[Federal Register Volume 81, Number 42 (Thursday, March 3, 2016)]
[Notices]
[Pages 11354-11358]
[FR Doc No: 2016-04616]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2013-0109, Notice 2]

Decision That Certain Nonconforming Model Year 2006-2007 European
Market Ferrari 599 GTB Passenger Cars Manufactured Prior to September
2007 Are Eligible for Importation

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Grant of petition.

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SUMMARY: This document announces a decision by the National Highway
Traffic Safety Administration (NHTSA) that certain model year (MY)
2006-2007 European market Ferrari 599 GTB passenger cars (PCs)
manufactured prior to September 2007 that were not originally
manufactured to comply with all applicable Federal motor vehicle safety
standards (FMVSS), are eligible for importation into the United States
because they are substantially similar to vehicles originally
manufactured for importation into and sale in the United States that
were certified by their manufacturer as complying with the safety
standards (the U.S. certified version of the MY 2007 Ferrari 599 GTB
PC), and they are capable of being readily altered to conform to the
standards.

DATES: This decision became effective on February 26, 2016.

ADDRESSES: For further information contact George Stevens, Office of
Vehicle Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a motor vehicle
originally manufactured for importation into and sale in the United
States, certified as required under 49 U.S.C. 30115, and of the same
model year as the model of the motor vehicle to be compared, and is
capable of being readily altered to conform to all applicable FMVSS.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register

of each petition that it receives, and affords interested persons an
opportunity to comment on the petition. At the close of the comment
period, NHTSA decides, on the basis of the petition and any comments
that it has received, whether the vehicle is eligible for importation.
The agency then publishes this decision in the Federal Register.
    J.K. Technologies, LLC, of Baltimore, Maryland (``JK'') (Registered
Importer# RI-90-006), petitioned NHTSA to decide whether MY 2006-2007
European market Ferrari 599 GTB PCs manufactured prior to September
2007 are eligible for importation into the United States. NHTSA
published a notice of the petition on March 24, 2014 (79 FR 16099) to
afford an opportunity for public comment. The reader is referred to
that notice for a thorough description of the petition.

Comments

    On April 23, 2014, NHTSA received comments from Ferrari North
America, Inc. (FNA), on behalf of Ferrari SpA, the vehicle's original
manufacturer. In its comments, Ferrari stated that while it agreed that
the U.S.- and the non-U.S.-certified versions of the vehicle are
``substantially similar'' within the meaning of 49 U.S.C.
30141(a)(1)(A)(i), it strongly disputed JK's assertions that the non-
U.S.-certified version could be readily altered to comply with all
applicable FMVSS. FNA elaborated by presenting detailed reasons for its
assertions with respect to specific FMVSS.
    On May 21, 2014, NHTSA forwarded FNA's comments to JK to accord it
an opportunity to respond and asked it to submit its response by June
4, 2014. By letter dated June 10, 2014, JK requested a 45-day extension
in order to gather engineering data to adequately address the concerns
raised by FNA. NHTSA approved JK's request for extension. JK provided
its initial response on August 17, 2014 and submitted supplemental
information on February 17, 2015.
    A summary of FNA's comments, JK's responses, and the conclusions
that NHTSA has reached with regard to the issues raised by the parties
is set forth below.

Analysis of Comments and Agency Conclusions

    NHTSA has reviewed the petition, FNA's comments and JK's responses
to those comments, and has concluded that only the nonconforming
European Market versions of the vehicles described in the petition are
substantially similar to the U.S.-certified version of the MY 2006 and
2007 Ferrari 599 GTB PC and are capable of being readily altered to
comply with all applicable FMVSS. NHTSA has also decided that an RI who
imports or modifies one of these vehicles must include in the statement
of conformity and associated documents (referred to as a ``conformity
package'') it submits to NHTSA under 49 CFR 592.6(d) specific proof, as
described below, to show that the vehicle was manufactured to conform
to, or was successfully altered to conform to, each of the following
standards:
    FMVSS No. 101 Controls and Displays: FNA commented that the
Electronic Control Unit (``ECU'') for the instrument cluster would have
to be ``reflashed'' with a ``Proxy'' file from the Ferrari factory to
ensure that all of the other ECUs on the Control Area Network (``CAN'')
are aware of the new ECU and are communicating properly. FNA
additionally commented that the necessary reprogramming to achieve
conformity to the standard can only be completed with proprietary
hardware and software which is not available to RI's and can only be
obtained from Ferrari and/or FNA.
    JK responded that it has the Ferrari tools and the required access
to reflash all computers as required.
    NHTSA has decided that a description of how the programming changes
were completed and how compliance with the standard was verified must
be included in each conformity package. Photographs, printouts, and/or
images of the installation computer's monitor (``screenshots''), as
practicable, must also be submitted as proof that the reprogramming was
carried out successfully.
    FMVSS No. 108 Lamps, Reflective Devices, and Associated Equipment:
FNA commented that the reprogramming identified by JK would necessitate
reflashing the control system with a ``Proxy'' file from the Ferrari
Factory in order to assure that all aspects of the lighting system
perform in accordance with this standard.
    JK responded that it has the Ferrari tools and the required access
to reflash all computers as required.
    NHTSA has decided that a description of how the programming changes
were accomplished and how compliance with FMVSS No. 108 is verified
must accompany each conformity package. Photographs, printouts, and/or
screenshots, as practicable, must also be submitted as proof that the
reprogramming was carried out successfully.
    FMVSS No. 111 Rearview Mirrors: FNA commented that in addition to
the modifications noted in the petition, the driver's outside rearview
mirror would need to be replaced.
    JK responded that no comment is necessary.
    NHTSA has decided that proof, including photographs, must be
submitted with each conformity package to show that the vehicle is
equipped with a driver's side rear view mirror that allows the vehicle
to meet the applicable requirements of FMVSS No. 111.
    FMVSS No. 114 Theft Protection and Rollaway Prevention: As was the
case with FMVSS Nos. 101 and 108, FNA contended that reprogramming
could only be completed with proprietary hardware and software that is
not available to RIs and can only be obtained from Ferrari and/or FNA.
    JK responded that it has the Ferrari tools and the required access
to reflash all computers as required.
    NHTSA has decided that a description of how the programming changes
were completed and how compliance was verified must accompany each
conformity package. Additionally, photographs, printouts, and/or
screenshots, as practicable, must be submitted as proof that the
reprogramming was carried out successfully.
    FMVSS No. 118 Power-Operated Window, Partition, and Roof Panel
Systems: FNA commented that the reprogramming identified by JK is not
necessary for the vehicles to conform to the standard.
    Despite FNA's comment, NHTSA has decided that a description of how
the vehicle's conformity was determined must accompany each conformity
package. If any modifications were necessary to achieve conformity, a
description of those modifications must be included in the conformity
package.
    FMVSS No. 138 Tire Pressure Monitoring Systems: In its petition, JK
claimed that the subject non-U.S.-certified vehicles conform to FMVSS
No. 138 as originally manufactured. FNA commented that tire pressure
monitoring systems (TPMS) are not standard equipment on all European
Ferrari 599 GTB vehicles and that substantial work would be required to
bring vehicles into compliance with the standard. FNA further asserted
that because of the extent and complexity of the required changes,
vehicles not originally equipped with TPMS cannot be ``readily
altered'' to comply with the standard.
    JK responded that it has access to the appropriate equipment and
has experience in installing TPMS and the

equipment to make sure those systems are working properly.
    NHTSA notes that because the subject nonconforming vehicles were
manufactured prior to September 1, 2007, the date on or after which
100% of passenger cars must meet the requirements of FMVSS No. 138,
compliance of the subject vehicles with FMVSS No. 138 is not an issue.
An RI only needs to conform a vehicle to standards that are fully
phased in by the vehicle's date of manufacture.
    FMVSS No. 205 Glazing Materials: FNA commented that JK's assertion
that the glazing material complies with the standard was incorrect. FNA
states that the rear corner glazing directly behind the B-Pillar on
both sides of the vehicle is made of plastic, which does not comply
with the standard.
    JK responded that the vehicle it inspected was equipped with
compliant glazing, as it is properly labeled. JK states that each
vehicle imported will be inspected and if not in compliance, will be
brought into compliance by adding the appropriate glass.
    NHTSA has decided that photographic evidence of the required
markings to demonstrate that the glazing complies with the standard
must be submitted with each conformity package.
    FMVSS No. 207 Seating Systems: FNA commented that replacement of
the driver and passenger seats with U.S.-model components would not be
physically possible in the European market model due to differences in
the chasses. Specifically, FNA stated that the chassis in the U.S.-
model vehicles ``dips down in order to accommodate the weight sensors
needed to comply with the requirements of FMVSS No. 208.''
    JK disagreed with FNA's claim that there is a ``dip'' in the
chassis, but noted that some of the chasses have ``different seat
mounts.'' JK provided parts listings and diagrams showing the different
mounts.
    JK also responded that the seat frames and mounting points are the
same in the U.S.-model and European market vehicles, but observed that
there are four brackets that are welded to the [chasses] of the
European market vehicles on the passenger side only that could be
removed, and U.S.-model seats and seat runners installed onto the
resulting flat surface of the [chassis].
    Ferrari also commented that, ``JKT acknowledges that both driver
and passenger seating systems in the European vehicle must be replaced
with U.S. seats.''
    JK responded:

    The reason the seats need to be replaced is NOT a safety issue.
It's a leather matching issue. If you ``choose'' to replace the
passenger seat so that you get the U.S. seat with the baby seat
tether hole, then you must replace the driver's seat to match the
leather color [in the a replaced passenger seat].
    If you choose to make a template and cut the hole for the baby
seat tether [in the passenger seat] then you do not need to replace
either seat. There is NO difference in the design or mounting points
between the European seats and the U.S. seats. There are differences
in the levels of the leather and options in both the U.S. seats and
the European seats.

    NHTSA has decided that a description of the seating systems present
on the vehicle at the time of importation, including all differences
from the U.S.-model, with part numbers and diagrams where applicable,
and a description of all modifications necessary to conform the vehicle
to the standard must accompany each conformity package. Additionally,
photographs, as practicable, must be submitted as proof that
modifications were carried out successfully.
    FMVSS No. 208 Occupant Protection: FNA commented that JK did not
identify all components that need to be replaced in order to bring the
airbag system into compliance. FNA specifically notes that the European
versions of the subject vehicles are not equipped with a ``PASS AIR BAG
OFF'' telltale, which is required for compliance. Additionally, FNA
stated that JK did not identify certain portions of the instrument
panel that differ from those on the U.S.-certified version of the
vehicle and that would have to be changed to assure compliance with the
unbelted crash requirements of the standard.
    JK responded that the installation of the U.S. version instrument
panel and reprogramming will ensure that a compliant system is
installed providing the telltales that meet the requirements of FMVSS
No. 208.
    JK further stated that after the brackets are removed, it can
install the rails and seats properly with the software and systems. JK
states that it will program, reset, and test the systems, bringing them
into compliance with the standard.
    JK later clarified that the European vehicle it inspected was
equipped with the proper parts as well as the proper programs and
systems to meet the requirements of the standard in the same manner as
the U.S.-version of the vehicle, including the complete instrument
systems, dash, and ``passenger airbag off'' light.
    NHTSA has decided that each conformity package must include a
detailed description of the occupant protection system in place on the
vehicle at the time it was delivered to the RI and a similarly detailed
description of the occupant protection system in place after the
vehicle is altered, including photographs of all required labeling. The
description must also include assembly diagrams and associated part
numbers for all components that were removed from and installed on the
vehicle, a description of how the programming changes were completed,
and a description of how compliance was verified. Additionally,
photographs (e.g., screenshots) or report printouts, as practicable,
must be submitted as proof that the reprogramming was carried out
successfully. Proof must also be furnished that all portions of the
instrument panel in the vehicle, after all conformance modifications
are performed, are identical to the U.S. version instrument panel, or
proof in the form of dynamic test results showing that the vehicle, as
altered, conforms to the unbelted occupant requirements of FMVSS No.
208.
    FMVSS No. 209 Seat Belt Assemblies: FNA commented that, as JK
acknowledged in the petition, some European market vehicles are
equipped with four-point seat belt assemblies that do not comply with
this standard. FNA contends that the belts could not simply be replaced
by a registered importer, due to the absence of an anchorage on the B-
pillar.
    JK responded that the vehicle it inspected was equipped with ``the
correct belts.'' JK indicated that if a vehicle is equipped with the
non-compliant four-point seat belts it can make the appropriate tools
to install the correct belts, using a U.S.-model vehicle as a guide.
    NHTSA has decided that each conformity package must include
photographic evidence that conforming safety belts have been installed
in the vehicle. Safety belt anchorages are addressed in the following
discussion of FMVSS No. 210.
    FMVSS No. 210 Seat Belt Assembly Anchorages: In the petition, JK
claims that the subject non-U.S. certified vehicles conform to FMVSS
No. 210 as originally manufactured. FNA commented that European market
vehicles that were equipped with optional four-point harnesses lack b-
pillar anchorages that are necessary for the installation of compliant
three-point harnesses. FNA expressed concern about the ability of an RI
to install this anchorage and ensure that it meets the performance
requirements of the standard without Ferrari's templates

and tools, which are only used during production.
    JK responded that any vehicle found to be equipped with the
optional belts and lacking the aforementioned anchorage would have to
be modified to meet this standard. JK further states that it will draw
a template from a U.S. donor vehicle and that, as a result, all parts
and engineering of the anchorage would be identical to the Ferrari
mounting point. JK asserts that less than one percent of production is
equipped with the optional belts.
    NHTSA has decided that conformity packages for vehicles that
require modification must include a detailed description of the
alterations made to achieve conformity with the standard. The
description must include sufficient information to validate how the
alterations allowed the vehicle to meet the requirements of the
standard. This information must include photographic evidence that the
modification was carried out, as well as testing and/or engineering
analysis reports documenting how the RI has verified that the
alterations will allow the vehicle to meet all applicable requirements
of the standard.
    FMVSS No. 225 Child Restraint Anchorage Systems: FNA stated that
European market vehicles do not include a top tether anchor plate that
is included on U.S. market vehicles. FNA further expressed doubts about
an anchorage installed by an RI being able to meet the strength
requirements of the standard.
    JK responded that it has the parts and tools to install the
anchorage properly.
    NHTSA has decided that conformity packages for vehicles that
require modification must include a detailed description of the
alterations made to achieve conformity with the standard. The
description must include sufficient information to validate how the
alterations allowed the vehicle to meet the requirements of the
standard. This information must include photographic evidence that the
modification was carried out, as well as testing and/or engineering
analysis reports documenting how the RI has verified that the
alterations will allow the vehicle to meet all applicable requirements
of the standards.
    FMVSS No. 301 Fuel System Integrity: FNA stated that the
modifications to the fuel system that JK identified in the petition,
while necessary to comply with emissions requirements, have no bearing
on compliance with FMVSS No. 301. However, FNA additionally stated its
belief that the addition of rear bumper reinforcements is necessary to
insure compliance with FMVSS No. 301.
    JK responded that no comment was necessary.
    NHTSA has decided that the fuel system modifications identified in
the petition are necessary to bring the vehicles into compliance with
the standard. Additionally, NHTSA has decided that each conformity
package must include a detailed description of all modifications made
to achieve conformity with the standard. This description must include
part numbers for each part replaced and be supported with photographic
evidence of the modifications made to achieve conformity.
    FMVSS No. 401 Interior Trunk Release: FNA expressed agreement that
the modifications described in the petition are necessary to conform
the vehicle to the standard. The company noted, however, that the
reprogramming could only be completed with proprietary hardware and
software, which is not available to RIs and can only be obtained from
Ferrari and/or FNA.
    JK responded that it has access to all of the parts and programming
necessary to bring the vehicle into compliance.
    NHTSA has decided that each conformity package must include a
description of how the programming changes were completed and how
compliance was verified. Additionally, photographs, printouts, and/or
screenshots, as practicable, must be submitted as proof that the
reprogramming was carried out.
    49 CFR part 581 Bumper Standard: FNA commented that in addition to
the modifications described by JK in its petition, additional bumper
reinforcements would have to be installed in both the front and the
rear of the vehicle.
    JK responded that no comment was necessary.
    NHTSA has decided that each conformity package must include a
detailed description of all modifications made to achieve conformity
with the standard, including necessary modifications to the bumper
reinforcements. This description must include part numbers for each
part replaced and be supported with photographic evidence of the
modifications made to achieve conformity.
    In addition to the information specified above, each conformity
package must include evidence showing how the RI verified that the
changes it made in loading or reprograming vehicle software to achieve
conformity with each FMVSS did not also cause the vehicle to fall out
of compliance with any other applicable FMVSS.

NHTSA's Decision

    Accordingly, on the basis of the foregoing, NHTSA hereby decides
that model year 2006 and 2007 European market Ferrari 599 GTB passenger
cars not originally manufactured to comply with all applicable FMVSS
and manufactured from September 1, 2006 to August 31, 2007 are
substantially similar to model year 2007 Ferrari 599 GTB passenger cars
manufactured prior to September 1, 2007 for importation into and/or
sale in the United States and certified under 49 U.S.C. 30115, and are
capable of being readily altered to conform to all applicable Federal
Motor Vehicle Safety Standards.
    Vehicle Eligibility Numbers: Ferrari stated in its comments on the
subject petition that it did not certify any Ferrari 599 GTB passenger
cars as model year 2006 for the U.S.-market. The agency notes that it
previously decided that model year 2006 Ferrari 599 [GTB \1\] passenger
cars not originally manufactured to comply with all applicable FMVSS
manufactured prior to September 1, 2006 are eligible for importation as
model year 2006 vehicles under VSP-518 (75 FR 34524). At the time,
NHTSA relied on Ferrari's submission of VIN deciphering information
under 49 CFR part 565, dated February 22, 2006, which indicated that
the company planned to apply the model year 2006 designation to Ferrari
599 GTB passenger cars manufactured for sale in the United States. The
agency also took note of the fact that Ferrari did not comment on the
petition that resulted in eligibility number VSP-518 with regard to the
model year designation.
---------------------------------------------------------------------------

    \1\ At the time the decision was made, the full model name was
abbreviated in the grant notice for the petition. The full model
name is included here for consistency.
---------------------------------------------------------------------------

    After the original 2006 Ferrari 599 GTB petition was granted on
July 7, 2009, NHTSA amended the definition of the term ``model year''
in 49 CFR 593.4 for the purpose of import eligibility decisions. The
amendment was made to eliminate much of the confusion confronting RIs
over the issue of whether a given vehicle manufactured for sale abroad
has a substantially similar U.S.-certified counterpart of the same
model year. The amendment, made in a final rule published on August 25,
2011 (76 FR 53072), deleted ``the calendar year that begins on
September 1 and ends on August 31 of the next calendar year,'' as one
of the alternative definitions of the term

``model year.'' In place of the deleted text, the amendment added the
following alternative definition: ``The calendar year (i.e., January 1
through December 31) in which manufacturing operations are completed on
the vehicle at its place of main assembly.''
    In light of this change in the definition of ``model year,'' as
well as Ferrari's failure to raise any issue regarding the model year
designation in response to the original model year 2006 599 GTB
petition, NHTSA considers Ferrari's comment on this issue in the
subject petition to be moot.
    Consequently, NHTSA reaffirms that nonconforming Ferrari 599 GTB
passenger cars manufactured between January 1, 2006 and August 31, 2006
continue to be eligible under VSP-518.
    NHTSA has also decided that nonconforming model year 2006 European
market Ferrari 599 GTB passenger cars manufactured from September 1,
2006 through December 31, 2006 and nonconforming model year 2007
European market Ferrari 599 GTB passenger cars manufactured from
September 1, 2006 through December 31, 2007, are admissible under
vehicle eligibility number VSP-576. This number must be indicated on
the form HS-7 accompanying entry of the vehicles eligible for entry.

    Authority:  49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8.

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2016-04616 Filed 3-2-16; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 82, Number 4 (Friday, January 6, 2017)]
[Notices]
[Page 1748]
[FR Doc No: 2016-32055]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2016-0029; OMB No. 1660-0112]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; FEMA Preparedness Grants: Transit Security
Grant Program (TSGP)

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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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 February 6, 2017.

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>
FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Records Management Division, 500 C Street SW., Washington, DC 20472-
3100, or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This information collection previously
published in the Federal Register on October 12, 2016 at 81 FR 70434
with a 60 day public comment period. No comments were received. The
purpose of this notice is to notify the public that FEMA will submit
the information collection abstracted below to the Office of Management
and Budget for review and clearance.

Collection of Information

    Title: FEMA Preparedness Grants: Transit Security Grant Program
(TSGP).
    Type of information collection: Extension, without change, of a
currently approved information collection.
    OMB Number: 1660-0112.
    Form Titles and Numbers: FEMA Form 089-4, TSGP Investment
Justification Template.
    Abstract: The TSGP is an important component of the Department of
Homeland Security's effort to enhance the security of the Nation's
critical infrastructure. The program provides funds to owners and
operators of transit systems to protect critical surface transportation
infrastructure and the traveling public from acts of terrorism, major
disasters, and other emergencies.
    Affected Public: State, Local, or Tribal Government.
    Estimated Number of Respondents: 123.
    Estimated Total Annual Burden Hours: 5,043 hours.
    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $208,981.92. There are no annual costs to respondents'
operations and maintenance costs for technical services. There are no
annual start-up or capital costs. The cost to the Federal Government is
$774,018.00.

    Dated: December 27, 2016.
Richard W. Mattison
Records Management Program Chief, Mission Support, Federal Emergency
Management Agency, Department of Homeland Security.
[FR Doc. 2016-32055 Filed 1-5-17; 8:45 am]
 BILLING CODE 9111-46-P


[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Proposed Rules]
[Pages 65592-65601]
[FR Doc No: 2018-27577]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-1046; Product Identifier 2018-CE-049-AD]
RIN 2120-AA64

Airworthiness Directives; Piper Aircraft, Inc. 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
certain Piper Aircraft, Inc. (Piper) Model PA-28-140, PA-28-150, PA-28-
151, PA-28-160, PA-28-161, PA-28-180, PA-28-181, PA-28-235, PA-28R-180,
PA-28R-200, PA-28R-201, PA-28R-201T, PA-28RT-201, PA-28RT-201T, PA-32-
260, and PA-32-300 airplanes. This proposed AD was prompted by a report
of a fatigue crack found in a visually inaccessible area of the lower
main wing spar cap. This proposed AD would require calculating the
factored service hours for each main wing spar to determine when an
inspection is required, inspecting the lower main wing spar bolt holes
for cracks, and replacing any cracked main wing spar. We are proposing
this AD to address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by February 4,
2019.

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.

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-2018-
1046; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations (phone: 800-647-
5527) is listed above. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Dan McCully, Aerospace Engineer,
Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College Park, Georgia
30337; phone:<PHONE_NUMBER>; 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-2018-1046;
Product Identifier 2018-CE-049-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM 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 NPRM.

Discussion

    We received a report of a fatigue crack found in the lower main
wing spar cap on a Piper Model PA-28R-201 airplane. An investigation
revealed that repeated high-load operating conditions accelerated the
fatigue crack growth in the lower main wing spar cap. In addition,
because of the structural configuration of the wing assembly, the
cracked area was inaccessible for a visual inspection. Model PA-28-140,
PA-28-150, PA-28-151, PA-28-160, PA-28-161, PA-28-180, PA-28-181, PA-
28-235, PA-28R-180, PA-28R-200, PA-28R-201T, PA-28RT-201, PA-28RT-201T,
PA-32-260, and PA-32-300 airplanes have similar wing spar structures as
the Model PA-28R-201.
    Airplanes used in training and other high-load environments are
typically operated for hire and have inspection programs that require
100-hour inspections. We determined the number of 100-hour inspections
an airplane has undergone is the best indicator of the airplane's usage
history. Using the criteria in FAA Advisory Circular AC 23-13A,
``Fatigue, Fail-Safe, and Damage Tolerance Evaluation of Metallic
Structure for Normal, Utility, Acrobatic, and Commuter Category
Airplanes,'' which you can find at http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgAdvisoryCircular.nsf/MainFrame?OpenFrameset, we developed a factored service hours formula
based on the number of 100-hour inspections completed on the airplane.
A review of the airplane maintenance records to determine the
airplane's usage and the application of the factored service hours
formula will identify when an airplane meets the criteria for the
proposed eddy current inspection of the lower main wing spar bolt
holes.
    Only an airplane with a main wing spar that has a factored service
life of 5,000 hours, has had either main wing spar replaced with a
serviceable main wing spar (more than zero hours TIS), or has airplane
maintenance records that are missing or incomplete, must have the eddy
current inspection.
    This condition, if not addressed, could result in the wing
separating from the fuselage in flight.

Related Service Information

    We reviewed Piper Aircraft Corporation Service Bulletin No. 886,
dated June 8, 1988, and The New Piper Aircraft, Inc. Service Bulletin
No. 978A, dated August 6, 1999. These service bulletins contain
procedures for determining initial and repetitive inspection times
based on the aircraft's usage and visually inspecting the wing lower
spar caps and the upper wing skin adjacent to the fuselage and forward
of each main spar for cracks. We also reviewed Piper Aircraft
Corporation Service Letter No. 997, dated May 14, 1987. This service
letter contains procedures for replacing airplane wings.

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 reviewing the airplane maintenance
records to determine the number of 100-hour inspections completed on
each installed main wing spar and using the number of 100-hour
inspections to calculate the factored service hours for each main wing
spar. This proposed AD would also require inspecting the lower main
wing spar bolt holes for cracks once a main wing spar exceeds the
specified factored service hours and replacing any main wing spar when
a crack is indicated. This proposed AD would only apply when an
airplane has either accumulated 5,000 or more hours time-in-service
(TIS); has had either main wing spar replaced with a serviceable main
wing spar (more than zero hours TIS); or has missing and/or incomplete
maintenance records.

Interim Action

    We consider this proposed AD interim action. The inspection reports
will provide us additional data for determining the cause of the
cracking. After analyzing the data, we may take further rulemaking
action.

Costs of Compliance

    We estimate that this proposed AD affects 19,696 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
----------------------------------------------------------------------------------------------------------------
Review airplane maintenance      2 work-hours x $85  Not applicable.............            $170      $3,348,320
 records and calculate factored   per hour = $170.
 service hours.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do the eddy current inspection.
Because some airplanes are only used non-commercially and will not
accumulate the specified factored service hours in the life of the
airplane, we have no way of determining the number of airplanes that
might need this inspection:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
              Action                      Labor cost         Parts cost               Cost per product
----------------------------------------------------------------------------------------------------------------
Inspect the lower main wing spar    1.5 work-hours x $85              $20  $147.50 per wing spar.
 and replace the attach nuts and     per hour = $127.50
 bolts.                              per wing spar.
Report inspection results to the    1 work-hour x $85 =               N/A  $85.
 FAA.                                $85.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
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
this replacement:

                                         On-Condition Replacement Costs
----------------------------------------------------------------------------------------------------------------
              Action                       Labor cost           Parts cost             Cost per product
----------------------------------------------------------------------------------------------------------------
Replace main wing spar...........  32 work-hours x $85 per            $5,540  $8,260 per wing spar.
                                    hour = $2,720 per wing
                                    spar.
----------------------------------------------------------------------------------------------------------------

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a currently valid OMB Control Number. The OMB
Control Number for this information collection is 2120-0056. Public
reporting for this collection of information is estimated to be
approximately 1 hour per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, completing and reviewing the collection of
information. All responses to this collection of information are
mandatory. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for
reducing this burden to: Information Collection Clearance Officer,
Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX
76177-1524.

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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to small airplanes, gliders,
balloons, airships, domestic business jet transport airplanes, and
associated appliances to the Director of the Policy and Innovation
Division.

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):

Piper Aircraft, Inc.: Docket No. FAA-2018-1046; Product Identifier
2018-CE-049-AD.

(a) Comments Due Date

    We must receive comments by February 4, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Piper Aircraft, Inc. airplanes, certificated
in any category, with a model and serial number shown in Table 1 to
paragraph (c) of this AD, and that meet at least one of the criteria
in paragraphs (c)(1), (2), or (3) of this AD.
    (1) Has accumulated 5,000 or more hours time-in-service (TIS);
or
    (2) Has had either main wing spar replaced with a serviceable
main wing spar (more than zero hours TIS); or
    (3) Has missing and/or incomplete maintenance records.

[GRAPHIC] [TIFF OMITTED] TP21DE18.005

BILLING CODE 4910-13-C

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 57, Wings.

(e) Unsafe Condition

    This AD was prompted by a report of a fatigue crack found in a
visually inaccessible area of the lower main wing spar cap. We are
issuing this AD to detect and correct fatigue cracks in the lower
main wing spar cap bolt holes. The unsafe condition, if not
addressed, could result in the wing separating from the fuselage in
flight.

(f) Compliance

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

(g) Review Airplane Maintenance Records and Calculate Factored Service
Hours for Each Main Wing Spar

    (1) Within 30 days after the effective date of this AD, review
the airplane maintenance records and determine the number of 100-
hour inspections completed on the airplane since new and any record
of wing spar replacement(s).
    (i) If a main wing spar has been replaced with a new (zero hour
TIS) main wing spar, count the number of 100-hour inspections from
the time of installation of the new main wing spar.
    (ii) If either main wing spar has been replaced with a
serviceable main wing spar (more than zero hours TIS) or the
airplane maintenance records are missing or incomplete, the factored
service hours cannot be determined. Perform the eddy current
inspection as specified in paragraph (h) of this AD.
    (2) Before further flight after completing the action in
paragraph (g)(1) of this AD, calculate the factored service hours
for each main wing spar using the following formula: (N x 100) + [T-
(N x 100)]/17 = Factored Service Hours, where N is the number of
100-hour inspections and T is the total hours TIS of the airplane.
Thereafter, after each annual inspection and 100-hour TIS
inspection, recalculate the factored service hours for each main
wing spar until the main wing spar has accumulated 5,000 or more
factored service hours.
    (3) An example of determining factored service hours for an
airplane with no 100-hour inspections is as follows: The airplane
maintenance records show that the airplane has a total of 12,100
hours TIS, and only annual inspections have been done. Both main
wing spars are original factory installed. In this case, N = 0 and T
= 12,100. Use those values in the formula as follows:

(0 x 100) + [12,100-(0 x 100)]/17 = 711 factored service hours on
each main wing spar.
    (4) An example of determining factored service hours for an
airplane with both 100-hour and annual inspections is as follows:
The airplane was originally flown for personal use, then for
training for a period of time, then returned to personal use. The
airplane maintenance records show that the airplane has a total of
5,600 hours TIS, and nineteen 100-hour inspections have been done.
Both main wing spars are original factory installed. In this case, N
= 19 and T = 5,600. Use those values in the formula as follows: (19
x 100) + [5,600-(19 x 100)]/17 = (1,900 + 218) = 2,118 factored
service hours on each main wing spar.

(h) Eddy Current Inspect

    Within the compliance time specified in paragraph (h)(1) or (2)
of this AD, eddy current inspect the inner surface of each bolt hole
on the lower main wing spar cap for cracks by using the procedure in
appendix 1 of this AD.
    (1) Within 100 hours TIS after complying with paragraph (g) of
this AD or within 100 hours TIS after a main wing spar accumulates
5,000 factored service hours, whichever occurs later; or
    (2) For airplanes with an unknown number of factored service
hours on a main wing spar, within the next 100 hours TIS after the
effective date of this AD or within 60 days after the effective date
of this AD, whichever occurs later.

(i) Replace the Main Wing Spar

    If a crack is found during an inspection required in paragraph
(h) of this AD, before further flight, replace the main wing spar
with a new (zero hours TIS) main wing spar or with a main wing spar
that has been inspected as specified in appendix 1 of this AD and no
cracks were found.

(j) Report Inspection Results

    Within 30 days after completing an inspection required in
paragraph (h) of this AD, using Appendix 2, ``Inspection Results
Form,'' of this AD, report the inspection results to the FAA at the
Atlanta ACO Branch. Submit the report to the FAA using the contact
information found in appendix 2 of this AD.

(k) Special Flight Permit

    A special flight permit may only be issued to operate the
airplane to a location where the inspection requirement of paragraph
(h) of this AD can be performed. This AD prohibits a special flight
permit if the inspection reveals a crack in a main wing spar.

(l) Paperwork Reduction Act Burden Statement

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty
for failure to comply with a collection of information subject to
the requirements of the Paperwork Reduction Act unless that
collection of information displays a currently valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 1 hour per response, including the
time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, completing and reviewing
the collection of information. All responses to this collection of
information are mandatory. Send comments regarding this burden
estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to: Information
Collection Clearance Officer, Federal Aviation Administration, 10101
Hillwood Parkway, Fort Worth, TX 76177-1524.

(m) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Atlanta ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (n) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(n) Related Information

    For more information about this AD, contact Dan McCully,
Aerospace Engineer, Atlanta ACO Branch, FAA, 1701 Columbia Avenue,
College Park, Georgia 30337; phone:<PHONE_NUMBER>; fax: (404) 474-
5605; email<EMAIL_ADDRESS>BILLING CODE 4910-13-C

[GRAPHIC] [TIFF OMITTED] TP21DE18.006

[GRAPHIC] [TIFF OMITTED] TP21DE18.007

[GRAPHIC] [TIFF OMITTED] TP21DE18.008

[GRAPHIC] [TIFF OMITTED] TP21DE18.009

BILLING CODE 4910-13-P

    Issued in Kansas City, Missouri, on December 7, 2018.
Melvin J. Johnson,
Aircraft Certification Service, Deputy Director, Policy and Innovation
Division, AIR-601.
[FR Doc. 2018-27577 Filed 12-20-18; 8:45 am]
 BILLING CODE 4910-13-P


MEMORANDUM

DATE: 11/21/14

FROM: 		Ken Mitchell/EPA Region 4

TO:CLEAN POWER PLAN FOR EXISTING POWER PLANTS; DOCKET ID: OAR - 2013-0602

SUBJECT:DISCUSSION OF THE CLEAN POWER Plan with the Georgia Environmental Protection Division

SUMMARY:
REGION 4 PROVIDED INFORMATION ON THE CLEAN POWER PLAN to the Georgia Environmental
Protection Division on August 13, 2014.  The Clean Power Plan for Existing Power Plants was
proposed on June 2, 2014.
ATTENDEES:

EPA
Beverly Banister/EPA R4
Carol Kemker/EPA R4
Jeaneanne Gettle/EPA R4
Ken Mitchell/EPA R4
David McNeal/EPA R4
David Solomon/EPA OAQPS
Lisa Conner/EPA OAQPS
Elineth Torres/EPA OAQPS
Julia Miller/EPA OAP
Erika Wilson/EPA OAP
Erich Eichmann/EPA OAP
Matt Clouse/EPA OAP
Other EPA Staff

External Stakeholders
Albert Pierce/GA EPD
Karen Hays/GA EPD
Mary Walker/GA EPD
Keith Bentley/GA EPD
Jud Turner/GA EPD

ATTACHMENT

Advance Questions for Discussion of the Clean Power Plan with the Georgia Environmental Protection
Division on 8/13/14

Subject
Question

Dispatch to Natural Gas CC
Dispatch is currently performed based on economics.  What regulatory mechanism does EPA anticipate states using to require utilities to give priority to CO2 emissions over cost?  Implementation of a minimum dispatch requirement for NGCC would have significant impacts on our publically-owned utilities and their customers (Oglethorpe Power and MEAG Power).

Renewable generation  -  basis for SE target of 10 %
The SE target of 10% was set based on the NC standard, which covers both RE and EE generation as opposed to RE only.  Is the basis for the 10 % assignment technically correct?

Renewable generation  -  credit to generator or purchaser
Who gets credit for renewable power purchased out-of-state?  The state purchasing or the state with the generation?  Has EPA changed their position on the answer previously given (which was the state purchasing the power gets the credit)?  How are wind and solar quantified for calculation of emissions performance?  Are there enforceable compliance mechanisms other than an RPS or EERS?

Modeling
Can EPA's modelers work with our modelers so that we can evaluate the modeling runs that EPA did?   We would like to see the output files in an understandable format and be walked through the modeled compliance scenario.

Mass-based goal
SE states have requested a webinar from EPA Region 4.  The current discussion of methodology in TSD is inadequate.  Does EPA plan to calculate an equivalent mass goal for each state and when might we expect to see it? If EPA is not doing the conversion calculation, when will EPA provide detailed guidance?

Is switching from rate-based goal to mass-based goal allowed?  How and when and how often?  Would you have to submit a plan revision every time you switched?
Plan flexibility
Many aspects of the energy infrastructure and technology will undoubtedly change between now and 2030. States will need some mechanism to adapt our plan to accommodate those changes relatively quickly (i.e. not a 2 year review process). How does EPA envision this working?

Emissions Performance Level (60.5740)
Rule 60.5770(a)(3): (a)(3) The conversion must represent the tons of CO2 emissions that are projected to be emitted, in the absence of emissions standards contained in the plan, if the affected EGUs were to perform at an average lb CO2 /MWh rate equal to the rate-based goal for the state identified in Table 1 of this Subpart.
   oo Georgia's rate-based goal is 834 while our coal emissions rate (after HR improvement) and NGCC emissions rate are 2157 and 841 lbs/MWh, respectively.  Even if we dropped coal generation to 0, we would be left with an equivalent emissions rate of 841.  This would fail the equivalency test in paragraph (a)(3).  No state that operates coal-fired EGUs and has a goal below 900 lbs/MWh would be able to meet the requirement as stated.  Please clarify.

Other questions:

   1. How can a state account for or adjust in the event that a zero emission IPP either shuts down or does not reach expected capacity say in 2025?
   2. Does EPA have a planned approach for dealing with some type major disruption in the energy markets that may occur in the future? Same question for an unexpected shutdown of an existing nuclear plant?
   3. What does a federal state plan look like?
   4. If two or more states request the two year extension to develop a multistate program and despite good faith efforts, the plan is not completed, how will EPA react and what will the path forward be for the states involved?
   5. A state plan will be based on achieving certain levels of HRI, natural gas dispatch, RE, EE, assumed capacity factors for various fuel types and other methods that reduce carbon. Will the state be held accountable to meet each component of the plan or simply to meet the final goal?
   6. Why did EPA include an interim goal, and why is it so close the final goal? Can states propose an alternative interim goal as long as the final goal is reached in 2030?
   7. Can a new source be included as an affected unit for 111(d)?


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I have been a smoker for most of my adult life, and have not smoked any conventional tobacco products in several months, directly as a result of e-cigarettes. While there are many ways to quit smoking cigarettes, I believe e-liquids and e-cigarettes are a consumers choice, and safer according to a study published January 9th, 2014 by Igor Burstyn of the Department of Environmental and Occupational Health, School of Public Health, Drexel University.

I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Notices]
[Pages 51179-51180]
[FR Doc No: 2014-20360]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0007]

Fee for Using a Tropical Disease Priority Review Voucher in
Fiscal Year 2015

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the fee rates for using a tropical disease priority review
voucher for fiscal year (FY) 2015. The Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as amended by the Food and Drug Administration
Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect
priority review user fees for certain applications for approval of drug
or biological products when those applications use a tropical disease
priority review voucher awarded by the Secretary of Health and Human
Services. These vouchers are awarded to the sponsors of certain
tropical disease product applications, submitted after September 27,
2007, upon FDA approval of such applications. The amount of the fee
submitted to FDA with applications using a tropical disease priority
review voucher is determined each FY based on the average cost incurred
by FDA in the review of a human drug application subject to priority
review in the previous FY. This notice establishes the tropical disease
priority review fee rate for FY 2015.

FOR FURTHER INFORMATION CONTACT: Robert J. Marcarelli, Office of
Financial Management, Food and Drug Administration, 8455 Colesville
Rd., COLE-14202F, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 1102 of FDAAA (Pub. L. 110-85) added section 524 to the
FD&C Act (21 U.S.C. 360n). In section 524, Congress encouraged
development of new drug and biological products for prevention and
treatment of certain tropical diseases by offering additional
incentives for obtaining FDA approval of such products. Under section
524, the sponsor of an eligible human drug application submitted after
September 27, 2007, for a qualified tropical disease (as defined in
section 524(a)(3) of the FD&C Act), shall receive a priority review
voucher upon approval of the tropical disease product application. The
recipient of a tropical disease priority review voucher may either use
the voucher with a future submission to FDA under section 505(b)(1) of
the FD&C Act (21 U.S.C. 355(b)(1)) or section 351 of the Public Health
Service Act (42 U.S.C. 262), or transfer (including by sale) the
voucher to another party that may then use it. A priority review is a
review conducted with a Prescription Drug User Fee Act (PDUFA) goal
date of 6 months after the filing date.
    The applicant that uses a priority review voucher is entitled to a
priority review but must pay FDA a priority review user fee in addition
to any other fee required by PDUFA. FDA published a draft guidance on
its Web site about how this tropical disease priority review voucher
program operates (available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080599.pdf).
    This notice establishes the tropical disease priority review fee
rate for FY 2015 as $2,562,000 and outlines FDA's process for
implementing the collection of the priority review user fees. This rate
is effective on October 1, 2014, and will remain in effect through
September 30, 2015, for applications submitted with a tropical disease
priority review voucher. The payment of this priority review user fee
is required in addition to the payment of any other fee that would
normally apply to such an application under PDUFA before FDA will
consider the application complete and acceptable for filing.

II. Tropical Disease Priority Review User Fee for FY 2015

    Under section 524(c)(2) of the FD&C Act, the amount of the tropical
disease priority review user fee is determined each FY based on the
average cost incurred by FDA in the review of a human drug application
subject to priority review in the previous FY. The priority review
voucher fee is intended to cover the incremental costs for FDA to do a
priority review on a product that would otherwise get a standard
review. The formula provides the Agency with the added resources to
conduct a priority review while still ensuring a robust priority review
voucher program that is consistent with the Agency's public health goal
of encouraging the development of new drug and biological products.
    A priority review is a review conducted with a PDUFA goal date of 6
months after the filing date. Normally, an application for a Center for
Drug Evaluation and Research product will qualify for a priority review
if FDA determines that the product, if approved, provides a safe and
effective therapy where no satisfactory alternative therapy exists or
is a significant improvement compared to marketed products, including
non-drug products and/or therapies, in the treatment, diagnosis, or
prevention of a disease. A Center for Biologics Evaluation and Research
product will qualify for a priority review if FDA determines that the
product, if approved, is a significant improvement in the safety or
effectiveness of the treatment, diagnosis, or prevention of a serious
or life-threatening disease. FDA committed to review and act on 90
percent of the applications granted priority review status no later
than 6 months after the filing date. An application that does not
receive a priority designation will receive a standard review. Under
the goals identified in the letters referenced in section 101(b) of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), FDA commits to reviewing and acting on 90 percent of standard
applications within 10 months of the date of filing. A priority review
involves a more intensive level of effort and a higher level of
resources than a standard review.
    Section 524 of the FD&C Act specifies that the fee amount should be
based on the average cost incurred by the Agency in the review of a
human drug application subject to a priority review in the previous FY.
FDA is setting fees for FY 2015, and the previous fiscal year is FY
2014. However, the FY 2014 submission cohort has not been closed out
yet, and the cost data for FY 2014 are not complete. The latest year
for which FDA has complete cost data is FY 2013. Furthermore, because
FDA has never tracked the cost of reviewing applications that get
priority review as a separate cost subset, FDA estimated this cost
based on other data that the Agency has tracked. FDA uses data that the
Agency estimates and publishes on its Web site each year--standard
costs for review. FDA does not publish a standard cost for ``the review
of a human drug application subject to priority review in the previous
fiscal year.'' However, we expect all such applications would contain
clinical data. The standard cost application categories with clinical
data that FDA does publish each year are: (1) New drug applications
(NDAs) for a new molecular entity (NME) with clinical data, and (2)
biologics license applications (BLAs).
    The worksheets for standard costs for FY 2013, the latest year for
which standard cost data are available, show a

standard cost (rounded to the nearest thousand dollars) of $5,122,000
for a NME NDA and $4,090,000 for a BLA. Based on these standard costs,
the total cost to review the 53 applications in these two categories in
FY 2013 (31 NME NDAs with clinical data and 22 BLAs) was $248,762,000.
(Note: These numbers exclude the President's Emergency Plan for AIDS
Relief NDAs; no investigational new drug review costs are included in
this amount.) Twenty of these applications (12 NDAs and 8 BLAs)
received priority review, which would mean that the remaining 33
received standard reviews. Because a priority review compresses a
review that ordinarily takes 10 months into 6 months, FDA estimates
that a multiplier of 1.67 (10 months divided by 6 months) should be
applied to non-priority review costs in estimating the effort and cost
of a priority review as compared to a standard review. This multiplier
is consistent with published research on this subject. In the article
``Developing Drugs for Developing Countries,'' published in ``Health
Affairs'', Volume 25, Number 2, in 2006, the comparison of historical
average review times by David B. Ridley, Henry G. Grabowski, and
Jeffrey L. Moe supports a priority review multiplier in the range of
1.48 to 2.35. The multiplier derived by FDA falls well below the
midpoint of this range. Using FY 2013 figures, the costs of a priority
and standard review are estimated using the following formula:

(20 [alpha] x 1.67) + (33 [alpha]) = $248,762,000

Where ``[alpha]'' is the cost of a standard review and ``[alpha] times
1.67'' is the cost of a priority review. Using this formula, the cost
of a standard review for NME NDAs and BLAs is calculated to be
$3,746,000 (rounded to the nearest thousand dollars) and the cost of a
priority review for NME NDAs and BLAs is 1.67 times that amount, or
$6,256,000 (rounded to the nearest thousand dollars). The difference
between these two cost estimates, or $2,510,000, represents the
incremental cost of conducting a priority review rather than a standard
review.
    For FY 2015 fee, FDA will need to adjust the FY 2013 incremental
cost by the average amount by which FDA's average costs increased in
the 3 years prior to FY 2014, to adjust the FY 2013 amount for cost
increases in FY 2014. That adjustment, published in the Federal
Register on August 1, 2014 (see 79 FR 44807 at 44809), setting FY 2015
PDUFA fees, is 2.0813 percent for the most recent year, not compounded.
Increasing the FY 2013 incremental priority review cost of $2,510,000
by 2.0813 percent results in an estimated cost of $2,562,000 (rounded
to the nearest thousand dollars). This is the priority review user fee
amount for FY 2015 that must be submitted with a priority review
voucher in FY 2015, in addition to any PDUFA fee that is required for
such an application.

III. Priority Review Fee Schedule for FY 2015

    The fee rate for FY 2015 is set out in table 1:

     Table 1--Tropical Disease Priority Review Schedule for FY 2015
------------------------------------------------------------------------
                 Fee category                     Fee rate for FY 2015
------------------------------------------------------------------------
Application submitted with a priority review                 $2,562,000
 voucher in addition to the normal PDUFA Fee..
------------------------------------------------------------------------

IV. Implementation of Priority Review Fee

    Under section 524(c)(4)(A) of the FD&C Act, the priority review
user fee is due upon submission of a human drug application for which
the priority review voucher is used. Section 524(c)(4)(B) of the FD&C
Act specifies that the application will be considered incomplete if the
priority review user fee and all other applicable user fees are not
paid in accordance with FDA payment procedures. In addition, FDA may
not grant a waiver, exemption, reduction, or refund of any fees due and
payable under this section of the FD&C Act and FDA may not collect
priority review voucher fees prior to a relevant appropriation for fees
for that FY. Beginning with FDA's appropriation for FY 2009, the annual
appropriation language states specifically that ``priority review user
fees authorized by 21 U.S.C. 360n (section 524 of the FD&C Act) may be
credited to this account, to remain available until expended.'' (Pub.
L. 111-8, Section 5, Division A, Title VI).
    The priority review fee established in the new fee schedule must be
paid for any application that is received on or after October 1, 2014,
and submitted with a priority review voucher. This fee must be paid in
addition to any other fee due under PDUFA. Payment must be made in U.S.
currency by check, bank draft, or U.S. postal money order payable to
the order of the Food and Drug Administration. The user fee
identification (ID) number should be included on the check, followed by
the words ``Priority Review.'' Payments can be mailed to: Food and Drug
Administration, P.O. Box 979107, St. Louis, MO 63197-9000.
    If checks are sent by a courier that requests a street address, the
courier can deliver the checks to: U.S. Bank, Attention: Government
Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery only.) The FDA post office
box number (P.O. Box 979107) must be written on the check. The tax
identification number of FDA is 53-0196965.
    Wire transfer payments may also be used. Please reference your
unique user fee ID number when completing your transfer. The
originating financial institution may charge a wire transfer fee.
Please ask your financial institution about the fee and include it with
your payment to ensure that your fee is fully paid. The account
information is as follows: New York Federal Reserve Bank, U.S. Dept. of
Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Account
Number: 75060099, Routing Number: 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 8455 Colesville Rd., Silver Spring, MD 20993-0002.

    Dated: August 22, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20360 Filed 8-26-14; 8:45 am]
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[Federal Register Volume 83, Number 109 (Wednesday, June 6, 2018)]
[Notices]
[Pages 26277-26278]
[FR Doc No: 2018-12096]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2232-698]

Notice of Availability of Environmental Assessment; Duke Energy
Carolinas, LLC

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission (Commission) regulations,
18 CFR part 380 (Order No. 486, 52 FR 47897), the Office of Energy
Projects has reviewed an application submitted by Duke Energy
Carolinas, LLC (licensee) to allow Carolina Sand, Inc. (Carolina Sand),
in Burke County, North Carolina, the use of Catawba-Wateree
Hydroelectric (FERC No. 2232) project lands and waters to conduct
hydraulic sand mining. The project is located on the Catawba and
Wateree rivers in Burke, McDowell, Caldwell, Catawba, Alexander,
Iredell, Mecklenburg, Lincoln, and Gaston counties, North Carolina, and
York, Lancaster, Chester, Fairfield, and Kershaw counties in South
Carolina. The project does not occupy federal land.
    An Environmental Assessment (EA) has been prepared as part of

Commission staff's review of the proposal. In the application, Carolina
Sand proposes to resume activity at a previously used sand dredging
location, to remove an average of 33,000 tons or 25,385 cubic yards of
sand from Lake Rhodhiss per year. This EA contains Commission staff's
analysis of the probable environmental impacts of the proposed
amendment and concludes that approval of the proposal would not
constitute a major federal action significantly affecting the quality
of the human environment.
    The EA is available for electronic review and reproduction at the
Commission's Public Reference Room, located at 888 First Street NE,
Room 2A, Washington, DC 20426. The EA may also be viewed on the
Commission's website at http://www.ferc.gov using the eLibrary link.
Enter the docket number (P-2232) in the docket number field to access
the document. For assistance, contact FERC Online Support at
[email protected] or toll-free at<PHONE_NUMBER> or for TTY,
(202) 502-8659.
    For further information, contact Alicia Burtner at<PHONE_NUMBER>
or by email at [email protected].

    Dated: May 29, 2018
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2018-12096 Filed 6-5-18; 8:45 am]
BILLING CODE 6717-01-P