[Federal Register: April 2, 2009 (Volume 74, Number 62)]
[Notices]
[Page 14977-14978]
[DOCID:fr02ap09-45]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

March 26, 2009.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER08-1178-003; EL08-88-004.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corporation
submits Attachment A- Exceptional Dispatch Amendment Compliance Filing.
    Filed Date: 03/23/2009.
    Accession Number: 20090324-0295.
    Comment Date: 5 p.m. Eastern Time on Monday, April 13, 2009.

    Docket Numbers: ER09-380-001.
    Applicants: PacifiCorp
    Description: PacifiCorp submits its Transmission Interconnection
Agreement.
    Filed Date: 03/05/2009.
    Accession Number: 20090305-0175.
    Comment Date: 5 p.m. Eastern Time on Monday, April 06, 2009.

    Docket Numbers: ER09-583-001.
    Applicants: ITC Midwest LLC.
    Description: ITC Midwest LLC submits the cover sheet to the
Agreement redesignated as required under the Midwest ISO's Fourth
Revised Volume.
    Filed Date: 03/25/2009.
    Accession Number: 20090326-0027.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 15, 2009.

    Docket Numbers: ER09-850-000.
    Applicants: Public Service Company of Colorado.
    Description: Public Service Company of Colorado submits Amended and
Restated Power Supply Agreement with Holy Cross Electric Association,
Inc dated 2/18/09.
    Filed Date: 03/16/2009.
    Accession Number 20090317-0259.
    Comment Date: 5 p.m. Eastern Time on Monday, April 06, 2009.

    Docket Numbers: ER09-851-000.
    Applicants: PJM Interconnection L.L.C.
    Description: PJM Interconnection, LLC submits a notice of
cancellation of a wholesale market participation agreement with Granger
Energy of Honeybrook, LLC.
    Filed Date: 03/16/2009.
    Accession Number: 20090317-0260.
    Comment Date: 5 p.m. Eastern Time on Monday, April 06, 2009.

    Docket Numbers: ER09-852-000.
    Applicants: PJM Interconnection L.L.C.
    Description: PJM Interconnection, LLC submits notice of
cancellation of an interim interconnection service agreement with
Connectiv Bethlehem, LLC, etc.
    Filed Date: 03/16/2009.
    Accession Number: 20090317-0261.
    Comment Date: 5 p.m. Eastern Time on Monday, April 06, 2009.

    Docket Numbers: ER09-884-000.
    Applicants: TransAlta Energy Marketing Corporation.
    Description: Petition of Transalta Energy Marketing Corporation for
authority to sell energy, capacity, and ancillary services at market-
based rates, acceptance of initial rate schedule, waivers, and blanket
authority.
    Filed Date: 03/25/2009.
    Accession Number: 20090326-0076.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 15, 2009.

    Take notice that the Commission received the following open access
transmission tariff filings:

    Docket Numbers: OA09-23-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Request for Waiver of Southwest Power Pool, Inc.
    Filed Date: 03/26/2009.
    Accession Number: 20090326-5041.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 16, 2009.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-7348 Filed 4-1-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: April 16, 2007 (Volume 72, Number 72)]
[Notices]
[Page 18988-18989]
[DOCID:fr16ap07-77]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0632; FRL-8299-4]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Application for Experimental Use
Permit to Ship and Use a Pesticide for Experimental Purposes Only, EPA
ICR Number 0276.13, OMB Control Number 2070-0040

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. The ICR, which is abstracted below,
describes the nature of the information collection activity and its
expected burden and costs.

DATES: Additional comments may be submitted on or before May 16, 2007.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OPP-
2006-0632, to (1) EPA online using http://www.regulations.gov (our preferred method), by e-mail to<EMAIL_ADDRESS>or by mail to: OPP Regulatory

Public Docket (7502P), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, and (2) OMB by mail to: 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: Cameo Smoot, Field and External
Affairs Division, Office of Pesticide Programs, 7506P, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; 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 October 25, 2006, (71 FR 62436), EPA sought comments on
this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments on this
ICR during the 60-day comment period. 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
No. EPA-HQ-OPP-2006-0632, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the OPP Regulatory Public

Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. This 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>.
    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, 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: Application for Experimental Use Permit to Ship and Use a
Pesticide for Experimental Purposes Only.
    ICR Status: This is a request to renew an existing approved
collection. This ICR is scheduled to expire on May 31, 2007. Under OMB
regulations, the Agency may continue to conduct or sponsor the
collection of information while this submission is pending at OMB. This
ICR describes the nature of the information collection and its
estimated burden and cost.
    Abstract: This information collection provides the EPA with the
data necessary to determine whether to issue an experimental use permit
(EUP) under section 5 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), as amended. FIFRA requires that before a
pesticide product may be distributed or sold in the U.S. it must be
registered by EPA. However, section 5 authorizes EPA to issue
experimental use permits which allow pesticide companies to temporarily
ship pesticide products for experimental use for the purpose of
gathering data necessary to support the application for registration

of a pesticide product. In general, EUP's are issued either for a
pesticide not registered with the Agency or for a registered pesticide
for a use not registered with the Agency. The permit applications are
voluntarily submitted to the Agency, however applicants must submit the
applicable information to be granted a permit.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average about
10 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: Pesticide Registrants and other
agricultural chemical manufacturing.
    Estimated Number of Respondents: 75.
    Frequency of Response: On occasion.
    Estimated Total Annual Hour Burden: 757.
    Estimated Total Annual Labor Cost: $48,237.
    Changes in the Estimates: There is no change of hours in the total
estimated burden currently identified in the OMB Inventory of Approved
ICR Burdens.

    Dated: April 6, 2007.
Robert Gunter,
Acting Director, Collection Strategies Division.
[FR Doc. E7-7143 Filed 4-13-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 143 (Wednesday, July 25, 2018)]
[Proposed Rules]
[Pages 35154-35157]
[FR Doc No: 2018-15859]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2018-N-2689]

Facilitating Competition and Innovation in the Biological
Products Marketplace; Public Hearing; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing a public hearing on FDA's approach to enhancing competition
and innovation in the biological products marketplace, including by
facilitating greater availability of biosimilar and interchangeable
products.

DATES: The public hearing will be held on Tuesday, September 4, 2018,
from 9 a.m. to 5 p.m. The public hearing may be extended or may end
early, depending on the level of public participation. Persons seeking
to attend or to present at the public hearing must register by Tuesday,
August 14, 2018. Section III provides attendance and registration
information. Electronic or written comments will be accepted after the
public hearing until Friday, September 21, 2018.

ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for public hearing
participants (non-FDA employees) is through Building 1, where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before Friday, September 21, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of Friday, September 21, 2018.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2018-N-2689 for ``Facilitating Competition and Innovation in the
Biological Products Marketplace; Public Hearing; Request for
Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://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 https://www.regulations.gov. Submit both copies to the
Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Allison Hoffman, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 1314, Silver
Spring, MD 20993,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The Biologics Price Competition and Innovation Act of 2009 (BPCI
Act) amended the Public Health Service Act (PHS Act) and other statutes
to create an abbreviated licensure pathway for biological products
shown to be biosimilar to, or interchangeable with, an FDA-licensed
biological reference product. The BPCI Act was intended to balance
innovation and consumer interests. The abbreviated licensure pathway,
in section 351(k) of the PHS Act, allows an applicant (a ``351(k)
applicant'') to rely, in part, on FDA's previous determination of
safety and effectiveness for the reference product for approval. The
BPCI Act provides, among other things, exclusivity periods for certain
biological products licensed in ``stand alone'' applications under
section 351(a) of the PHS Act.
    As the marketplace of biological products continues to expand and
evolve, FDA expects that increased availability of biosimilars and
interchangeable products will result in more competition and create
savings for patients and the healthcare system. At the same time, we
recognize that there are challenges to the rapid growth of this
marketplace. For instance, although FDA has approved 11 marketing
applications for biosimilars as of July 1, 2018, FDA is aware that the
majority of biosimilars licensed by FDA have not yet been marketed and
are not available to patients.
    Although such delays in the market entry of an approved biosimilar
are outside FDA's control, we remain focused on FDA's critical role in
increasing the availability of biosimilars and interchangeable
products. Recognizing that this is a crucial time in the emergence of
the marketplace of biosimilar and interchangeable products, FDA
recently developed a Biosimilars Action Plan. This Plan focuses on four
key areas: (1) Improving the efficiency of the biosimilar and
interchangeable product development and approval process; (2)
maximizing scientific and regulatory clarity for the biosimilar product
development community; (3) developing effective communications to
improve understanding of biosimilars among patients, clinicians, and
payors; and (4) supporting market competition by reducing gaming of FDA
requirements or other attempts to unfairly delay competition.
    FDA's Biosimilars Action Plan builds on the Agency's substantial
progress, to date, implementing the approval pathway for biosimilar and
interchangeable products. For example, FDA has issued guidance for
industry on numerous scientific and regulatory issues related to the
development of proposed biosimilar and interchangeable products. FDA
also created the Biosimilar Product Development (BPD) Program to
facilitate the rapid development of biosimilar and interchangeable
products. Through enrollment in this program, FDA provides detailed,
product-specific advice to manufacturers. As of July 1, 2018, 68
programs were enrolled in the BPD Program and FDA had received meeting
requests to discuss the development of biosimilars for 31 different
reference products.
    FDA has also prioritized its efforts to provide useful information
about licensed biological products to the public. FDA publishes the
Purple Book: Lists of Licensed Biological Products with Reference
Product Exclusivity and Biosimilarity or Interchangeability Evaluations
\1\ to provide information on licensed biological products, including
information on exclusivity for reference products and on whether a
product has been demonstrated to be biosimilar to, or interchangeable
with, a reference product. Another FDA priority is the development of
educational materials for patients, healthcare providers, and other
stakeholders to increase knowledge about biological products, including
biosimilar and interchangeable products. For example, FDA launched an
educational campaign in October 2017 to promote understanding by
healthcare providers of biosimilar and interchangeable products and how
these products can help patients (see, https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580435.htm).
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    \1\https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm411418.htm.
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    As FDA continues working to implement the BPCI Act, FDA welcomes
input from the public on how the Agency can enhance its efforts to
increase access by patients to state-of-the-art, lifesaving treatment
options by encouraging innovation and competition in the biological
products marketplace. FDA will hold a public hearing on September 4,
2018, from 9 a.m. to 5 p.m., to provide an opportunity for all
interested stakeholders to submit comments.
    The format of the hearing involves presentations from the public.
The Agency will not be inviting specific presenters; rather, with this
document, FDA is soliciting presentations from interested stakeholders.
FDA also invites interested persons to submit written comments to the
docket on the topics described in section II.

II. Purpose and Scope of the Public Hearing

    FDA is soliciting input from the public on how to facilitate
greater availability of biosimilar and interchangeable products while
retaining the balance between competition and innovation that Congress
intended to achieve under the BPCI Act. FDA is holding a public hearing
to receive information and comments from a broad group of stakeholders,
including patients,

researchers, healthcare providers, manufacturers, interested industry,
professional organizations, and the public. The Agency has determined
that a public hearing is the most appropriate way to ensure public
engagement.
    FDA welcomes any relevant information that stakeholders wish to
share. FDA is particularly interested in stakeholder input on how the
Agency can achieve the following goals:
     Facilitate the efficient development of biosimilar and
interchangeable products using state-of-the-art science;
     Develop information resources, as well as scientific or
regulatory tools, to streamline the development of biosimilar and
interchangeable products;
     Enhance the efficiency of FDA review of marketing
applications for biosimilar and interchangeable products;
     Provide additional scientific or regulatory clarity
regarding FDA's regulation of biological products, including FDA's
review and approval of marketing applications for biological products;
     Increase healthcare provider, patient, and payor
understanding of biological products, including biosimilar and
interchangeable products; and
     Support market competition by addressing attempts to game
FDA requirements or otherwise delay market entry of competing
biological products.
    FDA is also interested in stakeholder input on the following
questions about additional steps FDA can take, within its statutory
authority, related to the Agency's regulation of biological products:
    1. FDA is aware that many of the biosimilar products that have been
licensed by FDA are not yet marketed and available to patients. What
can FDA do to help biosimilars and interchangeable products reach
patients more quickly after these products are licensed?
    2. FDA uses the Purple Book to provide information about biological
products licensed under section 351 of the PHS Act. What additional
information or features could be incorporated into the Purple Book to
make it more useful to stakeholders, including patients, healthcare
providers, pharmacists, and manufacturers?
    3. FDA expects that the number of licensed biosimilar and
interchangeable products will continue to increase in the coming years.
In many, if not most, cases, FDA anticipates that multiple products
will be licensed as biosimilar to, or interchangeable with, a given
reference product. What additional steps can FDA take to facilitate the
evolution of the biosimilar and interchangeable product marketplace?
What can FDA do to ensure that confidence in these products among
patients, healthcare providers, pharmacists, and other stakeholders
will continue to grow?
    4. Extensive analytical characterization of the proposed biosimilar
product and the reference product serves as the foundation for a
demonstration of biosimilarity. FDA recognizes that obtaining and
testing multiple lots of the reference product adds to the costs of
developing a biosimilar product. What can FDA do to help reduce
development costs arising from analytical studies of the reference
product without compromising FDA's robust scientific standards for
licensure of products under section 351(k) of the PHS Act? FDA is
particularly interested in stakeholder comments on (1) the number of
lots of each product (the proposed biosimilar product and the reference
product) that should be used in analytical studies submitted to support
licensure of a proposed biosimilar product; and (2) how a 351(k)
applicant should account for and evaluate any observed variability in
analytical attributes among lots of the reference product or the
proposed biosimilar product.
    5. A 351(k) applicant may, with adequate scientific justification,
use a non-U.S.-licensed comparator product in certain studies submitted
to support licensure of a proposed biosimilar product. What additional
steps can FDA take to facilitate multinational development programs
that may include non-U.S.-licensed comparators, to help support
development of biosimilar products?
    6. FDA expects continued innovation in the biological product
marketplace, including innovation during the lifecycle of reference
products licensed under section 351(a) of the PHS Act. What can FDA do
to ensure that product changes during the lifecycle of reference
products (e.g., changes in product presentation) are adequately
incentivized without inappropriately deterring competition from
biosimilar and interchangeable products, with the overall goal of
balancing of innovation and competition?
    7. Patents or exclusivity may protect one or more conditions of use
(e.g., indications) of the reference product. As a result, 351(k)
applicants may seek licensure of the proposed biosimilar product for
fewer than all of the conditions of use for which the reference product
is licensed. Once a condition of use is no longer protected by patents
or exclusivity, FDA anticipates that 351(k) applicants often will seek
licensure of their product for this condition of use. What challenges
do 351(k) applicants face in this context and what should FDA do to
achieve the appropriate balance between innovation and competition when
one or more conditions of use of the reference product are protected by
exclusivity or patents?
    8. The scope of exclusivity under section 351(k)(7) of the PHS Act
may also affect biological product innovation and market entry of
biosimilars. Accordingly, FDA seeks comment on the potential
application of ``umbrella exclusivity'' under section 351(k)(7). If
umbrella exclusivity were to apply in this context, a biological
product that would not be eligible for a new period of exclusivity
under section 351(k)(7)(C) would nevertheless be protected for the
duration of the exclusivity period for a previously approved reference
product. See, for example, 54 FR 28872 at 28897 (July 10, 1989) for an
explanation of how umbrella exclusivity functions under the Hatch-
Waxman scheme, a related and potentially instructive context (available
at: https://cdn.loc.gov/service/ll/fedreg/fr054/fr054130/fr054130.pdf).
Thus, umbrella exclusivity could help shield certain biological
products that would otherwise not be eligible for their own period of
exclusivity under section 351(k)(7)(C) from biosimilar competition.
What considerations support recognition of umbrella exclusivity under
section 351(k)(7), and what considerations disfavor recognizing
umbrella exclusivity? How would umbrella exclusivity promote biological
product innovation, and what effect would it have on market entry of
biosimilars? What is the relevance and significance, if any, of the
patent scheme in considering this issue?
    9. What other challenges have the potential to disrupt the balance
between innovation and competition in the biological product
marketplace and how can FDA or other stakeholders address these
challenges?

III. Participating in the Public Hearing

    Registration and Requests for Oral Presentations: The FDA
Conference Center at the White Oak location is a Federal facility with
security procedures and limited seating. Attendance will be free and on
a first-come, first-served basis. If you wish to attend (either in
person or by webcast (see Streaming Webcast of the Public Hearing))
and/or present at the hearing, please register for the hearing and, if
appropriate, request an oral presentation or participation in

the open public hearing by sending an email to [email protected]
by Tuesday, August 14, 2018. Requests for participation in the open
public hearing are accepted until 9 a.m. on Tuesday September 4, 2018,
and will be accepted as long as time allows. The email should contain
complete contact information for each attendee (name, title, degree(s),
affiliation, address, email address, and telephone number). For those
wishing to present at the hearing, the email should also include a
presentation title. Those without email access can register by
contacting Allison Hoffman at<PHONE_NUMBER> by Tuesday, August 14, 2018
(see FOR FURTHER INFORMATION CONTACT). An agenda for the hearing and
any other background materials will be made available 5 days before the
hearing at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/UCM610692.htm.
    FDA will try to accommodate all persons who wish to make a
presentation. Individuals wishing to present should identify the number
of the specific question, or questions, they wish to address. This will
help FDA organize the presentations. Individuals and organizations with
common interests should consolidate or coordinate their presentations
and request time for a joint presentation. FDA will notify registered
presenters of their scheduled presentation times. The time allotted for
each presenter will depend on the number of individuals who wish to
speak. Presenters are encouraged to submit an electronic copy of their
presentation (PowerPoint or PDF) to [email protected] on or
before Thursday, August 16, 2018. Those who are not giving electronic
presentations are encouraged to submit a single slide (PowerPoint or
PDF) with their name, affiliation, and topic. Persons registered to
make either an oral presentation or participate as part of the open
public hearing are encouraged to arrive at the hearing room early and
check in at the onsite registration table to confirm their designated
presentation time. An agenda for the hearing and any other background
materials will be made available 5 days before the hearing at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm580561.htm.
    If you need special accommodations because of a disability, please
contact [email protected] (see FOR FURTHER INFORMATION CONTACT)
no later than Friday, August 17, 2018, at 12 noon Eastern Time.
    Streaming Webcast of the Public Hearing: For those unable to attend
in person, FDA will provide a live webcast of the hearing. To join the
hearing via the webcast, please go to https://collaboration.fda.gov/biosimilarspart15.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Dockets Management Staff (see ADDRESSES).

IV. Notification of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by FDA senior management from the Office of the
Commissioner, the Center for Drug Evaluation and Research, and the
Center for Biologics Evaluation and Research. Under Sec.  15.30(f) (21
CFR 15.30(f)), the hearing is informal and the rules of evidence do not
apply. No participant may interrupt the presentation of another
participant. Only the presiding officer and panel members can pose
questions; they can question any person during or at the conclusion of
each presentation. Public hearings under part 15 are subject to FDA's
policy and procedures for electronic media coverage of FDA's public
administrative proceedings (21 CFR part 10, subpart C). Under 21 CFR
10.205, representatives of the media may be permitted, subject to
certain limitations, to videotape, film, or otherwise record FDA's
public administrative proceedings, including presentations by
participants. The hearing will be transcribed as stipulated in Sec.
15.30(b) (see Transcripts). To the extent that the conditions for the
hearing, as described in this notification, conflict with any
provisions set out in part 15, this notification acts as a waiver of
those provisions as specified in Sec.  15.30(h).

    Dated: July 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15859 Filed 7-24-18; 8:45 am]
 BILLING CODE 4164-01-P


1 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA __________________________________________ ) ) KENTUCKIANS FOR THE COMMONWEALTH, ) ) Civ. No. 06CV00184 ( RMU) FRIENDS OF THE CHATTAHOOCHEE, ) ) and ) ) SIERRA CLUB ) ) Plaintiffs, ) ) vs. ) ) STEPHEN L. JOHNSON ) Administrator ) United States Environmental Protection Agency ) ) Defendant. ) __________________________________________)

[ PROPOSED] CONSENT DECREE WHEREAS, Plaintiffs, Kentuckians for the Commonwealth, Friends of the Chattahoochee and Sierra Club filed their Complaint ( Civil Case No. 1: 06cv00184 ( RMU)) on February 2, 2006 and their First Amended Complaint on April 14, 2006 pursuant to Section 304( a)( 2) of the Clean Air Act (" CAA" or " the Act"), 42 U. S. C. §

7604( a)( 2).

WHEREAS, Plaintiffs' First Amended Complaint alleged that Defendant Stephen L. Johnson in his official capacity as Administrator of the United States Environmental Protection Agency ( hereinafter " the Administrator"), has failed to perform nondiscretionary duties to review, and if appropriate, revise the New Source Performance 2 Standards (" NSPS") for nonmetallic mineral processing plants (" Subpart OOO") and for coal preparation plants (" Subpart Y") as required by CAA Section 111( b), 42 U. S. C. §

7411( b)( 1)( B), and to publish notice of such action in the Federal Register as required by CAA Section 307( d), 42 U. S. C. § 7607( d).

WHEREAS, pursuant to Section 111( b)( 1)( B) of the Act, 42 U. S. C. §

7411( b)( 1)( B), every eight years the Administrator is required to review and, if appropriate, revise, each NSPS standard of performance.

WHEREAS, pursuant to Section 111( a)( 1) of the Act, 42 U. S. C. § 7411( a)( 1), the term " standard of performance" means " a standard for emissions of air pollutants which reflects the degree of emission limitation achievable through the application of the best system of emission reduction which ( taking into account the cost of achieving such reduction and any nonair quality health and environmental impact and energy requirements) the Administrator determines has been adequately demonstrated."

WHEREAS, Plaintiffs and the Administrator ( collectively " the Parties") wish to effectuate a settlement of the above captioned matter, including Plaintiffs' claims for costs of litigation and reasonable attorneys' fees, without expensive and protracted litigation.

WHEREAS, the Parties consider this Decree to be an adequate and equitable resolution of the claims in the above captioned matter.

WHEREAS, the Court, by entering this Decree, finds that the Decree is fair,

reasonable, in the public interest, and consistent with the CAA, 42 U. S. C. § § 7401 et seq.

NOW THEREFORE, before the taking of testimony, without trial or determination of any issue of fact or law, and upon the consent of the Parties, it is hereby 3 ORDERED, ADJUDGED and DECREED that:

1. This Court has subject matter jurisdiction over the claims set forth in the First Amended Complaint and to order the relief contained in this Decree. Venue is proper in the United States District Court for the District of Columbia.

2. Within eighteen ( 18) months of entry of this Decree, the appropriate EPA official shall sign, and within 10 business days of signing, forward to the Federal Register for publication one or a combination of the following: ( a) a proposed or final determination under CAA section 111( b)( 1)( B), 42 U. S. C. § 7411( b)( 1)( B), that review of NSPS Subpart OOO is " not appropriate in light of readily available information on the efficacy of such standard;" ( b) a proposed determination under CAA Section 111( b)( 1)( B), 42 U. S. C. § 7411( b)( 1)( B), that based on a complete review of NSPS Subpart OOO, revision is not appropriate; or ( c) a proposed rule containing revisions to NSPS Subpart OOO based on the procedure required by CAA Section 111( b), 42 U. S. C.

§ 7411( b).

3. Within eighteen ( 18) months of entry of this Decree, the appropriate EPA official shall sign, and within 10 business days of signing, forward to the Federal Register for publication one or a combination of the following: ( a) a proposed or final determination under CAA section 111( b)( 1)( B), 42 U. S. C. § 7411( b)( 1)( B), that review of NSPS Subpart Y is " not appropriate in light of readily available information on the efficacy of such standard;" ( b) a proposed determination under CAA Section 111( b)( 1)( B), 42 U. S. C. § 7411( b)( 1)( B), that based on a complete review of NSPS Subpart Y, revision is not appropriate; or ( c) a proposed rule containing revisions to 4 NSPS Subpart Y based on the procedure required by CAA Section 111( b), 42 U. S. C. §

7411( b).

4. Within thirty ( 30) months from the date of entry of this Decree, the appropriate EPA official shall sign, and within 10 business days of signing, forward to the Federal Register for publication, one or a combination of the following: ( a) a final determination under CAA section 111( b)( 1)( B), 42 U. S. C. § 7411( b)( 1)( B), that review of NSPS Subpart OOO is " not appropriate in light of readily available information on the efficacy of such standard;" ( b) a final determination under CAA Section 111( b)( 1)( B), 42 U. S. C. § 7411( b)( 1)( B), that based on a complete review of NSPS Subpart OOO, revision is not appropriate; or ( c) a final rule containing revisions to NSPS Subpart OOO based on the procedure required by CAA Section 111( b), 42 U. S. C. § 7411( b).

5. Within thirty ( 30) months from the date of entry of this Decree, the appropriate EPA official shall sign, and within 10 business days of signing, forward to the Federal Register for publication, one or a combination of the following: ( a) a final determination under CAA section 111( b)( 1)( B), 42 U. S. C. § 7411( b)( 1)( B), that review of NSPS Subpart Y is " not appropriate in light of readily available information on the efficacy of such standard;" ( b) a final determination under CAA Section 111( b)( 1)( B), 42 U. S. C. § 7411( b)( 1)( B), that based on a complete review of NSPS Subpart Y, revision is not appropriate; or ( c) a final rule containing revisions to NSPS Subpart Y based on the procedure required by CAA Section 111( b), 42 U. S. C. § 7411( b).

6. The Parties agree and acknowledge that before this Decree is entered by the Court, the Administrator must provide notice of this Decree in the Federal Register and an opportunity for public comment pursuant to CAA section 113( g), 42 U. S. C. § 5 7413( g). After this Decree has undergone notice and comment, the Administrator and/ or the Attorney General, as appropriate, shall promptly consider any such written comments in determining whether to withdraw or withhold their consent to the Decree, in accordance with CAA section 113( g), 42 U. S. C. § 7413( g). Once the Administrator and/ or the Attorney General elect whether or not to withdraw or withhold their consent to this Decree, the Administrator shall provide written notice of that election to Plaintiffs as expeditiously as possible. If the Administrator and/ or the Attorney General do not elect to withdraw or withhold their consent, the Parties shall promptly file a motion that requests that the Court enter this Decree.

7. Any provision of this Decree may be modified by ( a) written stipulation of the Parties with notice to the Court, or ( b) by the Court following motion of any party to this Decree, pursuant to the Federal Rules of Civil Procedure, and upon consideration of any response by the non moving party.

8. Plaintiffs and the Administrator shall not challenge the terms of this Decree or this Court's jurisdiction to enter and enforce this Decree. Upon entry, no party shall challenge the terms of this Decree.

9. The deadline for filing a motion for costs of litigation ( including attorneys' fees) for activities performed prior to execution of this Decree is hereby extended until 60 days after this Decree is entered by the Court. During this 60 day period, the Parties shall seek to resolve informally any claim for costs of litigation ( including attorneys' fees), and if they cannot, will submit that issue to the Court for resolution. Nothing in this paragraph shall be construed as an admission or concession 6 by the Administrator that Plaintiffs are entitled to or eligible for recovery of any costs or attorneys' fees.

10. Except as provided herein, nothing in this Decree shall be construed to limit or modify any discretion accorded the Administrator by the CAA or by general principles of administrative law in taking the actions which are the subject of this Decree.

11. Nothing in this decree shall be construed as an admission of any issue of fact or law.

12. Nothing in this Decree shall be construed to confer upon the district court jurisdiction to review any final decision made by the Administrator pursuant to this Decree. Nothing in this Decree shall be construed to confer upon the district court jurisdiction to review any issues that are within the exclusive jurisdiction of the United States Courts of Appeals pursuant to CAA section 307 ( b)( 1), 42 U. S. C. § 7607( b)( 1).

Nothing in the terms of this Decree shall be construed to waive any remedies or defenses the Parties may have under Section 307( b)( 1) of the Clean Air Act, 42 U. S. C. §

7607( b)( 1).

13. The obligations imposed upon the Administrator under this Decree can only be undertaken using appropriated funds. No provision of this Decree shall be interpreted as or constitute a commitment or requirement that the Administrator obligate or pay funds in contravention of the Anti Deficiency Act, 31 U. S. C. § 1341, or any other applicable federal statute. 7 14. Any notices required or provided for by this Decree shall be made in writing, via facsimile or other means, and sent to the following:

For Plaintiffs:

ROBERT UKEILEY Law Office of Robert Ukeiley 433 Chestnut Street Berea, KY 40403 Fax: ( 859) 986 1299 For Defendant:

AMMIE ROSEMAN ORR TODD GLEASON United States Department of Justice Environmental Defense Section P. O. Box 23986 Washington, D. C. 20026 3986 Fax ( 202) 514 8865 SUSAN STAHLE U. S. Environmental Protection Agency Office of General Counsel ARN: MC 2344A 1200 Pennsylvania Ave., N. W. Washington, DC 20460 Fax: ( 202) 564 5603 15. In the event of a dispute between the Parties concerning the interpretation or implementation of any aspect of this Decree, the disputing party shall provide the other Parties with a written notice outlining the nature of the dispute and requesting informal negotiations. If the Parties cannot reach an agreed upon resolution within five ( 5)

business days after receipt of the notice, any party may move the Court to resolve the dispute. 8 16. The Court shall retain jurisdiction to determine and effectuate compliance with this Decree. When the Administrator's obligations under Paragraphs 2 through 5 have been completed, and the Plaintiffs' claims for costs of litigation have been resolved pursuant to the process described in Paragraph 9, the above captioned matter shall be dismissed with prejudice. The Parties shall file the appropriate notice with the Court so that the Clerk may close the file.

17. The undersigned representatives of each Party certify that they are fully authorized by the Party they represent to bind that Party to the terms of this Decree.

COUNSEL FOR PLAINTIFF:

Dated: _______________ __, 2006 Respectfully submitted,

_____________________________ Robert Ukeiley ( MD14062) Law Office of Robert Ukeiley 433 Chestnut Street Berea, KY 40403 Tel: ( 859) 986 5402 Fax: ( 859) 986 1299 E mail: rukeiley@ igc. org 9 COUNSEL FOR DEFENDANT:

Dated: ______________ __, 2006 Respectfully submitted,

Sue Ellen Wooldridge Assistant Attorney General Env. & Natural Resources Division _____________________________ AMMIE ROSEMAN ORR TODD GLEASON United States Department of Justice Environmental Defense Section P. O. Box 23986 Washington, D. C. 20026 3986 Phone ( 202) 616 7501 Fax ( 202) 514 8865 ammie. roseman orr@ usdoj. gov Of Counsel for Defendant: SUSAN STAHLE Office of General Counsel U. S. Environmental Protection Agency Office of General Counsel ARN: MC 2344A 1200 Pennsylvania Ave., N. W. Washington, DC 20460 SO ORDERED.

Dated: _________________, 2006 _____________________________ RICARDO M. URBINA United States District Judge


[Federal Register Volume 75, Number 81 (Wednesday, April 28, 2010)]
[Rules and Regulations]
[Pages 22240-22245]
[FR Doc No: 2010-9835]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0551; FRL-8818-8]

Cyprodinil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of
cyprodinil in or on canola, seed. Syngenta Crop Protection, Inc.
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective April 28, 2010. Objections and
requests for hearings must be received on or before June 28, 2010, and
must be filed in accordance with the instructions

provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY
INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0551. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Lisa Jones, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 308-9424; e-mail address<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 those
engaged in the following activities:
     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 to
provide 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. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test guidelines
referenced in this document electronically, please go to http://www.epa.gov/oppts and select ``Test Methods and Guidelines.''

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0551 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
June 28, 2010. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0551, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of September 4, 2009 (74 FR 45848) (FRL-
8434-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8E7502) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro,
NC, 27409. The petition requested that 40 CFR 180.532 be amended by
establishing tolerances for residues of the fungicide cyprodinil, in or
on canola, seed, imported at 0.03 parts per million (ppm). That notice
referenced a summary of the petition prepared by Syngenta Crop
Protection, Inc., the registrant, which is available to the public in
the docket, http://www.regulations.gov. There were no comments received
in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for cyprodinil including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with cyprodinil
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Cyprodinil has low acute toxicity via the oral, dermal, and
inhalation routes. Cyprodinil is mildly irritating to the eyes and
negligibly irritating to the skin. It is a dermal sensitizer.
    The major target organs of cyprodinil are the liver in both rats
and mice and the kidney in rats. Liver effects observed consistently in
subchronic and chronic studies in rats and mice include increased liver
weights, increases in serum clinical chemistry parameters associated
with adverse effects on liver function, hepatocyte hypertrophy, and
hepatocellular necrosis. Adverse kidney effects include tubular lesions
and inflammation following subchronic exposure of male rats. The
hematopoietic system also appeared to be a target of cyprodinil,
causing mild anemia in rats exposed subchronically. Chronic effects in
dogs were limited to decreased body-weight gain, decreased food
consumption and decreased food efficiency. There was no evidence of
increased susceptibility in the developmental rat or rabbit study
following in utero exposure or in the 2-generation reproduction study
following prenatal or postnatal exposure. No neurotoxicity studies with
cyprodinil are available. However, there was no evidence of
neuropathological effects in the available oral-toxicity studies.
    There was no evidence of carcinogenic potential in either the rat
chronic toxicity/carcinogenicity or mouse carcinogenicity studies and
no concern for mutagenicity.
    Toxicological points of departure (PODs) were selected for dietary
and drinking water exposure scenarios. A POD for acute dietary exposure
was selected for the population subgroup females 13 to 49 years old
based on a developmental toxicity study in rabbits. No acute endpoint
was identified for the remaining population subgroups. The POD for
chronic dietary exposure was selected from a chronic/carcinogenicity
feeding study in rats.
    Specific information on the studies received and the nature of the
adverse effects caused by cyprodinil as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Cyprodinil Human Health Risk
Assessment for Proposed New Use of Cyprodinil on Imported Canola
Seed'', pp. 24 through 27, in docket ID number EPA-HQ-OPP-2009-0551.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies the toxicological POD and levels of concern (LOC) to use in
evaluating the risk posed by human exposure to the pesticide. For
hazards that have a threshold below which there is no appreciable risk,
the toxicological POD is used as the basis for derivation of reference
values for risk assessment. PODs are developed based on a careful
analysis of the doses in each toxicological study to determine the dose
at which no adverse effects are observed (the NOAEL) and the lowest
dose at which adverse effects of concern are identified (the LOAEL).
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level - generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD) - and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
     A summary of the toxicological endpoints for cyprodinil used for
human risk assessment is shown in the Table of this unit.

      Table -- Summary of Toxicological Doses and Endpoints for cyprodinil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                          NOAEL = 150 milligrams/  Acute RfD = 1.5 mg/kg/   Developmental Toxicity
 (Females 13-50 years of age)........   kilograms/day (mg/kg/    day                       rabbit
                                        day) UFA = 10x          aPAD = 1.5 mg/kg/day...  LOAEL = 400 mg/kg/day
                                       UFH = 10x..............                            based on slight
                                       FQPA SF = 1x...........                            increase of litters
                                                                                showing extra ribs
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL= 2.7 mg/kg/day     Chronic RfD = 0.027 mg/  2-Year Chronic Toxicity/
All populations......................   UFA = 10x                kg/day                   Carcinogenicity - rat
                                       UFH = 10x..............  cPAD = 0.027 mg/kg/day.  LOAEL = 35.6 mg/kg/day
                                       FQPA SF = 1x...........                            based on degenerative
                                                                                liver lesions
                                                                                (spongiosis hepatic)
                                                                                in males
----------------------------------------------------------------------------------------------------------------
Cancer                                                  Not likely to be carcinogenic in humans.
all routes...........................
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyprodinil, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyprodinil tolerances in 40 CFR
180.532. EPA assessed dietary exposures from cyprodinil in food as
follows:

    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for cyprodinil. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA did not use anticipated residue and/or percent crop
treated (PCT) information in the acute dietary assessment for
cyprodinil. Tolerance level residues and 100 PCT were assumed for all
existing and proposed food commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA did not use
anticipated residue and/or PCT information in the chronic dietary
assessment for cyprodinil. Tolerance level residues and 100 PCT were
assumed for all existing and proposed food commodities.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or non-linear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized.
     Based on the data summarized in Unit III.A., EPA has concluded
that cyprodinil is not likely to be carcinogenic to humans. Therefore,
a dietary exposure assessment for the purpose of assessing cancer risk
is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for cyprodinil. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for cyprodinil in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of cyprodinil. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    EPA estimated the surface water exposure levels using the the
Pesticide Root Zone Model/Exposure Analysis Modeling System Ground
water estimates were calculated using the Tier 1 Screening
Concentration in Ground Water model. Estimated Drinking Water
Concentrations for cyprodinil and its metabolite CGA-249287 were
derived based on a maximum application rate of 0.469 pound active
ingredient / per acre (lb a.i./A (applied 3 times/season)) on grapes
assuming minimum intervals between application. The concentrations have
been adjusted with the Percent Crop Area (PCA) of 0.87 for a national
assessment.
    Estimated drinking water concentrations of cyprodinil are:
    i. 35 parts per billion (ppb) for surface water and 0.11 ppb for
ground water for acute exposures; and
    ii. 20 ppb for surface water and 0.11 ppb for ground water for
chronic non-cancer exposures.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 35 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 20 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Cyprodinil is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine
whether cyprodinil has a common mechanism of toxicity with other
substances. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to cyprodinil
and any other substances and, cyprodinil does not appear to produce a
toxic metabolite produced by other substances which have tolerances in
the U. S. For the purposes of this tolerance reassessment action,
therefore, EPA has not assumed that cyprodinil has a common mechanism
of toxicity with other substances. For information regarding EPA's
efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the policy statements released by EPA's OPP concerning common mechanism
determinations and procedures for cumulating effects from substances
found to have a common mechanism on EPA's website at http://www.epa.gov/fedrgstr/EPA_PEST/2002/January/Day_16/.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. No increase in
susceptibility was seen in developmental toxicity studies in rat and
rabbit or reproductive toxicity studies in the rat. Toxicity to
offspring was observed at dose levels the same or greater than those
causing maternal or parental toxicity. Based on the results of
developmental and reproductive toxicity studies, there is not a concern
for increased qualitative and/or quantitative susceptibility following
in utero exposure to cyprodinil.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for cyprodinil is complete except for a
Neurotoxicity Battery (870.6200 a and b) and an Immunotoxicity Study
(870.7800) which

are required under the revised 40 CFR part 158 Toxicology Data
Requirements. Based on the results of the available toxicity studies
for cyprodinil, however, there is no evidence of neurotoxicity or
immunotoxicity, and EPA does not believe that these required studies
will demonstrate that the PADs need to be lowered.
    ii. There is no indication that cyprodinil is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. There is no evidence that cyprodinil results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. EPA made conservative (protective) assumptions in estimating
dietary exposure and in the and drinking water modeling used to assess
exposure to cyprodinil in drinking water. These assessments will not
underestimate the exposure and risks posed by cyprodinil.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the appropriate PODs to ensure
that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to cyprodinil will occupy 4% of the aPAD for females 13 to 49 years
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
cyprodinil from food and water will utilize 70% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. There are no residential uses for cyprodinil.
    3. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in mice and rats at doses that were judged
to be adequate to assess the carcinogenic potential, cyprodinil is not
expected to pose a cancer risk to humans.
    4. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to cyprodinil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (namely, high performance liquid
chromatography with ultraviolet detector (HPLC/UV)) is available to
enforce the tolerance expression on plant commodities. In addition, a
high performance liquid chromatography with mass spectrometry (HPLC/MS)
method (Method No. GRM010.01A) is available for determining residues of
cyprodinil and its metabolite CGA- 304075 (free+conjugated) in
livestock commodities.
    These methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    There are no established or proposed Codex, Canadian or Mexican
MRLs for cyprodinil on canola.

V. Conclusion

    Therefore, a tolerance is established for residues of cyprodinil,
in or on canola, seed, at 0.03 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not

a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: April 15, 2010.
G. Jeffery Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.532, in paragraph (a), alphabetically add the following
commoditiy to the table to read as follows:

Sec.  180.532  Cyprodinil; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Canola, seed\1\......................................               0.03
                                * * * * *
------------------------------------------------------------------------
\1\ Import only

* * * * *

[FR Doc. 2010-9835 Filed 4-27-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Notices]
[Pages 33327-33328]
[FR Doc No: 2011-14070]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2011-0005]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request, OMB No. 1660-0062; State/Local/Tribal Hazard
Mitigation Plans

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice; 30-day notice and request for comments; extension,
without change, of a currently approved information collection; OMB No.
1660-0062; FEMA Form--None.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before July 8, 2011.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Records Management Division, 1800 South Bell Street, Arlington, VA
20598-3005, facsimile number<PHONE_NUMBER>, or e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Collection of Information

    Title: State/Local/Tribal Hazard Mitigation Plans.
    Type of information collection: Extension, without change, of a
currently approved information collection.

    OMB Number: 1660-0062.
    Form Titles and Numbers: None.
    Abstract: The purpose of State, Local and Tribal Hazard Mitigation
Plan requirements is to support the administration of FEMA Mitigation
grant programs, and contemplate a significant State, Local and Tribal
commitment to mitigation activities, comprehensive mitigation planning,
and strong program management. Implementation of plans, pre-identified
cost-effective mitigation measures will streamline the disaster
recovery process. Mitigation plans are the demonstration of the goals,
priorities to reduce risks from natural hazards.
    Affected Public: State, local or Tribal Government.
    Estimated Number of Respondents: 56.
    Frequency of Response: On occasion.
    Estimated Average Hour Burden per Respondent: New Plan Development,
2,080 hours; Mitigation Plan Updates, 320 hours; Mitigation Plans
Review by States, 8 hours.
    Estimated Total Annual Burden Hours: 768,320 hours.
    Estimated Cost: There are no operation and maintenance, or capital
and start-up costs associated with this collection of information.

    Dated: June 1, 2011.
Lesia M. Banks,
Director, Records Management Division, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2011-14070 Filed 6-7-11; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 79, Number 91 (Monday, May 12, 2014)]
[Proposed Rules]
[Pages 26906-26909]
[FR Doc No: 2014-10783]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0913; Directorate Identifier 2012-NE-23-AD]
RIN 2120-AA64

Airworthiness Directives; Honeywell International Inc. Turboprop
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Honeywell International Inc. TPE331-5, -5A, -5AB, -5B, -10, -
10R, -10U, -10UF, -10UG, -10UGR, and -10UR model turboprop engines.
This proposed AD was prompted by engine propeller shaft coupling
failures, leading to unexpected propeller pitch changes resulting in
high aerodynamic and asymmetric drag on the airplanes using these
engines. This proposed AD would require removing certain part number
(P/N) propeller shaft couplings from service. This proposed AD would
also require inserting a copy of Honeywell International Inc. Operating

Information Letter OI331-26, dated March 2, 2010, into the applicable
Airplane Flight Manuals. We are proposing this AD to prevent loss of
airplane control, leading to an accident.

DATES: We must receive comments on this proposed AD by July 11, 2014.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Honeywell International Inc., 111 S. 34th Street, Phoenix, AZ 85034-
2802; phone:<PHONE_NUMBER>; Web site: http://portal.honeywell.com. You
may view this service information at the FAA, Engine & Propeller
Directorate, 12 New England Executive Park, Burlington, MA. For
information on the availability of this material at the FAA, call 781-
238-7125.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2012-
0913; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Joseph Costa, Aerospace Engineer, Los
Angeles Aircraft Certification Office, FAA, Transport Airplane
Directorate, 3960 Paramount Blvd., Lakewood, CA 90712-4137; phone: 562-
627-5246; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2012-0913;
Directorate Identifier 2012-NE-23-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We have received numerous reports of propeller shaft couplings, P/
Ns 3107065-1 and 865888-3, failing. These propeller shaft couplings
experience fatigue cracks at the corners of the lubrication slots that
may result in separation and fragmentation of the propeller shaft
coupling. That separation causes a sudden loss of drive torque from the
engine's power section to the propeller shaft (called drivetrain
uncoupling). After a drivetrain uncoupling, the engine's fuel pump
continues to provide fuel to the power section, and with no propeller
load and no engine control changes by the pilot, the engine power
section will accelerate to the fuel control's overspeed governor set
point. Even though the propeller drive is uncoupled, the propeller
blade pitch is still controlled by the propeller governor. During this
overspeed condition, the propeller governor is designed to move the
propeller blades toward higher pitch until full feather is reached with
the propeller not rotating or rotating very slowly. Under certain
conditions the power section will remain at about 104% RPM with the
propeller blades in feather position and the propeller not rotating or
rotating very slowly, until the engine is shut down by the pilot.

Potential Unsafe Failure Scenarios

    After a propeller shaft drivetrain uncoupling, the speed of the
engine's power section may be reduced: (1) From full power, by the
pilot retarding the power lever to flight idle, which reduces fuel to
the power section; (2) at flight idle, because the fuel control reduces
the fuel supply to the power section and/or; (3) by fragmentation of
the propeller shaft coupling and secondary damage to the gears in the
gearbox. If the resulting speed of the power section falls below the
propeller governor set point (set by the pilot-controlled condition
lever), the propeller governor will move the propeller out of feather
to a low-pitch, high-drag position.
    Also, after a propeller shaft drivetrain uncoupling, a pilot
reacting to the overspeed of the power section may inadvertently retard
the power lever to flight idle. Doing so will cause the propeller
governor to move the feathered propeller to a low-pitch, high-drag
condition.
    Several reports during maintenance test flights and in-service
operations of twin-engine airplanes have shown that inadvertent
movement of the propeller blade pitch to a low blade angle create a
high aerodynamic and asymmetric drag with resultant uncommanded yaw and
roll response on the airplane. Following this unexpected yaw and roll
response, stabilization and control of the airplane may range from
unusually difficult to catastrophic, and pilots may lack sufficient
time to properly assess the engine problem, initiate an engine
emergency shutdown, and activate the feather valve.
    The drivetrain uncoupling events described previously lead to loss
of thrust, cause the propeller blade pitch to go to a low-blade angle,
and create a high aerodynamic and asymmetric drag on the airplane. The
low-blade angle may result in loss of airplane control, leading to an
accident. After a review of about 40 years of National Transportation
Safety Board fatal accident reports of multi-engine airplanes with
TPE331 engines, we determined that certain airplanes are more at risk
by engine-failure events than others. Therefore, we are proposing
compliance times in this AD that address the risk by airplane after a
propeller shaft coupling failure.

Relevant Service Information

    Allied-Signal Aerospace Company, Garrett Engine Division Service
Bulletin No. TPE331-72-0873, Revision 1, dated May 20, 1993, describes
procedures for replacing the affected P/Ns of propeller shaft couplings
with a defined redesigned propeller shaft coupling.
    Honeywell International Inc. Operating Information Letter OI331-26,
dated March 2, 2010, describes emergency procedures for aircrew if a
propeller shaft coupling fails.

FAA's Determination

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

Proposed AD Requirements

    This proposed AD would require removing propeller shaft couplings,
P/Ns 3107065-1, 865888-3, 865888-6, and 865888-8, from service.
    This proposed AD would also require inserting a copy of Honeywell
International Inc. Operating Information Letter OI331-26, dated March
2, 2010, into the applicable Airplane Flight Manual, Pilot Operating
Handbook, or Manufacturer's Operating Manual.

Costs of Compliance

    We estimate that this proposed AD would affect 485 engines
installed on airplanes of U.S. registry. We also estimate that it would
take about one hour per engine to perform the actions required by this
proposed AD, if done at next turbine hot section scheduled inspection,
and 40 hours per engine if done at an unscheduled access of the
propeller shaft coupling. We also estimate that 400 engines would have
the replacement actions done at a scheduled time of next turbine hot
section inspection, and 85 engines would have the replacement actions
done at an unscheduled access of the propeller shaft coupling. We also
estimate that the average labor rate is $85 per hour. Required parts
would cost about $12,000 per engine. Based on these figures, we
estimate the total cost of the proposed AD to U.S. operators to be
$6,143,000.

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Honeywell International Inc. (Type Certificate Previously Held by
AlliedSignal Inc., Garrett Engine Division; Garrett Turbine Engine
Company; and AiResearch Manufacturing Company of Arizona): Docket
No. FAA-2012-0913; Directorate Identifier 2012-NE-23-AD.

(a) Comments Due Date

    We must receive comments by July 11, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Honeywell International Inc. TPE331-5, -5A, -
5AB, -5B, -10, -10R, -10U, -10UF, -10UG, -10UGR, and -10UR model
turboprop engines, with a propeller shaft coupling, part number (P/
N) 3107065-1, 865888-3, 865888-6, or 865888-8, installed.

(d) Unsafe Condition

    This AD was prompted by engine propeller shaft coupling failures
leading to unexpected propeller pitch changes resulting in high
aerodynamic and asymmetric drag on the airplanes using these
engines. We are issuing this AD to prevent loss of airplane control,
leading to an accident.

(e) Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) Engines Installed In Mitsubishi MU-2B Series (MU-2 Series)
Airplanes: Remove from service the affected propeller shaft coupling
at the earliest of the following:
    (i) Next piece-part exposure; or
    (ii) Next turbine (hot) section inspection (HSI); or
    (iii) Before accumulating an additional 1,200 cycles after the
effective date of this AD.
    (2) Engines Installed In Construcciones Aeronauticas, S.A.
(CASA) C-212 Series, and Twin Commander 690 and 695 Series (Jetprop
Commander) Airplanes: Remove from service the affected propeller
shaft coupling at the earliest of the following:
    (i) Next piece-part exposure; or
    (ii) Next turbine HSI; or
    (iii) Before accumulating an additional 2,400 cycles after the
effective date of this AD.
    (3) Engines Installed In British Aerospace Jetstream 3101
Series, Dornier Luftfahrt Dornier 228 Series, and M7 (formerly
Fairchild, Swearingen) SA226 and SA227 Series Airplanes, and All
Other Airplanes Not Listed in this AD Using Affected Engines: Remove
from service the affected propeller shaft coupling at the earliest
of the following:
    (i) Next piece-part exposure; or
    (ii) Next turbine HSI; or
    (iii) Before accumulating an additional 3,600 cycles after the
effective date of this AD.
    (4) Inserting a Copy of Honeywell International Inc. Operating
Information Letter into the FAA-Approved Flight Manual:
    Within 60 days after the effective date of this AD, for
airplanes with engine propeller shaft coupling, P/N 3107065-1,
865888-3, 865888-6, or 865888-8, installed, insert a copy of
Honeywell International Inc. Operating Information Letter OI331-26,
dated March 2, 2010, into the Emergency Procedures Section of the
applicable Airplane Flight Manual, Pilot Operating Handbook, or
Manufacturer's Operating Manual.

(f) Definition

    For the purpose of this AD, next piece-part exposure is when the
nose cone assembly is removed from the engine.

(g) Installation Prohibition

    After the effective date of this AD, do not install any
propeller shaft coupling, P/N 3107065-1, 865888-3, 865888-6, or
865888-8, into any engine.

(h) Alternative Methods of Compliance (AMOCs)

    The Manager, Los Angeles Aircraft Certification Office, FAA, may
approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19
to make your request.

(i) Related Information

    (1) For more information about this AD, contact Joseph Costa,
Aerospace Engineer, Los Angeles Aircraft Certification Office, FAA,
Transport Airplane Directorate, 3960 Paramount Blvd., Lakewood, CA
90712-4137; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Allied-Signal Aerospace Company Service Bulletin No. TPE331-
72-0873, Revision 1, dated May 20, 1993, addresses acceptable
replacement parts, and other information pertaining to the subject
of this AD.
    (3) For service information identified in this AD, contact
Honeywell International Inc., 111 S. 34th Street, Phoenix, AZ 85034-
2802; phone:<PHONE_NUMBER>; Web site: http://portal.honeywell.com.
    (4) You may view this service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on May 6, 2014.
Colleen M. D'Alessandro,
Assistant Directorate Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2014-10783 Filed 5-9-14; 8:45 am]
BILLING CODE 4910-13-P