[Federal Register: February 21, 2008 (Volume 73, Number 35)]
[Notices]
[Page 9563-9564]
[DOCID:fr21fe08-57]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2007-0054; FRL-8531-1]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Vinyl Chloride
(Renewal); EPA ICR Number 0186.11, OMB Control Number 2060-0071

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before March 24,
2008.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2007-0054, to (1) EPA online using http://www.regulations.gov (our preferred method), or by e-mail to<EMAIL_ADDRESS>or by mail to:

EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
2201T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2) OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street,
NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Compliance Assessment
and Media Programs Division, Office of Compliance, Mail Code 2223A,
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On March 9, 2007 (72 FR 10735), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2007-0054, which is available for public viewing
online at http://www.regulations.gov, or in person viewing at the

Enforcement and Compliance Docket and Information Center in the EPA
Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue,
NW., Washington, DC. The EPA Docket Center Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Reading Room is<PHONE_NUMBER>,
and the telephone number for the Enforcement and Compliance Docket is
(202) 566-1752.
    Use EPA's electronic docket and comment system at http://www.regulations.gov
, to submit or view public comments, access the

index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov, as EPA

receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://www.regulations.gov
.

    Title: NESHAP for Vinyl Chloride (Renewal).
    ICR Numbers: EPA ICR Number 0186.11, OMB Control Number 2060-0071.
    ICR Status: This ICR is scheduled to expire on April 30, 2008.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, and displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: The National Emissions Standards for Hazardous Air
Pollutants (NESHAP) for Vinyl Chloride (VC) were proposed on December
24, 1975, promulgated on October 21, 1976, and

amended on June 7, 1977, September 30, 1986, September 23, 1988, and
December 23, 1992. These standards apply to exhaust gases and
oxychlorination vents at ethylene dichloride (EDC) plants; exhaust gas
at vinyl chloride monomer (VCM) plants; and exhaust gases, reactor
opening losses, manual vent valves, and stripping residuals at
polyvinyl chloride (PVC) plants. The standards also apply to relief
valves and fugitive emission sources at all three types of plants.
    In the Administrator's judgment, vinyl chloride emissions from
polyvinyl chloride (PVC), ethylene dichloride (EDC), and vinyl chloride
monomer (VCM) plants cause or contribute to air pollution that may
reasonably be anticipated to result in an increase in mortality or an
increase in serious irreversible, or incapacitating reversible illness.
Vinyl chloride is a known human carcinogen which causes a rare cancer
of the liver. In order to ensure compliance with the standard, adequate
recordkeeping and reporting is necessary. This information enables the
Agency to: (1) Ensure that facilities that are affected continue to
operate the control equipment and use proper work practices to achieve
compliance; (2) notification of startup indicates to enforcement
personnel when a new facility has been constructed and is thus subject
to the standards; and (3) provides a means for ensuring compliance.
    The standards require daily measurements from the continuous
monitoring system and of the reactor pressure and temperature.
Establishment of a continuous monitoring program is a high priority of
the Agency. The continuous monitoring system monitors VC emissions from
the stack to judge compliance with the numerical limits in the
standards. The parameters are used to judge the operation of the
reactor so that the source and EPA will be aware of improper operation
and maintenance. The standards implicitly require the initial reports
required by the General Provisions of 40 CFR 61.7 and 61.9. These
initial reports include application for approval of construction or
modification, and notification of startup. The standards also require
quarterly reporting of vinyl chloride emissions from stripping, reactor
openings, and exhausts. Reports must be submitted within 10 days of
each valve discharge and manual vent valve discharge.
    The owner/operator must make the following one-time-only reports:
Application for approval of construction or modification; notification
of startup; application of a waiver of testing (if desired by source);
and an initial report. The initial report includes a list of the
equipment installed for compliance, a description of the physical and
functional characteristics of each piece of equipment, a description of
the methods which have been incorporated into the standard operation
procedures for measuring or calculating emissions, and a statement that
equipment and procedures are in place and are being used. Generally,
the one-time-only reports are required of all sources subject to NESHAP
regulation.
    Any owner or operator subject to the provisions of this part shall
maintain a file of these measurements, and retain the file for at least
five years following the date of such measurements, maintenance
reports, and records. All reports are sent to the delegated state or
local authority. In the event that there is no such delegated
authority, the reports are sent directly to the EPA regional office.
This information is being collected to assure compliance with 40 CFR
part 63, subpart W, and 40 CFR part 63, subpart A, as authorized in
section 112 and 114(a) of the Clean Air Act. The required information
consists of emissions data and other information that have been
determined to be private.
    An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB Control Number. The OMB Control Number for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are
identified on the form and/or instrument, if applicable.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 60
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Vinyl Chloride.
    Estimated Number of Respondents: 28.
    Frequency of Response: On occasion, quarterly and initially.
    Estimated Total Annual Hour Burden: 11,825.
    Estimated Total Annual Cost: $2,014,515, which is comprised of $0
annualized Capital Startup costs, $1,260,000 in annualized Operating
and Maintenance (O&M) costs, and $754,515 annualized Labor costs.
    Changes in the Estimates: There is no change in the labor hours or
cost in this ICR compared to the previous ICR. This is due to two
considerations. First, the regulations have not changed over the past
three years and are not anticipated to change over the next three
years. Secondly, the growth rate for the industry is very low, negative
or non-existent, so there is no significant change in the overall
burden.
    Since there are no changes in the regulatory requirements and there
is no significant industry growth, the labor hours and cost figures in
the previous ICR are used in this ICR and there is no change in burden
to industry.

    Dated: February 12, 2008.
Sara Hisel-McCoy,
Director, Collection Strategies Division.
[FR Doc. E8-3229 Filed 2-20-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Proposed Rules]
[Pages 39035-39037]
[FR Doc No: 2018-16796]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2013-0492; FRL-9981-67--Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Delaware; Interstate Transport Requirements for the 2010 1-Hour Sulfur
Dioxide Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve portions of a state implementation plan (SIP) revision
submittal from the State of Delaware. This revision addresses the
infrastructure requirement for interstate transport of pollution with
respect to the 2010 1-hour sulfur dioxide (SO2) national
ambient air quality standard (NAAQS). This action is being taken under
the Clean Air Act (CAA).

DATES: Written comments must be received on or before September 7,
2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2013-0492 at http://www.regulations.gov, or via email to
[email protected]. For

comments submitted at Regulations.gov, follow the online instructions
for submitting comments. Once submitted, comments cannot be edited or
removed from Regulations.gov. For either manner of submission, EPA may
publish any comment received to its public docket. Do not submit
electronically any information you consider to be confidential business
information (CBI) or other information whose disclosure is restricted
by statute. Multimedia submissions (audio, video, etc.) must be
accompanied by a written comment. The written comment is considered the
official comment and should include discussion of all points you wish
to make. EPA will generally not consider comments or comment contents
located outside of the primary submission (i.e., on the web, cloud, or
other file sharing system). For additional submission methods, please
contact the person identified in the For Further Information Contact
section. For the full EPA public comment policy, information about CBI
or multimedia submissions, and general guidance on making effective
comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Joseph Schulingkamp,<PHONE_NUMBER>,
or by email at [email protected].

SUPPLEMENTARY INFORMATION: On May 29, 2013, the State of Delaware,
through the Delaware Department of Natural Resources and Environmental
Control (DNREC) submitted a SIP revision addressing the infrastructure
requirements under section 110(a)(2) of the CAA for the 2010 1-hour
SO2 NAAQS.

I. Background

A. General

    On June 2, 2010, the EPA promulgated a revised primary
SO2 standard, establishing a new 1-hour primary standard at
the level of 75 parts per billion (ppb), based on the 3-year average of
the annual 99th percentile of 1-hour daily maximum concentrations
(hereafter ``the 2010 1-hour SO2 NAAQS''). At the same time,
the EPA also revoked the previous 24-hour and annual primary
SO2 standards. See 75 FR 35520 (June 22, 2010). See 40 CFR
50.11. The previous SO2 air quality standards were set in
1971, including a 24-hour average primary standard at 140 ppb and an
annual average primary standard at 30 ppb. See 36 FR 8186 (April 30,
1971).
    Current scientific evidence links short-term exposures to
SO2, ranging from five minutes to 24 hours, with an array of
adverse respiratory effects including bronchoconstriction and increased
asthma symptoms. These effects are particularly important for
asthmatics at elevated ventilation rates (e.g., while exercising or
playing). Studies also show a connection between short-term exposure
and increased visits to emergency departments and hospital admissions
for respiratory illnesses, particularly in at-risk populations
including children, the elderly, and asthmatics.

B. EPA's Infrastructure Requirements

    Pursuant to section 110(a)(1) of the CAA, states are required to
submit a SIP revision to address the applicable requirements of section
110(a)(2) within three years after promulgation of a new or revised
NAAQS or within such shorter period as EPA may prescribe. Section
110(a)(2) requires states to address basic SIP elements to assure
attainment and maintenance of the NAAQS--such as requirements for
monitoring, basic program requirements, and legal authority. Section
110(a) imposes the obligation upon states to make a SIP submission to
EPA for a new or revised NAAQS, but the contents of that submission may
vary depending upon the facts and circumstances of each NAAQS and what
is in each state's existing SIP. In particular, the data and analytical
tools available at the time the state develops and submits the SIP
revision for a new or revised NAAQS affect the content of the
submission. The content of such SIP submission may also vary depending
upon what provisions the state's existing SIP already contains.
    Specifically, section 110(a)(1) provides the procedural and timing
requirements for SIP submissions. Section 110(a)(2) lists specific
elements that states must meet for infrastructure SIP requirements
related to a newly established or revised NAAQS such as requirements
for monitoring, basic program requirements, and legal authority that
are designed to assure attainment and maintenance of the NAAQS.

C. Interstate Pollution Transport Requirements

    Section 110(a)(2)(D)(i)(I) of the CAA requires a state's SIP to
include adequate provisions prohibiting any emissions activity in one
state that contributes significantly to nonattainment, or interferes
with maintenance, of the NAAQS in any downwind state. The EPA sometimes
refers to these requirements as prong 1 (significant contribution to
nonattainment) and prong 2 (interference with maintenance), or jointly
as the ``good neighbor'' provision of the CAA. Further information can
be found in the Technical Support Document (TSD) for this rulemaking
action, which is available online at www.regulations.gov, Docket number
EPA-R03-OAR-2013-0492.

II. Summary of SIP Revision and EPA Analysis

    On May 29, 2013, Delaware submitted, through DNREC, a revision to
its SIP to satisfy the infrastructure requirements of section 110(a)(2)
of the CAA for the 2010 1-hour SO2 NAAQS, including the
interstate transport requirements of section 110(a)(2)(D)(i)(I). On
January 22, 2014 (79 FR 3506), the EPA approved Delaware's
infrastructure SIP submittal for the 2010 1-hour SO2 NAAQS
for all applicable elements of section 110(a)(2) with the exception of
110(a)(2)(D)(i)(I). This proposed rulemaking action is addressing the
portions of Delaware's infrastructure submittal for the 2010 1-hour
SO2 NAAQS that pertain to transport
requirements.1 2
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    \1\ For the EPA's explanation of its ability to act on discrete
elements of section 110(a)(2), see 80 FR 2865 (Approval and
Promulgation of Air Quality Implementation Plans; District of
Columbia; Infrastructure Requirements for the 2008 Ozone, 2010
Nitrogen Dioxide, and 2010 Sulfur Dioxide National Ambient Air
Quality Standards; Approval of Air Pollution Emergency Episode Plan
(January 21, 2015)).
    \2\ This proposed approval action is based on the information
contained in the administrative record for this action, and does not
prejudge any other future EPA action that may make other
determinations regarding any of the subject state's air quality
status. Any such future actions, such as area designations under any
NAAQS, will be based on their own administrative records and the
EPA's analyses of information that becomes available at those times.
Future available information may include, and is not limited to,
monitoring data and modeling analyses conducted pursuant to the
EPA's SO2 Data Requirements Rule (80 FR 51052, August 21,
2015) and information submitted to the EPA by states, air agencies,
and third-party stakeholders such as citizen groups and industry
representatives.
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    The portions of Delaware's May 29, 2013 SIP submittal addressing
interstate transport (for section 110(a)(2)(D)(i)(I)) discuss how
Delaware does not significantly contribute with respect to the 2010 1-
hour SO2 NAAQS to nonattainment in, or interfere with
maintenance in, any other state and discusses prevailing wind direction
in the region. Additionally, Delaware described in its submittal
several existing SIP-approved measures and other federally enforceable
source-specific measures, pursuant to permitting requirements under the
CAA, that apply to SO2 sources within the state.
    Based on EPA's analysis, EPA agrees with Delaware's general
conclusion that

the existing Delaware SIP is adequate to prevent sources in Delaware
from significantly contributing to nonattainment or interfering with
maintenance in another state with respect to the 2010 1-hour
SO2 NAAQS. A detailed summary of EPA's review and rationale
for proposed approval of this SIP revision as meeting CAA section
110(a)(2)(D)(i)(I) for the 2010 1-hour SO2 NAAQS may be
found in the TSD.

III. Proposed Action

    EPA is proposing to approve the portions of Delaware's May 29, 2013
SIP revision addressing interstate transport for the 2010 1-hr
SO2 NAAQS as these portions meet the requirements in section
110(a)(2)(D)(i)(I) of the CAA. EPA is soliciting public comments on the
issues discussed in this document. These comments will be considered
before taking final action.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule, addressing Delaware's interstate
transport requirements for the 2010 1-hour SO2 NAAQS, does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), because the SIP is not approved to apply
in Indian country located in the state, and EPA notes that it will not
impose substantial direct costs on tribal governments or preempt tribal
law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Reporting and recordkeeping requirements, Sulfur oxides.

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

    Dated: July 12, 2018.
Cosmo Servidio,
Regional Administrator, Region III.
[FR Doc. 2018-16796 Filed 8-7-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: March 22, 2006 (Volume 71, Number 55)]
[Notices]
[Page 14524-14525]
[DOCID:fr22mr06-70]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0542; FRL-7769-7]

Notice of Filing of Pesticide Petitions for Establishment of
Regulations for Residues of the Insecticide Imidacloprid in or on
Various Food Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of pesticide
petitions proposing the establishment of regulations for residues of
the insecticide imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-
2-imidazolidinimine in or on various food commodities.

DATES: Comments must be received on or before April 21, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0542 and pesticide petition numbers (PPs)
3E6543, 3E6561, 3E6738, 3E6760, 5E6920, 5E6921, 5E6922, and 5E6923, by
one of the following methods:
     http://www.regulations.gov/. Follow the on-line

instructions for submitting comments.
     Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Hand Delivery: Public Information and Records Integrity
Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1801
S. Bell St., Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-
2005-0542. The docket facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
docket facility is<PHONE_NUMBER>. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0542. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at http://www.regulations.gov/, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The http://www.regulations.gov website is an ``anonymous access''

system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going at
regulations.gov, your e-mail address will be captured automatically and
included as part of the comment that is placed in the public docket and
made available on the Internet. If you submit an electronic comment,
EPA recommends that you include your name and other contact information
in the body of your comment and with any disk or CD ROM you submit. If
EPA cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses. For
additional information about EPA's public docket, visit the EPA Docket
Center homepage at http://www.epa.gov/epahome/dockets.htm/.

     Docket: All documents in the docket are listed in the
regulation.gov index. Although listed in the index, some information is
not publicly available, e.g., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically at
http://www.regulations.gov or in hard copy at the Public Information

and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1801 S. Bell St., Arlington, VA. The Docket Facility is
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division,
(7505C), Office of Pesticide Programs, U. S. Environmental Protection
Agency, 1200 Pennsylvania Ave., NW,

Washington, DC 20460-0001;<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
     2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. What Action is the Agency Taking?

    EPA is printing a summary of each pesticide petition received under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, proposing the establishment or amendment of regulations in
40 CFR part 180 for residues of pesticide chemicals in or on various
food commodities. EPA has determined that this pesticide petition
contains data or information regarding the elements set forth in FFDCA
section 408(d)(2); however, EPA has not fully evaluated the sufficiency
of the submitted data at this time or whether the data support granting
of the pesticide petition. Additional data may be needed before EPA
rules on this pesticide petition.
    Pursuant to 40 CFR 180.7(f), a summary of the petition included in
this notice, prepared by the petitioner along with a description of the
analytical method available for the detection and measurement of the
pesticide chemical residues is available on EPA's Electronic Docket at
http://www.regulations.gov/. To locate this information on the home

page of EPA's Electronic Docket, select ``Quick Search'' and type the
OPP docket ID number. Once the search has located the docket, clicking
on the ``Docket ID'' will bring up a list of all documents in the
docket for the pesticide including the petition summary.

New Tolerance

    1. PP 3E6543. Interregional Research Project No. 4 (IR-4), 681 U.
S. Highway No. 1 South, North Brunswick, NJ 08902-3390, proposes to
establish a tolerance for residues of the insecticide imidacloprid, 1-
[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine in or on
food commodities [caneberry subgroup 13-A at 0.05 parts per million
(ppm);
    2. PP 3E6561. coffee at 0.6 ppm;
    3. PP 3E6738. seed of: Black mustard, borage, crambe, field
mustard, flax, Indian mustard, Indian rapeseed, rapeseed, safflower,
and sunflower at 0.05 ppm;
    4. PP 3E6760. atemoya, biriba, cherimoya, custard apple, ilama,
soursop, and sugar apple at 0.2 ppm;
    5. PP 5E6920. almond hulls at 2.5 ppm; and pistachio and tree nut
group 14 at 0.01 ppm;
    6. PP 5E6921. pomegranate at 0.7 ppm;
    7. PP 5E6922. banana at 0.6 ppm; and
    8. PP 5E6923. herbs subgroup 19-A dried at 62.0 ppm; and herbs
subgroup 19-A fresh at 6.0 ppm.
    The analytical method is a common moiety method for imidacloprid
and its metabolites containing the 6-chloropyridinyl moiety using a
permanganate oxidation, silyl derivatization, and capillary gas
chromatography mass spectrometry (GS MS) selective ion monitoring.
There is a confirmatory method specifically for imidacloprid and
several metabolites utilizing GC/MS and high power liquid
chromatography ultraviolet (HPLC UV) which has been validated by the
EPA as well. Imidacloprid and its metabolites are stable for at least
24 months in the commodities when frozen.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: March 13, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 06-2636 Filed 3-21-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: December 1, 2010 (Volume 75, Number 230)]
[Rules and Regulations]
[Page 74610-74616]
[DOCID:fr01de10-3]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-1067; Directorate Identifier 2009-NM-071-AD;
Amendment 39-16516; AD 2010-23-26]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A300 B2-1C, B2K-3C, B2-
203, B4-2C, B4-103, and B4-203 Airplanes; and Model A300 B4-601, B4-
603, B4-620, B4-622, B4-605R, B4-622R, and F4-605R Airplanes

AGENCY: Federal Aviation Administration, Department of Transportation.

ACTION: Final rule.

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

SUMMARY: We are superseding an existing airworthiness directive (AD)
for the products listed above. This AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    Following the occurrence of cracks on the MLG [main landing
gear] rib 5 RH [right-hand] and LH [left-hand] attachment fitting
lower flanges, DGAC [Direction G[eacute]n[eacute]rale de l'Aviation
Civile] France AD 2003-318(B) [parallel to part of FAA AD 2006-12-
13] was issued to require repetitive inspections and, as terminating
action * * *[.]
    Subsequently, new cases of cracks were discovered during
scheduled maintenance checks by operators of A300B4 and A300-600
type aeroplanes on which the terminating action * * * [was]
embodied. This condition, if not corrected, could affect the
structural integrity of those aeroplanes.
* * * * *

We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective January 5, 2011.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of January 5,
2011.
    On July 18, 2006 (71 FR 33994, June 13, 2006), the Director of the
Federal Register approved the incorporation by reference of certain
other publications listed in this AD.
    On April 12, 2000 (65 FR 12077, March 8, 2000), the Director of the
Federal Register approved the incorporation by reference of certain
other publications listed in this AD.

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT:  Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-2125; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on November 18, 2009
(74 FR 59483), and proposed to supersede AD 2006-12-13, Amendment 39-
14639 (71 FR 33994, June 13, 2006). That NPRM proposed to correct an
unsafe condition for the specified products. The MCAI states:

    Following the occurrence of cracks on the MLG [main landing
gear] rib 5 RH [right-hand] and LH [left-hand] attachment fitting
lower flanges, DGAC [Direction G[eacute]n[eacute]rale de l'Aviation
Civile] France AD 2003-318(B) [parallel to part of FAA AD 2006-12-
13] was issued to require repetitive inspections and, as terminating
action, the embodiment of Airbus Service Bulletins (SB) A300-57-0235
and A300-57-6088 * * *.
    Subsequently, new cases of cracks were discovered during
scheduled maintenance checks by operators of A300B4 and A300-600
type aeroplanes on which the terminating action SB's were embodied.
This condition, if not corrected, could affect the structural
integrity of those aeroplanes.
    To address and correct this condition, Airbus developed an
inspection programme for aeroplanes modified in accordance with SB
A300-57-0235 or A300-57-6088. This inspection programme was required
to be implemented by DGAC France AD F-2005-113, original issue and
later revision 1 [parallel to part of FAA AD 2006-12-13].
    A new EASA [European Aviation Safety Agency] AD 2008-0111,
superseding DGAC France AD F-2005-113R1, was issued to reduce the
applicability. For aeroplanes already compliant with DGAC France AD
F-2005-113R1, no further action was required.
    Since EASA AD 2008-0111 issuance, Airbus reviewed the inspection
programmes of SB A300-57A0246 and SB A300-57A6101 to introduce
repetitive inspections including a new inspection technique for
holes 47 and 54 and to reduce inspections threshold and intervals
from 700 Flight Cycles (FC) to 400 FC until a revised terminating
action is made available.
    For the reasons stated above, AD 2009-0081 superseded EASA AD
2008-0111 and required operators to comply with the new inspection
programme introduced in

Revisions 3 of Airbus SB A300-57A0246 and Airbus SB A300-57A6101.
    This AD is revised to introduce an optional terminating action
which consists of spot-facing the sensitive holes of the MLG Rib 5
(LH and RH) bottom flanges.

Required actions include contacting Airbus for repair instructions, if
necessary, and doing the repair. You may obtain further information by
examining the MCAI in the AD docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comment received.

Request To Revise Proposed Costs of Compliance

    FedEx Express commented that the NPRM would affect 57 of its
airplanes. FedEx Express states that the inspections do not require any
special inspection techniques, training, or tooling, and that it has
scheduled the proposed inspections although it has not yet inspected
any airplanes. FedEx Express also states that the inspection interval
is sufficient, but if cracks are found, significant downtime will be
required.
    From these comments, we infer that FedEx Express is requesting that
we revise the Costs of Compliance section of the NPRM. We do not agree
with the request. We recognize that, in accomplishing the requirements
of any AD, operators might incur ``incidental'' costs in addition to
the ``direct'' costs that are reflected in the cost analysis presented
in the AD preamble. However, the cost analysis in AD rulemaking actions
typically does not include incidental costs. We have, however, reviewed
the figures that we have used over the past several years to calculate
costs to operators. To account for various inflationary costs in the
airline industry, we find it necessary to increase the labor rate used
in these calculations from $80 per work hour to $85 per work hour. The
cost impact information, below, reflects this increase in the specified
hourly rate. We have also corrected the calculations used in
determining the cost to operators.

Explanation of Change to the NPRM

    Paragraph (p)(5) of the NPRM specifies contacting Airbus for a
repair solution and doing the repair. The European Aviation Safety
Agency (EASA) has assumed responsibility for the airplane models
subject to this AD. Therefore, we have revised paragraph (p)(5) of this
AD to add a provision for making repairs using a method approved by
either the Manager of the International Branch, ANM-116, Transport
Airplane Directorate, FAA or the EASA (or its delegated agent).

Explanation of Change to AD

    We have revised paragraphs (j) and (k) of this AD; and Tables 1, 2,
3, 4, and 5 of this AD to remove Airbus Model A300 B2-1A, F4-622R, and
C4-605R Variant F airplanes. We have determined that these airplanes
were inadvertently carried over from the paragraph callouts of the
previous AD into the NPRM. These airplanes are not subject to the
identified unsafe condition and therefore are not affected by this AD.

Conclusion

    We reviewed the available data, including the comment received, and
determined that air safety and the public interest require adopting the
AD with the changes described previously. We also determined that these
changes will not increase the economic burden on any operator or
increase the scope of the AD.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect about 155 products of U.S.
registry.
    The actions that are required by AD 2006-12-13 and retained in this
AD take about 76 work-hours per product, at an average labor rate of
$85 per work hour. Required parts cost about $10,270 per product. Based
on these figures, the estimated cost of the currently required actions
is $16,730 per product.
    We estimate that it will take about 3 work-hours per product to
comply with the new basic requirements of this AD. The average labor
rate is $85 per work-hour. Based on these figures, we estimate the cost
of this AD to the U.S. operators to be $39,525 or $255 per product.

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

    We determined that 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 this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
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 removing Amendment 39-14639 (71 FR
33994, June 13, 2006) and adding the following new AD:

2010-23-26 Airbus: Amendment 39-16516. Docket No. FAA-2009-1067;
Directorate Identifier 2009-NM-071-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective January
5, 2011.

Affected ADs

    (b) This AD supersedes AD 2006-12-13, Amendment 39-14639.

Applicability

    (c) This AD applies to the airplanes, certificated in any
category, identified in paragraphs (c)(1) and (c)(2) of this AD;
except airplanes on which Airbus Modification 11912 or 11932 has
been installed.
    (1) Airbus Model A300 B2-1C, B2K-3C, B2-203, B4-2C, B4-103, and
B4-203 airplanes.
    (2) Airbus Model A300 B4-601, B4-603, B4-620, B4-622, B4-605R,
B4-622R, and F4-605R airplanes.

Subject

    (d) Air Transport Association (ATA) of America Code 57: Wings.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    Following the occurrence of cracks on the MLG [main landing
gear] rib 5 RH [right-hand] and LH [left-hand] attachment fitting
lower flanges, DGAC [Direction G[eacute]n[eacute]rale de l'Aviation
Civile] France AD 2003-318(B) [parallel to part of FAA AD 2006-12-
13] was issued to require repetitive inspections and, as terminating
action, the embodiment of Airbus Service Bulletins (SB) A300-57-0235
and A300-57-6088 * * *.
    Subsequently, new cases of cracks were discovered during
scheduled maintenance checks by operators of A300B4 and A300-600
type aeroplanes on which the terminating action SB's were embodied.
This condition, if not corrected, could affect the structural
integrity of those aeroplanes.
    To address and correct this condition, Airbus developed an
inspection programme for aeroplanes modified in accordance with SB
A300-57-0235 or A300-57-6088. This inspection programme was required
to be implemented by DGAC France AD F-2005-113, original issue and
later revision 1 [parallel to part of FAA AD 2006-12-13].
    A new EASA [European Aviation Safety Agency] AD 2008-0111,
superseding DGAC France AD F-2005-113R1, was issued to reduce the
applicability. For aeroplanes already compliant with DGAC France AD
F-2005-113R1, no further action was required.
    Since EASA AD 2008-0111 issuance, Airbus reviewed the inspection
programmes of SB A300-57A0246 and SB A300-57A6101 to introduce
repetitive inspections including a new inspection technique for
holes 47 and 54 and to reduce inspections threshold and intervals
from 700 Flight Cycles (FC) to 400 FC until a revised terminating
action is made available.
    For the reasons stated above, AD 2009-0081 superseded EASA AD
2008-0111 and required operators to comply with the new inspection
programme introduced in Revisions 3 of Airbus SB A300-57A0246 and
Airbus SB A300-57A6101.
    This AD is revised to introduce an optional terminating action
which consists of spot-facing the sensitive holes of the MLG Rib 5
(LH and RH) bottom flanges.
Required actions include contacting Airbus for repair instructions,
if necessary, and doing the repair.

Restatement of Requirements of AD 2000-05-07

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

Repetitive Inspections

    (g) Perform a detailed inspection and a high-frequency eddy
current (HFEC) inspection to detect cracks in Gear Rib 5 of the main
landing gear (MLG) attachment fittings at the lower flange, in
accordance with the Accomplishment Instructions of any applicable
service bulletin listed in Table 1 and Table 2 of this AD, at the
time specified in paragraph (g)(1) or (g)(2) of this AD. After April
12, 2000 (the effective date of AD 2000-05-07, Amendment 39-11616),
only the service bulletins listed in Table 2 of this AD may be used.
Repeat the inspections thereafter at intervals not to exceed 1,500
flight cycles, until the actions specified in paragraph (i), (j), or
(l) of this AD are accomplished.

                                    Table 1--Revision 01 of Service Bulletins
----------------------------------------------------------------------------------------------------------------
                                        Airbus Service      Revision
               Model--                    Bulletin--         level--                     Dated--
----------------------------------------------------------------------------------------------------------------
A300 B4-601, B4-603, B4-620, B4-622,       A300-57-6087              01  March 11, 1998.
 B4-605R, B4-622R and F4-605R
 airplanes.
A300 B2-1C, B2K-3C, B2-203, B4-2C, B4-     A300-57-0234              01  March 11, 1998.
 103, and B4-203 airplanes.
----------------------------------------------------------------------------------------------------------------

                                  Table 2--Other Revisions of Service Bulletins
----------------------------------------------------------------------------------------------------------------
                                     Airbus Service
              Model--                  Bulletin--        Revision level--                  Dated--
----------------------------------------------------------------------------------------------------------------
A300 B4-601, B4-603, B4-620, B4-        A300-57A6087  02, including          June 24, 1999.
 622, B4-605R, B4-622R, and F4-                        Appendix 01.
 605R airplanes.
                                    ................  03, including          May 19, 2000.
                                                       Appendix 01.
                                    ................  04, including          February 19, 2002.
                                                       Appendix 01.
                                    ................  05, including          March 10, 2008.
                                                       Appendix 01.
A300 B2-1C, B2K-3C, B2-203, B4-2C,      A300-57A0234  02...................  June 24, 1999.
 B4-103, and B4-203 airplanes.
                                    ................  03, including          September 2, 1999.
                                                       Appendix 01.
                                    ................  04, including          May 19, 2000.
                                                       Appendix 01.
                                    ................  05, including          February 19, 2002.
                                                       Appendix 01.
----------------------------------------------------------------------------------------------------------------

     (1) For airplanes that have accumulated 20,000 or more total
flight cycles as of March 9, 1998 (the effective date of AD 98-03-
06, Amendment 39-10298): Inspect within 500 flight cycles after
March 9, 1998.
    (2) For airplanes that have accumulated less than 20,000 total
flight cycles as of March 9, 1998: Inspect prior to the accumulation
of 18,000 total flight cycles, or within 1,500 flight cycles after
March 9, 1998, whichever occurs later.

    Note 1: For the purposes of this AD, a detailed inspection is
defined as: ``An intensive visual examination of a specific
structural area, system, installation, or assembly to detect damage,
failure, or irregularity. Available lighting is normally
supplemented with a direct source of good lighting at intensity
deemed appropriate by the inspector. Inspection aids such as mirror,
magnifying lenses, etc., may be used. Surface cleaning and elaborate
access procedures may be required.''

    Note 2: Accomplishment of the initial detailed and HFEC
inspections prior to April 12, 2000, in accordance with Airbus
Service Bulletin A300-57A0234 or A300-57A6087, both dated August 5,
1997, as applicable, is considered acceptable for compliance with
the initial inspections required by paragraph (g) of this AD.

Repair for Any Crack Found During Inspections Required by Paragraph (g)
of This AD

    (h) If any crack is detected during any inspection required by
paragraph (g) of this AD, prior to further flight, accomplish the
requirements of paragraph (h)(1) or (h)(2) of this AD, as
applicable.
    (1) If a crack is detected at one hole only, and the crack does
not extend out of the spotface of the hole, repair in accordance
with the Accomplishment Instructions of the applicable service
bulletin in Table 2 of this AD.
    (2) If a crack is detected at more than one hole, or if any
crack at any hole extends out of the spotface of the hole, repair in
accordance with a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA, or the
European Aviation Safety Agency (EASA) (or its delegated agent).

Terminating Modification for Repetitive Inspections Required by
Paragraphs (g) and (j) of This AD

    (i) Except as required by paragraph (l) of this AD, prior to the
accumulation of 21,000 total flight cycles, or within 2 years after
October 20, 1999 (the effective date of AD 99-19-26, amendment 39-
11313), whichever occurs later: Modify Gear Rib 5 of the MLG
attachment fittings at the lower flange in accordance with the
Accomplishment Instructions of the applicable service bulletin in
Table 3 of this AD. After July 18, 2006 (the effective date of AD
2006-12-13), only Revision 04 of Airbus Service Bulletin A300-57-
6088, and Revisions 04 and 05 of Airbus Service Bulletin A300-57-
0235 may be used. Accomplishment of this modification constitutes
terminating action for the repetitive inspection requirements of
paragraphs (g) and (j) of this AD.

                             Table 3--Service Bulletins for Terminating Modification
----------------------------------------------------------------------------------------------------------------
                                     Airbus Service
              Model--                  Bulletin--        Revision level--                  Dated--
----------------------------------------------------------------------------------------------------------------
A300 B4-601, B4-603, B4-620, B4-        A300-57-6088  01, including          February 1, 1999.
 622, B4-605R, B4-622R, and F4-                        Appendix 01.
 605R airplanes.
                                    ................  02...................  September 5, 2002.
                                    ................  04...................  December 3, 2003.
A300 B2-1C, B2K-3C, B2-203, B4-2C,      A300-57-0235  01, including          February 1, 1999.
 B4-103, and B4-203 airplanes.                         Appendix 01.
                                    ................  03...................  September 5, 2002.
                                    ................  04...................  March 13, 2003.
                                    ................  05...................  December 3, 2003.
----------------------------------------------------------------------------------------------------------------

    Note 3: Accomplishment of the modification required by paragraph
(i) of this AD prior to April 12, 2000, in accordance with Airbus
Service Bulletin A300-57-6088 or A300-57-0235, both dated August 5,
1998; as applicable; is acceptable for compliance with the
requirements of that paragraph.

Restatement of Requirements of AD 2006-12-13

Additional Repetitive Inspections

    (j) For airplanes on which the modification specified in
paragraph (i) or (l) of this AD has not been done before July 18,
2006 (the effective date of AD 2006-12-13, Amendment 39-14639),
perform a detailed and an HFEC inspection to detect cracks of the
lower flange of Gear Rib 5 of the MLG at holes 43, 47, 48, 49, 50,
52, and 54, in accordance with the applicable service bulletin
listed in Table 4 of this AD. Perform the inspections at the
applicable time specified in paragraph (j)(1), (j)(2), (j)(3), or
(j)(4) of this AD. Repeat the inspections thereafter at intervals
not to exceed 700 flight cycles until the terminating modification
required by paragraph (l) of this AD is accomplished. Accomplishment
of the inspections per paragraph (j) of this AD terminates the
inspection requirements of paragraph (g) of this AD.

                              Table 4--Service Bulletins for Repetitive Inspections
----------------------------------------------------------------------------------------------------------------
                                     Airbus Service
              Model--                  Bulletin--        Revision level--                  Dated--
----------------------------------------------------------------------------------------------------------------
A300 B4-601, B4-603, B4-620, B4-        A300-57A6087  04, including          February 19, 2002.
 622, B4-605R, B4-622R, and F4-                        Appendix 01.
 605R airplanes.
                                    ................  05, including          March 10, 2008.
                                                       Appendix 01.
A300 B2-1C, B2K-3C, B2-203, B4-2C,      A300-57A0234  05, including          February 19, 2002.
 B4-103, and B4-203 airplanes.                         Appendix 01.
----------------------------------------------------------------------------------------------------------------

    (1) For Model A300 B2-1C, B2K-3C, B2-203, B4-2C, B4-103, and B4-
203 airplanes; and Model A300 B4-601, B4-603, B4-620, B4-622, B4-
605R, B4-622R, and F4-605R airplanes that have accumulated 18,000 or
more total flight cycles as of July 18, 2006: Within 700 flight
cycles after July 18, 2006.
    (2) For Model A300 B2-1C, B2K-3C, and B2-203 airplanes that have
accumulated less than 18,000 total flight cycles as of July 18,
2006: Prior to the accumulation of 18,000 total flight cycles, or
within 700 flight cycles after July 18, 2006, whichever occurs
later.
    (3) For Model A300 B4-2C, B4-103, and B4-203 airplanes that have
accumulated less than 18,000 total flight cycles as of July 18,
2006: Prior to the accumulation of 14,500 total flight cycles, or
within 700 flight cycles after July 18, 2006, whichever occurs
later.

    (4) For Model A300 B4-601, B4-603, B4-620, B4-622, B4-605R, B4-
622R, and F4-605R airplanes that have accumulated less than 18,000
total flight cycles as of July 18, 2006: Prior to the accumulation
of 11,600 total flight cycles, or within 700 flight cycles after
July 18, 2006, whichever occurs later.

Crack Repair

    (k) If any crack is detected during any inspection required by
paragraph (j) of this AD, prior to further flight, accomplish the
requirements of paragraphs (k)(1) and (k)(2) of this AD, as
applicable.
    (1) If a crack is detected at only one hole, and the crack does
not extend out of the spotface of the hole, repair in accordance
with Airbus Service Bulletin A300-57A0234, Revision 05, including
Appendix 01, dated February 19, 2002 (for Model A300 B2-1C, B2K-3C,
B2-203, B4-2C, B4-103, and B4-203 airplanes); or A300-57A6087,
Revision 04, including Appendix 01, dated February 19, 2002; or
A300-57A6087, Revision 05, dated March 10, 2008 (for Model A300 B4-
601, B4-603, B4-620, B4-622, B4-605R, B4-622R, and F4-605R
airplanes); as applicable.
    (2) If a crack is detected at more than one hole, or if any
crack at any hole extends out of the spotface of the hole, repair in
accordance with a method approved by the Manager, International
Branch, ANM-116, or the EASA (or its delegated agent).

Terminating Modification for Repetitive Inspections Required by
Paragraphs (g) and (j) of This AD for Certain Airplanes

    (l) For airplanes on which the terminating modification in
paragraph (i) of this AD has not been accomplished before July 18,
2006: At the earlier of the times specified in paragraphs (l)(1) and
(l)(2) of this AD, modify Gear Rib 5 of the MLG attachment fittings
at the lower flange. Except as provided by paragraph (m) of this AD,
do the modification in accordance with the applicable service
bulletin in Table 5 of this AD. This action terminates the
repetitive inspections requirements of paragraphs (g) and (j) of
this AD.
    (1) Prior to the accumulation of 21,000 total flight cycles, or
within 2 years after October 20, 1999, whichever is later.
    (2) Within 16 months after July 18, 2006.

                             Table 5--Service Bulletins for Terminating Modification
----------------------------------------------------------------------------------------------------------------
                                     Airbus Service
              Model--                  Bulletin--        Revision level--                  Dated--
----------------------------------------------------------------------------------------------------------------
A300 B4-601, B4-603, B4-620, B4-        A300-57-6088  04...................  December 3, 2003.
 622, B4-605R, B4-622R and F4-605R
 airplanes.
A300 B2-1C, B2K-3C, B2-203, B4-2C,      A300-57-0235  04...................  March 13, 2003.
 B4-103, and B4-203 airplanes.
                                    ................  05...................  December 3, 2003.
----------------------------------------------------------------------------------------------------------------

    (m) Where the applicable service bulletin specified in paragraph
(l) of this AD specifies to contact Airbus for modification
instructions; or if there is a previously installed repair at any of
the affected fastener holes; or if a crack is found when
accomplishing the modification: Prior to further flight, modify in
accordance with a method approved by the Manager, International
Branch, ANM-116, or the EASA (or its delegated agent).

Actions Accomplished per Previous Issues of Service Bulletins

    (n) Actions accomplished before July 18, 2006, in accordance
with the service bulletins listed in Table 6 of this AD, are
considered acceptable for compliance with the corresponding action
specified in paragraphs (g) through (m) of this AD.

                                  Table 6--Previous Issues of Service Bulletins
----------------------------------------------------------------------------------------------------------------
       Airbus Service Bulletin--               Revision level--                          Dated--
----------------------------------------------------------------------------------------------------------------
A300-57-0235..........................  02, including Appendix 01.....  September 27, 1999.
                                        03............................  September 5, 2002.
A300-57-6088..........................  02............................  September 5, 2000.
                                        03............................  March 13, 2003.
----------------------------------------------------------------------------------------------------------------

No Reporting

    (o) Although the service bulletins identified in Tables 1, 2, 3,
4, 5, and 6 of this AD specify to submit certain information to the
manufacturer, this AD does not include such a requirement.

New Requirements of This AD:

Actions and Compliance

    (p) Unless already done, do the following actions.
    (1) At the applicable time specified in paragraph (p)(2) of this
AD, perform a detailed inspection for cracking at the locations
specified in paragraphs (p)(1)(i), (p)(1)(ii), and (p)(1)(iii) of
this AD, in accordance with the Accomplishment Instructions of
Airbus Mandatory Service Bulletin A300-57A0246, Revision 03, dated
March 11, 2009; or Revision 04, dated September 9, 2009; or Airbus
Mandatory Service Bulletin A300-57A6101, Revision 03, dated March
11, 2009; or Revision 04, dated September 9, 2009; as applicable.
    (i) The bottom flange and vertical web in the area between the
wing rear spar/gear rib 5 attachment and the forward reaction-rod
pick-up lug.
    (ii) On the inboard side, around the fastener holes at locations
43, 47 to 50, 52, and 54.
    (iii) On the outboard side, the lower flange, the vertical web
and around the fastener holes at locations 43, 47 to 50, 52 and 54.
    (2) Do the inspection required by paragraph (p)(1) of this AD at
the later of the times in paragraphs (p)(2)(i) and (p)(2)(ii) of
this AD.
    (i) Within 400 flight cycles after the accomplishment of the
actions required by paragraph (i) or (l) of this AD, as applicable.
    (ii) Within 400 flight cycles or 4 months after the effective
date of this AD, whichever occurs first.
    (3) If no cracking is detected during the inspection required by
paragraph (p)(1) of this AD, before further flight, perform a
fluorescent penetrant inspection (FPI) at holes location 47 and 54,
in the right-hand and left-hand MLG rib 5 attachment fitting lower
flange, in accordance with the Accomplishment Instructions of Airbus
Mandatory Service Bulletin A300-57A0246, Revision 03, dated March
11, 2009; or Revision 04, dated September 9, 2009; or Airbus
Mandatory Service Bulletin A300-57A6101, Revision 03, dated March
11, 2009; or Revision 04, dated September 9, 2009; as applicable.
    (4) Thereafter, at intervals not to exceed 400 flight cycles,
repeat the detailed and FPI inspections, in accordance with the
Accomplishment Instructions of Airbus Mandatory Service Bulletin
A300-57A0246, Revision 03, dated March 11, 2009; or Revision 04,
dated September 9, 2009; or Airbus Mandatory Service Bulletin A300-

57A6101, Revision 03, dated March 11, 2009; or Revision 04, dated
September 9, 2009; as applicable.
    (5) If any crack is detected during any of the inspections
required by paragraphs (p)(1), (p)(3), and (p)(4) of this AD, and
Airbus Mandatory Service Bulletin A300-57A0246, Revision 03, dated
March 11, 2009; or Revision 04, dated September 9, 2009; or Airbus
Mandatory Service Bulletin A300-57A6101, Revision 03, dated March
11, 2009; or Revision 04, dated September 9, 2009; recommends
contacting Airbus for appropriate action: Before further flight,
contact Airbus for a repair solution, and do the repair; or repair
the cracking using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA, or EASA or its
delegated agent.
    (q) Spot-facing the sensitive holes on the bottom flange MLG
ribs, in accordance with the Accomplishment Instructions of Airbus
Mandatory Service Bulletin A300-57-0254, dated June 4, 2010, or
Airbus Mandatory Service Bulletin A300-57-6110, dated June 7, 2010;
as applicable; terminates the repetitive inspection requirements of
paragraph (p)(4) of this AD.

FAA AD Differences

    Note 4: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (r) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to ATTN: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 227-2125; fax<PHONE_NUMBER>. Before using any approved AMOC
on any airplane to which the AMOC applies, notify your principal
maintenance inspector (PMI) or principal avionics inspector (PAI),
as appropriate, or lacking a principal inspector, your local Flight
Standards District Office. The AMOC approval letter must
specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

Related Information

    (s) Refer to MCAI EASA Airworthiness Directive 2009-0081R1,
dated July 30, 2010, and the service information specified in Table
7 of this AD, for related information.

                                      Table 7--Related Service Information
----------------------------------------------------------------------------------------------------------------
               Airbus--                           Revision--                             Dated--
----------------------------------------------------------------------------------------------------------------
Mandatory Service Bulletin A300-        03, including Appendices 1 and  March 11, 2009.
 57A0246.                                2.
                                        04, including Appendices 1 and  September 9, 2009.
                                         2.
Mandatory Service Bulletin A300-57-     0, including Appendix 1.......  June 4, 2010.
 0254.
Mandatory Service Bulletin A300-        03, including Appendixes 1 and  March 11, 2009.
 57A6101.                                2.
                                        04, including Appendices 1 and  September 9, 2009.
                                         2.
Mandatory Service Bulletin A300-57-     0, including Appendix 1.......  June 7, 2010.
 6110.
Service Bulletin A300-57A0234.........  02............................  June 24, 1999.
                                        03, including Appendix 01.....  September 2, 1999.
                                        04, including Appendix 01.....  May 19, 2000.
                                        05, including Appendix 01.....  February 19, 2002.
Service Bulletin A300-57A6087.........  02, including Appendix 01.....  June 24, 1999.
                                        03, including Appendix 01.....  May 19, 2000.
                                        04, including Appendix 01.....  February 19, 2002.
                                        05, including Appendix 01.....  March 10, 2008.
Service Bulletin A300-57-0235.........  04............................  March 13, 2003.
                                        05............................  December 3, 2003.
Service Bulletin A300-57-6088.........  04............................  December 3, 2003.
----------------------------------------------------------------------------------------------------------------

Material Incorporated by Reference

    (t) You must use the service information specified in Table 8 of
this AD to do the actions required by this AD, as applicable, unless
the AD specifies otherwise.

                                 Table 8--All Material Incorporated by Reference
----------------------------------------------------------------------------------------------------------------
               Airbus--                           Revision--                             Dated--
----------------------------------------------------------------------------------------------------------------
Mandatory Service Bulletin A300-        03, including Appendices 1 and  March 11, 2009.
 57A0246.                                2.
                                        04, including Appendices 1 and  September 9, 2009.
                                         2.
Mandatory Service Bulletin A300-57-     0, including Appendix 1.......  June 4, 2010.
 0254.
Mandatory Service Bulletin A300-        03, including Appendices 1 and  March 11, 2009.
 57A6101.                                2.
                                        04, including Appendices 1 and  September 9, 2009.
                                         2.
Mandatory Service Bulletin A300-57-     0, including Appendix 1.......  June 7, 2010.
 6110.
Service Bulletin A300-57A0234.........  02............................  June 24, 1999.
                                        03, including Appendix 01.....  September 2, 1999.
                                        04, including Appendix 01.....  May 19, 2000.
                                        05, including Appendix 01.....  February 19, 2002.
Service Bulletin A300-57A6087.........  02, including Appendix 01.....  June 24, 1999.
                                        03, including Appendix 01.....  May 19, 2000.
                                        04, including Appendix 01.....  February 19, 2002.
                                        05, including Appendix 05.....  March 10, 2008.
Service Bulletin A300-57-0235.........  04............................  March 13, 2003.
                                        05............................  December 3, 2003.
Service Bulletin A300-57-6088.........  04............................  December 3, 2003.
----------------------------------------------------------------------------------------------------------------

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information contained in
Table 9 of this AD under 5 U.S.C. 552(a) and 1 CFR part 51.

                                 Table 9--New Material Incorporated by Reference
----------------------------------------------------------------------------------------------------------------
               Airbus--                           Revision--                             Dated--
----------------------------------------------------------------------------------------------------------------
Mandatory Service Bulletin A300-        03, including Appendices 1 and  March 11, 2009.
 57A0246.                                2.
                                        04, including Appendices 1 and  September 9, 2009.
                                         2.
Mandatory Service Bulletin A300-57-     Original......................  June 4, 2010.
 0254.
Mandatory Service Bulletin A300-        05, including Appendix 1......  March 10, 2008.
 57A6087.
Mandatory Service Bulletin A300-        03, including Appendices 1 and  March 11, 2009.
 57A6101.                                2.
                                        04, including Appendices 1 and  September 9, 2009.
                                         2.
Mandatory Service Bulletin A300-57-     0, including Appendix 1.......  June 7, 2010.
 6110.
----------------------------------------------------------------------------------------------------------------

     (2) The Director of the Federal Register previously approved
the incorporation by reference of the service information specified
in Table 10 of this AD on July 18, 2006 (71 FR 33994, June 13,
2006).

                    Table 10--Material Previously Incorporated by Reference in AD 2006-12-13
----------------------------------------------------------------------------------------------------------------
               Airbus--                           Revision--                             Dated--
----------------------------------------------------------------------------------------------------------------
Service Bulletin A300-57A0234.........  04, including Appendix 01.....  May 19, 2000.
                                        05, including Appendix 01.....  February 19, 2002.
Service Bulletin A300-57A6087.........  03, including Appendix 01.....  May 19, 2000.
                                        04, including Appendix 01.....  February 19, 2002.
Service Bulletin A300-57-0235.........  04............................  March 13, 2003.
                                        05............................  December 3, 2003.
Service Bulletin A300-57-6088.........  04............................  December 3, 2003.
----------------------------------------------------------------------------------------------------------------

     (3) The Director of the Federal Register previously approved
the incorporation by reference of the service information specified
in Table 11 of this AD on April 12, 2000 (65 FR 12077, March 8,
2000).

                    Table 11--Material Previously Incorporated by Reference in AD 2000-05-07
----------------------------------------------------------------------------------------------------------------
               Airbus--                           Revision--                             Dated--
----------------------------------------------------------------------------------------------------------------
Service Bulletin A300-57A0234.........  02............................  June 24, 1999.
                                        03, including Appendix 01.....  September 2, 1999.
Service Bulletin A300-57A6087.........  02, including Appendix 01.....  June 24, 1999.
----------------------------------------------------------------------------------------------------------------

     (4) For service information identified in this AD, contact
Airbus SAS--EAW (Airworthiness Office), 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; e-mail<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (5) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (6) You may also review copies of the 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/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on November 3, 2010.
Dionne Palermo,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-28589 Filed 11-30-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)]
[Notices]
[Pages 5095-5096]
[FR Doc No: 2018-02230]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 10532-006]

Water Facilities Authority a Joint Power Agency; Notice of
Application for Surrender of Exemption, Soliciting Comments, Motions To
Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Proceeding: Application for surrender of conduit
exemption.
    b. Project No.: 10532-006.
    c. Date Filed: January 18, 2018.
    d. Licensee: Water Facilities Authority a Joint Power Agency (WFA-
JPA).
    e. Name of Project: WFA-JPA Regional Water Supply Energy Recovery
Facilities Project.
    f. Location: The project is located on a water transmission
pipeline near the City of Ontario, San Bernardino, California.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Licensee Contact: Ms. Chelsea Murphy, Natural Resources Project
Manager, SWCA Environmental Consultants, 150 South Arroyo Parkway,
Second Floor, Pasadena, California, Telephone:<PHONE_NUMBER> ext.
6609, [email protected].
    i. FERC Contact: Ms. Rebecca Martin,<PHONE_NUMBER>,
[email protected].
    j. Deadline for filing comments, interventions, and protests is
February 28, 2018. The Commission strongly encourages electronic
filing. Please file motions to intervene, protests and comments using
the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. The first page of any filing should include
docket number P-10532-006.
    k. Description of Request: The project consists of the existing
water supply transmission system and one powerhouse containing one
turbine generating unit with a total rated capacity of 225 kilowatts
(kW). The project has not operated since October 7, 2005. The demand
for water at the project has been around 0.5 million gallons per day
(MGD). The minimum required flow required to operate the hydrogenerator
is 6.1 MGD. As a result, the exemptee, has determined it would like to
surrender the exemption. Electricity to the hydrogenerator has been
permanently disconnected. No ground disturbance is associated with the
proposed surrender and project features will remain in place.
    l. This filing may be viewed on the Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
10532-006) excluding the last three digits in the docket number field
to access the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of
new filings and issuances related to this or other pending projects.
For assistance, call 1-866-208-3676 or email
[email protected], for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction in the Commission's
Public Reference Room located at 888 First Street NE, Room 2A,
Washington, DC 20426, or by calling<PHONE_NUMBER>.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.212 and .214. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). All comments, motions to intervene, or protests should relate
to the surrender application that is the subject of this notice.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application. If an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they

must also serve a copy of the document on that resource agency. A copy
of all other filings in reference to this application must be
accompanied by proof of service on all persons listed in the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b) and 385.2010.

    Dated: January 29, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-02230 Filed 2-2-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 193 (Wednesday, October 5, 2016)]
[Notices]
[Pages 69064-69066]
[FR Doc No: 2016-24050]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Bioequivalence Recommendations; Draft and
Revised Draft Guidances for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of additional draft and revised draft product-specific
bioequivalence (BE) recommendations. The recommendations provide
product-specific guidance on the design of BE studies to support
abbreviated new drug applications (ANDAs). In the Federal Register of
June 11, 2010, FDA announced the availability of a guidance for
industry entitled ``Bioequivalence Recommendations for Specific
Products'' that explained the process that would be used to make
product-specific BE recommendations available to the public on FDA's
Web site. The BE recommendations identified in this notice were
developed using the process described in that guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 5, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2007-D-0369 for ``Product-Specific Bioequivalence Recommendations;
Draft and Revised Draft Guidances for Industry.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-
796-5850.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific BE
recommendations available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process as a means
to develop and disseminate product-specific BE recommendations and
provide a meaningful opportunity for the public to consider and comment
on those recommendations. Under that process, draft recommendations are
posted on FDA's Web site and announced periodically in the Federal
Register. The public is encouraged to submit comments on those
recommendations within 60 days of their announcement in the Federal
Register. FDA considers any comments received and either publishes
final recommendations or publishes revised draft recommendations for
comment. Recommendations were last announced in the Federal Register on
June 17, 2016 (81 FR 39672). This notice announces draft product-
specific BE recommendations, either new or revised, that are posted on
FDA's Web site.

II. Drug Products for Which New Draft Product-Specific BE
Recommendations Are Available

    FDA is announcing the availability of a new draft guidance for
industry on product-specific BE recommendations for drug products
containing the following active ingredients:

Table 1--New Draft Product-Specific BE Recommendations for Drug Products
------------------------------------------------------------------------

-------------------------------------------------------------------------
Acetaminophen; Oxycodone hydrochloride
Alectinib hydrochloride
Betamethasone dipropionate
Betamethasone valerate
Captopril
Carbidopa; levodopa
Cholic acid
Clobetasol propionate (multiple reference listed drugs)
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir alafenamide fumarate
Crotamiton (multiple reference listed drugs)
Desonide
Dexlansoprazole
Elbasvir; grazoprevir
Eltrombopag Olamine
Esomeprazole magnesium
Fluticasone propionate
Halobetasol propionate
Hydrocodone bitartrate (multiple reference listed drugs)
Hydrocortisone valerate
Ibuprofen
Iron dextran
Methylphenidate hydrochloride
Morphine sulfate
Olopatadine hydrochloride
Oxymorphone hydrochloride
Prochlorperazine

Pyrazinamide
Rolapitant hydrochloride
Triamcinolone acetonide (multiple reference listed drugs)
Umeclidinium bromide
------------------------------------------------------------------------

III. Drug Products for Which Revised Draft Product-Specific BE
Recommendations Are Available

    FDA is announcing the availability of a revised draft guidance for
industry on product-specific BE recommendations for drug products
containing the following active ingredients:

   Table 2--Revised Draft Product-Specific BE Recommendations for Drug
                                Products
------------------------------------------------------------------------

-------------------------------------------------------------------------
Bacitracin
Buprenorphine
Clonidine
Cyclosporine
Dexlansoprazole
Diclofenac Epolamine
Erythromycin
Estradiol (multiple reference listed drugs)
Ethinyl Estradiol; Norelgestromin
Fentanyl
Granisetron
Icosapent ethyl
Lansoprazole
Lidocaine
Menthol; Methyl Salicylate
Mesalamine
Methylphenidate
Morphine sulfate
Nicotine
Nitroglycerin (multiple reference listed drugs)
Omega-3-acid ethyl esters
Oxybutynin
Oxycodone HCl
Pantoprazole sodium
Rivastigmine
Rotigotine
Scopolamine
Selegiline
Testosterone
------------------------------------------------------------------------

    For a complete history of previously published Federal Register
notices related to product-specific BE recommendations, go to http://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on the
product-specific design of BE studies to support ANDAs. They do not
establish any rights for any person and are not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: September 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-24050 Filed 10-4-16; 8:45 am]
 BILLING CODE 4164-01-P