............  Annual Status Report/No Form....              50               1              50          1 hour              50          $65.30          $2,950
                                                                                ---------------------------------------------------------------------------------------------------------------
    Total.....................................  ................................             100  ..............             100  ..............             250  ..............         $16,010
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Note: The ``Avg. Hourly Wage Rate'' for each respondent includes a 1.4 multiplier to reflect a fully-loaded wage rate.

    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $16,010.00. There are no annual costs to respondents
operations and maintenance costs for technical services. There is no
annual start-up or capital costs. The cost to the Federal Government is
$2,107.92.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) Evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: March 28, 2013.
Charlene D. Myrthil,
Director, Records Management Division, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2013-08279 Filed 4-9-13; 8:45 am]
BILLING CODE 9111-19-P


[Federal Register: December 2, 2005 (Volume 70, Number 231)]
[Notices]
[Page 72300-72301]
[DOCID:fr02de05-38]

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ENVIRONMENTAL PROTECTION AGENCY

Draft Air Quality Criteria for Lead

[E-Docket ID No. ORD-2004-0018; FRL-8004-3]

AGENCY: Environmental Protection Agency.

ACTION: Notice of public comment period on a first external review
draft.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing a
public comment period for the draft document titled, ``Air Quality
Criteria for Lead; First External Review Draft'' (EPA/600/R-05/144).
The document was prepared by the National Center for Environmental
Assessment within EPA's Office of Research and Development.
    EPA is releasing this draft document solely for the purpose of
seeking public comment. It does not represent and should not be
construed to represent any Agency policy, viewpoint, or determination.
EPA will consider any public comments submitted in accordance with this
notice when revising the document.

DATES: The public comment period begins on or about December 1, 2005,
and ends February 15, 2006. Technical comments should be in writing and
must be received by EPA by February 15, 2006. Comments may be submitted
electronically via EPA's E-Docket, by mail, by facsimile, or by hand
delivery/courier. Please follow the detailed instructions as provided
in the SUPPLEMENTARY INFORMATION section of this notice.

ADDRESSES: The draft ``Air Quality Criteria for Lead; First External
Review Draft'' is available primarily via the Internet on the National
Center for Environmental Assessment's home page under the Recent
Additions and Publications menus at http://www.epa.gov/ncea. A limited

number of CD-ROM or paper copies will be available. Contact Ms. Diane
Ray by phone<PHONE_NUMBER>), fax<PHONE_NUMBER>), or e-mail
<EMAIL_ADDRESS>to request either of these, and please provide your
name, your mailing address, and the document title, ``Air Quality
Criteria for Lead; First External Review Draft,'' (EPA/600/R-05/144) to
facilitate processing of your request.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Office of Environmental Information Docket;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or e-mail:
<EMAIL_ADDRESS>
    For technical information, contact Lori White, Ph.D., NCEA;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or e-mail:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. Information about the Project/Document

    Section 108(a) of the Clean Air Act directs the Administrator to
identify certain pollutants which ``may reasonably be anticipated to
endanger public health and welfare'' and to issue air quality criteria
for them. These air quality criteria are to ``accurately reflect the
latest scientific knowledge useful in indicating the kind and extent of
all identifiable effects on public health or welfare which may be
expected from the presence of [a] pollutant in the ambient air * * *.''
Under section 109 of the Act, EPA is then to establish National Ambient
Air Quality Standards (NAAQS) for each pollutant for which EPA has
issued criteria. Section 109(d) of the Act requires subsequent periodic
review and, if appropriate, revision of existing air quality criteria
to reflect advances in scientific knowledge on the effects of the
pollutant on public health and welfare. EPA is also to revise the
NAAQS, if appropriate, based on the revised criteria.
    Lead is one of six ``criteria'' pollutants for which EPA has
established air quality criteria and NAAQS. On November 9, 2004 (69 FR
64926), EPA formally initiated its current review of the criteria and
NAAQS for lead, requesting the submission of recent scientific
information on specified topics. One of the next steps in this process
was to prepare a project work plan for revision of the existing ``Air
Quality Criteria for Lead,'' EPA-600/8-83/028aF-dF (published in June
1986) and an associated supplement (EPA-600/8-89/049F) published in
1990. Accordingly, a draft of EPA's ``Project Work Plan for Revised Air
Quality Criteria for Lead'' (NCEA-R-1465) was released on January 7,
2005 for public comment (70 FR 1439) and was discussed by the Clean Air
Scientific Advisory Committee (CASAC) via a publicly accessible March
28, 2005, teleconference consultation (70 FR 11629). On July 15, 2005
(70 FR 41007), several workshops were announced to discuss, with
invited recognized scientific experts, initial draft materials that
dealt with various lead-related issues being addressed in the draft
AQCD for lead. These workshops were held August 4-5, 16-18, and 17-19,
2005.
    After the end of the comment period on the Air Quality Criteria for
Lead, First External Review Draft, EPA will

present the draft at a public meeting for review by CASAC. Public
comments received will be provided to the CASAC review panel. There
will be a Federal Register notice to inform the public of the exact
date and time of that CASAC meeting.

II. How To Submit Technical Comments to EPA's E-Docket

    EPA has established an official public docket for information
pertaining to the revision of the Lead AQCD, Docket ID No. ORD-2004-
0018. The official public docket is the collection of materials
available for public viewing and includes the documents specifically
referenced in this action, any public comments received, and other
information related to this action, but excludes Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is available for public viewing
at the Office of Environmental Information (OEI) Docket in the
Headquarters EPA Docket Center, (EPA/DC) EPA West Building, Room B102,
1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center
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<PHONE_NUMBER>, and the telephone number for the OEI
Docket is<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or e-mail:
<EMAIL_ADDRESS>
    An electronic version of the public docket is available through
EPA's electronic public docket and comment system, E-Docket. You may
use E-Docket at http://www.epa.gov/edocket/ to submit or view public

comments, to access the index of the contents of the official public
docket, and to access those documents in the public docket that are
available electronically. Once in the system, select ``search,'' then
key in the appropriate docket identification number.
    Certain types of information will not be placed in E-Docket.
Information claimed as CBI and other information for which disclosure
is restricted by statute will not be available for public viewing in
the official public docket or in E-Docket. EPA's policy is that
copyrighted material will not be placed in E-Docket but will be
referenced there and will be available as printed material in the
official public docket.
    If you intend to submit comments to EPA, please note that it is
EPA's policy to make public comments available for public viewing as
received and without change at the EPA Docket Center or in E-Docket.
This policy applies to information submitted electronically or in paper
form, except where restricted by copyright, CBI, or statute. When EPA
identifies a comment containing copyrighted material, EPA will provide
a reference to that material in the version of the comment that is
placed in EPA's electronic public docket. The entire printed comment,
including the copyrighted material, will be available in the official
public docket.
    Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to E-Docket. Public
comments that are mailed or delivered to the Docket will be scanned and
placed in E-Docket. Where practical, physical objects will be
photographed, and the photograph will be placed in E-Docket with a
brief description written by the docket staff.
    You may submit comments electronically, by mail, by facsimile, or
by hand delivery/courier. To ensure proper receipt by EPA, include the
appropriate docket identification number with your submission. Please
ensure that your comments are submitted within the specified comment
period. Comments received after the closing date will be marked
``late,'' and may only be considered if time permits.
    If you submit comments electronically, EPA recommends that you
include your name, mailing address, and an e-mail address or other
contact information in the body of your comment. Also include this
contact information on the outside of any submitted disk or CD-ROM, and
in any cover letter accompanying the disk or CD-ROM. This ensures that
you can be identified as the person submitting the comment and allows
EPA to contact you in case the Agency cannot read your submission due
to technical difficulties or needs further information on the substance
of your comment. EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket and
made available in E-Docket. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, it may
delay or preclude consideration of your comment.
    Electronic submission of comments to E-Docket is EPA's preferred
method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket
, and follow the online instructions for submitting

comments. To access EPA's electronic public docket from the EPA
Internet Home Page, select ``Information Sources,'' ``Dockets,'' and
``EPA Dockets.'' Once in the system, select ``search,'' and then key in
Docket ID No. ORD-2004-0018. The system is an ``anonymous access''
system, which means EPA will not know your identity, e-mail address, or
other contact information unless you provide it in the body of your
comment.
    Comments may be sent by electronic mail (e-mail) to
<EMAIL_ADDRESS>Attention: Docket ID No. ORD-2004-0018. In contrast

to EPA's electronic public docket, EPA's e-mail system is not an
``anonymous access'' system. If you send an e-mail comment directly to
the docket without going through EPA's E-Docket, EPA's e-mail system
automatically captures your e-mail address, and it becomes part of the
information in the official public docket and in E-Docket.
    You may submit comments on a disk or CD-ROM that you mail to the
OEI Docket mailing address. Files will be accepted in WordPerfect,
Word, or PDF format. Avoid the use of special characters and any form
of encryption.
    If you provide comments in writing, please submit one unbound
original with pages numbered consecutively, and three copies of the
comments. For attachments, provide an index, number pages consecutively
with the comments, and submit an unbound original and three copies.

    Dated: November 23, 2005.
Peter W. Preuss,
Director, National Center for Environmental Assessment.
 [FR Doc. E5-6760 Filed 12-1-05; 8:45 am]

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