[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Notices]
[Pages 32197-32200]
[FR Doc No: 2015-13756]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2015-0055]

Notice of Coordinated Remedy Program Proceeding for the
Replacement of Certain Takata Air Bag Inflators

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

ACTION: Notice.

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SUMMARY: In order to prioritize, organize, and phase multiple recalls
to remedy defective Takata frontal air bag inflators, the National
Highway Traffic Safety Administration (``NHTSA'') is opening
proceedings, including a public docket..NHTSA is considering issuing
one or more administrative orders that would coordinate remedy programs
associated with defective Takata air bag inflators. Coordination of the
remedy programs may include, among other things, ``acceleration,''
prioritization, organization, and/or phasing of some or all such air
bag inflator remedy programs. It may further include coordination as to
air bag inflator sourcing, production, allocation, delivery,
installation, and adequacy of the remedy. This notice explains events
leading to today's action and NHTSA's authority to open such a
proceeding. It also describes some of the issues that the agency
anticipates considering in the proceeding and information the agency
requests from commenters as part of such a proceeding.

ADDRESSES: You may submit comments to the docket number identified in
the heading of this document by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, West Building Ground Floor, Rm. W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery or Courier: U.S. Department of
Transportation, West Building Ground Floor, Rm. W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590 between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Regardless of how you submit your comments, you should mention the
docket number of this document.
    You may call the Docket at<PHONE_NUMBER>.
    Note that all comments received will be posted without change to
http://www.regulations.gov, including any personal information
provided.

FOR FURTHER INFORMATION CONTACT: For non-legal issues, Scott Yon,
Office of Defects Investigation, National Highway Traffic Safety
Administration (telephone:<PHONE_NUMBER>); for legal issues, Arija
Flowers, Office of the Chief Counsel, NCC-111, National Highway Traffic
Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590
(telephone:<PHONE_NUMBER>). Information regarding NHTSA's investigation
into Takata Air Bag Inflator ruptures is available on

NHTSA's Web site at: http://www.safercar.gov/rs/takata/index.html.

SUPPLEMENTARY INFORMATION: To mitigate and control the risk of serious
injury or death due to an air bag inflator rupture, and to ensure that
all affected vehicles in the United States are equipped with safe air
bags as quickly as possible, NHTSA is considering exercising its
authority under the National Traffic and Motor Vehicle Safety Act of
1966, as amended and recodified (the ``Safety Act''), 49 U.S.C. 30101,
et seq., to provide national-level leadership and to facilitate the
prioritization, organization, and phasing of the remedy programs of TK
Holdings, Inc. (``Takata'') and all vehicle manufacturers having
recalled, defective Takata frontal air bag inflators. This includes the
remedy programs of BMW of North America, LLC (``BMW''), Chrysler Group,
LLC (``Chrysler''), Ford Motor Company (``Ford''), General Motors, LLC
(``GM''), American Honda Motor Company (``Honda''), Mazda North
American Operations (``Mazda''), Mercedes-Benz, LLC--DBA Sprinter (``M-
B Sprinter'') (as to Sprinter Vans only), Mitsubishi Motors North
America, Inc. (``Mitsubishi''), Nissan North America, Inc.
(``Nissan''), Subaru of America, Inc. (``Subaru''), and Toyota Motor
Engineering and Manufacturing (``Toyota'') (collectively, the
``Manufacturers'').

I. The Reasons for a Coordinated Remedy

    The number of recalled air bag inflators and impacted vehicles and
manufacturers, in combination with the supply issues related to these
air bag recalls, presents an unprecedented level of complexity to the
recall and remedy process. As of the date of this Federal Register
Notice, these recalls of defective Takata air bag inflators constitute
the largest Safety Act recall in NHTSA's history, and one of the
largest consumer product recalls in United States history, with
approximately 34 million air bag inflators currently requiring
replacement. The risk of harm presented by the defective Takata air bag
inflators transcends the scope of the usual Safety Act recall.
Accordingly, NHTSA is hereby opening a coordinated remedy program
proceeding.
    Each of the Manufacturers, with the exception of M-B Sprinter, has
previously elected a remedy program of repair for at least some of
their affected vehicles (specifically, for vehicles that were covered
by prior Manufacturer recalls). See 49 U.S.C. 30120(a)(1)(A). These
remedy programs are individual to each of the Manufacturers, creating a
patch-work solution that NHTSA believes may not adequately address the
safety risks presented by the defective Takata air bag inflators within
a reasonable time. Based on the currently available data, these recalls
involve varying levels of risk of harm which must be mitigated and
controlled: The risk of the air bag inflator rupturing when the air bag
is inflated, which may result in serious injury or death to vehicle
occupants without prior warning.
    Specifically, NHTSA is issuing this notice pursuant to its
authority under the Safety Act to ``accelerate'' remedy programs, 49
U.S.C. 30120(c)(3) and 49 CFR 573.14, to inspect and investigate, 49
U.S.C. 30166(b)(1), to ensure that defective vehicles and equipment are
recalled and remedied, 49 U.S.C. 30118 through 30120, and to ensure
that the remedy for the defect is adequate, 49 U.S.C. 30120, as
delegated by the Secretary of Transportation (``the Secretary''), 49
CFR 1.95 and 501.2(a)(1). Given the severity of the possible harm,
variable nature of the risk of harm to be mitigated and controlled,
unprecedented number of vehicles and entities affected, and imperative
for public confidence in the safety of their vehicle air bags, NHTSA is
therefore opening a public proceeding, including a public docket, to
investigate challenges and solutions related to the Takata air bag
inflator recalls and to gather public comments on those issues.
    NHTSA also anticipates collaborating in this proceeding with other
Tier One inflator suppliers, which may include ARC Automotive, Inc.
(``ARC''), Autoliv Americas (``Autoliv''), Key Safety Systems (``Key
Safety''), Toyoda Gosei North America Corporation (``Toyoda''), TRW
Automotive (``TRW''), and Special Devices, Inc./Daicel Group
(``Daicel'') (collectively, the ``Suppliers'') to craft solutions that
further mitigate and control the risk of harm by ensuring safe air bags
in every motor vehicle in the United States.

II. Background on Defective Takata Frontal Air Bag Inflators

    The first recall involving a rupturing Takata driver side frontal
air bag inflator was initiated by Honda on November 11, 2008, and was
designated by NHTSA as Recall No. 08V-593. At that time, the defect was
thought to be the result of a specific manufacturing issue involving
one of the propellant presses at Takata's Moses Lake, Washington plant.
Due to various discrepancies in Takata's recordkeeping for the affected
parts, Honda had to expand the scope of the recall several times
between 2009 and 2011. Those recall expansions were designated by NHTSA
as Recall Nos. 09V-259, 10V-041, and 11V-260.
    The first recall involving a rupturing Takata passenger side
frontal air bag inflator was initiated by Takata on April 11, 2013, and
involved the following vehicle manufacturers: BMW, Honda, Mazda,
Nissan, and Toyota. The various recall submissions were designated by
NHTSA as Recall Nos. 13E-017, 13V-130, 13V-132, 13V-133, 13V-136, and
13V-172. At that time, the defect was thought to be the result of two
specific manufacturing issues--(1) The possibility that the auto-reject
function on the propellant press had been manually disabled, and (2)
the possibility that certain propellant lots were exposed to
uncontrolled moisture conditions at Takata's Monclova, Mexico plant.
    Between August 2013 and April 2014, NHTSA received three Vehicle
Owner Questionnaires (VOQs) that alleged air bag inflator ruptures in
vehicle populations outside the scope of the prior driver side and
passenger side frontal air bag recalls. In late-May 2014, Takata
confirmed the three ruptures with NHTSA's Office of Defects
Investigation (ODI), and notified ODI of an additional three ruptures
(for a total of six rupture incidents between August 2013 and May
2014). On June 10, 2014, NHTSA convened a conference call, after which
Takata and the affected vehicle manufacturers agreed to initiate
regional parts collection campaigns in Florida, Hawaii, Puerto Rico,
and the U.S. Virgin Islands. The initial data underlying these regional
actions indicated that certain Takata frontal air bag inflators in
regions prone to long-term high absolute humidity and temperatures pose
a safety risk.
    On June 11, 2014, NHTSA opened a preliminary evaluation, PE14-016,
to investigate the six identified rupture incidents involving driver
side and passenger side frontal air bag inflators manufactured by
Takata. (PE14-016 was later upgraded to an engineering analysis, EA15-
001, on February 24, 2015.)
    During the period of October through December 2014, service
campaigns related to the passenger side frontal air bags were converted
to recalls and the geographic scope was expanded, though still limited
to certain regions with higher levels of absolute humidity and high
temperatures. Also during this period, NHTSA sent letters to Takata and
the Manufacturers (except M-B Sprinter, whose air bag inflators were
not then identified as having any defect) regarding their efforts and
abilities, individually, to accelerate the supply of

replacement air bags and emphasizing the importance of their continued
efforts to promptly and effectively remedy the serious safety risk
posed to consumers by the defective Takata air bag inflators. Further,
as part of its ongoing investigation and oversight of the defective
Takata frontal air bag inflators, NHTSA issued a pair of Special Orders
to Takata on October 30, and November 18, 2014, a Special Order to
Honda on November 5, 2014, and General Orders to BMW, Chrysler, Ford,
GM, Honda, Mazda, Mitsubishi, Nissan, Subaru, and Toyota on November
18, 2014.
    Also on November 18, 2014, NHTSA publicly demanded that the five
auto manufacturers with affected driver side frontal air bag inflators
expand their regional campaigns and conduct a nationwide recall of
vehicles equipped with the subject driver side frontal air bag
inflators. This decision was based on, among other things, the agency's
evaluation of a recent driver side frontal air bag failure in a vehicle
outside the current regional recall area, and its relationship to five
previous driver side frontal air bag inflator ruptures. Beginning in
December 2014, BMW, Chrysler, Ford, Honda and Mazda initiated national
service campaigns or safety improvement campaigns on vehicles with
these driver side frontal air bag inflators.
    On November 26, 2014, NHTSA demanded that Takata conduct a national
recall of driver side frontal air bag inflators. In a response dated
December 2, 2014, Takata declined to do so. Despite Takata's response,
NHTSA continued insisting that Takata conduct a national recall.
    On May 18, 2015, at NHTSA's urging, Takata filed four Defect
Information Reports (``DIR's'') pursuant to 49 CFR 573.6. In those
DIR's, Takata determined that a defect exists in certain models of
frontal air bag inflators (specifically, the PSDI, PSDI-4, PSDI-4K,
SPI, PSPI and PSPI-L).
    As of May 27, 2015, ruptured Takata air bag inflators allegedly
resulting in death or injury have been confirmed in 95 incidents in the
United States. Many of these incidents resulted in serious injury to
vehicle occupants. In five of the incidents, the vehicle's driver died,
allegedly as a result of injuries sustained from the rupture of the air
bag inflator. In other incidents, vehicle occupants allegedly suffered
injuries including cuts or lacerations to the face or neck, broken or
fractured facial bones, loss of eyesight, broken teeth, and traumatic
brain injury.

III. Coordinated Remedy Program Proceeding

    The Safety Act requires manufacturers to remedy safety-related
defects in motor vehicles. 49 U.S.C. 30120(a). The remedy must be
adequate to protect the American public from the safety risk posed by
the defect. 49 U.S.C. 30120(c). Manufacturers are required to notify
both the Secretary and vehicle owners of safety related defects, 49
U.S.C. 30118, including procedures for owners to follow to have the
safety-related defect remedied, 49 U.S.C. 30119. The Safety Act also
authorizes the Secretary to conduct investigations to enforce the
Safety Act, 49 U.S.C. 30166(b)(1), issue general and special orders
(responses to which are compulsory), hold hearings, and take testimony,
49 U.S.C. 30166(g)(1). If the Secretary determines that a
manufacturer's remedy program is not likely to be capable of completion
within a reasonable time, the Secretary may require the manufacturer to
``accelerate'' the remedy program if the Secretary finds that there is
a risk of serious injury or death if the remedy program is not
accelerated, and that acceleration of the remedy program can be
reasonably achieved by expanding the sources of replacement parts,
expanding the number of authorized repair facilities, or both. 49
U.S.C. 30120(c)(3). The Secretary has delegated his authorities under
the Safety Act, including each of the above, to the NHTSA
Administrator, 49 CFR 1.95(a) and 501.2(a)(1). Accordingly, NHTSA is
opening this coordinated remedy proceeding to investigate issues
related to the remedy of defective Takata frontal air bag inflators and
to coordinate remedy programs, if and as appropriate based upon the
findings of the proceeding.
    As an initial matter, NHTSA seeks a full, open, and collaborative
process, without compromising NHTSA's objectives of safety, that
facilitates thoughtful problem-solving and engages all regulated
entities in developing and implementing solutions to this significant
safety risk. For example, NHTSA anticipates that it will collaborate
with the Manufacturers, gathering information and data from each
Manufacturer regarding, among other things, information related to
production of replacement frontal air bag inflators and their
distribution. Upon receipt, public versions of all responses to NHTSA's
requests will be posted to this docket.
    NHTSA also anticipates engaging the Suppliers in a cooperative,
collaborative process seeking, among other things, information related
to current production capabilities, possible enhanced production
capabilities in the future, and any challenges to quickly increasing
production of these specific parts. This process will involve
requesting specific information from Suppliers and engaging in candid,
thoughtful dialogue with Suppliers.
    NHTSA further anticipates significant industry outreach to
facilitate the forging of collaborative partnerships. Among other
approaches, NHTSA anticipates convening one or more meetings,
individually and/or in groups, with Takata, Manufacturers, Suppliers,
and/or others to candidly discuss the challenges these industries are
facing and, again, work collaboratively to create solutions that
further mitigate and control the risk of harm presented by defective
Takata air bag inflators and the challenges to achieving a satisfactory
recall/remedy completion rate. Further, NHTSA may decide to hold a
public hearing and, if so, NHTSA will provide information on the scope,
date, time, and location of, and how to participate in, such a hearing
in a subsequent Federal Register Notice.

IV. NHTSA's Request for Public Comments

    While NHTSA will request certain information from Takata,
Manufacturers, Suppliers, and other regulated entities in this
proceeding, NHTSA also seeks comments from the public. NHTSA requests
comments regarding, among other things, how NHTSA can most effectively
exercise its authority with respect to prioritizing, organizing, and
phasing recall and remedy programs involving the defective Takata
frontal air bag inflators as described above, and methods for ensuring
that Manufacturers and Takata achieve satisfactory recall/remedy
completion rates.
    NHTSA also requests comments on how Takata, Manufacturers,
Suppliers, and other regulated entities would comply with one or more
administrative orders that NHTSA may issue at the conclusion of this
proceeding, upon consideration of the relevant data, facts found, and
choices made. NHTSA is further requesting comments on the possible
terms of any such order(s). In particular, NHTSA requests comments
relating to (1) whether, and how, NHTSA should order Takata and/or
other regulated entities to source replacement parts for Manufacturers,
(2) whether, and how, NHTSA should issue an accelerated remedy
directive to Takata and/or some (or all) Manufacturers, (3) whether,
and how, NHTSA should order Takata and/or Manufacturers to prioritize
certain

vehicles or certain regions in its allocation of replacement parts, (4)
whether, and how, NHTSA should order a replacement schedule for
replacement frontal inflators/air bags if Takata and/or Manufacturers
cannot provide assurances for the ongoing safety of the inflators, and
(5) whether, and how, NHTSA should order additional authorized repair
facilities, or any other regulated entity, to aid Takata and/or
Manufacturers in timely completing remedy programs.

    Authority: 49 U.S.C. 30101, et seq., 30118-30120, 30120(c)(3),
30166(b)(1), 30166(g)(1); 49 CFR 573.6, 573.14; delegations of
authority at 49 CFR 1.95(a), 501.2(a)(1).

    Issued: June 1, 2015.
Mark R. Rosekind,
Administrator.
[FR Doc. 2015-13756 Filed 6-4-15; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 82, Number 131 (Tuesday, July 11, 2017)]
[Notices]
[Pages 32049-32050]
[FR Doc No: 2017-14420]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2017-0034; Notice 1]

Michelin North America, Inc., Receipt of Petition for Decision of
Inconsequential Noncompliance

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

ACTION: Receipt of petition.

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SUMMARY: Michelin North America, Inc. (MNA), has determined that
certain BFGoodrich gForce Rival S summer performance tires do not fully
comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 139, New
Pneumatic Radial Tires for Light Vehicles. MNA filed a noncompliance
report dated April 17, 2017. MNA also petitioned NHTSA on May 5, 2017,
for a decision that the subject noncompliance is inconsequential as it
relates to motor vehicle safety.

DATES: The closing date for comments on the petition is August 10,
2017.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited in the title of this notice and be
submitted by any of the following methods:
     Mail: Send comments by mail addressed to 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 comments by hand to U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. The
Docket Section is open on weekdays from 10 a.m. to 5 p.m. except
Federal Holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) Web site at https://www.regulations.gov/. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided.
    All comments and supporting materials received before the close of
business on the closing date indicated above will be filed in the
docket and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the fullest extent possible.
    When the petition is granted or denied, notice of the decision will
also be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    All comments, background documentation, and supporting materials
submitted to the docket may be viewed by anyone at the address and
times given above. The documents may also be viewed on the Internet at
https://www.regulations.gov by following the online instructions for
accessing the dockets. The docket ID number for this petition is shown
in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000, (65 FR 19477-78).

SUPPLEMENTARY INFORMATION:
    I. Overview: Michelin North America, Inc. (MNA), has determined
that certain BFGoodrich gForce Rival S summer performance tires do not
fully comply with paragraph S5.2(d) of FMVSS No. 139, New Pneumatic
Radial Tires for Light Vehicles. MNA filed a noncompliance report dated
April 17, 2017, pursuant to 49 CFR part 573, Defect and Noncompliance
Responsibility and Reports. MNA also petitioned NHTSA on May 5, 2017,
pursuant to 49 U.S.C. 30118(d) and 30120(h) and 49 CFR part 556, for an
exemption from the notification and remedy requirements of 49 U.S.C.
Chapter 301 on the basis that this noncompliance is inconsequential as
it relates to motor vehicle safety.
    This notice of receipt of MNA's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    II. Tires Involved: Approximately 370 BFGoodrich gForce Rival S
summer performance tires, size P335/30ZR18 95W LL, manufactured between
March 2, 2017, and March 30, 2017, are potentially involved.
Specifically, these tires are marketed to sports car owners who compete
in track racing, autocross, and other such activities and events.
    III. Noncompliance: MNA explains that the noncompliance is that the
tire size designation markings on the sidewalls of the subject tires do
not contain the tire type code designator symbol from The Tire and Rim
Association yearbook, as required by paragraph S5.2(d) of FMVSS No.
139. Specially, the subject tire size reads ``335/30ZR18 95W LL'' but
should read ``P335/30ZR18 95W LL.''
    IV. Rule Text: Paragraph S5.2(d) of FMVSS No. 139 states, in
pertinent part:

    S5.2 Performance requirements. Each tire shall conform to each
of the following:

    . . .
    (d) Its load rating shall be that specified either in a
submission made by an individual manufacturer, pursuant to S4, or in
one of the publications described in S4 for its size designation,
type and each appropriate inflation pressure. If the maximum load
rating for a particular tire size is shown in more than one of the
publications described in S4, each tire of that size designation
shall have a maximum load rating that is not less than the published
maximum load rating, or if there are differing maximum load ratings
for the same tire size designation, not less than the lowest
published maximum load rating.

    V. Summary of MNA's Petition: MNA described the subject
noncompliance and stated its belief that the noncompliance is
inconsequential as it relates to motor vehicle safety.
    In support of its petition, MNA submitted the following reasoning:
    (a) Application--The subject tires are marked with the correct
maximum load and pressure load index, and load description (``Light
Load'') to ensure proper application. Additionally, the tires have the
correct tread sticker label showing the correct size designation, part
number, etc. to ensure proper application.
    (b) Usage--The tire is marketed as a performance summer tire
commonly used for competition events on tracks or autocross courses.
Thus, the users of these products are enthusiasts who are attentive to
details about vehicles and equipment such as tires. In such competition
events the vehicles are normally operated at the lightest loads
possible for performance optimization. These tires are normally not
used in situations involving vehicles with full passenger or cargo
loads.
    (c) Other Markings--All other markings conform to the applicable
regulations.
    (d) Performance--The subject tire meets all performance
requirements of FMVSS No. 139. In the event the tire is fitted to an
application calling for the European Tire and Rim Technical
Organization (ETRTO) standard load application of up to 850 kgs because
of the missing ``P'' prefix, there should be no performance concerns.
The tire has been tested to FMVSS No. 139 using the ETRTO standard load
as a basis and it fulfills all performance requirements.
    MNA concluded by expressing the belief that the subject
noncompliance is inconsequential as it relates to motor vehicle safety,
and that its petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject tires that MNA no longer
controlled at the time it determined that the noncompliance existed.
However, any decision on this petition does not relieve equipment
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant tires under their control after MNA
notified them that the subject noncompliance existed.

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

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2017-14420 Filed 7-10-17; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 85, Number 198 (Tuesday, October 13, 2020)]
[Notices]
[Pages 64614-64615]
[FR Doc No: 2020-21135]

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DEPARTMENT OF TRANSPORTATION

[Docket No. DOT-OST-2020-0084]

Information Collection; Improving Customer Experience (OMB
Circular A-11, Section 280 Implementation)

AGENCY: Office of the Secretary, Department of Transportation.

ACTION: Notice; request for comment.

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SUMMARY: The Department of Transportation (DOT) has under OMB review
the following proposed Information Collection Request ``Improving
Customer Experience (OMB Circular A-11, Section 280 Implementation)''
for approval under the Paperwork Reduction Act (PRA).

DATES: Submit comments on or before: November 12, 2020.

ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Please
provide a copy of your comments to Claire Barrett, Departmental Chief
Privacy and Information Governance Officer, 1200 New Jersey Ave. SE,
Washington, DC 20590; or by email to<EMAIL_ADDRESS>Please reference OMB
Control Number 2105-NEW, Improving Customer Experience (OMB Circular A-
11, Section 280 Implementation) in the subject line of your comments.

FOR FURTHER INFORMATION CONTACT: Requests for additional information
should be directed to Amira Boland, Office of Management and Budget,
725 17th St. NW, Washington, DC 20006,<PHONE_NUMBER>, or via email to
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Title: Improving Customer Experience (OMB Circular A-11, Section
280 Implementation).
    Abstract: A modern, streamlined and responsive customer experience
means: Raising government-wide customer experience to the average of
the private sector service industry; developing indicators for high-
impact Federal programs to monitor progress towards excellent customer
experience and mature digital services; and providing the structure
(including increasing transparency) and resources to ensure customer
experience is a focal point for agency leadership.
    This proposed information collection activity provides a means to
garner customer and stakeholder feedback in an efficient, timely manner
in accordance with the Administration's commitment to improving
customer service delivery as discussed in Section 280 of OMB Circular
A-11 at https://www.performance.gov/cx/a11-280.pdf.
    As discussed in OMB guidance, agencies should identify their
highest-impact customer journeys (using customer volume, annual program
cost, and/or knowledge of customer priority as weighting factors) and
select touchpoints/transactions within those journeys to collect
feedback.
    These results will be used to improve the delivery of Federal
services and programs. It will also provide government-wide data on
customer experience that can be displayed on www.performance.gov to
help build transparency and accountability of Federal programs to the
customers they serve.
    As a general matter, these information collections will not result
in any new system of records containing privacy information and will
not ask questions of a sensitive nature, such as sexual behavior and
attitudes, religious beliefs, and other matters that are commonly
considered private. DOT will only submit collections if they meet the
following criteria.
     The collections are voluntary;
     The collections are low-burden for respondents (based on
considerations of total burden hours or burden-hours per respondent)
and are low-cost for both the respondents and the Federal Government;
     The collections are non-controversial and do not raise
issues of concern to other Federal agencies;
     Any collection is targeted to the solicitation of opinions
from respondents who have experience with the program or may have
experience with the program in the near future;
     Personally identifiable information (PII) is collected
only to the extent necessary and is not retained;
     Information gathered is intended to be used for general
service improvement and program management purposes
     Upon agreement between OMB and the agency all or a subset
of information may be released as part of A-11, Section 280
requirements only on performance.gov. Summaries of customer research
and user testing activities may be included in public-facing customer
journey maps or summaries.
     Additional release of data must be done coordinated with
OMB.
    These collections will allow for ongoing, collaborative and
actionable communications between the Agency, its customers and
stakeholders, and

OMB as it monitors agency compliance on Section 280. These responses
will inform efforts to improve or maintain the quality of service
offered to the public. If this information is not collected, vital
feedback from customers and stakeholders on services will be
unavailable.
    Current Action: New Collection of Information.
    Type of Review: New.
    Affected Public: Individuals and Households, Businesses and
Organizations, State, Local or Tribal Government.
    Estimated Number of Respondents: Below is a preliminary estimate of
the aggregate burden hours for this new collection. DOT will provide
refined estimates of burden in subsequent notices.
    Average Expected Annual Number of Activities: Approximately five
types of customer experience activities such as feedback surveys, focus
groups, user testing, and interviews.
    Average Number of Respondents per Activity: 1 response per
respondent per activity.
    Annual Responses: 2,001,550.
    Average Minutes per Response: 2 minutes-60 minutes, dependent upon
activity.
    Burden Hours: DOT requests approximately 101,125 burden hours.
    Request for Comments: Comments submitted in response to this notice
will be summarized and/or included in the request for OMB approval.
Comments are invited on: (a) Whether the collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information shall have practical utility; (b) the
accuracy of the agency's estimate of the burden of the collection of
information; (c) ways to enhance the quality, utility, and clarity of
the information to be collected; (d) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques or other forms of information
technology; and (e) estimates of capital or start-up costs and costs of
operation, maintenance, and purchase of services to provide
information.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, disclose or provide
information to or for a Federal agency. This includes the time needed
to review instructions; to develop, acquire, install and utilize
technology and systems for the purpose of collecting, validating and
verifying information, processing and maintaining information, and
disclosing and providing information; to train personnel and to be able
to respond to a collection of information, to search data sources, to
complete and review the collection of information; and to transmit or
otherwise disclose the information.
    All written comments will be available for public inspection
Regulations.gov.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid Office of Management and Budget control number.

Claire W. Barrett,
Departmental Chief Privacy and Information Governance Officer.
[FR Doc. 2020-21135 Filed 10-9-20; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 84, Number 131 (Tuesday, July 9, 2019)]
[Notices]
[Pages 32749-32751]
[FR Doc No: 2019-14528]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2281]

Incorporating Alternative Approaches in Clinical Investigations
for New Animal Drugs; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comment.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a public meeting entitled ``Incorporating Alternative
Approaches in Clinical Investigations for New Animal Drugs.'' This
public meeting and request for comments is intended to support FDA
guidance development as required by the Animal Drug and Animal Generic
Drug User Fee Amendments of 2018. The topics to be discussed will
inform the development of guidance to assist sponsors in incorporating
complex adaptive and other novel investigation designs, data from
foreign countries, real world evidence (including ongoing surveillance
activities, observational studies, and registry data), biomarkers, and
surrogate endpoints into proposed clinical investigation protocols and
applications for new animal drugs under the Federal Food, Drug, and
Cosmetic Act (FD&C Act). FDA is seeking comments from stakeholders,
including representatives of regulated industry, consumer groups,
academia, veterinarians, and food producers.

DATES: The public meeting will be held on July 16, 2019, from 8:30 a.m.
to 5 p.m. Submit either electronic or written comments on this public
meeting by August 17, 2019.

ADDRESSES: The public meeting will be held at Johns Hopkins
University--Montgomery County, Gilchrist Hall, 9601 Medical Center Dr.,
Rockville, MD 20850. Free parking is available on site.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before August 17, 2019. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of August 17, 2019. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-2281 for ``Incorporating Alternative Approaches in Clinical
Investigations for New Animal Drugs.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9

a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Susan Storey, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., HFV-131,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public meeting entitled ``Incorporating
Alternative Approaches in Clinical Investigations for New Animal
Drugs.'' This public meeting and request for comment is intended to
support FDA guidance development as required under section 305 of the
Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (Pub.
L. 115-234). Section 305 directs FDA to develop guidance to address
several alternative approaches in clinical investigations for new
animal drugs, including incorporating complex adaptive and other novel
investigation designs, data from foreign countries, real world evidence
(including ongoing surveillance activities, observational studies, and
registry data), biomarkers, and surrogate endpoints into proposed
clinical investigation protocols and applications for new animal drugs
under sections 512 and 571 of the FD&C Act (21 U.S.C. 360b, 360ccc).
Section 305 also directs FDA to conduct a public meeting to allow the
Agency to gather input from stakeholders, including representatives of
regulated industry, consumer groups, academia, veterinarians, and food
producers before developing the guidance.

II. Topics for Discussion at the Public Meeting

    The purpose of this public meeting is to facilitate discussion and
obtain input from stakeholders about the use of complex adaptive and
other novel investigation designs, data from foreign countries, real
world evidence, and biomarkers and surrogate endpoints in drug
development and regulatory decision making.
    The meeting is expected to include four sessions that focus on the
following topics: (1) Complex adaptive and other novel investigation
designs; (2) data from foreign countries; (3) real world evidence; and,
(4) biomarkers and surrogate endpoints. Within each session and
following all sessions there will be an opportunity for public comment.
To facilitate the development of guidance on these topics, please
consider the following questions. When responding please identify the
topic and question in your response.

Topic 1: Complex Adaptive and Other Novel Investigation Designs

    1. In September 2018, FDA published draft Guidance for Industry:
Adaptive Designs for Clinical Trials of Drugs and Biologics, which
applies to human drugs and biologics (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/adaptive-design-clinical-trials-drugs-and-biologics). How should these apply to study designs
for animal drugs? What are the potential study adaptation features that
could be applied to animal drug investigations? What are the challenges
and possible solutions to apply these adaptations to studies for animal
drugs? To what type of studies for animal drugs would these study
designs be most applicable?
    2. How does complex adaptive design differ from adaptive design?
What constitutes other novel investigation designs? What examples are
directly applicable to animal drug development?
    3. Are there partnerships that can be formed between FDA and the
regulated industry, academia, or other groups to facilitate the
development or use of these novel investigational designs for animal
drug development? What strategic work is needed to enable the regulated
industry to make full use of these novel investigational designs for
animal drug development? What methods are needed, such as the use of
simulations or modeling, to facilitate the use of these novel
investigational designs for animal drug development?

Topic 2: Data From Foreign Countries

    For the purposes of this meeting, FDA considers data from foreign
countries to be data from investigations or studies conducted outside
the United States (U.S.). FDA can accept data from studies conducted
outside the United States to support a new animal drug application,
provided the applicant demonstrates that the data are adequate under
applicable standards to support approval (section 569B of the FD&C Act;
21 U.S.C. 360bbb-8b). FDA also accepts data from studies conducted
outside the United States to support a food additive petition for a
food additive intended for use in animal food, when provided by the
petitioner (section 409(k)(1) of the FD&C Act; 21 U.S.C. 348(k)(1)).
While the regulatory standards for approval differ between animal drugs
and animal food additives, data from foreign countries can be used to
support either approval if the data meet the appropriate regulatory
standards.
    1. What challenges and potential solutions do you have in meeting
the requirements of substantial evidence of effectiveness, as defined
in 21 CFR 514.4, when using data from foreign countries for an animal
drug?
    2. Typically in the United States, when we wish to show a test drug
is no worse than an active control, that active control is an approved
animal drug in the United States. A non-inferiority analysis is used to
statistically demonstrate this relationship. In studies conducted
outside the United States, an active control may be used that is not
approved for that use in the United States. In the absence of a U.S.
approval for the active control, FDA cannot interpret non-inferiority
to the unapproved active control. What challenges exist in utilizing
these studies? What criteria should FDA use to accept a study where the
active control is not approved in the United

States? What are potential options or solutions to enable FDA to use
these studies?
    3. What challenges exist in demonstrating that data from foreign
countries were generated under conditions representative of typical
conditions in the United States for an animal drug or food additive?
What are potential solutions to these challenges?
    4. What challenges exist in designing studies for an animal drug or
food additive to meet the approval requirements of different
jurisdictions? What are possible solutions to these challenges?
    5. What challenges exist in study conduct and the collection and
interpretability of data from foreign countries (both manual and
electronic) that may influence study quality and data integrity to
support the approval of an animal drug or food additive? What are
possible solutions to these challenges?
    6. What other challenges have you encountered and what potential
solutions would you propose with regard to providing data from foreign
countries to FDA?

Topic 3: Real World Evidence

    There is significant activity within FDA aimed at clarifying how to
determine if real-world data (RWD) are sufficient to generate real-
world evidence (RWE) that could be used for regulatory decision making
by the Agency. In August 2017, FDA published a guidance document
entitled, ``Guidance for Industry and Food and Drug Administration
Staff: Use of Real-World Evidence to Support Regulatory Decision-Making
for Medical Devices'' (available at https://www.fda.gov/media/99447/download) and, in accordance with the 21st Century Cures Act (Pub. L.
114-255), released a draft framework entitled ``Framework for FDA's
Real-World Evidence Program'' (available at https://www.fda.gov/media/120060/download) in December 2018 for human drug and biological
products.
    1. How should FDA define RWE for making regulatory decisions for
animal drugs? What sources of RWD should FDA consider to generate RWE
for animal drugs?
    2. What challenges exist for the use of RWE for animal drug
approvals? What are possible solutions to these challenges?
    3. In what contexts might RWD/RWE be used to generate clinical
evidence for regulatory decision making for animal drugs?
    4. What factors should FDA consider when evaluating RWE for animal
drugs?

Topic 4: Biomarkers and Surrogate Endpoints

    Biomarkers have long been a part of veterinary medicine. Examples
include routine tests such as body temperature, heart rate, complete
blood cell count and clinical chemistry, radiographs, and intraocular
pressure. Numerous technological advancements have greatly increased
the number of available biomarkers while reducing their cost.
Unfortunately, many potential biomarkers are not validated for their
use and interpretation in clinical investigations. FDA's Center for
Drug Evaluation and Research (CDER) has a formal Biomarker
Qualification Program, related guidance, and affiliated consortia to
support the development and use of biomarkers in regulatory decision
making for human drugs (https://www.fda.gov/drugs/drug-development-tool-qualification-programs/cder-biomarker-qualification-program). FDA
is seeking stakeholder feedback on how to best support the
identification and development of new biomarkers for new animal drug
applications and on ways to better incorporate biomarkers and surrogate
endpoints into animal drug development.
    1. What are the expectations of sponsors, researchers,
veterinarians, and producers for the use of biomarkers in the context
of animal drug regulation and how might biomarkers be used in addition
to surrogate endpoints in the design and conduct of clinical studies?
    2. Biomarkers are commonly used for diagnosing disease to enroll
patients, sample size estimations, and pilot/proof-of-concept studies.
What information should be provided to FDA to support their use in
these contexts (e.g., analytical validation, clinical validation,
establishing clinical utility, companion diagnostics etc.)?
    3. What are the major challenges in translating potential
biomarkers and/or surrogate endpoints into practical tools in clinical
trials? What are possible solutions to these challenges?
    4. How do we determine the evidentiary criteria for evaluating
biomarker use?
    5. Should FDA's Center for Veterinary Medicine develop a biomarker
qualification program like CDER's? Would such a program be beneficial,
and is it something that stakeholders (e.g., drug sponsors) would use?
Are there other approaches to the development and acceptance of
biomarkers for animal drugs?

III. Information About the Public Meeting

    Additional information about the public meeting is available on our
website at https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/public-meeting-incorporating-alternative-approaches-clinical-investigations-new-animal-drugs. If time and space permit, onsite
registration on the day of the public meeting will be provided
beginning at 8 a.m. We will post a notice on the above website no later
than July 12 as to whether onsite registration is available.
    Streaming Webcast of the Public Meeting: This public meeting will
also be webcast. Registration for the webcast is required. Information
to register for the webcast is available at https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/public-meeting-incorporating-alternative-approaches-clinical-investigations-new-animal-drugs. You
can register for the webcast up until the time of the meeting.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. For a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available at
https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/public-meeting-incorporating-alternative-approaches-clinical-investigations-new-animal-drugs.

    Dated: July 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14528 Filed 7-8-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Page 24981]
[FR Doc No: 2023-08682]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas & Oil Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP23-691-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Compliance filing: Penalty Crediting Report for 2022
to be effective N/A.
    Filed Date: 4/19/23.
    Accession Number: 20230419-5034.
    Comment Date: 5 p.m. ET 5/1/23.

    Docket Numbers: RP23-692-000.
    Applicants: Midcontinent Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Fuel Tracker Filing 4/19/23 to
be effective 6/1/2023.
    Filed Date: 4/19/23.
    Accession Number: 20230419-5084.
    Comment Date: 5 p.m. ET 5/1/23.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 19, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-08682 Filed 4-24-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 167 (Tuesday, August 28, 2018)]
[Rules and Regulations]
[Pages 43739-43742]
[FR Doc No: 2018-18576]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0792; Product Identifier 2017-NE-28-AD; Amendment
39-19336; AD 2018-15-04]
RIN 2120-AA64

Airworthiness Directives; General Electric Company Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
General Electric Company (GE) CF6-80A, CF6-80A1, CF6-80A2, CF6-80A3,
CF6-80C2A1, CF6-80C2A2, CF6-80C2A3, CF6-80C2A5, CF6-80C2A5F, CF6-
80C2A8, CF6-80C2B1, CF6-80C2B1F, CF6-80C2B2, CF6-80C2B2F, CF6-80C2B4,
CF6-80C2B4F, CF6-80C2B5F, CF6-80C2B6, CF6-80C2B6F, CF6-80C2B6FA, CF6-
80C2B7F, CF6-80C2D1F, CF6-80C2L1F, and CF6-80C2K1F turbofan engines.
This AD was prompted by an uncontained failure of a high-pressure
turbine (HPT) stage 2 disk that resulted in a fire. This AD requires
ultrasonic inspection (UI) of HPT stage 1 and 2 disks. We are issuing
this AD to address the unsafe condition on these products.

DATES: This AD is effective October 2, 2018.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of October 2,
2018.

ADDRESSES: For service information identified in this final rule,
contact General Electric Company, GE Aviation, Room 285, 1 Neumann Way,
Cincinnati, OH, 45215; phone:<PHONE_NUMBER>; email:
[email protected]. You may view this service information at
the FAA, Engine and Propeller Standards Branch, 1200 District Avenue,
Burlington, MA, 01803. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available on the
internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2017-0792.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0792; 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 final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) is Docket Operations, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Matthew Smith, Aerospace Engineer, ECO
Branch, FAA, 1200 District Avenue, Burlington, MA, 01803; phone: 781-
238-7735; fax:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a supplemental notice of proposed rulemaking (SNPRM) to
amend 14 CFR part 39 by adding an AD that would apply to certain GE
CF6-80A, CF6-80A1, CF6-80A2, CF6-80A3, CF6-80C2A1, CF6-80C2A2, CF6-
80C2A3, CF6-80C2A5, CF6-80C2A5F, CF6-80C2A8, CF6-80C2B1, CF6-80C2B1F,
CF6-80C2B2, CF6-80C2B2F, CF6-80C2B4, CF6-80C2B4F, CF6-80C2B5F, CF6-
80C2B6, CF6-80C2B6F, CF6-80C2B6FA, CF6-80C2B7F, CF6-80C2D1F, CF6-
80C2L1F, and CF6-80C2K1F turbofan engines with HPT disks with part
numbers and serial numbers (S/Ns) listed in Table 1 and 2 of Appendix A
in GE Service Bulletin (SB) CF6-80C2 SB 72-1562 R03, dated January 10,
2018 and Table 1 of Appendix A in GE SB CF6-80A SB 72-0869 R01, dated
October 19, 2017. The SNPRM published in the Federal Register on March
30, 2018 (83 FR 13703). We preceded the SNPRM with a notice of proposed
rulemaking (NPRM) that published in the Federal Register on September
7, 2017 (82 FR 42261). The NPRM proposed to require UI of HPT stage 1
and 2 disks. The NPRM was prompted by an uncontained failure of an HPT
stage 2 disk that resulted in a fire. The SNPRM proposed to require the
same UI of HPT stage 1 and 2 disks, remove certain engine models, and
to add a new part number to the applicability of this AD. The SNPRM
also proposed to revise references to the service information in this
AD because, since the publication of the NPRM, GE published the list of
affected HPT S/Ns in two separate SBs applicable to the CF6-80A and
CF6-80C2 engines. We are issuing this AD to address the unsafe
condition on these products.

Comments

    We gave the public the opportunity to participate in developing
this final rule. The following presents the comments received on the
SNPRM and the FAA's response to each comment.

Request To Change the Applicability

    All Nippon Airways (ANA) and Japan Airlines (JAL) requested that we
change the applicability, paragraph (c), to include S/Ns that are
listed in revisions of GE CF6-80C2 SB 72-1562 and GE CF6-80A SB 72-0869
that have not yet been published. ANA and JAL reasoned that the SB
revisions will include an updated list of affected S/Ns.
    We disagree. While future SB revisions may include additional
affected S/Ns, we do not require compliance based on service
information that has not been published. The applicability of this AD
is based on the most recently published service information. Any
further change in applicability would require a notice and comment
rulemaking for those affected S/Ns. We did not change this AD.

Request To Improve the UI Criteria

    JAL requested that we improve the UI criteria to avoid false-
positive indications resulting in rejection of disks. JAL reasoned that
GE may publish a GE CF6-80C2 SB 72-1562 revision in which GE will
modify the UI criteria.
    We disagree. While a future SB revision may include updated UI
criteria, we do not require compliance based on service information
that has not yet been published. We based the UI criteria on the most
recently published service information. We will review any Alternative
Methods of Compliance (AMOC) requests submitted if different UI
criteria, not specified in this AD, are desired. We did not change this
AD.

Request To Change the Definition of ``Piece-Part Exposure''

    ANA requested that we change the definition of ``piece-part
exposure'' to the separation of the HPT stage 1 or stage 2 disk from
the thermal shield within the HPT rotor module.
    We disagree. The current definition is sufficient to describe the
piece-part exposure. We did not change this AD.

Support for the AD

    Boeing Company, FedEx, and United Airlines expressed support for
the SNPRM as written.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this final rule as proposed except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
SNPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the SNPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this final
rule.

Related Service Information Under 1 CFR Part 51

    We reviewed GE CF6-80C2 SB 72-1562 R03, dated January 10, 2018. The
SB describes procedures for UI of CF6-80C2 turbofan engine HPT stage 1
and 2 disks. We also reviewed GE CF6-80A SB 72-0869 R01, dated October
19, 2017. The SB describes procedures for UI of CF6-80A turbofan engine
HPT stage 2 disks. This service information is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 640 HPT disks on engines installed
on airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
UI of HPT disk........................  10 work-hours x $85 per               $0            $850        $544,000
                                         hour = $850.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to engines, propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation Division.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

2018-15-04 General Electric Company: Amendment 39-19336; Docket No.
FAA-2017-0792; Product Identifier 2017-NE-28-AD.

(a) Effective Date

    This AD is effective October 2, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to General Electric Company (GE) CF6-80A, CF6-
80A1, CF6-80A2, CF6-80A3, CF6-80C2A1, CF6-80C2A2, CF6-80C2A3, CF6-
80C2A5, CF6-80C2A5F, CF6-80C2A8, CF6-80C2B1, CF6-80C2B1F, CF6-
80C2B2, CF6-80C2B2F, CF6-80C2B4, CF6-80C2B4F, CF6-80C2B5F, CF6-
80C2B6, CF6-80C2B6F, CF6-80C2B6FA, CF6-80C2B7F, CF6-80C2D1F, CF6-
80C2L1F, and CF6-80C2K1F turbofan engines with high-pressure turbine
(HPT) disks with serial numbers listed in Table 1 and 2 of Appendix
A in GE CF6-80C2 Service Bulletin (SB) 72-1562 R03, dated January
10, 2018; and Table 1 of Appendix A in GE CF6-80A SB 72-0869 R01,
dated October 19, 2017.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7250, Turbine/
Turboprop Engine--Turbine Section.

(e) Unsafe Condition

    This AD was prompted by an uncontained failure of an HPT stage 2
disk. We are issuing this AD to prevent failure of the HPT stage 1
disk (CF6-80C2) and the HPT stage 2 disk (CF6-80C2 and CF6-80A). The
unsafe condition, if not addressed, could result in an uncontained
HPT disk release, damage to the engine, and damage to the airplane.

(f) Compliance

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

(g) Required Actions

    After the effective date of this AD, perform an ultrasonic
inspection (UI) for cracks in HPT stage 1 and stage 2 disks on the
CF6-80C2 turbofan engine and in HPT stage 2 disks on the CF6-80A
turbofan engine at each piece-part level exposure in accordance with
the Accomplishment Instructions, paragraph 3.A.(2), in GE CF6-80C2
SB 72-1562 R03, dated January 10, 2018, or the Accomplishment
Instructions, paragraph 3.A.(2) in GE CF6-80A SB 72-0869 R01, dated
October 19, 2017, as applicable to the engine model.

(h) Non-Required Actions

    The reporting requirements specified in the Accomplishment
Instructions, paragraphs 3.A.(2)(c) and 3.A.(2)(f), of GE CF6-80C2
SB 72-1562 R03, dated January 10, 2018, are not required by this AD.

(i) Definition

    For the purpose of this AD, ``piece-part exposure'' of the HPT
stage 1 or stage 2 disk is separation of that HPT disk from its
mating rotor parts within the HPT rotor module (thermal shield and
HPT stage 1 and stage 2 disk respectively).

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office send it to the attention of the person
identified in paragraph (k) of this AD. You may email your request
to: [email protected].
    (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.

(k) Related Information

    For more information about this AD, contact Matthew Smith,
Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA, 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email: [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) General Electric Company (GE) CF6-80A Service Bulletin (SB)
72-0869 R01, dated October 19, 2017.
    (ii) GE CF6-80C2 SB 72-1562 R03, dated January 10, 2018.
    (3) For GE service information identified in this AD, contact
General Electric Company, GE Aviation, Room 285, 1 Neumann Way,
Cincinnati, OH, 45215; phone:<PHONE_NUMBER>; email:
[email protected].
    (4) You may view this service information at FAA, Engine and
Propeller Standards Branch, 1200 District Avenue, Burlington, MA,
01803. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on August 21, 2018.
Karen M. Grant,
Acting Manager, Engine and Propeller Standards Branch, Aircraft
Certification Service.
[FR Doc. 2018-18576 Filed 8-27-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: February 7, 2008 (Volume 73, Number 26)]
[Notices]
[Page 7348-7349]
[DOCID:fr07fe08-107]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57255; File No. SR-ISE-2007-76]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing of Proposed Rule Change and Amendment No. 1
Thereto Relating to Voluntary Professionals

February 1, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that on August 24, 2007, the International Securities Exchange, LLC
(``ISE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been substantially
prepared by the Exchange. On January 25, 2008, ISE filed Amendment No.
1 to the proposed rule change. The Commission is publishing this notice
to solicit comments on the proposed rule change, as amended, from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE proposes to allow, on a purely voluntary basis, non-broker-
dealer customers to designate their orders as ``Voluntary
Professional.'' Voluntary Professional orders will be treated the same
as non-customer orders for purposes of execution priority and the ISE
schedule of fees. The text of the proposed rule change is available at
ISE, the Commission's Public Reference Room, and http://www.iseoptions.com.

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 ISE 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 these statements may be examined at the places specified in
Item IV below. The ISE 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Under ISE rules, a ``Public Customer'' is any person or entity that
is not a broker or dealer in securities and a ``Public Customer Order''
is an order for the account of a Public Customer.\3\ A ``Non-Customer''
is any person or entity that is a broker or dealer in securities and a
``Non-Customer Order'' is an order for the account of a broker or
dealer.\4\ These terms are used in specific ISE rules that provide
certain marketplace advantages to Public Customer Orders over Non-
Customer Orders. In particular, under ISE rules Public Customer Orders
are given priority over Non-Customer Orders and market maker quotes at
the same price, and subject to certain exceptions, members are not
charged a transaction fee for the execution of Public Customer Orders,
but are subject to cancellation fees related to the execution of Public
Customer Orders.
---------------------------------------------------------------------------

    \3\ ISE Rule 100(a)(32) and (33).
    \4\ ISE Rule 100(a)(22) and (23).
---------------------------------------------------------------------------

    Members have indicated that certain of their non-broker-dealer
customers employing sophisticated trading strategies that involve
cancelling a large percentage of their orders before the orders are
executed would prefer to have their orders categorized as Non-Customer
Orders, thereby gaining relief from the Exchange's cancellation fee
that member firms pass through to these customers. Accordingly, the
Exchange proposes to allow, on a purely voluntary basis, non-broker-
dealer customers to instruct member firms, in writing, to designate
their orders as Voluntary Professional.\5\ Such orders would be
considered Non-Customer Orders for purposes of ISE Rules 713 (Priority
of Quotes and Orders), 716 (Block Trades), 722 (Complex Orders), and
723 (Price Improvement Mechanism for Crossing Transactions). For orders
designated as Voluntary Professional, ISE would charge members standard
transaction fees currently applicable to broker-dealer orders, which
means that the cancellation fee will not be applicable to such orders.
---------------------------------------------------------------------------

    \5\ The Exchange is also proposing to make non-substantive
changes to correct cross references in Rule 100(a) to the
Constitution, and to clarify that the term Public Customer means a
person ``or entity'' that is not a broker or dealer securities.
---------------------------------------------------------------------------

    Under the proposal, Voluntary Professionals would participate in
ISE's allocation process on equal terms with broker-dealer orders and
market maker quotes. The proposal would also result in members paying
the same transaction fees for the execution of Voluntary Professional
orders as they do for broker-dealer orders. By definition, the
Voluntary Professional designation would not otherwise affect these
non-broker-dealer individuals or entities under the ISE rules. The
Exchange notes that Voluntary Professional orders would continue to be
treated the same as Public Customer Orders for purposes of linkage-
related rules. For example, the ISE would provide the same away-market
protection for orders designated as Voluntary Professional as it does
for orders designated as Public Customer Orders by preventing incoming
marketable orders from automatically executing at prices inferior to
the best bid or offer on another national securities exchange. As
provided in ISE Rule 714, such Voluntary Professional orders would be
handled by the Primary Market Maker who may, according to ISE Rule
1901(c), send a P/A order to another exchange to get a better price for
the customer.
2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(5) that an exchange have rules that are
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism for a free and open market and a national
market system, and, in general, to protect investors and the public
interest.

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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-ISE-2007-76 on the

subject line.

Paper Comments

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

    All submissions should refer to File Number SR-ISE-2007-76. 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 at (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 ISE. 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-ISE-2007-76 and should be
submitted on or before February 28, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-2267 Filed 2-6-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 81 (Wednesday, April 27, 2016)]
[Notices]
[Pages 24818-24820]
[FR Doc No: 2016-09785]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-N-2016-1134]

Public Meeting on Patient-Focused Drug Development for Patients
Who Have Received an Organ Transplant

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a public meeting and an opportunity for public comment on Patient-
Focused Drug Development for patients who have received an organ
transplant. Patient-Focused Drug Development is part of FDA's
performance commitments made as part of the fifth authorization of the
Prescription Drug User Fee Act (PDUFA V). The public meeting is
intended to allow FDA to obtain patient perspectives on the impact of
receiving an organ transplant on daily life and patient views on
treatment approaches; the input from this public meeting will help in
developing topics for further discussion. FDA is also interested in
discussing issues related to scientific challenges in developing drugs
to manage organ transplantation. In the afternoon, FDA will hold a
workshop and provide information for and gain perspective from patients
and patient advocacy organizations, health care providers, academic
experts, and industry on various aspects of clinical development of
drug products intended to manage organ transplantation.

DATES: The public meeting will be held on September 27, 2016, from 9
a.m. to 5 p.m. Please register here for the meeting by September 20,
2016: http://organtransplantpfdd.eventbrite.com. Submit electronic or
written comments to the public docket by November 27, 2016.

ADDRESSES: The meeting and workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (Rm.1503), Silver Spring, MD 20993-0002. Participants must enter
through Building 1 and undergo security screening. For more information
on parking and security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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):Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-1134 for ``Public Meeting on Patient-Focused Drug
Development for Patients Who Have Received an Organ Transplant.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    FDA will post the agenda approximately 5 days before the meeting
at: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm495933.htm.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301-796-
5003, FAX:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background on Patient-Focused Drug Development

    FDA has selected patients who have received an organ transplant as
the focus of a public meeting under Patient-Focused Drug Development,
an initiative that involves obtaining a better understanding of patient
perspectives on the severity of a disease and the available therapies
for these conditions. Patient-Focused Drug Development is being
conducted to fulfill FDA performance commitments that are part of the
reauthorization of the PDUFA under Title I of the Food and Drug Safety
and Innovation Act (Pub. L. 112-144). The full set of performance
commitments is available at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
    FDA committed to obtain the patient perspective on 20 disease areas
during the course of PDUFA V. For each disease area, the Agency will
conduct a public meeting to discuss the disease and its impact on
patients' daily lives, the types of treatment benefit that matter most
to patients, and patients' perspectives on the adequacy of the
available therapies. These meetings will include participation of FDA
review divisions, the relevant patient communities, and other
interested stakeholders.
    On July 2, 2015, FDA published a notice (80 FR 32816) in the
Federal Register announcing the disease areas for meetings in fiscal
years 2016-2017, final 2 years of PDUFA V time frame. The Agency used
several criteria outlined in that notice to develop the list of disease
areas. FDA obtained public comment on the Agency's proposed criteria
and potential disease areas through a public docket. In selecting the
set of disease areas, FDA carefully considered the public comments
received and the perspectives of review divisions at FDA. More
information, including the list of disease areas and a general schedule
of meetings, is posted at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.

II. Public Meeting and Workshop Information

A. Purpose and Scope of the Meeting

    The purpose of this Patient-Focused Drug Development meeting is to
obtain input on organ transplantation and current approaches to
management of organ transplantation. In 2015, over 25,000 people in the
United States received an organ transplant. Organ transplantation
requires pharmacologic and non-pharmacologic management before and
after receipt. There are FDA-approved therapies used to assist the
immune system in responding properly to the transplanted organ.
Treatment requires a combination of drugs given for the lifetime of a
transplanted organ. FDA is committed to working with all stakeholders
to develop safe and effective therapies for affected individuals.
    The questions that will be asked of patients and patient
stakeholders at the meeting are listed in this section, organized by
topic. For each topic, a brief initial patient panel discussion will
begin the dialogue. This will be followed by a facilitated discussion
inviting comments from other patient and patient stakeholder
participants. In addition to input generated through this public
meeting, FDA is interested in receiving patient input addressing these
questions through written comments, which can be submitted to the
public docket (see ADDRESSES). When submitting comments, if you are
commenting on behalf of a child, please indicate that you are doing so
and

answer the following questions as much as possible from the patient's
perspective.
Topic 1: Disease Symptoms and Daily Impacts That Matter Most to
Patients
    1. What have been the most significant changes in your overall
health since you received your transplanted organ?
    (a) How long has it been since you received your transplant?
    2. Focusing on symptoms related to your organ transplant and post-
transplant effects, which 1-3 symptoms have the most significant impact
on your life? (Examples may include pain, infection, anxiety, etc.)
    3. Are there specific activities that are important to you but that
you cannot do at all or as fully as you would like because of your
transplant? (Examples of activities may include sleeping through the
night, driving, walking/running, exercising, etc.)
    (a) How do your symptoms and their negative impacts affect your
daily life on the best days? On the worst days? (Examples may include
limitations on the ability to undertake physically strenuous
activities, restrictions on the ability to travel, lack of appetite,
fatigue, etc.)
    4. How has your experience with your transplanted organ changed
over time? Do particular symptoms come and go as your duration of time
with a transplanted organ has increased? If so, do you know of anything
that makes your symptoms better? Worse?
    5. What worries you most about your health post-transplant?
Topic 2: Patients' Perspectives on Transplant and Treatment Impacts
    1. What are you currently doing to maintain your transplanted organ
or treat related health concerns following transplantation? (Examples
may include immunosuppressants, antibiotics, antivirals, over-the-
counter products, and other therapies including non-drug therapies)
    (a) How has your post-transplant treatment regimen changed over
time, and why?
    2. How well does your current treatment regimen manage the most
significant symptoms you experience post-transplantation?
    (a) How well do these treatments improve your ability to do
specific activities that are important to you in your daily life?
    (b) How well have these treatments worked for you as your
experiences post-transplant have changed over time?
    3. What are the most significant downsides to your current
treatments, and how do they affect your daily life? (Examples of
downsides may include bothersome side effects, need for multiple
medications, risk of infection, need for hospitalization, etc.)
    (a) What are the biggest challenges you face in maintaining your
post-transplant treatment regimen? (Examples of challenges may be
bothersome side effects, need for multiple medications, etc.)
    4. What specific things would you look for in an ideal treatment
for managing your transplanted organ?
    In the afternoon, discussion will be related to scientific topics,
with the goal of understanding issues that may affect the development
of drugs for the treatment of organ transplantation and identifying
topics for future discussion. Discussion topics for the afternoon will
include the following: Current treatment considerations, adherence,
clinical trial designs, and clinical trial endpoints.

B. Meeting Attendance and Participation

    If you wish to attend this meeting, visit http://organtransplantpfdd.eventbrite.com. Please register by September 20,
2016. If you are unable to attend the meeting in person, you can
register to view a live Webcast of the meeting. You will be asked to
indicate in your registration if you plan to attend in person or via
the Webcast. Seating will be limited, so early registration is
recommended. Registration is free and will be on a first-come, first-
served basis. However, FDA may limit the number of participants from
each organization based on space limitations. Registrants will receive
confirmation once they have been accepted. Onsite registration on the
day of the meeting will be based on space availability. If you need
special accommodations because of a disability, please contact Graham
Thompson (see FOR FURTHER INFORMATION CONTACT) at least 7 days before
the meeting.
    Patients who are interested in presenting comments as part of the
initial panel discussions will be asked to indicate in their
registration which topic(s) they wish to address. These patients also
must send to<EMAIL_ADDRESS>a brief summary of responses to
the topic questions by September 12, 2016. Panelists will be notified
of their selection approximately 7 days before the public meeting. We
will try to accommodate all patients and patient stakeholders who wish
to speak, either through the panel discussion or audience
participation; however, the duration of comments may be limited by time
constraints.
    FDA will hold an open public comment period to give the public an
opportunity to comment. Registration for open public comment will occur
at the registration desk on the day of the meeting and workshop on a
first-come, first-served basis.
    Docket Comments: Regardless of if you attend the public meeting,
you can submit electronic or written responses to the questions
pertaining to Topics 1 and 2 to the public docket (see ADDRESSES) by
November 27, 2016. 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.
    Transcripts: As soon as a transcript is available, FDA will post it
at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm495933.htm.

    Dated: April 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09785 Filed 4-26-16; 8:45 am]
BILLING CODE 4164-01-P