[Federal Register Volume 80, Number 68 (Thursday, April 9, 2015)]
[Rules and Regulations]
[Pages 19017-19019]
[FR Doc No: 2015-07705]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0839; Directorate Identifier 2015-CE-006-AD;
Amendment 39-18131; AD 2015-07-03]
RIN 2120-AA64

Airworthiness Directives; Cessna Aircraft Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Cessna Aircraft Company (Cessna) Model 402C and 414A airplanes. This AD
requires repetitively inspecting the engine mount beams for cracks and
contacting Cessna for FAA-approved corrective action if cracks are
found. This AD also requires sending an inspection report to the FAA
and to Cessna. This AD was prompted by reports of cracks found across
the engine mount beams. We are issuing this AD to correct the unsafe
condition on these products.

DATES: This AD is effective April 24, 2015.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 24,
2015.
    We must receive comments on this AD by May 26, 2015.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Cessna
Aircraft Company, Customer service, P.O. Box 7706, Wichita, KS 67277;
telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Internet: http://www.cessnasupport.com. You may review this referenced service
information at the FAA, Small Airplane Directorate, 901 Locust, Kansas
City, Missouri 64106. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available on the
Internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2015-0839.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
0839; 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 street address for the Docket Office (phone:
800-647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Gary Park, Aerospace Engineer, Wichita
Aircraft Certification Office, FAA, 1801 S. Airport Road, Room 100,
Wichita, Kansas 67209; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We received reports of cracks found on the engine mount beams of
certain Cessna Aircraft Company (Cessna) Model 402C airplanes. The
cracks found run across the beam and extend beyond the doubler located
under the aft engine mount and aft of the forward engine mount.
Investigation revealed that the cause of the cracks is fatigue.
    The engine beam mounts of the Cessna Model 402C airplanes are the
same type design as that of the Cessna Model 414A airplanes.
    This condition, if not detected and corrected, could result in
failure of an engine mount beam and could lead to engine separation
with consequent loss of power and loss of control. We are issuing this
AD to correct the unsafe condition on these products.

Relevant Service Information Under 1 CFR Part 51

    We reviewed Cessna Aircraft Company Multi-engine Service Letter No.
MEL-54-01, dated March 20, 2015, including the undated Attachment,
``Inspection Results Form.'' The Cessna Aircraft Company Multi-engine
Service Letter describes procedures for inspecting the engine mount
beams for cracks and reporting the inspection results to Cessna. This
information is reasonably available at http://www.regulations.gov by
searching for and locating Docket No. FAA-2015-0839, or you may see
ADDRESSES for other ways to access this service information.

FAA's Determination

    We are issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

AD Requirements

    This AD requires repetitively inspecting the engine mount beams for
cracks and contacting Cessna for an FAA-approved corrective action if
cracks are found. This AD also requires sending the inspection results
to the FAA and to Cessna.

Differences Between This AD and the Service Information

    Cessna Aircraft Company Multi-engine Service Letter No. MEL-54-01,
dated March 20, 2015, including the undated Attachment, ``Inspection
Results Form,'' specifies reporting the inspection results to Cessna.
In this AD, we also require that the inspection results be reported to
the FAA.

FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this

AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because
cracks in the engine mount beam could cause the engine mount beam to
fail and lead to engine separation with consequent loss of power and
loss of control. Therefore, we find that notice and opportunity for
prior public comment are impracticable and that good cause exists for
making this amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, we invite you to send any written data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include the docket number FAA-2015-0839 and
Directorate Identifier 2015-CE-006-AD at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this AD. We will
consider all comments received by the closing date and may amend this
AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD affects 555 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                    Labor cost            Parts cost      Cost per product      operators
----------------------------------------------------------------------------------------------------------------
Prepare airplane for             3 work-hours x $85 per  Not applicable...  $255 per           $141,525 per
 inspections.                     hour = $255 per                            inspection cycle.  inspection cycle
                                  inspection cycle.
X-ray inspection of the engine   8 work-hours x $85 per  $180.............  $860 per           $477,300 per
 mount beams (4 engine mount      hour = $680 per                            inspection cycle.  inspection cycle
 beams per airplane).             inspection cycle.
Eddy current inspection of the   1 work-hour x $85 per   Not applicable...  $85 per            $47,175 per
 engine mount beams (4 engine     hour = $85 per                             inspection cycle.  inspection cycle
 mount beams per airplane).       inspection cycle.
Visual inspection of the engine  1 work-hour x $85 per   Not applicable...  $85 per            $47,175 per
 mount beams (4 engine mount      hour = $85 per                             inspection cycle.  inspection cycle
 beams per airplane).             inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We have no way of knowing the extent of cracks that may be found
during the required inspections. Therefore, we have no way of
determining the cost of the corrective action.

Paperwork Reduction Act

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

Authority for This Rulemaking

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

Regulatory Findings

    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):

2015-07-03 Cessna Aircraft Company: Amendment 39-18131; Docket No.
FAA-2015-0839; Directorate Identifier 2015-CE-006-AD.

(a) Effective Date

    This AD is effective April 24, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Cessna Aircraft Company Model 402C airplanes,
serial numbers 402C0001 through 402C1020, and Model 414A airplanes,
serial numbers 414A0001 through 414A1212, certificated in any
category.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 54, Nacelles/Pylons.

(e) Unsafe Condition

    This AD was prompted by reports of cracks found on the engine
mount beams. We are issuing this AD to prevent failure of the engine
mount beams, which could lead to engine separation with consequent
loss of power and loss of control.

(f) Compliance

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

(g) Inspect Engine Mount Beams

    At the compliance times specified in paragraphs (g)(1) through
(g)(4) of this AD, inspect each engine mount beam using radiographic
(x-ray), eddy current, and visual methods following the
Accomplishment Instructions in Cessna Aircraft Company Multi-engine
Service Letter No. MEL-54-01, dated March 20, 2015. If total hours
time-in-service (TIS) on an engine mount beam is unknown, use the
airplane's total hours TIS.
    (1) For each engine mount beam that has accumulated less than
20,000 hours TIS, initially inspect at whichever of the following
that occurs later and repetitively thereafter at intervals not to
exceed 200 hours TIS as long as no cracks are found:
    (i) At or before the accumulation of 15,000 hours TIS on each
engine beam; or
    (ii) Within the next 100 hours TIS after the effective date of
this AD or within the next 90 days after the effective date of this
AD, whichever occurs first.
    (2) For each engine mount beam that has accumulated 20,000 hours
TIS but no more than 24,999 hours TIS, initially inspect at
whichever of the following that occurs first and repetitively
thereafter at intervals not to exceed 200 hours TIS as long as no
cracks are found:
    (i) Within the next 75 hours TIS after the effective date of
this AD; or
    (ii) Within the next 60 days after the effective date of this
AD.
    (3) For each engine mount beam that has accumulated 25,000 hours
TIS but no more than 30,000 hours TIS, initially inspect at
whichever of the following that occurs first and repetitively
thereafter at intervals not to exceed 200 hours TIS as long as no
cracks are found:
    (i) Within the next 50 hours TIS after the effective date of
this AD; or
    (ii) Within the next 45 days after the effective date of this
AD.
    (4) For each engine mount beam that has accumulated more than
30,000 hours TIS, initially inspect at whichever of the following
that occurs first and repetitively thereafter at intervals not to
exceed 200 hours TIS as long as no cracks are found:
    (i) Within the next 25 hours TIS after the effective date of
this AD; or
    (ii) Within the next 30 days after the effective date of this
AD.

(h) Contact Cessna Aircraft Company

    If any cracks are found during any inspection required in
paragraphs (g)(1) through (g)(4) of this AD, before further flight,
contact Cessna Aircraft Company at the address specified in
paragraph (m)(3) of this AD for an FAA-approved corrective action
developed specifically for this AD.

(i) Reporting Requirement

    Within 10 days after each inspection required in paragraphs
(g)(1) through (g)(4) of this AD or within 10 days after the
effective date of this AD, whichever occurs later, using the undated
Attachment, ``Inspection Results Form,'' to Cessna Aircraft Company
Multi-engine Service Letter No. MEL-54-01, dated March 20, 2015,
report the results to the FAA, Wichita Aircraft Certification Office
(ACO) at the address specified in paragraph (l) of this AD. Report
the result of each inspection to the FAA, Wichita ACO, for one year
after the date of the initial inspection required in paragraphs
(g)(1) through (g)(4) of this AD. Also report the results of the
initial inspection to Cessna at the address specified in paragraph
(m)(3) of this AD.

(j) Paperwork Reduction Act Burden Statement

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty
for failure to comply with a collection of information subject to
the requirements of the Paperwork Reduction Act unless that
collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Wichita 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 paragraph
(l) of this AD.
    (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.

(l) Related Information

    Gary Park, Aerospace Engineer, Wichita ACO, FAA, 1801 S. Airport
Road, Room 100, Wichita, Kansas 67209; phone:<PHONE_NUMBER>; fax:
(316) 946-4107; continued operational safety email<EMAIL_ADDRESS>engineer contact email<EMAIL_ADDRESS>
(m) 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) Cessna Aircraft Company Multi-engine Service Letter No. MEL-
54-01, dated March 20, 2015, including the undated Attachment,
``Inspection Results Form.''
    (ii) Reserved.
    (3) For Cessna Aircraft Company service information identified
in this AD, contact Cessna Aircraft Company, Customer service, P.O.
Box 7706, Wichita, KS 67277; telephone:<PHONE_NUMBER>; fax: (316)
517-7271; email<EMAIL_ADDRESS>Internet: http://www.cessnasupport.com.
    (4) You may view this service information at the FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-
2015-0839.
    (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 Kansas City, Missouri, on March 30, 2015.
Pat Mullen,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.

[FR Doc. 2015-07705 Filed 4-8-15; 8:45 am]
 BILLING CODE 4910-13-P


MEMORANDUM

DATE:	November 20, 2014

TO:	Carbon Power Plan for Existing Power Plants; Docket ID: OAR-2013-0602

FROM:	Rob Lawrence EPA/Region 6/PD

SUBJECT:	August 7, 2014 Call with the Houston Regional Air Quality Planning Advisory Council regarding the Proposed Carbon Power Plan for Existing Power Plants

SUMMARY

A conference call was made by EPA to the Houston Regional Air Quality Planning Advisory Council and the attendees listed below on August 7, 2014, to discuss the proposed Carbon Power Plan for Existing Power Plants, which was proposed on June 2, 2014.

ATTENDEES

Participants:	Melissa Bain (Houston-Galveston Area Council), Laura Blackburn (League of Women Voters), Paula Warren (Harris County Judge's office), Ben Carmine (NRG Energy), Cynthia Luong (Leidos), and Ken Fontain (freelance reporter)

EPA Participants:	Carl Young, Terry Johnson, and Rob Lawrence


[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)]
[Notices]
[Pages 40006-40007]
[FR Doc No: 2017-17842]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0493]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Additional Criteria
and Procedures for Classifying Over-the-Counter Drugs as Generally
Recognized as Safe and Effective and Not Misbranded

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by
September 22, 2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0688.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Additional Criteria and Procedures for Classifying Over-the-Counter
Drugs as Generally Recognized as Safe and Effective and Not
Misbranded--21 CFR 330.14, OMB Control Number 0910-0688--Revision

    This information collection supports Agency regulations.
Specifically, FDA regulations at Sec.  330.14 (21 CFR 330.14) establish
additional criteria and procedures for classifying over-the-counter
(OTC) drugs as generally recognized as safe and effective and not
misbranded. These regulations state that

OTC drug products introduced into the U.S. market after the OTC drug
review began and OTC drug products without any marketing experience in
the United States can be evaluated under the monograph process if the
conditions (e.g., active ingredients) meet certain ``time and extent''
criteria outlined in the regulations. The regulations allow a time and
extent application (TEA) to be submitted to us by any party for our
consideration to include new conditions in the OTC drug monograph
system. TEAs must provide evidence described in Sec.  330.14(c)
demonstrating that the condition is eligible for inclusion in the
monograph system. (Section 330.14(d) specifies the number of copies and
address for submission of a TEA.) If a condition is found eligible, any
interested parties can submit safety and effectiveness information as
explained in Sec.  330.14(f). Safety and effectiveness data includes
the data and information listed in Sec.  330.10(a)(2), a listing of all
serious adverse drug experiences that may have occurred (Sec.
330.14(f)(2)), and an official or proposed compendial monograph (Sec.
330.14(i)).
    Based on our experience with submissions we have received under
Sec.  330.14, we estimate that we will receive two TEAs and two safety
and effectiveness submissions each year, and that it will take
approximately 1,525 hours to prepare a TEA and 2,350 hours to prepare a
comprehensive safety and effectiveness submission. This information is
reflected in rows 1 and 2 of table 1.
    Recently FDA revised its regulations at 21 CFR part 330 (81 FR
84465, November 23, 2016), thus adding 6 hours to FDA's estimated
annual reporting burden for the information collection. Specifically,
Sec.  330.14(j) clarifies the requirements on content and format
criteria for a safety and effectiveness data submission, and provides
procedures for FDA's review of the submissions and determination of
whether a submission is sufficiently complete to permit a substantive
review. Section 330.14(j)(3) describes the process for cases in which
FDA refuses to file the safety and effectiveness data submission. Under
Sec.  330.14(j)(3), if FDA refuses to file the submission, the Agency
will notify the sponsor in writing, state the reason(s) for the
refusal, and provide the sponsor with 30 days in which to submit a
written request for an informal conference with the Agency about
whether the Agency should file the submission. We estimate that
approximately one respondent will annually submit a request for an
informal conference, and that preparing and submitting each request
will take approximately 1 hour. This is reflected in row 3 of table 1.
    Under Sec.  330.14(j)(4)(iii), the safety and effectiveness data
submission must contain a signed statement that the submission
represents a complete safety and effectiveness data submission and that
the submission includes all the safety and effectiveness data and
information available to the sponsor at the time of the submission,
whether positive or negative. We estimate that approximately two
respondents annually will submit such signed statements, and that
preparing and submitting each signed statement will take approximately
1 hour. This is reflected in row 4 of table 1.
    Under Sec.  330.14(k)(1), FDA, in response to a written request
from a sponsor, may withdraw consideration of a TEA submitted under
Sec.  330.14(c) or a safety and effectiveness data submission submitted
under Sec.  330.14(f). We estimate that approximately one respondent
will annually submit such a request, and that preparing and submitting
the request will take approximately 1 hour. This is reflected in row 5
of table 1.
    Under Sec.  330.14(k)(2), a sponsor may request that FDA not
withdraw consideration of a TEA or safety and effectiveness data
submission. We estimate one respondent will annually submit such a
request, and that preparing and submitting the request will take
approximately 2 hours. This is reflected in row 6 of table 1.
    In the Federal Register of May 30, 2017 (82 FR 24723), we published
a 60-day notice requesting public comment on the proposed extension of
this collection of information. No comments were received.
    We therefore estimate the burden of this collection of information
as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    21 CFR part 330; activity        Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
330.14(c) and (d); time and                    2               1               2           1,525           3,050
 extent application and
 submission of information......
330.14(f) and (i); safety and                  2               1               2           2,350           4,700
 effectiveness data.............
330.14(j)(3); sponsor request                  1               1               1               1               1
 for informal conference........
330.14(j)(4); sponsor signed                   2               1               2               1               2
 statement that submission is
 complete.......................
330.14(k)(l); sponsor request                  1               1               1               1               1
 for FDA withdraw of TEA
 consideration..................
330.14(k)(2); sponsor request                  1               1               1               2               2
 for FDA to not deem submission
 withdrawn......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           7,756
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17842 Filed 8-22-17; 8:45 am]
BILLING CODE 4164-01-P


TABLE 22.1: YEAR 1 GROSS AND NET REVENUE TABLE 22.2: YEAR 2 GROSS AND NET REVENUE TABLE 22.3: YEAR 3 GROSS AND NET REVENUE These tables are not included since none of the alternatives are technically feasible. See Summary of Economic Feasibility below. U. S. Orchard Replant Page 52 MEASURES OF ECONOMIC IMPACTS OF METHYL BROMIDE ALTERNATIVES CALIFORNIA GRAPE AND TREE FRUIT LEAGUE   STONE FRUIT  TABLE E. 1: ECONOMIC IMPACTS OF METHYL BROMIDE ALTERNATIVES CALIFORNIA GRAPE AND TREE FRUIT LEAGUE   RAISIN AND TABLE GRAPES  TABLE E. 2: ECONOMIC IMPACTS OF METHYL BROMIDE ALTERNATIVES CALIFORNIA WALNUT COMMISSION  TABLE E. 3: ECONOMIC IMPACTS OF METHYL BROMIDE ALTERNATIVES ALMOND HULLERS & PROCESSORS ASSOCIATION  TABLE E. 4: ECONOMIC IMPACTS OF METHYL BROMIDE ALTERNATIVES These tables are not included since none of the alternatives are technically feasible. See Summary of Economic Feasibility below.

SUMMARY OF ECONOMIC FEASIBILITY An economic analysis was not done for this sector because most of the losses cannot be quantified. The critical use nomination ( CUN) for this sector does not include areas where soil conditions are ideal and township caps do not restrict the use of 1,3 D. This CUN only applies to areas where township caps or certain soil types do not permit the use or effective use of 1,3 D. In such areas there are no technically or economically feasible alternatives and tree losses are likely to be greater than 20% ( McKenry, 1999). 1,3 D in combinations with chloropicrin or metam sodium is economically feasible in ideal soil conditions when not restricted California township caps on 1,3 D. Where soil conditions permit the effective use of 1,3 D an estimated 5% tree loss is expected from the use of 1,3 D in various combinations with chloropicrin and metam sodium. A 5% tree loss is considered a moderate loss, making the treatment economically feasible, providing there are no other losses.

Where 1,3 D is not permitted there are no effective nematicides. Trees that survive are not likely to be as healthy and could suffer yield losses. If a nematode infestation causes the death of trees, then replacement trees would also suffer the same infestation unless there use of an effective nematicide, or possibly several years of fallow.

An economic analysis was not done because most of the losses cannot be quantified since there are no data to substantiate the magnitude of these losses. These losses include:   Delayed planting   Fallow   Additional use of herbicides   Tree loss   Replant costs to replace tree losses   Loss of trees replanted   Yield loss of fruit or nuts   Delayed achievement of full yield potential   Earlier loss of productivity of whole orchard U. S. Orchard Replant Page 53 A number of soil pathogens and nematodes, many still poorly understood, occur over the lifespan of an orchard. It is important that the grower be able to reduce the amount of inoculum in the soil to ensure that the young trees have the opportunity to get off to a vigorous start to ensure survival. 1,3 D, chloropicrin, and metam sodium have shown promise on some soil types, but long term research on tree survival and on yield impacts is incomplete. If the alternatives do not work as effectively as MB, then it is possible that other losses could occur, such as additional replanting, higher yield losses, and shorter lifespan of the whole orchard reducing the ability to amortize the initial investment costs.

PART F. FUTURE PLANS 23. WHAT ACTIONS WILL BE TAKEN TO RAPIDLY DEVELOP AND DEPLOY ALTERNATIVES FOR THIS CROP?

The development of technologies to improve efficacy of alternatives, such as deep injection methods, soil moisture management by improving drip technologies, use of fallow, crop rotation, tolerant rootstocks, and improved experience with chemical/ non chemical combinations. Even where MB is considered critical, an improvement in efficient delivery techniques will result in reduction of MB use requirements. Considering that this sector uses MB only once in the life of the orchard, use of alternatives to replace MB will have to be well considered in light of the long term impact on fruit and nut production. As previously described, McKenry ( 1999) has outlined several approaches through field research studies that can help address MB alternatives for almonds, as well as walnuts, grapes, and stone fruit. These include use of herbicides to kill remnant roots, use of fallow and crop rotations, use of " virgin" soil as an amendment to possibly reduce replant problem, resistant rootstocks when available, irrigation regimes to improve consistency of metam sodium, etc. Field studies on these perennial crops require considerable time to conduct and until replicated trials can be analyzed MB is required. The consortia requesting MB are currently developing timelines for transition from MB to alternatives. These timelines should be presented in the very near future.

The amount of MB requested for research purposes is considered critical for the development of effective alternatives. Without MB for use as a standard treatment, the research studies can never address the comparative performance of alternatives. This would be a serious impediment to the development of alternative strategies. The U. S. government estimates that orchard replant research will require 1658 kg per year of MB for 2005 and 2006. This amount of MB is necessary to conduct research on alternatives and is in addition to the amounts requested in the submitted CUE applications. U. S. Orchard Replant Page 54 24. ARE THERE PLANS TO MINIMIZE THE USE OF METHYL BROMIDE FOR THE CRITICAL USE IN THE FUTURE?

As stated in Section 23, minimizing use of MB can be achieved through the development of technologies to improve efficacy of alternatives, such as deep injection methods or soil moisture management, and still have reasonable cost effectiveness. Even where MB is considered critical, an improvement in efficient delivery techniques will result in reduction of MB use requirements, even though use of MB is only used once in the long life of these orchards. Research that is currently being conducted by all of the crop groups of this sector should help identify strategies to most effectively manage replant disorder.

25. ADDITIONAL COMMENTS ON THE NOMINATION?

The U. S. Nomination for MB is for orchard replant areas where alternatives are not suitable, either because of legal restrictions or physical features, such as unacceptable soil type. The critical use exemption nomination for orchard replant has been reviewed by the U. S. government and meets the guidelines of The Montreal Protocol on Substances That Deplete the Ozone Layer. This use is considered critical in the designated areas because there are no effective alternatives or substitutes available. MB is critical in the numerous orchards where 1,3 D will not be an effective treatment to orchard replant disorder, such as where orchards have medium to heavy soils, and/ or township cap restrictions for 1,3 D. Under these circumstances MB is critical for use in 2007, and its absence will result in a significant burden for the fruit and nut industries of California.

26. CITATIONS Browne, G., Connell, J., McLaughlin S., Lee, R., Schneider, S., and Trout, T. 2004. Potential of chemical and non chemical approaches for managing Prunus replant disease. Annual International Research Conference on Methyl Bromide Alternatives ( 2004). http:// mbao. org/

Browne, G., Connell, J., Becherer, H., McLaughlin, S., Schneider, S., Lee, R., and Hosoda, E. 2003a. Evaluation of rootstocks and fumigants for control of almond replant disease. Annual International Research Conference on Methyl Bromide Alternatives ( 2003). http:// mbao. org/

Browne, G., Trout, T., Becherer, H., McLaughlin, S., Lee, R., Gartung, J., Gillis, M., Schneider, S., and Bulluck, R. 2003b. Pre plant cropping and fallowing effects on severity of Prunus replant disease. Annual International Research Conference on Methyl Bromide Alternatives ( 2003). http:// mbao. org/ U. S. Orchard Replant Page 55 Browne, G. T., Connell, J. H., Bulluck, L. R., Trout, T. J., and Schneider, S. M. 2002a. Management and etiology of replant disorder on almond and peach. Annual International Research Conference on Methyl Bromide Alternatives ( 2002). http:// mbao. org/

Browne, G., Trout, T. and Bulluck, R. 2002b. Cultural control and etiology of replant disease of Prunus spp. University of California, Sustainable Agriculture Research and Education Program. http:// www. sarep. ucdavis. edu/ grants/ reports/ mebr/ browne/ browne. html Duncan, R. A., McKenry, M., and Scow, K. 2003. Evaluation of pre and post plant treatments for replanted peach orchards. Annual International Research Conference on Methyl Bromide Alternatives ( 2003). http:// mbao. org/

Ferris, H. and Walker, M. A. 2002. Development of grape rootstocks with broad and durable nematode resistance. University of California Sustainable Agriculture Research and Education Program. Final Report ( updated May, 2003). http:// www. sarep. ucdavis. edu/ Grants/ Reports/ MeBr/ Ferris/ ferris. html Gan, J., Becker, J. O., Ernst, F. F., Hutchinson, C., Knuteson, J. A., and Yates, S. R. 2000. Surface application of ammonium thiosulfate to reduce 1,3 dichloropropene volatilization from soil. Pest Management Science 56: 264 270.

Lampinen, B., Browne, Schneider, S., Shrestha, A., Holtz, B., and Simon, L. 2004. Alternative pre plant soil fumigation treatments for deciduous tree crops. Annual International Research Conference on Methyl Bromide Alternatives ( 2004). http:// mbao. org/

Martin, F. N. 2003. Development of alternative strategies for management of soilborne pathogens currently controlled with methyl bromide. Annual Review of Phytopathology 41: 325 350.

McKenry, M. 2001. Performance of metam sodium drenched to six different replant sites. Annual International Research Conference on Methyl Bromide Alternatives ( 2001). http:// mbao. org/

McKenry, M. V. 1999. The replant problem and its management. Contractor for California Association of Nurseryman. Prepared for California Department of Pesticide Regulation. Catalina Publishing, Fresno, California, USA. ( See CUE 03 0013, CUE 03 0014 request packages of California Grape and Tree Fruit League, and CUE 03 0029 request of California Walnut Commission.)

McKenry, M., Buzo, T., Kaku, and S. 1995. First year evaluation of tree and vine growth and nematode development following 17 pre plant treatments. In: University of California Plant Protection Quarterly. Vol. 5, No. 4. http:// www. uckac. edu/ ppq/ PDF/ 95oct. pdf Schneider, S., Trout. T., Browne, G., Ajwa, H., and Sims, J. 2004. Vineyard replant   performance of methyl bromide alternatives over time. Annual International Research Conference on Methyl Bromide Alternatives ( 2004). http:// mbao. org/ U. S. Orchard Replant Page 56 Schneider, S., Trout. T., Browne, G., Ajwa, H., and Sims, J. 2003. Vineyard replant field trials. Annual International Research Conference on Methyl Bromide Alternatives ( 2003). http:// mbao. org/

Schneider, S., Trout. T., Browne, G., Ajwa, H., and Sims, J. 2002. Vineyard replant disorder   results after 1,2, and 4 growing seasons. Annual International Research Conference on Methyl Bromide Alternatives ( 2002). http:// mbao. org/

Schneider, S., Ajwa, H., Trout. T., and Sims, J. 2000. Alternatives for vineyard replant and grapevine nurseries. Annual International Research Conference on Methyl Bromide Alternatives ( 2000). http:// mbao. org/

Schneider, Ajwa, H. Trout, T. and Sims, J. 1999. Grape replant disorder   an integrated management approach. USDA, Agricultural Research Service, Methyl Bromide Alternatives. http:// www. ars. usda. gov/ is/ np/ mba/ oct99/ grape. htm Trout. T., Ajwa, H., Schneider, S., Gartung, J. 2002. Fumigation and fallowing effects on replant problems in California peach. Annual International Research Conference on Methyl Bromide Alternatives ( 2002). http:// mbao. org/ U. S. Orchard Replant Page 57 APPENDIX A. 2007 Methyl Bromide Usage Numerical Index ( BUNI). 2003 Area Requested %

Amount ( kgs) Hectares ( ha) Use Rate ( kg/ ha)

267,531 796 336 26,356 77 340 30,205 108 280 79,664 238 334 403,757 1,219 331 69% 69% 1%

Low EPA High Low High Low High Low High Low High Low High Low HIGH LOW 336 336 0 0 0 0 60 35 8 2 0 0 50 35 50% 35%

340 340 0 0 0 0 35 35 8 2 0 0 50 35 50% 35%

280 280 0 0 0 0 85 85 8 2 0 0 50 35 50% 35%

334 334 0 0 0 0 50 35 8 2 0 0 50 35 50% 35%

Strip Bed Treatment Currently Use Alternatives? Research /

Transition Plans Tarps /

Deep Injection Used Pest

free Cert.

Requirement Change from Prior CUE Request (+/) Verified Historic MB Use /

State Loss per Hectare (

US$/

ha) Loss per Kilogram of MB (

US$/

kg) Loss as a %

of Gross Revenue Loss as a %

of Net Revenue Y+ N Yes Yes Deep No 0 Yes No Yes Yes Deep No 0 Yes No Yes Yes Deep No 0 Yes Y+ N Yes Yes Deep No + 3 Yes Alternatives 1,3 D may not be suitable due to soil type, pests or township caps Notes 1 2 3 Conversion Units: 1 Pound = Kilograms Hectare Most Likely Impact Value: High 24% Low 76% Research Amount ( kgs)

1658 not available not available Average Hectares in the US:

% of Average Hectares Requested:

Unsuitable Terrain (%) Unsuitable Soil (%) Regional Hectares**

366,101 1x/ 20years 1x/ 20years 1x/ 40years Combined Impacts (%)

Not included as there is no technically feasible alternative.

Quality/ Time/ Market Window/ Yield Loss (%) Marginal Strategy Economic Analysis CA Walnut Commission  Orchard TOTAL OR AVERAGE 2007 Nomination Options Frequency of Treatment in years CA Grape & Tree Fruit League  Grapes (%) Key Pest Distribution Use Rate ( kg/ ha) (%) Karst ( Telone)

CA Walnut Commission  Orchard Adjustments to Requested Amounts CA Grape & Tree Fruit League  Grapes CA Walnut Commission  Orchard REGION CA Grape & Tree Fruit League  Stone Fruits CA Grape & Tree Fruit League  Grapes CA Walnut Commission  Orchard Almond Hullers & Processors Association Almond Hullers & Processors Association REGION CA Grape & Tree Fruit League  Stone Fruits 0.453592 1 Acre =

Other Considerations Dichotomous Variables ( Y/ N)

CA Grape & Tree Fruit League  Stone Fruits Other Issues 0.404686 CA Grape & Tree Fruit League  Stone Fruit reported historical use rates that were grossly underestimated for normal fumigation use. A use rate of 300 pounds ai/ acre was multiplied by the reported acreage to reflect a more accurate estimate of methyl bromide used.

This applicant only replanted every 20 years, so change from 2002 is not necessarily relevant since replant in 2002 reflects status of market in ~ 1982, which was less than planting in 1970s that are now being replanted.

Almond Hullers & Processors Association Nomination Amount Regulatory Issues (%)

Almond Hullers & Processors Association (%) 100 ft Buffer Zones REGION CA Grape & Tree Fruit League  Stone Fruits CA Grape & Tree Fruit League  Grapes 1,315,190 % Reduction from Initial Request 1,315,190 * Due to the nature of these applications, the historical reported data varies greatly from year to year. Therefore an average of the usage from 1997 through 2001 were used.

CA Grape & Tree Fruit League  Stone Fruit requested 8100 acres but only 65% of those acres are fumigated due to strip bed treatment, therefore the acreage was adjusted downward.

1x/ 20years 0% 0% 20% 20% 72%

60%

20%

1,046,003 1,046,003 1,046,003 523,002

 148,544  39,126 27,388 206,384     103,192 72,235 226,796  346,543 242,580 165,561  97,281   34,140 23,898 716,449  23,362  () QPS HIGH LOW MOST LIKELY IMPACT VALUE Subtractions from Requested Amounts ( kgs) Combined Impacts Adjustment ( kgs)

2007 Request () Double Counting () Growth () Use Rate Adjustment 338 0%

1,315,190 3,940 334 205 809 280 78,252 1,267,691 3,748 381 0%

206,384 567 364 428,072 1,281 334 0%

226,796 2,061 336 0%

165,561 433 382 68,280 201 340 0%

716,449 2,131 336 693,087 2007 Amount of Request 1998~ 2002 Average Use* Quarantine and Pre Shipment Kilograms ( kgs) Hectares ( ha) Use Rate ( kg/ ha) Kilograms ( kgs) Hectares ( ha) Use Rate ( kg/ ha)

REGION Sector: ORCHARD REPLANT 2007 Methyl Bromide Usage Numerical Index ( BUNI) Date: 1/ 26/ 2005 Methyl Bromide Critical Use Exemption Process U. S. Orchard Replant Page 58 Footnotes for Appendix A: Values may not sum exactly due to rounding. 1. Average Hectares in the US   Average Hectares in the US is the average of 2001 and 2002 total hectares in the US in this crop when available. These figures were obtained from the USDA National Agricultural Statistics Service. 2. % of Average Hectares Requested  Percent (%) of Average Hectares Requested is the total area in the sector's request divided by the Average Hectares in the US. Note, however, that the NASS categories do not always correspond one to one with the sector nominations in the U. S. CUE nomination ( e. g., roma and cherry tomatoes were included in the applicant's request, but were not included in NASS surveys). Values greater than 100 percent are due to the inclusion of these varieties in the U. S. CUE request that were not included in the USDA NASS: nevertheless, these numbers are often instructive in assessing the requested coverage of applications received from growers. 3. 2007 Amount of Request   The 2007 amount of request is the actual amount requested by applicants given in total pounds active ingredient of methyl bromide, total acres of methyl bromide use, and application rate in pounds active ingredient of methyl bromide per acre. U. S. units of measure were used to describe the initial request and then were converted to metric units to calculate the amount of the US nomination. 4. 2001 & 2002 Average Use   The 2001 & 2002 Average Use is the average of the 2001 and 2002 historical usage figures provided by the applicants given in total pounds active ingredient of methyl bromide, total acres of methyl bromide use, and application rate in pounds active ingredient of methyl bromide per acre. Adjustments are made when necessary due in part to unavailable 2002 estimates in which case only the 2001 average use figure is used. 5. Quarantine and Pre Shipment   Quarantine and pre shipment ( QPS) hectares is the percentage (%) of the applicant's request subject to QPS treatments. 6. Regional Hectares, 2001 & 2002 Average Hectares   Regional Hectares, 2001 & 2002 Average Hectares is the 2001 and 2002 average estimate of hectares within the defined region. These figures are taken from various sources to ensure an accurate estimate. The sources are from the USDA National Agricultural Statistics Service and from other governmental sources such as the Georgia Acreage estimates. 7. Regional Hectares, Requested Acreage %  Regional Hectares, Requested Acreage % is the area in the applicant's request divided by the total area planted in that crop in the region covered by the request as found in the USDA National Agricultural Statistics Service ( NASS). Note, however, that the NASS categories do not always correspond one to one with the sector nominations in the U. S. CUE nomination ( e. g., roma and cherry tomatoes were included in the applicant's request, but were not included in NASS surveys). Values greater than 100 percent are due to the inclusion of these varieties in the U. S. CUE request that were not included in the USDA NASS: nevertheless, these numbers are often instructive in assessing the requested coverage of applications received from growers. 8. 2007 Nomination Options   2007 Nomination Options are the options of the inclusion of various factors used to adjust the initial applicant request into the nomination figure. 9. Subtractions from Requested Amounts   Subtractions from Requested Amounts are the elements that were subtracted from the initial request amount. 10. Subtractions from Requested Amounts, 2007 Request   Subtractions from Requested Amounts, 2007 Request is the starting point for all calculations. This is the amount of the applicant request in kilograms. 11. Subtractions from Requested Amounts, Double Counting  Subtractions from Requested Amounts, Double Counting is the estimate measured in kilograms in situations where an applicant has made a request for a CUE with an individual application while their consortium has also made a request for a CUE on their behalf in the consortium application. In these cases the double counting is removed from the consortium application and the individual application takes precedence. 12. Subtractions from Requested Amounts, Growth or 2002 CUE Comparison  Subtractions from Requested Amounts, Growth or 2002 CUE Comparison is the greatest reduction of the estimate measured in kilograms of either the difference in the amount of methyl bromide requested by the applicant that is greater than that historically used or treated at a higher use rate or the difference in the 2007 request from an applicant's 2002 CUE application compared with the 2007 request from the applicant's 2003 CUE application. 13. Subtractions from Requested Amounts, QPS  Subtractions from Requested Amounts, QPS is the estimate measured in kilograms of the request subject to QPS treatments. This subtraction estimate is U. S. Orchard Replant Page 59 calculated as the 2007 Request minus Double Counting, minus Growth or 2002 CUE Comparison then multiplied by the percentage subject to QPS treatments. Subtraction from Requested Amounts, QPS = ( 2007 Request   Double Counting   Growth)*( QPS %) 14. Subtraction from Requested Amounts, Use Rate Difference   Subtractions from requested amounts, use rate difference is the estimate measured in kilograms of the lower of the historic use rate or the requested use rate. The subtraction estimate is calculated as the 2007 Request minus Double Counting, minus Growth or 2002 CUE Comparison, minus the QPS amount, if applicable, minus the difference between the requested use rate and the lowest use rate applied to the remaining hectares. 15. Adjustments to Requested Amounts   Adjustments to requested amounts were factors that reduced to total amount of methyl bromide requested by factoring in the specific situations were the applicant could use alternatives to methyl bromide. These are calculated as proportions of the total request. We have tried to make the adjustment to the requested amounts in the most appropriate category when the adjustment could fall into more than one category. 16. (%) Karst topography   Percent karst topography is the proportion of the land area in a nomination that is characterized by karst formations. In these areas, the groundwater can easily become contaminated by pesticides or their residues. Regulations are often in place to control the use of pesticide of concern. Dade County, Florida, has a ban on the use of 1,3D due to its karst topography. 17. (%) 100 ft Buffer Zones   Percentage of the acreage of a field where certain alternatives to methyl bromide cannot be used due the requirement that a 100 foot buffer be maintained between the application site and any inhabited structure. 18. (%) Key Pest Impacts  Percent (%) of the requested area with moderate to severe pest problems. Key pests are those that are not adequately controlled by MB alternatives. For example, the key pest in Michigan peppers, Phytophthora spp. infests approximately 30% of the vegetable growing area. In southern states the key pest in peppers is nutsedge. 19. Regulatory Issues (%)  Regulatory issues (%) is the percent (%) of the requested area where alternatives cannot be legally used ( e. g., township caps) pursuant to state and local limits on their use. 20. Unsuitable Terrain (%)   Unsuitable terrain (%) is the percent (%) of the requested area where alternatives cannot be used due to soil type ( e. g., heavy clay soils may not show adequate performance) or terrain configuration, such as hilly terrain. Where the use of alternatives poses application and coverage problems. 21. Cold Soil Temperatures   Cold soil temperatures is the proportion of the requested acreage where soil temperatures remain too low to enable the use of methyl bromide alternatives and still have sufficient time to produce the normal ( one or two) number of crops per season or to allow harvest sufficiently early to obtain the high prices prevailing in the local market at the beginning of the season. 22. Combined Impacts (%)  Total combined impacts are the percent (%) of the requested area where alternatives cannot be used due to key pest, regulatory, soil impacts, temperature, etc. In each case the total area impacted is the conjoined area that is impacted by any individual impact. The effects were assumed to be independently distributed unless contrary evidence was available ( e. g., affects are known to be mutually exclusive). For example, if 50% of the requested area had moderate to severe key pest pressure and 50% of the requested area had karst topography, then 75% of the area was assumed to require methyl bromide rather than the alternative. This was calculated as follows: 50% affected by key pests and an additional 25% ( 50% of 50%) affected by karst topography. 23. Qualifying Area  Qualifying area ( ha) is calculated by multiplying the adjusted hectares by the combined impacts. 24. Use Rate  Use rate is the lower of requested use rate for 2007 or the historic average use rate. 25. CUE Nominated amount  CUE nominated amount is calculated by multiplying the qualifying area by the use rate. 26. Percent Reduction  Percent reduction from initial request is the percentage of the initial request that did not qualify for the CUE nomination. 27. Sum of CUE Nominations in Sector  Self explanatory. 28. Total US Sector Nomination  Total U. S. sector nomination is the most likely estimate of the amount needed in that sector. 29. Dichotomous Variables   dichotomous variables are those which take one of two values, for example, 0 or 1, yes or no. These variables were used to categorize the uses during the preparation of the nomination. 30. Strip Bed Treatment   Strip bed treatment is ` yes' if the applicant uses such treatment, no otherwise. U. S. Orchard Replant Page 60 31. Currently Use Alternatives   Currently use alternatives is ` yes' if the applicant uses alternatives for some portion of pesticide use on the crop for which an application to use methyl bromide is made. 32. Research/ Transition Plans   Research/ Transition Plans is ` yes' when the applicant has indicated that there is research underway to test alternatives or if applicant has a plan to transition to alternatives. 33. Tarps/ Deep Injection Used   Because all pre plant methyl bromide use in the US is either with tarps or by deep injection, this variable takes on the value ` tarp' when tarps are used and ` deep' when deep injection is used. 34. Pest free cert. Required  This variable is a ` yes' when the product must be certified as ` pest free' in order to be sold 35. Other Issues. Other issues is a short reminder of other elements of an application that were checked 36. Change from Prior CUE Request This variable takes a `+' if the current request is larger than the previous request, a ` 0' if the current request is equal to the previous request, and a `` if the current request is smaller that the previous request. 37. Verified Historic Use/ State This item indicates whether the amounts requested by administrative area have been compared to records of historic use in that area. 38. Frequency of Treatment   This indicates how often methyl bromide is applied in the sector. Frequency varies from multiple times per year to once in several decades. 39. Economic Analysis   provides summary economic information for the applications. 40. Loss per Hectare   This measures the total loss per hectare when a specific alternative is used in place of methyl bromide. Loss comprises both the monetized value of yield loss ( relative to yields obtained with methyl bromide) and any additional costs incurred through use of the alternative. It is measured in current US dollars. 41. Loss per Kilogram of Methyl Bromide   This measures the total loss per kilogram of methyl bromide when it is replaced with an alternative. Loss comprises both the monetized value of yield loss ( relative to yields obtained with methyl bromide) and any additional costs incurred through use of the alternative. It is measured in current US dollars. 42. Loss as a % of Gross revenue   This measures the loss as a proportion of gross ( total) revenue. Loss comprises both the monetized value of yield loss ( relative to yields obtained with methyl bromide) and any additional costs incurred through use of the alternative. It is measured in current US dollars. 43. Loss as a % of Net Operating Revenue  This measures loss as a proportion of total revenue minus operating costs. Loss comprises both the monetized value of yield loss ( relative to yields obtained with methyl bromide) and any additional costs incurred through use of the alternative. It is measured in current US dollars. This item is also called net cash returns. 44. Quality/ Time/ Market Window/ Yield Loss (%)   When this measure is available it measures the sum of losses including quality losses, non productive time, missed market windows and other yield losses when using the marginal strategy. 45. Marginal Strategy  This is the strategy that a particular methyl bromide user would use if not permitted to use methyl bromide. U. S. Orchard Replant Page 61 APPENDIX B. 2006 Methyl Bromide Reconsideration for Orchard Replant.

Overview of the U. S. Nomination The U. S. requested 827.994 metric tons of methyl bromide for use in orchard replant for 2006. The request was distributed as follows: 826.336 metric tons for orchard use and 1.658 metric tons for research purposes.

MBTOC recommended a reduced amount of 527.6 metric tons but appeared to agree that for certain conditions there are no feasible alternatives. Discussion with MBTOC members at the 16th MOP ( Prague, November 2004) indicated that the basis for the recommended reduction was that MBTOC believes that alternatives are available for non heavy ( non clay) soils. In addition during that discussion MBTOC members admitted that the amount of methyl bromide used in a given year could vary widely based on the health of the orchards and the economics of producing the crop.

USG technical experts remain skeptical that technically and economically feasible alternatives are available but observe that less methyl bromide is used in this sector. The U. S. does not agree with the technical basis of the MBTOC's rationale for the reduction, but will not contest it at this time. The U. S. reserves the right to re visit this issue should we become aware of data demonstrating that there are no technically and economically feasible alternatives in the specific circumstances of the nomination.

U. S. 2006 nomination The U. S., therefore, accepts the MBTOC recommendation of 527.6 metric tons.


[Federal Register Volume 87, Number 142 (Tuesday, July 26, 2022)]
[Rules and Regulations]
[Pages 44278-44279]
[FR Doc No: 2022-16008]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 171

[EPA-HQ-OPP-2021-0831; FRL-9134.1-03-OCSPP]
RIN 2070-AL01

Notification of Submission to the Secretary of Agriculture;
Pesticides; Certification of Pesticide Applicators; Further Extension
to Expiration Date of Certification Plans; Draft Final Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification of submission to the Secretary of Agriculture.

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

SUMMARY: This document notifies the public as required by the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) that EPA has
forwarded to the United States Department of Agriculture (USDA) a draft
final regulatory document concerning ``Pesticides; Certification of
Pesticide Applicators; Further Extension to Expiration Date of
Certification Plans'' (RIN 2070-AL01). The draft regulatory document is
not available to the public until after it has been signed and made
available by EPA.

DATES: See Unit I. under SUPPLEMENTARY INFORMATION.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0831, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is<PHONE_NUMBER>. Please review the
visitor instructions and additional information about the docket
available at https://www.epa.gov/dockets. The docket contains
historical information and this Federal Register document; it does not
contain the draft final rule.

FOR FURTHER INFORMATION CONTACT: Carolyn Schroeder, Pesticide Re-
Evaluation Division (Mailcode 7508M), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. What action is EPA taking?

    FIFRA section 25(a)(2)(B) requires the EPA Administrator to provide
the Secretary of USDA with a copy of any draft final rule at least 30
days before signing it in final form for publication in the Federal
Register. The draft final rule is not available to the public until
after it has been signed by EPA. If the Secretary of USDA comments in
writing regarding the draft final rule within 15 days after receiving
it, the EPA Administrator shall include the comments of the Secretary
of USDA, if requested by the Secretary of USDA, and the EPA
Administrator's response to those comments with the final rule that
publishes in the Federal Register. If the Secretary of USDA does not
comment in writing within 15 days after receiving the draft final rule,
the EPA Administrator may sign the final rule for publication in the
Federal Register any time after the 15-day period.

II. Do any statutory and executive order reviews apply to this
notification?

    No. This document is merely a notification of submission to USDA.
As such, none of the regulatory assessment requirements apply to this
document.

List of Subjects in Part 171

    Environmental protection, Agricultural worker safety, Applicator
competency, Certified applicator, Pesticide safety training, Pesticide
worker safety, Pesticides and pests, Restricted use pesticides.

    Dated: July 20, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2022-16008 Filed 7-25-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 11, 2009 (Volume 74, Number 46)]
[Notices]
[Page 10597-10598]
[DOCID:fr11mr09-91]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-E-0230]

Determination of Regulatory Review Period for Purposes of Patent
Extension; CERENIA TABLETS

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) has determined the
regulatory review period for CERENIA TABLETS and is publishing this
notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of Patents and Trademarks, Department of Commerce, for the
extension of a patent which claims that animal drug product.

ADDRESSES:  Submit written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit

electronic comments to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Beverly Friedman, Office of
Regulatory Policy, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For animal drug products, the
testing phase begins on the earlier date when either a major
environmental effects test was initiated for the drug or when an
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360b(j)) became effective and runs until the approval
phase begins. The approval phase starts with the initial submission of
an application to market the animal drug product and continues until
FDA grants permission to market the drug product. Although only a
portion of a regulatory review period may count toward the actual
amount of extension that the Director of Patents and Trademarks may
award (for example, half the testing phase must be subtracted as well
as any time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for an animal
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(4)(B).
    FDA recently approved for marketing the animal drug product CERENIA
TABLETS (maropitant citrate monohydrate). CERENIA TABLETS is indicated
for the prevention of acute vomiting in dogs and the prevention of
vomiting due to motion sickness in dogs. Subsequent to this approval,
the Patent and Trademark Office received a patent term restoration
application for CERENIA TABLETS (U.S. Patent No. 6,255,320) from Pfizer
Inc., and the Patent and Trademark Office requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated May 6, 2008, FDA advised the Patent and Trademark Office
that this animal drug product had undergone a regulatory review period
and that the approval of CERENIA TABLETS represented the first
permitted commercial marketing or use of the product. Shortly
thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
CERENIA TABLETS is 1,887 days. Of this time, 1,841 days occurred during
the testing phase of the regulatory review period, while 46 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    1. The date an exemption under section 512(j) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360b(j)) became effective: December
1, 2001. The applicant claims November 21, 2000, as the date the
investigational new animal drug application (INAD) became effective.
However, the date that a major health or environmental effects test is
begun or the date on which the agency acknowledges the filing of a
notice of claimed investigational exemption for a new animal drug,
whichever is earlier, is the effective date for the INAD. According to
FDA records, December 1, 2001, is the effective date for the INAD.
    2. The date the application was initially submitted with respect to
the animal drug product under section 512 of the Federal Food, Drug,
and Cosmetic Act: December 15, 2006. The applicant claims December 13,
2006, as the date the new animal drug application (NADA) for CERENIA
TABLETS (NADA 141-262) was initially submitted. However, a review of
FDA records reveals that NADA 141-262 was initially submitted on
December 15, 2006.
    3. The date the application was approved: January 29, 2007. FDA has
verified the applicant's claim that NADA 141-262 was approved on
January 29, 2007.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 267 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by May 11, 2009. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by September 8,
2009. To meet its burden, the petition must contain sufficient facts to
merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d
sess., pp. 41-42, 1984.) Petitions should be in the format specified in
21 CFR 10.30.
    Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments and petitions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 17, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-5109 Filed 3-10-09; 8:45 am]

BILLING CODE 4160-01-S