[Federal Register Volume 82, Number 103 (Wednesday, May 31, 2017)]
[Proposed Rules]
[Pages 24900-24902]
[FR Doc No: 2017-10980]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0513; Directorate Identifier 2016-NM-152-AD]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Dassault Aviation Model FALCON 2000EX airplanes. This proposed AD was
prompted by a quality review of delivered airplanes, which identified a
manufacturing deficiency of some engine air inlet anti-ice ``piccolo''
tubes. This proposed AD would require inspecting each anti-ice
``piccolo'' tube assembly of certain engine air inlets for
discrepancies, and doing corrective actions if necessary. We are
proposing this AD to address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by July 17, 2017.

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 NPRM, contact Dassault
Falcon Jet, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201-
440-6700; Internet http://www.dassaultfalcon.com. You may view this
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0513; 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
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2017-0513;
Directorate Identifier 2016-NM-152-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 based on 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

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2016-0168, dated August 17, 2016 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Dassault Aviation
Model FALCON 2000EX airplanes. The MCAI states:

    A quality review of recently delivered aeroplanes identified a
manufacturing deficiency of some engine air inlet anti-ice
``piccolo'' tubes.

    This condition, if not detected and corrected, could lead to
reduced performance of the engine anti-ice protection system, with
consequent ice accretion and ingestion, possibly resulting in dual
engine power loss and reduced control of an aeroplane.
    The subsequent investigation demonstrated that, for engines
equipped with an air inlet affected by the manufacturing deficiency,
operating an engine at or above the minimum N1 value applicable for
combined wing and engine anti-ice operations provides efficient
engine anti-ice performance during stand-alone engine anti-ice
operation.
    To address this potential unsafe condition, EASA issued EASA AD
2015-0101-E (later revised) to require amendment of the applicable
Aeroplane Flight Manual (AFM) for aeroplanes having engine air
inlets Part Number (P/N) 06ND71600-1 not marked NORDAM Rework Kit
(or ``NRK'') on the associated data plate.
    Since that [EASA] AD was issued, Dassault Aviation published
Service Bulletin (SB) F2000EX-384 (later revised), providing
instructions for a one-time inspection and applicable corrective
actions, to recover the full operational capability of the
aeroplanes equipped with affected parts.
    For the reasons described above, this [EASA] AD supersedes EASA
AD 2015-0102R1, retaining its requirements, [and] additionally
requires a one-time inspection of each affected anti-ice ``piccolo''
tube assembly and, depending on findings, accomplishment of the
applicable corrective actions. This [EASA] AD also prohibits
installation of an affected part on an aeroplane.

    The required actions include a detailed inspection and borescope
inspection for discrepancies, which include determining if the opening
diameter of the anti-ice tube assembly is incorrect or the perforation
holes are blocked by residue. The corrective actions include repair or
rework, if necessary. You may examine the MCAI in the AD docket on the
Internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2017-0513.

Other Related Rulemaking

    On June 19, 2015, we issued AD 2015-13-08, Amendment 39-18195 (80
FR 37150, June 30, 2015) (``AD 2015-13-08''), applicable to all
Dassault Aviation Model FALCON 2000EX airplanes. That AD requires
revising the airplane flight manual to include a procedure for
addressing minimum fan speed rotation (N1) values during stand-alone
engine anti-ice system operation for engines equipped with certain air
inlets. That AD was prompted by a quality review of certain delivered
airplanes, which identified a manufacturing deficiency of some engine
air inlet anti-ice ``piccolo'' tubes. The actions required by that AD
are intended to detect and correct reduced performance of the engine
anti-ice protection system, leading to ice accretion and ingestion into
the engines, which could result in dual engine power loss and
consequent reduced controllability of the airplane.

Actions Since Issuance of AD 2015-13-08

    This NPRM would not supersede AD 2015-13-08. Rather, we have
determined that a stand-alone AD would be more appropriate to address
the changes in the MCAI. This NPRM would require inspections and
corrective actions of the anti-ice ``piccolo'' tube assembly of the
engine air inlet. Accomplishment of the actions specified in paragraph
(g) of this proposed AD would then terminate all of the requirements of
AD 2015-13-08.

Related Service Information Under 1 CFR Part 51

    We reviewed Dassault Falcon 2000EX Service Bulletin F2000EX-384,
Revision 1, dated March 1, 2016. This service information describes
procedures for inspecting each anti-ice ``piccolo'' tube assembly of
each engine air inlet for discrepancies, and corrective actions. This
service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    We estimate that this proposed AD affects 181 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Inspection............................  5 work-hours x $85 per                $0            $425         $76,925
                                         hour = $425.
----------------------------------------------------------------------------------------------------------------

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

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Rework anti-ice tube assembly.................  2 work-hours x $85 per hour =             $1,711          $1,881
                                                 $170.
----------------------------------------------------------------------------------------------------------------

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; 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):

Dassault Aviation: Docket No. FAA-2017-0513; Directorate Identifier
2016-NM-152-AD.

(a) Comments Due Date

    We must receive comments by July 17, 2017.

(b) Affected ADs

    This AD affects AD 2015-13-08, Amendment 39-18195 (80 FR 37150,
June 30, 2015) (``AD 2015-13-08'').

(c) Applicability

    This AD applies to all Dassault Aviation Model FALCON 2000EX
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 30, Ice and Rain
Protection.

(e) Reason

    This AD was prompted by a quality review of certain delivered
airplanes, which identified a manufacturing deficiency of certain
engine air inlet anti-ice ``piccolo'' tubes. We are issuing this AD
to detect and correct discrepancies of each anti-ice ``piccolo''
tube assembly of certain engine air inlets; this condition could
result in reduced performance of the engine anti-ice protection
system, leading to ice accretion and ingestion into the engines, and
possibly resulting in dual engine power loss and consequent reduced
controllability of the airplane.

(f) Compliance

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

(g) Inspection

    For airplanes other than those on which an engine air inlet
having part number (P/N) 06ND71600-1, with a marking ``NTR-RKFAL97''
``NTR-RKFAL98,'' ``F2000EX-384,'' or ``F2000EX-384-R1'' on the air
inlet data plate has been incorporated on both engines: Within 1,300
flight hours or 26 months after the effective date of this AD,
whichever occurs first; inspect each anti-ice ``piccolo'' tube
assembly of each engine air inlet for discrepancies (i.e., an
incorrect opening diameter of the anti-ice tube assembly or
perforation holes blocked by residue), and do all applicable
corrective actions, in accordance with the Accomplishment
Instructions of Dassault Falcon 2000EX Service Bulletin F2000EX-384,
Revision 1, dated March 1, 2016; except as required by paragraph (h)
of this AD. Do all applicable corrective actions before further
flight.

(h) Service Information Exception

    Where Dassault Falcon 2000EX Service Bulletin F2000EX-384,
Revision 1, dated March 1, 2016, specifies to contact Dassault for
appropriate action: Before further flight, accomplish corrective
actions in accordance with the procedures specified in paragraph
(k)(2) of this AD.

(i) Terminating Action

    Accomplishment of the actions required by paragraph (g) of this
AD terminates all the requirements of AD 2015-13-08 for that
airplane.

(j) Parts Installation Limitation

    As of the effective date of this AD, installation of an engine
air inlet having part number (P/N) 06ND71600-1 on any airplane is
allowed, provided the engine air inlet data plate shows the marking
``NTR-RKFAL97,'' ``NTR-RKFAL98,'' ``F2000EX-384,'' or ``F2000EX-384-
R1.''

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to the attention of
the person identified in paragraph (l)(2) of this AD. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Dassault Aviation's EASA
Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2016-0168, dated August 17, 2016, for related
information. This MCAI may be found in the AD docket on the Internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2017-0513.
    (2) For more information about this AD, contact Tom Rodriguez,
Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
    (3) For service information identified in this AD, contact
Dassault Falcon Jet, P.O. Box 2000, South Hackensack, NJ 07606;
telephone<PHONE_NUMBER>; Internet http://www.dassaultfalcon.com. You
may view this service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on May 18, 2017.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-10980 Filed 5-30-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 210 (Monday, October 31, 2016)]
[Notices]
[Page 75393]
[FR Doc No: 2016-26229]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-157-000]

Moapa Southern Paiute Solar, LLC; Supplemental Notice That
Initial Market-Based Rate Filing Includes Request for Blanket Section
204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Moapa Southern Paiute Solar, LLC`s application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability is November 14, 2016.
    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
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic 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
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY,
call<PHONE_NUMBER>.

    Dated: October 25, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-26229 Filed 10-28-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 140 (Monday, July 24, 2017)]
[Notices]
[Pages 34318-34319]
[FR Doc No: 2017-15400]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2016-0801]

Collection of Information Under Review by Office of Management
and Budget; OMB Control Number: 1625-0086

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting approval for
reinstatement, with change, of the following collection of information:
1625-0086, Great Lakes Pilotage. Our ICR describes the information we
seek to collect from the public. Review and comments by OIRA ensure we
only impose paperwork burdens commensurate with our performance of
duties.

DATES: Comments must reach the Coast Guard and OIRA on or before August
23, 2017.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2016-0801] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. Alternatively, you
may submit comments to OIRA using one of the following means:
    (1) Email<EMAIL_ADDRESS>    (2) Mail: OIRA, 725 17th Street NW., Washington, DC 20503,
attention: Desk Officer for the Coast Guard.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S. Coast
Guard, 2703 Martin Luther King Jr. Ave. SE., Stop 7710, Washington, DC
20593-7710.

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

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection. The Coast Guard invites comments on whether
this ICR should be granted based on the Collection being necessary for
the proper performance of Departmental functions. In particular, the
Coast Guard would appreciate comments addressing: (1) the practical
utility of the Collection; (2) the accuracy of the estimated burden of
the Collection; (3) ways to enhance the quality, utility, and clarity
of information subject to the Collection; and (4) ways to minimize the
burden of the Collection on respondents, including the use of automated
collection techniques or other forms of information technology. These
comments will help OIRA determine whether to approve the ICR referred
to in this Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2016-0801], and must be received by August 23,
2017.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that Web site's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).

    OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Number: 1625-0086.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard has published the 60-day notice (81 FR 85984, November 29,
2016) required by 44 U.S.C. 3506(c)(2). That Notice elicited no
comments. Accordingly, no changes have been made to the Collections.

Information Collection Request

    Title: Great Lakes Pilotage.
    OMB Control Number: 1625-0086.
    Summary:The Office of Great Lakes Pilotage is seeking a revision of
OMB's current approval for Great Lakes Pilotage data collection
requirements for the three U.S. pilot associations it regulate. This
revision would require continued submission of data to an electronic
collection system. This system is identified as the Great Lakes
Electronic Pilot Management System which will eventually replace the
manual paper submissions currently used to collect data on bridge
hours, vessel delay, vessel detention, vessel cancellation, vessel
movement, pilot travel, revenues, pilot availability, and related data.
This revision ensures the required data is available in a timely manner
and allows immediate accessibility to data crucial from both an
operational and rate-making standpoint.
    Need: To comply with the statutory and regulatory requirements
respecting the rate-making and oversight functions imposed upon the
agency.
    Forms: CG-4509, Application for Registration as United States
Registered Pilot.
    Respondents: The three U.S. pilot associations regulated by the
Office of Great Lakes Pilotage and members of the public applying to
become Great lakes Registered Pilots.
    Frequency: Daily, Weekly, Monthly, Quarterly, Semi-annually,
Annually, On occasion; Frequency dictated by marine traffic levels and
association staffing.
    Hour Burden Estimate: The estimated burden has increased from 18
hours to 19 hours a year.

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

    Dated: July 18, 2017.
Marilyn Scott-Perez,
Chief, U.S. Coast Guard, Office of Information Management.
[FR Doc. 2017-15400 Filed 7-21-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 112 (Monday, June 11, 2012)]
[Notices]
[Pages 34389-34390]
[FR Doc No: 2012-14000]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-E-0399]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Progel Pleural Air Leak Sealant

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for Progel Pleural Air Leak Sealant and is
publishing this notice of that determination as required by law. FDA
has made the determination because of the submission of an application
to the Director of Patents and Trademarks, Department of Commerce, for
the extension of a patent which claims that medical device.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6284, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of Patents and Trademarks may award (half
the testing phase must be subtracted as well as any time that may have
occurred before the patent was issued), FDA's determination of the
length of a regulatory review period for a medical device will include
all of the testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA recently approved for marketing the medical device, Progel
Pleural Air Leak Sealant. Progel Pleural Air Leak Sealant is indicated
for application to visceral pleura during an open thoracotomy after
standard visceral pleural closure with, for example, sutures or
staples, of visible air leaks (>=2 mm) incurred during open resection
of lung parenchyma. Subsequent to this approval, the Patent and
Trademark Office received a patent term restoration application for
Progel Pleural Air Leak Sealant (U.S. Patent No. RE38158) from Neomend,
Inc., and the Patent and Trademark Office requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated June 8, 2011, FDA advised the Patent and Trademark Office
that this medical device had undergone a regulatory review period and
that the approval of Progel Pleural Air Leak Sealant represented the
first permitted commercial marketing or use of the product. Thereafter,
the Patent and Trademark Office requested that the FDA determine the
product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
Progel Pleural Air Leak Sealant is 3,854 days. Of this time, 787 days
occurred during the testing phase of the regulatory review period,
while 3067 days occurred during the approval phase. These periods of
time were derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: June 29, 1999. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) required under section 520(g) of the FD&C Act for human tests to
begin became effective June 29, 1999.
    2. The date an application was initially submitted with respect to
the device under section 515 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e): August 23, 2001. FDA has verified the applicant's
claim that the premarket approval application (PMA) for Progel Pleural
Air Leak Sealant (PMA P010047) was initially submitted August 23, 2001.
    3. The date the application was approved: January 14, 2010. FDA has
verified the applicant's claim that PMA P010047 was approved on January
14, 2010.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 5 years of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by August 10, 2012. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by December 10, 2012. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document.
    Comments and petitions that have not been made publicly available
on http://www.regulations.gov may be viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 29, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-14000 Filed 6-8-12; 8:45 am]
BILLING CODE 4160-01-P