[Federal Register Volume 83, Number 113 (Tuesday, June 12, 2018)]
[Notices]
[Pages 27365-27366]
[FR Doc No: 2018-12618]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Reduced
Vertical Separation Minimum

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on March 30, 2018. Aircraft Operators seeking operational
approval to conduct Reduced Vertical Separation Minimum (RVSM)
operations must submit application to the FAA.

DATES: Written comments should be submitted by July 12, 2018.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
[email protected], or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW, Washington,
DC 20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

FOR FURTHER INFORMATION CONTACT: Barbara Hall at<PHONE_NUMBER>, or by
email at: [email protected].

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0679.
    Title: Reduced Vertical Separation Minimum.
    Form Numbers: N/A.
    Type of Review: Renewal.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on March 30, 2018 (83 FR 13810). Aircraft operators
seeking operational approval to conduct RVSM operations within the 48
contiguous states of the United States (U.S.), Alaska, and that portion
of the Gulf of Mexico where the FAA provides air traffic services must
submit their application to the Certificate Holding District Office
(CHDO). The CHDO registers RVSM approved airframes in the FAA RVSM
Approvals Database to track the approval status for operator airframes.
Application information includes evidence of aircraft equipment and
RVSM qualification information along with operational training and
program elements.
    Respondents: Operators wishing to operate in RVSM airspace are
required to submit application to the FAA. The FAA estimates processing
1,426 initial applications annually and 3,330 updates to existing
approvals.
    Frequency: An operator must make application for initial approval
to operate in RVSM airspace, or whenever

requesting an update to an existing approval.
    Estimated Average Burden per Response: 4.00 hours for updates to
existing applications and 6.8 hours for application for initial
approvals.
    Estimated Total Annual Burden: 23,017 hours.

    Issued in Washington, DC, on June 6, 2018.
Barbara Hall,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, ASP-110.
[FR Doc. 2018-12618 Filed 6-11-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 36 (Monday, February 24, 2014)]
[Notices]
[Page 10209]
[FR Doc No: 2014-03787]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

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

Extension: Form 144;
OMB Control No. 3235-0101, SEC File No. 270-112.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') this request for extension of the previously
approved collections of information discussed below.
    Form 144 (17 CFR 239.144) is used to report the sale of securities
during any three-month period that exceeds 5,000 shares or other units
and has an aggregate sales price that does not exceed $50,000. Under
Sections 2(a)(11), 4(a)(1), 4(a)(2), 4(a)(4) and 19(a) of the
Securities Act of 1933 (15 U.S.C. 77b(a)(11), 77d(a)(1), 77d(a)(2),
77d(a)(4) and 77s(a)) and Rule 144 (17 CFR 230.144) there under, the
Commission is authorized to solicit the information required to be
supplied by Form 144. The objectives of the rule could not be met, if
the information collection was not required. The information collected
must be filed with the Commission and is publicly available. Form 144
takes approximately one burden hour per response and is filed by 500
respondents for a total of 500 total burden hours.
    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 OMB control number.
    The public may view the background documentation for this
information collection at the following Web site, www.reginfo.gov.
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to<EMAIL_ADDRESS>and (ii) Thomas Bayer, Director/Chief Information
Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100
F Street NE., Washington, DC 20549 or send an email to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days of
this notice.

    Dated: February 18, 2014.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-03787 Filed 2-21-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 225 (Friday, November 24, 2017)]
[Notices]
[Pages 55919-55920]
[FR Doc No: 2017-25363]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2008-0028]

Petition for Waiver of Compliance

    Under Part 211 of Title 49 Code of Federal Regulations (CFR), this
provides the public notice that on November 14, 2017, Riverport
Railroad, LLC (RVPR), petitioned the Federal Railroad Administration
(FRA) for a waiver of compliance from certain provisions of the Federal
railroad safety regulations contained at 49 CFR part 223. FRA assigned
the petition Docket Number FRA-2008-0028.
    Specifically, RVPR seeks to renew a waiver of compliance from the
glazing regulations in 49 CFR 223.11, Requirements for existing
locomotives, for one locomotive, identified as RVPR 4029. RVPR is a
terminal/switching railroad on the former Department of Defense (DOD)
Savanna Army Depot. This installation is located in rural northwestern
Illinois in Jo Daviess and Carroll Counties. RVPR states they own 80
percent of the adjoining land, and the other 20 percent is privately
owned and access controlled. The BNSF Railway interchanges cars with
RVPR at Robinson Spur where there are eight interchange tracks. All
trackage is enclosed and there are no overhead structures or bridges
where objects could be thrown at trains. RVPR operates at 10 miles per
hour or less, and provides car storage for customers, as well as
servicing a railcar repair and a railcar cleaning company.
    The locomotive is a 60-ton 500-horsepower diesel electric
locomotive numbered 4029. This engine was manufactured in 1950 and
remanufactured for DOD between 1987

and 1990. This unit has safety glass in all cab windows, but they are
marked in accordance with DOD standards.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by January 8, 2018 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2017-25363 Filed 11-22-17; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 76, Number 35 (Tuesday, February 22, 2011)]
[Notices]
[Pages 9838-9840]
[FR Doc No: 2011-3799]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63909; File No. SR-FINRA-2011-005]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Proposed Rule Change Relating to
Promissory Note Proceedings

February 15, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 4, 2011, the Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been substantially prepared by
FINRA. The Commission is publishing this notice to solicit comments on
the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to amend Rule 13806 of the Code of Arbitration
Procedure for Industry Disputes (``Industry Code'') to provide that
FINRA will appoint a chair-qualified public arbitrator to a panel
resolving a promissory note dispute instead of appointing a chair-
qualified public arbitrator also qualified to resolve a statutory
discrimination claim.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA, and at
the Commission's Public Reference Room.

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

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

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

1. Purpose
    In 2009, FINRA implemented new procedures to expedite the
administration of cases that solely involve a broker-dealer's claim
that an associated person failed to pay money owed on a promissory
note.\3\ Under

these procedures, FINRA appoints a single chair-qualified public
arbitrator from the roster of arbitrators approved to hear statutory
discrimination claims (a statutory discrimination qualified arbitrator)
\4\ to resolve the dispute.\5\ These specially qualified arbitrators
are public chair-qualified arbitrators who also are attorneys familiar
with employment law and have at least ten years of legal experience. In
addition, they may not have represented primarily the views of
employers or of employees within the last five years. FINRA proposed
using statutory discrimination qualified arbitrators because of the
depth of their experience and their familiarity with employment law. At
the time that FINRA filed the proposed rule change, these arbitrators
were underutilized at the forum.
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    \3\ See Securities Exchange Act Rel. No. 60132 (June 17, 2009),
74 FR 30191 (June 24, 2009) (File No. SR-FINRA-2009-015). FINRA
announced implementation of New Rule 13806 (Promissory Note
Proceedings) in Regulatory Notice 09-48. The effective date was
September 14, 2009.
    \4\ See Rule 13802(c)(3).
    \5\ Under Rule 13806, if an associated person does not file an
answer, or files an answer but does not assert any counterclaims or
third party claims, regardless of the amount in dispute, a single
statutory discrimination qualified arbitrator decides the case. If
an associated person files a counterclaim or third party claim,
FINRA bases panel composition on the amount of the counterclaim or
third party claim. For counterclaims and third party claims that are
not more than $100,000, FINRA appoints a single statutory
discrimination qualified arbitrator. For counterclaims and third
party claims of more than $100,000, FINRA appoints a three-
arbitrator panel comprised of a statutory discrimination qualified
arbitrator, a public arbitrator, and a non-public arbitrator.
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    Since implementing the new procedures, FINRA has found that
promissory note cases do not require extensive experience or depth of
knowledge (or the limitation on representation of employers or of
employees within the last five years). In a majority of completed
cases, arbitrators decided the case on the pleadings and the respondent
broker did not appear.\6\ Experience with the new procedures leads
FINRA to propose amending the Industry Code to provide that FINRA will
appoint a chair-qualified public arbitrator to a panel resolving a
promissory note dispute instead of appointing a statutory
discrimination qualified arbitrator. Chair-qualified arbitrators have
completed chair training and are attorneys who have served through
award on at least two cases, or, if not attorneys, are arbitrators who
have served through award on at least three cases.\7\
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    \6\ Of the first 175 promissory note cases completed,
arbitrators decided the case on the pleadings 76 percent of the time
(unless the case concluded by settlement or some other means).
    \7\ See Rule 12400(c).
---------------------------------------------------------------------------

    In addition, the number of promissory note cases has more than
doubled in the past two years. As a result of this substantial
increase, it is becoming more difficult to appoint panels solely with
statutory discrimination qualified arbitrators to these cases. Under
the proposed rule change, the number of arbitrators available for
appointment in promissory note cases would increase significantly. The
proposed rule change would ensure that FINRA has a sufficient number of
qualified arbitrators readily available to resolve these matters.
    FINRA proposes to announce the effective date of the proposed rule
change in a Regulatory Notice to be published no later than 60 days
following Commission approval. The effective date will be 30 days
following publication of the Regulatory Notice announcing Commission
approval.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\8\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes that the proposed rule change is
consistent with the provisions of the Act noted above because it would
ensure that FINRA has a sufficient number of qualified arbitrators
readily available to resolve promissory note cases.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    Written comments were neither solicited nor received.

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

    Within 45 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 shall:
    (A) By order approve or disapprove 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-FINRA-2011-005 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2011-005. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of FINRA.
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-FINRA-2011-005
and

should be submitted on or before March 15, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
Cathy H. Ahn,
Deputy Secretary.
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    \9\ 17 CFR 200.30-3(a)(12).
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[FR Doc. 2011-3799 Filed 2-18-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 164 (Friday, August 25, 2017)]
[Notices]
[Pages 40643-40644]
[FR Doc No: 2017-17997]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket Number NHTSA-2017-0067; Notice 1]

Reports, Forms, and Record Keeping Requirements

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

ACTION: Request for public comment on proposed collection of
information.

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SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatement of previously approved collections.
    This document describes one collection of information for which
NHTSA intends to seek extension of OMB approval.

DATES: Comments must be received on or before October 24, 2017.

ADDRESSES: You may submit comments identified by DOT Docket No. NHTSA-
2017-0067 by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays. Telephone: 1-800-647-
5527.
     Fax:<PHONE_NUMBER>.
    Instructions: All submissions must include the agency name and
docket number for this proposed collection of information. Note that
all comments received will be posted without change to https://www.regulations.gov, including any personal information provided.
Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov or the street
address listed above. Follow the online instructions for accessing the
dockets.

FOR FURTHER INFORMATION CONTACT: George Stevens, NHTSA 1200 New Jersey
Avenue SE., Room W43-490, Washington, DC 20590. Mr. Steven's telephone
number is<PHONE_NUMBER>. Please identify the relevant collection of
information by referring to its OMB Control Number.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulation at 5 CFR
1320.8(d), an agency

must ask for public comment on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (iii) how to enhance the quality, utility, and clarity of the
information to be collected;
    (iv) how to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g. permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following proposed collections of information:
    Type of Request: Extension of clearance.
    OMB Control Number: 2127-0045.
    Form Number: This collection of information uses no form.
    Title: 49 CFR 556, Petitions for Inconsequentiality.
    Affected Public: Businesses or other for profit entities.
    Abstract: If a motor vehicle or item of replacement motor vehicle
equipment is determined to contain a defect related to motor vehicle
safety or not to comply with an applicable Federal motor vehicle safety
standard (FMVSS), the manufacturer is required under 49 U.S.C. 30118 to
furnish NHTSA and owners, purchasers, and dealers of the motor vehicle
or motor vehicle equipment with notification of the defect or
noncompliance. The manufacturer must also remedy the defect or
noncompliance without charge under 49 U.S.C. 30120.
    A manufacturer may be exempted from these requirements under 49
U.S.C. 30118(d) if the agency decides, upon application of the
manufacturer, that the defect or noncompliance is inconsequential as it
relates to motor vehicle safety. That section provides that the agency
may only take such action after publishing notice in the Federal
Register and providing an opportunity for any interested person to
present information, views, and arguments.
    Regulations implementing this provision are found in 49 CFR part
556 Exemption for Inconsequential Defect or Noncompliance. The
regulations provide that each petition submitted under part 556 must:
    (1) Be written in the English language;
    (2) Be submitted in three copies to NHTSA;
    (3) State the full name and address of the applicant, the nature of
its organization (e.g., individual, partnership, or corporation) and
the name of the State or county under the laws of which it is
organized;
    (4) Describe the motor vehicle or item of replacement equipment,
including the number involved and the period of production, and the
defect or noncompliance concerning which an exemption is sought, and
    (5) Set forth all data, views, and arguments of the petitioner
supporting the petition. See 49 CFR 556.4(b).
    The regulations also provide that the petition must be accompanied
by three copies of the report of the defect or noncompliance that the
manufacturer has compiled for submission to NHTSA under 49 CFR part 573
Defect and Noncompliance Responsibility and Reports, and be submitted
no later than 30 days after the manufacturer determines the existence
of the defect or noncompliance or is notified that NHTSA has determined
the existence of the defect or noncompliance. See 49 CFR 556.4(b)(6)
and (c).
    The agency receives, on average, 30 petitions per year seeking
exemptions under part 556 for an inconsequential defect or
noncompliance. The agency estimates that it would take, on average,
five hours for a manufacturer to compile, organize, and submit the
information needed to support each petition.
    Estimated Annual Burden: 150 hours.
    Number of Respondents: 30.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.

Jeffrey M. Giuseppe,
Acting Associate Administrator, Enforcement.
[FR Doc. 2017-17997 Filed 8-24-17; 8:45 am]
 BILLING CODE 4910-59-P


 From: <EMAIL_ADDRESS> To: Byron Bunker/AA/USEPA/US@EPA  Cc: <EMAIL_ADDRESS><EMAIL_ADDRESS> Date: 03/31/2011 07:48 PM  Subject: EPA and NHTSA regulatory exemptions do not match

Byron:

I know that the official time for submitting comments has passed, but I only recently noticed something that is definitely confusing and potentially a problem with the NPRM text:  the NHTSA and EPA exemptions do not match.  I do not know whom at NHTSA to contact (Coralie?), so perhaps you can forward this on.

Your regs and NHTSA differ in a significant way.  In general, I recommend against any slight textual difference between the two agencies' regulations, even if the intended meanings of both regulations are the same.  There will always be a chance of different interpretations or unintended consequences of textual between the regulations.  But here, the regulations are quite different, to the point that the NHTSA regulation renders invalid the EPA exemption.  NHTSA's regulation needs to change in order to allow proper industry functioning.

The EPA regulations at 40 CFR §§1036.601 and 1037.601 provide for exemptions, including a test exemption like the one that we manufacturers currently use for criteria pollutant exemption on R&D vehicles.  In many cases we build, import, or alter a vehicle for testing in conditions representative of our customer-fleets' operations.  We sell the vehicle to the customer with a 85 CFR §85.1705 exemption covering the introduction into commerce, on conditions including that the customer (1) test the vehicle in representative duty and (2) allow us to either (a) upgrade the vehicle and engine to full compliance at the end a year or year and a half (sometimes we need to extend the exemption) or (b) get rid of the vehicle if we cannot bring it into compliance as a certified configuration.  We do this because in-use testing of a limited number of vehicles occurs in parallel with final development processes and associated certification testing.  Stated another way:  testing and certifying development-stage hardware is not practical.

The NHTSA regulations in the NPRM do not contain a test exemption for tractors or vocational vehicles.  Those regulations contain exemptions for off-road vehicles, for small businesses, and for a certain percentage of heavy-duty pickup and van sales but not for the types of test vehicles about which I am presently concerned.  So, if we have a vehicle that is (say) a one-off prototype test tractor or vocational vehicle, then we can exempt that vehicle from EPA regulations but not NHTSA's.  Specifically, 49 CFR §535.8 provides for precertification and end-of-year reports without exemptions for any vehicles.  That section and §535.9, however, seem to indicate that NHTSA compliance is equivalent to EPA compliance (i.e., compliance with 40 CFR §1037.730 reporting requirements and EPA AB&T limits).  In turn, we have to report to NHTSA the fuel consumption of vehicles that EPA exempts, although those vehicles might not count toward NHTSA compliance.  (I write "seem to" and "might" because, I admit, I am confused about this.)  In any case, we still have to report.  So there is the difference:  NHTSA requires reporting (at the least) of fuel consumption of vehicles that EPA exempts.

You might say:  if we merely have to report on the vehicles, but we are not responsible for compliance (in the sense of AB&T limit compliance), then what is the problem with the difference?  The problem is that reporting requires testing and/or calculation of Cd*A, and these are resource-intensive processes.  Even if NTHSA is fine with manufacturers submitting "sand-bagged" Cd*A numbers (i.e., reporting all exempt vehicles as Classic-bin vehicles, knowing that the values do not count against AB&T limits), there is a problem with either (1) requiring manufacturers to expend resources on exempt vehicles or (2) requiring us to inaccurately report data under signature of a company official.  The only way around this is for us to certify all vehicles, rendering the EPA exemptions invalid.  These are valuable exemptions from our sake and (I think) yours, because they help us develop new vehicles on a reasonable time-frame.

In turn, I recommend that NHTSA adopt the EPA exemptions (either word-for-word or by saying "EPA exemptions apply").

Sorry for the long email, but this was not an easy problem to describe.  And, as we start preparing our test vehicles for 2012 (model year 2013), it is a problem we will need to address.

Regards, Dave ------------------------- David Kayes Compliance and Regulatory Affairs --- Environmental Compliance Daimler Trucks (503) 745-9162 Office (503) 265-9838 Mobile <EMAIL_ADDRESS> If you are not the intended addressee, please inform us immediately that you have received this e-mail in error, and delete it. We thank you for your cooperation.


[Federal Register Volume 87, Number 169 (Thursday, September 1, 2022)]
[Rules and Regulations]
[Pages 53651-53654]
[FR Doc No: 2022-18923]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0160; Project Identifier AD-2022-00009-E;
Amendment 39-22150; AD 2022-17-12]
RIN 2120-AA64

Airworthiness Directives; CFM International, S.A. Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain CFM International, S.A. (CFM) LEAP-1A model turbofan engines.
This AD was prompted by reports of two in-flight shutdowns (IFSDs) and
subsequent investigation by the manufacturer that revealed cracks in
the high-pressure turbine (HPT) rotor stage 1 blades. This AD requires
initial and repetitive borescope inspections (BSIs) of the HPT rotor
stage 1 blades. Depending on the results of the BSIs, this AD requires
either additional BSIs at reduced intervals or replacement of the HPT
rotor stage 1 blades. This AD also requires sending the inspection
results to CFM if any unserviceable finding is found. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective October 6, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of October 6,
2022.

ADDRESSES: For service information identified in this final rule,
contact CFM International, S.A., Aviation Operations Center, 1 Neumann
Way, M/D Room 285, Cincinnati, OH 45125; phone:<PHONE_NUMBER>; email:
[email protected]. You may view this service information at
the FAA, Airworthiness Products Section, Operational Safety 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 at www.regulations.gov by searching for and locating
Docket No. FAA-2022-0160.

Examining the AD Docket

    You may examine the AD docket at www.regulations.gov by searching
for and locating Docket No. FAA-2022-0160; 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, any comments
received, and other information. The address for Docket Operations is
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: Mehdi Lamnyi, Aviation Safety
Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803;
phone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain CFM LEAP-1A23,
LEAP-1A24, LEAP-1A24E1, LEAP-1A26, LEAP-1A26CJ, LEAP-1A26E1, LEAP-1A29,
LEAP-1A29CJ, LEAP-1A30, LEAP-1A32, LEAP-1A33, LEAP-1A33B2, and LEAP-
1A35A (LEAP-1A) model turbofan engines. The NPRM published in the
Federal Register on March 21, 2022 (87 FR 15896). The NPRM was prompted
by reports of two single-engine IFSDs on airplanes powered by LEAP-1A
model turbofan engines, operating extensively in the Middle East and
North Africa (MENA) region. A post-flight BSI of the HPT module
revealed that the engine failures were due to cracks in the HPT rotor
stage 1 blades. After investigation, the manufacturer determined that
engines operating in the MENA region are susceptible to accelerated HPT
rotor stage 1 blade deterioration and airfoil distress due to the
build-up of dust. In the NPRM, the FAA proposed to require initial and
repetitive BSIs of the HPT rotor stage 1 blades and HPT stator stage 1
nozzle set and, depending on the results of the inspections, additional
BSIs at reduced intervals or replacement of the HPT rotor stage 1
blades or HPT stator stage 1 nozzle set. In the NPRM, the FAA proposed
to require a BSI of the HPT rotor stage 1 blades and HPT stator stage 1
nozzle set installed on the sister engine of the same airplane if
certain criteria are met. In the NPRM, the FAA also proposed to require
sending the inspection results to CFM if any unserviceable finding is
found. The FAA is issuing this AD to address the unsafe condition on
these products.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from three commenters. The commenters
were Air Line Pilots Association, International (ALPA), CFM, and an
individual commenter. The following presents the comments received on
the NPRM and the FAA's response to each comment.

Support for the AD

    ALPA expressed support for the AD as written.

Use of a Proprietary Ground Operation System as an Alternate Means of
Compliance

    An individual commenter stated that using a specific ground
operation taxi system could provide an alternate means of compliance
for this AD. The commenter reasoned that limiting engine operation
during ground operations would increase the interval between
inspections from 150 cycles to 450 cycles and from 300 cycles to 900
cycles. The commenter also stated that use of this ground operation
taxi system would reduce costs on operators, result in fuel burn
reduction, and reduce carbon emissions.
    The FAA did not change this AD as a result of this comment. The
compliance timing for the actions required by this AD are based on the
accumulated number of takeoffs and flight cycles, not on engine
operating hours. In addition, it has not been demonstrated that
variation in operation of the engine on the ground and during taxi has
any impact on the unsafe condition addressed by this AD.

Availability of Revised Service Information

    CFM commented that revised service information, CFM Service
Bulletin (SB) LEAP-1A-72-00-0461-01A-930A-D, Issue 003-00, dated July
13, 2022, has been published. CFM identified that this revised service
information removes references to the HPT stator stage 1 nozzle set,
adds an inspection credit for the engines for which the conditional
inspection of the sister engine installed on the same airplane is
applicable, updates the BSI guidance for the HPT stator stage 1 blades,
and removes the requirement to share all videos and images with CFM.
    In response to this comment, the FAA revised this AD to reference
CFM SB LEAP-1A-72-00-0461-01A-930A-D, Issue 003-00, dated July 13,
2022. The FAA also removed all references to the HPT stator stage 1
nozzle set and associated SB paragraph references as proposed in the
NPRM. The FAA has also added paragraph (i), Credit for Previous
Actions, to this AD to provide credit for the initial BSI required by
paragraph (g)(1)(i) or (2)(i) of this AD if the initial BSI was
performed before the

effective date of this AD using CFM SB LEAP-1A-72-00-0461-01A-930A-D,
Issue 002-00, dated December 21, 2021.

Conclusion

    The FAA reviewed the relevant data, considered any comments
received, and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these products. Except for minor editorial changes, and
any other changes described previously, this AD is adopted as proposed
in the NPRM. None of the changes will increase the economic burden on
any operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed CFM SB LEAP-1A-72-00-0461-01A-930A-D, Issue 003-
00, dated July 13, 2022. This service information specifies procedures
for performing a BSI of the HPT rotor stage 1 blades for LEAP-1A model
turbofan engines operating in the MENA region, performing all
applicable corrective actions, and reporting any unserviceable HPT
rotor stage 1 blade findings to CFM.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES.

Interim Action

    The FAA considers this AD to be an interim action. The inspection
reports that are required by this final rule will enable the
manufacturer to obtain better insight into the nature, cause, and
extent of the cracking, and eventually to develop final action to
address the unsafe condition. Once final action has been identified,
the FAA might consider additional rulemaking.

Costs of Compliance

    The FAA estimates that this AD affects 0 engines installed on
airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
BSI the HPT rotor stage 1 blades....  4 work-hours x $85 per               $0             $340               $0
                                       hour = $340.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary reporting
and replacements that would be required based on the results of the
inspection. The agency has no way of determining the number of aircraft
that might need these replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replace the HPT rotor stage 1 blades..........  150 work-hours x $85 per hour =         $988,200      $1,000,950
                                                 $12,750.
BSI the HPT rotor stage 1 blades (on the        4 work-hours x $85 per hour =                  0             340
 sister engine).                                 $340.
Report BSI results to CFM.....................  1 work-hour x $85 per hour = $85               0              85
----------------------------------------------------------------------------------------------------------------

Paperwork Reduction Act

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

Authority for This Rulemaking

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

Regulatory Findings

    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) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

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:

2022-17-12 CFM International, S.A.: Amendment 39-22150; Docket No.
FAA-2022-0160; Project Identifier AD-2022-00009-E.

(a) Effective Date

    This airworthiness directive (AD) is effective October 6, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to CFM International, S.A. (CFM) LEAP-1A23,
LEAP-1A24, LEAP-1A24E1, LEAP-1A26, LEAP-1A26CJ, LEAP-1A26E1, LEAP-
1A29, LEAP-1A29CJ, LEAP-1A30, LEAP-1A32, LEAP-1A33, LEAP-1A33B2, and
LEAP-1A35A model turbofan engines with an installed high-pressure
turbine (HPT) rotor stage 1 blade, having part number (P/N)
2747M92P01, P/N 2553M91G03, P/N 2553M91G05, P/N 2553M91G06, P/N
2553M91G07, or P/N 2553M91G08 that has accumulated more than 800
Middle East and North Africa (MENA) takeoffs.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7250, Turbine
Section.

(e) Unsafe Condition

    This AD was prompted by reports of two in-flight shutdowns and
subsequent investigation by the manufacturer that revealed cracks in
the HPT rotor stage 1 blades. The FAA is issuing this AD to prevent
failure of the HPT rotor stage 1 blades. The unsafe condition, if
not addressed, could result in failure of the engine, in-flight
shutdown, loss of thrust control, and loss of the airplane.

(f) Compliance

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

(g) Required Actions

    (1) Group 1 Engines: Borescope Inspection (BSI) of HPT Rotor
Stage 1 Blades
    For Group 1 engines with an affected HPT rotor stage 1 blade
installed:
    (i) Within 100 flight cycles (FCs) after accumulating 800 MENA
takeoffs on the HPT rotor stage 1 blade, before the HPT rotor stage
1 blade accumulates 1,750 cycles since new (CSN), or within 100 FCs
after the effective date of this AD, whichever occurs later, perform
an initial BSI of the HPT rotor stage 1 blades in accordance with
the Accomplishment Instructions, paragraphs 5.E.(1)(c), of CFM
Service Bulletin LEAP-1A-72-00-0461-01A-930A-D, Issue 003-00, dated
July 13, 2022 (the SB).
    (ii) Thereafter, at intervals not to exceed 150 FCs since the
last BSI, perform a repetitive BSI of the HPT rotor stage 1 blades
in accordance with the Accomplishment Instructions, paragraphs
5.E.(1)(c), of the SB.
    (2) Group 2 Engines: BSI of HPT Rotor Stage 1 Blades
    For Group 2 engines with an affected HPT rotor stage 1 blade
installed:
    (i) Within 100 FCs after accumulating 800 MENA takeoffs on the
HPT rotor stage 1 blade, before the HPT rotor stage 1 blade
accumulates 2,600 CSN, or within 100 FCs after the effective date of
this AD, whichever occurs later, perform an initial BSI of the HPT
rotor stage 1 blades in accordance with the Accomplishment
Instructions, paragraphs 5.E.(1)(c), of the SB.
    (ii) Thereafter, at intervals not to exceed 300 FCs since the
last BSI, perform a repetitive BSI of the HPT rotor stage 1 blades
in accordance with the Accomplishment Instructions, paragraphs
5.E.(1)(c), of the SB.
    (3) BSI Results Disposition
    Based on the results of the BSI required by paragraph (g)(1) or
(2) of this AD, as applicable, either re-inspect or replace the HPT
rotor stage 1 blades set using the criteria, compliance times, and
procedures referenced in the Accomplishment Instructions, paragraph
5.E.(1)(f), of the SB.
    (4) Conditional Inspection of the Sister Engine on the Same
Airplane
    (i) Based on the BSI results disposition required by paragraph
(g)(3) of this AD, if re-inspection or replacement of the HPT rotor
stage 1 is required within 50 FCs based on the criteria, compliance
times, and procedures referenced in the Accomplishment Instructions,
paragraph 5.E.(1)(f), of the SB, then perform the actions required
in paragraph (g)(4)(ii) of this AD.
    (ii) Within 5 FCs after performing the inspection required by
paragraph (g)(1) or (2) of this AD, as applicable, either inspect or
replace the HPT rotor stage 1 blades on the sister engine using the
procedures and compliance times in the Accomplishment Instructions,
paragraph 5.E.(1)(g), of the SB. Where the SB specifies to remove
the engine, this AD requires replacement of the HPT rotor stage 1
blades.
    (5) Reporting Requirements
    If, during any inspection required by paragraph (g)(1), (2),
(3), or (4) of this AD, as applicable, any HPT unserviceable finding
is found on an engine as identified in the Accomplishment
Instructions, paragraph 5.E.(1)(f) of the SB, within 30 days of
performing the inspection, report the HPT rotor stage 1 blade
unserviceable finding to CFM in accordance with the Accomplishment
Instructions, paragraph 5.E.(1)(f)1, of the SB.

    Note 1 to paragraph (g):  The Accomplishment Instructions in
paragraph 5.E.(1)(f) of the SB reference applicable aircraft
maintenance manual tasks for procedures and compliance times for the
actions required by paragraphs (g)(3) through (5) of this AD.

(h) Definitions

    (1) Group 1 engines are CFM LEAP-1A29, LEAP-1A29CJ, LEAP-1A30,
LEAP-1A32, LEAP-1A33, LEAP-1A33B2, and LEAP-1A35A model turbofan
engines.
    (2) Group 2 engines are CFM LEAP-1A23, LEAP-1A24, LEAP-1A24E1,
LEAP-1A26, LEAP-1A26CJ, and LEAP-1A26E1 model turbofan engines.
    (3) For the purpose of this AD, a ``MENA takeoff'' is any
takeoff accomplished in the MENA region, as defined in the Planning
Information, paragraph 3.D., of the SB.
    (4) For the purpose of this AD, ``sister engine'' refers to the
other engine installed on the same airplane.

(i) Credit for Previous Actions

    You may take credit for the initial BSI required by paragraph
(g)(1)(i) or (2)(i) of this AD if you performed the initial BSI
before the effective of this AD using CFM Service Bulletin LEAP-1A-
72-00-0461-01A-930A-D, Issue 002-00, December 21, 2021.

(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 and email 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 Mehdi Lamnyi,
Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<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) CFM Service Bulletin LEAP-1A-72-00-0461-01A-930A-D, Issue
003-00, dated July 13, 2022.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact CFM
International, S.A.,

Aviation Operations Center, 1 Neumann Way, M/D Room 285, Cincinnati,
OH 45125; phone:<PHONE_NUMBER>; email:
[email protected].
    (4) You may view this service information at FAA, Airworthiness
Products Section, Operational Safety 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, email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on August 12, 2022.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2022-18923 Filed 8-31-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: January 15, 2009 (Volume 74, Number 10)]
[Notices]
[Page 2601-2605]
[DOCID:fr15ja09-112]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0661]

Unique Device Identification System; Public Workshop; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

    The Food and Drug Administration (FDA) is announcing a public
workshop entitled: ``Unique Device Identification System.'' The purpose
of the public workshop is to obtain information to help us better
understand the issues involved in the establishment of a unique device
identification system (UDI system) and request comments on this topic.
    Dates and Time: The public workshop will be held on, February 12,
2009, from 9 a.m. to 5 p.m. See section V of this document for
additional dates associated with registration and participation in the
workshop.
    Location: The public workshop will be held at the Marriott
Gaithersburg Washingtonian Center, 9751 Washingtonian Blvd.,
Gaithersburg, MD 20878,<PHONE_NUMBER>.
    Contact Person: Jay Crowley, Food and Drug Administration, Center
for Devices and Radiological Health (HFZ-500), 1350 Piccard Dr.,
Rockville, MD 20852,<PHONE_NUMBER>, or Stephen Ripley, Food and Drug
Administration, Center for Biologics Evaluation and Research (HFM-17),
1401 Rockville Pike, suite 200N, Rockville, MD 20852,<PHONE_NUMBER>.
    Registration: Register electronically at http://www.fda.gov/cdrh/
ocd/udi/index.htmlby January 30, 2009. There is no registration fee for
the public workshop. Early registration is recommended because seating
is limited. Registration on the day of the public workshop will be
provided on a space available basis beginning at 8 a.m.
    If you need special accommodations due to a disability, please
contact Jay Crowley (see Contact Person) by January 30, 2009.
    Comments: Regardless of attendance at the public workshop,
interested persons may submit written or electronic comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. Submit a single copy of
electronic comments or two paper copies of any mailed comments, except
that individuals may submit one paper copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. The deadline for submitting comments regarding this
public workshop is February 27, 2009. Received comments may be seen in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

SUPPLEMENTARY INFORMATION:

I. Background

A. What Does Section 226 of the Food and Drug Administration Amendments
Act of 2007 (FDAAA) Require?

    On September 27, 2007, President George W. Bush signed into law
FDAAA (Public Law 110-85). Section 226 of FDAAA amended the Federal
Food, Drug, and Cosmetic Act (the act) by requiring the establishment
of a UDI system. Specifically, section 226(a) of FDAAA created a new
section 519(f) of the act (21 U.S.C. 360i(f)) stating that ``The
Secretary shall promulgate regulations establishing a unique device
identification system for medical devices requiring the label of
devices to bear a unique identifier, unless the Secretary requires an
alternative placement or provides an exception for a particular device
or type of device. The unique identifier shall adequately identify the
device through distribution and use, and may include information on the
lot or serial number.''
    A UDI system may provide for early detection of the warning signs
of a defective device and facilitate device recalls (Ref. 1) and other
possible benefits of a UDI system have been suggested.

B. Why Are We Holding a Public Workshop?

    The enactment of section 519(f) of the act has raised many
questions for our consideration. For example, the statute requires the
UDI to go on the device's label, but it also allows for ``alternative
placement'' and for exceptions. Thus,

what circumstances would justify alternative placement of the UDI, and
which devices should receive an exception from a UDI requirement?
Consequently, we are issuing this notice to announce that we will hold
a public workshop to discuss and to invite comment on the questions set
out in section II. B of this document.

II. Issues to Be Considered

A. Organization and Basic Instructions

    We invite comments on the questions presented in this section. We
intend to discuss these same questions at the public workshop. If you
wish to comment in writing on a particular question, please identify
the question that you are addressing before providing your response to
the question. For example, your comment could take the following
format:
    ``Question 1--[Quote the question].''
    ``Response--[Insert your response].''
    You do not have to address each question. Additionally, for those
questions pertaining to economic issues or the prevalence of a
particular problem or action, please provide data and/or references so
that we may understand the basis for your comment, figures, and any
assumptions that you used.
    As this workshop will only take place over the course of a single
day, in order to most effectively use this time and obtain as much
information from as many diffferent points of view as possible, the
public workshop will be divided into sessions that focus on each of the
main topic areas. Each session will begin with an invited presentation
to describe the issue. This will be followed by a moderated question
and comment session. Following this discussion, the moderator will open
up the discussion to questions and comments on the topic from the
audience. Though limited, at the end of the day there will be time for
other presentations.
    Because of the workshop's format, we will only have a short time
for additional presentations. We encourage attendees to raise their
issues and concerns during the discussion portion of the main topic
areas. We also encourage persons and groups having similar interests to
consolidate their information and present it through a single
representative.
    Additionally, through this public workshop, we hope to gain greater
understanding of various automatic identification technologies.
Therefore, we invite manufacturers and organizations that market or
have in development automatic identification technologies, which could
be used with medical devices, to display these technologies. Questions
about whether your product or technology would fall within the scope of
this vendor display should be directed to the contact persons listed at
the beginning of this notice.
    You may register to present at the public workshop or participate
in the vendor display at http://www.fda.gov/cdrh/ocd/udi/index.html.
Because of time constraints, vendors may register either to present at
the public workshop or participate in the vendor display. You may not
register for both. If you choose to participate in the vendor display,
you will have the opportunity to share information about your products
with FDA and other attendees when they visit your display.

B. Questions Pertaining to the UDI System

1. Which types of devices or particular devices should be subject to
the requirements of a UDI system? Which types of devices or particular
devices should be excepted?
    Section 519(f) of the act states that the Secretary of Health and
Human Services may provide ``an exception for a particular device or
type of device.'' However, the statute does not specify any criteria
for an exception, nor does it describe the scope of an exception.
    a. Should all devices be subject to the requirements of a UDI
system? Please explain your reasoning.
    b. Are there types of devices or particular devices that should
receive an exception from the requirements of a UDI system? If so, what
types of devices or particular devices should receive an exception and
why?
2. What are the characteristics or aspects necessary to uniquely
identify a device?
    Section 519(f) of the act states that the UDI ``shall adequately
identify the device through distribution and use, and may include
information on the lot or serial number.'' The statutory language does
not describe the characteristics or features that make a device
``unique'' or that ``adequately identify the device through
distribution and use.''
    a. What characteristics are needed to uniquely identify a device?
    b. What core attributes, elements, or characteristics of a device
should constitute a minimum data set for a device identifier?
    c. What changes to an attribute, element, or characteristic
associated with the unique identification of a device change should
result in a new UDI?
    d. Should the UDI include a component that represents package size
or packaging level?
    e. To what extent would or should the list of unique device
characteristics vary depending on the type of device?
3. What should be the UDI's components?
    a. Could existing standards, such as the standards used by GS1,
Health Industry Business Communications Council (HIBCC), or others be
used as a model for the UDI system? What are the advantages and
disadvantages of these existing organizations and standards?
    b. Some identification systems currently in use employ a
combination of a device identifier (meaning information that identifies
the manufacturer, make, and/or model of the device) and a production
identifier (meaning information that relates to the lot or serial
number). What should the device ``identifier'' component of the UDI
cover or contain?
    c. With respect to the production identifier, we note that the
statute says that the UDI may include information on the device's lot
or serial number. When should lot or serial number information be
required for a device? Are there particular devices for which serial
numbers should be required? If yes, what particular devices should be
labeled with a serial number? Please explain your reasoning.
    d. How might we ensure that UDIs, regardless of the manufacturers
or devices associated with those UDIs, are uniform or standardized in
their structure or composition? For example, the NDC (National Drug
Code) number is always 10 digits long and always presents the labeler
code first, followed by the product code and then the package code.
Should we limit the number of ways that the UDI can be created or the
standards to be used?
    e. How should the UDI be created to ensure that UDIs are unique?
4. Where should the UDI be placed? What should be the criteria for
alternative placement of the UDI?
    The statute requires the label of devices to bear a unique
identifier, unless we require an ``alternative placement'' or provide
an exception. Section 201(k) of the act defines ``label'' ``as a
display of written, printed, or graphic matter upon the immediate
container of any article; and a requirement made by or under authority
of this act that any word, statement, or other information appear on
the label shall not be considered to be complied with unless such word,
statement, or other information also appears on the

outside container or wrapper, if any there be, of the retail package of
such article, or is easily legible through the outside container or
wrapper.''
    a. Should we specify where on the label the UDI must appear? If so,
where should the UDI appear on the label? Please explain your
reasoning.
    i. Should we allow the components of the UDI to be placed
separately on the same package or on different levels of packaging? For
example, if the UDI consists of a device identifier component and a
production identifier component, should we allow the device identifier
component of the UDI to be placed in one location and allow the
production identifier component to be placed elsewhere on the label or
on the device? Please explain your reasoning.
    As another example, some devices are packaged individually and then
packaged again in a larger container (such as a ``shelf pack''). We are
aware that some manufacturers would prefer placing both the device
identifier component of the UDI and the production identifier component
of the UDI on the larger container and placing only the device
identifier component of the UDI on the individual packages. Separating
UDI components or allowing part (rather than all) of the UDI on package
labels may provide for flexibility in product labeling, but also
generate confusion as to which UDI to read or scan (if the UDI
components are separated) or limit the usefulness of the UDI if a
component of the UDI is not present.
    ii. For barcodes (whether linear or two-dimensional (2D)), should
we require the UDI to be expressed in a concatenated manner (whereby
the components of the UDI are expressed on the same line adjacent to
each other) or in a stacked manner (whereby one component of the UDI
rests atop the other component)?
    b. Are there devices where we should require the UDI to appear on
the device itself (direct part marking)? For example, it might be
beneficial to put the UDI on the device itself if the device is re-
processed because this might help firms identify or record how many
times a particular device has been reprocessed. Similarly, certain
single use devices (SUDs) sometimes are reprocessed, so a UDI on the
device itself could facilitate the mandatory and voluntary MedWatch
reporting relating to such reprocessed devices or facilitate other
activities (such as documenting sterilization reprocessing of SUDs and
validation studies) associated with SUDs. Conversely, are there devices
where the UDI cannot or should not go on the device itself? If so,
please describe those devices and explain why the UDI cannot or should
not go on the device.
    c. If we allow for ``alternative placement'' of the UDI for some
particular devices or types of devices, what should be the general
criteria for requiring ``alternative placement'' of the UDI, e.g., such
as on the device itself or other location that is not on the label?
    d. What specific challenges or limitations exist regarding
``alternative placement?'' For example, placing a UDI in an automatic
identification form on an implantable device may present issues as to
whether the automatic identification technology affects the device's
integrity or function. As another example, certain devices, such as
software, may pose particular challenges for how to label with a UDI.
5. How should the UDI be presented?
    We are aware of several automatic identification technologies in
use, such as linear bar codes, 2D bar codes, and radio frequency
identification. We also note that various FDA regulations and
initiatives have required or recommended one or more automatic
identification technologies (see 21 CFR 201.25 (bar code label
requirement for human drug products); 21 CFR 610.67 (bar code label
requirement for biological products); Ref. 2; and section 505D of the
act (21 U.S.C. 355e) (regarding ``pharmaceutical security'' and
specifying ``promising technologies'' such as RFID (radio-frequency
identification), nanotechnology, encryption technologies, and other
``track-and-trace or authentication technologies'') ). Therefore:
    a. Should we require human-readable UDIs or automatic
identification of UDIs or both? Are there devices where it would be
sufficient to have human-readable UDIs alone? Please explain your
reasoning. For example, devices used in a home care setting might not
need an automatic identification UDI because the home might not be
equipped to read the automatic identifier. Are there situations where
we should require both human-readable and automatic identification
UDIs? Please explain your reasoning.
    b. Should we specify a particular type of automatic identification
technology or should we allow the automatic identification technology
to vary depending on the type of device? Should we identify automatic
identification standards (as opposed to specific technologies) that can
be used? Please explain your reasoning. Specifying a particular type of
automatic identification technology would enable hospitals and other
parties who might read or use a UDI to make specific investments in
scanning or reading equipment, but the technology chosen might not be
easily applied to all devices (if we require the UDI to be placed
somewhere other than the label.) For this question, we are particularly
interested in hearing from parties who might use UDIs as well as
entities that may have already adopted or installed device
identification systems.
    c. Should we allow the use of different automatic identification
technologies to express different parts of the UDI? For example, the
device identifier component might be expressed in a linear bar code and
the production identifier component might be expressed in a 2D bar
code. Allowing the use of different technologies for different
components of the UDI may enable manufacturers to make more efficient
use of label space or space on the device itself, but it also could
generate confusion as to which identifier to read or scan and could
necessitate the purchase of several types of reading and scanning
equipment.
    d. Are there existing standards or systems we should consider in
establishing the requirements for how the UDI must be presented? For
example, we are aware of various standards organizations, such as GS1
and the HIBCC, that exist and have specific formats or specifications
for automatic identifiers for products. Should we allow any or all of
these standards to be used?
6. How should the UDI Database be developed and maintained?
    For parties to benefit from UDI information, it would seem
necessary for those parties to know, at a minimum, the UDIs that exist,
the specific device associated with each UDI, and the information
associated with each UDI. It might be efficient for one entity to
collect the UDIs, associate those UDIs with specific devices, and make
the information associated with those UDIs publicly available. However,
it is also conceivable (but perhaps less efficient or more costly) that
the information could rest with individual manufacturers themselves
(rather than FDA) or with a third party or third parties. Consequently:
    a. How and when should we require UDIs and associated information
to be entered into a database? How frequently should we require changes
to a UDI or to the information associated with or linked to a UDI to be
reported?
    b. Aside from information that is necessary to uniquely identify a
device,

what other information (if any) should be part of a UDI system database
or otherwise linked to the UDIs?
    c. If variable data (such as a lot or serial number) is necessary
to uniquely identify a device, should such data be included in a UDI
system database?

C. Questions Pertaining to Possible Impacts of a UDI System

    Many production situations that might be affected by UDI
requirements are complex. In its basic form, a device identifier is a
series of digits and/or letters associated with a specific device. At a
minimum, a system can be thought of as the set of procedures that allow
stakeholders to use an identifier. Through public consultation,
however, FDA has found that there are many different views as to the
purpose of a UDI system and different opinions about how to describe
and implement a UDI system. Because of the diversity of affected
devices and manufacturing processes, we expect that affected entities
might comply with UDI requirements in a variety of ways. If you respond
to the following questions about the costs and benefits of a UDI
system, we encourage you to provide as much detail and context as
possible. For example, if you identify exceptional costs related to
incorporating a UDI in certain production lines, we need to understand
the production process details. In addition, we specifically invite
small businesses to provide information about a UDI's potential impact.
1. What is the magnitude of the problem to be addressed by the
establishment of a UDI system?
    Please describe and provide qualitative or quantitative evidence of
the incidence of deaths, injuries and illnesses associated with medical
devices. What role would a UDI system play in helping to reduce the
incidence of such deaths, injuries, and illnesses and how might the
structure of a UDI system facilitate this role?
2. Questions for manufacturers
    a. Current practices. Describe your current practices for applying
standards to medical devices, marking identifiers on medical device
labeling and managing medical device identifier data. For example, how
do you currently use classification standards such as UNSPSC (United
Nations Standard Products Service Code), nomenclature standards such as
GMDN (Global Medical Device Nomenclature), and identification standards
such as GS1 or HIBCC? What percent of your devices are not currently
marked with a standardized identifier? Please describe any plans you
have to change these practices in the near future.
    b. Changing current identifiers. If you were to add a UDI or change
the presentation of your current identifier, please describe your
approximate expected capital and operating costs (including labor) to
plan for, implement, and apply a UDI to product labeling. To provide
context for your estimate, please explain your expected approach to
adding a UDI, considering the possibility that a UDI might be a static
number (e.g., a manufacturer/product code) or that it might include a
variable number (e.g., manufacturer/product/lot code).
    c. Encoding variable data. If you were to add a UDI bar code with
variable data (such as lot or serial number) to medical device
labeling, please describe how you would print the variable bar coded
information. For example, do you foresee using on-line label printing,
other in-house printing, or contract printers to add a UDI bar code?
    d. Production line impacts. Considering your operations, are there
products where adding a UDI (human readable or barcode; static or
variable) to labeling would not be feasible without major capital
investment or overhauling production lines? If so, please describe the
products and suggest alternatives or solutions.
    e. Small devices and small packages. A UDI could present a
challenge for some small packages. What percentage of your product line
consists of devices whose small size could make placing a UDI on a
label problematic? Of those devices identified, what ``alternative
placement'' of the UDI would be feasible? Please explain your
reasoning. Please describe the nature of the problems and costs to
solve such problems. Please suggest alternatives or solutions.
3. Questions for hospitals, nursing homes, and clinics
    a. Using a UDI. If UDIs were placed on at least some medical
devices, what functions could a UDI serve in your institution?
    b. Expenses. What expenses do you foresee in attempting to capture
and use UDIs placed on medical devices? If you foresee using UDIs, how
would you modify operations in your facility?
    c. Adverse event reporting and recalls. How would capturing the UDI
change your recall management or adverse event reporting? For recalls
or adverse events involving the most serious device malfunctions or
failures, how have problems in device identification impaired your
recall management or adverse event reporting? Please describe the
magnitude of the problems you have encountered.

III. References

    The following references have been placed on display in the
Division of Dockets Management (see Comments) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. 153 Cong. Rec. H10597 (daily ed., September 19, 2007)
(statement of Rep. Hooley).
    2. FDA, ``FDA Counterfeit Drug Task Force Report: 2006 Update,''
p. 12, (http://www.fda.gov/oc/initiatives/counterfeit/report6_
06.pdf) (advocating use of RFID).

IV. Where and When Will the Public Workshop Occur?

    We will hold the public workshop on February 12, 2009, from 9 a.m.
to 5 p.m., at the Marriott Gaithersburg Washingtonian Center, 9751
Washingtonian Blvd., Gaithersburg, MD 20878.

V. Do You Have To Register To Attend a Public Workshop or To Make a
Presentation?

    If you wish to make a presentation at or to attend the public
workshop, please register online at http://www.fda.gov/cdrh/ocd/udi/
index.html by January 30, 2009. The online registration form will
instruct you as to the information you should provide. Space may be
limited, and we will close on-site registration when the maximum
seating capacity is reached.
    We will try to accommodate all persons who wish to make a
presentation. The time allotted for presentations will depend on the
number of people who wish to speak on a given topic, and the public
workshop schedule. Similarly, the time allotted to each topic may vary
depending on the expressed interests of persons registering for the
public workshop. To obtain updates on the public workshop, please visit
http://www.fda.gov/cdrh/ocd/udi/index.html. Additionally, regardless of
whether you wish to make a presentation or simply attend the public
workshop, if you need any special accommodations (such as wheelchair
access or a sign language interpreter), please notify Jay Crowley (see
Contact Person) by January 30, 2009.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be

accepted by FDA only through FDMS at http://www.regulations.gov.
    Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at http://www.fda.gov/cdrh/ocd/udi.index.html.

    Dated: January 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-784 Filed 1-14-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: November 25, 2008 (Volume 73, Number 228)]
[Notices]
[Page 71715-71717]
[DOCID:fr25no08-134]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration, DOT.

ACTION: Notice.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995 and its
implementing regulations, the Federal Railroad Administration (FRA)
hereby announces that it is seeking an extension of the following
currently approved information collection activities. These information
collection activities received a six-month emergency approval from OMB.
FRA seeks this extension while it works on developing a proposed rule
related to the same topic of inappropriate cell phone use and other
electronic/electrical devices by railroad employees while on-duty.
Before submitting these information collection requirements for
clearance by the Office of Management and Budget (OMB), FRA is
soliciting

public comment on specific aspects of the activities identified below.

DATES: Comments must be received no later than January 26, 2009.

ADDRESSES: Submit written comments on any or all of the following
proposed activities by mail to either: Mr. Robert Brogan, Office of
Safety, Planning and Evaluation Division, RRS-21, Federal Railroad
Administration, 1200 New Jersey Ave., SE., Mail Stop 17, Washington, DC
20590, or Ms. Nakia Jackson, Office of Information Technology, RAD-20,
Federal Railroad Administration, 1200 New Jersey Ave., SE., Mail Stop
35, Washington, DC 20590. Commenters requesting FRA to acknowledge
receipt of their respective comments must include a self-addressed
stamped postcard stating, ``Comments on OMB control number 2130-0579.''
Alternatively, comments may be transmitted via facsimile to (202) 493-
6216 or<PHONE_NUMBER>, or via e-mail to Mr. Brogan at
<EMAIL_ADDRESS>or to Ms. Jackson at<EMAIL_ADDRESS>
Please refer to the assigned OMB control number in any correspondence
submitted. FRA will summarize comments received in response to this
notice in a subsequent notice and include them in its information
collection submission to OMB for approval.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Office of Safety,
Planning and Evaluation Division, RRS-21, Federal Railroad
Administration, 1200 New Jersey Ave., SE., Mail Stop 17, Washington, DC
20590 (telephone:<PHONE_NUMBER>) or Ms. Nakia Jackson, Office of
Information Technology, RAD-20, Federal Railroad Administration, 1200
New Jersey Ave., SE., Mail Stop 35, Washington, DC 20590 (telephone:
(202) 493-6073). (These telephone numbers are not toll-free.)

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA),
Public Law 104-13, section 2, 109 Stat. 163 (1995) (codified as revised
at 44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR Part
1320, require Federal agencies to provide 60-days notice to the public
for comment on information collection activities before seeking
approval for reinstatement or renewal by OMB. 44 U.S.C. 3506(c)(2)(A);
5 CFR 1320.8(d)(1), 1320.10(e)(1), 1320.12(a). Specifically, FRA
invites interested respondents to comment on the following summary of
proposed information collection activities regarding (i) whether the
information collection activities are necessary for FRA to properly
execute its functions, including whether the activities will have
practical utility; (ii) the accuracy of FRA's estimates of the burden
of the information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (iii) ways
for FRA to enhance the quality, utility, and clarity of the information
being collected; and (iv) ways for FRA to minimize the burden of
information collection activities on the public by automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology (e.g., permitting electronic
submission of responses). See 44 U.S.C. 3506(c)(2)(A)(i)-(iv); 5 CFR
1320.8(d)(1)(i)-(iv). FRA believes that soliciting public comment will
promote its efforts to reduce the administrative and paperwork burdens
associated with the collection of information mandated by Federal
regulations. In summary, FRA reasons that comments received will
advance three objectives: (i) Reduce reporting burdens; (ii) ensure
that it organizes information collection requirements in a ``user
friendly'' format to improve the use of such information; and (iii)
accurately assess the resources expended to retrieve and produce
information requested. See 44 U.S.C. 3501.
    Below is a brief summary of currently approved information
collection activities that FRA will submit for clearance by OMB as
required under the PRA:
    OMB Control Number: 2130-0579.
    Title: FRA Emergency Order No. 26, Notice No. 1.
    Abstract: Emergency Order No. 26--and its associated collection of
information--is FRA's direct and proactive response to the September
12, 2008, Chatsworth, California, collision of a Union Pacific (UP)
freight train and a Metrolink commuter train, which resulted in the
deaths of 25 people and numerous injuries to train occupants, as well
as to other train accidents/incidents involving cell phone use and use
of electronic/electrical devices that have occurred throughout the
country recently. The collection of information under Emergency Order
No. 26 is aimed at ensuring that railroads revise their programs of
operational tests and inspections, as necessary, to include the
requirements of E.O. 26 and specifically include a minimum number of
operational tests and inspections; and at ensuring railroads instruct
each of their operating employees and supervisors of railroad operating
employees concerning the requirements of E.O. 26 and implementing
railroad rules and instructions. The collection of information under
E.O. 26 also contains a provision that allows railroads to petition for
relief from this Order by adopting other means of ensuring that
railroad operating employees are not distracted from their duties by
use of electronic or electrical devices or by implementing technology
that will prevent inappropriate acts and omissions from resulting in
injury to persons.
    Form Number(s): N/A.
    Affected Public: Businesses.
    Respondent Universe: 718 railroads; 130,000 Railroad Employees.
    Frequency of Submission: One-time; on occasion.
    Reporting Burden:

----------------------------------------------------------------------------------------------------------------
                                      Respondent         Total annual      Average time per      Total annual
   Emergency order item No. 26         universe            responses           response          burden hours
----------------------------------------------------------------------------------------------------------------
(1)--Revision of Railroad's       718 Railroads 20    718 amended         1 hour............  718
 Program of Operational Tests      New Railroads.      programs.          1 hour............  20
 and Inspections Under 49 CFR                         20 amended
 217 to Include Requirements of                        programs.
 E.O. 26.
(2) Employee Training in          130,000 RR          130,000 Trained     15 minutes........  32,500
 Requirements of E.O. 26 and       Employees.          Employees.
 Implementing Railroad Rules and
 Instructions.
(3) Petitions of Relief from      718 Railroads.....  Zero (0) Petitions  Zero (0) minutes/   Zero (0)
 E.O. 26.                                                                  hours.
----------------------------------------------------------------------------------------------------------------

    Total Responses: 130,738.
    Total Annual Estimated Burden: 33,238 hours.
    Status: Regular review.
    Pursuant to 44 U.S.C. 3507(a) and 5 CFR 1320.5(b),
1320.8(b)(3)(vi), FRA informs all interested parties that it may not
conduct or sponsor, and a respondent is not required to respond

to, a collection of information unless it displays a currently valid
OMB control number.

    Authority: 44 U.S.C. 3501-3520.

    Issued in Washington, DC, on November 19, 2008.
Kimberly Orben,
Director, Office of Financial Management, Federal Railroad
Administration.
[FR Doc. E8-27908 Filed 11-24-08; 8:45 am]

BILLING CODE 4910-06-P