[Federal Register Volume 79, Number 84 (Thursday, May 1, 2014)]
[Notices]
[Page 24729]
[FR Doc No: 2014-09913]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1394]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Guidance for Industry on Special
Protocol Assessment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Guidance for Industry on Special
Protocol Assessment'' has been approved by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On February 19, 2014, the Agency submitted a
proposed collection of information entitled ``Guidance for Industry on
Special Protocol Assessment'' to OMB for review and clearance under 44
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0470.
The approval expires on March 31, 2017. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: April 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09913 Filed 4-30-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 87, Number 217 (Thursday, November 10, 2022)]
[Proposed Rules]
[Pages 67840-67842]
[FR Doc No: 2022-24430]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1419; Project Identifier MCAI-2022-01002-R]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.a. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Leonardo S.p.a. Model AB139 and AW139 helicopters. This
proposed AD was prompted by a report of a damaged tail rotor duplex
bearing (TRDB). This proposed AD would require repetitively inspecting
certain TRDBs and depending on the results, replacing the TRDB or tail
rotor actuator (TRA), or as an option, replacing the sliding control
assembly. This proposed AD would also require replacing an affected
TRDB with a serviceable TRDB at a specified threshold and prohibit the
installation of certain TRDBs or sliding control assemblies on any
helicopter, as specified in a European Union Aviation Safety Agency
(EASA) AD, which is proposed for incorporation by reference (IBR). The
FAA is proposing this AD to address the unsafe condition on these
products.

DATES: The FAA must receive comments on this proposed AD by December
27, 2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-1419; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this NPRM, any comments received, and other
information. The street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For service information identified in this NPRM, contact
EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone: +49 221
8999 000; email: [email protected]. You may find this material on the
EASA website at ad.easa.europa.eu.
     You may view this service information at the FAA, Office
of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Dan McCully, Program Manager, COS
Program Management Section, Operational Safety Branch, Compliance &
Airworthiness Division, FAA, 1701 Columbia Ave., Mail Stop: ACO,
College Park, GA 30337; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-1419; Project Identifier
MCAI-2022-01002-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Dan
McCully, Program Manager, COS Program Management Section, Operational
Safety Branch, Compliance & Airworthiness Division, FAA, 1701 Columbia
Ave., Mail Stop: ACO, College Park, GA 30337; telephone<PHONE_NUMBER>;
email [email protected]. Any commentary that the FAA receives
that is not specifically designated as CBI will be placed in the public
docket for this rulemaking.

Background

    EASA, the Technical Agent for the Member States of the European
Union, issued a series of ADs, with the most recent being EASA
Emergency AD 2022-0182-E, dated August 30, 2022 (EASA AD 2022-0182-E),
to correct an unsafe condition for all serial-numbered Leonardo S.p.A.
Helicopters, formerly Finmeccanica S.p.A, AgustaWestland S.p.A., Agusta
S.p.A.; and AgustaWestland Philadelphia Corporation, formerly Agusta
Aerospace Corporation, Model AB139 and AW139 helicopters. EASA AD 2022-
0182-E defines the ``affected part'' as TRDB part number (P/N)
3G6430V00151, P/N 3G6430V00152, and P/N 3G6430V00153, the ``affected
TRA'' as TRA P/N 3G6730V00731 and P/N 3G6730V00732, and the ``affected
assembly'' as sliding control assembly P/N 3G6430A02531. EASA initially
issued EASA AD 2022-0152-E, dated July 26, 2022, which was superseded
by EASA AD 2022-0182-E.

    This proposed AD was prompted by a report of a damaged TRDB.
According to EASA, after an investigation, it was determined that the
TRDB had been removed from a sliding control assembly and reinstalled
on another sliding control assembly, even though Aircraft Maintenance
Programme procedures do not allow reinstallation of a removed TRDB. The
FAA is proposing this AD to ensure the proper installation of a TRDB
and prevent a TRDB from remaining in service beyond its life limit. See
EASA AD 2022-0182-E for additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2022-0182-E requires repetitively inspecting certain
affected parts, and depending on the results, replacing the affected
part with a serviceable part, and for certain conditions, replacing the
affected TRA or sliding control assembly, as defined therein. EASA AD
2022-0182-E also requires replacing affected parts with serviceable
parts at specified thresholds. EASA AD 2022-0182-E also prohibits the
installation of certain TRDBs or sliding control assemblies on any
helicopter.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Other Related Service Information

    The FAA also reviewed Leonardo Helicopters Emergency Alert Service
Bulletin No. 139-725, Revision A, dated August 9, 2022 (EASB 139-725
Rev A). EASB 139-725 Rev A specifies procedures for inspecting for
rotation between the trunnion and pitch control rod, and applying
slippage marks; inspecting the visible areas of the TRDB (including
seals) for wear, damages, corrosion, particles, grease leakage, grease
leakage particles (including magnetic/metallic particles), and
roughness in its movement, and accomplishing a TRDB operational test.
Finally, EASB 139-725 Rev A specifies procedures for replacing a TRDB
and TRA, discarding the removed TRDB, and sending certain photos and
information to Leonardo S.p.A.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its emergency AD. The FAA is proposing
this AD after evaluating all known relevant information and determining
that the unsafe condition described previously is likely to exist or
develop on other helicopters of the same type designs.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in EASA AD 2022-0182-E, described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this proposed AD.''

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2022-0182-E by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2022-0182-E in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in EASA AD 2022-0182-E does not mean that
operators need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2022-
0182-E. Service information referenced in EASA AD 2022-0182-E for
compliance will be available at regulations.gov by searching for and
locating Docket No. FAA-2022-1419 after the FAA final rule is
published.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 80 helicopters of U.S. Registry. Labor rates are estimated at
$85 per work-hour. Based on these numbers, the FAA estimates the
following costs to comply with this proposed AD.
    Inspecting the TRDB would take up to about 12 work-hours and parts
would cost about $100 for an estimated cost of up to $1,120 per
helicopter and $89,600 for the U.S. fleet, per inspection cycle. If
required, replacing a TRDB would take about 3 additional work-hours and
parts would cost about $2,100, for an estimated cost of $2,355 per
helicopter. Replacing a TRA would take about 2 additional work-hours
and parts would cost about $42,802, for an estimated cost of $42,972
per helicopter. Alternatively, replacing the sliding control assembly
would take about 6 work-hours and parts would cost about $11,500, for
an estimated cost of $12,010 per helicopter.
    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected operators.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Leonardo S.p.a.: Docket No. FAA-2022-1419; Project Identifier MCAI-
2022-01002-R.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by December 27, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Leonardo S.p.a. Model AB139 and AW139
helicopters, certificated in any category.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 6400, Tail Rotor
System.

(e) Unsafe Condition

    This AD was prompted by a report of a damaged tail rotor duplex
bearing (TRDB) that was improperly installed on a sliding control
assembly. The FAA is issuing this AD to ensure the proper
installation of a TRDB and prevent a TRDB from remaining in service
beyond its life limit. The unsafe condition, if not detected and
corrected, could lead to structural failure of the TRDB, possibly
resulting in loss of control of the helicopter.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraphs (h) and (i) of this AD: Comply
with all required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA)
Emergency AD 2022-0182-E, dated August 30, 2022 (EASA AD 2022-0182-
E).

(h) Exceptions to EASA AD 2022-0182-E

    (1) Where EASA AD 2022-0182-E requires compliance in terms of
flight hours, this AD requires using hours time-in-service (TIS).
    (2) Where EASA AD 2022-0182-E refers to July 28, 2022 (the
effective date of EASA AD 2022-0152-E, dated July 26, 2022) and its
effective date, this AD requires using the effective date of this
AD.
    (3) Where the service information referenced in EASA AD 2022-
0182-E specifies discarding certain parts, this AD requires removing
those parts from service.
    (4) Where the service information referenced in EASA AD 2022-
0182-E specifies returning a part to the manufacturer, this AD does
not require that action.
    (5) The ``Remarks'' section of EASA AD 2022-0182-E does not
apply to this AD.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2022-
0182-E specifies to submit certain information to the manufacturer,
this AD does not include that requirement.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (k)(2) of
this AD. Information may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Additional Information

    (1) Refer to EASA AD 2022-0182-E for related information. This
EASA AD may be found in the AD docket at regulations.gov under
Docket No. FAA-2022-1419.
    (2) For more information about this AD, contact Dan McCully,
Program Manager, COS Program Management Section, Operational Safety
Branch, Compliance & Airworthiness Division, FAA, 1701 Columbia
Ave., Mail Stop: ACO, College Park, GA 30337; telephone (404) 474-
5548; email [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) Emergency AD
2022-0182-E, dated August 30, 2022.
    (ii) Reserved.
    (3) For EASA AD 2022-0182-E, contact EASA, Konrad-Adenauer-Ufer
3, 50668 Cologne, Germany; phone: +49 221 8999 000; email:
[email protected]. You may find this material on the EASA website
at ad.easa.europa.eu.
    (4) You may view this service information at FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-
321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on November 3, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-24430 Filed 11-9-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 67 (Friday, April 6, 2018)]
[Notices]
[Pages 14872-14873]
[FR Doc No: 2018-07035]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2018-0187]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0032

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting an extension of
its approval for the following collection of information: 1625-0032,
Vessel Inspection Related Forms and Reporting Requirements Under Title
46 U.S. Code; without change. Our ICR describes the information we seek
to collect from the public. Before submitting this ICR to OIRA, the
Coast Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before June 5, 2018.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2018-0187] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the internet
at http://www.regulations.gov. Additionally, copies are available from:
COMMANDANT (CG-612), ATTN: PAPERWORK REDUCTION ACT MANAGER, U.S. COAST
GUARD, 2703 MARTIN LUTHER KING JR AVE SE, STOP 7710, WASHINGTON, DC
20593-7710.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. In response to
your comments, we may revise this ICR or decide not to seek an
extension of approval for the Collection. We will consider all comments
and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2018-0187], and
must be received by June 5, 2018

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted

without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).

Information Collection Request

    Title: Vessel Inspection Related Forms and Reporting Requirements
Under Title 46 U.S. Code.
    OMB Control Number: 1625-0032.
    Summary: This collection of information requires owners, operators,
agents or masters of certain inspected vessels to obtain and/or post
various forms as part of the Coast Guard's Commercial Vessel Safety
Program.
    Need: The Coast Guard's Commercial Vessel Safety Program
regulations are found in 46 CFR, including parts 2, 26, 31, 71, 91,
107, 115, 126, 169, 176 and 189, as authorized in Title 46 U.S. Code. A
number of reporting and recordkeeping requirements are contained
therein.
    Forms: CG-841, Certificate of Inspection; CG-854, Temporary
Certificate of Inspection; CG-948, Permit to Proceed to Another Port
for Repairs; CG-949, Permit to Carry Excursion Party; CG-950,
Application for Permit to Carry Excursion Party; CG-950A, Application
for Special Permit; and CG-2832, Vessel Inspection Record.
    Respondents: Owners, operators, agents and masters of vessels.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has increased from 1,642
hours to 1,705 hours a year due to an increase in the estimated annual
number of respondents.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: March 29, 2018.
James D. Roppel,
U.S. Coast Guard, Division Chief, Directives and Publications.
[FR Doc. 2018-07035 Filed 4-5-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Notices]
[Pages 72878-72879]
[FR Doc No: 2013-28921]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM12-15-000; Docket No. RM01-5-000]

Revisions to Procedural Regulations Governing Filing, Indexing
and Service by Oil Pipelines, Electronic Tariff Filings; Notice of
Changes to eTariff Part 341 Type of Filing Codes

    Order No. 780, effective June 28, 2013, revised Part 341 of the
Commission's regulations to revise the filing, indexing and service
procedures used by oil pipelines.\1\ Take notice that, effective
December 23, 2013, the list of available eTariff Type of Filing Codes
(TOFC) will be modified as follows: \2\
---------------------------------------------------------------------------

    \1\ Filing, Indexing and Service Requirements for Oil Pipelines,
143 FERC ] 61,137 (2013) (Order No. 780).
    \2\ The type of filing business process categories are described
in the Implementation Guide for Electronic Filing of Parts 35, 154,
284, 300, and 341 Tariff Filings (August 12, 2013), found on the
Commission's Web site, http://www.ferc.gov/docs-filing/etariff/implementation-guide.pdf.

----------------------------------------------------------------------------------------------------------------
                                                                               New or
         TOFC                Filing title            Filing category           revised     Description of change
----------------------------------------------------------------------------------------------------------------
830...................  Rate Changes, Initial  Normal....................               R  Citation updated.
                         Rates & Other Tariff
                         Changes.
840...................  Embargo of effective   Normal....................               R  Terminated. Use TOFC
                         tariff.                                                            830.
850...................  Postponement of        Amendment.................               R  Terminated. Replaced
                         Tariff.                                                            by TOFC 1240.
870...................  Cancellation of        Normal....................               R  Citation updated.
                         Tariff (partial).
970...................  New company tariff     Baseline--New.............               R  Citation updated.
                         (Baseline).
1230..................  Amendment............  Amendment.................               N  Amend any pending
                                                                                Normal TOF Category
                                                                                filing.
1240..................  Postponement of        Motion....................               N  To push out the
                         Suspended Tariff.                                                  effective date of a
                                                                                Suspended Tariff
                                                                                Record.
1250..................  Concurrence..........  Normal....................               N  Concurrence Filing.
----------------------------------------------------------------------------------------------------------------

    In addition, the Filing Titles for the Part 284 program have been
modified to be more descriptive.
    For more information, contact Aaron Kahn, Office of Energy Market
Regulation at<PHONE_NUMBER> or send an email to<EMAIL_ADDRESS>
    Dated: November 26, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-28921 Filed 12-3-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)]
[Notices]
[Pages 8102-8103]
[FR Doc No: 2016-03295]

=======================================================================
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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2016-0001]

National Advisory Committee on Occupational Safety and Health

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Announcement of special meeting.

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SUMMARY: The National Advisory Committee on Occupational Safety and
Health (NACOSH) will hold a special meeting on March 4, 2016, in
Washington, DC, to consider and make recommendations on OSHA's draft
Safety and Health Program Management Guidelines.

DATES: NACOSH will meet from 2 to 5 p.m., Friday, March 4, 2016.
    Comments, requests to speak, speaker presentations, requests for
special accommodations and requests to attend the meeting by
teleconference: You must submit (postmark, send, transmit) comments,
requests to address NACOSH, speaker presentations, requests for special
accommodations for the NACOSH meeting and requests to attend the
meeting by teleconference by Wednesday, February 24, 2016.

ADDRESSES: NACOSH will meet in Room N-5437A, Conference Rooms A-B, U.S.
Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210.
    Submission of comments, requests to speak and speaker
presentations: You may submit comments and requests to speak at the
NACOSH meeting, identified by the docket number for this Federal
Register notice (Docket No. OSHA-2016-0001), by one of the following
methods:
    Electronically: You may submit materials, including attachments,
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the online instructions for making
submissions.
    Facsimile: If your submission, including attachments, does not
exceed 10 pages, you may fax it to the OSHA Docket Office at (202) 693-
1648.
    Regular mail, express mail, hand delivery, or messenger/courier
service (hard copy): You may submit your materials to the OSHA Docket
Office, Docket No. OSHA-2016-0001, Room N-2625, U.S. Department of
Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone
(202) 693-2350 (TTY<PHONE_NUMBER>). OSHA's Docket Office accepts
deliveries (hand deliveries, express mail, and messenger/courier
service) during normal business hours, 8:15 a.m. to 4:45 p.m. e.t.,
weekdays.
    Requests for special accommodations and requests to attend the
meeting by teleconference: Please submit requests for special
accommodations to attend the NACOSH meeting and requests to attend the
meeting by teleconference, by email, telephone, or hard copy to Ms.
Gretta Jameson, OSHA Office of Communications, Room N-3647, U.S.
Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210;
telephone<PHONE_NUMBER> (TTY<PHONE_NUMBER>); email
<EMAIL_ADDRESS>    Instructions: Your submissions must include the Agency name and the
docket number for this Federal Register notice (Docket No. OSHA-2016-
0001). Due to security-related procedures, submissions by regular mail
may experience significant delays. Please contact the OSHA Docket
Office for information about security procedures for making submissions
by hand delivery, express delivery, or messenger/courier service. For
additional information about submissions, see the SUPPLEMENTARY
INFORMATION section of this notice.
    OSHA will post in the NACOSH docket, without change, any comments,
requests to speak, and speaker presentations, including any personal
information that you provide. Therefore, OSHA cautions interested
parties about submitting personal information such as Social Security
numbers and birthdates.

FOR FURTHER INFORMATION CONTACT:
    For press inquiries: Mr. Frank Meilinger, Director, OSHA Office of
Communications, Room N-3647, U.S. Department of Labor, 200 Constitution
Avenue NW., Washington, DC 20210; telephone<PHONE_NUMBER> (TTY (877)
889-5627); email<EMAIL_ADDRESS>    For general information: Ms. Michelle Walker, Director, OSHA
Technical Data Center, Directorate of Technical Support and Emergency
Management, Room N-2625, U.S. Department of Labor,, 200 Constitution
Avenue NW., Washington, DC 20210; telephone<PHONE_NUMBER> (TTY (877)
889-5627); email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: NACOSH will hold a special meeting on
Friday, March 4, 2016, in Washington, DC. The purpose of this special
meeting is to allow NACOSH to consider and make recommendations on
OSHA's draft Safety and Health Program Management Guidelines. Some
NACOSH members may attend by teleconference. NACOSH meetings are open
to the public.
    NACOSH was established by Section 7(a) of the Occupational Safety
and Health Act of 1970 (OSH Act) (29 U.S.C. 651, 656) to advise,
consult with and make recommendations to the Secretary of Labor and the
Secretary of Health and Human Services on matters relating to the
administration of the OSH Act. NACOSH is a continuing advisory
committee of indefinite duration.
    NACOSH operates in accordance with the Federal Advisory Committee
Act (FACA) (5 U.S.C. App. 2), its implementing regulations (41 CFR part
102-3), and OSHA's regulations on NACOSH (29 CFR part 1912a).
    OSHA transcribes and prepares detailed minutes of NACOSH meetings.
OSHA posts the transcripts and minutes in the public docket along with
written comments, speaker presentations, and other materials submitted
to NACOSH or presented at NACOSH meetings.

Public Participation, Submissions and Access to Public Record

    All NACOSH meetings are open to the public. Individuals attending
NACOSH meetings at the U.S. Department of Labor must enter the building
at the Visitors' Entrance at 3rd and C Streets NW., and pass through
building security. Persons attending the meeting must have valid
government-issued photo identification (e.g., driver's license) to
enter the building. For additional information about attending the
NACOSH meeting (in person or by teleconference), please contact Ms.
Jameson (see ADDRESSES section).
    Individuals requesting special accommodations to attend the NACOSH
meeting and requesting to attend the meeting by teleconference should
contact Ms. Jameson.
    Submission of comments: You may submit comments using one of the
methods listed in the ADDRESSES section. Your submission must include
the Agency name and docket number for this Federal Register notice
(Docket No. OSHA-2016-0001). OSHA will provide copies of any
submissions to the NACOSH members.
    Because of security-related procedures, submissions by regular mail
may experience significant delays. For information about security
procedures for submitting materials by hand delivery, express mail, and
messenger/courier service, please contact the OSHA Docket Office.
    Requests to speak and speaker presentations: If you want to address
NACOSH at the meeting you must submit a request to speak, as well as
any written or electronic presentation, by

February 24, 2016, using one of the methods listed in the ADDRESSES
section. Your request must state:
     The amount of time requested to speak;
     The interest you represent (e.g., business, organization,
affiliation), if any; and
     A brief outline of the presentation.
    PowerPoint presentations and other electronic materials must be
compatible with PowerPoint 2010 and other Microsoft Office 2010
formats. The NACOSH Chair may grant requests to address NACOSH as time
and circumstances permit.
    Public docket of NACOSH meetings: OSHA places comments, requests to
speak, and speaker presentations, including any personal information
you provide, in the NACOSH docket, without change. Those documents also
may be available online at http://www.regulations.gov. Therefore, OSHA
cautions you about submitting certain personal information such as
Social Security numbers and birthdates.
    OSHA also places in the NACOSH docket meeting transcripts, meeting
minutes, documents presented at the NACOSH meeting, and other documents
pertaining to the NACOSH meetings. These documents may be available
online at http://www.regulations.gov.
    Access to the public record of NACOSH meetings: To read or download
documents in the NACOSH docket, go to Docket No. OSHA-2016-0001 at
http://www.regulations.gov. The index for that Web page lists all of
the documents in the docket; however, some documents (e.g., copyrighted
materials) are not publicly available through that Web page. All
documents in the NACOSH docket, including materials not available
through http://www.regulations.gov, are available in the OSHA Docket
Office. Please contact the OSHA Docket Office for assistance in making
submissions to, or obtaining materials from, the NACOSH docket.
    Electronic copies of this Federal Register notice are available at
http://www.regulations.gov. This notice, as well as news releases and
other relevant information, also are available on OSHA's Web page at
http://www.osha.gov.

Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this notice
under the authority granted by 29 U.S.C. 656; 5 U.S.C. App. 2; 29 CFR
part 1912a; 41 CFR part 102-3; and Secretary of Labor's Order No. 1-
2012 (77 FR 3912 (1/25/2012)).

     Signed at Washington, DC, on February 11, 2016.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2016-03295 Filed 2-16-16; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Notices]
[Pages 16257-16258]
[FR Doc No: 2019-07724]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2012-0533; FRL-9991-89-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NSPS for Phosphate Fertilizer (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NSPS for Phosphate Fertilizer
Industry (EPA ICR Number 1061.14, OMB Control Number 2060-0037), to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. This is a proposed
extension of the ICR, which is currently approved through April 30,
2019. Public comments were previously requested, via the Federal
Register, on May 30, 2018 during a 60-day comment period. This notice
allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An agency may neither conduct nor sponsor, and
a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before May 20, 2019.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2012-0533, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to [email protected], or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW, Washington, DC 20460; and (2) OMB via email
to [email protected]. Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change, including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov, or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The New Source Performance Standards (NSPS), for
Phosphate Fertilizer Industry (40 CFR part 60, subparts T, U, V, W, and
X) were proposed on October 22, 1974, promulgated on August 6, 1975,
and amended on August 19, 2015. These regulations apply to both
existing facilities and new facilities that engage in the manufacture
of phosphate fertilizers (wet-process phosphoric acid plants, super-
phosphoric acid plants, diammonium phosphate plants, and triple
superphosphate plants), and have a design capacity of more than 15 tons
of equivalent phosphorous pentoxide (P2O5) feed
per calendar day. These standards also apply to new and existing
facilities that store granular triple superphosphate. These same
standards establish fluoride emission limitations as a measure of
phosphorus-bearing feed material at affected facilities. The affected
facilities may include a combination of reactors, filters, evaporators,
hot wells, acid sumps, cooling tanks, granulators, dryers, coolers,
screens, mills, mixers, curing belts (dens), coolers, and facilities
which store run-of-pile triple superphosphate, depending on the type of
plant. New facilities include those that commenced construction,
modification or reconstruction after the date of proposal. This
information is being collected to assure compliance with 40 CFR part
60, subpart T, U, V, W, and X.
    In general, all NSPS standards require initial notifications,
performance tests, and periodic reports by the owners/operators of the
affected facilities. They are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility, or any period during which the
monitoring system is inoperative. These notifications, reports, and
records are essential in determining compliance,

and are required of all affected facilities subject to NSPS.
    Form Numbers: None.
    Respondents/affected entities: New and existing facilities that
engage in the manufacture of phosphate fertilizers and have a design
capacity of more than 15 tons of equivalent phosphorous pentoxide
(P2O5) feed per calendar day.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subparts T, U, V, W, and X).
    Estimated number of respondents: 13 (total).
    Frequency of response: Initially, occasionally and semiannually.
    Total estimated burden: 1,390 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $478,000 (per year), which includes $320,000
in annualized capital/startup and/or operation & maintenance costs.
    Changes in the Estimates: There is no change in the labor hours or
cost in this ICR compared to the previous ICR. This is due to two
considerations: (1) The regulations have not changed over the past
three years and are not anticipated to change over the next three
years; and (2) the growth rate for the industry is very low, negative
or non-existent, so there is no significant change in the overall
burden.

Courtney Kerwin,
 Director, Regulatory Support Division.
[FR Doc. 2019-07724 Filed 4-17-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 184 (Tuesday, September 23, 2014)]
[Notices]
[Pages 56816-56818]
[FR Doc No: 2014-22513]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0502]

Report on the Standardization of Risk Evaluation and Mitigation
Strategies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft report entitled ``Standardizing and Evaluating
Risk Evaluation and Mitigation Strategies (REMS)''. This report
describes the Agency's findings concerning strategies to standardize
risk evaluation and mitigation strategies (REMS), where appropriate,
with the goal of reducing the burden of implementing REMS on
practitioners, patients, and others in various health care settings. As
part of the reauthorization of the Prescription Drug User Fee Act
(PDUFA), FDA has committed to standardizing REMS to better integrate
them into the existing and evolving health care system. FDA is
publishing this report to allow the public to provide comment on the
report as it relates to PDUFA.

DATES: Submit either electronic or written comments by November 24,
2014.

ADDRESSES: Submit written requests for single copies of the draft
report to the Division of Drug Information, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft report.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. Identify comments with the docket number found in brackets in
the heading of this document.

FOR FURTHER INFORMATION CONTACT: Richard Currey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6125, Silver Spring, MD 20993-0002, 301-
796-3918, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>or Adam Kroetsch, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-0002; 301-
796-3842, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft report entitled
``Standardizing and Evaluating Risk Evaluation and Mitigation
Strategies (REMS).'' This report describes the Agency's findings
concerning strategies to standardize REMS, where appropriate, with the
goal of reducing the burden on practitioners, patients, and others in
various health care settings. The Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110-85), enacted on September 27, 2007,
established FDA's authority to require REMS for prescription drug and
biological products when it determines that such a strategy is
necessary to ensure that the benefits of a drug outweigh the risks.
Since that time, REMS have become a key tool in augmenting FDA's drug
safety capacities. The Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144), enacted on July 9, 2012,
amended FDA's REMS authorities and strengthened the Agency's ability to
safeguard and advance public health. Among other things, FDASIA
reauthorized the Prescription Drug User Fee Act (known as ``PDUFA V,''
reflecting the fifth reauthorization of PDUFA). As part of its PDUFA V
commitments, FDA agreed, among other things, to ``measure the
effectiveness of REMS and standardize and better integrate REMS into
the health care system.'' To this end, ``FDA will . . . continue to
develop techniques to standardize REMS and with stakeholder input seek
to integrate them into the existing and evolving (e.g., increasingly
electronic) health care system.'' FDA also agreed to hold one or more
public meetings to explore strategies to standardize REMS, where
appropriate, with the goal of reducing the burden of implementing REMS
on practitioners, patients, and others in various health care settings,
and to issue a report of the Agency's findings identifying at least one
priority project with a work plan for project completion in the areas
of pharmacy systems, prescriber education, providing benefit-risk
information to patients, and practice settings.
    FDA held a 2-day public meeting on REMS Standardization and
Assessment on July 25-26, 2013, on approaches to standardizing REMS and
better

integrating them into the health care delivery system. A transcript of
the public meeting and a background document, as well as FDA
presentations made at the meeting, are available on FDA's Web site at
http://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm351029.htm.
    This report summarizes stakeholder engagement achieved in fiscal
year (FY) 2013, including suggestions and recommendations received from
meetings, an expert panel workshop, and comments received
electronically (posted to a Federal docket) and via teleconferences.
Stakeholder feedback guided the Agency in selecting four priority
projects within the areas specified by PDUFA V: (1) Providing benefit/
risk information to patients, (2) prescriber education, (3) pharmacy
systems, and (4) practice settings. This report briefly reviews the
background and context for REMS as well as FDA initiatives for REMS
administration and program improvement, summarizes key feedback from
stakeholders and experts, and presents the design and the proposed
workplans of projects in the four designated priority areas.

II. Draft Report Describing Findings Concerning REMS Standardization
and Plans for Projects To Standardize REMS

A. Stakeholder Recommendations

    Stakeholder input and recommendations received by FDA in 2013
emphasize the need for better communication by FDA about REMS, improved
leveraging of information technology, and flexibility to tailor REMS
programs to specific health care settings. The four priority projects
that are discussed in detail at the end of the report flow, in part,
from these recommendations, and represent the Agency's next steps
toward an improved and integrated REMS strategy.
    FDA found that stakeholders in various settings have successfully
implemented REMS requirements, in some cases developing systems to
manage REMS requirements specific to their institutions and integrate
the REMS into their practices. However, FDA also heard that REMS
programs affect specific stakeholder responsibilities and
organizational structures differently, presenting a central challenge
to standardizing REMS while meeting the needs of multiple stakeholders
across an array of health care environments. Stakeholders indicated
that they want flexibility to implement a REMS program based upon the
nature of the health care setting.
    Stakeholders emphasized that communication by FDA about REMS should
be improved. They stated that FDA communications about REMS are often
inadequate, inconsistent, unclear, or too difficult to access,
navigate, and digest.
    Stakeholders recommended that FDA create more comprehensive,
evidence-based, and organized communications that can function within
existing health care systems; deliver clear, actionable information to
clinicians; and help to ensure that patients receive the drugs they
require with excellent safety monitoring and oversight. They frequently
suggested that FDA invest in and improve leveraging of existing
information technology systems to better integrate REMS into standard
medical practice and ongoing health care delivery.
    Several stakeholders noted that current REMS documentation is not
standardized and generally cannot be easily searched, queried, or
managed. They recommended Structured Product Labeling (SPL) as a
possible designated standard that may allow for a centralized,
standardized REMS information repository.
    Several stakeholders expressed interest in human factors evaluation
methods like Failure Modes and Effect Analysis (FMEA) or a ``Health
Care FMEA'' that might be deployed to help to develop criteria for
levels of risk (e.g., illness, injury, death) that could prompt
regulatory action.
    Stakeholders suggested that REMS assessments might benefit from
leveraging of data sources (e.g., electronic health records, claims
data) to conduct assessments. A related recommendation was that FDA
assess programs earlier and more frequently throughout a product's life
cycle, and apply information gleaned from assessments to modify REMS if
needed.

B. Priority Projects

    Guided by stakeholder feedback and recommendations, FDA has
identified four priority projects, one for each topic area described
previously. Each project responds to input the Agency has received
regarding significant areas of opportunity for REMS standardization and
evaluation efforts.
 Project 1: Providing Benefit-Risk Information to Patients
    This project aims to improve the tools used for prescriber-to-
patient counseling about REMS drugs. To that end, FDA proposes to
conduct research into existing REMS patient counseling tools, other
patient counseling initiatives, and counseling literature to identify
current tactics and strategies for patient counseling about medication
benefits and risk. The Agency intends to seek feedback from a range of
stakeholders to identify opportunities to improve the content, format,
processes, techniques, and delivery of effective counseling within REMS
programs. In addition, FDA intends to develop a public report of
findings and counseling processes and tools that could serve as the
basis for designing new tools and validating them in demonstration
projects.
 Project 2: Prescriber Education
    Numerous stakeholders asked FDA to facilitate the provision of
health care provider continuing education (CE) for the education and
training that is provided in a REMS program. This project will assess
whether it is feasible to provide CE certified by the Accreditation
Council of Continuing Medical Education, Accreditation Commission for
Education in Nursing, and Accreditation Council for Pharmacy Education
associated with a specific REMS. FDA will seek to determine at what
stage in the drug approval process CE development would best fit (e.g.,
before or after product approval) and which CE model(s) would be best
suited for this type of activity; and provide an analysis of the time
and resource burden associated with developing such CE programs.
 Project 3: Pharmacy Systems
    FDA proposes to identify an approach for incorporating REMS
information into SPL. The project's purpose is to develop a method to
share clear and consistent information about the content of REMS,
including REMS documents, requirements, and materials. Doing so will,
among other things, facilitate integrating REMS into pharmacy systems
and health information technology, including systems for electronic
prescribing. SPL will also enable FDA to make structured REMS
information available to health care providers and patients, and
provide a single conduit of comprehensive information about REMS
programs.
 Project 4: Practice Settings
    The purpose of this project is to provide a centralized,
standardized, reliable, and user-friendly repository of information
about REMS, including stakeholders' specific activities and
requirements under each REMS program. FDA intends to develop its REMS
Web page as a central source of REMS information, which will provide
stakeholders in a range of practice settings with a reliable and
accessible resource to help them quickly learn

about REMS programs, understand and comply with REMS requirements, and
compare requirements across REMS to minimize confusion associated with
complying with multiple REMS programs.

C. Scope of the Report

    This report describes the Agency's findings concerning strategies
to standardize REMS where appropriate, with the goal of reducing the
burden of implementing REMS on practitioners, patients, and others in
various health care settings. This report contains project plans to:
(1) Increase access to REMS-related information through the use of SPL,
(2) enhance the Agency's REMS Web page to better meet the needs of
stakeholders, (3) assess the feasibility of using accredited CE courses
for prescriber training, and (4) enhance existing tools for prescribers
to communicate with patients regarding risks of drugs with REMS, and
how those risks should be weighed against the potential benefits of the
drug.

III. Electronic Access

    Persons with access to the Internet may obtain the document on
FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm350852.htm or http://www.regulations.gov.

IV. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. After consideration of comments, FDA will
finalize the report and project plans. The Agency intends to post
updates to the project plans on FDA's Web site.

    Dated: September 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22513 Filed 9-22-14; 8:45 am]
BILLING CODE 4164-01-P


You Asked For the Following: Year : From: 1980 To: 2003 State : Chesapeake By State Species : WEAKFISH " Year"," State"," Species"," Metric Tons"," Pounds","$" " 1980"," Maryland"," WEAKFISH"," 257.7"," 568,200"," 1 33,692" " 1980"," Virginia"," WEAKFISH"," 2,831.3"," 6,241,900"," 1,5 09,740" " 1981"," Maryland"," WEAKFISH"," 153.5"," 338,500"," 1 35,720" " 1981"," Virginia"," WEAKFISH"," 1,121.2"," 2,471,900"," 1,1 02,026" " 1982"," Maryland"," WEAKFISH"," 113.0"," 249,200"," 1 13,063" " 1982"," Virginia"," WEAKFISH"," 974.9"," 2,149,200"," 1,1 85,701" " 1983"," Maryland"," WEAKFISH"," 176.9"," 390,000"," 1 75,231" " 1983"," Virginia"," WEAKFISH"," 1,176.1"," 2,592,900"," 1,3 48,555" " 1984"," Maryland"," WEAKFISH"," 147.4"," 325,000"," 1 49,938" " 1984"," Virginia"," WEAKFISH"," 956.6"," 2,109,000"," 1,1 02,400" " 1985"," Maryland"," WEAKFISH"," 143.4"," 316,110"," 1 82,018" " 1985"," Virginia"," WEAKFISH"," 944.5"," 2,082,186"," 1,1 01,263" " 1986"," Maryland"," WEAKFISH"," 152.7"," 336,700"," 1 76,698" " 1986"," Virginia"," WEAKFISH"," 904.5"," 1,994,100"," 9 21,028" " 1987"," Maryland"," WEAKFISH"," 166.4"," 366,900"," 2 34,262" " 1987"," Virginia"," WEAKFISH"," 890.3"," 1,962,800"," 1,0 63,535" " 1988"," Maryland"," WEAKFISH"," 377.7"," 832,600"," 3 28,098" " 1988"," Virginia"," WEAKFISH"," 668.2"," 1,473,200"," 9 12,652" " 1989"," Maryland"," WEAKFISH"," 337.4"," 743,800"," 5 20,910" " 1989"," Virginia"," WEAKFISH"," 465.0"," 1,025,200"," 8 64,687" " 1990"," Maryland"," WEAKFISH"," 300.4"," 662,361"," 4 45,554" " 1990"," Virginia"," WEAKFISH"," 547.7"," 1,207,560"," 1,0 98,020" " 1991"," Maryland"," WEAKFISH"," 148.9"," 328,251"," 2 30,769" " 1991"," Virginia"," WEAKFISH"," 480.7"," 1,059,679"," 7 58,574" " 1992"," Maryland"," WEAKFISH"," 174.8"," 385,426"," 2 10,536" " 1992"," Virginia"," WEAKFISH"," 249.5"," 549,961"," 4 20,617" " 1993"," Maryland"," WEAKFISH"," 82.5"," 181,863"," 1 47,037" " 1993"," Virginia"," WEAKFISH"," 493.5"," 1,088,047"," 7 33,182" " 1994"," Maryland"," WEAKFISH"," 63.9"," 140,907"," 1 30,708" " 1994"," Virginia"," WEAKFISH"," 587.1"," 1,294,224"," 7 30,804" " 1995"," Maryland"," WEAKFISH"," 31.5"," 69,417"," 60,400" " 1995"," Virginia"," WEAKFISH"," 673.6"," 1,485,065"," 7 22,174" " 1996"," Maryland"," WEAKFISH"," 60.2"," 132,795"," 1 02,777" " 1996"," Virginia"," WEAKFISH"," 719.9"," 1,587,186"," 1,4 90,503" " 1997"," Maryland"," WEAKFISH"," 87.4"," 192,634"," 83,711" " 1997"," Virginia"," WEAKFISH"," 706.7"," 1,557,980"," 6 83,920" " 1998"," Maryland"," WEAKFISH"," 110.9"," 244,467"," 1 13,420" " 1998"," Virginia"," WEAKFISH"," 845.5"," 1,863,928"," 5 54,280" " 1999"," Maryland"," WEAKFISH"," 101.4"," 223,455"," 1 30,027" " 1999"," Virginia"," WEAKFISH"," 759.3"," 1,674,052"," 9 99,885" " 2000"," Maryland"," WEAKFISH"," 94.5"," 208,315"," 1 12,956" " 2000"," Virginia"," WEAKFISH"," 618.2"," 1,362,829"," 8 90,905" " 2001"," Maryland"," WEAKFISH"," 84.3"," 185,815"," 98,639" " 2001"," Virginia"," WEAKFISH"," 508.9"," 1,121,961"," 7 87,851" " 2002"," Maryland"," WEAKFISH"," 50.5"," 111,391"," 74,674" " 2002"," Virginia"," WEAKFISH"," 518.9"," 1,144,068"," 8 06,912" " 2003"," Maryland"," WEAKFISH"," 21.5"," 47,409"," 40,412" " 2003"," Virginia"," WEAKFISH"," 208.4"," 459,385"," 3 62,065"


<COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE  (8/15/2007)>

<EPA Registration Division contact: [Sidney Jackson<PHONE_NUMBER>]>

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<TEMPLATE:>

<[Chemtura Corporation]  EPA ASSIGNED PP#s: 7E7286 & 7E7258>

<	EPA has received a pesticide petition  from [Interregional Research
Project Number 4 (IR-4)], [Princeton, NJ  08540] proposing, pursuant to
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(d), to amend 40 CFR part 180.476 >

<(Options (pick one)>

<	1. by establishing a tolerance for residues of Leafy greens (subgroup
4A) Cilantro leaves, Brassica head and stem vegetables (subgroup 5A);
Swiss chard; Hops, dried cones; Papaya (which includes black sapote,
canistel mamey sapote, mango sapodilla and star apple); and pineapple. >

<		[1-[1-((4-chloro-2-(trifluoromethyl)
phenyl)imino)-2propoxyethyl]-1H-imidazole] in or on the raw agricultural
commodity [Leafy greens except spinach (subgroup4A) and cilantro] at [35
ppm] parts per million (ppm); Swiss chard at 18 ppm; Pineapple at 4.0
ppm; Papaya (Sapote black, canistel, Sapote, mamey, Mango, Sapodilla,
star apple) at 2.5 ppm; Hop, dried cones at 50.0 ppm. .  EPA has
determined that the petition contains data or information regarding the
elements set forth in section 408 (d)(2) of the FDDCA; however, EPA has
not fully evaluated the sufficiency of the submitted data at this time
or whether the data supports granting of the petition. Additional data
may be needed before EPA rules on the petition.>

<A. Residue Chemistry>

<	1. Plant metabolism. [In crops, the metabolism of [14C]-Phenyl]
triflumizole was investigated in cucumber, pears, grapes and apples. The
major metabolites were:
N-(4chloro-2trifluoromethylphenyl)-n-propoxyacetamidine  (FM-6-1),
N-(4-chloro-2-trifluoromethylphenyl)-n-propoxyacetanilide  (FD-1-1) and
the free or conjugated products of
N-(4-chloro-2-trifluoromethylphenyl)-hydroxyacetamidine (the
0-dealkylation product of FM-6-1),
N-(4-chloro-2-trifluoromethylphenyl)-hydroxyacetanilide (FD-2-1) and the
triflumizole aniline (FA-1-1).]

	2. Animal metabolism. [In livestock, oral administration of
[14C]-triflumizole was conducted twice daily for 5 days at 14 mg/kg/day
(equivalent to 280 ppm in feed for the cow) and 144 mg/kg/day
(equivalent to 50 ppm in feed for chicken). On the sixth day the animals
were sacrificed and meat, milk and egg samples were analyzed.  Cow’s
liver, kidney, fat and muscle contained 11.26, 3.36, 0.66, and 0.30 ppm
of [14C]-triflumizole equivalent, respectively. Residues in milk reached
a plateau of about 0.7 ppm after 24 hours. Chicken liver, kidney, fat,
and muscle contained 1.10, 0.74, 0.17 and 0.05 ppm of [14C]-triflumizole
equivalent, respectively.  Residues in eggs reach a maximum of 0.30 ppm
level. Metabolites identified in these tissues were mainly triflumizole
aniline (FA-1-1) and the sulfate/glucuronide conjugates of the 6-hydroxy
derivative of triflumizole aniline (FA-1-5). The latter was the major
metabolite in milk. Unchanged triflumizole was present in trace amounts
in the whole egg.>

<	3. Analytical method. [The analytical method is suitable for analyzing
crops for residues of triflumizole and its aniline containing
metabolites at the proposed tolerance levels. The analytical method has
been independently validated. Residue levels of triflumizole are
converted to FA-1-1 by acidic and alkaline reflux, followed by
distillation. Residues are then extracted and subjected to SPE
purification. Detection and quantitation are conducted by gas
chromatograph equipped with nitrogen phosphorus detector, electron
capture detector or mass spectrometry detection. The limit of
quantitation of the method has been determined in the range of 0.01 ppm
to 0.05 ppm for the combined residues of triflumizole and FA-1-1. The
enforcement methodology has been submitted to the Food & Drug
Administration for publication in the Pesticide Analytical Manual, Vol.
II (PAM II).]>

<	4. Magnitude of residues. [Section 3 registrations for triflumizole is
currently exist for several commodities (e.g., apple, cherry, filbert,
grape, pear, strawberry, cucurbits, and meat, milk, poultry and eggs)
and feed items. The proposed group tolerance for leafy brassica
vegetables (subgroup 5B) at 20 ppm is pending (PP#7E7183). The subject
of the August 23, 2006 Federal Register notice regarding triflumizole
was the establishment and/or extension of emergency exemption tolerances
on several crops in Texas (i.e., parsley leaves, dandelion leaves, swiss
chard, collard, kale, kohlrabi, mustard greens, Chinese napa cabbage,
broccoli, coriander leaves and turnips greens). Many of these crops are
in subgroup 4A leafy greens and 5A head and stem brassica, so the
purpose of this dietary exposure assessment is to expand the uses of
triflumizole to all crops in subgroup 4A , 5A and 5B to Swiss chard,
hops, papya (which includes black sapote, canistel, mamey sapote, mango,
sapodilla and star apple), and pineapple.]>

<B. Toxicological Profile>

<	1. Acute toxicity.  [The database includes the following studies for
triflumizole technical: a rat acute oral study with a LD50 of 1.42 g/kg;
a rabbit acute dermal study with a LD50 >5 g/kg; a rat acute inhalation
study with LC50  >3.2 mg/l; a rabbit primary ocular irritation study
which showed mild irritation; a rabbit primary dermal irritation study
which showed no irritation; a guinea pig dermal sensitization study
which showed slight dermal sensitization potential. The database also
includes the following studies for Procure 480SC: a rat acute oral study
with a LD50 >2 g/kg; a rabbit acute dermal study with a LD50 >5 g/kg; a
rat acute inhalation study with a LC50 >3.3 mg/l; a rabbit primary
ocular irritation study which showed slight irritation; a rabbit primary
dermal irritation study which showed no irritation; a guinea pig dermal
sensitization study which was negative for skin sensitization. Acute
neurotoxicity study of triflumizole in rats. Male and female rats were
administered a single dose of triflumizole by oral gavage at levels of
0, 25, 100, 200 (female) and 400 (male) mg/kg and observed for 15 days.
Decreased motor activity was noted 3 to 6 hours post exposure in male
and female rats at 100 mg/kg and above. Functional Observational Battery
(FOB) effects included a decrease rearing counts in females, decreases
in forelimb and hind limb grip strength in males and forelimb grip
strength in females at 100 mg/kg and above. The NOEL was considered to
be 25 mg/kg based on clinical findings and functional observational
battery evaluations at 100 mg/kg.]>

<	2. Genotoxicty. [Triflumizole was negative in all genotoxicity assays
including: Ames assay in S. typhimurium, gene conversion assay in yeast
strain D4, REC assay in B. subtilis, unscheduled DNA synthesis (UDS)
assay in cultured rat hepatocytes, chromosome aberration assay in
cultured Chinese hamster lung (CHL) cells and a mouse micronucleus
assay.]>

<	3. Reproductive and developmental toxicity. [In a developmental
toxicity study, triflumizole was administered by oral gavage to
pregnant, female Sprague Dawley rats at dosage levels of 0, 10, 35 or
120 mg/kg/day. Maternal toxicity, as evidenced by a substantial
reduction in body weight gain, was seen at 35 and 120 mg/kg/day. At
these dosage levels there was a decrease in fetal viability in the form
of late resorptions. There were no teratogenic effects. The no observed
effect level (NOEL) for maternal and developmental toxicity was 10
mg/kg/day.

Triflumizole was also administered by oral gavage to pregnant, female
New Zealand White rabbits at dosage levels of 0, 5, 25, or 50 mg/kg/day.
Maternal toxicity was observed at a dose level of 50 mg/kg/day as
demonstrated by a reduction in body weight gain. There were no
developmental or teratogenic effects. The NOEL for maternal toxicity was
25/mg/kg/day and the NOEL for developmental toxicity was greater than 50
mg/kg/day.

The reproductive toxicity of triflumizole was evaluated in rat
reproduction study, conducted on three generations, at dietary
concentrations of 0, 30, 70 and 170 ppm. Fertility was not affected by
treatment. There was an increase in placental weight in the Flb, F2b and
F3b litters and a statistically significant increase in gestation length
in the high dose group at the F1a interval and at all three dose levels
at the F3a interval. Critical review of the gestation length data
demonstrated that theNOEL for reproductive effects in this study is 70
ppm (MRID # 47136402), which was the original conclusion of the study
director at Life Science Research. This is based on the increase in
gestation length seen at 170 ppm in two of six matings. In addition, the
NOEL for systemic parental toxicity was greater than 170 ppm and the
NOEL for developmental toxicity was 70 ppm (3.5 mg/kg/day) based upon
increased incidences of hydroureter and space between the body wall and
organs. ]>

<	4. Subchronic toxicity. [To assess sub-acute dermal toxicity,
triflumizole was applied to the backs of male and female Sprague Dawley
rats for 6 hours per day for three weeks at dose levels of 10, 100 and
1000 mg/kg/day.  Female rats exposed to 1000 mg/kg/day exhibited mild
fatty vacuolation in the liver, which was within the range of normal
biological variation.  Therefore, the no-observed effect level (NOEL)
for subchronic dermal toxicity in rats was considered to be greater than
1000 mg/kg/day.

90 Day Neurotoxicity Study of Triflumizole in Rats. Male and female rats
were administered triflumizole in the diet at levels of 70, 700 or 2000
ppm (4.1, 40.9, 117.3 mg/kg/day male and 4.9, 47.8, and 133.3 mg/kg/day
females) for a period of 90 days. The NOEL for general toxicity was 70
ppm based on body weight (significantly higher in males at 700 ppm and
significantly lower in females at 2000 ppm), food consumption (lower in
females at 2000 ppm), hematology (values were slightly lower in males
and females at 2000 ppm and at week 4 in the 700 ppm dose group) and
pathology evaluations (higher in mean and relative liver weights in
males an females at 700 and 2000 ppm, hepatocellular hypertrophy in
males and females at 700 and 2000 ppm). The NOEL for neurotoxicity was
2000 ppm.] >

<	5. Chronic toxicity. [Triflumizole was fed to male and female beagle
dogs for one year at dietary concentrations of 0, 100, 300 and 1,000 ppm
to assess chronic toxicity. At a dosage level of 1,000 ppm there was an
increase in serum liver enzymes and a decrease in RBC concentration. The
NOEL for chronic toxicity in dogs was 300 ppm (7.5 mg/kg/day).

Triflumizole was fed to male and female Sprague Dawley rats for two
years at dietary concentrations of 0, 100, 400 and 1,600 ppm to assess
chronic toxicity. At the high dose level there was a substantial
reduction in body weight gain in males and females. At the mid and high
dose levels there was an increase in liver weight. Fatty vacuolization
of the liver was seen at all dose levels and hepatocytic hypertrophy was
seen in high and mid-dose males and females. Female rats given 400 or
1,600 ppm were confined to hepatocytic fatty vacuolation and hypertrophy
in females. These changes were less severe than those seen in rats given
400 or 1,600 ppm and were considered by the laboratory to be indicative
of adaptive metabolic change.   No evidence of oncogenic effects were
demonstrated in rats.  The dietary level of 100 ppm (5 mg/kg/day) is
considered to be a NOEL.]  >

<	6. Animal metabolism. [Triflumizole, [14C-Phenyl]
1-(1-((4-chloro-2-trifluoromethylphenyl)imino)-2-propoxyethyl)-1H-imidaz
ole, was found to be rapidly absorbed and excreted in rats. Two days
after oral dosing, 78% was found to be excreted in the urine and 20% in
the feces. No sex difference was noted. It appears that the loss of the
imidazole ring was the basic step in the metabolic pathway of the
fungicide in mammals.  The elimination of the imidazole ring yielded
initially N-(4-chloro-2-trifluoromethylphenyl)-n-propoxyacetamidine
(FM-6-1), and N-(4-chloro-2trifluoromethyphenyl-n-propoxyacetanilide
(FD-1-1). Other hydroxylated  metabolites identified (free, or as
sulfate/glucuronide conjugates) included, amoung others,
N-(4-chloro-2-trifluoromethylphenyl)-hydroxyacetamidine (FM-8-1);
4-chloro-2-trifluoromethyl-hydroxyacetanilide (FD-2-1); and
4-chloro-2-trifluoromethyl-6-hydroxyaniline (FA-1-5). ] >

<	7. Metabolite toxicology. [Both plant and animals produce the same
metabolites that were identified in the metabolism studies; therefore,
the toxicity of the metabolites has essentially been evaluated in the
rat toxicology studies.]>

<	8. Endocrine disruption. [In the rat reproduction study there was an
increase in placental weight in females at the high dose level of 170
ppm. There was also a biologically significant increase in gestation
length in high dose F0 and F2 females (Fla and F3a intervals). The NOEL
for endocrine effects is 70 ppm (3.5 mg/kg/day)]>

<C. Aggregate Exposure>

<	1. Dietary exposure. [Based on dietary, drinking water and
non-occupational exposure assessments, there is reasonable certainty of
no harm to the US population, any population subgroup, or infants and
children from acute or chronic exposure to triflumizole.]>

<	i. Food. [Chronic dietary exposures were estimated utilizing Dietary
Exposure Evaluation Model software with Food Commodity Intake Database
(DEEM-FCID), version 2.16. EPA’s most recent estimate of chronic
estimated dietary exposures for triflumizole are reported in the August
23, 2006, Federal Register notice which established emergency exemption
tolerances on a variety of crops. In the assessment, EPA used a mixture
of anticipated residues (i.e., mean residues from field trials) and
tolerances for the different crops. EPA included percent crop treated
information from Biological and Economic Analysis Division (BEAD) for
apples, grapes and pears, while all others were assumed to be 100%
treated. EPA used modified processing factors for apples and grapes
based on previously submitted studies, while default processing factors
were used for all other foods. EPA also included an estimated
concentration in drinking water of 40 ppb, which is the chronic (annual
average) concentration in surface water generated by the FIRST model, in
the residue file. In the August 23, 2006, Federal Register notice, EPA
used a cPAD of 0.015 mg/kg/day.  Since that time Chemtura has
resubmitted documentation supporting a revised cPAD for triflumizole of
0.035 mg/kg/day (MRID # 47136402).  The revise cPAD will be used in this
assessment.  The total chronic dietary exposures are estimated to be
35.7% of the cPAD for the general US population, 15.9% for all infants,
39.3% for children aged 1-2 years old, and 41.0% for children aged 3-5
years old.  Chronic dietary exposures below 100% of the cPAD are
reasonably anticipated to result in no harm to exposed populations.

For the acute assessment, EPA’s August 23, 2006, assessment assumed
tolerance-level residues, and 100% crop treated for all crops. EPA used
modified processing factors for apples and grapes based on previously
submitted studies, while default processing factors were used for all
other foods. Drinking water was included directly into the dietary
assessment using the acute (peak) concentration for surface water (191
ppb) estimated by the FIRST model. For this updated assessment, an acute
residue file was created using all the information and assumptions from
the EPA assessment and then adding the proposed crops assuming
tolerance-level residues, 100% crop treated and default processing
factors. Acute exposures were calculated using DEEM-FCID version 2.16.
The acute population adjusted dose (aPAD) for triflumizole is 0.25
mg/kg/day for the general population and 0.1 mg/kg/day for females aged
13-49. At the 95th percentile, which is the appropriate point of
comparison for this conservative Tier 1 acute dietary assessment, the
estimated acute exposure range from 23.43% of the aPAD for all infants
to 40.23% of the aPAD for children aged 1-2 years old. For females aged
13-49 years old, the 95th percentile acute dietary exposure is 69.12% of
the subpopulation-specific aPAD (0.1 mg/kg/day). Acute dietary exposures
below 100% of the aPAD are reasonably anticipated to result in no harm
to exposed populations.]>

<	ii. Drinking Water. [Tier I screen models FIRST (First Index Reservoir
Screening Tool) and SCI-GRO (Screening Concentrations in Ground Water)
were used to predict estimates of triflumizole concentrations in surface
and groundwater, respectively. Drinking water levels of comparison
(DWLOCs) were estimated and compared to drinking water estimated
concentrations (DWECs) using EPA standard operating procedures. DWECs
were obtained from the August 23, 2006, acute exposures. The chronic
DWLOCs are 98 ppb for toddlers, 324 ppb for adult females and 369 ppb
for all adults. The chronic and acute DWECs are below the chronic and
acute DWLOCs, respectively, for all population groups and exposure
durations.]>

<	2. Non-dietary exposure. [There are no registered or proposed uses for
application by homeowners. For the proposed residential uses, only
professional handlers would apply triflumizole to woody ornamentals
(trees, shrubs, vines). Triflumizole is not used or proposed for use on
lawns or turf. Therefore, residential exposure is not likely.]>

<D. Cumulative Effects>

<	[The potential for cumulative effects of triflumizole, an imidazole,
and other substances that have a common mechanism of toxicity was
considered. The mammalian toxicity of triflumizole is well defined. No
reliable information exists to indicate that toxic effects produced by
triflumizole would be cumulative with those of any other chemical
compounds. Therefore, consideration of a common mechanism of toxicity
with other compounds is not appropriate. Thus, only the potential risks
of triflumizole are considered in the aggregate exposure assessment.
]>

<E. Safety Determination>

<	U.S. population. [i. Short-Term Risk.  The acute population adjusted
dose (aPAD) for triflumizole is 0.25 mg/kg/day for the general
population and 0.1 mg/kg/day for females aged 13-49.   Acute dietary
exposure to children (1-2 yrs) was 0.1006 mg/kg/day and was 40.23% of
the aPAD. Acute dietary exposure to females 13-49 yrs was 0.0691
mg/kg/day, and was 69.12% of the aPAD. The acute drinking water level of
concern (DWLOC) was calculated to be 658 ppb, and the model-predicted
acute EECs of 191 ppb for surface water and 0.12 ppb for groundwater are
less than this DWLOC. Therefore, acute aggregate exposure from
triflumizole is not expected to exceed the aPAD.

ii. Chronic Risk. In the August 23, 2006, Federal Register Notice, EPA
used a cPAD of 0.015 mg/kg/day. Since that time, Chemtura has
resubmitted documentation supporting a revised cPAD for Triflumizole of
0.035 mg/kg/day (MRID# 47136402). The chronic Population Adjusted Dose
(cPAD) of 0.035 mg/kg bw/day was based on the NOEL of 3.5 mg/kg/day from
the rat reproduction study, a 100x uncertainty factor, and a 1x FQPA
safety factor. The chronic dietary exposure to the general U.S.
population was 0.0125 mg/kg/day and was 35.7% of the cPAD. The chronic
dietary exposure to children (1-2 yrs) was 0.0138 mg/kg/day and 39.3% of
the cPAD. The chronic DWLOC was calculated to be 160 ppb, and the
model-predicted chronic EECs of 40 ppb for surface water and 0.12 ppb
for groundwater are less than this DWLOC. Therefore, chronic aggregate
exposure from triflumizole is not expected to exceed the cPAD.]

>

<	2. Infants and children. [Acute dietary exposure to children (1-2 yrs)
was 0.1006 mg/kg/day and was 40.23% of the aPAD. The chronic dietary
exposure to children (3-5 yrs) was 0.0144 mg/kg/day and 41% of the
cPAD.]>

<F. International Tolerances>

<	[Maximum Residue Limits have been established for Chinese cabbage,
kale turnip greens and leafy greens in Japan at 1.0 ppm.]>