Supporting Statement

for

Information Collection Request

Information Requirements for Locomotives and Locomotive Engines

(Renewal)

EPA ICR # 1800.06; OMB Control Number 2060-0392

42 USC 7521 § 206

42 USC 7521 § 213(d)

40 CFR Part 92

40 CFR Part 1033

June 30, 2009

Certification and Compliance Division

Office of Transportation and Air Quality

Office of Air and Radiation

U.S. Environmental Protection Agency

1.  Identification of the Information Collection

1(a)  Title and Number of the Information Collection

	Information Requirements for Locomotive and Locomotive Engines
(Renewal), EPA ICR Number 1800.06, OMB Number 2060-0392.

1(b)  Short Characterization

	This supporting statement is for the renewal of an existing ICR.  Under
Title II of the Clean Air Act (42 U.S.C. 7521 et seq.; CAA), EPA is
charged with issuing certificates of conformity for locomotives and
locomotive engines that comply with applicable emission standards.  Such
a certificate must be issued before locomotives and locomotive engines
may be legally introduced into commerce.  To apply for a certificate of
conformity, manufacturers and remanufacturers of locomotives and
locomotive engines are required to submit descriptions of their planned
production, including detailed descriptions of emission control systems
and test data.  This information is organized by "engine family" groups
expected to have similar emission characteristics and is submitted every
year, at the beginning of the model year.  There are also recordkeeping
requirements.

	Those locomotive and locomotive engine manufacturers and
remanufacturers electing to participate in the Averaging, Banking, and
Trading (ABT) program are also required to submit information regarding
the calculation, actual generation, and usage of credits in quarterly
reports, and an end-of-the-year report.  These reports are used for
certification and enforcement purposes.  Participants must also maintain
records for eight years regarding the engine families included in the
program.

	The CAA also mandates EPA verify that manufacturers have successfully
translated their certified prototype engines into mass produced engines,
and that these engines comply with emission standards throughout their
useful lives.  Under the Production-line Testing (PLT) Program,
manufacturers are required to test a sample of engines as they leave the
assembly line.  The Installation Audit Program requires remanufacturers
to audit the installation of a sample of remanufactured engines.  These
self-audit programs (collectively referred to as the "PLT Program")
allow manufacturers and remanufacturers to monitor compliance with
statistical certainty and minimize the cost of correcting errors through
early detection.  Under the In-use Testing Program (In-use),
manufacturers and remanufacturers are required to test locomotives after
a number of years of use to verify compliance with emission standards
throughout their useful lives.

	This information is collected by the Heavy-Duty and Nonroad Engines
Group  (HDNEG), Compliance and Innovative Strategies Division (CISD),
Office of Transportation and Air Quality (OTAQ), Office of Air and
Radiation (OAR), U.S. Environmental Protection Agency (EPA).  Besides
CISD, this information could be used by the Office of Enforcement and
Compliance Assurance (OECA) and the Department of Justice for
enforcement purposes.  Non-confidential portions of the applications are
also disclosed in a public database and over the Internet.  This
information is used by trade associations, environmental groups, and the
public.  The information is usually submitted in an electronic format,
and it is stored in HDNEG's certification database.

	It has been estimated that a total of ten locomotive and locomotive
engine manufacturers and remanufacturers will respond to this collection
with an approximate cost of $2,349,724.

2.  Need for and Use of the Collection

2(a)  Need/Authority for the Collection

	Locomotive and locomotive engine manufacturers may not legally
introduce their products into US commerce unless EPA has certified that
their production complies with applicable emission standards.  To ensure
compliance with these statutes, EPA reviews product information and
manufacturers' test results.  EPA may also tests some locomotives and
locomotive engines to confirm manufacturers' results.

	EPA's emission certification programs are statutorily mandated; the
agency does not have discretion to cease these functions.  Under Section
206(a) of the CAA (42 USC 7521):

"The Administrator shall test, or require to be tested in such manner as
he deems appropriate, any new motor vehicle or new motor vehicle engine
submitted by a manufacturer to determine whether such vehicle or engine
conforms with the regulations prescribed under §202 of this Act.  If
such vehicle or engine conforms to such regulations, the Administrator
shall issue a certificate of conformity upon such terms, and for such
period (not in excess of one year) as he may prescribe."

	This provision is extended to Nonroad engines and vehicles pursuant to
§213(d) of the CAA.

	EPA also conducts, under 40 CFR 92 Subpart D, an Averaging, Banking,
and Trading (ABT) Program.  This program is one of many regulatory
features designed to enhance the compliance flexibility for and reduce
the burden on the affected engine manufacturers, without compromising
the expected emissions benefit derived from these emissions standards.

	Section 206(b)(1) of the CAA authorizes EPA to require testing of new
vehicles and engines to verify compliance.  The requirements of the
Locomotive Production Line Testing Program are codified at 40 CFR 92,
Subpart F.

	Section 207(b) of the Acts mandates the establishment of methods and
testing procedures to ascertain whether certified engines in actual use
in fact comply with applicable emission standards throughout their
useful lives.  The In-use Testing Program procedures for locomotives are
codified at 40 CFR 92, Subpart G.

2(b)  Practical Utility/Users of the Data

	EPA uses the information requested under this collection to verify and
support a three stage compliance assurance system envisioned in the CAA.
 First, certification information is needed to verify that the proper
prototype engines have been selected to represent each locomotive family
(group of locomotives expected to have similar emission
characteristics), and that the necessary testing has been performed to
assure that each locomotive family complies with emission standards.
Based on this information, EPA issues a certificate of conformity.
However, prototypes are often hand-built and not typical of assembly
line engines.

	Second, information collected under the PLT program is used to verify
that manufacturers and remanufacturers have successfully translated
their prototypes into mass-produced engines.  Engines are taken directly
from the assembly line and tested.

	Lastly, in-use testing is designed to determine if locomotives
maintained in accordance with the manufacturer's or remanufacturer's
instructions still emit at acceptable levels after a number of years of
actual use.  If a family of locomotives is found not to comply,
manufacturers are required to recall the family.

	The ABT program allows manufacturers to generate emission credits.
Under averaging, a manufacturer could certify one or more engine
families within its product line at levels above the emission standard,
provided the increased emissions are offset by emission reductions from
one or more families certified below the standard.  The average
emissions (weighted by horsepower and production) from all the
manufacturer's engine families involved in the program in a given model
year must be at or below the emission standard.  The banking program
allows manufacturers to bank credits generated in one model year for use
in averaging or trading in subsequent model years.  The trading program
allows credit transactions between manufacturers.

	The information will be received and used by HDNEG, CISD, OTAQ, and
OAR.  Non-confidential portions of the information submitted to HDNEG
are available to and used by importers, environmental groups, members of
the public and state and local government organizations.

3.  Non-duplication, Consultations, and Other Collection Criteria

3(a)  Non-duplication

	The information requested under this ICR is required by statute.
Because of its specialized (and sometimes confidential) nature, and the
fact that most of it must be submitted to EPA before locomotives and
locomotive engines can be sold, the information collected is not
available from any other source.  Furthermore, some of the data
requested under the ABT program, such as actual sales volumes, are
claimed as confidential business information (CBI) by manufacturers, and
as such, EPA can only obtain these data if submitted by the
manufacturers.  Participation in the ABT program is voluntary.

3(b)  Public Notice Required Prior to ICR Submission to OMB

	An announcement of the public comment period for this ICR renewal was
published in the Federal Register (73 FR 2487) on January 15, 2008.
This document may be accessed through the Federal Register's website at
 HYPERLINK "http://www.gpoaccess.gov/fr/index.html"
http://www.gpoaccess.gov/fr/index.html .  In addition, all documents
associated with this ICR renewal are accessible on   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov , under Docket #
EPA-HQ-OAR-2007-1184.  No comments were received in response to this ICR
renewal.

3(c)  Consultations

EPA consulted less than ten past respondents regarding this information
collection burden.

Contact:	David Brann

Company:	EM Diesels

Phone:<PHONE_NUMBER>

Contact:	Stan Shakenis

Company:	Motive Power, Inc.

Phone:<PHONE_NUMBER>

3(d)  Effects of Less Frequent Collection

	The CAA states that emission certification must be done on a yearly
basis (CAA 206(a)(1)), coinciding with the industry's "model year."
Major product changes typically occur at the start of a model year.  For
these reasons, a collection frequency of less than a model year is not
possible.  However, when an engine design is "carried over" to a
subsequent model year, the amount of new information required is
substantially reduced.  This applies to both manufacturers and
remanufacturers.

	Entities electing to engage in emission credit trades or transfers must
submit quarterly reports of their holdings or receipts when their
credits are gain or lost.  The number of credits generated or lost is
proportional to the number of engines produced; therefore, it is best
for manufacturers trading credits to update their credit calculations
every quarter when they update their internal production volume reports.
 This ensures that the manufacturer holds valid credits and warns
manufacturers in advance of the need to acquire credits.  Manufacturers
must not have a negative credit balance at the end of the year.

	Production-line testing (PLT) reports must also be submitted on a
quarterly basis for similar reasons.  Manufacturers are required to test
up to one percent of their production at random to ensure that mass
produced locomotives and locomotive engines comply with emission
requirements.  (Remanufacturers are required to conduct PLT testing only
if EPA believes that a problem might exist.)  If a problem is found,
manufacturers must correct it and might need to recall locomotives or
locomotive engines that have already been sold.  By conducting this
quality control testing on a quarterly basis, manufacturers learn about
any problems early and are, therefore, able to minimize costs.

	In-use testing reports must be submitted once per year, within three
months of the completion of the required testing.  Manufacturers and
remanufacturers are only required to test one engine or locomotive
family per year.  Providing this information to EPA at a less frequent
interval would compromise the Agency's ability to expeditiously evaluate
the emissions results and determine, in a timely manner, whether in-use
locomotives conform to emission standards.  Any delay in making such a
determination reduces the universe of locomotives which will be reached
by the recall because both engine scrappage and owners' unwillingness to
participate in recalls increase with the age of the locomotive.

3(e)  General Guidelines

	According to 40 CFR 92.215(a)(3), 92.308(d) and 92.509(b),
certification, ABT and PLT related records must be maintained for eight
years.  However, "records may be retained as hard copy or reduced to
computer disks, etc., depending on the record retention procedures of
the manufacturer or remanufacturer," provided that in every case all the
information contained in the hard copy is retained.  These recordkeeping
requirements stem mainly from the statutory requirement to warrant some
items for long periods of time and because locomotives have extremely
long useful lives.  In addition, the manufacturers must comply with
requirements to recall vehicles and engines failing to meet emission
standards during their useful lives.

	Manufacturers are required to submit confidential business information
such as sales projections and certain sensitive technical descriptions
(please see Section 4(b)(i) for reference).  This information is kept
confidential in accordance with the Freedom of Information Act, EPA
regulations at 40 CFR Part 2, and class determinations issued by EPA's
Office of General Counsel.  Also, non-proprietary information submitted
by manufacturers is held as confidential until the specific locomotive
or locomotive engine to which it pertains is available for purchase.

	No other general guideline is exceeded by this information collection.

3(f)  Confidentiality

	Manufacturers and remanufacturers are allowed to assert a claim of
confidentiality over information provided to EPA.  Confidentiality is
provided in accordance with the Freedom of Information Act and EPA
regulations at 40 CFR Part 2.  For further detail, refer to Section
3(e).

3(g)  Sensitive Questions

	No sensitive questions are asked in this information collection.

4.  Respondents and Information Requested

4(a)  Respondents/North American Industry Classification System (NAICS)
Codes

	Respondents are manufacturers of Nonroad equipment and engines within
the following North American Industry Classification System (NAICS)
codes:

333618	Other Engine Equipment Manufacturing

336510	Railroad Rolling Stock manufacturing

482111	Line-haul Railroads

4(b)  Information Requested

	To obtain a certificate of conformity, all manufacturers and
remanufacturers must describe their products and supply test data to
verify compliance.  This information is organized by "engine family"
groups expected to have similar emission characteristics.  The burden
associated with certifying a given engine family is reduced after the
first production year (model year), because data and information from
previous years can be "carried over" when no significant changes have
occurred.  For instance, an engine family certified in model year 2001
can be certified in the 2002 model year by "carry over" of data and
paperwork from the 2001 model year if no significant changes have
occurred to the engine family between model years.  Allowing
manufacturers and remanufacturers to "carry over" data and paperwork
saves them the burden of duplication of data and paperwork which would
occur in the absence of such provisions.  Manufacturers and
remanufacturers must also retain records.

	To participate in the ABT programs, manufacturers and remanufacturers
submit calculations of the amount of credits they generate or need to
certify each locomotive family, based on each family's emission limit
and sales volume.  Participation in the program is voluntary.

	Information requested under the PLT and in-use programs consists mainly
of test results and a description of the locomotives tested and the
conditions under which the tests took place.  This information is
essential to determine if locomotives and locomotive engines are in fact
complying with emission standards at different stages.  Whereas the
certification test information indicates whether a specific engine
prototype is capable of meeting emission standards, PLT data is used to
determine if mass-produced engines also comply.  In-use data verifies
that correctly maintained engines also meet the standards when they
reach 50 to 75 percent of their useful lives.

(i)  Data Items

	The data items in the Tables A to J are requested under these
information collections.  Although most of them must be included in the
certification application, some of them are only required to be kept in
records and submitted upon request, as provided by 92.203(g)(1) and
92.215.

	EPA encourages respondents to apply for a certificate of conformity
electronically and is developing a simple electronic application
template.  A complete application consists of (1) a Statement of
Compliance, (2) a Family Information Entry Form - General Information,
(3) a set of Engine Data Forms (Engine Data Forms 1 through 3), (4) a
Test Information Entry Form (Main Test Information Form and Aggregate
Data Test Information Form), (5) a Locomotive Engine Model Information
Entry Form, and (6) a Part Summary Form.  Tables A, B, and C list the
information items requested in the forms.

	The Locomotive Engine Model Information Entry Form is requested to
evaluate whether engine families were developed correctly.  The
information contained in this form allows EPA engineers to know if the
engine models were grouped correctly, and, most important, if the test
data submitted corresponds to the worst case within that family.  The
calculation of the engine's rated power, torque, etc., is customary
business practice.

	The Part Summary Form allows EPA to make sure that locomotives are
actually built and engines installed properly and in their certified
configurations.  This information is used when conducting PLT and
installation audits (see Section 4(b)(i)(C) below).

A.  Certification

	For each engine family that complies with EPA emission standards and
requirements, the manufacturer or remanufacturer must submit a number of
information items as part of an application for certification (see Table
A).  Manufacturers and remanufacturers must keep certification-related
records for eight years (92.215(a)(3)) except routine emission records
(see Table B).  Routine emission records must be kept for only one year.
 Per 92.215(a)(6), EPA can void any certificate ab initio for a
locomotive or engine family for which the manufacturer or remanufacturer
does not keep adequate records or fails to provide them upon request by
the Agency.  Per 92.215(a)(4), EPA can require manufacturers and
remanufacturers to submit or retain additional information not
specifically listed here.  Manufacturers and remanufacturers must also
provide access to duly identified EPA officials to any records or
facilities where the information was gathered (i.e., testing facilities;
92.215(d)).  When a manufacturer or remanufacturer needs to make running
changes (i.e., changes to a certified engine, or to add an engine model
to an already certified engine family) a number of data items must be
submitted using the same electronic format used to apply for a
certificate of conformity.  The required items for the certification
application, certification-related recordkeeping, and running changes,
are listed below in Tables A, B, and C, respectively.

Table A

Information Items Requested under the Certification Program

●  All emission control system components.	92.203(d)(2)(i)

	●  Each auxiliary emission control device (AECD).	92.203(d)(2)(iii)

A description of the test locomotive or engine.	92.203(d)(3)

Special or alternate test procedures, if applicable.	92.203(d)(4)

A description of the operating cycle and the period of operation
necessary to accumulate service hours on the test locomotive or engine
and stabilize emission levels.	92.203(d)(5)

A description of all adjustable operating parameters.	92.203(d)(6)

Projected U.S. production information for each configuration.
92.203(d)(8)

A description of the test equipment and fuel proposed to be used.
92.203(d)(9)

All test data obtained by the manufacturer or remanufacturer on each
test engine or locomotive.	92.203(d)(10)

Intended useful life.	92.203(d)(11)

Deterioration factors.	92.203(d)(12); 92.206(b)

At the Administrator's request, the manufacturer or remanufacturer must
supply such additional information as may be required to evaluate the
application.	92.203(e)

If, after a review, EPA determines additional testing is required, the
manufacturer or remanufacturer must provide required test data within 30
days or cease production of the affected locomotives or engines.
92.210(e)(2)

Table B

Recordkeeping requirements - Certification Program

●  A brief history of all test engines.	92.215(a)(2)

	●  A descriptions of any modifications made to the test engine.
92.215(a)(2)(i)(A)

A complete record of all emission tests performed.	92.215(a)(2)(i)(B)

Record and description of all maintenance and other servicing performed.
92.215(a)(2)(i)(C)

Record and description of each test performed to diagnose engine or
emission control system performance.	92.215(a)(2)(i)(D)

A brief description of any significant events affecting the vehicle.
92.215(a)(2)(i)(E)

Copies of all instructions or explanations regarding the use, repair,
adjustment, maintenance, or testing of such locomotive or engine,
relevant to the control of

crankcase, or exhaust emissions issued by the manufacturer or
remanufacturer, for use by other manufacturers or remanufacturers,
assembly plants, distributors, dealers, owners and operators.  Any
material not translated into the English language need not be submitted
unless specifically requested by the Administrator.	92.215(b)

Table C

Running Changes

Information Item	Regulatory Reference

Notification of changes made to the application and request to amend the
application.	92.210(a)

A full description of the change to be made.	92.210(b)(1)

Engineering evaluations or data showing that engines as modified or
added will comply with all applicable emission standards.	92.210(b)(2)

A determination whether the original test fleet selection is still
appropriate, and proposed new test fleet selections, if applicable.
92.210(b)(3)

Upon request, test data on the engine changed or added.	92.210(c)

Supporting documentation, test data and engineering evaluations as
appropriate to demonstrate that all affected engines will still meet
applicable emission standards.	92.210(e)(1)

Manufacturers or remanufacturers requesting a hearing on EPA's denial or
revocation of a certificate of conformity must file their request within
30 days of EPA's decision.  The request must be in writing, and must set
forth their objections to EPA's decision and data to support the
objections.	92.208(c)

(7)

	The Locomotive Engine Model Information Entry Form is requested to
evaluate whether engine families were developed correctly.  The
information contained in this form allows EPA engineers to know if the
engine models were grouped correctly, and, most important, if the test
data submitted corresponds to the worst case within that family.  The
calculation of the engine's rated power, torque, etc., is customary
business practice.

	The Part Summary Form allows EPA to make sure that locomotives are
actually built and engines installed properly and in their certified
configurations.  This information is used when conducting PLT and
installation audits (see Section 4(b)(i)(C) below).

B.  Average, Banking, and Trading

	Since all new locomotives and locomotive engines are required to meet
both the line-haul and switch duty-cycle standards, manufacturers and
remanufacturers can participate in separate line-haul and switch ABT
programs.  They cannot, however, use credits generated under one program
to satisfy the requirements of the other.  Credits can only be generated
for NOx and PM.  Only manufacturers and remanufacturers of new
locomotives and new locomotive engines manufactured or remanufactured in
the 1999 model year or later can participate.  Failure to submit and
keep accurate information can result in EPA voiding the certificate of
the affected family ab initio, among other penalties.  The information
that must be submitted for each engine family participating in ABT and
the associated recordkeeping requirements are listed in Tables D and E,
below.  Note that Records are to be kept for eight years (92.309(d)).

Table D

Information Items Required under the ABT Program

Information Item	Regulatory Reference

A declaration of intent to include this specific engine family in one or
both of the ABT programs.  Separate declarations are needed for each
program and each pollutant.	92.306(a)(1)

Family emission limits.	92.306(a)(2)

Detailed calculations of projected emission credits based on quarterly
production projections for each participating family and for each
pollutant, using the applicable equation and the applicable values.  If
negative credits are generated, the source for offsetting the deficit
and where the quarterly projected credits will be applied should be
listed.	92.306(a)(3)

A statement that the locomotives or locomotive engines for which
certification is requested will not, to the best of the manufacturer's
or remanufacturer's belief, cause the manufacturer or remanufacturer to
have a negative credit balance at the end of the year.	92.306(a)(4)

(cont.)

Table D

Information Items Required under the ABT Program (cont.)

Information Item	Regulatory Reference

Based on this information, each manufacturer's certification application
must demonstrate:

1)  That at the end of model year production, each engine family has a
net emissions balance equal to or greater than zero for any pollutant
and program;

2)  That the manufacturer or remanufacturer will obtain sufficient
credits to offset negative credits (and if credits are purchased, the
identity of the specific source); and

3)  The designated use of generated/supplied credits.	92.306(b)(1) - (3)

End-of-year reports including a summary of credit activity, all
information included in quarterly reports (to be submitted within 120
days of the end of the calendar year).	92.306(d) 92.309(c) and (d)

Quarterly reports (applicable to those holding or receiving transfers
only and to be submitted within 90 days of the end of the calendar
quarter) including:

1)  Source/recipients of credits, copies of trading contracts, details
of pollutants, etc.; and

2)  Details of the engine family, sales, etc., per 92.308(c).	92.309(b)

A statement accompanying all end-of-year and quarterly reports
certifying the accuracy and authenticity of the reports.	92.309(e)

Table E

Recordkeeping Requirements:  ABT Program

Information Item	Regulatory Reference

Manufacturers and Remanufacturers of Locomotive Engines

EPA engine family and configuration	92.308(a)(1)

Engine identification number	92.308(a)(2)

Engine build date and model year	92.308(a)(3)

Power rating	92.308(a)(4)

Purchaser and destination	92.308(a)(5)

Assembly plant	92.308(a)(6)

Manufacturers and Remanufacturers of Engine Families

EPA engine family and model year	92.308(b)(1)

Family emission limit	92.308(b)(2)

(cont.)

Table E

Recordkeeping Requirements:  ABT Program (cont.)

Information Item	Regulatory Reference

Manufacturers and Remanufacturers of Engine Families (cont.)

Rated horse power for each configuration	92.308(b)(3)

Projected and actual production/sales volume for the calendar year
92.308(b)(4) and (5)

Useful life	92.308(b)(6)

For families participating in trading, the following records must be
kept quarterly

Model year and engine family	92.308(c)(1)

Actual quarterly and cumulative applicable production/sales volume
92.308(c)(2)

Value required to calculate credits	92.308(c)(3)

Resulting type and number of credits generated/required	92.308(c)(4)

How and where credit surpluses are dispersed	92.308(c)(5)

How and through what means credit deficits are met	92.308(c)(6)

C.  Audit Programs: Manufacturer Production-Line Testing (PLT) Program
and Remanufacturer Installation Audit Program

	Only manufacturers of freshly manufactured locomotive engines are
subject to PLT requirements described in Table F.  However, if EPA has
reason to believe that there are problems with a remanufacturer's
production, the Agency can extend this requirement to that
remanufacturer.  Remanufacturers are subject to the audit requirements
described on Table H.  Per 92.215(a)(4), EPA can require manufacturers
and remanufacturers to submit or retain additional information not
specifically listed here.

	Each calendar quarter, manufacturers must conduct testing on a sample
of locomotives or locomotive engines taken directly from the assembly
line.  Per 92.508(e), within 30 days of the end of each quarter,
manufacturers must report the information listed in Table F.  The
recordkeeping requirements associated with the PLT program are listed in
Table G.  Note that records must be kept for eight years after
completion of all testing (92.309(b)).

Table F

Information Items Required Under the PLT Program

Information Item	Regulatory Reference

The location and description of the test facilities where testing was
conducted.	92.508(e)(1)

Total production and sample size for each engine family.	92.508(e)(2)

Applicable standards and/or FELs.	92.508(e)(3)

A description of the test locomotives or locomotive engines.
92.508(e)(4)

For each test conducted:

1)  Description of the test locomotive or locomotive engine, including
engine family and configuration, year, make, built date, engine ID
number, etc.;

2)  Location(s) where service accumulation was conducted and description
of accumulation procedure and schedule, if applicable;

3)  Test number, date, test procedure used, initial test results before
and after rounding, final test results, etc.;

4)  Complete description of any adjustment, modification, repair,
preparation, maintenance, and testing which was performed on the test
locomotive or locomotive engine; and

5) Any other information the Administrator may request.	92.508(e)(5)

For each failed locomotive or locomotive engine, a description of the
remedy and test results for all retests as required by Sec. 92.512(g).
92.508(e)(6)

The date of the end of the locomotive or locomotive engine
manufacturer's model year production for each engine family tested.
92.508(e)(7)

A statement found at 92.508(e)(8) signed and endorsement by an
authorized representative of the manufacturer or remanufacturer.
92.508(e)(8)

Upon request, manufacturers must also submit:

1)  Projected production for each configuration within each engine
family for which certification has been requested and/or approved;
and/or

2)  Number of locomotives or engines, by configuration and assembly
plant, scheduled for production.	92.509(c)(1) - (2)

Table G

Recordkeeping Requirements:  PLT Program

Information Item	Regulatory Reference

A description of all testing equipment used and each test cell that can
be used to perform PLT, in accordance with 92.503.	92.309(a)(1)

●  The date, time, and location of each test or audit.	92.309(a)(2)(i)

●  The method by which the green engine factor was calculated or the
number of hours of service accumulated on the test locomotive or
locomotive engine when the test began and ended.	92.309(a)(2)(ii)

●  The names of all supervisory personnel involved in the conduct of
the production line test or audit.	92.309(a)(2)(iii)

●  A record and description of any adjustment, repair, preparation or
modification performed on test locomotives or locomotive engines, giving
the date, associated time, justification, name(s) of the authorizing
personnel, and names of all supervisory personnel responsible for the
conduct of the action.	92.309(a)(2)(iv)

●  If applicable, the date the locomotive or locomotive engine was
shipped from the assembly plant, associated storage facility or port
facility, and the date the locomotive or locomotive engine was received
at the testing facility.	92.309(a)(2)(v)

●  A complete record of all emission tests or audits performed (except
tests performed directly by EPA), including all individual worksheets
and/or other documentation relating to each test, or exact copies.
92.309(a)(2)(vi)

●  A brief description of any significant events during testing not
otherwise described, commencing with the test locomotive or locomotive
engine selection process and including such extraordinary events as
engine damage during shipment.	92.309(a)(2)(vii)

Each calendar quarter, remanufacturers must audit the installation of
locomotives covered by its certificate(s) of conformity for proper
components, component settings, and component installations on randomly
chosen locomotives in an engine family.  Within 30 days of the end of
each quarter, remanufacturers must report the information summarized
below in Table H.

Table H

Information Items Required under the Remanufacturer

Installation Audit Program

Information Item	Regulatory Reference

The location and description of the test facilities where the audit was
conducted.	92.511(g)(1)

Total production and sample size for each engine family.	92.511(g)(2)

Applicable standards and/or FELs.	92.511(g)(3)

(cont.)

Table H

Information Items Required under the Remanufacturer

Installation Audit Program (cont.)

Information Item	Regulatory Reference

For each audit conducted: A description of the audit locomotive or
locomotive engine, including engine family and configuration, year,
make, built date, engine ID number, etc., and any other information the
Administrator may request.	92.511(g)(4)

For each failed locomotive or locomotive engine, a description of the
remedy and test results for all retests as required by Sec. 92.512(g).
92.511(g)(5)

A statement found at 92.511(g)(6) signed and endorsement by an
authorized representative of the manufacturer or remanufacturer.
92.511(g)(6)

	When a locomotive or locomotive engine fails PLT or an audit, the
certificate of conformity issued to that locomotive or locomotive engine
family is suspended, effective from the time the testing of that
locomotive or locomotive engine is completed.  The affected manufacturer
or remanufacturer must then remedy the nonconformity, retest or
re-audit, and submit reports with the following information:

Table I

Suspended Certificates and Hearings

●  A statement as to which configuration(s) within a family is to be
the subject of the hearing.	92.513(c)(1)

●  A concise statement of the issues to be raised by the manufacturer
or remanufacturer at the hearing.	92.513(c)(2)

●  A statement specifying reasons why the manufacturer or
remanufacturer believes it will prevail on the merits of each of the
issues raised.	92.513(c)(3)

●  A summary of the evidence which supports the manufacturer's or
remanufacturer's position on each of the issues raised.	92.513(c)(4)

D. In-use Testing Program

	Manufacturers and remanufacturers must test, each year, a sample of
used locomotives from one of their certified locomotive engine families
previously chosen by EPA.  If one manufacturer holds certificates for
both freshly manufactured engine families and remanufactured engine
families, EPA can request the manufacturer to test one engine family of
each category (92.603(a)(1)).  EPA may request a manufacturer to test
more than one engine family if it has reason to believe that engines in
an engine family do not comply with in-use standards (92.603(a)(2)).
Engine families of less than ten locomotives per year do not need to
participate in in-use testing (92.603(2)).  For each locomotive tested,
the manufacturer or remanufacturer must submit the information listed
below in Table J within 30 days of completion of the testing.

Table J

Information Items Requested under the Locomotive In-use Testing Program

Information Item	Regulatory Reference

All results generated.	92.607(a)

For each individual locomotive tested:

●  Engine family, and configuration.	92.607(a)(1)

●  Locomotive and engine models.	92.607(a)(2)

●  Locomotive and engine serial numbers.	92.607(a)(3)

●  Date of manufacture and/or remanufacture(s), as applicable.
92.607(a)(4)

●  Megawatt-hours of use (or miles, as applicable).	92.607(a)(5)

●  Date and time of each test attempt.	92.607(a)(6)

●  Results (if any) of each test attempt.	92.607(a)(7)

●  Results of all emission testing.	92.607(a)(8)

●  Summary of all maintenance and/or adjustments performed.
92.607(a)(9)

●  Summary of all modifications and/or repairs.	92.607(a)(10)

●  Determinations of noncompliance.	92.607(a)(11)

●  The statement at 92.607(a)(12) signed and endorsement by an
authorized representative of the manufacturer or remanufacturer.
92.607(a)(12)

For each engine family tested:

●  The serial numbers of all locomotive that were excluded from the
test sample because they did not meet maintenance requirements.
92.607(b)(1)

●  The owner of each locomotive(or other entity responsible for the
maintenance of the locomotive).	92.607(b)(2)

●  The specific reasons why the locomotives were excluded from the
test sample.	92.607(b)(3)

(ii)  Respondent Activities

The activities a manufacturer or remanufacturer needs to perform to
comply with the requirements of the certification program are as
follows:

●	Review the regulations and the guidance document;

●

●	Develop locomotive and locomotive engine family groups;

●	Test locomotives and locomotive engines for compliance with emission
standards;

●	Develop deterioration factors;

●	Data entry and analysis;

●	Submit the application for certification;

●	Prepare and submit carry over applications;

●	Prepare and submit running changes; and

●	Retain and maintain records, and submit them upon request.

Manufacturers and remanufacturers electing to participate in the ABT
programs will carry out the following activities:

●	Review the regulations and the guidance document;

●	Pre-certification activities;

●	Determine which engine families will participate in ABT;

●	Project applicable production volumes for the model year for all
participating families;

●	Submit ABT information with the certification application;

●	Gather information about credit sources/recipients;

●	Monitor production volumes and engine sales (customary business
practice);

●	Develop and submit quarterly reports;

●	Develop and submit end-of-year reports; and

●	Store, file, and maintain information as required.

Activities manufacturers and remanufacturers need to carry out to comply
with PLT and audits requirements are:

●	Gather/maintain production data (customary business practice);

●	Read instructions and regulations;

●	Train personnel;

●	Project testing needs and plan schedules;

●	Select engines to be tested;

●	Inspect engines to be tested;

●	Test engines;

●	Enter data and analyze it;

●	Prepare and submit reports; and

●	Keep records.

Activities associated with in-use testing are:

●	Read instructions and regulations;

●	Train personnel;

●	Procure locomotives;

●	Test locomotives;

●	Enter data and analyze it;

●	Prepare and submit reports; and

●	Keep records.

5.  The Information Collected -- Agency Activities, Collection
Methodology, and Information Management

5(a)  Agency Activities

	As part of the implementation of the certification programs, EPA
officials carry out the following activities:

●	Review and interpret regulations, provide guidance;

●	Gather applications from the industry, enter data into the database;

●	Review the applications for completeness and accuracy;

●	Verify that the correct engines have been selected and tested;

●	Answer questions from manufacturers and the public;

●	Issue appropriate certificates of conformity;

●	Periodically perform maintenance or enhance the database;

●	Make data available to the public, including making it available
through the Internet;

●	Analyze and manage requests for confidentiality;

●	Determining if "carry over" of data from a previous model year is
appropriate or if new testing will be required; and

●	Store, file and maintain data.

	Activities related to ABT involve:

●	Review requirements and providing guidance;

●	Enter the data into the database;

●	Receive quarterly and final reports, reviewing calculations, making
sure that the information submitted by manufacturers and remanufacturers
is accurate and complete;

●	Audit manufacturers and remanufacturers reports and files to make
sure all participants have zero or positive credit balances at the end
of the year; and

●	Keep records.

To ensure through the PLT Program that mass-produced locomotives and
locomotive engines do comply with emission standards, EPA must:

●	Answer questions from manufacturers, remanufacturers and the public;

●	Review submissions for format and completeness;

●	Input data into the database;

●	Analyze and compare results to standards and FELs;

●	Request and review additional information as needed;

●	Take any appropriate enforcement actions;

●	Keep records of the information submitted and EPA's actions and
determinations;

●	Periodically perform maintenance or make enhancements to the
database;

●	Make data from completed test programs available to the public,
including posting it on the Internet; and

●	Analyze and manage requests for confidentiality.

The EPA activities associated with the implementation of the In-use
Testing Program are similar:

●	Evaluate testing requirements;

●	Review information and identify engines for testing (if additional
testing is needed);

●	Inform manufacturers or remanufacturers of any additional testing
required (if needed);

●	Answer manufacturers' questions;

●	Review submissions for format and completeness;

●	Enter results into the database;

●	Analyze, compare and file information submitted;

●	Periodically request and review additional information;

●	Periodically perform maintenance or make enhancements to the
database;

●	Make data from completed test programs available to the public,
including posting it on the Internet; and

●	Analyze and manage requests for confidentiality.

5(b)  Collection Methodology and Management

	EPA currently makes extensive use of electronic media in gathering and
evaluating information from locomotive and locomotive engine
manufacturers and remanufacturers.  HDNEG has developed application
templates for locomotive programs and manufacturers and remanufacturers
submit most of the information in electronic formats.

	Once the electronic applications and reports are received, the
information is entered into the Certification Database and reviewed for
completeness.  If the manufacturer chooses to make hard copy submittals,
then EPA manually enters the information into the database.  The
certification reviewer analyses the information to ensure compliance
with the CAA and applicable regulations.

	In the future, the public will be able to access non-confidential
portions of the applications and testing reports by contacting the HDNEG
or through the Engine Certification Information Center at
http://www.epa.gov/otaq/certdata.htm.

	Currently, manufacturers must submit signed statements of compliance in
hard copy.  EPA is working to enable e-signature, so that we can receive
the complete application by electronic transmission directly from the
manufacturer, further reducing costs and burden for both the industry
and the agency.

5(c)  Small Entity Flexibility

	EPA has exempted remanufactured locomotive and locomotive engines owned
by small railroads (as defined by the Small Business Administration)
from the definition of 'new locomotive' and 'new locomotive engine';
thus exempting these remanufactured locomotives and locomotive engines
from compliance with certain emission standards and regulations.  This
is due to the fact that the number of locomotives owned and operated by
small railroads is very low and that the contribution of these engines
to the sector's emission inventory is considered to be trivial.

	Furthermore, EPA has made available to small manufacturers and
remanufacturers a streamlined certification program for small
businesses, applicable through the 2006 model year design to reduce the
financial burden of compliance.  Remanufacturers have the option of
testing locomotives (or locomotive engines) using a modified version of
the FTP, or  testing using a less rigorous alternate procedure, subject
to sales restrictions set by EPA.

	Under the In-use Testing Program, locomotive families of less than 10
locomotives are exempted from the requirements of the program.  This
provision, found at 92.6039(a)(2), reduces the cost of the program for
manufacturers and remanufacturers with limited production.

	Under the other programs included in this ICR (ABT and PLT), the
information being requested is considered to be the minimum needed to
effectively conduct and maintain their integrity.  Further measures to
simplify reporting for small businesses do not appear prudent or
necessary.

5(d)  Collection Schedule

	Collection frequency in the certification program is largely determined
by the manufacturer's marketing and product plans.  Information must be
submitted for each 'model year' that a manufacturer intends to build (or
import) an engine model.  A certificate of conformity must be obtained
before the start of production (or importation).  Taking these two
considerations into account, manufacturers normally submit information
on an annual basis and submit their certification applications at their
earliest convenience.  In-use testing reports are also submitted once a
year.

	ABT and PLT reports, however, are submitted quarterly, as required by
40 CFR 92.309(b) and 92.508(e).

6.  Estimating the Burden and Cost of the Collection

6(a)  Estimating Respondent Burden

	Burden estimates were taken from previous ICRs and adjusted to reflect
comments from fewer than ten respondents consulted by EPA.  These
estimates are included in Table 1 below, and Tables 2 through 4.

6(b)  Estimating Respondent Costs

(i)  Estimating Burden Hours

	To estimate labor costs, EPA used the Bureau of Labor Statistics' (BLS)
National Industry-specific Occupational Wage Estimates (May 2008) for
the Engine and Turbines Industry under Standard Industrial
Classification (SIC) code 351 and increased by a factor of 1.6 to
account for benefits and overhead.  A reference between the applicable
SIC and NAICS codes used to update hourly rates for this ICR is
available on the BLS website at:    HYPERLINK
"http://www.bls.gov/oes/2008/may/naics3_336000.htm"
http://www.bls.gov/oes/2008/may/naics3_336000.htm  .  Mean, hourly rates
were used for this estimate and are listed below.

Table 1

Labor Costs Estimates

Occupation	SOC Code Number	Mean Hourly Rate (BLS)	Rate Increased by
Factor of 1.6

Mechanical  Engineers	17-2141	$33.75	$54.00

Engineering Managers	11-9041	$54.63	$87.40

Lawyers	23-1011	$67.14	$107.42

Secretaries, Except Legal, Medical and Executive	43-6014	$14.25	$22.80

(ii)  Estimating Capital and Operations and Maintenance Costs

	Operation and Maintenance costs associated were estimated at
$399,802.70.  These expenses include the cost of diskettes,
photocopying, postage expenses, calls, maintenance of emission
laboratories, and testing costs.  Diskettes are used by manufacturers to
submit their electronic applications and to keep records.

	There are only seven locomotive and locomotive engine manufacturers in
the US market.  Two of them have in-house testing facilities for
certification testing and research.  The cost of maintaining these
laboratories have been estimated at $69,300 per year.  This estimate
includes the cost of test fuels, calibration gases, and equipment.

	Smaller companies and prefer to hire a contractor to conduct the
necessary certification emission testing in the contractor's facilities.
 EPA has estimated that testing at a private facility costs, on average,
$41,200.  This figure includes the cost of gathering both the line-haul
and switch data required.  This is a one-time expense per engine family
since manufacturers and remanufacturers can carry over emissions data
from one model year to the next.  This cost has been annualized over the
approval period requested for this ICR (three years):  $41,200/three
years = $13,733 per year.

	The costs associated with maintaining a laboratory were included only
in Table 2 (Certification), but omitted from Tables 3, 4 and 5 which
include the burden for ABT, PLT, and In-use Testing, respectively.
These tables are included in the associated Excel file.

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 when submitting an application for a certificate of conformity.  This
fee is requested under the authority of the CAA Section 217.  EPA
recently published the new schedule of fees in the document CISD-07-01,
which can be found at:
http://www.epa.gov/oms/cert/dearmfr/cisd0701rev.pdf.

	The new fees rule provides for a reduction in fee when "the full fee
exceeds one percent of the projected aggregate retail price of all
vehicles or engines covered by that certificate" (69 FR 26226, Section
F).  The reduced fee must not exceed one percent of the aggregate retail
price of the vehicles and engines covered by the certificate.  More
information regarding reduced fee certification can be found at:
http://www.epa.gov/otaq/fees.htm.

	Based on previous year’s data, EPA estimates that in the next three
years an estimated 19 out of 40 new engine families have more than ten
locomotives.  Engine families with less than ten locomotives are not
required to be tested in-use.  Although manufacturers and
remanufacturers are required to test at least two locomotives in each
new engine families, they are only required to test one locomotive per
"carry over" family.  This provision further reduces the financial
burden imposed by the In-use Program upon manufacturers and
remanufacturers.  Section 6(d) outlines EPA's estimates of new engine
families vs. carry over families.

	In assessing the In-use Testing Program's financial burden, EPA also
factored in the loss of revenue resulting from stopping a locomotive for
testing.  That cost was calculated to be around $2,060 per day for two
days of testing.  This amounts to $4,120 per test or locomotive or
$1,373 over the life of this ICR.

	Capital costs were covered by the previous ICR and incurred by
locomotive and locomotive engine manufacturers at the beginning of the
certification program.  Therefore, capital costs are excluded from this
ICR.  EPA does not expect any new locomotive or locomotive engine
manufacturers or remanufacturers to enter the US market in the next
three years and build its own emission testing laboratories.  Other
emission testing expenses are included as O&M costs as explained above.

(iii)  Capital/Start-up Costs

	There are no capital or start-up costs associated with the renewal of
this ICR.  (See 6(b)(ii) for details.)

(iv)  Annualizing Capital Costs

	There are no capital costs associated with the renewal of this ICR.
(See 6(b)(ii) for details.)

6(c)  Estimating Agency Burden

	Table 5 summarizes EPA's labor costs associated with this information
collection.  These costs are based on 2007 hourly wage rates obtained
from the Office of Personnel Management and adjusted by a factor of 1.6
to account for benefits and overhead.  Specific labor costs for each
program are listed in Tables 7 through 10, which are included in the
associated Excel file.

Table 6

Agency Labor Costs

Occupation	Hourly Rate	Rates Increased by a Factor of 1.6

Engineer (GS-13/10)	$41.71	$66.74

Lawyers (GS-13/7)	$45.65	$73.04

Managers (GS-15)	$52.88	$84.61

	The salary of a senior for clerical support is $13.81 per hour plus
approximately 150% increase for benefits, for a total of $21.72.  These
data were obtained from HDNEG's financial officer.

6(d)  Estimating the Respondent Universe and Total Burden and Costs

	EPA receives approximately 100 certification applications from three
manufacturers and seven remanufacturers.  (Some of the companies in both
categories are the same; the actual number of companies affected by this
collection is ten).  EPA estimates that in the following three years, an
average of 60 of those applications will be "carry overs”.  The
remaining 40 applications represent new engine families for which new
emissions data was collected.  The majority of these new applications
will come from remanufacturers as a result the new regulations
promulgated in 2008.

	About three respondents are currently participating in the ABT program
with approximately19 engine families.  All manufacturers and
remanufacturers must participate in the PLT and In-use Testing Programs.

6(e)  Bottom Line Burden Hours and Cost Tables

(i)  Respondent Tally

Table 11

Total Estimated Respondent Burden and Cost Summary

Program	Number of Respon-dents	Number of Activities	Total Hours Per Year
Total Labor Cost Per Year	Total Annual Capital Costs	Total Annual O&M
Costs	Total Costs

Certification	10	9	7,052	$346,534 	$0 	$684,308 	$1,030,842

ABT	3	7	1,029	$53,381 	$0 	$21 	$53,402

PLT	10	10	10,880	$490,629 	$0 	$2,662 	$493,291

In-use Testing	10	7	2,168	$93,882 	$0 	$678,308 	$772,190

Total	10	33	21,129	$984,425 	$0 	$1,365,299 	$2,349,724

(ii)  The Agency Tally

Table 12

Total Estimated Agency Burden and Cost Summary

Program	Number of Respon-dents	Number of Activities	Total Hours Per Year
Total Labor Cost Per Year	Total Annual Capital Costs	Total Annual O&M
Costs	Total

Certification	10	11	1,766	$214,421	$0	$2,615	$217,036

ABT	3	4	41	$2,552	$0	$5	$2,557

PLT	10	4	460	$37,992	$0	$77	$38,069

In-use	10	4	343	$30,402	$0	$170	$30,572

Total	10	23	2,610	$285,367	$0	$2,867	$288,234

6(f)  Reasons for Change in Burden

	There is a slight decrease (159 hours) in the total estimated burden
for ICR 1800.06 from the burden currently identified in the OMB
Inventory of Approved ICR Burdens.  This decrease is due to changes in
the estimated number of new applications EPA expects to receive during
the next three years as opposed to carry over applications.

6(g)  Burden Statement

	Locomotive and locomotive engine manufacturers and remanufacturers
spend, on average, 91 hours per response in emission certification and
compliance activities.

	These estimates include time to review applicable regulations and
guidance documents, generate and gather the necessary information,
submit applications and reports, and maintain records.

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

	To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID Number
EPA-HQ-OAR-2007-1184, which is available for online viewing at
HYPERLINK "http://www.regulations.gov"  www.regulations.gov , or in
person viewing at the Air and Radiation Docket and Information Center in
the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution
Avenue, NW, Washington, D.C.  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 Reading Room is (202)
566-1744, and the telephone number for the Air and Radiation Docket and
Information Center is<PHONE_NUMBER>.  An electronic version of the
public docket is available at www.regulations.gov.  This site can be
used to submit or view public comments, access the index listing of the
contents of the public docket, and to access those documents in the
public docket that are available electronically.  When in the system,
select "search," then key in the Docket ID Number identified above.
Also, you can send comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th Street, NW,
Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include
the EPA Docket ID Number EPA-HQ-OAR-2007-1184 and OMB Control Number
2060-0392 in any correspondence.

-  PAGE   26 -


[Federal Register Volume 76, Number 29 (Friday, February 11, 2011)]
[Notices]
[Pages 7866-7867]
[FR Doc No: 2011-3167]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0600]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Animal Drug User Fee
Cover Sheet, Form 3546

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March
14, 2011.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0539.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Animal Drug User Fee Cover Sheet; FDA Form 3546--(OMB Control Number
0910-0539)--Extension

    Under section 740 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 379j-12), as amended by the Animal Drug User Fee
Act (ADUFA), FDA has the authority to assess and collect for certain
animal drug user fees. Because the submission of user fees concurrently
with applications and supplements is required, review of an application
cannot begin until the fee is submitted. The types of fees that require
a cover sheet are certain animal drug application fees and certain
supplemental animal drug application fees. The cover sheet (FDA Form
3546) is designed to provide the minimum necessary information to
determine whether a fee is required for the review of an application or
supplement, to determine the amount of the fee required, and to assure
that each animal drug user fee payment and each animal drug application
for which payment is made is appropriately linked to the payment that
is made. The form, when completed electronically, will result in the
generation of a unique payment identification number used in tracking
the payment. FDA will use the information collected to initiate
administrative screening of new animal drug applications and
supplements to determine if payment has been received.
    In the Federal Register of November 29, 2010 (75 FR 73103), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Annual
                 FD&C Act Section amended by ADUFA                        No. of       frequency per     Total annual      Hours per       Total hours
                                                                       respondents        response        responses         response
--------------------------------------------------------------------------------------------------------------------------------------------------------
740(a)(1) FDA Form 3546 (Cover Sheet)..............................              76                1               76                1               76
                                                                    ------------------------------------------------------------------------------------
    Total..........................................................  ...............  ...............  ...............  ...............              76
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Respondents to this collection of information are new animal drug
applicants or manufacturers. Based on FDA's database system, there are
an estimated 140 manufacturers of products or sponsors of new animal
drugs potentially subject to ADUFA. However, not all manufacturers or
sponsors will have any submissions in a given year and some may have
multiple submissions. The total number of annual responses is based on
the

number of submissions received by FDA in fiscal year 2008. The
estimated hours per response are based on past FDA experience with the
various submissions. The hours per response are based on the average of
these estimates.

    Dated: February 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-3167 Filed 2-10-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 188 (Friday, September 27, 2013)]
[Rules and Regulations]
[Pages 59625-59626]
[FR Doc No: 2013-23525]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2013-0850]

Drawbridge Operation Regulation; Lake Pontchartrain, Near
Slidell, LA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Norfolk Southern Railroad Bridge
across Lake Pontchartrain, mile 4.80, near Slidell, St. Tammany Parish,
Louisiana. The deviation is necessary to replace worn joints on the
north draw of the bridge. This deviation allows the bridge to remain
closed to vessel traffic for six hours on three consecutive days.

DATES: This deviation is effective from 8 a.m. through 2 p.m. on
October 8, 9 and 10, 2013.

ADDRESSES: The docket for this deviation, [USCG-2013-0850] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Jim Wetherington, Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you
have questions on viewing the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Norfolk Southern Corporation, the bridge
owner, requested three, 6-hour closures for the Norfolk Southern RR
Bridge over Lake Pontchartrain, Mile 4.80, near Slidell, St. Tammany
Parish, LA. The bridge has a horizontal clearance of 105 feet and a
vertical clearance of two feet, above Mean Sea Level, in the closed-to-
navigation position and an unlimited vertical clearance in the open-to-
navigation position.
    The bridge opens on signal as per 33 CFR 117.5. The deviation
period will be October 8, 9 and 10, 2013 from 8 a.m. through 2 p.m.
each of those days. These closure periods will allow the replacement of
the bridge joints as required in a normal maintenance cycle.
    This waterway is used by both commercial and recreational vessel
traffic. No previous coordination was made with the waterway users
though the closure times were chosen to minimize the impact to these
users.
    Vessels able to pass through the bridge in the closed positions may
do so at anytime. The bridge will not be able to open for emergencies
and there is no immediate alternate route for vessels to pass. The
Coast Guard will also inform the users of the waterways through our
Local and Broadcast Notices to Mariners

of the change in operating schedule for the bridge so that vessels can
arrange their transits to minimize any impact caused by the temporary
deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: September 16, 2013.
David M. Frank,
Bridge Administrator.
[FR Doc. 2013-23525 Filed 9-26-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 78 (Monday, April 23, 2018)]
[Notices]
[Pages 17701-17703]
[FR Doc No: 2018-08406]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2018-0037; Notice No. 1] [Draft Safety Advisory 2018-
01]

Draft Safety Advisory Related to Temporary Signal Suspensions
AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT)

ACTION: Notice of draft Safety Advisory; request for comment.

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SUMMARY: This document provides notice of FRA's intent to issue a
Safety Advisory addressing railroad operations under temporary signal
suspensions. The Safety Advisory would identify existing industry best
practices railroads utilize when implementing temporary signal
suspensions and would recommend that railroads conducting rail
operations under temporary signal suspensions develop and implement
procedures and practices consistent with the identified best practices.
The Safety Advisory would also recommend that railroads take certain
other actions to ensure the safety of railroad operations during
temporary signal suspensions. FRA believes that actions consistent with
the draft Safety Advisory will reduce the risk of serious injury or
death both to railroad employees and members of the public. FRA invites
public comment on all aspects of the draft Safety Advisory.

DATES: Interested persons are invited to submit comments on the draft
Safety Advisory provided below on or before June 22, 2018.

ADDRESSES: Comments in response to this notice may be submitted by any
of the following methods:
     Website: The Federal eRulemaking Portal,
www.Regulations.gov. Follow the website's online instructions for
submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Management Facility, U.S. Department of
Transportation, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590.
     Hand Delivery: Docket Management Facility, U.S. Department
of Transportation, 1200 New Jersey Avenue SE, Room W12-140 on the
Ground level of the West Building, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Instructions: All submissions must include the agency name, docket
name, and docket number for this notice, Docket No. FRA-2018-0037;
Notice No. 1. Note that all comments received will be posted without
change to http://www.Regulations.gov, including any personal
information provided. Please see the Privacy Act Statement in this
document.

FOR FURTHER INFORMATION CONTACT: Douglas Taylor, Staff Director,
Operating Practices, Office of Railroad Safety, FRA, 1200 New Jersey
Avenue SE, Washington, DC 20590, telephone<PHONE_NUMBER>; or Carolyn
Hayward-Williams, Staff Director, Signal & Train Control Division,
Office of Railroad Safety, FRA, 1200 New Jersey Avenue SE, Washington,
DC 20590, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Draft Safety Advisory

    A review of FRA's accident/incident data shows that overall, rail
transportation, both passenger and freight, is safe. However, recent
rail accidents occurring in areas where a railroad has temporarily
suspended the signal system, typically for purposes of maintenance,
repair, or installation of additional components for a new or existing
system, demonstrate that rail operations during the signal suspension
present increased safety risks. Further, these accidents show that if
the increased risks associated with rail operations under a temporary
signal suspension are not addressed, serious unsafe conditions and
practices are introduced into rail transportation.
    Most recently, on February 4, 2018, both the engineer and conductor
of National Railroad Passenger Corporation (Amtrak) Train P09103 were
killed and 115 passengers injured,\1\ when their train collided head-on
with a CSX Transportation, Inc. freight train (Train F77703). The
collision occurred at approximately 2:27 a.m. in Cayce, South Carolina
when the Amtrak train, traveling south from New York City, New York, to
Miami, Florida, and operating on a track warrant, was diverted from the
main track through a misaligned switch. The misaligned switch sent the
Amtrak train into the siding where the CSX train was parked, resulting
in a head-on collision with an impact speed of 50 miles per hour (mph).
The lead locomotive and six of the seven cars in the Amtrak train
derailed. At the time of the accident, eight Amtrak crew members and
139 passengers were on board the train.
---------------------------------------------------------------------------

    \1\ Including 92 individuals who were transported to medical
facilities for treatment and 23 people who received first aid at a
triage area established near the accident site.
---------------------------------------------------------------------------

    While the cause of the February 4, 2018, accident has not yet been
determined, FRA's preliminary investigation indicates that despite the
CSX train crew reporting to the train dispatcher that the switch was
lined correctly, the crew did not restore the main track switch to its
normal position as required by Federal regulation (49 CFR 218.105) and
CSX's own operating rules. Instead, it appears the crew left the switch
misaligned in the reverse position (i.e., lined for the siding, not the
main line). Amtrak Train P09103 was the next train to traverse this
location. The misaligned switch diverted the Amtrak train into the
siding and into the standing CSX train parked on the siding. Notably,
CSX signal personnel had suspended the signal system for the area where
the accident occurred to upgrade the system with positive train control
(PTC) technology.\2\ Signal personnel had stopped working for the day
at the time of the accident, yet the temporary signal suspension
remained in place.
---------------------------------------------------------------------------

    \2\ PTC is a system designed to prevent train-to-train
collisions, overspeed derailments, incursions into established work
zone limits, and the movement of a train through a switch left in
the wrong position, as described in subpart I of 49 CFR part 236 and
49 U.S.C. 20157(i)(5).
---------------------------------------------------------------------------

    The National Transportation Safety Board (NTSB) is investigating
this accident under its legal authority. 49 U.S.C. 1101 et seq.; 49 CFR
831.2(b). As is customary, FRA is participating in the NTSB's
investigation and is also investigating the accident under its own
authority. 49 U.S.C. 20902; 49 CFR 1.89(a). While NTSB has not yet
issued any formal findings, on February 13, 2018, NTSB issued a Safety
Recommendation Report \3\ regarding

train operations during signal suspensions to FRA. In its report, NTSB
recommended that FRA issue an emergency order directing railroads to
require train crews to approach switches at restricted speed when
signal suspensions are in effect and a switch has been reported relined
for a main track. NTSB further recommended that after the switch
position is verified, train crews should be required to report to the
dispatcher that the switch is correctly lined for the main track before
subsequent trains are permitted to operate at maximum-authorized speed.
FRA is issuing this draft Safety Advisory consistent with the NTSB's
recommendation. Issuance of a Safety Advisory allows FRA to make all
railroads aware of both the safety concerns identified and information
and practices that specifically address the issues raised. Moreover,
issuance of a Safety Advisory provides all railroads the flexibility to
review and revise their existing operating rules and practices as
necessary to ensure the safety of their rail operations, without
imposing rigid, and inherently limited, new requirements on the
industry.
---------------------------------------------------------------------------

    \3\ NTSB, Safety Recommendation Report: Train Operation During
Signal Suspension, Report No. RSR-18/01, Recommendation No. R-18-005
(Feb. 13, 2018), https://www.ntsb.gov/investigations/AccidentReports/Reports/RSR1801.pdf (NTSB Report).
---------------------------------------------------------------------------

    As noted in the NTSB Report, a similar accident occurred on March
14, 2016, near Granger, Wyoming, when at 9:41 p.m., a westbound Union
Pacific Railroad (UP) freight train (Train KG1LAC-13) traveled from the
main track through a switch into a controlled siding and collided head-
on with a standing eastbound UP freight train (Train LCK41-14). The
collision occurred at a recorded speed of 30 mph and the engineer of
the striking train sustained minor injuries. Similar to the recent
accident in Cayce, South Carolina, at the time of this 2016 accident,
UP was installing and testing PTC technology on the main track. While
this work was in progress, UP suspended the signals in the area and
established absolute blocks intended to provide for the safe movement
of trains through the area without signals. NTSB determined the
probable cause of the accident was the employee-in-charge incorrectly
using information from a conversation with the train dispatcher as
authorization to send a train into the area where the signal system
suspension was in effect. The NTSB also found that a contributing
factor was the involved conductor pilot's failure to check the switch
position before authorizing the train to enter the area.
    The trains involved in both the Cayce, South Carolina, and Granger,
Wyoming, accidents were operating under temporary signal suspensions
where the signal systems that would normally govern operations through
the areas were suspended as the railroads installed additional
components to comply with the statutory mandate to implement a PTC
system.
    FRA realizes that railroads suspend signal systems for a variety of
reasons, including for example, maintenance or repair purposes, to
install a new system, or to add additional components to an existing
system. Although temporary signal suspensions are necessarily common
occurrences, rail operations under signal suspensions should be rare
and appropriately limited. FRA believes that, as exemplified by the
accidents described above, rail operations under the temporary loss of
protections provided by an existing signal system have a high potential
of introducing new safety risks and amplify the safety risks
encountered because railroad employees accustomed to the safety an
existing signal system provides must operate in an environment they may
not encounter on a regular basis. Indeed, a temporary signal suspension
requires operating employees to immediately apply operating rules and
practices different than those to which they are accustomed. Because a
person's routine may include learned habits that are difficult to set
aside when a temporary condition is imposed, operating employees may
also need specialized instruction on the applicable rules and
practices. Such risks must be addressed to provide for the safety of
train operations during the loss of protection afforded by the signal
system. Moreover, if a railroad elects to operate trains in signal
suspension territory, the scope of the signal suspension should be
limited in both geographic area and duration and rail operations
through or within the territory should be limited.
    Federal regulations do not prohibit railroads from temporarily
suspending existing signal systems for purposes of performing
maintenance, upgrades, repairs, or implementing PTC technology.
However, FRA regulations in 49 CFR part 235 require railroads to apply
for FRA approval for certain discontinuances and modifications of
signal systems. Specifically, FRA's regulations provide for both a
formal approval process in 49 CFR 235.5 for a variety of signal system
changes and also an expedited approval process in 49 CFR 235.6 for
modifications directly associated with the implementation of a PTC
system. Although the safety of railroad operations during temporary
signal suspensions may be addressed under these approval processes,
part 235 also excludes various signal system changes from FRA approval
(49 CFR 235.7).
    FRA's regulations also require individual railroads to adopt and
comply with operating rules addressing the operation of hand-operated
main track switches. See 49 CFR 218.105. Specifically, Sec.  218.105
requires railroads to designate in writing the normal position of hand-
operated main track switches and, with limited exceptions, requires
those switches to be lined and locked in the designated position when
not in use. That same section requires employees to conduct a job
briefing before leaving a location where any hand-operated main track
switch was operated and all crewmembers to communicate to confirm the
position of the switch. Further, Sec.  218.105 generally requires an
employee releasing the limits of a main track authority in non-signaled
territory (including an area under temporary signal suspension) where a
hand-operated switch is used to clear the main track to report to the
train dispatcher that the hand-operated main track switch has been
restored to its normal position and locked, prior to departing the
switch's location and after conducting the required job briefing. Upon
the employee's report, Sec.  218.105 requires the train dispatcher to
repeat the reported switch position information to the employee
releasing the limits and requires the employee releasing the limits to
confirm to the train dispatcher that the information is correct.
    In addition to these regulatory requirements, virtually all
railroads have adopted additional operational protections to ensure the
safety of rail operations when an existing signal system is temporarily
suspended. FRA reviewed the current operating practices of several
railroads and engaged in discussions with these railroads to identify
the industry's best safety practices related to temporary suspension of
an existing signal system. As a result of this outreach, FRA believes
that certain operational safeguards railroads already undertake
constitute the best practices within the industry when temporarily
suspending a signal system. These best practices, include:
     Take all practical measures to ensure sufficient personnel
are present to continue signal work until the system is restored to
proper operation. If sufficient personnel are not present, the signal
suspension should be terminated until such time as sufficient personnel
are on hand.
     If a railroad elects to allow train traffic through
suspension limits:

    [cir] Establish the smallest limits possible for the signal
suspension (if possible, no more than three (3) control points or use
phased limits to allow restoration of the signal system as work is
completed);
    [cir] Minimize the duration of the signal suspension to the
shortest time period possible (if possible, no more than twelve (12)
hours); and
    [cir] Take all practical measures to ensure only through traffic is
allowed to operate within the limits (avoiding any train meets or any
moves requiring the manipulation of switches within the suspension
limits).
     If any switches within the suspension limits are
manipulated, consistent with 49 CFR 218.105(d), establish an effective
means of verifying that all switches have been returned to the proper
position prior to any train traffic operating through the limits. (For
example, require spiking or clamping of switches followed by locking
for through movement after use; utilize a signal employee to tend the
switch and to establish agreement between assigned crewmembers and the
switch tender that the switch is properly lined; and/or require the
first train through the limits after the manipulation of any switch to
operate at restricted speed).
    Recommendations: Considering the accidents discussed above, and to
ensure the safety of the Nation's railroads, their employees, and the
public, FRA recommends that railroads take actions consistent with the
following:
    1. Develop and implement procedures and practices consistent with
the industry best practices discussed above for rail operations
conducted under temporary signal suspensions.
    2. Inform employees of the circumstances surrounding the February
4, 2018, accident in Cayce, South Carolina, and the March 14, 2016,
accident near Granger, Wyoming, discussed above, emphasizing the
potential consequences of misaligned switches and the relevant Federal
regulations and railroad operating rules intended to prevent such
accidents.
    3. Review, and as appropriate, revise all operating rules related
to operating hand-operated main track switches (including operating
rules required by 49 CFR 218.105(d)), to enhance them to ensure (a)
train crews and others restore switches to their normal position after
use, and (b) the position of switches are clearly communicated to train
control employees and/or dispatcher(s) responsible for the movement of
trains through the area where the signal system is temporarily
suspended. In doing so, railroads should pay particular attention to
those main track switches where employees report clear of the main
track to the train dispatcher.
    4. Increase supervisory operational oversight and conduct
operational testing on the applicable operating rules pertaining to the
operation of hand-operated main track switches. This should include
face-to-face initial job briefings with all train and engine (T&E)
crews that will operate in any area where the signal system will be
temporarily suspended.
    5. Enhance instruction on the relevant operating rules concerning
the operation of hand-operated main track switches in non-signaled
areas, including the operating rules required by 49 CFR 218.105(d)
during both initial and periodic instruction required by 49 CFR 217.11.
In doing so, railroads should emphasize the applicability of the rules
to area(s) where the signal system is temporarily suspended and the
need to ensure and verify that all hand-operated main track switches
manipulated within any suspension limits have been returned to the
proper position prior to operating any trains through the limits.
    6. Stress to T&E employees the importance of thorough and accurate
job briefings when operating hand-operated main track switches,
particularly in areas where the signal system is temporarily suspended,
and specifically when releasing main track authority. Ensure adequate
processes and procedures are in place enabling clear and timely
communication of switch positions between and among all dispatching,
T&E, and train control employees responsible for operating, performing
work, or authorizing trains to operate through areas where the signal
system is temporarily suspended, including processes and procedures for
communicating switch position information during shift handovers.
Encourage employees, in case of any doubt or uncertainty regarding the
position of such switches, to immediately contact the train dispatcher
or take other appropriate action to confirm the position of the switch
prior to authorizing a train to operate through the limits of the area.
    FRA requests public comment on all aspects of this draft Safety
Advisory.
    Privacy Act Statement: Anyone can search the electronic form of all
comments received into any of DOT's dockets by the name of the
individual submitting the comment (or signing the comment, if submitted
on behalf of an association, business, labor union, etc.). You may
review DOT's complete Privacy Act Statement in the Federal Register
published on April 11, 2000 (65 FR 19477), or you may visit http://www.regulations.gov/#!privacyNotice.

    Issued in Washington, DC, on April 18, 2018.
Ronald Louis Batory,
Administrator.
[FR Doc. 2018-08406 Filed 4-20-18; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 79, Number 180 (Wednesday, September 17, 2014)]
[Notices]
[Pages 55793-55794]
[FR Doc No: 2014-22162]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0233; FRL-9916-72]

Office of Pesticide Programs; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA's Office of Pesticide Programs, the U.S. Department of
Agriculture (USDA), and the U.S. Fish and Wildlife Service (FWS) and
the National Marine Fisheries Service (NMFS) (collectively, the
Services), are holding a 1-day workshop to provide a forum for
stakeholders to offer scientific and technical feedback on the interim
approaches that were issued in November 2013 by EPA, USDA, and the
Services in response to the National Academy of Sciences (NAS) report
entitled, ``Assessing Risks to Endangered and Threatened Species from
Pesticides.'' The workshop is an opportunity for stakeholders and
agencies to continue their dialogue on the technical aspects of
implementing the NAS recommendations, building upon public meetings
held in November and December 2013, April 2014, and the implementation
of the enhanced stakeholder engagement process that was finalized in
March 2013. The workshop is not designed to, or intended to be a
decisionmaking forum; consensus will not be sought or developed at the
meeting. This meeting furthers the agencies' goal of developing a
consultation process for pesticide impacts on listed species that is
efficient, inclusive, and transparent.

DATES: The meeting will be held on October 6, 2014, from 9 a.m. to 5
p.m.
    Requests to participate in the meeting must be received on or
before September 26, 2014.
    To request accommodation of a disability, please contact the person
listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10
days prior to the meeting, to give EPA as much time as possible to
process your request.

ADDRESSES: The meeting will be held in the Rachel Carson Room at FWS,
Skyline, Bldg. 7, 5275 Leesburg Pike, Bailey's Crossroads, VA. See Unit
III. for additional information.
    Requests to participate in the meeting, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0233, are submitted to the
person listed under FOR FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT:
    For general information contact: Catherine Eiden, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For meeting logistics or registration contact: Keith A Paul, U.S.
Fish and Wildlife Service Headquarters, Ecological Services, 5275
Leesburg Pike, Falls Church, VA 22041-3803; telephone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; cell:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you develop,
manufacture, formulate, sell, and/or apply pesticide products, and if
you are interested in the potential impacts of pesticide use on listed
species. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2014-0233, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

II. Background

    The workshop is an opportunity for stakeholders and agencies to
continue their dialogue on the technical aspects of implementing the
NAS recommendations, building upon public meetings held in November and
December 2013, April 2014, and the implementation of the enhanced
stakeholder engagement process that was finalized in March 2013. The
workshop is not designed, or intended to be a decisionmaking forum;
consensus will not be sought, or developed at the meeting.
    Stakeholders will be asked to provide scientific and technical
information that could potentially be used by the agencies to inform
various scientific determinations that will be made during the course
of evaluation pesticides, including:

    1. Systematic methods for implementing ``Weight of Evidence''
analysis that consider both quantitative and qualitative data.
    2. Approaches for ensuring ``Data Quality.''
    3. The consideration of ``uncertainty'' in the scientific
assessment process.

While the focus of this public meeting is on the three topics noted in
this unit, comments on all aspects of the materials previously provided
to the public will be accepted. The agencies' interim approach document
entitled, ``Interagency Approach for Implementation of the National
Academy of Sciences Report'' dated November 13, 2013, and the
presentation materials from the November 2013 stakeholder workshop are
available at the following Web site: http://www.epa.gov/oppfead1/endanger/2013/nas.html.
    In addition to the scientific and technical information presented
by stakeholders, representatives from Federal agencies will join the
dialogue to ask clarifying questions of the presenters and to respond
to questions regarding the pesticide registration process and
Endangered Species Act consultation. The agencies see this forum as an
integral component of the stakeholder engagement process developed for
pesticide consultations and contributes to the agencies' commitment to
adapt and refine the interim approaches as we progress through the
initial consultations.

III. Participation in This Meeting

    1. Requests to participate in the meeting, identified by docket ID
number EPA-HQ-OPP-2014-0233, must be received on or before September
26, 2014. Do not submit any information considered confidential
business information (CBI) in your request to participate in the
meeting sent to the person listed under FOR FURTHER INFORMATION
CONTACT.
    2. Public parking is available for attendees; follow the blue signs
to the lot. There is a fee for all day parking.
    3. Attendees will need to present identification at the Security
check-in.
    4. Webinar and teleconference information will be provided to
participants requesting access via webinar and telephone.

    Authority: 7 U.S.C. 136 et seq.

    Dated: September 11, 2014.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2014-22162 Filed 9-16-14; 8:45 am]
BILLING CODE 6560-50-P