[Federal Register Volume 83, Number 101 (Thursday, May 24, 2018)]
[Notices]
[Pages 24127-24128]
[FR Doc No: 2018-11113]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0279]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Prescription Drug
Marketing; Administrative Procedures, Policies, and Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June
25, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0435.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Prescription Drug Marketing Act of 1987--Administrative Procedures,
Policies, and Requirements

OMB Control Number 0910-0435--Extension

    This information collection supports FDA regulations codified at
part 203 (21 CFR part 203) implementing the Prescription Drug Marketing
Act of 1987 (PDMA). The PDMA was intended to ensure safe and effective
drug products and to avoid an unacceptable risk that counterfeit,
adulterated, misbranded, subpotent, or expired drugs are sold to
consumers. The reporting and recordkeeping requirements found in the
regulations are intended to help achieve the following goals: (1) To
ban the reimportation of prescription drugs produced in the United
States, except when reimported by the manufacturer or under FDA
authorization for emergency medical care; (2) to ban the sale,
purchase, or trade, or the offer to sell, purchase, or trade, of any
prescription drug sample; (3) to limit the distribution of drug samples
to practitioners licensed or authorized to prescribe such drugs or to
pharmacies of hospitals or other healthcare entities at the request of
a licensed or authorized practitioner; (4) to require licensed or
authorized practitioners to request prescription drug samples in
writing; (5) to mandate storage, handling, and recordkeeping
requirements for prescription drug samples; (6) to prohibit, with
certain exceptions, the sale, purchase, or trade, or the offer to sell,
purchase, or trade, of prescription drugs that were purchased by
hospitals or other healthcare entities or that were donated or supplied
at a reduced price to a charitable organization; and (7) to require
unauthorized wholesale distributors to provide, prior to the wholesale
distribution of a prescription drug to another wholesale distributor or
retail pharmacy, a statement identifying each prior sale, purchase, or
trade of the drug.
    In the Federal Register of December 14, 2017 (82 FR 58808), we
published a notice soliciting public comment of the information
collection. One caller responded to the notice asking about the impact
the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug
Quality Security Act of 2013) has on the information collection. We
note that the Agency is currently proposing to amend its regulations at
part 203 to reflect changes resulting from enactment of the DSCSA (RIN
0910-AH56). While we expect these changes will result in a reduction of
burden associated with the information collection, current regulations
and associated information collection requirements remain in effect.
Upon finalization of rulemaking, we will revise the information
collection accordingly.
    We therefore estimate the burden for the information collection as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
    21 CFR section/a ctivity        Number of     responses per   Total annual    Average burden    Total hours
                                   respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
203.11--Reimportation..........               1               1               1  0.5 (30                       1
                                                                                minutes).
203.30(a)(1) and (b)--Drug               61,961              12         743,532  0.06 (4                  44,612
 sample requests.                                                                 minutes).
203.30(a)(3), (a)(4), and (c)--          61,961              12         743,532  0.06 (4                  44,612
 Drug sample receipts.                                                            minutes).
203.31(a)(1) and (b)--Drug              232,355             135      31,367,925  0.04 (2.5             1,254,717
 sample requests.                                                                 minutes).
203.31(a)(3), (a)(4), and (c)--         232,355             135      31,367,925  0.03 (2                 941,038
 Drug sample receipts.                                                            minutes).
203.37(a)--Falsification of                  50               4             200  0.25 (15                     50
 records.                                                                         minutes).
203.37(b)--Loss or theft of                  50              40           2,000  0.25 (15                    500
 samples.                                                                         minutes).
203.37(c)--Convictions.........               1               1               1  1..............               1
203.37(d)--Contact person......              50               1              50  0.08 (5                       4
                                                                                minutes).
203.39(g)--Reconciliation                     1               1               1  1..............               1
 report.
                                --------------------------------------------------------------------------------
    Total......................  ..............  ..............  ..............  ...............       2,285,536
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                     Average burden
    21 CFR Section/Activity         Number of      records per    Total annual         per          Total hours
                                  recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
203.23(a) and (b)--Returned              31,676               5         158,380  0.25 (15                 39,595
 drugs.                                                                           minutes).
203.23(c)--Returned drugs                31,676               5         158,380  0.08 (5                  12,670
 documentation.                                                                   minutes).
203.30(a)(2) and 203.31(a)(2)--           2,208             100         220,800  0.5 (30                 110,400
 Practitioner verification.                                                       minutes).
203.31(d)(1) and (2)--Inventory           2,208               1           2,208  40.............          88,320
 record and reconciliation
 report.
203.31(d)(4)--Investigation of              442               1             442  24.............          10,608
 discrepancies and losses.
203.31(e)--Representatives                2,208               1           2,208  1..............           2,208
 lists.
203.34--Administrative systems.              90               1              90  40.............           3,600
203.37(a)--Falsification of                  50               4             200  6..............           1,200
 drug sample records.
203.37(b)--Loss or theft of                  50              40           2,000  6..............          12,000
 drug samples.
203.39(d)--Destroyed or                      65               1              65  1..............              65
 returned drug samples.
203.39(e)--Donated drug samples           3,221               1           3,221  0.5 (30                   1,611
                                                                                minutes).
203.39(f)--Distribution of                3,221               1           3,221  8..............          25,768
 donated drug samples.
203.39(g)--Drug samples donated           3,221               1           3,221  8..............          25,768
 to charitable institutions.
203.50(a)--Drug origin                      125             100          12,500  0.17 (10                  2,125
 statement.                                                                       minutes).
203.50(b)--Drug origin                      125             100          12,500  0.5 (30                   6,250
 statement retention.                                                             minutes).
203.50(d)--Authorized                       691               1             691  2..............           1,382
 distributors of record.
                                --------------------------------------------------------------------------------
    Total......................  ..............  ..............  ..............  ...............         343,570
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of Agency data, we retain the currently approved
burden estimate for the information collection, as reflected in tables
1 and 2 above.

    Dated: May 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11113 Filed 5-23-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: December 18, 2009 (Volume 74, Number 242)]
[Notices]
[Page 67285-67287]
[DOCID:fr18de09-110]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61155; File No. SR-MSRB-2009-18]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Notice of Filing of Proposed Rule Change Consisting of
Amendments to Rule G-37 (Political Contributions and Prohibitions on
Municipal Securities Business) and Rule G-8 (Books and Records To Be
Made by Brokers, Dealers and Municipal Securities Dealers)

December 11, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 4, 2009, the Municipal Securities Rulemaking Board
(``MSRB'') filed with the Securities and Exchange Commission
(``Commission'' or ``SEC'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the MSRB.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The MSRB has filed with the Commission a proposed rule change
consisting of proposed amendments to Rule G-37 (political contributions
and prohibitions on municipal securities business) and Rule G-8 (books
and records to be made by brokers, dealers and municipal securities
dealers). The MSRB requested that the proposed rule change become
effective on, and would apply solely to contributions made on or after,
the first business Monday at least five business days after Commission
approval.
    The text of the proposed rule change is available on the MSRB's Web
site (http://www.msrb.org/msrb1/sec.asp), at the MSRB's principal
office, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the MSRB included statements
concerning the purpose of and basis for the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The MSRB has prepared summaries, set forth in Sections
A, B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The proposed amendments to Rule G-37 would require the public
disclosure of contributions to bond ballot campaigns made by dealers,
municipal finance professionals (``MFPs''), their political action
committees (``PACs'') and non-MFP executive officers on MSRB Form G-37.
Dealers would be required to report on revised Form G-37 the official
name of each bond ballot campaign receiving contributions during such
calendar quarter, the jurisdiction (including city/county/State or
political subdivision) by or for which municipal securities, if
approved, would be issued, the contribution amount made and the
category of contributor. The proposal would provide a de minimis
exception from the reporting of contributions on Form G-37 made by an
MFP or non-MFP executive officer to a bond ballot campaign for a ballot
initiative with respect to which such person is entitled to vote if all
contributions by such person to such bond ballot campaign, in total, do
not exceed $250 per ballot initiative. The amendments would parallel
the existing disclosure requirements for contributions to issuer
officials and State and local political parties. Such amendments would
not, however, provide for a ban on municipal securities business as a
result of contributions to bond ballot campaigns.
    The proposed amendments to Rule G-8 would require dealers to create
and maintain records of the non-de minimis contributions to bond ballot
campaigns that would be required to be disclosed on Form G-37 under the
proposed amendments to Rule G-37.
2. Statutory Basis
    The MSRB has adopted the proposed rule change pursuant to Section
15B(b)(2)(C) of the Act,\3\ which provides that the MSRB's rules shall:
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    \3\ 15 U.S.C. 78o-4(b)(2)(C).

    [B]e designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in
regulating, clearing, settling, processing information with respect
to, and facilitating transactions in municipal securities, to remove
impediments to and perfect the mechanism of a free and open

market in municipal securities, and, in general, to protect
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investors and the public interest.

    The MSRB believes that the proposed rule change is consistent with
the Act because it will protect investors and the public interest and
will assist with preventing fraudulent and manipulative acts and
practices by allowing the public and regulators to monitor dealer
contributions to bond ballot campaigns, thereby further reducing the
opportunity for pay-to-play practices in the municipal securities
market.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The MSRB does not believe the proposed rule change will impose any
burden on competition not necessary or appropriate in furtherance of
the purposes of the Act since it would apply equally to all dealers.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    On June 22, 2009, the MSRB published a notice requesting comment on
draft amendments to Rule G-37.\4\ The MSRB received comments from seven
commentators.\5\ Three of the seven commentators were generally
supportive of the proposed change, with certain exceptions detailed
below.\6\ Two of the seven commentators were against the proposed
change.\7\ Two other commentators did not express an opinion regarding
whether they supported the proposed change.\8\
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    \4\ See MSRB Notice 2009-35 (June 22, 2009).
    \5\ See letters from Robert J. Stracks, Counsel, BMO Capital
Markets (``BMO'') to Leslie Carey, dated August 7, 2009; Robert K.
Dalton, Vice Chairman, George K. Baum & Company (``Baum'') to Leslie
Carey, dated July 30, 2009, along with supplemental letter from Kent
J. Lund, Executive Vice-President, Chief Compliance Officer to
Leslie Carey, dated August 7, 2009; Stratford Shields, Managing
Director, Morgan Stanley (``Morgan Stanley'') to Leslie Carey, dated
July 30, 2009; Frank Fairman, Managing Director and Rebecca
Lawrence, Assistant General Counsel, Piper Jaffray (``Piper'') to
Leslie Carey, dated August 7, 2009; Michael Decker, Co-Chief
Executive Officer and Mike Nichols, Co-Chief Executive Officer,
Regional Bond Dealers Association (``RBDA'') to Leslie Carey, dated
August 7, 2009; Leslie Norwood, Managing Director and Associate
General Counsel, Securities Industry and Financial Markets
Association (``SIFMA'') to Leslie Carey, dated August 7, 2009; and
Kenneth E. Williams, President, Chief Executive Officer, Stone &
Youngberg (``Stone & Youngberg'') to Leslie Carey dated August 13,
2009.
    \6\ See letters from Morgan Stanley, Piper and SIFMA.
    \7\ See letters from Baum and RDBA.
    \8\ See letters from BMO and Stone & Youngberg.
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    General. Morgan Stanley supported the proposed change but requested
that the MSRB consider having bond ballot campaign contributions result
in a ban on municipal securities business. SIFMA also supported the
proposed change and noted that ``there are no uniform disclosure
methodologies or transparency vehicles for bond ballot measure campaign
contributions across the various State and local jurisdictions that may
have bond ballot measures.'' SIFMA further stated ``the transparency
this rule change will create would reap benefits that outweigh any
additional compliance burdens and costs for the municipal securities
dealer community.''
    Piper supported the disclosure of contributions to bond election
campaigns but not those by individual MFPs and executive officers.
Piper noted it is not aware that contributions to bond ballot measures
by individuals are prevalent and stated that such contributions are
likely subject to State and local reporting requirements. Stone &
Youngberg stated that the proposed change may seem a way ``to keep in
check the appearance of impropriety in the municipal marketplace'' but
that, unless the MSRB requires disclosures or bans with respect to all
contributions of time or money that are given by any employee at banks
and dealer firms to entities that issue municipal bonds, the rules will
continue to favor certain participants in the municipal finance
business. BMO stated that it was not sure of the rationale for
disclosure of dealer contributions to bond ballot campaigns.
    After reviewing the comments, the MSRB is filing the proposed rule
change to require the public disclosure of dealer contributions to bond
ballot campaigns. The MSRB believes, as noted by SIFMA, that the
proposed rule change would create a uniform disclosure regime to track
and make available to public scrutiny bond ballot campaign
contributions by dealers in the municipal securities market, thereby
increasing available information to municipal securities market
participants and the general public. The MSRB does not believe that a
ban on municipal securities business as a result of a contribution to a
bond ballot campaign is warranted at this time but notes that the
disclosures provided for under the proposed rule change will assist in
determining, in the future, whether it would be appropriate to consider
further action in this area.
    The MSRB does not agree with Piper's comments that the proposed
rule change should not require the disclosure of contributions by
individual MFPs and executive officers since the MSRB does not believe
that a satisfactory basis for providing different disclosure
requirements for bond ballot contributions as compared to other
political contributions or payments as is currently required under Rule
G-37 has been established. The MSRB notes that patterns and practices
observed through the disclosures that would be required under the
proposed rule change could serve as a basis for making such
differentiation in connection with any further regulatory action in
this area in the future, if appropriate.
    In-Kind Contributions. SIFMA stated that the use of in-house
resources should not be reported because the valuation of such services
may be difficult to ascertain. BMO also noted that, if the proposed
amendments are approved, they ``should either only require reporting of
cash contributions or require much more general information as to in-
kind services as opposed to cash contributions'' because the
requirement to value and report in-kind contributions is ``fraught with
impossible practical difficulties.'' The RBDA similarly stated, ``it
would be extraordinarily difficult in many cases for dealers to
segregate in-kind services for bond ballot campaigns from other
services provided in the context of underwriting bond issues and to
value those services accurately.'' Baum requested that in-kind services
be treated differently from cash contributions because ``measurement of
in-kind contributions may represent a real challenge * * *.''
    The existing definition of contribution in Rule G-37 is not limited
to cash payments and generally would cover anything of value, including
in-kind contributions.\9\ The MSRB has determined not to amend the term
contribution and dealers would be required to report such contributions
to bond ballot campaigns just as they are currently required to report
such non-cash contributions under Rule G-37 with respect to political
contributions to issuer officials.\10\ The MSRB believes

the public disclosure of such contributions, including cash and in-kind
services, will allow public scrutiny of such contributions and the
potential connection between such contributions and the awarding of
municipal securities business.
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    \9\ Contribution is defined in Rule G-37(g) as any gift,
subscription, loan, advance, or deposit of money or anything of
value made: (A) For the purpose of influencing any election for
Federal, State or local office; (B) for payment of debt incurred in
connection with any such election; or (C) for transition or
inaugural expenses incurred by the successful candidate for State or
local office.
    \10\ The MSRB has previously provided guidance regarding the
treatment of contributions as the use of dealer resources or the
incurrence of expenses by dealers in connection with a political
campaign. The MSRB has made clear that Rule G-37 does not prohibit
or limit individuals from providing volunteer services in support of
an issuer official so long as dealer resources were not used, and
has also noted that certain incidental expenses incurred by such
individual would generally not be treated as a contribution. See
Rule G-37 Question and Answers II.18 (May 24, 1994) and II.19
(August 18, 1994). These principles would apply equally to
individuals providing volunteer services in connection with a bond
ballot campaign.
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    Constitutionality. Baum and the RBDA did not support the proposed
change that would require disclosure of bond ballot campaign
contributions and noted that such contributions do not have an element
of pay-to-play that may exist for contributions to campaigns for
political office because, for bond ballot measures, no individual
politician benefits directly from the outcome of a bond ballot
election. They also asserted that bond ballot campaign contributions
are subject to strict scrutiny for possible violations of the First
Amendment, citing Dallman et al. v. Ritter et al.\11\
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    \11\ Findings of Fact, Conclusions of Law and Order Entering
Preliminary Injunction issued in Dallman et al. v. William Ritter
and Rich L. Gonzales and Daniel Ritchie et al. v. Bill Ritter and
Rich Gonzales (Case No. 09CV1188 consolidated with 09CV1200), (D.
Colo. 2009) [hereinafter Dallman].
---------------------------------------------------------------------------

    Dallman concerned the constitutionality of an amendment to
Colorado's constitution, passed by voter election in Colorado in
November 2008, which prohibits contributions to promote or influence a
bond ballot issue election by a person wishing to qualify for a sole
source government contract relating to the ballot issue. Plaintiffs
claimed that the amendment violated their First Amendment rights to
free speech and association. The court stated that, ``the part of
Amendment 54 that bans those subject to it from contributing to ballot
measure campaigns is subject to strict scrutiny. A vote for or against
a ballot measure is an exercise of free speech, and an economic
contribution to a committee designed to support or oppose a ballot
measure is similarly of constitutional magnitude.'' \12\ The court then
determined that the amendment to prohibit bond ballot measure
contributions was not narrowly tailored to advance a compelling state
interest and was unconstitutional.
---------------------------------------------------------------------------

    \12\ Dallman, p. 19.
---------------------------------------------------------------------------

    The MSRB believes that the requirement to provide public disclosure
of contributions to bond ballot campaigns does not hamper or interfere
with an individual's ability to be involved with and/or support issues
related to bond ballot campaigns. The MSRB does not believe the
proposed rule change will impinge upon the First Amendment rights of
individuals and/or firms that will be responsible for providing
disclosure of bond ballot measure contributions \13\ because the
proposed rule change would only require disclosure and would not
prohibit contributions, as was at issue in Dallman. Disclosure
obligations do not present the same constitutional issues as do direct
or indirect prohibitions or limitations on contributions.
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    \13\ In Blount v. Securities and Exchange Commission, 61 F.3d
938, 948 (DC Cir. 1995), the District Court determined that existing
Rule G-37 advanced a compelling governmental interest to protect
investors that did not abridge First Amendment rights and stated
that ``municipal finance professionals are not in any way restricted
from engaging in the vast majority of political activities,
including making direct expenditures for the expression of their
views.''
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III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    A. By order approve such proposed rule change, or
    B. Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-MSRB-2009-18 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-MSRB-2009-18. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the MSRB. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-MSRB-2009-18 and should be
submitted on or before January 8, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-30084 Filed 12-17-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 246 (Friday, December 21, 2012)]
[Notices]
[Page 75630]
[FR Doc No: 2012-30771]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission hereby gives notice that
members of the Commission's staff may attend the following meeting
related to the transmission planning activities of ISO New England
Inc., New York Independent System Operator, Inc., and PJM
Interconnection, L.L.C.:
    Joint Inter-Regional Planning Task Force/Electric System Planning
Working Group December 20, 2012, 11:00 a.m. to 4:00 p.m., Local Time.
    The above-referenced meeting is open to stakeholders and will be
held at:

NYISO's offices, Rensselaer, NY.

    Further information may be found at www.nyiso.com.
    The discussions at the meetings described above may address matters
at issue in the following proceedings:
    Docket No. ER08-1281, New York Independent System Operator, Inc.
    For more information, contact James Eason, Office of Energy Market
Regulation, Federal Energy Regulatory Commission at<PHONE_NUMBER> or
<EMAIL_ADDRESS>
    Dated: December 17, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-30771 Filed 12-20-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 69 (Tuesday, April 10, 2018)]
[Notices]
[Pages 15390-15391]
[FR Doc No: 2018-07256]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1262]

Notice of Approval of Products Under Voucher: Rare Pediatric
Disease Priority Review Vouchers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of several approvals of products redeeming a priority review
voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug Administration Safety and Innovation Act
(FDASIA), authorizes FDA to award priority review vouchers to sponsors
of approved rare pediatric disease product applications that meet
certain criteria. FDA is required to publish notice of the issuance of
vouchers as well as the approval of products redeeming a voucher.

FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>, Fax: 301-
796-9856, email: [email protected].

SUPPLEMENTARY INFORMATION: Under section 529 of the FD&C Act (21 U.S.C.
360ff), which was added by FDASIA, FDA will report the issuance of rare
pediatric disease priority review vouchers and the approval of products
for which a voucher was redeemed.
    FDA has determined that the following approved drugs meet the
redemption criteria:
     PRALUENT (alirocumab) approved July 24, 2015,
     SOLIQUA (insulin glargine and lixisenatide) approved
November 21, 2016, and
     JULUCA (dolutegravir and rilpivirine) approved November
21, 2017.
    For further information about the Rare Pediatric Disease Priority
Review Voucher Program and for a link to the full text of section 529
of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about PRALUENT (alirocumab), SOLIQUA (insulin glargine and
lixisenatide), and JULUCA (dolutegravir and rilpivirine), go to the
``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: April 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07256 Filed 4-9-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 57 (Friday, March 26, 2021)]
[Proposed Rules]
[Pages 16126-16130]
[FR Doc No: 2021-05561]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0189; Project Identifier AD-2020-00645-R]
RIN 2120-AA64

Airworthiness Directives; Various Restricted Category Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for type certificated Model UH-1H restricted category helicopters. This
proposed AD was prompted by multiple reports of failure of the main
driveshaft. This proposed AD would require establishing a life limit
for certain main driveshafts, and a one-time and repetitive inspections
of the main driveshafts. The FAA is proposing this AD to address the
unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by May 10,
2021.

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 https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Army
Publishing Directorate, 9301 Chapek Rd., Bldg 1458, Fort Belvoir, VA
22060-5447; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>or at https://armypubs.army.mil/.
    You may also contact the following as applicable:
    Arrow Falcon Exporters Inc., 2081 S Wildcat Way, Porterville, CA
93257; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    Global Helicopter Technology, Inc., P.O. Box 180681, Arlington,
Texas 76096; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    Hagglund Helicopters, LLC, 5101 NW A Avenue, Pendleton, OR 97801;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>.
    JASPP Engineering Services, LLC., 511 Harmon Terrace, Arlington, TX
76010; telephone<PHONE_NUMBER>; or at www.jjaspp.com.
    Northwest Rotorcraft, LLC, 1000 85th Ave. SE, Olympia, WA 98501;
telephone<PHONE_NUMBER>; or at www.nwhelicopters.com.
    Overseas Aircraft Support, Inc., P.O. Box 898, Lakeside, AZ 85929;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
    Richards Heavylift Helo, Inc., 1181 Osprey Nest Point, Orange Park,
FL 32073;<PHONE_NUMBER>; email<EMAIL_ADDRESS>    Rotorcraft Development Corporation, P.O. Box 430, Corvallis, MT
59828; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    Southwest Florida Aviation International, Inc., 28000-A9 Airport
Road, Bldg. 101, Punta Gorda, FL 33982-9587; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>    Tamarack Helicopters, Inc., 2849 McIntyre Rd., Stevensville, MT
59870; telephone<PHONE_NUMBER>; or at www.tamarackhelicopters.com.
    You may view this service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0189; 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, any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Matthew L. Thompson, Aerospace
Engineer, DSCO Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0189; Project Identifier
AD-2020-00645-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential

under the FOIA, and they will not be placed in the public docket of
this NPRM. Submissions containing CBI should be sent to Matthew L.
Thompson, Aerospace Engineer, DSCO Branch, FAA, 10101 Hillwood Pkwy.,
Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Any commentary that the FAA receives which
is not specifically designated as CBI will be placed in the public
docket for this rulemaking.

Background

    The FAA proposes to adopt a new AD for type certificated Model UH-
1H restricted category helicopters. The type certificate holders for
these helicopters include but are not limited to Arrow Falcon Exporters
Inc.; Global Helicopter Technology, Inc.; Hagglund Helicopters, LLC;
JJASPP Engineering Services, LLC.; Northwest Rotorcraft, LLC; Overseas
Aircraft Support, Inc.; Richards Heavylift Helo, Inc.; Rotorcraft
Development Corporation; Southwest Florida Aviation International,
Inc.; and Tamarack Helicopters, Inc.
    This proposed AD was prompted by multiple reports of failure of a
main driveshaft. This proposed AD would require establishing a life
limit for certain part-numbered main driveshafts, removing and
inspecting the main driveshaft, inspecting the alignment of the main
driveshaft installation, and repetitive inspections of the main
driveshaft. As an optional terminating action, this AD allows the
installation of a certain part-numbered main driveshaft not affected by
this unsafe condition. This condition, if not addressed, could result
in loss of engine power to the transmission and subsequent loss of
control of the helicopter.

FAA's Determination

    The FAA is issuing this NPRM after determining that the unsafe
condition described previously is likely to exist or develop on other
products of the same type design.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Headquarters, Department of the Army, Aviation
Unit and Intermediate Maintenance Instructions Army Model UH-1H/V/EH-
1H/X Helicopters, Technical Manual TM 55-1520-210-23-1, Change No. 42,
dated April 14, 2003. This service information contains main driveshaft
assembly figures and specifies procedures for the main driveshaft
disassembly, cleaning, inspecting, repairing, lubricating and assembly,
installing, and inspecting and correction of its alignment.
    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 ADDRESSES.

Proposed AD Requirements in This NPRM

    This proposed AD would require, before further flight after the
effective date of this AD, establishing a life limit of 5,000 hours
time-in-service (TIS) for KAflex main driveshaft part number (P/N)
SKCP2180-1, SKCP2281-1, SKCP2281-1R, and SKCP2281-103. This proposed AD
would also require, within 25 hours TIS after the effective date of
this AD, removing the main driveshaft and inspecting the main
driveshaft for any broken, loose, or missing hardware; each flex frame
and mount bolt torque stripe for movement; each joint for fretting
corrosion; the main driveshaft for damage; and the alignment of the
main driveshaft, and if required, adjusting the alignment. This
proposed AD would then require, at intervals not to exceed 300 hours
TIS, repeating the inspections with the main driveshaft installed.
    As an optional terminating action, this proposed AD would allow
installing KAflex main driveshaft P/N SKCP3303-1.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 384 helicopters of U.S. registry. Labor rates are estimated at
$85 per work-hour. Based on these numbers, the FAA estimates that
operators may incur the following costs in order to comply with this
proposed AD.
    Determining the total hours TIS of the main driveshaft would take
about 0.5 work-hour for an estimated cost of about $43 per helicopter
and $16,512 for the U.S. fleet. Removing and inspecting the main
driveshaft would take about 4 work-hours for an estimated cost of $340
per helicopter and $130,560 for the U.S. fleet. Inspecting the
installed main driveshaft would take about 1 work-hour for an estimated
cost of about $85 per helicopter and $32,640 for the U.S. fleet, per
inspection cycle. Inspecting the alignment of the main driveshaft
installation would take about 2 work-hours for an estimated cost of
$170 per helicopter and $65,280 for the U.S. fleet. If required,
adjusting the alignment would take about 0.5 work-hour for an estimated
cost of $43 per instance. Replacing a main driveshaft would take about
1 work-hour and parts would cost about $54,000, for an estimated cost
of $54,085 per replacement.

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.
    The FAA is 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

    The FAA 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) Would not affect intrastate aviation in Alaska, and
    (3) Would 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:

Various Restricted Category Helicopters: Docket No. FAA-2021-0189;
Project Identifier AD-2020-00645-R.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by May 10, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to restricted category Model UH-1H helicopters;
current type certificate holders include but are not limited to
Arrow Falcon Exporters Inc.; Global Helicopter Technology, Inc.;
Hagglund Helicopters, LLC; JJASPP Engineering Services, LLC.;
Northwest Rotorcraft, LLC; Overseas Aircraft Support, Inc.; Richards
Heavylift Helo, Inc.; Rotorcraft Development Corporation; Southwest
Florida Aviation International, Inc.; and Tamarack Helicopters,
Inc., with KAflex main driveshaft part number (P/N) SKCP2180-1,
SKCP2281-1, SKCP2281-1R, or SKCP2281-103 installed.

    Note 1 to paragraph (c):  Helicopters with an SW205 designation
are Southwest Florida Aviation International, Inc., Model UH-1H
helicopters.

(d) Subject

    Joint Aircraft System Component (JASC) Code: 6310, Engine/
Transmission Coupling.

(e) Unsafe Condition

    This AD was prompted by multiple reports of failure of the main
driveshaft. The unsafe condition, if not addressed, could result in
loss of engine power to the transmission and subsequent loss of
control of the helicopter.

(f) Compliance

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

(g) Required Actions

    (1) Before further flight after the effective date of this AD,
determine the total hours time-in-service (TIS) of the main
driveshaft.
    (i) If the main driveshaft has accumulated less than 5,000 total
hours TIS, before exceeding 5,000 total hours TIS, remove the main
driveshaft from service.
    (ii) If the main driveshaft has accumulated 5,000 or more total
hours TIS, before further flight, remove the main driveshaft from
service.
    (2) Thereafter following paragraph (g)(1) of this AD, remove the
main driveshaft from service before accumulating 5,000 total hours
TIS.
    (3) Within 25 hours TIS after the effective date of this AD,
remove main driveshaft P/N SKCP2180-1, SKCP2281-1, SKCP2281-1R, or
SKCP2281-103 by following 6-24.3. Removal--Main Driveshaft P/N
SKCP2281-103, of Headquarters, Department of the Army, Aviation Unit
and Intermediate Maintenance Instructions Army Model UH-1H/V/EH-1H/X
Helicopters, Technical Manual TM 55-1520-210-23-1, Change No. 42,
dated April 14, 2003 (TM 55-1520-210-23-1) and:
    (i) Inspect for any broken, loose, or missing hardware. If there
is broken or loose hardware, before further flight, remove the
driveshaft from service. If there is missing hardware, before
further flight, replace the driveshaft.
    (ii) Visually inspect each flex frame and mount bolt torque
stripe (red or yellow) for movement. If there is any torque stripe
movement, before further flight, replace the driveshaft.
    (iii) Visually inspect each joint for fretting corrosion, which
may be indicated by red metallic particles. If there is any grease,
oil, or dirt covering a joint, clean the area and visually inspect
again. If there is any fretting corrosion, before further flight,
replace the driveshaft.
    (iv) Inspect the main driveshaft for mechanical damage,
corrosion, an edge dent, and nick as shown in Figure 1 to paragraph
(g)(3)(iv) of this AD. For the purposes of this inspection,
mechanical damage may be indicated by a crack, scratch, or wear; and
corrosion may be indicated by corrosion or pitting. If there is a
scratch, wear, corrosion, pitting, an edge dent, or a nick within
allowable limits, before further flight, repair the main driveshaft
in accordance with FAA-approved procedures. If there is a crack, or
a scratch, wear, corrosion, pitting, an edge dent, or a nick that
exceeds allowable limits, before further flight, replace the
driveshaft.
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    (4) Before installing the main driveshaft following paragraph
(g)(3) of this AD, and with the engine adapter installed in the end
of the engine output shaft, inspect the alignment of the main
driveshaft installation between the transmission input drive quill
coupling and the engine output shaft adapter by following 6-24.
Alignment--Main Driveshaft, paragraphs c. through g., of TM 55-1520-
210-23-1. If there is misalignment, before further flight, adjust
the alignment by following 6-24. Alignment--Main Driveshaft,
paragraphs h. through j., of TM 55-1520-210-23-1.
    (5) Within 300 hours TIS after the effective date of this AD,
and thereafter within intervals not to exceed 300 hours TIS, with

the main driveshaft installed, accomplish the actions in paragraphs
(g)(3)(i) through (iv) of this AD.
    (6) As an optional terminating action for the requirements of
this AD, you may install KAflex main driveshaft P/N SKCP3303-1.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, DSCO 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 Related Information. Information may be emailed to<EMAIL_ADDRESS>    (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.

(i) Related Information

    (1) For more information about this AD, contact Matthew L.
Thompson, Aerospace Engineer, DSCO Branch, FAA, 10101 Hillwood
Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact Army
Publishing Directorate, 9301 Chapek Rd., Bldg 1458, Fort Belvoir, VA
22060-5447; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>or at https://armypubs.army.mil/.
You may view the service information identified in this AD at the
FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information
on the availability of this material at the FAA, call (817) 222-
5110. You may also contact the following, as applicable:
    (i) Arrow Falcon Exporters Inc., 2081 S Wildcat Way,
Porterville, CA 93257; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (ii) Global Helicopter Technology, Inc., P.O. Box 180681,
Arlington, Texas 76096; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (iii) Hagglund Helicopters, LLC, 5101 NW A Avenue, Pendleton, OR
97801; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax (541) 276-
1597.
    (iv) JASPP Engineering Services, LLC., 511 Harmon Terrace,
Arlington, TX 76010; telephone<PHONE_NUMBER>; or at www.jjaspp.com.
    (v) Northwest Rotorcraft, LLC, 1000 85th Ave. SE, Olympia, WA
98501; telephone<PHONE_NUMBER>; or at www.nwhelicopters.com.
    (vi) Overseas Aircraft Support, Inc., P.O. Box 898, Lakeside, AZ
85929; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
    (vii) Richards Heavylift Helo, Inc., 1181 Osprey Nest Point,
Orange Park, FL 32073;<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (viii) Rotorcraft Development Corporation, P.O. Box 430,
Corvallis, MT 59828; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (ix) Southwest Florida Aviation International, Inc., 28000-A9
Airport Road, Bldg. 101, Punta Gorda, FL 33982-9587; telephone (941)
637-1161; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (x) Tamarack Helicopters, Inc., 2849 McIntyre Rd., Stevensville,
MT 59870; telephone<PHONE_NUMBER>; or at
www.tamarackhelicopters.com.

    Issued on March 12, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-05561 Filed 3-25-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: September 28, 2010 (Volume 75, Number 187)]
[Proposed Rules]
[Page 59661-59666]
[DOCID:fr28se10-18]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 187

[Docket No. FAA-2010-0326; Notice No. 10-12]
RIN 2120-AJ68

Update of Overflight Fees

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This NPRM proposes to adjust existing Overflight Fees by using
current FAA cost accounting data and air traffic activity data. This
action is necessary because operational costs for providing air traffic
control and related services for Overflights have increased steadily
since the fees were established in 2001. The adjustment of Overflight
Fees would result in an increased level of cost recovery for the
services being provided.

DATES: Send your comments on or before December 27, 2010.

ADDRESSES: You may send comments identified by Docket Number FAA-2010-
0326 using any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue, SE., Room W12-
140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.

For more information on the rulemaking process, see the SUPPLEMENTARY
INFORMATION section of this document.

    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket web site, anyone can
find and read the electronic form of all comments received into any of
our dockets, including the name of the individual sending the comment
(or signing the comment for an association, business, labor union,
etc.). You may review DOT's complete Privacy Act Statement in the
Federal Register published on April 11, 2000 (65 FR 19477-78) or you
may visit http://DocketsInfo.dot.gov.
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time and follow the online
instructions for accessing the docket, or, go to Docket Operations in
Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this proposed rule contact David Lawhead, Office of Financial Controls,
Financial Analysis Division (AFC 300), Federal Aviation Administration,
800 Independence Avenue, SW., Washington, DC 20591; telephone (202)
267-9759 facsimile<PHONE_NUMBER>, e-mail to<EMAIL_ADDRESS>For
legal questions concerning this proposed rule contact Michael Chase,
AGC-240, Office of Chief Counsel, Regulations Division, Federal
Aviation Administration, 800 Independence Avenue, SW., Washington, DC
20591; telephone:<PHONE_NUMBER>; e-mail to<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Later in this preamble under the Additional
Information section, we discuss how you can comment on this proposal
and how we will handle your comments. Included in this discussion is
related information about the docket, privacy, and the handling of
proprietary or confidential business information. We also discuss how
you can get a copy of related rulemaking documents.

Authority for This Rulemaking

    The FAA's authority to establish these fees is found in Title 49 of
the United States Code. This rulemaking is promulgated under the
authority described in Chapter 453, Section 45301 et seq. Under that
Chapter, the FAA is charged with prescribing regulations for the
collection of fees for air traffic control and related services
provided to aircraft, other than military and civilian aircraft of the
United States government or a foreign government, that transit U.S.-
controlled airspace, but neither take off from nor land in the United
States (``Overflights''). This proposed regulation is within the scope
of that authority.

I. Background

    The FAA's Overflight Fees were initially authorized in the Federal
Aviation Reauthorization Act of 1996 (Pub. L. 104-264, enacted October
9, 1996). Overflight Fees are charges for aircraft flights that transit
U.S.-controlled airspace, but neither land in nor depart from the
United States. Following enactment of the initial fee authority, and as
mandated by that authority, the FAA issued an Interim Final Rule (IFR),
``Fees for Air Traffic Services for Certain Flights through U.S.
Controlled Airspace'' (62 FR 13496), on March 20, 1997. Under the terms
of the IFR, the FAA sought public comment on the IFR while concurrently
beginning to assess Overflight Fees 60 days after its publication, on
May 19, 1997.
    On July 17, 1997, petitions for judicial review of the IFR were
filed in the U.S.

Court of Appeals for the District of Columbia (the Court) by the Air
Transport Association of Canada (ATAC) and seven foreign air carriers.
Those petitions were consolidated into a single case (Asiana Airlines
v. FAA, 134 F.3d 393 (D.C. Cir. 1998)). The litigation proceeded
throughout the remainder of 1997 while the FAA continued to collect
fees pursuant to the statute.
    On January 30, 1998, the Court issued a decision, upholding the FAA
on three process and procedure issues, but vacating the Rule because
the Court found that the methodology the FAA used to allocate costs did
not conform to the statute. The FAA immediately suspended billing
operations, and eventually refunded nearly $40 million in fees that had
then been collected.
    Although the 1997 IFR (62 FR 13496) had been set aside by the
Court, the statutory requirement that the FAA establish Overflight Fees
through an IFR remained in effect. One of the principal criticisms the
FAA had received from the public commenters on its 1997 IFR concerned
the quality of the cost information upon which the Overflight Fees were
based. The FAA had already begun developing a new Cost Accounting
System (CAS) in 1996. Early data from the new CAS was becoming
available in 1998. Thus, when the FAA decided, following the initial
litigation, to issue a new IFR, a key element of that decision was that
the fees would be derived from cost data from the new CAS.
    A new IFR was published in the Federal Register on June 6, 2000 (65
FR 36002), with fees scheduled to go into effect on August 1, 2000.
This new IFR was challenged in court by the ATAC and a slightly
different group of seven foreign air carriers. The FAA began assessing
and collecting the new Overflight Fees as scheduled on August 1, 2000,
while public comments were still being received by the FAA on its
second IFR. The litigation proceeded concurrently, with oral arguments
held on May 14, 2001.
    On July 13, 2001, the Court again vacated the FAA's IFR, this time
because the Court believed the FAA had failed to explain a key
assumption in its costing methodology. (Air Transport Association of
Canada v. FAA; 00-1344, July 13, 2001). Under the Court's order, there
were 45 days before the IFR was to be vacated. As noted above, the FAA
had solicited public comment on the IFR at the time it was published.
The FAA had received many comments on the several issues raised in the
litigation. At the time the Court's decision was issued, the FAA was
nearing completion of a Final Rule that would address these issues in
the disposition of public comments section of its preamble.
    The FAA therefore proceeded on two fronts. It successfully
petitioned the Court not to vacate the IFR while it proceeded
concurrently with issuance of the Final Rule (``Fees for FAA Services
for Certain Flights,'' 66 FR 43680) on August 20, 2001, with revised
fees effective immediately. In addition to addressing the public
comments received on the IFR, the Final Rule reduced fees by about 15
percent due to adjustments in the original cost data. A new challenge
to the revised fees was brought after the issuance of the Final Rule by
ATAC and the same group of air carriers. The two cases, one challenging
the IFR (65 FR 36002) issued in 2000 and the other challenging the
Final Rule (66 FR 43680) issued in 2001, were combined by the Court
into a single case.
    While the litigation was still pending, on November 19, 2001,
Congress enacted the Aviation and Transportation Security Act (ATSA),
which included a provision that amended the Overflight Fee
authorization (1) To require that the fees be ``reasonably'' (rather
than ``directly'') related to costs, (2) to clarify that the
Administrator has sole authority to determine the costs upon which the
fees are based, and (3) to state explicitly that such cost
determinations by the Administrator are not subject to judicial review.
Meanwhile, the litigation proceeded into 2003, with the FAA continuing
to collect the fees as required by statute.
    On April 8, 2003, the Court issued a decision setting aside the
Final Rule and remanding it back to the FAA, finding that the agency
had not adequately explained its handling of controller labor costs in
deriving the fees. Air Transport Association of Canada v. FAA, 323 F.3d
1093 (D.C. Cir. 2003). The Court also found that the Overflight Fees
amendments in the ATSA statute were inapplicable because of a generic
``savings'' provision in the ATSA legislation that stated that nothing
enacted in ATSA was applicable to any litigation ongoing prior to the
date of enactment of ATSA. Fee collections were immediately suspended.
    On December 12, 2003, Congress enacted VISION 100--CENTURY OF
AVIATION REAUTHORIZATION ACT, (Vision 100). Section 229 of that Act
explicitly ``adopted, legalized, and confirmed'' both the IFR published
in 2000 and the Final Rule published in 2001. In addition, the FAA was
directed to hold a consultation meeting with users (those who pay the
Overflight Fees to the FAA) and to submit a report to Congress
addressing the issues that had been in dispute in the litigation before
resuming the billing and collection of the Overflight Fees.
    Because there were ambiguous and potentially conflicting provisions
in Vision 100 concerning Overflight Fees, the Administrator issued an
Order on July 21, 2004, that set forth her interpretation of the
language of the statute and, based on that interpretation, made
determinations as to the ultimate disposition of Overflight Fees
collected by the FAA under both the 2000 IFR and the 2001 Final Rule.
The FAA retained a portion of the funds collected under the Final Rule,
while either refunding or providing credits to the airlines for all of
the fees collected under the IFR and a portion of the fees collected
under the Final Rule. A copy of that Order, ``Order Directing the
Disposition of Certain Fees Collected by the Federal Aviation
Administration Pursuant to 49 U.S.C. Section 45301,'' has been placed
in the docket.
    The FAA met with users in September 2004 and submitted a report to
Congress at the same time, as mandated by the Vision 100 statute. This
cleared the way for the FAA to resume the billing and collection of
Overflight Fees. In most cases, amounts previously collected by the FAA
under the IFR and under the Final Rule up until the date of the ATSA
enactment were provided as credits to frequent payers. These amounts
were, in most cases, roughly offset by amounts owed by the carriers and
other users for the one-year period from March 2003 through February
2004. The carriers had not been billed for this period while the
litigation was ongoing, but were ultimately determined by the
Administrator to be liable for those fees.
    Since that time, the FAA has followed the normal process of issuing
monthly bills for the services provided to Overflights. The fees
currently being charged were derived from cost and activity data for FY
1999. This NPRM proposes to update the existing fees by using cost and
activity data for FY 2008 to derive the fees. The cost methodology
applied in this NPRM is applied in the same manner as in 2001, except
that overhead has been included in the cost base for the fees this time
as a direct result of the ATSA amendment that changed the previous
statutory requirement that fees be ``directly'' related to costs to a
less stringent requirement that the fees be ``reasonably'' related to
costs.
    The FAA's CAS has been evolving and improving over time. The CAS
has always relied on the best available data,

and as new systems and techniques have evolved, the quality and
accuracy of the data has improved. There are areas, such as the
reporting of labor costs, where costs were allocated or assigned in the
past based on estimates, but today are determined by actual data. This
is not a difference in how the data is gathered, but rather an
improvement in the quality and accuracy of the basic data. A detailed
explanation of how the CAS data was assembled can be found in the
``Costing Methodology Report, FY 2008,'' which has been placed in the
docket for this rulemaking.

Overflight Fees Aviation Rulemaking Committees (ARC)

    In 2004, the FAA established an Overflight Fees ARC. That Committee
held two meetings in early 2005, but never issued a report or made a
recommendation to the FAA before its Charter expired. Subsequently, on
December 17, 2008, the FAA issued a new Charter for an Overflight Fees
ARC to advise and make recommendations to the FAA on the updating of
its Overflight Fees. The Overflight Fees ARC met several times in 2009
and issued its report and recommendations to the FAA on August 26,
2009. A copy of this report has been placed in the docket. The report
contains three principal recommendations:
    1. That the FAA pursue the updating of its Overflight Fees through
the normal notice and comment type of rulemaking, rather than through
the interim final rule process previously mandated by Congress;
    2. That, in updating the fees, the FAA abide by the policies of the
International Civil Aviation Organization (ICAO), whereby the principle
of gradualism is applied so that any substantial fee increase (as in
this case where a 9-year update is involved) is spread over several
years; and
    3. That, in this instance, the specific increases be accomplished
over 4 increments, on October 1st of each year from 2011 through 2014,
with annual increases of 14% for Enroute and 8% for Oceanic.
    The FAA believes that the ARC recommendations are a reasonable
approach to move forward on a consensus basis to update its Overflight
Fees. This NPRM proposes to implement the recommendations of the ARC.
It should be noted that the annual increases recommended by the ARC
(14% for the Enroute fee and 8% for the Oceanic fee) were derived from
information presented to the ARC by the FAA. The FAA had shown the ARC
that, in order for the FAA to approach the cost recovery called for by
Federal policy guidance on user fees, based on actual cost and activity
data for FY 2008, fee increases of approximately 69% and 36%,
respectively, for Enroute and Oceanic, would be necessary. Spreading
this increase over 4 years produces the recommended levels of 14% per
year, compounded, for Enroute and 8% per year, compounded, for Oceanic.
    The actual dollar amounts of each fee as of each of the four
October 1st fee revision dates would be as follows:

------------------------------------------------------------------------
                                                  Enroute      Oceanic
                                                  (per 100     (per 100
                  Time period                     nautical     nautical
                                                   miles)       miles)
------------------------------------------------------------------------
October 1, 2011...............................       $38.44       $17.22
October 1, 2012...............................        43.82        18.60
October 1, 2013...............................        49.95        20.09
October 1, 2014...............................        56.86        21.63
------------------------------------------------------------------------

II. Discussion of the Proposal

    The proposed rule would update the FAA's existing Overflight Fees,
which are presently based on Fiscal Year (FY) 1999 cost and activity
data. The fees have not been updated since they were initially
established on August 20, 2001.
    The current fees are derived arithmetically from final FAA CAS data
for FY 1999 and from the Enhanced Traffic Management System (ETMS) data
for the same year. The updated fees would be derived using basically
the same methodology as in 2001, but would be derived from final,
audited CAS data and ETMS data for FY 2008. The only difference would
be that the updated fees would include overhead in the cost base.
Overhead originally was excluded from the cost base for the existing
fees, but would be included in the derivation of the updated fees as
the result of the previously discussed change in the applicable
statutory authority (changing the requirement that fees be ``directly''
related to costs to a requirement that the fees be ``reasonably''
related to costs).
    Separate overflight fees have been established, and are currently
in effect, for flights that transit U.S.-controlled airspace in each of
two operational environments--Enroute and Oceanic--without either
taking off from or landing in the United States. The updated Enroute
fee would be derived by taking (from CAS) the total costs incurred in
the Enroute environment in FY 2008 and dividing that number by the
number of miles flown in U.S.-controlled Enroute airspace in FY 2008.
This would produce a per-mile cost that would be levied as a charge per
100 nautical miles flown, using Great Circle Distance (GCD), from point
of entry into, to point of exit from, U.S.-controlled airspace. The
separate Oceanic fee is determined in precisely the same manner, by
dividing total Oceanic costs for FY 2008 by the total number of Oceanic
miles flown in FY 2008. The actual step-by-step derivation of these
fees, using actual numbers for FY 2008, is shown in the ``Overflight
Fee Development Report'' which is included in the docket for this
rulemaking.

Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires
that the FAA consider the impact of paperwork and other information
collection burdens imposed on the public. The FAA has determined that
there would be no new requirement for information collection associated
with this proposed rule. The FAA information used to track and bill
overflights (including the information collection necessary to
implement this proposal) is accessed from flight plans filed with the
FAA. The collection of Domestic and International Flight Plans is
approved under OMB collection Control  2120-0026. The FAA
seeks comment on whether a revision to this information collection
would be necessary as a result of this proposal.

International Compatibility

    In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to comply with
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the

maximum extent practicable. The FAA has reviewed the corresponding ICAO
Standards and Recommended Practices and has identified no differences
with these proposed regulations.

III. Regulatory Evaluation, Regulatory Flexibility Determination, and
Unfunded Mandates Assessment

    Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 directs that each Federal agency
shall propose or adopt a regulation only upon a reasoned determination
that the benefits of the intended regulation justify its costs. Second,
the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires
agencies to analyze the economic impact of regulatory changes on small
entities. Third, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires agencies to prepare a written assessment of the costs,
benefits, and other effects of proposed or final rules that include a
Federal mandate likely to result in the expenditure by State, local, or
tribal governments, in the aggregate, or by the private sector, of $100
million or more annually (adjusted for inflation with base year of
1995). This portion of the preamble summarizes the FAA's analysis of
the economic impacts of this proposed rule.
    Department of Transportation Order DOT 2100.5 prescribes policies
and procedures for simplification, analysis, and review of regulations.
If the expected cost impact is so minimal that a proposed or final rule
does not warrant a full evaluation, this order permits that a statement
to that effect and the basis for it to be included in the preamble if a
full regulatory evaluation of the cost and benefits is not prepared.
Such a determination has been made for this proposed rule. The
reasoning for this determination follows:

Benefit

    The benefit of this proposed rule would be that the overflight fees
will be more closely related to the actual costs of providing FAA's
services for these flights.

Costs

    Taxes and government fees are a transfer payment, and, by OMB
directive, transfers are not considered a societal cost. Therefore,
this rule imposes no costs. We do provide an estimate of the transfers.
There would be a 4-year phase-in of fees with yearly increases (14%
Enroute and 8% Oceanic). Increases would begin in 2011 and end in 2014.
We have determined that approximately 80% of Overflight Fees for
domestic operators would be Enroute and 20% would be Oceanic. (See
Table 1.)
    Most of the transfers from this proposed rule would be borne by
foreign operators. The estimated transfers from foreign operators to
the FAA are about $73 million ($52 million, present value). (See Table
2.)
    Using the preceding information, the FAA estimates that the total
transfers resulting from this proposed rule from U.S. entities to the
FAA over 5 years would be about $1.1 million ($0.8 million, present
value). Again, government fees and taxes are considered transfers and
not societal costs, so this proposed rule does not increase society's
costs.
[GRAPHIC] [TIFF OMITTED] TP28SE10.001

    The FAA has, therefore, determined that this proposed rule is not
an economically ``significant regulatory action'', but is a
``significant regulatory action'' for other reasons as defined in
section 3(f) of Executive Order 12866

and is ``significant'' as defined in DOT's Regulatory Policies and
Procedures.

Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (RFA) establishes ``as a
principle of regulatory issuance that agencies shall endeavor,
consistent with the objective of the rule and of applicable statutes,
to fit regulatory and informational requirements to the scale of the
business, organizations, and governmental jurisdictions subject to
regulation.'' To achieve that principle, the RFA requires agencies to
solicit and consider flexible regulatory proposals and to explain the
rationale for their actions. The RFA covers a wide-range of small
entities, including small businesses, not-for-profit organizations and
small governmental jurisdictions.
    Agencies must perform a review to determine whether a proposed or
final rule will have a significant economic impact on a substantial
number of small entities. If the agency determines that it will, the
agency must prepare a regulatory flexibility analysis as described in
the Act.
    The FAA ranked in descending order all domestic entities based on
their Overflight Fees. Then we identified 5 small entities having
publicly-available financial information (using a size standard of
1,500 or fewer employees) in the top 20 percent of the ranking. We
retrieved their annual revenue from World Aviation Directory and
compared it to their annualized compliance costs. Of these 5 entities,
all of them have annualized compliance costs as a percentage of annual
revenues lower than 0.1 percent. We believe this economic impact is not
significant. Consequently, the FAA certifies that the proposed rule
would not have a significant economic impact on a substantial number of
small entities.

Unfunded Mandates Assessment

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement
assessing the effects of any Federal mandate in a proposed or final
agency rule that may result in an expenditure of $100 million or more
(in 1995 dollars) in any one year by State, local, and tribal
governments, in the aggregate, or by the private sector; such a mandate
is deemed to be a ``significant regulatory action.'' The FAA currently
uses an inflation-adjusted value of $143.1 million in lieu of $100
million. This proposed rule does not contain such a mandate; therefore,
the requirements of Title II of the Act do not apply.

Executive Order 13132, Federalism

    The FAA has analyzed this proposed rule under the principles and
criteria of Executive Order 13132, Federalism. We determined that this
action 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, and, therefore, would not have federalism implications.

Environmental Analysis

    FAA Order 1050.1E identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined this proposed rulemaking action qualifies for the
categorical exclusion identified in paragraph 312d and involves no
extraordinary circumstances.

Regulations That Significantly Affect Energy Supply, Distribution, or
Use

    The FAA has analyzed this NPRM under Executive Order 13211, Actions
Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (May 18, 2001). We have determined that it is not
a ``significant regulatory action'' under the executive order because,
while it is a ``significant regulatory action'' under DOT's Regulatory
Policies and Procedures, it is not likely to have a significant adverse
effect on the supply, distribution, or use of energy.

Plain English

    Executive Order 12866 (58 FR 51735, Oct. 4, 1993) requires each
agency to write regulations that are simple and easy to understand. We
invite your comments on how to make these proposed regulations easier
to understand, including answers to questions such as the following:
     Are the requirements in the proposed regulations clearly
stated?
     Do the proposed regulations contain unnecessary technical
language or jargon that interferes with their clarity?
     Would the regulations be easier to understand if they were
divided into more (but shorter) sections?
     Is the description in the preamble helpful in
understanding the proposed regulations?
    Please send your comments to the address specified in the Addresses
section of this preamble.

Additional Information

Comments Invited
    The FAA invites interested persons to participate in this
rulemaking by submitting written comments, data, or views. We also
invite comments relating to the economic, environmental, energy, or
federalism impacts that might result from adopting the proposals in
this document. The most helpful comments reference a specific portion
of the proposal, explain the reason for any recommended change, and
include supporting data. To ensure the docket does not contain
duplicate comments, please send only one copy of written comments, or
if you are filing comments electronically, please submit your comments
only one time.
    We will file in the docket all comments we receive, as well as a
report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Proprietary or Confidential Business Information

    Do not file in the docket information that you consider to be
proprietary or confidential business information. Send or deliver this
information directly to the person identified in the FOR FURTHER
INFORMATION CONTACT section of this document. You must mark the
information that you consider proprietary or confidential. If you send
the information on a disk or CD-ROM, mark the outside of the disk or
CD-ROM and also identify electronically within the disk or CD-ROM the
specific information that is proprietary or confidential.
    Under 14 CFR 11.35(b), when we are aware of proprietary information
filed with a comment, we do not place it in the docket. We hold it in a
separate file to which the public does not have access, and we place a
note in the docket that we have received it. If we receive a request to
examine or copy this information, we treat it as any other request
under the Freedom of Information Act (5 U.S.C. 552). We process such a
request under the DOT procedures found in 49 CFR part 7.

Availability of Rulemaking Documents

    You can get an electronic copy of rulemaking documents using the
Internet by--
    1. Searching the Federal eRulemaking Portal (http://
www.regulations.gov);
    2. Visiting the FAA's Regulations and Policies Web page at http://
www.faa.gov/regulations_policies; or
    3. Accessing the Government Printing Office's Web page at http://
www.gpoaccess.gov/fr/index.html.
    You can also get a copy by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling<PHONE_NUMBER>. Make
sure to identify the docket number or notice number of this rulemaking.
    You may access all documents the FAA considered in developing this
proposed rule, including economic analyses and technical reports, from
the Internet through the Federal eRulemaking Portal referenced in
paragraph (1).

List of Subjects in 14 CFR Part 187

    Administrative practice and procedure, Air transportation.

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend Chapter I of Title 14, Code of Federal
Regulations, as follows:

PART 187--FEES

    1. The authority citation for part 187 continues to read as
follows:

    Authority:  31 U.S.C. 9701, 49 U.S.C. 106(g), 49 U.S.C.
106(l)((6), 40104-401-5, 40109, 40113-40114, 44702.

    2. In part 187, Appendix B is amended by revising paragraph (e)(2)
to read as follows:

Appendix B to Part 187--Fees for FAA Services for Certain Flights

* * * * *
    (e) * * *
    (2) A User (operator of an Overflight) is assessed a fee for
each 100 nautical miles (or portion thereof) flown in each segment
and type of U.S.-controlled airspace. Separate calculations are made
for transiting Enroute and Oceanic airspace. The total fee charged
for an Overflight between any entry and exit point is equal to the
sum of these two charges. This relationship is summarized as:
Rij = X*DEij + Y*DOij,

Where:

Rij = the fee charged to aircraft flying between entry point i and
exit point j,
DEij = total great circle distance traveled in each
segment of U.S.-controlled Enroute airspace expressed in hundreds of
nautical miles for aircraft flying between entry point i and exit
point j for each segment of Enroute airspace.
DOij = total great circle distance traveled in each
segment of U.S.-controlled Oceanic airspace expressed in hundreds of
nautical miles for aircraft flying between entry point i and exit
point j for each segment of Oceanic airspace.

    X and Y = the values respectively set forth in the following
schedule:

------------------------------------------------------------------------
             Time period                 X (Enroute)       Y (Oceanic)
------------------------------------------------------------------------
Through September 30, 2011..........            $33.72            $15.94
October 1, 2011 through September                38.44             17.22
 30, 2012...........................
October 1, 2012 through September                43.82             18.60
 30, 2013...........................
October 1, 2013 through September                49.95             20.09
 30, 2014...........................
October 1, 2014 and beyond..........             56.86             21.63
------------------------------------------------------------------------

* * * * *

    Issued in Washington, DC, on September 22, 2010.
Carl W. Burrus,
Director, Office of Financial Controls.
[FR Doc. 2010-24342 Filed 9-27-10; 8:45 am]
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[Federal Register Volume 79, Number 207 (Monday, October 27, 2014)]
[Notices]
[Pages 63921-63922]
[FR Doc No: 2014-25532]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1630]

Draft Guidance for Industry on Qualification for the Use of
Galactomannan in Serum and Bronchoalveolar Lavage Fluid; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Draft Guidance
on Qualification of Biomarker--Galactomannan in Studies of Treatments
of Invasive Aspergillosis.'' This draft guidance provides
recommendations on the use of Galactomannan detection in serum and/or
bronchoalveolar lavage (BAL) fluid as the sole microbiological
criterion to classify patients as having probable invasive
Aspergillosis (IA) for enrollment in clinical trials. This draft
guidance provides the context of use for which this biomarker drug
development tool (DDT) is qualified through the Center for Drug
Evaluation and Research (CDER) DDT Qualification Program. In the
Federal Register of January 7, 2014, FDA announced the availability of
a guidance for industry entitled ``Qualification Process for Drug
Development Tools,'' which described the process that would be used to
qualify DDTs and to make new DDT qualification recommendations
available on FDA's Web site. The qualification recommendations in this
draft guidance were developed using the process described in that
guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 26, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Marianne Noone, Center for Drug
Evaluation and Research (Office of Translational Sciences, Immediate
Office), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
21, Rm. 4528, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Draft Guidance on Qualification of Biomarker--Galactomannan
in studies of treatments of invasive Aspergillosis.'' This draft
guidance provides recommendations on the use of Galactomannan detection
in serum and/or BAL fluid as the sole microbiological criterion to
classify patients as having probable IA for enrollment in clinical
trials. The draft guidance provides the context of use for which this
biomarker DDT is qualified through the CDER DDT Qualification Program.
Qualification of this biomarker for this specific context of use
represents the conclusion that analytically valid measurements of the
biomarker can be relied on to have a specific use and interpretable
meaning. Further, the biomarker can be used by drug developers for the
qualified context in submission of investigational new drug
applications, new drug applications, and biologics licensing
applications without the relevant CDER review group reconsidering and
reconfirming the suitability of the DDT. Qualification means that the
use of this biomarker in the specific context of use is not limited to
a single, specific drug development program. Making the qualification
recommendations widely known and available for use by drug developers
will contribute to drug innovation, thus supporting public health. The
draft guidance is an attachment to the guidance for industry entitled
``Qualification Process for Drug Development Tools.''
    In March 2006, FDA issued the ``Critical Path Opportunities Report
and List,'' in which FDA described six key areas along the critical
path to improved therapies and listed specific opportunities for
advancement within these topic areas. The report noted that a new
product development toolkit containing new scientific and technical
methods was needed to improve the efficiency of drug development.
    In 2008, the Mycoses Study Group proposed using Galactomannan in
serum and BAL fluid as an indicator of IA in lieu of culture in
patients with hematologic malignancies and recipients of allogeneic
hematopoietic stem cell transplants and who also have radiologic
evidence suggestive of invasive fungal infection (Ref. 1). A
qualification review team of experts evaluated the data supporting the
proposed context of use and rendered a qualification recommendation.
The qualification recommendation in the draft guidance includes the
following information:
     A use statement;
     conditions for qualified use of the assay;
     patient populations;

     limitations for use of the Galactomannan assay;
     considerations for sample acquisition and documentation;
     analysis of study results; and
     performance characteristics of the assay.
    Innovative and improved DDTs can help streamline the drug
development process, improve the chances for clinical trial success,
and yield more information about a treatment and/or disease. DDTs
include, but are not limited to, biomarkers, clinical outcome
assessments and animal models. Refer to DDTs Qualification Programs at
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/default.htm for additional
information.
    As stated previously in the Federal Register of January 7, 2014 (79
FR 831), FDA announced the availability of the guidance for industry
entitled ``Qualification Process for Drug Development Tools,'' which
described the process that would be used to qualify DDTs and to make
new DDT qualification recommendations available on FDA's Web site at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. CDER has developed this formal process to work
with developers of these biomarker DDTs to guide the developers as they
refine the tools and rigorously evaluate them for use in the regulatory
context. Once qualified, DDTs will be publicly available for use in any
drug development program for the qualified context of use. As described
in the January 2014 guidance, biomarker DDTs should be developed and
reviewed using this process.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on
Galactomannan in serum and BAL fluid. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance contains an information collection that is subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The information collection
has been approved under the OMB control numbers 0910-0001 and 0910-
0014. The information requested in the guidance is currently submitted
to FDA to support medical product effectiveness (see 21 CFR 312.30, 21
CFR 314.50(d)(5), and 21 CFR 314.126(b)(6)).

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

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

V. Reference

    The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday, and is
available electronically at http://www.regulations.gov.

    1. De Pauw, B., T.J. Walsh, J.P. Donnelly, et al., ``Revised
Definitions of Invasive Fungal Disease from European Organization for
Research and Treatment of Cancer/Invasive Fungal Infections Cooperative
Group and the National Institute of Allergy and Infectious Diseases
Mycoses Study Group (EORTC/MSG) Consensus Group,'' Clinical Infectious
Diseases (2008) 46: 1813-1821.

    Dated: October 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25532 Filed 10-24-14; 8:45 am]
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