[Federal Register Volume 78, Number 55 (Thursday, March 21, 2013)]
[Rules and Regulations]
[Pages 17290-17294]
[FR Doc No: 2013-05199]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0847; Directorate Identifier 2008-NM-056-AD;
Amendment 39-17375; AD 2013-05-03]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 777-200, -200LR, -300, and -300ER series
airplanes. This AD was prompted by fuel system reviews conducted by the
manufacturer. This AD requires doing an inspection to identify the part
number of the motor-operated valve (MOV) actuators of the main and
center fuel tanks; replacing certain MOV actuators with new MOV
actuators; and measuring the electrical resistance of the bond from the
adapter plate to the airplane structure, and doing corrective actions
if necessary. We are issuing this AD to prevent electrical current from
flowing through an MOV actuator into a fuel tank, which could create a
potential ignition source inside the fuel tank. This condition, in
combination with flammable fuel vapors, could result in a fuel tank
explosion and consequent loss of the airplane.

DATES: This AD is effective April 25, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of April 25,
2013.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Rebel Nichols, Aerospace Engineer,
Propulsion Branch, ANM-140S, Seattle Aircraft Certification Office
(ACO), FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-
917-6509; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a supplemental notice of proposed rulemaking (SNPRM) to
amend 14 CFR part 39 to include an

airworthiness directive (AD) that would apply to the specified
products. That SNPRM published in the Federal Register on December 23,
2010 (75 FR 80738). The original NPRM (73 FR 45893, August 7, 2008)
proposed to require doing an inspection of the MOV actuators of the
main and center fuel tanks for a certain part number (P/N); replacing
the MOV actuator with a new MOV actuator if necessary; and measuring
the electrical resistance of the bond from the adapter plate to the
airplane structure, and corrective actions if necessary. The original
NPRM also proposed to require revising the Airworthiness Limitations
section of the Instructions for Continued Airworthiness. The SNPRM
proposed to revise the original NPRM by adding airplanes and removing
the requirement for revising the Airworthiness Limitations section of
the Instructions for Continued Airworthiness.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the SNPRM (75
FR 80738, December 23, 2010) and the FAA's response to each comment.

Support for the SNPRM (75 FR 80738, December 23, 2010)

    Continental Airlines has no technical objections, issues, or
comments to the SNPRM (75 FR 80738, December 23, 2010).

Request To Revise Applicability To Include Part Number

    Boeing requested that the applicability of the SNPRM (75 FR 80738,
December 23, 2010) be revised to include the phrase, ``with MOV
actuator part number MA20A1001-1 installed.'' Boeing stated that the
change will avoid future alternative methods of compliance (AMOC)
requests.
    We disagree with revising the applicability of this AD because
paragraph (c) of this AD clearly defines the airplanes affected by this
AD. For those affected airplanes, paragraph (g) of this AD requires
inspection of the MOV actuators to determine their part number. If an
MOV actuator with P/N MA20A1001-1 is found, that actuator must be
replaced, as required by paragraph (h) of this AD. No change has been
made to the AD in this regard.

Request To Allow Installation of Certain Parts

    Boeing requested that, if the applicability of the SNPRM (75 FR
80738, December 23, 2010) is not revised, we add a statement allowing
MOV actuators certified after P/N MA30A1001 to be installed without
AMOC approval. Boeing stated that this would allow normal maintenance
to resume once P/N MA20A1001-1 is removed. Boeing stated that the
aircraft configuration with an MOV actuator having P/N MA30A1001
becomes the mandated configuration, because the SNPRM requires the
installation of that specific part number. Boeing stated that the SNPRM
would not allow the installation of actuators approved after P/N
MA30A1001 without AMOC approval.
    We agree with the commenter's request. In the case of this MOV
actuator, we will allow--without AMOC approval--replacement of the
affected MOV actuator with a Boeing part. The replacement part must be
fully interchangeable with the part specified in Boeing Service
Bulletin 777-28A0034, Revision 2, dated September 20, 2010, and must be
approved by the FAA after September 20, 2010. Paragraph (h) of this AD
has been revised to include this provision.

Request for Further Investigation

    China Southern Airlines requested that we further investigate the
ignition potential of P/N MA20A1001-1 to find a better solution that
does not require installing the new P/N MA30A1001. The commenter stated
that it would like to see P/N MA30A1001 experience better reliability
than P/N MA20A1001 before we require a big cost burden on operators.
    We disagree with the request to further investigate P/N MA20A1001-
1. That part number was identified as unsafe during the Special Federal
Aviation Regulation No. 88 (SFAR 88) (66 FR 23086, May 7, 2001) system
safety assessment reviews conducted by the manufacturer and must be
replaced. Steps have been taken to improve the reliability of P/N
MA30A1001, and that part does not have the identified unsafe condition
that is the subject of this AD. No change has been made to this AD in
this regard.

Request To Remove Paragraph (i) of the SNPRM (75 FR 80738, December 23,
2010)

    United Airlines (UAL) requested that we remove paragraph (i) of the
SNPRM (75 FR 80738, December 23, 2010), which prohibits installation of
MOV actuators having P/N MA20A1001-1 on any airplane as of the
effective date of this AD. UAL stated that the 777 Aircraft Maintenance
Manual (AMM) does not provide sufficient replacement instructions for
operators to maintain compliance with paragraph (i) of the SNPRM. UAL
stated that the proposed rule will cause undue economic hardship on
operators. UAL also noted that similar ADs do not contain a similar
parts prohibition paragraph. UAL also stated that paragraph (h) of the
SNPRM specifies to do ``all applicable corrective actions before
further flight''; therefore, an operator would have to replace all MOV
actuators at the same time.
    We disagree with the request to remove paragraph (i) of this AD.
Because an unsafe condition has been identified on P/N MA20A1001-1, we
have determined that P/N MA20A1001-1 cannot be allowed for
installation. This AD requires the replacement of all affected MOV
actuators from an operator's fleet within the specified compliance
time; however, the AD does not require replacement of all affected MOV
actuators on an airplane at the same time. Operators are allowed to
replace only one MOV actuator and then bring the aircraft back into
service. Paragraph (h) of this AD does specify doing all applicable
corrective actions before further flight, but the applicable corrective
actions are those associated with the measurement of the electrical
resistance of the bond. If an operator encountered unscheduled removal
of P/N MA20A1001-1, that part should be replaced with a part having an
accepted part number (i.e., P/N MA30A1001 or other FAA-approved
replacement). However, according to the provisions of paragraph (m) of
this AD, operators may request approval of an AMOC if the request is
submitted with substantiating data that prove the requested action will
provide an adequate level of safety. No change has been made to the AD
in this regard.

Request To Revise Proposed Costs of Compliance

    UAL requested that we revise or clarify the Costs of Compliance
section of the SNPRM (75 FR 80738, December 23, 2010). UAL considered
that the maximum costs are understated in the SNPRM. UAL stated that,
since there are 11 actuators on each airplane, the parts costs need to
be changed to include 11 actuators.
    We agree to revise the cost of parts in the Costs of Compliance
section of this AD. Since the labor cost is based on the total number
of work-hours required to replace all 11 actuators, the parts cost
should also be based on the total cost of 11 actuators. The Costs of
Compliance section has been revised accordingly.

Request To Permit Omission of Parts Inspection or Record Check

    UAL requested that paragraph (g) of the SNPRM (75 FR 80738,
December 23, 2010) be revised to include an additional paragraph that
permits operators to omit the parts inspection or records check and to
permit removal of the installed MOV, regardless of the part number, and
install the new part number, in accordance with Boeing Service Bulletin
777-28A0034, Revision 2, dated September 20, 2010. UAL stated that this
will allow operators to avoid costs associated with inspections and
records checks while achieving the same level of safety by ensuring
that P/N MA30A1001 is installed.
    We agree to add replacement of the MOV actuators as an optional
method of compliance with the inspection or records check required by
paragraph (g) of this AD. Replacing actuators with actuators having
part numbers other than P/N MA20A1001-1 addresses the identified unsafe
condition. We have added new paragraph (l) to this AD to allow the
option. We have re-identified subsequent paragraphs accordingly.

Request To Incorporate New Information in Information Notice

    UAL requests that operators be allowed to incorporate the
information contained in Boeing Service Bulletin Information Notice
(IN) 777-28A0034 IN 04, dated January 6, 2011, as an option for
compliance with the SNPRM (75 FR 80738, December 23, 1010).
    We agree that certain information identified in Boeing Service
Bulletin IN 777-28A0034 IN 04, dated January 6, 2011, should be
included in this AD. We have added paragraph (k)(1) to this AD to
specify the correct equipment number in the title of the work package
specified in the Accomplishment Instructions of Boeing Service Bulletin
777-28A0034, Revision 2, dated September 20, 2010. Boeing Service
Bulletin IN 777-28A0034 IN 04, dated January 6, 2011, also clarifies
certain weight and balance changes; however, because this AD does not
refer to that section of Boeing Service Bulletin 777-28A0034, Revision
2, dated September 20, 2010, no change to this AD is necessary in this
regard.

Other Changes Made to This AD

    We have added paragraph (k)(2) to this AD to exclude airplanes with
Airline Information Management System (AIMS) V1 installed from the
requirement to replace actuators at the spar valve location. The
currently available MOV actuator installed in those locations presents
a risk of a latent failure of the indication portion of the actuator,
which could lead to the inability to shut fuel off to an engine. For
AIMS V1-equipped airplanes, the risk associated with the creation of an
ignition source inside the fuel tank will need to be eliminated by
means other than replacing the actuator with P/N MA30A1001. Future
rulemaking for the AIMS V1-equipped airplanes might be needed to
address this SFAR 88 (66 FR 23086, May 7, 2001) issue. We have
coordinated this issue with Boeing.
    We have also clarified paragraph (j) of this AD by specifying that
credit is given for certain actions done ``before the effective date of
this AD'' using specific service information. We have also revised the
heading and wording of paragraph (j) of this AD. This change does not
affect the intent of that paragraph.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
SNPRM (75 FR 80738, December 23, 2010) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the SNPRM (75 FR 80738, December 23, 2010).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of the AD.

Costs of Compliance

    We estimate that this AD will affect 127 airplanes of U.S.
registry. We estimate the following costs to comply with this AD:

                                                 Estimated Costs
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            Action                Labor cost      Parts cost        Cost per product      Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Inspection of MOV Actuators..  Up to 6 work-                $0  Up to $510.............  Up to $64,770.
                                hours x $85
                                per hour =
                                $510.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the inspection. We have
no way of determining the number of aircraft that might need these
replacements.

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
              Action                    Labor cost               Parts cost                Cost per product
----------------------------------------------------------------------------------------------------------------
Replacement of 11 MOV Actuators    Up to 47 work-hours  Up to $60,247..............  Up to $64,242.
 Without Fuel Tank Access.          x $85 per hour =
                                    $3,995.
Replacement of 11 MOV Actuators    Up to 423 work-      Up to $60,247..............  Up to $96,202.
 With Fuel Tank Access.             hours x $85 per
                                    hour = $35,955.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2013-05-03 The Boeing Company: Amendment 39-17375; Docket No. FAA-
2008-0847; Directorate Identifier 2008-NM-056-AD.

(a) Effective Date

    This AD is effective April 25, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 777-200, -200LR, -
300, and -300ER series airplanes, certificated in any category, as
identified in Boeing Service Bulletin 777-28A0034, Revision 2, dated
September 20, 2010.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

(e) Unsafe Condition

    This AD results from fuel system reviews conducted by the
manufacturer. The Federal Aviation Administration is issuing this AD
to prevent electrical current from flowing through a motor-operated
valve (MOV) actuator into a fuel tank, which could create a
potential ignition source inside the fuel tank. This condition, in
combination with flammable fuel vapors, could result in a fuel tank
explosion and consequent loss of the airplane.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Inspection

    Except as provided by paragraph (l) of this AD: Within 60 months
after the effective date of this AD, do an inspection of the MOV
actuators of the main and center fuel tanks for part number (P/N)
MA20A1001-1, in accordance with the Accomplishment Instructions of
Boeing Service Bulletin 777-28A0034, Revision 2, dated September 20,
2010. A review of airplane maintenance records is acceptable in lieu
of this inspection if the part number can be conclusively determined
from that review.

(h) Replacement

    Except as provided by paragraphs (k)(1) and (k)(2) of this AD,
if any MOV actuator having P/N MA20A1001-1 is found during the
inspection required by paragraph (g) of this AD, within 60 months
after the effective date of this AD, replace the MOV actuator with
either a new or serviceable MOV actuator having P/N MA30A1001, or
with an MOV actuator that meets the criteria specified in paragraphs
(h)(1) and (h)(2) of this AD; and, as applicable, measure the
electrical resistance of the bond from the adapter plate to the
airplane structure and do all applicable corrective actions; in
accordance with the Accomplishment Instructions of Boeing Service
Bulletin 777-28A0034, Revision 2, dated September 20, 2010. Do all
applicable corrective actions before further flight.
    (1) The replacement MOV actuator must be a Boeing part that is
approved after the issuance of Boeing Service Bulletin 777-28A0034,
Revision 2, dated September 20, 2010, by the Manager, Seattle
Aircraft Certification Office (ACO), FAA; or the Boeing Commercial
Airplanes Organization Designation Authorization (ODA) that has been
authorized by the Manager, Seattle ACO, to approve the part.
    (2) The replacement MOV actuator must be fully interchangeable
with the part specified in Boeing Service Bulletin 777-28A0034,
Revision 2, dated September 20, 2010.

(i) Part Installation Prohibition

    As of the effective date of this AD, no person may install an
MOV actuator, P/N MA20A1001-1, on any airplane.

(j) Credit for Previous Actions

    This paragraph provides credit for the actions required by
paragraphs (g) and (h) of this AD, if those actions were performed
before the effective date of this AD using Boeing Alert Service
Bulletin 777-28A0034, dated August 2, 2007; or Boeing Alert Service
Bulletin 777-28A0034, Revision 1, dated May 20, 2010; except that
replacement of an MOV actuator must also include cap sealing the
bonding jumper, as described in Boeing Alert Service Bulletin 777-
28A0034, Revision 2, dated September 20, 2010; and provided that the
replacement is an MOV actuator identified in paragraph (j)(1) or
(j)(2) of this AD. Boeing Alert Service Bulletin 777-28A0034, dated
August 2, 2007; and Boeing Alert Service Bulletin 777-28A0034,
Revision 1, dated May 20, 2010; are not incorporated by reference in
this AD.
    (1) An MOV actuator that has P/N MA30A1001.
    (2) An MOV actuator that has a part number other than P/N
MA20A1001-1 and meets the criteria specified in paragraphs (h)(1)
and (h)(2) of this AD.

(k) Exceptions to Service Information

    (1) Work Package 9 of the Accomplishment Instructions of Boeing
Service Bulletin 777-28A0034, Revision 2, dated September 20, 2010,
refers to an incorrect part number, P/N V8166; the correct part
number that must be used is P/N V28166.
    (2) For airplanes with Airline Information Management System
(AIMS) V1 installed: MOV actuators at the spar valve locations (Work
Packages 1 and 2 of the Accomplishment Instructions of Boeing
Service Bulletin 777-28A0034, Revision 2, dated September 20, 2010),
are not required to be replaced.

(l) Optional Method of Compliance

    Replacing all MOV actuators at the main and center fuel tanks,
as specified in Boeing Service Bulletin 777-28A0034, Revision 2,
dated September 20, 2010, with new or serviceable MOV actuators
identified in paragraph (l)(1) or (l)(2) of this AD; and, as
applicable, measuring the electrical resistance of the bond from the
adapter plate to the airplane structure and doing all applicable
corrective actions; in accordance with the Accomplishment
Instructions of Boeing Service Bulletin 777-28A0034, Revision 2,
dated September 20, 2010; is an acceptable method of compliance with
the actions required by paragraph (g) of this AD.
    (1) MOV actuators that have P/N MA30A1001.
    (2) MOV actuators that have a part number other than P/N
MA20A1001-1 and meet the criteria specified in paragraphs (h)(1) and
(h)(2) of this AD.

(m) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
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 ACO, send it to the attention of the person
identified in the Related Information section of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.

(n) Related Information

    (1) For more information about this AD, contact Rebel Nichols,
Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, 1601 Lind
Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>; fax: 425-
917-6590; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.

(o) 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) Boeing Service Bulletin 777-28A0034, Revision 2, dated
September 20, 2010.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (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, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on February 25, 2013.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-05199 Filed 3-20-13; 8:45 am]
BILLING CODE 4910-13-P


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

EPA Registration Division contact: [Mark Suarez,<PHONE_NUMBER>]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert “NA-Remove” and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., “[insert company name],” with the information specific to your action.

TEMPLATE:

[BASF Corporation]

[Insert petition number]

	EPA has received a pesticide petition ([----------]) from [BASF Corporation], [26 Davis Drive, P.O. Box 13528, Research Triangle Park, North Carolina 27709-3528] 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 by establishing a tolerance for residues of the fungicide [Fluxapyroxad, (BAS 700 F); 1H-Pyrazole-4-carboxamide,3-(difluoromethyl)-1-methyl-N-(3',4',5'-triflu oro[1,1'-biphenyl]-2-yl)-, its metabolites, and degradates] in or on the following raw agricultural commodities[almond] at [0.05] parts per million (ppm); [almond, hulls] at [4.0] ppm; [berry, low growing, subgroup 13-07G] at [4.0] ppm; [bushberry, subgroup 13-07B] at [6.0] ppm; [caneberry, subgroup 13-07A] at [6.0] ppm; [fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F] at [2.0] ppm; [grapes] at [2.0] ppm; [grapes, raisin] at [5.7] ppm; [pecans] at [0.05] ppm; [rice, bran] at [8.5] ppm; [rice, grain] at [5.0] ppm; [rice, hulls] at [15.0] ppm; [rice, straw] at [20.0] ppm; [strawberry] at [4.0] ppm; [sugarcane, cane] at [3.0] ppm; [vegetable, brassica leafy, group 5] at [3.0] ppm; [vegetable, bulb, group 3-07] at [0.8] ppm; [vegetable, cucurbit, group 9] at [0.4] ppm; [vegetable, leafy, except brassica, group 4] at [15.0] ppm; [vegetable, root, except sugarbeet, subgroup 1B] at [0.7] ppm.  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism.[Nature of the residue studies were conducted in wheat, soybean and tomato as representative crops in order to characterize the fate of BAS 700 F (fluxapyroxad) in all crop matrices. Two radiocarbon labels were studied in each crop, with 14-C labels positioned in aniline and pyrazole ring structures. BAS 700 F was the predominant residue in most crops.  In all crops the BAS 700 F Residues of Concern (ROC) were characterized as parent BAS 700 F plus metabolites M700F048 and M700F002. A confined rotational crop study added metabolite M700F008 and confirmed that parent BAS 700 F plus metabolites M700F008, M700F048 and M700F002 were the residues of concern in the representative rotational crops of wheat, radish, and spinach.]

	2. Analytical method. [Independently validated analytical methods have been submitted for analyzing residues of parent BAS 700 F (fluxapyroxad) plus metabolites M700F008, M700F048 and M700F002 with appropriate sensitivity in all the crop and processed commodities for root and tuber vegetables (subgroups 1A, 1C, D), sugar beet tops,  legume vegetables including soybean (group 6), foliage of legume vegetables (group 7), fruiting vegetables (group 8), pome fruits (group 11), stone fruits (group 12), cereal grains (group 15), forage, fodder and straw of cereal grains (group 16), cotton, canola (rapeseed), sunflower and peanut and in animal meat, fat, liver and kidney matrices, poultry meat, fat, liver and skin, milk, cream and eggs for which tolerances have been established.]

	3. Magnitude of residues. [Field trials were carried out to determine the magnitude of the residue in/on Blueberry, Raspberry, Broccoli, Cabbage, Mustard greens, Green onion, Bulb onion, Cucumbers, Cantaloupe, Summer squash, Grapes, Head lettuce, Leaf lettuce, Celery, Spinach, Rice grain and straw, Carrot, roots, Radish, roots and tops, Sugarcane, Almond, nuts and hulls and Pecans, and a field accumulation study was performed in Crayfish. The number and locations of field trials are in accordance with OPPTS Guideline 860.1500. Field trials were carried out using the maximum label rates, the maximum number of applications, and the minimum pre-harvest interval (PHI) for all the crops. Residues of M700F048 and M700F002 were generally less than the limit of quantitation and often less than the limit of detection. Residues of M700F008 were significantly less than residues of BAS 700 F.  Detected residues of BAS 700 F in all crops support the proposed tolerances based on parent BAS 700 F.

Residues of BAS 700 F and M700F008 were monitored in the field accumulation study in crayfish, and residues of each were <10 ppb at all time points in crayfish tissue. The impact of the new commodities on the animal Maximum Reasonably Balanced Diets was minimal, and thus no changes in tolerances in animal commodities are proposed.]

B. Toxicological Profile

	1. Acute toxicity.  [BAS 700 F displayed low acute toxicity via the oral, dermal and inhalation routes of exposure.  It was not irritating to the eyes, only slightly irritating to the skin, and not a dermal sensitizer. The acute toxicity studies place technical BAS 700 F in toxicity category III for acute oral and dermal and category IV for acute inhalation, eye and skin irritation.  BAS 700 F is not a dermal sensitizer.]

	2. Genotoxicty. [BAS 700 F was not genotoxic in a battery of assays. BAS 700 F was negative for inducing mutations in bacterial and mammalian cell assays. No evidence of a clastogenic effect was observed in vitro or in vivo, and BAS 700 F did not cause unscheduled DNA synthesis in hepatocytes of treated rats.]

	3. Reproductive and developmental toxicity. [The reproductive and developmental toxicity of BAS 700 F was investigated in a 2-generation rat reproduction study as well as in rat and rabbit developmental toxicity studies. In the reproduction study, there were no effects on fertility, up to the highest dose tested of 300 mg/kg bw/d. At the high- and mid- (50 mg/kg bw/d) doses tested, BAS 700 F administration resulted in decreased food consumption, impaired body weight development, clinical chemistry and select organ weight changes and histopathology. Impairment of pup body weight development was also seen at these doses. The NOAEL for systemic and developmental toxicity was 10 mg/kg bw/day.

In the rat developmental toxicity study, slight maternal toxicity was observed at the high dose level of 1000 mg/kg bw/d, in the form of limited clinical chemistry, liver and thyroid weight effects, and thyroid histopathology. No evidence of developmental toxicity was observed in the rat up to the highest dose tested of 1000 mg/kg bw/d.

At the highest dose tested in the rabbit teratology study (60 mg/kg bw/d), maternal toxicity consisted of clinical signs, abortion, reduced food consumption, and impaired body weight development. The only developmental effect at the high dose, which caused substantial maternal toxicity, consisted of a commonly observed, reversible external variation, paw hyperflexion. Based on the effects described, the maternal and developmental NOAEL in rabbits was 25 mg/kg bw/d.]

	4. Subchronic toxicity. [The principal target organ in all studies in rats, mice and dogs was the liver, as indicated by organ weight changes and altered clinical chemistry parameters, which were consistent with liver enzyme induction. Histopathological changes in the liver were only evident in rats. The thyroid was also identified as a target organ in rats, as indicated by organ weight changes, histopathology and thyroid hormone changes. The lowest NOAEL in subchronic oral toxicity studies was approximately 7.3 mg/kg bw/day in the rat 90-day study.

No systemic toxicity was observed in a 28-day repeat dose dermal toxicity study at doses as high as 1000 mg/kg bw/day.

The neurotoxic potential of BAS 700 F was studied following both acute and subchronic oral administration in the rat. In the acute study, treatment-related neurobehavioral effects were noted in mid and high dose animals on the day of treatment. These consisted of slight increases of the landing foot-splay in high dose males, reduction in the number of rearings in males, and impaired motor activity in high and mid dose males and females. No effects on these parameters were observed on study days 7 and 14. Additionally, no treatment-related neuropathological findings (brain weight changes, neurohistopathological findings) were observed. Therefore, the affected parameters indicated a neuropharmacological effect rather than neuronal damage. Based on the results of this study the NOAEL for acute neurotoxicity was 125 mg/kg bw/d in male and female rats.

There was no indication of clinical (general clinical observation, FOB and motor activity) or neurohistopathological neurotoxicity in a subchronic neurotoxicity study. Systemic signs of toxicity were consistent with those seen in repeated dose studies with BAS 700 F. Under the conditions of the present study the no observed adverse effect level (NOAEL) for neurotoxicity was 5000 ppm (approximately 320 mg/kg bw/d), the highest dose tested.]

	5. Chronic toxicity. [Systemic toxicity in long term oral exposure studies in dogs, mice and rats included effects on food consumption, body weight development and clinical chemistry changes. The liver was identified as the main target organ in all species tested, as indicated by liver weight changes and non-neoplastic lesions. Additional target organs in the rat included the thyroid and bones. The spleen, gall bladder and prostate were affected in dogs.

BAS 700 F was not carcinogenic in C57BL mice following continuous dietary administration for 18 months at dietary concentrations up to 6000 ppm (approximately 1000 mg/kg bw/d). Treatment of BAS 700 F for 2 years in rats resulted in the induction of hepatocellular tumors in males at dose levels ≥ 250 ppm and in females at ≥ 1500 ppm. A mitogenic, Phenobarbital-like mechanism is proposed as the probable mode of action for liver tumor development in rats. This was supported by mechanistic studies on enzyme induction and S-Phase response in the liver, and indicates there is a threshold for tumor development and a margin of exposure cancer risk assessment is appropriate.

In the rat chronic/oncogenicity study, the NOAEL in males and females was 50 ppm (2.1 and 2.7 mg/kg bw/day, respectively). NOAEL’s in the mouse oncogenicity study were 150 ppm in males (21 mg/kg bw/day) and in females (33 mg/kg bw/day).  In a chronic dog study, the NOAEL was 300 ppm (approximately 8 mg/kg bw/day).]

	6. Animal metabolism. [The rat, goat and hen metabolism studies were conducted to determine the nature of the BAS 700 F residues in animals. Studies were conducted with radiolabeled BAS 700 F with 14-C labels positioned in aniline and pyrazole ring structures (hen metabolism, aniline ring label only). BAS 700 F was either excreted rapidly in urine and feces or transformed to a number of metabolites after administration to animals. All relevant metabolites were identified. Unchanged parent compound was found as the predominant component in most animal matrices. The metabolism of BAS 700 F in the animals is well understood. Degradation proceeds via N-demethylation of the pyrazole ring and/or hyroxylation of the biphenyl ring followed by subsequent O- and N-conjugation reactions to produce metabolites that are rapidly excreted, along with parent, and do not readily accumulate in tissues or milk. Residues in milk and most edible tissues are low. The same metabolic reactions were observed in each of the animals studied, so there is a consistent metabolic pathway for BAS 700 F in animals.  Rat, goat and hen metabolism studies were also conducted with radiolabeled M700F048, a N-glucoside of N-desmethyl BAS 700F, a plant metabolite, seen at levels >10 TRR in soybean seed in the plant metabolism study.  In all animals, the glucoside was readily hydrolyzed to generate M700F008, a key intermediate in the metabolism of BAS 700 F in animals. The radiolabeled residue was rapidly excreted with little uptake in tissue, following a metabolic pathway in all animals like that for BAS 700 F.  Rat. goat and hen metabolism studies were also conducted with radiolabeled M700F002, a carboxylic acid attached to the pyrazole-ring formed by cleavage of the BAS 700 F carboxamide bond.  M700F002 was seen at levels >10 TRR in soybean seed in the plant metabolism and was present only at low levels in the rat urine.  In all animal studies, M700F002 was not metabolized and was almost completely and rapidly excreted unchanged, with no uptake in tissue.]

	7. Metabolite toxicology. [The metabolism of BAS 700 F is similar in plants and mammals.  The metabolism of BAS 700 F, both in plants and animals, is largely based on two key transformation reactions, N-demethylation of the pyrazole moiety and hydroxylation of the biphenyl moiety.  Both reactions, combinations thereof, and subsequent conjugation reactions (e.g. glucose, glucuronic acid, cysteine) result in a range of common and structurally related compounds.  Due to the similar structural nature of most metabolites, the toxicity of most plant metabolites is adequately estimated from the results of studies performed with BAS 700 F in animals. In addition, the metabolism of metabolites M700F002, and M700F048 were each investigated in rat, goat and hen. Animal metabolism studies were performed with M700F002  since the plant metabolite was seen in the rat metabolism only at low levels in urine. In rat, goat and hen, M700F002 is rapidly and almost completely excreted unchanged with almost no uptake in tissue, milk or eggs.  M700F002 is not metabolized in animal to any significant extent.

Animal metabolism studies were performed with M700F048, a glucoside conjugate since the plant metabolite would not be formed in animal metabolism. In animal metabolism studies, M700F048 was rapidly hydrolyzed to metabolite M700F008, a key metabolite in the metabolic pathway of BAS 700 F.  Unchanged M700F048 was not detected in edible animal commodities.

Toxicology studies (Acute oral toxicity, Ames test, in vitro mutagenicity test in mammalian cells, in vitro chromosome aberration test, in vivo mouse micronucleus, 28/90-day rat feeding and developmental toxicity in rabbits) were conducted on three metabolites. Overall, M700F001, M700F002 and M700F048 are of low acute and subchronic toxicity in rats. The metabolites showed no genotoxic potential in a battery of genotoxicity studies. In addition, no adverse effects were observed up to the highest doses tested in developmental toxicity study with rabbits.]

	8. Endocrine disruption. [No specific tests have been conducted with BAS 700 F to determine whether the chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects.  However, there were no significant findings in other relevant toxicity studies (e.g., sub-chronic and chronic toxicity, developmental toxicity and multi-generation reproductive studies) which would suggest that BAS 700 F produces any endocrine disruption.]

C. Aggregate Exposure

	1. Dietary exposure. [The tolerance expression for dietary risk assessment is BAS 700 F and M700F008 in plant and animal commodities except milk, for which M700F010 is also included.  Exposure assessments were conducted to evaluate the potential risk due to acute and chronic dietary exposure of the U.S. population and all sub-populations. The assessments included all current established tolerances and the commodities proposed for tolerances and root and tuber vegetables (subgroups 1A, 1C, D), legume vegetables including soybean (group 06), fruiting vegetables (group 8), pome fruits (group 11), stone fruits (group 12), cereal grains (group 15), cotton, canola, sunflower (group 20), peanut and animal matrices including egg, milk and cream.]

	i. Food. [Acute Dietary Exposure Assessment

Acute dietary exposure estimates were based on a) tolerance values on crops approved as of May 14, 2012 with the factor of 1.5 that was used in the acute dietary assessment conducted as part of the evaluation by EPA (a few input values were changed as discussed below)  b) proposed tolerance values for crops included in this submission and processing factors for sugarcane refined sugar (0.04) and molasses (0.16) and c) current tolerances for animal commodities.  A 1.5 factor was not used to adjust the tolerances for the new commodities used in the assessment since the levels of metabolite M700F008 were always much less than 50% of the tolerance.  The analysis assumed 100% of all crops treated.  Values changed from the EPA dietary analysis of February 2012 are soybean seed commodities changed from 0.75 mg/kg to 0.15 mg/kg, sweet corn changed from 0.015 to 0.15 mg/kg and rice commodities to reflect new rice use. The impact of the new commodities on the animal Maximum Reasonably Balanced Diets was minimal and thus no changes in tolerances in animal commodities are proposed.

For drinking water all BAS 700 F uses were examined at maximum use rates, maximum number of applications, and all proposed application methods to determine which use would result in the highest water concentrations. The highest acute water concentration occurred from the rice use scenario.  The highest acute Estimated Drinking Water Concentrations (EDWC) for BAS 700 F were estimated to be 26.1 µg/L (ppb) in surface water.   The consumption of water was included in the analysis, and the residue concentration in water was set at 0.0261 mg/L based on the surface water concentration determined for the use in rice.

The consumption data was from the NHANES 2-day food consumption data for 2003 to 2008 and the assessment was performed using the Dietary Exposure Evaluation Module (DEEM-FCID) software.

The resulting exposure estimates were compared against the BAS 700 F acute Population Adjusted Dose (aPAD) of 1.25 mg/kg b.w./day for all populations. The endpoint is based on the NOAEL of 125 mg/kg/day with an FQPA safety factor of 1.  The most highly exposed sub-population was children 1-2 years old with 8.9 % utilization of the aPAD. The results of the acute dietary assessment are presented in Table 1.

Table 1. Results for BAS 700 F Acute Dietary Exposure (Food and Water) Considering all Current and Proposed Tolerances using DEEM-FCID at the 95th Percentile

Population	Exposure Estimate	% aPAD

Subgroups	(mg/kg b.w./day)

	U.S. Population	0.047194	3.8

All Infants (< 1 year old)	0.090603	7.2

Children (1-2 years old)	0.111309	8.9

Children (3-5 years old)	0.090178	7.2

Children (6-12 years old)	0.047793	3.8

Youth (13-19 years old)	0.031709	2.5

Adults (20-49 years old)	0.039777	3.2

Adults (50+ years old)	0.03779	3.0

Females (13-49 years old)	0.039958	3.2

The results of the analysis show that for all populations, the estimated exposures are well below the Agency's level of concern (< 100% aPAD). Additional refinements in the dietary risk assessment (i.e. utilizing anticipated residue values, percent crop treated values) would further reduce the estimated exposure values.

Chronic Dietary Exposure Assessment

The chronic dietary exposure estimates were based on combined residues of the highest average field trial (HAFT) values for parent and HAFT values for residues of M700F008 for all registered raw agricultural commodities and all newly proposed raw agricultural commodities except for the use of the mean residue values of BAS 700 F and HAFT values for residues of M700F008 for the commodities of barley, buckwheat, millet, oat, and rice.  Processing factors for apple juice (0.2), apple sauce (0.25), potato dry granules (1.17),  sugarcane refined sugar (0.04) and molasses (0.16) as determined in processing studies were used.  Some other changes were made to values used in the EPA evaluation of February 2012 in that apricot and nectarine residues were set equal to peach residues, rye and triticale residues were set equal to wheat residues and sweet corn was set to 0.15 mg/kg rather than 0.01 mg/kg.

For drinking water all BAS 700 F uses were examined at maximum use rates, maximum number of applications, and all proposed application methods to determine which use would result in the highest water concentrations. The highest chronic water concentration occurred from the use in paddy rice scenario.  The highest chronic EDWC’s for BAS 700F were estimated to be 23.623 µg/L in surface water. The consumption of water was included in the analysis, and the residue concentration in water was set at 0.0236 mg/L based on the surface water concentration determined for the use in paddy rice.

The consumption data was from the NHANES 2-day food consumption data for 2003 to 2008 and the assessment was performed using the Dietary Exposure Evaluation Module (DEEM-FCID) software.

The chronic Population Adjusted Dose (cPAD) used for U.S. population and all sub-populations is 0.021 mg/kg bw/day. This endpoint is based on the NOAEL value of 2.1 mg/kg bw/day using a FQPA safety factor of 1.  The most highly exposed population sub-group was children 1-2 years of age which utilized 70.3% cPAD.  The results of the chronic dietary assessment are presented in Table 2.

Table 2.  Results for BAS 700 F Chronic Dietary Exposure (Food and Water) Considering All  Commodities using DEEM-FCID

Population	Exposure Estimate	% cPAD

Subgroups	(mg/kg b.w./day)

	U.S. Population	0.005725	27.3

All Infants (< 1 year old)	0.009033	43.0

Children (1-2 years old)	0.014769	70.3

Children (3-5 years old)	0.011421	54.4

Children (6-12 years old)	0.006514	31.0

Youth (13-19 years old)	0.003794	18.1

Adults (20-49 years old)	0.004983	23.7

Adults (50+ years old)	0.005376	25.6

Females (13-49 years old)	0.005047	24.0

The results of the risk assessment show that for all populations the exposures are below a level of concern (< 100% cPAD). Additional refinements in the dietary risk assessment (i.e. utilizing anticipated residue values, percent crop treated values) would further reduce the estimated exposure values.]

	ii. Drinking water. [The consumption of BAS 700 F residues in drinking water was included in the dietary assessments above. For drinking water all BAS 700 F uses were examined at maximum use rates, maximum number of applications, and all proposed application methods to determine which use would result in the highest water concentrations. The highest acute and chronic water concentration occurred from the rice use scenario.  The highest acute Estimated Drinking Water Concentrations (EDWC) for BAS 700 F were estimated to be 26.1 µg/L (ppb) in surface water.  The consumption of water was included in the analysis, and the residue concentration in water was set at 0.0261 mg/L based on the surface water concentration determined for the use in rice.

The highest chronic water concentration occurred from the use in paddy rice. The     highest chronic EDWC’s for BAS 700F were estimated to be 23.623 µg/L in surface water. The consumption of water was included in the analysis, and the residue concentration in water was set at 0.0236 mg/L based on the surface water concentration determined for the use in paddy rice.

Short- and Intermediate-Term Aggregate Exposure and Risk (food, water, and residential)

Short- and intermediate-term aggregate risk assessments include exposure from food, water, and residential uses.  BAS 700 F is registered for use on residential turf.  Because no dermal hazard of concern was identified for BAS 700 F (fluxapyroxad), only inhalation exposure was assessed for residential handlers, and incidental ingestion was assessed for activities of children on treated turf.

The short-term oral NOAEL is 9.0 mg/kg bw/day and the intermediate-term NOAEL is 7.3 mg/kg bw/day.  The short-term aggregate risk assessment is presented in Table 3 and the intermediate-term aggregate risk assessment is presented in Table 4.

Table 3:  Short-Term Aggregate Exposure and Risk for BAS 700 F

Sub-Populations	Short-term Aggregate

 	Food + water exp. (mg/kg bw/day)	Residential exp (mg/kg bw/day)	Total exp (mg/kg bw/day)	MOE

US Population	0.005725	0.000000	0.005725	1572

Children 1-2 years old	0.014769	0.021385	0.036154	249

Table 4:  Intermediate-Term Aggregate Exposure and Risk for BAS 700 F

Sub-Populations	Intermediate-Term Aggregate

 	Food + water Exp. (mg/kg bw/day)	Residential Exp. (mg/kg bw/day) Total Exp. (mg/kg bw/day)	MOE

US Population	0.005725	0.000000	0.005725	1275

Children 1-2 years old	0.014769	0.021385	0.036154	202

The aggregate MOEs for dietary (food + water) and residential exposures are 202 and 249 for children 1-2 years old and 1275 and 1572 for the general US population.  These MOE values indicate that aggregate risk from the use of BAS 700 F is not a concern.    ]

	2. Non-dietary exposure.

[A residential exposure and risk assessment was conducted for the proposed residential use of fluxapyroxad products for disease control in turf. Because no dermal hazard of concern was identified for fluxapyroxad, only inhalation exposure was assessed for residential handlers, and incidental ingestion was assessed for activities of children on treated turf. In all exposure scenarios, the MOEs for residential use of fluxapyroxad were well above EPA’s level of concern (MOE < 100) indicating that these exposures are not of concern.

The combined post-application exposure for children 1 to <2 years old was estimated using highly conservative assumptions including: a) basing the transferable residue on the seasonal maximum application rate; b) combining all sources of incidental exposure; c) using EPA default values for children’s activities. With these highly conservative assumptions the incidental exposure was calculated to be 0.021385 mg/kg/day, resulting in short- and intermediate-term MOEs of 420 and 341, respectively.]

D. Cumulative Effects ["Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information'' concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity." Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to BAS 700 F. For the purposes of this tolerance action, therefore, BASF has not assumed that BAS 700 F has a common mechanism of toxicity with other substances.]

E. Safety Determination

	1. U.S. population. [Based on this risk assessment, BASF concludes that there is a reasonable certainty that no harm will result to the general population from the aggregate exposure to BAS 700 F from the proposed uses.]

	2. Infants and children. [Based on this risk assessment, BASF concludes that there is a reasonable certainty that no harm will result to infants or children from the aggregate exposure to BAS 700 F from the proposed uses.]

F. International Tolerances

	[European Maximum Residue Limits (MRL) were established for fluxapyroxad on multiple crops in October 2011 [Commission Regulation (EU) No 978/2011 of 3 October 2011; MRLs for fluxapyroxad (BAS 700 F) in various commodities of plant and animal origin. EFSA Journal 2011; 9(6):2196 [68 pp.].]

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 PAGE   2


[Federal Register Volume 88, Number 4 (Friday, January 6, 2023)]
[Notices]
[Pages 1060-1061]
[FR Doc No: 2023-00061]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP23-32-000]

Columbia Gas Transmission, LLC; Notice of Request Under Blanket
Authorization and Establishing Intervention and Protest Deadline

    Take notice that on December 21, 2022, Columbia Gas Transmission,
LLC (Columbia), 700 Louisiana Street, Suite 1300, Houston, Texas 77002,
filed a prior notice request pursuant to Sections 157.205, 157.208 and
157.216 of the Commission's regulations under the Natural Gas Act and
the blanket certificate issued by the Commission in Docket No. CP83-76-
000,\1\ requesting authorization to replace multiple segments of
pipeline located in Shenandoah County, Virginia, to comply with the
U.S. Department of Transportation's Pipeline and Hazardous Materials
Safety Administration (PHMSA) requirement for class locations changes
on Columbia's Lines VB, VB-Loop, and VB-5. (Lines VB, VB-Loop, and VB-5
Cedar Springs Class Replacement Project).
---------------------------------------------------------------------------

    \1\ Columbia Gas Transmission Corporation (predecessor to
Columbia Gas Transmission, LLC), 22 FERC ] 62,029 (1983).
---------------------------------------------------------------------------

    Columbia asserts that it has determined that the replacement of the
lines and maintaining its current maximum operating pressure is the
most appropriate option to maintain PHMSA compliance. Columbia states
that it will maintain full service to existing customers during the
replacement activities, therefore no impacts to Columbia's customers
are anticipated. Replacing these lines sections will also ensure that
Columbia provide reliable, safe, and efficient service. The estimated
cost of the Project is approximately $33,400,000, all as more fully set
forth in the request which is on file with the Commission and open to
public inspection.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (www.ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TTY,<PHONE_NUMBER>.
    Any questions concerning this application should be directed to
David A. Alonzo, Manager, Project Authorizations, Columbia Gas
Transmission, LLC, 700 Louisiana Street, Suite 1300, Houston, Texas
77002, by telephone<PHONE_NUMBER>, or by email
[email protected].

Public Participation

    There are three ways to become involved in the Commission's review
of this project: you can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on February 28, 2023.
How to file protests, motions to intervene, and comments is explained
below.

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\2\ any person \3\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for authorization
will be considered by the Commission.
---------------------------------------------------------------------------

    \2\ 18 CFR 157.205.
    \3\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
---------------------------------------------------------------------------

    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\4\ and must be submitted by
the protest deadline, which is February 28, 2023. A protest may also
serve as a motion to intervene so long as the protestor states it also
seeks to be an intervenor.
---------------------------------------------------------------------------

    \4\ 18 CFR 157.205(e).
---------------------------------------------------------------------------

Interventions

    Any person has the option to file a motion to intervene in this
proceeding.

Only intervenors have the right to request rehearing of Commission
orders issued in this proceeding and to subsequently challenge the
Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \5\ and the regulations under the NGA \6\ by the
intervention deadline for the project, which is February 28, 2023. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
---------------------------------------------------------------------------

    \5\ 18 CFR 385.214.
    \6\ 18 CFR 157.10.
---------------------------------------------------------------------------

    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before February 28, 2023. The filing of a comment alone will not
serve to make the filer a party to the proceeding. To become a party,
you must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP23-32-000 in your submission.
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; first select General'' and then select ``Protest'',
``Intervention'', or ``Comment on a Filing.'' The Commission's eFiling
staff are available to assist you at<PHONE_NUMBER> or
[email protected]
    (2) You can file a paper copy of your submission. Your submission
must reference the Project docket number CP23-32-000.

To mail via USPS, use the following address: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426.
To mail via any other courier, use the following address: Kimberly D.
Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852.

    Protests and motions to intervene must be served on the applicant
either by mail or email (with a link to the document) at: David A.
Alonzo, Manager, Project Authorizations, Columbia Gas Transmission,
LLC, 700 Louisiana Street, Suite 1300, Houston, Texas 77002, by
telephone<PHONE_NUMBER>, or by email [email protected].
    Any subsequent submissions by an intervenor must be served on the
applicant and all other parties to the proceeding. Contact information
for parties can be downloaded from the service list at the eService
link on FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at www.ferc.gov using the
``eLibrary'' link as described above. The eLibrary link also provides
access to the texts of all formal documents issued by the Commission,
such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: December 30, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-00061 Filed 1-5-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46012-46015]
[FR Doc No: 2015-18909]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0007]

Animal Generic Drug User Fee Rates and Payment Procedures for
Fiscal Year 2016

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates and payment procedures for fiscal year (FY) 2016 generic new
animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the
FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of
2013 (AGDUFA II), authorizes FDA to collect user fees for certain
abbreviated applications for generic new animal drugs, for certain
generic new animal drug products, and for certain sponsors of such
abbreviated applications for generic new animal drugs and/or
investigational submissions for generic new animal drugs. This notice
establishes the fee rates for FY 2016.

FOR FURTHER INFORMATION CONTACT: Visit FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm, or contact Lisa Kable, Center for Veterinary Medicine
(HFV-10), Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855,<PHONE_NUMBER>. For general questions, you may also email the
Center for Veterinary Medicine (CVM) at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 741 of the FD&C Act (21 U.S.C. 379j-21) establishes three
different types of user fees: (1) Fees for certain types of abbreviated
applications for generic new animal drugs; (2) annual fees for certain
generic new animal drug products; and (3) annual fees for certain
sponsors of abbreviated applications for generic new animal drugs and/
or investigational submissions for generic new animal drugs (21 U.S.C.
379j-21(a)). When certain conditions are met, FDA will waive or reduce
fees for generic new animal drugs intended solely to provide for a
minor use or minor species indication (21 U.S.C. 379j-21(d)).
    For FY 2014 through FY 2018, the FD&C Act establishes aggregate
yearly base revenue amounts for each of these fee categories. Base
revenue amounts established for fiscal years after FY 2014 may be
adjusted for workload. The target revenue amounts for each fee category
for FY 2016, after the adjustment for workload, are as follows: For
application fees the target revenue amount is $2,426,000; for product
fees the target revenue amount is $3,639,000; and for sponsor fees the
target revenue amount is $3,639,000.
    For FY 2016, the generic new animal drug user fee rates are:
$233,300 for each abbreviated application for a generic new animal drug
other than those subject to the criteria in section 512(d)(4) of the
FD&C Act (21 U.S.C. 360b(d)(4)); $116,650 for each abbreviated
application for a generic new animal drug subject to the criteria in
section 512(d)(4); $8,705 for each generic new animal drug product;
$83,800 for each generic new animal drug sponsor paying 100 percent of
the sponsor fee; $62,850 for each generic new animal drug sponsor
paying 75 percent of the sponsor fee; and $41,900 for each generic new
animal drug sponsor paying 50 percent of the sponsor fee. FDA will
issue invoices for FY 2016 product and sponsor fees by December 31,
2015. These fees will be due by January 31, 2016. The application fee
rates are effective for all abbreviated applications for a generic new
animal drug submitted on or after October 1, 2015, and will remain in
effect through September 30, 2016. Applications will not be accepted
for review until FDA has received full payment of related application
fees and any other fees owed under the Animal Generic Drug User Fee
program.

II. Revenue Amount for FY 2016

A. Statutory Fee Revenue Amounts

    AGDUFA II, Title II of Public Law 113-14, specifies that the
aggregate revenue amount for FY 2016 for abbreviated application fees
is $1,857,000 and each of the other two generic new animal drug user
fee categories, annual product fees and annual sponsor fees, is
$2,786,000 each (see 21 U.S.C. 379j-21(b)).

B. Inflation Adjustment to Fee Revenue Amount

    The amounts established in AGDUFA II for each year for FY 2014
through FY 2018 include an inflation adjustment; therefore, no further
inflation adjustment is required.

C. Workload Adjustment Fee Revenue Amount

    For each FY beginning after FY 2014, AGDUFA provides that statutory
fee revenue amounts shall be further adjusted to reflect changes in
review workload. (See 21 U.S.C. 379j-21(c)(2).)
    FDA calculated the average number of each of the four types of
applications and submissions specified in the workload adjustment
provision (abbreviated applications for generic new animal drugs,
manufacturing supplemental abbreviated applications for generic new
animal drugs, investigational generic new animal drug study
submissions, and investigational generic new animal drug protocol
submissions) received over the 5-year period that ended on September
30, 2013 (the base years), and the average number of each of these
types of applications and submissions over the most recent 5-year
period that ended on June 30, 2015.
    The results of these calculations are presented in the first two
columns in table 1. Column 3 reflects the percent change in workload
over the two 5-year periods. Column 4 shows the weighting factor for
each type of application, reflecting how much of the total FDA generic
new animal drug review workload was accounted for by each type of
application or submission in the table during the most recent 5 years.
Column 5 is the weighted percent change in each category of workload
and was derived by multiplying the weighting factor in each line in
column 4 by the percent change from the base years in column 3. At the
bottom right of table 1, the sum of the values in column 5 is
calculated, reflecting a total change in workload of 30.6305 percent
for FY 2016. This is the workload adjuster for FY 2016.

                                                         Table 1--Workload Adjuster Calculation
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Column 1  5-year                                                                Column 5
                     Application type                        average  (base    Column 2  latest  Column 3  percent       Column 4       weighted percent
                                                                 years)         5-year average         change        weighting factor        change
--------------------------------------------------------------------------------------------------------------------------------------------------------
Abbreviated New Animal Drug Applications (ANADAs)........               25.0               29.2                 17             0.3741             6.2855
Manufacturing Supplements ANADAs.........................              128.0              143.2                 12             0.2780             3.3015
Generic Investigational Study Submissions................               23.0               39.2                 70             0.2217            15.6183
Generic Investigational Protocol Submissions.............               17.2               24.6                 43             0.1261             5.4252
FY 2016 AGDUFA Workload Adjuster.........................  .................  .................  .................  .................            30.6305
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Over the last year FDA has continued to see more sponsors getting
involved in the generic animal drug approval process including pioneer
sponsors. This has contributed to small sustained increases in the
number of ANADAs, manufacturing supplements, and protocols submitted.
Additionally, more sponsors continue to pursue drug approvals that do
not qualify for a waiver of the requirement to conduct an in vivo
bioequivalence study. For this reason we are seeing a large sustained
increase in the number of generic investigational new animal drug study
submissions.
    As a result, the statutory revenue amount for each category of fees
for FY 2016 ($1,857,000 for application fees and $2,786,000 for both
product and sponsor fees) must now be increased by 30.6305 percent, for
a total fee revenue target in FY 2016 of $9,705,000 (rounded to the
nearest thousand dollars) for fees from all three categories. The
target for application fee revenue is $1,857,000 times 30.6305 percent,
for a total of $2,426,000, rounded to the nearest thousand. The target
for product fee revenue is $2,786,000 times 30.6305 percent, for a
total of $3,639,000, rounded to the nearest thousand dollars, and the
target for sponsor fee revenue is the same as for product fees
($3,639,000, rounded to the nearest thousand dollars).

III. Abbreviated Application Fee Calculations for FY 2016

    The term ``abbreviated application for a generic new animal drug''
is defined in 21 U.S.C. 379j-21(k)(1).

A. Application Fee Revenues and Numbers of Fee-Paying Applications

    The application fee must be paid for abbreviated applications for a
generic new animal drug that is subject to fees under AGDUFA and that
is submitted on or after July 1, 2008. The application fees are to be
set so that they will generate $2,426,000 in fee revenue for FY 2016.
This is the amount set out in the statute (21 U.S.C. 379j-21(b)(1))
after applying the workload adjuster.
    To set fees for abbreviated applications for generic new animal
drugs to realize $2,426,000, FDA must first make some assumptions about
the number of fee-paying abbreviated applications it will receive
during FY 2016.
    The Agency knows the number of applications that have been
submitted in previous years. That number fluctuates from year to year.
FDA is making estimates and applying different assumptions for two
types of full fee submissions: Original submissions of abbreviated
applications for generic new animal drugs and ``reactivated''
submissions of abbreviated applications for generic new animal drugs.
Any original submissions of abbreviated applications for generic new
animal drugs that were received by FDA before July 1, 2008, were not
assessed fees (21 U.S.C. 379j-21(a)(1)(A)). Some of these non-fee-
paying submissions were later resubmitted on or after July 1 because
the initial submission was not approved by FDA (i.e., FDA marked the
submission as incomplete and requested additional non-administrative
information) or because the original submission was withdrawn by the
sponsor. Abbreviated applications for generic new animal drugs
resubmitted on or after July 1, 2008, are subject to user fees. In this
notice, FDA refers to these resubmitted applications as ``reactivated''
applications.
    Also, under AGDUFA II, an abbreviated application for an animal
generic drug subject to the criteria in section 512(d)(4) of the FD&C
Act and submitted on or after October 1, 2013, shall be subject to 50
percent of the fee applicable to all other abbreviated applications for
a generic new animal drug.
    Regarding original submissions of abbreviated applications for
generic new animal drugs, FDA is assuming that the number of
applications that will pay fees in FY 2016 will equal the average
number of submissions over the 5 most recent completed years of AGDUFA
(FY 2010-FY 2014). FDA believes that this is a reasonable approach
after 6 complete years of experience with this program.
    The average number of original submissions of abbreviated
applications for generic new animal drugs over the 5 most recently
completed years is 8.6 applications not subject to the criteria in
section 512(d)(4) of the FD&C Act and 3.6 submissions subject to the
criteria in section 512(d)(4). Each of the submissions described under
section 512(d)(4) of the FD&C Act pays 50 percent of the fee paid by
the other applications and will be counted as one half of a fee. Adding
all of the applications not subject to the criteria in section
512(d)(4) of the FD&C Act and 50 percent of the number which are
subject to such criteria results in a total of 10.4 anticipated full
fees.
    Under AGDUFA I, FDA estimated the number of reactivations of
abbreviated applications for generic new animal drugs which had been
originally submitted prior to July 1, 2008. That number has decreased
over the years to the point that FDA no longer expects to receive any
reactivations of applications initially submitted prior to July 1,
2008, and will include no provision for them in its fee estimates.
Should such a submission be made, the submitter will be expected to pay
the appropriate fee.
    Based on the previous assumptions, FDA is estimating that it will
receive a total of 10.4 fee-paying generic new animal drug applications
in FY 2016 (8.6 original applications paying a full fee and 3.6
applications paying a half fee).

B. Application Fee Rates for FY 2016

    FDA must set the fee rates for FY 2016 so that the estimated 10.4
abbreviated applications that pay the fee will generate a total of
$2,426,000. To generate this amount, the fee for a generic new animal
drug application, rounded to the nearest hundred dollars, will have to
be $233,300, and for those applications that are subject to the

criteria set forth in section 512(d)(4) of the FD&C Act 50 percent of
that amount, or $116,650.

IV. Generic New Animal Drug Product Fee Calculations for FY 2016

A. Product Fee Revenues and Numbers of Fee-Paying Products

    The generic new animal drug product fee (also referred to as the
product fee) must be paid annually by the person named as the applicant
in an abbreviated application or supplemental abbreviated application
for a generic new animal drug product submitted for listing under
section 510 of the FD&C Act (21 U.S.C. 360), and who had an abbreviated
application or supplemental abbreviated application for a generic new
animal drug product pending at FDA after September 1, 2008 (see 21
U.S.C. 379j-21(a)(2)). The term ``generic new animal drug product''
means each specific strength or potency of a particular active
ingredient or ingredients in final dosage form marketed by a particular
manufacturer or distributor, which is uniquely identified by the
labeler code and product code portions of the national drug code, and
for which an abbreviated application for a generic new animal drug or
supplemental abbreviated application for a generic new animal drug has
been approved (21 U.S.C. 379j-21(k)(6)). The product fees are to be set
so that they will generate $3,639,000 in fee revenue for FY 2016, after
workload adjustment ($2,786,000 times 1.306305, rounded to the nearest
thousand dollars).
    To set generic new animal drug product fees to realize $3,639,000,
FDA must make some assumptions about the number of products for which
these fees will be paid in FY 2016. FDA gathered data on all generic
new animal drug products that have been submitted for listing under
section 510 of the FD&C Act and matched this to the list of all persons
who FDA estimated would have an abbreviated new animal drug application
or supplemental abbreviated application pending after September 1,
2008. As of June 2015, FDA estimates a total of 418 products submitted
for listing by persons who had an abbreviated application for a generic
new animal drug or supplemental abbreviated application for a generic
new animal drug pending after September 1, 2008. Based on this, FDA
believes that a total of 418 products will be subject to this fee in FY
2016.
    In estimating the fee revenue to be generated by generic new animal
drug product fees in FY 2016, FDA is assuming that no products invoiced
will qualify for minor use/minor species fee waiver (see 21 U.S.C.
379j-21(d)). FDA has changed the estimate of the percentage of products
that will not pay fees to zero percent this year, based on historical
data over the past 5 completed years of the AGDUFA program.
    Accordingly, the Agency estimates that a total of 418 products will
be subject to product fees in FY 2016.

B. Product Fee Rates for FY 2016

    FDA must set the fee rates for FY 2016 so that the estimated 418
products that pay fees will generate a total of $3,639,000. To generate
this amount will require the fee for a generic new animal drug product,
rounded to the nearest $5, to be $8,705.

V. Generic New Animal Drug Sponsor Fee Calculations for FY 2016

A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors

    The generic new animal drug sponsor fee (also referred to as the
sponsor fee) must be paid annually by each person who: (1) Is named as
the applicant in an abbreviated application for a generic new animal
drug, except for an approved application for which all subject products
have been removed from listing under section 510 of the FD&C Act, or
has submitted an investigational submission for a generic new animal
drug that has not been terminated or otherwise rendered inactive and
(2) had an abbreviated application for a generic new animal drug,
supplemental abbreviated application for a generic new animal drug, or
investigational submission for a generic new animal drug pending at FDA
after September 1, 2008 (see 21 U.S.C. 379j-21(k)(7) and 379j-
21(a)(3)). A generic new animal drug sponsor is subject to only one
such fee each fiscal year (see 21 U.S.C. 379j-21(a)(3)(C)). Applicants
with more than six approved abbreviated applications will pay 100
percent of the sponsor fee; applicants with more than one and fewer
than seven approved abbreviated applications will pay 75 percent of the
sponsor fee; and applicants with one or fewer approved abbreviated
applications will pay 50 percent of the sponsor fee (see 21 U.S.C.
379j-21(a)(3)(C)). The sponsor fees are to be set so that they will
generate $3,639,000 in fee revenue for FY 2016, after workload
adjustment ($2,786,000 times 1.306305, rounded to the nearest thousand
dollars).
    To set generic new animal drug sponsor fees to realize $3,639,000,
FDA must make some assumptions about the number of sponsors who will
pay these fees in FY 2016. FDA now has 6 complete years of experience
collecting these sponsor fees. Based on the number of firms that meet
this definition and the average number of firms paying fees at each
level over the 5 most recent completed years of AGDUFA (FY 2010 through
FY 2014), FDA estimates that in FY 2016, 12 sponsors will pay 100
percent fees, 17 sponsors will pay 75 percent fees, and 41 sponsors
will pay 50 percent fees. That totals the equivalent of 45.25 full
sponsor fees (12 times 100 percent or 12, plus 17 times 75 percent or
12.75, plus 41 times 50 percent or 20.5).
    FDA estimates that about 4 percent of all of these sponsors, or
1.81, may qualify for a minor use/minor species fee waiver (see 21
U.S.C. 379j-21(d)). FDA has changed the estimate of the percentage of
sponsors that will not pay fees to 4 percent this year, based on
historical data over the past 5 completed years of the AGDUFA program.
    Accordingly, the Agency estimates that the equivalent of 43.44 full
sponsor fees (45.25 minus 1.81) are likely to be paid in FY 2016.

B. Sponsor Fee Rates for FY 2016

    FDA must set the fee rates for FY 2016 so that the estimated
equivalent of 43.44 full sponsor fees will generate a total of
$3,639,000. To generate this amount will require the 100 percent fee
for a generic new animal drug sponsor, rounded to the nearest $50, to
be $83,800. Accordingly, the fee for those paying 75 percent of the
full sponsor fee will be $62,850, and the fee for those paying 50
percent of the full sponsor fee will be $41,900.

VI. Fee Schedule for FY 2016

    The fee rates for FY 2016 are summarized in table 2 of this
document.

                       Table 2--FY 2016 Fee Rates
------------------------------------------------------------------------
                                                           Fee rate for
        Generic new animal drug user fee category             FY 2016
------------------------------------------------------------------------
Abbreviated Application Fee for Generic New Animal Drug         $233,300
 except those subject to the criteria in section
 512(d)(4)..............................................

Abbreviated Application Fee for Generic New Animal Drug          116,650
 subject to the criteria in section 512(d)(4)...........
Generic New Animal Drug Product Fee.....................           8,705
100 Percent Generic New Animal Drug Sponsor Fee \1\.....          83,800
75 Percent Generic New Animal Drug Sponsor Fee \1\......          62,850
50 Percent Generic New Animal Drug Sponsor Fee \1\......          41,900
------------------------------------------------------------------------
\1\ An animal drug sponsor is subject to only one fee each fiscal year.

VII. Procedures for Paying FY 2016 Generic New Animal Drug User Fees

A. Abbreviated Application Fees and Payment Instructions

    The FY 2016 fee established in the new fee schedule must be paid
for an abbreviated new animal drug application subject to fees under
AGDUFA that is submitted on or after October 1, 2015. Payment must be
made in U.S. currency from a U.S. bank by check, bank draft, or U.S.
postal money order payable to the order of the Food and Drug
Administration, by wire transfer, or by automatic clearing house using
Pay.gov. (The Pay.gov payment option is available to you after you
submit a cover sheet. Click the ``Pay Now'' button). On your check,
bank draft, U.S. or postal money order, please write your application's
unique Payment Identification Number, beginning with the letters
``AG'', from the upper right-hand corner of your completed Animal
Generic Drug User Fee Cover Sheet. Also write the FDA post office box
number (P.O. Box 953877) on the enclosed check, bank draft, or money
order. Your payment and a copy of the completed Animal Generic Drug
User Fee Cover Sheet can be mailed to: Food and Drug Administration,
P.O. Box 979033, St. Louis, MO 63197-9000.
    If payment is made via wire transfer, send payment to U. S.
Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY
10045, Account Name: Food and Drug Administration, Account No.:
75060099, Routing No.: 021030004, Swift No.: FRNYUS33, Beneficiary:
FDA, 8455 Colesville Rd., Silver Spring, MD 20993-0002. You are
responsible for any administrative costs associated with the processing
of a wire transfer. Contact your bank or financial institution about
the fee and add it to your payment to ensure that your fee is fully
paid.
    If you prefer to send a check by a courier, the courier may deliver
the check and printed copy of the cover sheet to: U.S. Bank, Attn:
Government Lockbox 979033, 1005 Convention Plaza, St. Louis, MO 63101.
(Note: This address is for courier delivery only. If you have any
questions concerning courier delivery contact the U.S. Bank at 314-418-
4013. This phone number is only for questions about courier delivery.)
    The tax identification number of FDA is 53-0196965. (Note: In no
case should the payment for the fee be submitted to FDA with the
application.)
    It is helpful if the fee arrives at the bank at least a day or two
before the abbreviated application arrives at FDA's Center for
Veterinary Medicine (CVM). FDA records the official abbreviated
application receipt date as the later of the following: The date the
application was received by CVM, or the date U.S. Bank notifies FDA
that your payment in the full amount has been received, or when the
U.S. Department of the Treasury notifies FDA of payment. U.S. Bank and
the United States Treasury are required to notify FDA within 1 working
day, using the Payment Identification Number described previously.

B. Application Cover Sheet Procedures

    Step One--Create a user account and password. Log onto the AGDUFA
Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm137049.htm and scroll down the
page until you find the link ``Create AGDUFA User Fee Cover Sheet.''
Click on that link and follow the directions. For security reasons,
each firm submitting an application will be assigned an organization
identification number, and each user will also be required to set up a
user account and password the first time you use this site. Online
instructions will walk you through this process.
    Step Two--Create an Animal Generic Drug User Fee Cover Sheet,
transmit it to FDA, and print a copy. After logging into your account
with your user name and password, complete the steps required to create
an Animal Generic Drug User Fee Cover Sheet. One cover sheet is needed
for each abbreviated animal drug application. Once you are satisfied
that the data on the cover sheet is accurate and you have finalized the
cover sheet, you will be able to transmit it electronically to FDA and
you will be able to print a copy of your cover sheet showing your
unique Payment Identification Number.
    Step Three--Send the payment for your application as described in
Section VII.A of this document.
    Step Four--Please submit your application and a copy of the
completed Animal Generic Drug User Fee Cover Sheet to the following
address: Food and Drug Administration, Center for Veterinary Medicine,
Document Control Unit (HFV-199), 7500 Standish Pl., Rockville, MD
20855.

C. Product and Sponsor Fees

    By December 31, 2015, FDA will issue invoices and payment
instructions for product and sponsor fees for FY 2016 using this fee
schedule. Fees will be due by January 31, 2016. FDA will issue invoices
in November 2016 for any products and sponsors subject to fees for FY
2016 that qualify for fees after the December 2015 billing.

    Dated: July 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18909 Filed 7-31-15; 8:45 am]
BILLING CODE 4164-01-P