[Federal Register Volume 82, Number 76 (Friday, April 21, 2017)]
[Rules and Regulations]
[Pages 18690-18694]
[FR Doc No: 2017-07777]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-4674; Directorate Identifier 2016-SW-001-AD;
Amendment 39-18835; AD 2017-06-11]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

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

ACTION: Final rule; request for comments.

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SUMMARY: We are superseding Emergency Airworthiness Directive
(Emergency AD) 2015-24-51 for Airbus Helicopters Model EC120B.
Emergency AD 2015-24-51 required inspections of the air conditioning
system. This supersedure revises the applicability, some of the
terminology, and the

inspection requirements. This AD was prompted by a report of an
abnormal noise during flight of a Model EC120B helicopter that resulted
in a precautionary landing. We are issuing this AD to prevent an unsafe
condition on these products.

DATES: This AD becomes effective May 8, 2017.
    We must receive comments on this AD by June 20, 2017.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
4674; or in person at the Docket Operations Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the Supplemental Type Certificate (STC), the economic
evaluation, any comments received, and other information. The street
address for the Docket Operations Office (telephone<PHONE_NUMBER>) is in
the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.
    For service information identified in this final rule, contact Air
Comm Corporation, 1575 West 124th Avenue, Westminster, CO 80234,
telephone:<PHONE_NUMBER> (during business hours) or<PHONE_NUMBER>
(after hours), email<EMAIL_ADDRESS>Web site http://www.aircommcorp.com/contact. You may review the referenced service
information at the FAA, Office of the Regional Counsel, Southwest
Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Richard R. Thomas, Aviation Safety
Engineer, Denver Aircraft Certification Office, FAA, Technical
Operations Center, 26805 East 68th Avenue, Room 214, Denver, CO 80249;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments prior to it becoming effective. However, we
invite you 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 resulted
from adopting this AD. The most helpful comments reference a specific
portion of the AD, explain the reason for any recommended change, and
include supporting data. To ensure the docket does not contain
duplicate comments, commenters should send only one copy of written
comments, or if comments are filed electronically, commenters should
submit them only one time. We will file in the docket all comments that
we receive, as well as a report summarizing each substantive public
contact with FAA personnel concerning this rulemaking during the
comment period. We will consider all the comments we receive and may
conduct additional rulemaking based on those comments.

Discussion

    On November 27, 2015, we issued Emergency AD 2015-24-51, which was
made immediately effective to all known U.S. owners and operators of
Airbus Helicopters Model EC120B helicopters. Emergency AD 2015-24-51
applied to Model EC120B helicopters with an Air Comm Corporation (Air
Comm) air conditioning system installed in accordance with STC No.
SR00491DE. Emergency AD 2015-24-51 required, before further flight and
at intervals not to exceed 25 hours time-in-service (TIS), manually
inspecting the air conditioner compressor drive pulley (pulley) for
movement (play) between the pulley and the tail rotor output wheel
(wheel). If there was any movement, Emergency AD 2015-24-51 required
replacing the pulley and the wheel before further flight. If no play
existed, Emergency AD 2015-24-51 required an additional inspection for
wear and, if needed, replacing the pulley and the wheel. Emergency AD
2015-24-51 also required reporting information to the FAA to enable us
to obtain better insight into the cause of the unsafe condition.
    Emergency AD 2015-24-51was prompted by a report that the operator
of an Airbus Helicopters Model EC120B helicopter heard an abnormal
noise during flight that gradually became more pronounced, resulting in
a precautionary landing. While applying power to land, the helicopter
yawed left. Application of the right pedal did not correct the
rotation, requiring the pilot to perform a hovering auto rotation. A
preliminary investigation showed that the pulley and wheel mating
splines had worn away, allowing the pulley to rotate freely on the
wheel. Failure of the pulley and wheel during flight may result in the
loss of tail rotor drive and subsequent loss of directional control.

Actions Since AD 2014-24-51 Was Issued

    After Emergency AD 2015-24-51 was issued, we received a comment
from an operator requesting that we clarify the applicability of the
AD. The commenter notes that there are two different configurations for
the Air Comm conditioning system, the earlier of which has the output
flange that is terminating action in the AD already installed. However,
the applicability of Emergency AD 2015-24-51 does not distinguish
between the two configurations. Pictures from another operator we
received with an inspection report showed this earlier configuration
where the compressor is driven by a pulley mounted forward of the rotor
brake.
    We agree with the request to clarify the applicability. Pulleys
installed forward of the rotor brake are not part of the tail rotor
drive train and their failure would not result in a loss of directional
control. We have revised this AD to apply only to those helicopters
with an Air Comm air conditioning kit installed in accordance with STC
No. SR00491DE where the compressor is driven by a pulley installed aft
of the rotor brake. Helicopters that have an Air Comm air conditioning
kit installed in accordance with STC No. SR00491DE where the compressor
is driven by a pulley forward of the rotor brake are excluded from this
AD's requirements.
    We are replacing the term ``tail rotor output pinion'' used in
Emergency AD 2015-24-51 with ``tail rotor output wheel,'' because it is
the more commonly known term for this part.
    We also received a comment from an operator stating that if play
between the pulley and the wheel is found during the inspection, and if
the Air Comm pulley is replaced with an Airbus output flange, the AD
should not require that the wheel be replaced if it passes the damage
and wear criteria in the Airbus Helicopters maintenance manual. We
agree that in the absence of wear, regardless of any play, the wheel
should not have to be replaced. We are revising the required actions in
this AD to remove the inspection for play and instead require an
inspection of the

wheel for damage and wear, using criteria consistent with that in the
Airbus Helicopters maintenance manual.
    We also obtained additional information from Air Comm about the
effect of the terminating action in Emergency AD 2015-24-51 and whether
it is necessary to deactivate the airconditioning system. As a result,
we are removing from the terminating action the requirement to fully or
partially deactivate the air conditioning system. Replacing the Air
Comm pulley with Airbus Helicopters output flange part number
C632A2158201 partially deactivates the system. With the Air Comm pulley
replaced, the system is sufficiently deactivated. Cooling will no
longer be available, but the evaporator blowers will remain operable to
circulate air. Neither the air conditioning system nor the helicopter
will be damaged by removing the compressor drive belt and leaving the
circuit breakers engaged.
    We also have learned that this AD affects five helicopters of U.S.
registry, and not only the two helicopters noted in Emergency AD 2015-
24-51.

FAA's Determination

    We have reviewed the relevant information and determined that an
unsafe condition exists and is likely to exist or develop on other
helicopters of this same type design and that air safety and the public
interest require adopting the AD requirements as proposed.

Related Service Information

    We reviewed Air Comm Service Bulletin SB-EC120-111815, Revision A,
dated November 20, 2015. Air Comm reports that the pulley, mounted to
the Thomas coupling just aft of the main rotor brake caliper, is an
integral piece of the power transmission components for the tail rotor.
A field report indicated that the spline joint on the pulley can wear
beyond its capability to ensure power transmission to the tail rotor
shaft. Given that the installation is flight critical, the Air Comm
service bulletin specifies an inspection of the pulley-output wheel
interface. If excessive play or wear is found, the aircraft must be
made inoperable until unairworthy parts are replaced.

AD Requirements

    This AD requires, before further flight and at intervals not to
exceed 25 hours TIS, removing the pulley and visually inspecting the
pulley splines for wear and inspecting the exposed portion of the wheel
splines for cracks, scoring, metal pick-up, and measuring for wear. If
any of the splines on the pulley are not straight, contain any
inconsistent cross-sections end-to-end, or contain any localized
material deformation or any material loss, this AD requires replacing
the pulley before further flight. If there is cracking, any scoring or
metal pick-up, or if a measurement shows wear, this AD requires
replacing the wheel before further flight.
    This AD also requires reporting certain information to the FAA
within 10 days.
    Replacing the Air Comm pulley with Airbus Helicopters output flange
part number C632A2158201 constitutes terminating action for this AD.

Differences Between This AD and the Service Information

    The service information specifies recurring inspections after 100
flight hours, while this AD requires recurring inspections at intervals
not to exceed 25 hours TIS. The service information requires inspecting
the pulley and drive shaft (wheel) splines for excessive wear or
chatter and replacing the pulley and wheel if there is any play. This
AD requires replacing the pulley if any splines are not straight, have
inconsistent cross-sections, or contain material deformation or loss.
This AD requires replacing the wheel if cracking, scoring, or metal
pick-up are found, or measurement of the splines indicates excessive
wear. The service information requests that information be submitted to
Air Comm, while this AD requires the inspection results be reported to
the FAA.

Costs of Compliance

    We estimate that this AD will affect 5 helicopters of U.S. Registry
and that labor costs average $85 a work-hour. Based on these estimates
we expect that inspecting the pulley and wheel will take about 7.5
work-hours for a cost of $638 per helicopter and $3,190 for the U.S.
fleet per inspection cycle. Replacing an Air Comm pulley will cost
$2,380 for parts and 0.5 additional work-hour for a cost of $2,423 per
helicopter. Replacing an Airbus wheel will cost $19,231 for parts and
10 additional work-hours for a cost of $20,081 per helicopter. The
optional terminating action of installing an Airbus output flange will
cost $2,327 for parts and 0.5 additional work-hour for a cost of $2,370
per helicopter. Reporting the required inspection information to the
FAA will take about 0.5 work-hour for a cost of about $43 per
helicopter and $215 for the U.S. fleet.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting required by this AD
is mandatory. Comments concerning the accuracy of this burden and
suggestions for reducing the burden should be directed to the FAA at
800 Independence Ave. SW., Washington, DC 20591. ATTN: Information
Collection Clearance Officer, AES-200.

FAA's Justification and Determination of the Effective Date

    Providing an opportunity for public comments prior to adopting
these AD requirements would delay implementing the safety actions
needed to correct this known unsafe condition. Therefore, we find that
the risk to the flying public justifies waiving notice and comment
prior to the adoption of this rule because the required corrective
actions must be accomplished before further flight.
    Since an unsafe condition exists that requires the immediate
adoption of this AD, we determined that notice and opportunity for
prior public comment before issuing this AD are impracticable and
contrary to the public interest and that good cause exists to make this
AD effective in less than 30 days.

Authority for This Rulemaking

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

products identified in this rulemaking action.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2017-06-11 Airbus Helicopters: Amendment 39-18835; Docket No. FAA-
2016-4674; Directorate Identifier 2016-SW-001-AD.

(a) Applicability

    This AD applies to Airbus Helicopters Model EC120B helicopters
with an Air Comm Corporation (Air Comm) air conditioning kit
installed in accordance with supplemental type certificate (STC) No.
SR00491DE, where the compressor is driven by a pulley installed aft
of the rotor brake, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as failure of an air
conditioner compressor drive pulley (pulley) or tail rotor output
wheel (wheel), leading to loss of tail rotor drive and helicopter
control.

(c) Affected ADs

    This AD supersedes Emergency AD 2015-24-51, Directorate
Identifier 2015-SW-086-AD, dated November 27, 2015.

(d) Effective Date

    This AD becomes effective May 8, 2017.

(e) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(f) Required Actions

    (1) Before further flight, and at intervals not to exceed 25
hours time-in-service, disassemble the tail rotor drive system and
remove the pulley.
    (i) Visually inspect the pulley splines for wear. If any splines
are not straight, contain any inconsistent cross-sections end-to-
end, or contain any localized material deformation or any material
loss, replace the pulley before further flight.
    Note 1 to paragraph (f)(1)(i) of this AD: End-to-end (fore-and-
aft) movement witness marks and polishing are acceptable as the
pulley is allowed to slip fore and aft on the wheel per its intended
function.
    (ii) Inspect the exposed portion of each wheel spline for
cracking, scoring, metal pick-up, and wear by using Figure 1 to
paragraph (f)(1)(ii) of this AD. To inspect for wear, position two 3
mm (0.118 inch) rods in all diametrically opposed splines and
measure to determine whether there is a minimum of 37.3 mm (1.47
inches) across the outside diameter of the rods. If there is any
cracking, scoring or metal pick-up, or if a measurement is less than
37.3 mm, replace the wheel.
[GRAPHIC] [TIFF OMITTED] TR21AP17.000

    (2) Within 10 days after completing the initial inspection,
report the information requested in Appendix 1 to this AD by mail to
the Denver Aircraft Certification Office, FAA, Technical Operations
Center, 26805 East 68th Avenue, Room 214, Denver, CO 80249, attn.
Richard R. Thomas; by fax to<PHONE_NUMBER>; or by email to
<EMAIL_ADDRESS>    (3) Replacing the Air Comm pulley with Airbus Helicopters output
flange part number C632A2158201 constitutes terminating action for
this AD.

(g) Special Flight Permits

    Special flight permits are prohibited.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Denver Aircraft Certification Office, FAA, may
approve

AMOCs for this AD. Send your proposal to: Richard R. Thomas,
Aerospace Engineer, Denver Aircraft Certification Office, FAA,
Technical Operations Center, 26805 East 68th Avenue, Room 214,
Denver, CO 80249; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(i) Additional Information

    (i) Air Comm Service Bulletin No. SB-EC120-111815, Revision A,
dated November 20, 2015, which is not incorporated by reference,
contains additional information about the subject of this AD. For
service information identified in this AD, contact: Air Comm
Corporation, 1575 West 124th Avenue, Westminster, CO 80234,
telephone:<PHONE_NUMBER> (during business hours) or<PHONE_NUMBER>
(after hours); email<EMAIL_ADDRESS>Web site: http://www.aircommcorp.com/contact.
    (ii) You may view a copy of Supplemental Type Certificate No.
SR00491DE, reissued on November 24, 2014, on the Internet at http://www.regulations.gov by searching for and locating it in Docket No.
FAA-2016-4674.
    (iii) You may review a copy of the service information at the
FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.

(j) Subject

    Joint Aircraft Service Component (JASC) Code: 6500, Tail Rotor
Drive System.

    Issued in Fort Worth, Texas, on February 1, 2017.
Scott A. Horn,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.

Appendix 1 to AD 2017-06-11

    Please report the following to the Denver Aircraft Certification
Office, FAA, Technical Operations Center, by mail to 26805 East 68th
Avenue, Room 214, Denver, CO 80249, attn. Richard R. Thomas; by fax
to<PHONE_NUMBER>; or by email to<EMAIL_ADDRESS>    (1) Condition of the splined joint. Document any damage found
with photographs.
    (2) Flight hours since the air-conditioning kit was installed.
    (3) Aircraft serial number.
    (4) Pulley serial number (etched on the pulley's face).
    (5) Output wheel serial number from main gearbox, MAIN MODULE
hard card.
    (6) Primary operating location of the aircraft.
    (7) Approximate average percentage of time the air conditioner
is used.
    (8) Operator and maintenance facility contact information.
    (9) If parts are replaced, will air conditioning system remain
fully or partially operable?

[FR Doc. 2017-07777 Filed 4-20-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 69 (Tuesday, April 10, 2012)]
[Notices]
[Pages 21607-21609]
[FR Doc No: 2012-8581]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66741; No. SR-NASDAQ-2012-040]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Modify NASDAQ's Transaction Execution Fee and Credit Schedule

April 5, 2012.
    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 March 23, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') a proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. 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

    NASDAQ proposes to modify the Exchange's transaction execution fee
and credit schedule in Rule 7018. NASDAQ will implement the proposed
change on April 2, 2012. The text of the proposed rule change is
available at nasdaq.cchwallstreet.com, at NASDAQ'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 self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below,

of the most significant parts of such statements.

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

1. Purpose
    NASDAQ is amending its fee and credit schedule for transaction
executions in Rule 7018(a).\3\ First, with respect to orders that route
to the New York Stock Exchange (``NYSE'') to participate in its closing
process, NASDAQ is increasing the fee from $0.00085 per share executed
to $0.00095 per share executed. The proposed change mirrors an
identical change to the fee charged by NYSE for executing such
orders.\4\ Second, NASDAQ is increasing the monthly cap on fees charged
for routed orders that execute in the NYSE opening process from $10,000
to $15,000. The proposed change also mirrors an identical change made
by NYSE.\5\
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    \3\ Rule 7018(a) applies to executions of transactions at a
price of $1 or more. Fees for transactions at a price below $1
remain unchanged.
    \4\ Securities Exchange Act Release No. 66600 (March 14, 2012),
77 FR 16298 (March 20, 2012) (SR-NYSE-2012-07).
    \5\ Id.
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    Third, NASDAQ is amending Rule 7018(e) to increase the monthly cap
for orders executed in the NASDAQ Opening Cross from $10,000 to $15,000
per firm. The change is intended to keep the charges incurred by
members to participate in the NASDAQ Opening Cross comparable to the
charges incurred by NYSE members to participate in its opening process.
Fourth, NASDAQ is increasing the charge for LIST orders that are routed
for participation in the NYSEAmex closing process from $0.00085 to
$0.00095. The change is intended to maintain consistency between the
fees charged for closing process orders that route to NYSE and
NYSEAmex.
    Fifth, NASDAQ is amending Rule 7018(a) to introduce rebates with
respect to NASDAQ's new Supplemental Order type, which is expected to
be introduced in April 2012.\6\ Supplemental Orders, which resemble the
Tracking Orders that have long been in use at NYSEArca, are non-
displayed orders that post to the book, that are accessed only after
other liquidity on the NASDAQ book, and that execute only at the
national best bid or best offer (``NBBO''). NASDAQ is setting rebates
for use of these orders at a level that is equal to or slightly higher
than prevailing rebate rates for other forms of non-displayed orders
but lower than the rates for displayed liquidity. The goal of setting
the rebate at these levels is to encourage use of the new order type,
while maintaining consistency with NASDAQ's overall pricing philosophy
of encouraging displayed liquidity. Specifically, the rebate will be
$0.0018 per share executed for Supplemental Orders entered through a
market participant identifier (``MPID'') through which a member
provides an average daily volume during the month of more than 1
million shares of liquidity via Supplemental Orders, and $0.0015 per
share executed for all other Supplemental Orders.
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    \6\ Securities Exchange Act Release No. 66540 (March 8, 2012),
77 FR 15167 (March 14, 2012) (SR-NASDAQ-2012-031).
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2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\7\ in general, and with
Sections 6(b)(4) and (5) of the Act,\8\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and issuers and other persons using any
facility or system which NASDAQ operates or controls, and is not
designed to permit unfair discrimination between customers, issuers,
brokers or dealers. All similarly situated members are subject to the
same fee structure, and access to NASDAQ is offered on fair and non-
discriminatory terms.
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    \7\ 15 U.S.C. 78f.
    \8\ 15 U.S.C. 78f(b)(4) and (5).
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    The proposed changes to the fee to route orders to the NYSE closing
process and the monthly cap on fees charged for orders routed to the
NYSE opening process are reasonable because they correspond directly to
the fees charged by NYSE. These changes reflect an equitable allocation
of fees because they reflect the costs incurred by NASDAQ's routing
broker when sending orders to NYSE. Finally, the changes are not
unfairly discriminatory because they are charged to members that route
orders to NYSE and thereby require NASDAQ to incur the costs of routing
such orders.
    The proposed change to the monthly cap on fees charged for
participation in the NASDAQ Opening Cross is reasonable because it
ensures that total monthly costs of members to participate in the
NASDAQ Opening Cross are comparable to the monthly costs of members to
participate in the opening process of NASDAQ's primary competitor. As
is currently the case, once a member reaches the cap, its marginal rate
thereafter will be zero and its blended rate will decrease with each
additional transaction. NASDAQ believes that the proposed change
reflects an equitable allocation of fees because it believes that the
NASDAQ Opening Cross provides an extremely robust price discovery
process for its members, and that accordingly, it is equitable to
increase the maximum fees payable by members that participate in the
process. Finally, NASDAQ believes that the change is not unfairly
discriminatory because it applies solely to members that opt to
participate in the Opening Cross.
    The proposed change to the fee to route orders to the NYSEAmex
closing process is reasonable because it allows NASDAQ to maintain an
identical fee for routing to the NYSE and NYSEAmex close. Moreover,
although the fee charged to NASDAQ by NYSEAmex remains $0.00085 per
share, NASDAQ believes that it is reasonable to charge a $0.0001 per
share markup on such routed orders as a means of assisting NASDAQ in
covering its own costs of operations and earning a profit. NASDAQ
believes that the change reflects an equitable allocation of fees
because NYSEAmex is not a widely used routing destination, and
accordingly, it is equitable for NASDAQ to charge members a markup for
making use of NASDAQ's connection to it. Finally, NASDAQ believes that
the change is not unfairly discriminatory because it applies solely to
members that route orders to NYSEAmex.
    The proposed rebates for Supplemental Orders are reasonable because
they are consistent with or slightly higher than rebates currently paid
with respect to other non-displayed orders. NASDAQ believes that it is
reasonable to set the rebate at this level as a means of promoting use
of this new feature of its market. NASDAQ further believes that the
rebates reflect an equitable allocation of fees because Supplemental
Orders are designed to provide an additional means by which members may
offer liquidity at the NBBO. Accordingly, the orders are designed to
benefit not only members that enter them, but also members that can
access additional liquidity at the NBBO. NASDAQ believes that it is
equitable to set the rebates associated with use of these orders at a
level that is designed to provide these benefits. Finally, NASDAQ
believes that the rebates are not unfairly discriminatory, in that they
are set at levels that NASDAQ believes to be consistent with both its
overall pricing philosophy with respect to non-displayed orders and the
goal of

introducing Supplemental Orders to the market.
    Finally, NASDAQ notes that it operates in a highly competitive
market in which market participants can readily favor competing venues
if they deem fee levels at a particular venue to be excessive. In such
an environment, NASDAQ must continually adjust its fees to remain
competitive with other exchanges and with alternative trading systems
that have been exempted from compliance with the statutory standards
applicable to exchanges. Because numerous alternatives exist to the
execution and routing services offered by NASDAQ, if NASDAQ increases
its fees to an excessive extent, it will lose customers to its
competitors. Accordingly, NASDAQ believes that competitive market
forces help to ensure that the fees it charges for execution and
routing are reasonable, equitably allocated, and non-discriminatory.

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

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended. Because the market
for order and routing execution is extremely competitive, members may
readily opt to disfavor NASDAQ's execution services if they believe
that alternatives offer them better value. Accordingly, NASDAQ does not
believe that the proposed changes will unfairly affect the ability of
members or competitors to maintain their competitive standing in the
financial markets.

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

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\9\ At any time within 60 days of the filing
of the proposed rule change, the Commission summarily may temporarily
suspend such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

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 email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2012-040 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-NASDAQ-2012-040. This
file number should be included on the subject line if email 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 Web site viewing and printing 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 the filing also will be available for inspection and
copying at the principal office of the Exchange. 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-NASDAQ-2012-040 and should be submitted
on or before May 1, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-8581 Filed 4-9-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 180 (Monday, September 17, 2012)]
[Rules and Regulations]
[Pages 57010-57012]
[FR Doc No: 2012-22802]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-1407; Airspace Docket No. 11-AGL-25]
RIN 2120-AA66

Modification of Area Navigation (RNAV) Route Q-62; Northeast
United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action modifies area navigation (RNAV) route Q-62 by
extending it further west and incorporating two additional navigation
fixes. The route extension links two RNAV Standard Terminal Arrival
Routes (STARs) serving the Chicago O'Hare International Airport, IL,
terminal area with the high altitude route. The FAA is taking this
action to increase National Airspace System (NAS) efficiency and
enhance flight safety as aircraft transition from the en route airway
structure to the terminal area airspace phase of flight.

DATES: Effective date 0901 UTC, November 15, 2012. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace, Regulations
and ATC Procedures Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On Monday, February 6, 2012, the FAA published in the Federal
Register a notice of proposed rulemaking to modify RNAV route Q-62 in
Northeast United States by extending it further west (77 FR 5733).
Interested parties were invited to participate in this rulemaking
proceeding by submitting written comments on this proposal to the FAA.
No comments were received.

The Rule

    The FAA is amending Title 14, Code of Federal Regulations (14 CFR)
part 71 by extending high altitude RNAV route Q-62 to the west to
include the WATSN and DAIFE fixes. This action links the WATSN and
HALIE RNAV STARs serving Chicago O'Hare International Airport, IL, with
the high altitude route and establishes a seamless transition for
westbound air traffic from the New York metropolitan area into the
Chicago O'Hare International Airport, IL, terminal area. Additionally,
this action reduces ATC system complexity, air traffic controller and
pilot workload, voice communication requirements, and aircraft fuel
consumption. It also expands the use of RNAV within the NAS.
    High altitude RNAV routes are published in paragraph 2006 of FAA
Order 7400.9W dated August 8, 2012, and effective September 15, 2012,
which is incorporated by reference in 14 CFR 71.1. The RNAV route
listed in this document will be subsequently published in the Order.

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under Department of Transportation (DOT) Regulatory Policies and
Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant
preparation of a regulatory evaluation as the anticipated impact is so
minimal. Since this is a routine matter that will only affect air
traffic procedures and air navigation, it is certified that this rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it modifies the route structure of RNAV routes as required to
preserve the safe and efficient flow of air traffic.

Environmental Review

    The FAA has determined that this action is categorically excluded
from further environmental documentation according to FAA Order
1050.1E, paragraphs 311a, 311b, and 311i. The implementation of this
action will not result in any extraordinary circumstances in accordance
with paragraph 304 of Order 1050.1E.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

     Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9W,
Airspace Designations and Reporting Points, Dated August 8, 2012, and
effective September 15, 2012, is amended as follows:

Paragraph 2006--United States Area Navigation Routes

* * * * *

Q-62 WATSN, IN to SARAA, PA [Amended]

WATSN, IN...............................  FIX............................  (Lat. 41[deg]17'00'' N., long.
                                                                            86[deg]02'07'' W.)
DAIFE, IN...............................  WP.............................  (Lat. 41[deg]16'08'' N., long.
                                                                            85[deg]51'19'' W.)
NOLNN, OH...............................  WP.............................  (Lat. 41[deg]14'04'' N., long.
                                                                            84[deg]38'12'' W.)
WEEVR, OH...............................  WP.............................  (Lat. 41[deg]13'21'' N., long.
                                                                            84[deg]13'04'' W.)
PSKUR, OH...............................  WP.............................  (Lat. 41[deg]09'16'' N., long.
                                                                            82[deg]42'57'' W.)
FAALS, OH...............................  WP.............................  (Lat. 41[deg]02'51'' N., long.
                                                                            80[deg]52'40'' W.)
ALEEE, OH...............................  WP.............................  (Lat. 41[deg]00'28'' N., long.
                                                                            80[deg]31'54'' W.)
QUARM, PA...............................  WP.............................  (Lat. 40[deg]49'45'' N., long.
                                                                            79[deg]04'39'' W.)
BURNI, PA...............................  FIX............................  (Lat. 40[deg]39'25'' N., long.
                                                                            77[deg]48'14'' W.)
MCMAN, PA...............................  FIX............................  (Lat. 40[deg]38'16'' N., long.
                                                                            77[deg]34'14'' W.)
VALLO, PA...............................  FIX............................  (Lat. 40[deg]37'37'' N., long.
                                                                            77[deg]26'18'' W.)
RAVINE, PA (RAV)........................  VORTAC.........................  (Lat. 40[deg]33'12'' N., long.
                                                                            76[deg]35'58'' W.)
SUZIE, PA...............................  FIX............................  (Lat. 40[deg]27'12'' N., long.
                                                                            75[deg]58'22'' W.)
SARAA, PA...............................  FIX............................  (Lat. 40[deg]26'22'' N., long.
                                                                            75[deg]53'16'' W.)

    Issued in Washington, DC, on September 11, 2012.
Gary A. Norek,
Manager, Airspace Policy and ATC Procedures Group.
[FR Doc. 2012-22802 Filed 9-14-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Pages 65732-65733]
[FR Doc No: 2015-27172]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL16-6-000]

PJM Interconnection, L.L.C.; Notice of Filing

    Take notice that on October 19, 2015, PJM Interconnection, L.L.C.
filed Revisions to Operating Agreement, Schedule 1 RE FTR/ARR Revisions
to be effective 1/1/2016.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the Web site that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on November 9, 2015.

    Dated: October 20, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-27172 Filed 10-26-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 232 (Monday, December 5, 2022)]
[Notices]
[Pages 74425-74426]
[FR Doc No: 2022-26412]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-3101]

Abbreviated New Drug Applications: Pre-Submission Facility
Correspondence Related to Prioritized Generic Drug Submissions; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``ANDAs: Pre-Submission Facility Correspondence Related to Prioritized
Generic Drug Submissions.'' For purposes of implementing the Generic
Drug User Fee Amendments of 2022 (GDUFA III), the Pre-Submission
Facility Correspondence (PFC) process was revised as part of the
performance goals and program enhancements agreed to by FDA and
industry, as described in the GDUFA Reauthorization Performance Goals
and Program Enhancements, Fiscal Years 2023 through 2027 (GDUFA III
commitment letter). FDA assesses facility information submitted in a
PFC to inform the Agency's decision regarding the need for facility
inspections that support assessment of the abbreviated new drug
application (ANDA). A complete and accurate PFC allows the Agency to
begin the facility assessment process in advance of the planned ANDA
submission for priority ANDAs, allowing the Agency more time to make
preapproval inspection decisions. A PFC meeting the conditions outlined
in the revised draft guidance will qualify the ANDA for a shorter, 8-
month priority review goal. This revised draft guidance describes the
content, timing, and assessment of a complete and accurate PFC for
purposes of GDUFA III. Additionally, this revised draft guidance
provides information on the Agency's rationale for and current approach
to assessing a PFC and replaces the previous draft guidance for
industry, ``ANDAs: Pre-Submission of Facility Information Related to
Prioritized Generic Drug Applications (Pre-Submission Facility
Correspondence),'' issued in November 2017.

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 March 6, 2023. Submit either electronic or written comments
concerning the collection of information proposed in the draft guidance
by February 3, 2023.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-3101 for ``ANDAs: Pre-Submission Facility Correspondence
Related to Prioritized Generic Drug Submissions.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    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, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, 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.

FOR FURTHER INFORMATION CONTACT: Ranjani Prabhakara, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, rm. 6648, Silver Spring, MD 20993, 240-402-
4652.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``ANDAs: Pre-Submission Facility Correspondence
Related to Prioritized Generic Drug Submissions.'' This guidance
replaces the draft guidance for industry ``ANDAs: Pre-Submission of
Facility Information Related to Prioritized Generic Drug Applications
(Pre-Submission Facility Correspondence),'' issued in November 2017.
    The PFC is a mechanism under which FDA assesses facility
information submitted in a PFC to inform the Agency's decision
regarding the need for facility inspections that support assessment of
priority ANDAs, prior approval supplements (PASs), PAS amendments, and
ANDA amendments (collectively referred to herein as ANDAs). Under the
performance goals and program enhancements described in the GDUFA III
commitment letter, FDA agreed to a shorter 8-month goal date for action
on such priority generic drug submissions if a PFC meets specified
conditions.
    A complete and accurate PFC allows the Agency to begin the facility
assessment process in advance of the planned ANDA submission for
priority ANDAs. This lead time provides the Agency the opportunity to
determine whether facility inspections will be needed, and, when they
are, to initiate inspection planning earlier in the assessment of a
priority ANDA, helping the Agency to meet the shorter priority review
goal timeframe.
    This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidance, when finalized, will represent the current thinking of FDA on
``ANDAs: Pre-Submission Facility Correspondence Related to Prioritized
Generic Drug Submissions.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR 314 have been approved under OMB control
number 0910-0001. The collections of information in 21 CFR part 210 and
211 (Current Good Manufacturing Practice) have been approved under OMB
control number 0910-0139. The collections of information relating to
Form FDA 356h have been approved under OMB control number 0910-0338.
The collections of information relating to Form FDA 3794 have been
approved under OMB control number 0910-0727.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: November 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26412 Filed 12-2-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 16, 2008 (Volume 73, Number 242)]
[Notices]
[Page 76443-76448]
[DOCID:fr16de08-108]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Notice Requesting Expressions of Interest in Implementing a High-
Speed Intercity Passenger Rail Corridor

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice Requesting Expressions of Interest.

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

SUMMARY: Section 502 of the Passenger Rail Investment and Improvement
Act of 2008, Public Law 110-432 (October 16, 2008), requires the
Secretary of Transportation to ``issue a request for proposals for
projects for the financing, design, construction, operation, and
maintenance of a high-speed intercity passenger rail system operating
within'' either the Northeast Corridor or a Federally designated high-
speed rail (HSR) corridor. To satisfy this requirement, the FRA is
soliciting and encouraging the submission of Expressions of Interest
for potential projects to finance, design, construct, operate, and
maintain an improved HSR intercity passenger system in the Northeast
Corridor or in one of ten Federally designated corridors. FRA envisions
this as the first phase of a qualification process that Congress may
follow with more specific actions regarding particular proposals in one
or more corridors.

DATES: All Expressions of Interest submitted in response to this notice
shall be submitted by 5 p.m. e.t. on Monday, September 14, 2009, in
accordance with the instructions in ADDRESSES below. In order to gauge
possible interest in this process, FRA is requesting that participants
considering filing a response to this notice provide a letter with
names and contact information by Friday, January 30, 2009. The initial
letter will help FRA gauge interest in the Request for Expressions of
Interest (RFEI) process and will facilitate future communications to
participants, including invitation to a possible information session in
the spring of 2009 to further invite questions from participants and to
provide information and guidance regarding the RFEI process. Failure to
provide a letter will not prevent participants from submitting an
Expression of Interest in accordance with this notice.

ADDRESSES: Any questions, responses or Expressions of Interest in
response to this notice shall be submitted under the docket number FRA-
2008-0140 by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Fax: 1-202-493-2251.
    Instructions: All submissions must include the agency name and
docket number (FRA-2008-0140) for this RFEI process. Note that all
comments received will be posted, without change, to http://
www.regulations.gov, including any personal information. Please see the
Privacy Act heading in the SUPPLEMENTARY INFORMATION section of this
document for Privacy Act information related to any submitted comments
or materials. Internet users may access comments received by DOT at
http://www.regulations.gov.
    If you wish to submit any information under a claim of
confidentiality, submit

a version from which you have deleted the claimed confidential business
information to the docket as specified above and send two copies of
your complete submission, including the information you claim to be
confidential business information, following the steps outlined in
``Requests for Confidential Treatment'' in the SUPPLEMENTARY
INFORMATION section of this document to Mr. David Valenstein as
specified below.

FOR FURTHER INFORMATION CONTACT: For information from FRA, please
contact Mr. David Valenstein, Office of Railroad Development, Federal
Railroad Administration, 1200 New Jersey Avenue, SE., MS-20/W38-303,
Washington, DC 20590. Phone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: FRA anticipates that participants will have
questions during the RFEI process. In order to assure that all
respondents have equal access to such questions and their answers,
questions about this notice must be submitted to the docket as
specified in ADDRESSES above. Any responses provided by the FRA will be
posted to the docket; summary questions and answers will also be posted
on the FRA Web page for the RFEI process.
    Background on High-Speed Rail (HSR): HSR is self-guided intercity
passenger ground transportation that is time competitive with air and/
or auto on a door-to-door basis for trips in the approximate range of
100 to 500 miles. A corridor is a natural grouping of metropolitan
areas and markets that, by their proximity and configuration, lend
themselves to efficient service by HSR. The U.S. Department of
Transportation study that yielded these definitions, High-Speed Ground
Transportation for America (1997, available at [http://www.fra.dot.gov/
us/content/515]), went on to suggest that HSR--once built--could
potentially provide significant public benefits (congestion relief,
emissions reductions, and petroleum savings) while supporting its
continuing operations and future investment requirements from the
farebox. Actual results would vary from one corridor to another, and
would depend on a host of factors, including travel demand, fare
policies, characteristics of competing modes, source of motive power,
and operating practices and costs.
    Background on This Request for Expressions of Interest (RFEI):
Section 502 of the Passenger Rail Investment and Improvement Act of
2008 (``Section 502'') (Pub. L. 110-432, October 16, 2008), requires
the Secretary of Transportation to ``issue a request for proposals for
projects for the financing, design, construction, operation, and
maintenance of a high-speed intercity passenger rail system operating
within'' either the Northeast Corridor or a federally designated HSR
corridor. Section 502 prescribes that Expressions of Interest received
will be considered by the Secretary and possibly by commissions
representing affected and involved governors, mayors, freight
railroads, transit authorities, labor organizations, and Amtrak. The
results of these reviews will be summarized in one or more reports to
Congress, which will make recommendations for further action regarding
no more than one project concept for each corridor. FRA envisions this
as the first phase of a qualification process that Congress may follow
with more specific actions regarding particular proposals in one or
more corridors.
    Although authorized, no funds have been appropriated to support
implementation of HSR under this program, and the availability of such
funds in the future is not known. Respondents to this request
acknowledge, by virtue of their response, that the likelihood of future
funding and implementation of the projects covered by this notice is
unknown, and that the Federal Government will not be liable for any
costs incurred in the preparation of responses to this notice.
    Who May Respond: Responses to this RFEI are welcome from all
sources. Section 502 calls for comprehensive proposals that will
address all the tasks necessary to implement HSR. Potential proposers
are advised to verify, before committing resources to responding to
this RFEI, that they would be able to assemble a cohesive team that can
plan, organize, finance, design, and construct a complete HSR system in
an eligible corridor, as well as gain the support of the key public and
private stakeholders, and successfully operate and maintain it on a
long-term basis.
    Performance Standards for HSR Systems: Section 502 requires that
the HSR proposals for which Expressions of Interest are requested meet
certain travel time performance standards and meet any standards
established by the Secretary. The required performance standards are:
    (A) Northeast Corridor between New York and Washington: Proposed
express service must link Pennsylvania Station, New York, with Union
Station, Washington, with a reliable travel time of two hours.
    (B) All other eligible corridors, including the Northeast Corridor
between New York and Boston: Existing minimum intercity rail scheduled
service trip times (as shown in Amtrak's published timetable in effect
on October 16, 2008) between endpoints and all other main corridor
city-pairs must be reduced by a minimum of 25 percent, and a reliable
service provided. If no service presently exists in the corridor, the
proposer will need to demonstrate that the proposed service will be
reliable and time competitive in accordance with the definition of HSR
above.
    Eligible Corridors: Responses to this notice must address HSR
proposals located in part or all of one or more of the following
corridors that connect and serve the key metropolitan areas listed
(shown on the map at: http://www.fra.dot.gov/us/content/1272):
    (A) ``Northeast Corridor'' between Washington, DC; Baltimore, MD;
Wilmington, DE; Philadelphia, PA; Trenton, NJ; New York, NY; New Haven,
CT; Providence, RI; and Boston, MA. Separate service standards apply
north and south of New York City; see Performance Standards for HSR
Systems, above.
    (B) ``California Corridor'' connecting and between the San
Francisco Bay Area, Sacramento, Los Angeles, and San Diego, CA;
    (C) ``Empire Corridor'' between New York City, Albany and Buffalo,
NY, over the route of the former New York Central Railroad;
    (D) ``Pacific Northwest Corridor'' between Eugene and Portland, OR;
Seattle, WA; and Vancouver, BC, Canada;
    (E) ``South Central Corridor'' along three branches between Dallas/
Fort Worth, TX, and:
    (1) Austin and San Antonio, TX;
    (2) Oklahoma City and Tulsa, OK; and
    (3) Texarkana and Little Rock, AR;
    (F) ``Gulf Coast Corridor'' along three branches between New
Orleans, LA, and:
    (1) Birmingham, AL, and Atlanta, GA;
    (2) Houston, TX; and
    (3) Mobile, AL;
    (G) ``Chicago Hub Network'' along six routes between:
    (1) Chicago, IL; Milwaukee, WI; and Minneapolis-St. Paul, MN;
    (2) Chicago, IL, and Detroit, MI;
    (3) Chicago, IL, Toledo and Cleveland, OH;
    (4) Chicago, IL; Indianapolis, IN; and both Cincinnati, OH, and
Louisville, KY;
    (5) Chicago, IL; St. Louis, MO; and Kansas City, MO; and
    (6) The transversal extension between Cleveland, Columbus, and
Cincinnati, OH;

    (H) ``Florida Corridor'' between Miami, Orlando, and the Tampa Bay
region, FL;
    (I) ``Keystone Corridor'' between Philadelphia, Harrisburg, and
Pittsburgh, PA, over the route of the former Pennsylvania Railroad;
    (J) ``Northern New England Corridor'' along three branches between
Boston, MA, and:
    (1) Portland/Lewiston-Auburn, ME;
    (2) Concord, NH; Montpelier, VT; Montreal, QE, Canada; and
    (3) Springfield, MA, and to both New Haven, CT, and Albany, NY; and
    (K) ``Southeast Corridor'' along three branches between:
    (1) Washington, DC; Richmond, VA; Raleigh, Greensboro and
Charlotte, NC; Greenville, SC; and Atlanta, GA;
    (2) Raleigh, NC; Columbia, SC; Savannah, GA; Jacksonville, FL; and
    (3) Atlanta, Macon, and Jesup, GA, thence either or both Savannah,
GA and Jacksonville FL.
    Required Contents of Expressions of Interest: Complete responses
must contain the required contents, and will be evaluated by FRA to
determine if they satisfy the selection criteria in Evaluation and
Selection Process for Expressions of Interest below. The following
minimum requirements may be satisfied through a narrative statement
submitted by the applicant and supported by spreadsheet documents,
tables, graphics, drawings, and/or other materials, as appropriate.
Each Expression of Interest must:
    1. Designate a point of contact for the Expression of Interest and
provide his or her name and contact information, including a telephone
number, mailing address and e-mail address.
    2. Provide the name(s) and qualifications of the person(s)
submitting the Expression of Interest, and the names and qualifications
of the lead entity and each member/entity of the team proposed to
finance, design, construct, operate, and maintain the railroad,
railroad equipment, and related facilities, stations, and
infrastructure. Describe how such entities would be related to the lead
entity.
    3. Provide a short executive summary overview of the proposed
project concept, including:
    a. Markets served, including a concept map;
    b. Station locations;
    c. Trip times for major markets indicating that program performance
standards will be met;
    d. Peak and average operating speeds of the train service;
    e. Proposed routes and alignments, noting the extent of new rights-
of-way (ROW) and use of existing ROW, as well as a general discussion
of how the intended reliability requirements will be achieved;
    f. Type of train equipment to be used, the maximum speed of that
equipment, and any technologies used to meet trip time goals;
    g. Proposed organizational structure;
    h. Salient features of the intended operation as they may affect
operating practices and unit costs;
    i. Total capital cost and expected contributions by Federal, state,
and other public and private sources; and
    j. The benefits to the public and the national transportation
system, including an explanation as to why the project is cost-
effective and what advantages it offers over existing services.
    4. Provide a detailed technical description of the project,
including:
    a. Populations of markets served by each of the proposed stations;
    b. Existing intercity traffic (passengers, vehicle capacity,
frequency) by mode;
    c. Proposed station locations and, for each, whether it is existing
or new, and how it maximizes the use of existing infrastructure;
    d. How the project will facilitate convenient intermodal travel
connections with other transportation services and systems;
    e. Trip time and fare comparisons among proposed services, existing
rail services, if any, and competing modes for major city pairs;
    f. An operating plan with train service frequency, timetable, and
information on intermodal connections;
    g. Annual ridership and revenue projections for 10 years with
documentation of assumptions and methods and peaking characteristics;
    h. Operating costs with documentation of assumptions and methods;
    i. The impact of the project on highway and aviation congestion,
energy consumption, pollutant emissions, land use and economic
development;
    j. A description of how the design, construction, implementation,
and operation of the project will accommodate and allow for future
growth of existing and projected intercity, commuter, and freight rail
service;
    k. The impact of the project on other intercity, commuter, and
freight rail services;
    l. Proposed routes and alignments noting the extent of new ROW and
use of existing ROW;
    m. Required infrastructure investments and improvements, including
the feasibility of building new track and method for securing required
ROW;
    n. How adverse impacts of the project would be mitigated;
    o. The type and quantity of train equipment to be used, with
technical specifications, such as consist, maximum speed, passenger
capacity, energy consumption profile, acceleration and deceleration
rates;
    p. Project capital costs for major categories of expenditures
(track structures, tunnels, bridges, vehicles, stations, maintenance
equipment and facilities, communication and control systems, and power
systems), with documentation of assumptions and methods;
    q. A detailed analysis of the methods and technologies for
achieving the required reductions in trip times and the intended
reliability standards; and
    r. Synopses and references for any past high-speed rail studies
deemed relevant.
    5. Present a detailed financial plan for the proposed project,
including:
    a. Projected annual operating revenues by year and sources;
    b. Estimates of annual operating costs by type of expenditure;
    c. Annual schedule of capital costs required both initially and in
subsequent years to maintain a state-of-good-repair and to recapitalize
as necessary to sustain the initially proposed level of service or
higher levels of service;
    d. Sources and descriptions of capital funds, including terms,
conditions and expectation for return on equity, and
    e. Credit assumptions including sources, guarantees, terms,
maturity and special conditions;
    f. A description of the insurance program contemplated for
construction and operation;
    g. A description of construction cost risk sharing and rationale
for the proposed approach;
    h. A description of revenue and operating cost risk sharing and
rationale for the proposed approach;
    i. Projected funding for the full fair market compensation for any
asset, property right or interest, or service acquired from, owned, or
held by a private person or Federal entity that would be acquired,
impaired, or diminished in value as a result of a project, except as
otherwise agreed to by the private person or entity; and
    j. A projected financial statement for the proposed organization
showing annual revenues, costs, investments, and debt service from
project inception through construction, testing, and the first 20 years
of operation.

    6. Describe the institutional framework and address other
institutional issues, including:
    a. A project structure organization chart showing the proposer team
and all the relationships among the public and private entities
involved in the proposed project, a description of the relationships
among the entities responsible for the financing, design, construction,
operation and maintenance of the proposed project (including their
equity stakes), and the roles of other participants in the operational
aspects of the project;
    b. Any new entities required and how they will be structured
legally and financially;
    c. Integration of the proposed service with Amtrak, other HSR rail
services, other intercity passenger systems, and local access/egress
systems;
    d. The feasibility of gaining access to required ROW, the approach
to track capacity including building new track, and any public and
private agreements for facility access and the expected costs of each;
    e. Required governmental actions and approvals and the role of the
state government(s) in implementing the proposal; and
    f. The relationship to state rail plans and programs or, if not
already part of such plans or programs, a statement describing plans
for integration into them.
    7. Identify legislative actions needed, if any, to facilitate all
aspects of the proposed project, including:
    a. Required Federal, state and/or local legislation to authorize
and create a sponsoring entity for the project, or to remove legal
impediments to project implementation, or otherwise facilitate the
project;
    b. Required public funding commitments, Federal, state and/or
local;
    c. Any legislative action required to allow the project to benefit
from government-sponsored credit assistance programs, such as the
Railroad Rehabilitation and Improvement Financing program and the
Transportation Infrastructure Finance and Innovation Act program; and
    8. Describe how the project will be implemented to comply with
Federal, state and local laws, including but not limited to:
    a. Laws governing the rights and status of employees associated
with the route and service, including those specified in section 24405
of title 49 United States Code;
    b. Rail safety and security laws, orders, and regulations governing
HSR operations, including, but not limited to, the railroad safety
provisions in Part 49 of the Code of Federal Regulations and the
requirements of the Rail Safety Improvement Act of 2008;
    c. Environmental laws and regulations and the status or any
progress towards completion of required documentation or actions under
the National Environmental Policy Act, the National Historic
Preservation Act, section 4(f) of the DOT Act, or other applicable
Federal or state environmental impact assessment laws; and
    d. The Americans With Disabilities Act.
    Optional Contents Requested for Inclusion in Submissions: In
addition to the required contents, respondents are requested to
provide, at their option, their perspectives on what type of
contracting and financing strategies are most likely to facilitate
successful HSR projects. FRA is particularly interested in perspectives
that draw on prior experience with HSR projects. In responding to this
request, Expressions of Interest should address the following:
    a. What type of contracting structure is likely to provide the most
effective allocation of the risk and responsibility for each element of
the project (design, construction, financing, operation and
maintenance) between the private and public sectors?
    b. Should all of the project elements to be performed by the
private sector be procured in a single procurement or separately (for
example, separate procurements for civil works, the provision of
systems and equipment, and long-term operations and maintenance of the
system)?
    c. Should the project's financing rely on commercial ticket fares
and other revenue generated directly by the facility to pay for all or
any portion of the project's cost, and should the private partner
assume the risk that these revenues will be sufficient to repay all or
any portion of the project's financing?
    d. What role should public sector commitments play in financing the
project or particular components of the project, and what type of
public commitment would be most effective?
    e. What measures or commitments would be needed, including possible
legislation, to provide and facilitate multi-year Federal commitments
of any Federal financing needed for the project?
    f. What role should private equity play in financing the project or
particular components of the project and how would terms and conditions
affect public sector participation?
    g. Are there any key considerations that will encourage or dissuade
private sector involvement in the financing, design, construction, and
long-term operations and maintenance of HSR in the corridors identified
above?
    h. Should the commissions required by Section 502 be organized and
their work structured in the same way for all corridors, and what
structures and models should be considered to guide the commissions?
    i. How would the proposal contribute to the development of a
national HSR system?
    Format for Submissions: Each Expression of Interest shall be
submitted according to the instructions in ADDRESSES above. At a
minimum, two (2) hard copies and electronic format on optical media
(except oversized engineering drawings and maps, which may be submitted
solely in hard copy) shall be submitted. Responses may include maps or
graphics when they would illustrate information more effectively than
text.
    Text and graphic documents shall be submitted both as MS Word
documents and Adobe PDF documents, in Times New Roman, 12 point font,
with 1-inch margins. Spreadsheets containing financial information
shall be submitted as Microsoft Excel (or compatible) documents and
Adobe PDF documents.
    Each Expression of Interest should not exceed a maximum total of 75
pages, excluding appendices. The following sections shall be included
in any submission: Cover page, proposer name(s) and contact
information, project overview, detailed technical description, detailed
financial plan, institutional information, legislative actions, legal
compliance issues, and appendices containing any spreadsheets,
drawings, and tables. Optional content should be provided as an
additional section not included in the page count. The executive
summary project overview should not exceed two (2) pages in length.
    Evaluation and Selection Process for Expressions of Interest: FRA
will review responses and make determinations within 60 days of the
closing date, under Dates above. The Secretary will evaluate each
Expression of Interest in a two-step process. First, it will be
screened for its completeness in responding to this RFEI. Second, it
will undergo substantive review according to the selection criteria
outlined below.
    Selection Criteria: FRA will consider the extent to which each
Expression of Interest satisfies the following selection factors: (1)
The project detailed in the Expression of Interest demonstrates the
ability to achieve the specified reduction in minimum intercity rail
service trip times and the intended reliability standards. (2) The
Expression

of Interest is complete and includes all the elements in the
Requirements for Expressions of Interest section, above. (3) The
project detailed in the Expression of Interest is sufficiently credible
to warrant further consideration. (4) The project detailed in the
Expression of Interest is likely to result in a positive impact on the
Nation's transportation system. (5) The project detailed in the
Expression of Interest is cost-effective. (6) The project detailed in
the Expression of Interest is in the public interest.
    Step 1--Screening Process: Upon receipt of responses and after the
close of the Expression of Interest solicitation, FRA will evaluate
them and determine if each Expression of Interest is complete and if
there is evidence provided in the response that would support
conclusions, based on criteria 3 through 6 above. If FRA determines
that one or more Expressions of Interest satisfy this screening
evaluation, the Secretary would form a commission for each relevant
corridor to review and consider the response(s).
    Step 2--Selection Process: Section 502 requires the Secretary to
establish and support the formation of commissions, representing
affected and involved governors, mayors, freight railroads, transit
authorities, labor organizations, and Amtrak, that would assess the
responses, and authorizes appropriation of necessary funds for this
purpose. No funds have been appropriated for this purpose as of the
date of this RFEI. The commission(s) would review the Expressions of
Interest and prepare a report to the Secretary making recommendations
for further consideration.
    Following receipt of each commission's evaluation and
recommendations, the Secretary will consider the commission report(s)
and select Expression(s) of Interest that (i) demonstrate a high
likelihood of providing substantial benefits to the public and the
national transportation system; (ii) are cost-effective, considering
public commitments necessary for implementation and operation; and
(iii) promise significant advantages over existing services operating
in the same HSR corridor. The Secretary will then submit a report to
Congress on all selected Expression(s) of Interest. Subject to
appropriations and after submission of reports to Congress, up to
$5,000,000.00 may be made available for preliminary engineering under
49 U.S.C. Section 26104(a) for one selected proposal per corridor.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of FRA's dockets by the name of the
individual submitting the comment (or signing the comment, if submitted
on behalf of a State, association, business, or labor union). 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.
    Freedom of Information Act Applicability: Documents submitted to
the agency pursuant to this notice become agency records subject to the
public access provisions of the Freedom of Information Act (FOIA) (5
U.S.C. 552). FOIA generally provides that any person has a right,
enforceable in court, to obtain access to Federal agency records,
except to the extent that such records (or portions of them) are
protected from public disclosure by one of nine exemptions or by one of
three special law enforcement record exclusions. The Department of
Transportation's regulations implementing the FOIA are found at 49 CFR
Part 7. See the discussion later in this notice about the treatment of
trade secrets and commercial or financial information obtained from a
person that is privileged or confidential.
    Requests for Confidential Treatment: FRA recognizes that
Expressions of Interest submitted to the agency pursuant to this notice
may contain certain information that is or should be exempt from public
release, principally because the information constitutes trade secrets
or commercial or financial information obtained from a person that is
privileged or confidential as provided for in Freedom of Information
Act exemption 4 (5 U.S.C. 552(b)(4)). The term ``trade secret'' has
been fairly narrowly defined as a ``secret, commercially valuable plan,
formula, process, or device that is used for the making, preparing,
compounding, or processing of trade commodities and that can be said to
be the end product of either innovation or substantial effort. Public
Citizen Health Research Group v. FDA, 704 F.2d 1280, 1288 (DC Cir.
1983). FRA expects that there should be very limited, if any, need to
submit trade secret information in connection with this notice.
Commercial or financial information obtained from a person that is
privileged or confidential and thus exempt from release under FOIA
exemption typically involves information the release of which is likely
to cause substantial harm to the competitive position of the person
from whom the information was obtained. National Parks & Conservation
Association v. Morton, 498 F.2d 765, 770 (DC Cir. 1974). This is a
fairly restrictive standard and should serve to limit the volume of
exempt material that might be submitted.
    FRA also recognizes that the nature of the process established
through section 502 of the Passenger Rail Investment and Improvement
Act of 2008, with the potential involvement of a multi-member
commission that could be charged with reviewing proposals submitted
pursuant to this notice, could present significant challenges in
managing any confidential information that is submitted. Thus,
submitters are encouraged to carefully review the applicable standards
governing what constitutes trade secrets or confidential commercial or
financial information and to limit the submission of such information
to that specifically needed to respond to this notice.
    A request for confidential treatment with respect to a document or
portion thereof may be made in accordance with instructions in
ADDRESSES above on the basis that the information is--(1) Exempt from
the mandatory disclosure requirements of the Freedom of Information Act
(5 U.S.C. 552); (2) Required to be held in confidence by 18 U.S.C.
1905; or (3) Otherwise exempt by law from public disclosure. Any
document containing information for which confidential treatment is
requested shall be accompanied at the time of filing by a detailed
statement justifying non-disclosure and referring to the specific legal
authority claimed. Any document containing any information for which
confidential treatment is requested shall be marked ``CONFIDENTIAL'' or
``CONTAINS CONFIDENTIAL INFORMATION'' in bold letters. If
confidentiality is requested as to the entire document, or if it is
claimed that non-confidential information in the document is not
reasonably segregable from confidential information, the accompanying
statement of justification shall so indicate and support with specific
legal authority. If confidentiality is requested as to a portion of the
document, then the person filing the document shall file, together with
the document, a second copy of the document from which the information
for which confidential treatment is requested has been deleted. If the
person filing a document, of which only a portion is requested to be
held in confidence, does not submit a second copy of the document with
the confidential information deleted, FRA may assume that there is no
objection to public disclosure of the document in its entirety. FRA
retains the right to make its own determination with regard to any
claim of confidentiality. Notice of a decision by the FRA to deny a
claim, in whole or in part, and an opportunity to

respond shall be given to a person claiming confidentiality of
information no less than five days prior to its public disclosure. FRA
intends to address protection of confidential information by any
commission(s) formed to review submitted proposals through the
commission formation process. Submitters are welcome to offer
suggestions for managing confidential data along with their proposals.

    Issued in Washington, DC, on December 11, 2008.
Mark E. Yachmetz,
Associate Administrator for Railroad Development.
[FR Doc. E8-29795 Filed 12-15-08; 8:45 am]

BILLING CODE 4910-06-P