[Federal Register Volume 80, Number 187 (Monday, September 28, 2015)]
[Notices]
[Pages 58262-58264]
[FR Doc No: 2015-24508]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Fee for Using a Rare Pediatric Disease Priority Review Voucher in
Fiscal Year 2016

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the fee rate for using a rare pediatric disease priority
review

voucher for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as amended by the Food and Drug Administration
Safety and Innovation Act (FDASIA), authorizes FDA to determine and
collect rare pediatric disease priority review user fees for certain
applications for review of human drug or biological products when those
applications use a rare pediatric disease priority review voucher.
These vouchers are awarded to the sponsors of certain rare pediatric
disease product applications, submitted 90 days or more after July 9,
2012, upon FDA approval of such applications. The amount of the fee for
using a rare pediatric disease priority review voucher is determined
each FY based on the difference between the average cost incurred by
FDA in the review of a human drug application subject to priority
review in the previous FY, and the average cost incurred in the review
of an application that is not subject to priority review in the
previous FY. This notice establishes the rare pediatric disease
priority review fee rate for FY 2016 and outlines the payment
procedures for such fees.

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 908 of FDASIA (Pub. L. 112-144) added section 529 to the
FD&C Act (21 U.S.C. 360ff). In section 529 of the FD&C Act, Congress
encouraged development of new human drugs and biological products for
prevention and treatment of certain rare pediatric diseases by offering
additional incentives for obtaining FDA approval of such products.
Under section 529 of the FD&C Act, the sponsor of an eligible human
drug application submitted 90 days or more after July 9, 2012, for a
rare pediatric disease (as defined in section 529(a)(3)) shall receive
a priority review voucher upon approval of the rare pediatric disease
product application. The recipient of a rare pediatric disease priority
review voucher may either use the voucher for a future human drug
application submitted to FDA under section 505(b)(1) of the FD&C Act
(21 U.S.C. 355(b)(1)) or section 351(a) of the Public Health Service
Act (42 U.S.C. 262(a)), or transfer (including by sale) the voucher to
another party that may then use it for a human drug application
submitted to FDA under section 505(b)(1) of the FD&C Act or section
351(a) of the Public Health Service Act. A priority review is a review
conducted with a Prescription Drug User Fee Act (PDUFA) goal date of 6
months after the receipt or filing date, depending on the type of
application. Information regarding PDUFA goals is available at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
    The applicant that uses a rare pediatric disease priority review
voucher is entitled to a priority review of its eligible human drug
application, but must pay FDA a rare pediatric disease priority review
user fee in addition to any fee required by PDUFA for the application.
Information regarding the rare pediatric disease priority review
voucher program is available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm375479.htm.
    This notice establishes the rare pediatric disease priority review
fee rate for FY 2016 at $2,727,000 and outlines FDA's procedures for
payment of rare pediatric disease priority review user fees. This rate
is effective on October 1, 2015, and will remain in effect through
September 30, 2016.

II. Rare Pediatric Priority Review User Fee for FY 2016

    Under section 529(c)(2) of the FD&C Act, the amount of the rare
pediatric disease priority review user fee is determined each fiscal
year based on the difference between the average cost incurred by FDA
in the review of a human drug application subject to priority review in
the previous fiscal year, and the average cost incurred by FDA in the
review of a human drug application that is not subject to priority
review in the previous fiscal year. The rare pediatric disease priority
review voucher fee is intended to cover the incremental costs for FDA
to do a priority review on a human drug application 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 rare pediatric disease priority review voucher program that is
consistent with the Agency's public health goal of encouraging the
development of new human drugs and biological products for rare
pediatric diseases.
    A priority review is a review conducted with a PDUFA goal date of 6
months after the receipt or filing date, depending on the type of
application. Under the PDUFA goals letter, FDA has committed to
reviewing and acting on 90 percent of the applications granted priority
review status within this expedited timeframe. Normally, an application
for a human drug or biological product will qualify for priority review
if the product is intended to treat a serious condition and, if
approved, would provide a significant improvement in safety or
effectiveness. An application that does not receive a priority
designation will receive a standard review. Under the PDUFA goals
letter, FDA has committed to reviewing and acting on 90 percent of
standard applications within 10 months of the receipt or filing date
depending on the type of application. A priority review involves a more
intensive level of effort and a higher level of resources than a
standard review.
    Section 529 of the FD&C Act specifies that the rare pediatric
disease priority review voucher fee amount must be based on the
difference between the average cost incurred by the Agency in the
review of a human drug application subject to a priority review in the
previous fiscal year, and the average cost incurred by the Agency in
the review of a human drug application not subject to a priority review
in the previous fiscal year. FDA is setting a fee for FY 2016, which is
to be based on standard cost data from the previous fiscal year, FY
2015. However, the FY 2015 submission cohort has not been closed out
yet, thus the cost data for FY 2015 are not complete. The latest year
for which FDA has complete cost data is FY 2014. 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 publishes each year are: (1) New drug applications (NDAs)
for a new molecular entity (NME) with clinical data and (2) biologics
license applications (BLAs) with clinical data.
    The standard cost worksheets for FY 2014 show standard costs
(rounded to the nearest thousand dollars) of $5,646,000 for an NME NDA,
and $5,533,000 for a BLA. Based on these standard costs, the total cost
to review the 48 applications in these two categories in FY 2014 (30
NME NDAs and 18 BLAs with clinical data) was

$268,974,000. (Note: These numbers exclude the President's Emergency
Plan for AIDS Relief NDAs; no investigational new drug (IND) review
costs are included in this amount.) Twenty-nine of these applications
(20 NDAs and 9 BLAs) received priority review, which would mean that
the remaining 19 received standard reviews. Because a priority review
compresses a review schedule 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 which supports a priority review multiplier in the range of
1.48 to 2.35 (Ref. 1). The multiplier derived by FDA falls well below
the midpoint of this range. Using FY 2014 figures, the costs of a
priority and standard review are estimated using the following formula:

(29 [alpha] x 1.67) + (19 [alpha]) = $268,974,000

    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
$3,989,000 (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
$6,662,000 (rounded to the nearest thousand dollars). The difference
between these two cost estimates, or $2,673,000, represents the
incremental cost of conducting a priority review rather than a standard
review.
    For the FY 2016 fee, FDA will need to adjust the FY 2014
incremental cost by the average amount by which FDA's average costs
increased in the 3 years prior to FY 2015, to adjust the FY 2014 amount
for cost increases in FY 2015. That adjustment, published in the
Federal Register on August 3, 2015 (see 80 FR 46028 at 46029), is
2.0266 percent for the most recent year, not compounded. Increasing the
FY 2014 incremental priority review cost of $2,673,000 by 2.0266
percent results in an estimated cost of $2,727,000 (rounded to the
nearest thousand dollars). This is the rare pediatric disease priority
review user fee amount for FY 2016 that must be submitted with a
priority review voucher for a human drug application in FY 2016, in
addition to any PDUFA fee that is required for such an application.

III. Fee Schedule for FY 2016

    The fee rate for FY 2016 is set out in table 1:

  Table 1--Rare Pediatric Disease Priority Review Schedule for FY 2016
------------------------------------------------------------------------
               Fee category                     Fee rate for FY 2016
------------------------------------------------------------------------
Application submitted with a rare           $2,727,000
 pediatric disease priority review voucher
 in addition to the normal PDUFA Fee.
------------------------------------------------------------------------

IV. Implementation of Rare Pediatric Disease Priority Review User Fee

    Under section 529(c)(4)(A) of the FD&C Act, the priority review
user fee is due (i.e. the obligation to pay the fee is incurred) when a
sponsor notifies FDA of its intent to use the voucher. Section
529(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, section 529(c)(4)(C) specifies that FDA may
not grant a waiver, exemption, reduction, or refund of any fees due and
payable under this section of the FD&C Act. Beginning with FDA's
appropriation for FY 2015, the annual appropriation language states
specifically that priority review user fees authorized by 21 U.S.C.
360n and 360ff (section 529 of the FD&C Act) shall be credited to this
account, to remain available until expended.'' (Pub. L. 113-235,
Section 5, Division A, Title VI).
    The rare pediatric disease priority review fee established in the
new fee schedule must be paid for any application that is received on
or after October 1, 2015. In order to comply with this requirement, the
sponsor must contact FDA before providing official notification of its
intent to use the voucher.
    FDA will issue an invoice to the sponsor who has incurred a rare
pediatric disease priority review voucher fee when it receives the
sponsor's notification of intent to use the voucher. The invoice will
include instructions on how to pay the fee via wire transfer or check.
    As noted in section II, if a sponsor uses a rare pediatric disease
priority review voucher for a human drug application, the sponsor would
incur the rare pediatric disease priority review voucher fee in
addition to any PDUFA fee that is required for the application. The
sponsor would need to follow FDA's normal procedures for timely payment
of the PDUFA fee for the human drug application.

IV. Reference

    The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES), and may be seen by interested
person between 9 a.m. and 4 p.m., Monday through Friday.

1. Ridley, D. B., H. G. Grabowski, and J. L. Moe, ``Developing Drugs
for Developing Countries,'' Health Affairs, vol. 25, no. 2, pp. 313-
324, 2006.

    Dated: September 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24508 Filed 9-25-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Rules and Regulations]
[Page 46391]
[FR Doc No: 2018-19729]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2018-0632; Airspace Docket No. 17-AWA-4]
RIN 2120-AA66

Amendment of Chicago Class B and Chicago Class C Airspace;
Chicago, IL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule, technical amendment, correction.

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SUMMARY: This action corrects a final rule published in the Federal
Register of August 16, 2018, that amended the Chicago Class B and
Chicago Class C airspace area descriptions by changing references to
the Chicago O'Hare VHF Omnidirectional Range/Distance Measuring
Equipment (VOR/DME) to ``Point of Origin.'' Additionally, the Chicago
Class B and Chicago Class C airspace area descriptions were edited to
reflect the Chicago Midway International Airport name change to match
the current information in the FAA's aeronautical database. The Chicago
Class B airspace description listed in the rule is corrected to reflect
updated geographic coordinates for the Chicago O'Hare International
Airport airport reference point (ARP), updated geographic coordinates
for two points in the Area A description, and updated geographic
coordinates for one point in the Area F description.

DATES: Effective date 0901 UTC, October 11, 2018. The Director of the
Federal Register approves this incorporation by reference action under
Title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace Policy Group,
Office of Airspace Services, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

History

    The FAA published a final rule in the Federal Register for Docket
No. FAA-2018-0632 (83 FR 40662, August 16, 2018), amending the Chicago
Class B and Chicago Class C airspace area descriptions by changing
references to the Chicago O'Hare VOR/DME to ``Point of OrigiN''
Additionally, the Chicago Class B and Chicago Class C airspace area
descriptions were edited to reflect the Chicago Midway International
Airport name change. Subsequent to publication, the FAA identified
editorial errors in the Chicago Class B description to the geographic
coordinates of the Chicago O'Hare International Airport ARP, the
geographic coordinates to two points in Area A, and the geographic
coordinates to one point in Area F. To accurately reflect the Chicago
Class B airspace area on aeronautical charts and digital charting
applications, this correction changes the geographic coordinates of the
Chicago O'Hare International Airport ARP from ``(lat. 41[deg]58'38'' N,
long. 87[deg]54'29'' W)'' to read ``(lat. 41[deg]58'28'' N, long.
87[deg]54'24'' W)''; the geographic coordinates to two points in Area A
from ``(lat. 41[deg]57'12'' N, long. 88[deg]01'56'' W)'' to read
``(lat. 41[deg]57'26'' N, long. 88[deg]01'39'' W)'' and from ``(lat.
42[deg]05'03'' N, long. 87[deg]56'26'' W)'' to read ``(lat.
42[deg]05'03'' N, long. 87[deg]56'25'' W)''; and the geographic
coordinates to one point in Area F from ``(lat. 41[deg]50'40'' N, long.
88[deg]25'44'' W)'' to read ``(lat. 41[deg]50'39'' N, long.
88[deg]25'43'' W)''.

Correction to Final Rule

    Accordingly, pursuant to the authority delegated to me, in the
Federal Register of August 16, 2018 (83 FR 40662) FR Doc. 2018-17596,
Amendment of Chicago Class B and Chicago Class C Airspace; Chicago, IL,
is corrected as follows:

Sec.  71.1   [Amended]

AGL IL B Chicago, IL [Corrected]

    On page 40664, column 1, line 33, under Chicago O'Hare
International Airport (Primary Airport) remove the text that reads
``(lat. 41[deg]58'38'' N, long. 87[deg]54'29'' W)'' and add in its
place ``(lat. 41[deg]58'28'' N, long. 87[deg]54'24'' W)''.
    On page 40664, column 1, line 51, under Area A remove the text that
reads ``(lat. 41[deg]57'12'' N, long. 88[deg]01'56'' W)'' and add in
its place ``(lat. 41[deg]57'26'' N, long. 88[deg]01'39'' W)''.
    On page 40664, column 1, lines 56 and 57, under Area A remove the
text that reads ``(lat. 42[deg]05'03'' N, long. 87[deg]56'26'' W)'' and
add in its place ``(lat. 42[deg]05'03'' N, long. 87[deg]56'25'' W)''.
    On page 40664, column 3, line 6, under Area F remove the text that
reads ``(lat. 41[deg]50'40'' N, long. 88[deg]25'44'' W)'' and add in
its place ``(lat. 41[deg]50'39'' N, long. 88[deg]25'43'' W)''.

    Issued in Washington, DC, on September 5, 2018.
Rodger A. Dean Jr.,
Manager, Airspace Policy Group.
[FR Doc. 2018-19729 Filed 9-12-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 203 (Monday, October 23, 2017)]
[Notices]
[Pages 49027-49029]
[FR Doc No: 2017-22895]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-E-2358 and FDA-2014-E-2359]

Determination of Regulatory Review Period for Purposes of Patent
Extension; MITRACLIP CDS

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for MITRACLIP CDS and is
publishing this notice of that determination as required by law. FDA
has made the determination because of the submission of applications to
the Director of the U.S. Patent and Trademark Office (USPTO),
Department of Commerce, for the extension of a patent which claims that
medical device.

DATES: Anyone with knowledge that any of the dates as published (in the

SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
December 22, 2017. 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 April 23,
2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 22, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of December 22, 2017. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2014-E-2358 and FDA-2014-E-2359 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; MITRACLIP CDS.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 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 USPTO 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 has approved for marketing the medical device MITRACLIP CDS.
MITRACLIP CDS is indicated for the percutaneous reduction of
significant symptomatic mitral regurgitation (MR >= 3+) due to primary
abnormality of the mitral apparatus (degenerative MR) in patients who
have been determined to be at prohibitive risk for mitral valve surgery
by a heart team, which includes a cardiac surgeon experienced in mitral
valve surgery and a cardiologist experienced in mitral valve disease,
and in whom existing comorbidities would not preclude the expected
benefit from reduction of the mitral regurgitation. Subsequent to this
approval, the USPTO received patent term restoration applications for
MITRACLIP CDS (U.S.

Patent No. 7,288,097 from Abbott Vascular Inc., and U.S. Patent No.
7,464,712, from The Trustees of Columbia University in the City of New
York), and the USPTO requested FDA's assistance in determining the
patents' eligibility for patent term restoration. In a letter dated
November 2, 2015, FDA advised the USPTO that this medical device had
undergone a regulatory review period and that the approval of MITRACLIP
CDS represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
MITRACLIP CDS is 3,846 days. Of this time, 2,515 days occurred during
the testing phase of the regulatory review period, while 1,331 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: April 16, 2003. FDA has verified the
applicants' claims that the date the investigational device exemption
required under section 520(g) of the FD&C Act for human tests to begin
became effective was April 16, 2003.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): March 4,
2010. The applicants claim March 30, 2009, as the date the premarket
approval application (PMA) for MITRACLIP CDS (PMA P100009) was
initially submitted. However, FDA records indicate that the PMA
submitted on March 30, 2009, was incomplete. The complete PMA was
submitted on March 4, 2010, which is considered to be the PMA initially
submitted date.
    3. The date the application was approved: October 24, 2013. FDA has
verified the applicants' claims that PMA P100009 was approved on
October 24, 2013.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In the applications for patent extension,
the applicants seek 1,827 days or 1,721 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (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.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: October 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-22895 Filed 10-20-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 96 (Friday, May 17, 2013)]
[Notices]
[Pages 29162-29163]
[FR Doc No: 2013-11963]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting.

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, May 23,
2013 at 2:00 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Aguilar, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting will be:

Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings; and
Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact the Office of the
Secretary at<PHONE_NUMBER>.

     Dated: May 15, 2013.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-11963 Filed 5-15-13; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)]
[Rules and Regulations]
[Pages 72563-72565]
[FR Doc No: 2015-29200]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-3398; Directorate Identifier 2015-CE-031-AD;
Amendment 39-18328; AD 2015-16-07 R1]
RIN 2120-AA64

Airworthiness Directives; REIMS AVIATION S.A. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for REIMS
AVIATION S.A. Model F406 airplanes. This AD revises AD 2015-16-07,
which required inspection of the left-hand and right-hand rudder
control pedal torque tubes, and, depending on findings, replacement
with a serviceable part. This AD retains the actions of AD 2015-16-07
and adds additional acceptable serviceable replacement parts. The AD
was prompted by reports of detachment of the pilot's rudder control
pedal in flight. We are issuing this AD to require actions to address
the unsafe condition on these products.

DATES: This AD is effective December 28, 2015.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of August
18, 2015 (80 FR 49127).
    We must receive comments on this AD by January 4, 2016.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact ASI
Aviation, A[eacute]rodrome de Reims Prunay, 51360 Prunay, FRANCE;
telephone: +33 3 26 48 46 65; fax: +33 3 26 49 18 57; email: none;
Internet: http://asi-aviation.fr/asi-aviation-support/1.html (requires
user name and password). You may view this referenced service
information at the FAA, Small Airplane Directorate, 901 Locust, Kansas
City, Missouri 64106. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available on the
Internet at http://www.regulations.gov by searching for locating Docket
No. FAA-2015-3398.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
3398; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (telephone
(800) 647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Albert J. Mercado, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On August 6, 2015, we issued AD 2015-16-07, Amendment 39-18232 (80
FR 49127, August 17, 2015). That AD required actions intended to
address an unsafe condition on REIMS AVIATION S.A. Model F406 airplanes
and was based on mandatory continuing airworthiness information (MCAI)
originated by an aviation authority of another country.
    Since we issued AD 2015-16-07, Amendment 39-18232 (80 FR 49127,

August 17, 2015), we received a comment from Hageland Aviation
Services, Inc. requesting that we expand what is allowable to use as a
replacement part for the rudder control pedal torque tube as defined in
paragraph (f)(4) of AD 2015-16-07. The commenter requested that we
include a brand new rudder control pedal that has never been installed
on an airplane because it would have been inspected during
manufacturing. In addition, EASA revised AD 2015-0159-E (2015-0159R1)
to incorporate the above change.
    We agreed with the commenter and have revised this AD to add ``a
new rudder control pedal that has never been installed on an airplane''
to the definition of serviceable part.

Related Service Information Under 1 CFR Part 51

    ASI AVIATION has issued Service Bulletin No.: F406-104, dated July
28, 2015. The actions described in this service information are
intended to correct the unsafe condition identified in the MCAI. The
service information describes procedures for inspection of the left-
hand and right-hand rudder control pedal torque tubes, and, depending
on findings, replacement with a serviceable part. 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 of this AD.

FAA's Determination and Requirements of the 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 this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are issuing this AD because we
evaluated all information provided by the State of Design Authority and
determined the unsafe condition exists and is likely to exist or
develop on other products of the same type design.

FAA's Determination of the Effective Date

    An unsafe condition exists that allows for the immediate adoption
of this AD. The FAA has found there is justification to waive notice
and comment prior to adoption of this rule because it only changes the
definition of a serviceable part to give the option of installing a new
part without inspecting it since it already has been inspected at
manufacture. Therefore, we determine that notice and opportunity for
public comment before issuing this AD are unnecessary.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2014-1123; Directorate
Identifier 2014-CE-037-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD will affect 7 products of U.S. registry.
We also estimate that it will take about 5 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour.
    Based on these figures, we estimate the cost of the AD on U.S.
operators to be $2,975, or $425 per product.
    In addition, we estimate that any necessary follow-on actions will
take about 20 work-hours and require parts costing $10,000, for a cost
of $11,700 per product. We have no way of determining the number of
products that may need these actions.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2015-16-07 (80 FR 49127, August 17, 2015) and adding the following new
AD:

2015-16-07 R1 Reims Aviation S.A.: Amendment 39-18328; Docket No.
FAA-2015-3398; Directorate Identifier 2015-CE-031-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective December 28,
2015.

(b) Affected ADs

    This AD replaces AD 2015-16-07, Amendment 39-18232 (80 FR 49127,
August 17, 2015) (``AD 2015-16-07'').

(c) Applicability

    This AD applies to Reims Aviation S.A. Model F406 airplanes,
serial numbers 0001 through 0098, certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 27: Flight
Controls.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as detachment of
the pilot's rudder control pedal in flight. We are issuing this AD
to detect and correct cracking of the pilot rudder control pedal
which, if not corrected, could result in detachment of the pedal
with possible loss of airplane directional control.

(f) Actions and Compliance

    Unless already done, do the actions in paragraphs (f)(1) through
(f)(4) of this AD.
    (1) Before further flight after August 18, 2015 (the effective
date retained from AD 2015-16-07), do a visual inspection and a dye
or fluorescent penetrant inspection of the rudder control pedal
torque tubes, LH (Part Number (P/N) 5115260-1) and RH (P/N 5115260-
2), following the instructions of PART A of ASI AVIATION Service
Bulletin No.: F406-104, dated July 28, 2015.
    (2) If no crack is detected during the inspection required by
paragraph (f)(1) of this AD, within 100 hours time-in-service (TIS)
after August 18, 2015 (the effective date retained from AD 2015-16-
07), do a magnetic particle inspection of the rudder control pedal
torque tubes, LH (P/N 5115260-1) and RH (P/N 5115260-2), following
the instructions of PART B of ASI AVIATION Service Bulletin No.:
F406-104, dated July 28, 2015.
    (3) If any crack is detected on a rudder control pedal torque
tube during the inspection required by paragraph (f)(1) or (f)(2) of
this AD, before further flight, replace the affected part with a
serviceable part following the instructions of ASI AVIATION Service
Bulletin No.: F406-104, dated July 28, 2015.
    (4) For the purpose of this AD, a serviceable part is:
    (i) A rudder control pedal torque tube (LH P/N 5115260-1 or RH
P/N 5115260-2) that has had a magnetic particle inspection following
the instructions of PART B of ASI AVIATION Service Bulletin No.:
F406-104, dated July 28, 2015, and no cracks were found; or
    (ii) A new rudder control pedal torque tube (LH P/N 5115260-1 or
RH P/N 5115260-2) that has never been installed on an airplane.
    (5) You may install a rudder control pedal torque tube P/N
5115260-1 (LH) or P/N 5115260-2 (RH) on an airplane, provided it is
a serviceable part.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Albert J. Mercado, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>Before using any approved AMOC on any
airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.:
2015-0159-E, dated July 31, 2015, and EASA AD No.: 2015-0159R1,
dated August 24, 2015, for related information. You may examine the
MCAI on the Internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2015-3398.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (3) The following service information was approved for IBR on
August 18, 2015 (80 FR 49127).
    (i) ASI AVIATION Service Bulletin No.: F406-104, dated July 28,
2015.
    (ii) Reserved.
    (4) For service information identified in this AD, contact ASI
Aviation, A[eacute]rodrome de Reims Prunay, 51360 Prunay, FRANCE;
telephone: +33 3 26 48 46 65; fax: +33 3 26 49 18 57; email: none;
Internet: http://asi-aviation.fr/asi-aviation-support/1.html
(requires user name and password).
    (5) You may view this service information at the FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148. It is also available on the Internet at http://www.regulations.gov by searching for locating Docket No. FAA-2015-
3398.
    (6) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on November 6, 2015.
Melvin Johnson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-29200 Filed 11-19-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 44 (Thursday, March 6, 2014)]
[Notices]
[Page 12707]
[FR Doc No: 2014-04924]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 15c2-5; SEC File No. 270-195; OMB Control No. 3235-0198.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 15c2-5 (17 CFR 240.15c2-
5) under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.)
(``Exchange Act''). The Commission plans to submit this existing
collection of information to the Office of Management and Budget
(``OMB'') for extension and approval.
    Rule 15c2-5 prohibits a broker-dealer from arranging or extending
certain loans to persons in connection with the offer or sale of
securities unless, before any element of the transaction is entered
into, the broker-dealer: (1) Delivers to the person a written statement
containing the exact nature and extent of the person's obligations
under the loan arrangement; the risks and disadvantages of the loan
arrangement; and all commissions, discounts, and other remuneration
received and to be received in connection with the transaction by the
broker-dealer or certain related persons (unless the person receives
certain materials from the lender or broker-dealer which contain the
required information); and (2) obtains from the person information on
the person's financial situation and needs, reasonably determines that
the transaction is suitable for the person, and retains on file and
makes available to the person on request a written statement setting
forth the broker-dealer's basis for determining that the transaction
was suitable. The collection of information required by Rule 15c2-5 is
necessary to execute the Commission's mandate under the Exchange Act to
prevent fraudulent, manipulative, and deceptive acts and practices by
broker-dealers.
    The Commission estimates that there are approximately 50
respondents that require an aggregate total of 600 hours to comply with
Rule 15c2-5. Each of these approximately 50 registered broker-dealers
makes an estimated six annual responses, for an aggregate total of 300
responses per year. Each response takes approximately two hours to
complete. Thus, the total compliance burden per year is 600 burden
hours. The approximate cost per hour is $53.00 for clerical labor,
resulting in a total internal compliance cost of $31,800 (600 hours
@$53.00 per hour). These reflect internal labor costs; there are no
external labor, capital, or start-up costs.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number. Please direct your
written comments to: Thomas Bayer, Chief Information Officer,
Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F Street
NE., Washington, DC 20549, or send an email to<EMAIL_ADDRESS>
    Dated: February 28, 2014.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-04924 Filed 3-5-14; 8:45 am]
BILLING CODE 8011-01-P


Meeting between representatives from Amphastar Pharmaceuticals,
Inc./Armstrong Pharmaceuticals Inc. and USEPA on November 30, 2006.

On November 30, 2006, representatives from Amphastar Pharmaceuticals,
Inc./Armstrong Pharmaceuticals (Armstrong) met with EPA’s
Stratospheric Protection Division regarding EPA’s Proposed Rule on the
Allocation of Essential Use Allowances for Calendar Year 2007 (2007 EUA
Proposal).

I. Armstrong representatives: Jack Sihavy, Gregory Newell, Robert
Sussman, John Manthei, and Seth Mailhot; EPA representatives: Drusilla
Hufford, Ross Brennan, and Kirsten Cappel.

II. A Power Point (PPT) presentation was made; the contents of which
were claimed Confidential Business Information (CBI).  Confidential
information is located at EPA headquarters 1310 L St NW.

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

 PAGE

 PAGE   1


[Federal Register: February 26, 2009 (Volume 74, Number 37)]
[Notices]
[Page 8788-8789]
[DOCID:fr26fe09-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

February 19, 2009.
    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at http://www.ferc.gov using
the eLibrary link. Enter the docket number, excluding the last three
digits, in the docket number field to access the document. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.
    Exempt:

------------------------------------------------------------------------
         Docket No.            File date       Presenter or requester
------------------------------------------------------------------------
1. CP09-54-000..............      2-13-09  David Swearingen.
2. PF08-32-000..............       2-9-09  John Wisniewski \1\.

3. P-2210-169...............       2-9-09  T. Rogers \2\.
------------------------------------------------------------------------
\1\ Summary of Telephone conference.
\2\ Record of e-mail exchange.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-4082 Filed 2-25-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: January 9, 2008 (Volume 73, Number 6)]
[Proposed Rules]
[Page 1558-1560]
[DOCID:fr09ja08-15]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-0391; Directorate Identifier 2007-NM-271-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A318-100 and A319-100
Series Airplanes; A320-111 Airplanes; A320-200 Series Airplanes; and
A321-100 and A321-200 Series Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to supersede an existing airworthiness
directive (AD) that applies to certain Airbus Model A318-100 and A319-
100 series airplanes; A320-111 airplanes; A320-200 series airplanes;
and A321-100 and A321-200 series airplanes. The existing AD currently
requires a one-time inspection of the horizontal hinge pin of the 103VU
electrical panel in the avionics compartment to determine if the hinge
pin can move out of the hinge, and related investigative and corrective
actions if necessary. This proposed AD would require installing a hinge
pin stopper on the internal door of the 103VU electrical panel. This
proposed AD results from a report indicating that electrical wire
damage was found in the 103VU electrical panel due to contact between
the hinge pin and the adjacent electrical wire harness. We are
proposing this AD to prevent contact between the horizontal hinge pin
and the adjacent electrical wire harness, which could result in damage
to electrical wires, and consequent arcing and/or failure of associated
systems.

DATES: We must receive comments on this proposed AD by February 8,
2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the instructions for submitting comments.

     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Airbus, 1
Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Management Facility

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Tim Dulin, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-2141; 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-2007-0391;
Directorate Identifier 2007-NM-271-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov
, including any personal information you provide. We

will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On January 26, 2006, we issued AD 2006-03-10, amendment 39-14474
(71 FR 6665, February 9, 2006), for certain Airbus Model A318-100 and
A319-100 series airplanes; A320-111 airplanes; A320-200 series
airplanes; and A321-100 and A321-200 series airplanes. That AD requires
a one-time inspection of the horizontal hinge pin of the 103VU
electrical panel in the avionics compartment to determine if the hinge
pin can move out of the hinge, and related investigative and corrective
actions if necessary. That AD resulted from a report indicating that
electrical wire damage was found in the 103VU electrical panel due to
contact between the hinge pin and the adjacent electrical wire harness.
We issued that AD to prevent contact between the horizontal hinge pin
and the adjacent electrical wire harness, which could result in damage
to electrical wires, and consequent arcing and/or failure of associated
systems.

Actions Since Existing AD Was Issued

    Since we issued AD 2006-03-10, the European Aviation Safety Agency
(EASA), which is the Technical Agent for the Member States of the
European Community, has informed us that the inspections and applicable
corrective actions specified in Airbus All Operators Telex 25A1440,
dated February 15, 2005 (referred to in AD 2006-03-10 as the
appropriate source of service information for the required actions),
are not adequate to address the identified unsafe condition (i.e.,
contact between the horizontal hinge pin and the adjacent electrical
wire harness,

which could result in damage to electrical wires, and consequent arcing
and/or failure of associated systems).

Relevant Service Information

    Airbus has issued Service Bulletin A320-25-1535, dated April 27,
2007. The service bulletin describes procedures for installing a hinge
pin stopper on the internal door of the 103VU electrical panel.
Accomplishing the actions specified in the service information is
intended to adequately address the unsafe condition. The EASA mandated
the service information and issued airworthiness directive 2007-0214,
dated August 7, 2007, to ensure the continued airworthiness of these
airplanes in the European Union.

FAA's Determination and Requirements of the Proposed AD

    These airplanes are manufactured in France and are type
certificated for operation in the United States under the provisions of
section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and
the applicable bilateral airworthiness agreement. As described in FAA
Order 8100.14A, ``Interim Procedures for Working with the European
Community on Airworthiness Certification and Continued Airworthiness,''
dated August 12, 2005, the EASA has kept the FAA informed of the
situation described above. We have examined the EASA's findings,
evaluated all pertinent information, and determined that AD action is
necessary for airplanes of this type design that are certificated for
operation in the United States.
    This proposed AD would supersede AD 2006-03-10. This proposed AD
would require accomplishing the actions specified in the service
bulletin described previously.

Costs of Compliance

    This proposed AD would affect about 658 Airbus Model A318-100 and
A319-100 series airplanes; A320-111 airplanes; A320-200 series
airplanes; and A321-100 and A321-200 series airplanes of U.S. registry.
The new proposed actions would take about 1 work hour per airplane, at
an average labor rate of $80 per work hour. Required parts would cost
about $20 per airplane. Based on these figures, the estimated cost of
the new actions specified in this proposed AD for U.S. operators is
$65,800, or $100 per airplane.

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 have 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 that the 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); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket. See the
ADDRESSES section for a location to examine the regulatory evaluation.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, 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

    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]

    2. The Federal Aviation Administration (FAA) amends Sec.  39.13 by
removing amendment 39-14474 (71 FR 6665, February 9, 2006) and adding
the following new airworthiness directive (AD):

Airbus: Docket No. FAA-2007-0391; Directorate Identifier 2007-NM-
271-AD.

Comments Due Date

    (a) The FAA must receive comments on this AD action by February
8, 2008.

Affected ADs

    (b) This AD supersedes AD 2006-03-10.

Applicability

    (c) This AD applies to Airbus Model A318-111 and -112; A319-111,
-112, -113, -114, -115, -131, -132, and -133; A320-111, -211, -212,
-214, -231, -232, and -233; and A321-111, -112, -131, -211, -212, -
213, -231, and -232 airplanes; certificated in any category; all
manufactured serial numbers; except for those airplanes on which
Airbus Modification 36115 has been done in production or Airbus
Service Bulletin A320-25-1535, dated April 27, 2007, has been done
in service.

Unsafe Condition

    (d) This AD results from a report indicating that electrical
wire damage was found in the 103VU electrical panel due to contact
between the hinge pin and the adjacent electrical wire harness. We
are issuing this AD to prevent contact between the horizontal hinge
pin and the adjacent electrical wire harness, which could result in
damage to electrical wires, and consequent arcing and/or failure of
associated systems.

Compliance

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

Installation

    (f) Within 18 months after the effective date of this AD,
install a hinge pin stopper on the internal door of the 103VU
electrical panel in accordance with the Accomplishment Instructions
of Airbus Service Bulletin A320-25-1535, dated April 27, 2007.

Alternative Methods of Compliance (AMOCs)

    (g)(1) The Manager, International Branch, ANM-116, FAA, has the
authority to approve AMOCs for this AD, if requested in accordance
with the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.

Related Information

    (h) European Aviation Safety Agency airworthiness directive
2007-0214, dated August 7, 2007, also addresses the subject of this
AD.

    Issued in Renton, Washington, on December 19, 2007.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-152 Filed 1-8-08; 8:45 am]

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