[Federal Register Volume 87, Number 14 (Friday, January 21, 2022)]
[Rules and Regulations]
[Pages 3203-3205]
[FR Doc No: 2022-01147]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. FDA-2021-N-0993]

Medical Devices; Ophthalmic Devices; Classification of the
Retinal Diagnostic Software Device

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the retinal diagnostic software device into class II
(special controls). The special controls that apply to the device type
are identified in this order and will be part of the codified language
for the retinal diagnostic software device's classification. We are
taking this action because we have determined that classifying the
device into class II (special controls) will provide a reasonable
assurance of safety and effectiveness of the device. We believe this
action will also enhance patients' access to beneficial innovative
devices.

DATES: This order is effective January 21, 2022. The classification was
applicable on April 11, 2018.

FOR FURTHER INFORMATION CONTACT: Elvin Ng, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1304, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the retinal diagnostic software
device as class II (special controls), which we have determined will
provide a reasonable assurance of safety and effectiveness. In
addition, we believe this action will enhance patients' access to
beneficial innovation, by placing the device into a lower device class
than the automatic class III assignment.

    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation. When FDA classifies a device into
class I or II via the De Novo process, the device can serve as a
predicate for future devices of that type, including for 510(k)s (see
section 513(f)(2)(B)(i)) of the FD&C Act). As a result, other device
sponsors do not have to submit a De Novo request or premarket approval
application to market a substantially equivalent device (see section
513(i) of the FD&C Act, defining ``substantial equivalence''). Instead,
sponsors can use the less-burdensome 510(k) process, when necessary, to
market their device.

II. De Novo Classification

    On January 12, 2018, FDA received IDx, LLC's request for De Novo
classification of the IDx-DR. FDA reviewed the request in order to
classify the device under the criteria for classification set forth in
section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on April 11, 2018, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
886.1100.\1\ We have named the generic type of device retinal
diagnostic software device, and it is identified as a prescription
software device that incorporates an adaptive algorithm to evaluate
ophthalmic images for diagnostic screening to identify retinal diseases
or conditions.
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    \1\ FDA notes that the ACTION caption for this final order is
styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

    Table 1--Retinal Diagnostic Software Device Risks and Mitigation
                                Measures
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       Identified risks                    Mitigation measures
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False positive results leading  Clinical performance testing; Software
 to additional unnecessary       verification, validation, and hazard
 medical procedures.             analysis; and Protocol for technical
 Diagnostic software     specification changes.
 failure.
 Software failure.....
False negative results leading  Clinical performance testing; Software
 to delay of further             verification, validation, and hazard
 evaluation or treatment.        analysis; Protocol for technical
 Diagnostic software     specification changes; and Labeling.
 failure.
 Software failure.....
Operator failure to provide     Labeling, Training, and Human factors
 images that meet input          validation testing.
 quality specifications.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
    At the time of classification, retinal diagnostic software devices
are for prescription use only. Prescription devices are exempt from the
requirement for adequate directions for use for the layperson under
section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR
801.5, as long as the conditions of 21 CFR 801.109 are met.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulation, have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
886 is amended as follows:

PART 886--OPHTHALMIC DEVICES

0
1. The authority citation for part 886 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  886.1100 to subpart B to read as follows:

Sec.  886.1100   Retinal diagnostic software device.

    (a) Identification. A retinal diagnostic software device is a
prescription software device that incorporates an adaptive algorithm to
evaluate ophthalmic images for diagnostic screening to identify retinal
diseases or conditions.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Software verification and validation documentation, based on a
comprehensive hazard analysis, must fulfill the following:
    (i) Software documentation must provide a full characterization of
technical parameters of the software, including algorithm(s).
    (ii) Software documentation must describe the expected impact of
applicable image acquisition hardware characteristics on performance
and associated minimum specifications.
    (iii) Software documentation must include a cybersecurity
vulnerability and management process to assure software functionality.
    (iv) Software documentation must include mitigation measures to
manage failure of any subsystem components with respect to incorrect
patient reports and operator failures.
    (2) Clinical performance data supporting the indications for use
must be provided, including the following:
    (i) Clinical performance testing must evaluate sensitivity,
specificity, positive predictive value, and negative predictive value
for each endpoint reported for the indicated disease or condition
across the range of available device outcomes.
    (ii) Clinical performance testing must evaluate performance under
anticipated conditions of use.
    (iii) Statistical methods must include the following:
    (A) Where multiple samples from the same patient are used,
statistical analysis must not assume statistical independence without
adequate justification.
    (B) Statistical analysis must provide confidence intervals for each
performance metric.
    (iv) Clinical data must evaluate the variability in output
performance due to both the user and the image acquisition device used.
    (3) A training program with instructions on how to acquire and
process quality images must be provided.
    (4) Human factors validation testing that evaluates the effect of
the training program on user performance must be provided.
    (5) A protocol must be developed that describes the level of change
in device technical specifications that could significantly affect the
safety or effectiveness of the device.
    (6) Labeling must include:
    (i) Instructions for use, including a description of how to obtain
quality images and how device performance is affected by user
interaction and user training;
    (ii) The type of imaging data used, what the device outputs to the
user, and whether the output is qualitative or quantitative;
    (iii) Warnings regarding image acquisition factors that affect
image quality;
    (iv) Warnings regarding interpretation of the provided outcomes,
including:
    (A) A warning that the device is not to be used to screen for the
presence of diseases or conditions beyond its indicated uses;
    (B) A warning that the device provides a screening diagnosis only
and that it is critical that the patient be advised to receive followup
care; and
    (C) A warning that the device does not treat the screened disease;
    (v) A summary of the clinical performance of the device for each
output, with confidence intervals; and
    (vi) A summary of the clinical performance testing conducted with
the device, including a description of the patient population and
clinical environment under which it was evaluated.

    Dated: January 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01147 Filed 1-20-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 61 (Wednesday, March 30, 2022)]
[Notices]
[Pages 18469-18470]
[FR Doc No: 2022-06728]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2021-0068]

Agency Information Collection Activities; Submission to the
Office of Management and Budget for Review and Approval; Request for
Comment; Petitions for Hearings on Notification and Remedy of Defects

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

ACTION: Notice and request for comments on a request for extension of a
currently approved information collection.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (PRA),
this notice announces that the Information Collection Request (ICR)
summarized below will be submitted to the Office of Management and
Budget (OMB) for review and approval. The ICR describes the nature of
the information collection and its expected burden. This ICR is for a
request for extension of NHTSA's currently approved information
collection for petitions for hearings on notification and remedy of
defects. A Federal Register Notice with a 60-day comment period
soliciting comments on the ICR was published on January 18, 2022. No
comments were received.

DATES: Comments must be submitted on or before April 29, 2022.

ADDRESSES: Written comments and recommendations for the proposed
information collection, including suggestions for reducing burden,
should be submitted to the Office of Management and Budget at
www.reginfo.gov/public/do/PRAMain. To find this particular information
collection, select ``Currently under Review--Open for Public Comment''
or use the search function.

FOR FURTHER INFORMATION CONTACT: For additional information or access
to background documents, contact Nicholas LaBruna, Recall Management
Division (NEF-107), Room W46-438, NHTSA, 1200 New Jersey Ave. SE,
Washington, DC 20590. Telephone:<PHONE_NUMBER>. Please identify the
relevant collection of information by referring to its OMB Control
Number (2127-0039).

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501 et seq.), a
Federal agency must receive approval from the Office of Management and
Budget (OMB) before it collects certain information from the public and
a person is not required to respond to a collection of information by a
Federal agency unless the collection displays a valid OMB control
number. In compliance with these requirements, this notice announces
that the following information collection request will be submitted
OMB.
    Title: Petitions for Hearings on Notification and Remedy of
Defects.
    OMB Control Number: 2127-0039.
    Form Numbers(s): N/A.
    Type of Request: Extension of a currently approved information
collection.
    Type of Review Requested: Regular.
    Requested Expiration Date of Approval: 3 Years from the date of
approval.
    Summary of the Collection of Information: NHTSA reviews filed
complaints from vehicle owners and other information related to alleged
defects or noncompliances to decide whether to open an investigation.
Should a manufacturer determine or NHTSA decide, through testing,
inspection, investigation or research, that a motor vehicle or motor
vehicle equipment contains a defect related to motor vehicle safety or
does not comply with an applicable Federal motor vehicle safety
standard (FMVSS),

Section 30118 of title 49 of the United States Code requires the
manufacturer of motor vehicles or replacement equipment to notify
NHTSA, owners, purchasers, and dealers of the safety defect or
noncompliance. Section 30120 requires the manufacturer to remedy,
without charge, the defect or non-compliance and specifies the ways in
which a noncompliance or defect can be remedied. Sections 30118(e) and
30120(e) of title 49 specify that any interested person may petition
the Secretary of Transportation (NHTSA by delegation) to hold a hearing
to determine whether a manufacturer of motor vehicles or motor vehicle
equipment has reasonably met its obligation to notify owners,
purchasers, and dealers of vehicles or equipment of a safety-related
defect or noncompliance with a FMVSS in the manufacturer's products and
to remedy that defect or noncompliance.
    To implement these statutory provisions, NHTSA promulgated 49 CFR
part 557, Petitions for Hearings on Notification and Remedy of Defects.
Part 557 establishes procedures for the submission and disposition of
petitions for hearings on the issues of whether the manufacturer has
reasonably met its obligation to notify owners, purchasers, and dealers
of safety-related defects or noncompliance, or to remedy such defect or
noncompliance free of charge.
    Description of the Need for the Information and Proposed Use of the
Information: Persons who believe that a manufacturer has been deficient
in notifying owners, purchasers, or dealers of a safety related defect
or noncompliance with FMVSS, or has not remedied the problem in
accordance with statutory requirements, may petition the agency
pursuant to 49 CFR part 557. The agency uses the information collected
in the petition, and may use other information available to it, to
determine whether a hearing is necessary to determine whether a
manufacturer has reasonably met its obligation to notify owners,
purchasers, and dealers of the safety defect or noncompliance with
FMVSS, or to remedy that defect or noncompliance. Should the agency, on
the basis of information provided at that hearing or other information,
determine the manufacturer has not reasonably met its obligations, the
agency orders the manufacturer to take specified action to bring itself
into compliance with those obligations.
    60-Day Notice: A Federal Register notice with a 60-day comment
period soliciting public comments on the following information
collection was published on January 18, 2022 (87 FR 2664). No comments
were received.
    Affected Public: Businesses or other interested persons.
    Estimated Number of Respondents: 1 respondent.
    Frequency: On occasion.
    Estimated Total Annual Burden Hours: 1 hour.
    When NHTSA last sought approval for the extension of this
information collection, the agency estimated it would receive one
petition a year and estimated that, with an estimated one hour of
preparation time for each petition, the total annual burden for this
collection would be 1 hour. The agency now believes that a more
accurate estimate would be 0 petitions and 0 burden hours each year,
based on the agency not receiving of any such petitions submitted in
recent years. However, NHTSA continues to estimate that the time to
prepare a petition is 1 hour and, to account for the possibility of
receiving a petition in a given year, NHTSA estimates the total annual
burden of this collection to be 1 hour (1 petition x 1 hour to
prepare).
    Estimated Total Annual Burden Cost: $7.95.
    NHTSA estimates that the only cost burden to respondents (i.e.,
petitioners) except for the time invested (opportunity cost) associated
with the time to submit the petition will be postage costs. NHTSA
estimates that each mailed response is estimated to cost $7.95
(priority flat rate envelope from USPS). Therefore, the total cost for
the estimated 1 request per year is $7.95.
    Public Comments Invited: You are asked to comment on any aspects of
this information collection, including (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (c) ways to enhance
the quality, utility and clarity of the information to be collected;
and (d) ways to minimize the burden of the collection of information on
respondents, 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.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. chapter
35, as amended; 49 CFR 1.49; and DOT Order 1351.29.

Stephen Ridella,
Director, Office of Defects Investigation, NHTSA.
[FR Doc. 2022-06728 Filed 3-29-22; 8:45 am]
BILLING CODE P


[Federal Register Volume 83, Number 121 (Friday, June 22, 2018)]
[Notices]
[Page 29110]
[FR Doc No: 2018-13364]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2618-030 and 031]

Woodland Pulp, LLC; Notice of Application Accepted for Filing,
Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Federal Energy Regulatory Commission and is available
for public inspection:
    a. Type of Application: Fishway Operation and Maintenance Plan (P-
2618-030) and Fishway Evaluation Plan (P-2618-031).
    b. Project No: 2618-030 and -031.
    c. Date Filed: March 22, 2017.
    d. Applicant: Woodland Pulp, LLC (licensee).
    e. Name of Project: West Branch Hydroelectric Project.
    f. Location: The project is located on the West Branch of the St.
Croix River in Washington County, Maine.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: C. Scott Beal, Woodland Pulp, LLC, 144 Main
Street, Baileyville, ME 04619.
    i. FERC Contact: Michael Calloway at<PHONE_NUMBER>, or
[email protected].
    j. Deadline for filing comments, motions to intervene, and protests
is 45 days from the issuance of this notice by the Commission. The
Commission strongly encourages electronic filing. Please file motions
to intervene, protests, and comments using the Commission's eFiling
system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at [email protected],<PHONE_NUMBER> (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE, Washington, DC 20426. The first page of any filing should
include docket number P-2618-030 and P-2618-031.
    k. Description of Request: The licensee filed a Fishway Operation
and Maintenance Plan pursuant to Article 409 of the project license and
a Fishway Evaluation Plan pursuant to Article 410 of the project
license. Both plans only address fish passage and effectiveness
evaluation at the project's West Branch development; these plans do not
address passage and evaluation at the Sysladobsis development--because
of the licensee's pending amendment application (filed January 31,
2017) to remove the Sysladobsis development from the project license.
The Fishway Operation and Maintenance Plan filed pursuant to Article
409 describes the fish species that would be passed and how the
licensee would operate the fishway to ensure effectiveness. Under
Article 409, the licensee and the resource agencies were unable to
reach a consensus on which species to pass, therefore, the Commission
will evaluate the record to make a determination on this issue. The
Fishway Evaluation Plan filed pursuant to Article 410 provides a
framework for evaluating the effectiveness of the fishway to those
species selected for passage after operation of the fishway commences.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE, Room 2A, Washington, DC
20426, or by calling<PHONE_NUMBER>. This filing may also be viewed on
the Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call<PHONE_NUMBER> or email
[email protected], for TTY, call<PHONE_NUMBER>. A copy is also
available for inspection and reproduction at the address in item (h)
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title COMMENTS; PROTEST, or MOTION TO
INTERVENE as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person protesting or intervening; and (4) otherwise comply with the
requirements of 18 CFR 385.2001 through 385.2005. All comments, motions
to intervene, or protests must set forth their evidentiary basis and
otherwise comply with the requirements of 18 CFR 4.34(b). All comments,
motions to intervene, or protests should relate to the Fishway
Operation and Maintenance Plan and Fishway Evaluation Plan. Agencies
may obtain copies of plans directly from the applicant. A copy of any
protest or motion to intervene must be served upon each representative
of the applicant specified in the particular application. If an
intervener files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency. A copy of all other filings in reference to
this application must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.

    Dated: June 15, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-13364 Filed 6-21-18; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 239 (Tuesday, December 14, 2010)]
[Proposed Rules]
[Pages 77790-77793]
[FR Doc No: 2010-31371]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-1160; Directorate Identifier 2010-NM-148-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Model 767 Series
Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to supersede an existing airworthiness
directive (AD) that applies to all Model 767 airplanes. The existing AD
currently requires repetitive inspections to detect discrepancies of
the wiring and surrounding Teflon sleeves of the fuel tank boost pumps
and override/jettison pumps; replacement of the sleeves with new
sleeves, for certain airplanes; and repair or replacement of the wiring
and sleeves with new parts, as necessary. This proposed AD would reduce
the initial compliance time and repetitive inspection interval in the
existing AD. This proposed AD results from fleet information indicating
that the repetitive inspection interval in the existing AD is too long
because excessive chafing of the sleeving continues to occur much
earlier than expected between scheduled inspections. We are proposing
this AD to detect and correct chafing of the fuel pump wire insulation
and consequent exposure of the electrical conductor, which could result
in electrical arcing between the wires and conduit and consequent fire
or explosion of the fuel tank.

DATES: We must receive comments on this proposed AD by January 28,
2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management, P.
O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet https://www.myboeingfleet.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Douglas Bryant, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 917-6505; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2010-1160;
Directorate Identifier 2010-NM-148-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On May 23, 2000, we issued AD 2000-11-06, amendment 39-11754 (65 FR
34928, June 1, 2000), for all Model 767 airplanes. (A correction of the
rule was published in the Federal Register on August 1, 2000 (65 FR
46862).) That AD requires repetitive inspections to detect
discrepancies of the wiring and surrounding Teflon sleeves of the fuel
tank boost pumps and override/jettison pumps; replacement of the
sleeves with new sleeves, for certain airplanes; and repair or
replacement of the wiring and sleeves with new parts, as necessary.
That AD resulted from reports of chafing of Teflon sleeves that
surround and protect electrical wires inside conduits installed in the
fuel tanks. We issued that AD to ensure adequate protection to the fuel
pump wire insulation. Such chafing of the wire insulation could
eventually result in exposure of the electrical conductor, permit
arcing from the wire to the conduit, and create a potential for a fuel
tank fire or explosion.

Actions Since Existing AD Was Issued

    Since we issued AD 2000-11-06, we received fleet information from
the manufacturer indicating that excessive chafing of the sleeving
continues to occur much earlier than expected between scheduled
inspections. Due to that fact, the manufacturer has revised the service
information to reduce the initial and repetitive inspection intervals.

Relevant Service Information

    We have reviewed Boeing Alert Service Bulletin 767-28A0053,
Revision 2, dated June 24, 2010. Boeing Service Bulletin 767-28A0053,
Revision 1, dated August 5, 1999, was referred to as the appropriate
source of service information for accomplishing the actions in the
existing AD. Revision 2 of this service bulletin reduces the initial
compliance time and repetitive inspection interval for the repetitive
inspections required by the existing AD.

FAA's Determination and Requirements of the Proposed AD

    We have evaluated all pertinent information and identified an
unsafe condition that is likely to develop on other products of the
same type design. For this reason, we are proposing this AD, which
would supersede AD 2000-11-06 and would retain the requirements of the
existing AD at reduced compliance times.

Change to Existing AD

    This proposed AD would retain all requirements of AD 2000-11-06.
Since that AD was issued, the AD format has been revised, and certain
paragraphs have been rearranged. As a result, the corresponding
paragraph identifiers

have changed in this proposed AD, as listed in the following table:

                      Revised Paragraph Identifiers
------------------------------------------------------------------------
                                           Corresponding requirement in
     Requirement in AD  2000-11-06               this proposed AD
------------------------------------------------------------------------
paragraph (a)..........................  paragraph (g).
paragraph (b)..........................  paragraph (h).
paragraph (c)..........................  paragraph (i).
paragraph (d)..........................  paragraph (j).
paragraph (e)..........................  paragraph (k).
------------------------------------------------------------------------

Costs of Compliance

    There are about 932 airplanes of the affected design in the
worldwide fleet. This proposed AD would affect about 410 airplanes of
U.S. registry. The new requirements of this proposed AD add no
additional economic burden. The current costs for this proposed AD are
repeated below for the convenience of affected operators.
    The actions that are required by AD 2000-11-06 and retained in this
proposed AD take about 5 work-hours per airplane (for airplanes with
jettison pumps) or 3 work-hours per airplane (for airplanes without
jettison pumps), at an average labor rate of $85 per work-hour.
Required parts cost about $336 per airplane. Based on these figures,
the estimated cost of the currently required actions is either $761 or
$591 per airplane, per inspection cycle.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by removing Amendment 39-11754 (65 FR
34928, June 1, 2000) and adding the following new AD:

The Boeing Company: Docket No. FAA-2010-1160; Directorate Identifier
2010-NM-148-AD.

Comments Due Date

    (a) The FAA must receive comments on this AD action by January
28, 2011.

Affected ADs

    (b) This AD supersedes AD 2000-11-06, Amendment 39-11754.

Applicability

    (c) This AD applies to all The Boeing Company Model 767-200, -
300, -300F, and -400ER series airplanes, certificated in any
category.

Subject

    (d) Air Transport Association (ATA) of America Code 28: Fuel.

Unsafe Condition

    (e) This AD results from fleet information indicating that the
repetitive inspection interval in the existing AD is too long
because excessive chafing of the sleeving continues to occur much
earlier than expected between scheduled inspections. The Federal
Aviation Administration is issuing this AD to detect and correct
chafing of the fuel pump wire insulation and consequent exposure of
the electrical conductor, which could result in electrical arcing
between the wires and conduit and consequent fire or explosion of
the fuel tank.

Compliance

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

Restatement of Requirements of AD 2000-11-06, Amendment 39-11754

Inspections

    (g) Perform a detailed visual inspection to detect
discrepancies--including the presence of splices, cuts, splits,
holes, worn areas, and lacing ties installed on the outside of the
sleeves (except at the sleeve ends)--of the Teflon sleeves
surrounding the wiring of the fuel tank boost pumps and override/
jettison pumps, at the earlier of the times specified in paragraphs
(g)(1) and (g)(2) of this AD, in accordance with Boeing Service
Bulletin 767-28A0053, Revision 1, dated August 5, 1999; or Boeing
Alert Service Bulletin 767-28A0053, Revision 2, dated June 24, 2010;
as applicable. Repeat the inspection thereafter at intervals not to
exceed 60,000 flight hours or 30,000 flight cycles, whichever occurs
first. After the effective date of this AD, only Revision 2 of
Boeing Alert Service Bulletin 767-28A0053 may be used.
    (1) Prior to the accumulation of 50,000 total flight hours, or
within 90 days after July 6, 2000 (the effective date of AD 2000-11-
06), whichever occurs later.
    (2) Within 18 months after July 6, 2000.

    Note 1: For the purposes of this AD, a detailed visual
inspection is defined as: ``An intensive visual examination of a
specific structural area, system, installation, or assembly to
detect damage, failure, or irregularity. Available lighting is
normally supplemented with a direct source of good lighting at
intensity deemed appropriate by the inspector. Inspection aids such
as mirror, magnifying lenses, etc. may be used. Surface cleaning and
elaborate access procedures may be required.''

Corrective Actions

    (h) If any discrepancy is detected during any inspection
required by paragraph (g) of this AD: Prior to further flight,
remove the Teflon sleeves and perform a detailed visual inspection
to detect damage of the wiring, in accordance with paragraph D. of
the Accomplishment Instructions of Boeing Service Bulletin 767-
28A0053, Revision 1, dated August 5, 1999; or Boeing Alert Service
Bulletin 767-28A0053, Revision 2, dated June 24, 2010; as
applicable. After the effective date of this AD, only Revision 2 of
Boeing Alert Service Bulletin 767-28A0053 may be used.
    (1) If no damage to the wiring is detected, prior to further
flight, install new Teflon sleeves in accordance with Boeing Service

Bulletin 767-28A0053, Revision 1, dated August 5, 1999; or Boeing
Alert Service Bulletin 767-28A0053, Revision 2, dated June 24, 2010.
    (2) If any damage to the wiring is detected, prior to further
flight, accomplish the requirements of paragraph (i) of this AD.
    (i) If any damage to the wiring is detected during any
inspection required by paragraph (h) of this AD: Prior to further
flight, perform a detailed visual inspection to determine if the
wiring damage was caused by arcing, in accordance with paragraph D.
of the Accomplishment Instructions of Boeing Service Bulletin 767-
28A0053, Revision 1, dated August 5, 1999; or Boeing Alert Service
Bulletin 767-28A0053, Revision 2, dated June 24, 2010, as
applicable. After the effective date of this AD, only Revision 2 of
Boeing Alert Service Bulletin 767-28A0053 may be used.
    (1) If the wire damage was not caused by arcing: Prior to
further flight, repair any damaged wires or replace the wires with
new or serviceable wires, as applicable, and install new Teflon
sleeves; in accordance with Boeing Service Bulletin 767-28A0053,
Revision 1, dated August 5, 1999; or Boeing Alert Service Bulletin
767-28A0053, Revision 2, dated June 24, 2010.
    (2) If any damage caused by arcing is found: Prior to further
flight, perform an inspection for signs of fuel inside the conduit
or on the wires, in accordance with Boeing Service Bulletin 767-
28A0053, Revision 1, dated August 5, 1999; or Boeing Alert Service
Bulletin 767-28A0053, Revision 2, dated June 24, 2010.
    (i) If no sign of fuel is found, accomplish the actions
specified by paragraphs (i)(2)(i)(A), (i)(2)(i)(B), (i)(2)(i)(C),
and (i)(2)(i)(D) of this AD.
    (A) Prior to further flight, repair the wires or replace the
wires with new or serviceable wires, as applicable, in accordance
with Boeing Service Bulletin 767-28A0053, Revision 1, dated August
5, 1999; or Boeing Alert Service Bulletin 767-28A0053, Revision 2,
dated June 24, 2010.
    (B) Prior to further flight, install new Teflon sleeves, in
accordance with Boeing Service Bulletin 767-28A0053, Revision 1,
dated August 5, 1999; or Boeing Alert Service Bulletin 767-28A0053,
Revision 2, dated June 24, 2010.
    (C) Repeat the inspection for signs of fuel inside the conduit
thereafter at intervals not to exceed 500 flight hours, until the
requirements of paragraph (h)(2)(i)(D) of this AD have been
accomplished. If any fuel is found inside the conduit during any
inspection required by this paragraph, prior to further flight,
replace the conduit with a new or serviceable conduit in accordance
with Boeing Service Bulletin 767-28A0053, Revision 1, dated August
5, 1999; or Boeing Alert Service Bulletin 767-28A0053, Revision 2,
dated June 24, 2010. Thereafter, repeat the inspection specified in
paragraph (g) of this AD at intervals not to exceed 60,000 flight
hours or 30,000 flight cycles, whichever occurs first.
    (D) Within 6,000 flight hours or 18 months after the initial
fuel inspection specified by paragraph (h)(2) of this AD, whichever
occurs first, replace the conduit with a new or serviceable conduit,
in accordance with Boeing Service Bulletin 767-28A0053, Revision 1,
dated August 5, 1999; or Boeing Alert Service Bulletin 767-28A0053,
Revision 2, dated June 24, 2010. Such conduit replacement
constitutes terminating action for the repetitive fuel inspections
required by paragraph (i)(2)(i)(C) of this AD.
    (ii) If any fuel is found in the conduit or on any wire: Prior
to further flight, replace the conduit with a new or serviceable
conduit, replace damaged wires with new or serviceable wires, and
install new Teflon sleeves; in accordance with Boeing Service
Bulletin 767-28A0053, Revision 1, dated August 5, 1999; or Boeing
Alert Service Bulletin 767-28A0053, Revision 2, dated June 24, 2010.
Thereafter, repeat the inspection specified in paragraph (a) of this
AD at intervals not to exceed 60,000 flight hours or 30,000 flight
cycles, whichever occurs first.

Pump Retest

    (j) For any wire bundle removed and reinstalled during any
inspection required by this AD: Prior to further flight after such
reinstallation, retest the fuel pump in accordance with paragraph
G., H., I., or J., as applicable, of the Accomplishment Instructions
of Boeing Service Bulletin 767-28A0053, Revision 1, dated August 5,
1999.

Reporting Requirement

    (k) Submit a report of positive inspection findings (findings of
discrepancies only), along with any damaged wiring and sleeves, to
the Seattle Manufacturing Inspection District Office (MIDO), 2500
East Valley Road, Suite C-2, Renton, Washington 98057-3356; fax
(425) 227-1159; at the applicable time specified in paragraph (k)(1)
or (k)(2) of this AD. The report must include the airplane serial
number; the number of total flight hours and flight cycles on the
airplane; the location of the electrical cable on the airplane; and
a statement indicating, if known, whether any wire has ever been
removed and inspected during maintenance, along with the date (if
known) of any such inspection. Information collection requirements
contained in this regulation have been approved by the Office of
Management and Budget (OMB) under the provisions of the Paperwork
Reduction Act of 1980 (44 U.S.C. 3501 et seq.) and have been
assigned OMB Control Number 2120-0056.
    (1) For airplanes on which the initial inspection required by
paragraph (g) of this AD is accomplished after July 6, 2000: Submit
the report within 10 days after performing the initial inspection.
    (2) For airplanes on which the initial inspection required by
paragraph (g) of this AD has been accomplished prior to July 6,
2000: Submit the report for the initial inspection within 10 days
after the effective date of this AD.

New Reduced Inspection Intervals

Repetitive Inspections

    (l) Do the inspection required by paragraph (g) of this AD at
the time specified in paragraph (l)(1) or (l)(2) of this AD, as
applicable, in accordance with Boeing Alert Service Bulletin 767-
28A0053, Revision 2, dated June 24, 2010. Repeat the inspection
thereafter at intervals not to exceed 15,000 flight hours.
Accomplishing the first inspection in this paragraph ends the
repetitive inspection requirements of paragraph (g) of this AD.
    (1) For airplanes on which the inspection required by paragraph
(g) of this AD has been done as of the effective date of this AD: Do
the inspection within 15,000 flight hours after the most recent
inspection or within 6,000 flight hours after the effective date of
this AD, whichever occurs later; but not to exceed 60,000 flight
hours after the most recent inspection required by paragraph (g) of
this AD.
    (2) For airplanes on which the inspection required by paragraph
(g) of this AD has not been done as of the effective date of this
AD: Do the inspection before the accumulation of 15,000 total flight
hours or within 6,000 flight hours after the effective date of this
AD, whichever occurs later.

Paperwork Reduction Act Burden Statement

    (m) A federal agency may not conduct or sponsor, and a person is
not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave., SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

Alternative Methods of Compliance (AMOCs)

    (n)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. Send information to
Attn: Douglas Bryant, Aerospace Engineer, Propulsion Branch, ANM-
140S, FAA, Seattle ACO, 1601 Lind Avenue, SW., Renton, Washington
98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be e-mailed to<EMAIL_ADDRESS>    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (3) AMOCs approved previously in accordance with AD 2000-11-06,
Amendment 39-11754, are approved as

alternative methods of compliance with the corresponding
requirements of this AD. Compliance time extensions approved
previously in accordance with AD 2000-11-06 are not approved as
alternative methods of compliance for the compliance times required
by paragraph (l) of this AD.

    Issued in Renton, Washington, on November 15, 2010.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-31371 Filed 12-13-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: March 30, 2009 (Volume 74, Number 59)]
[Rules and Regulations]
[Page 14091-14092]
[DOCID:fr30mr09-11]

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

Federal Railroad Administration

49 CFR Part 225

Railroad Accidents/Incidents: Reports Classification, and
Investigations

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

ACTION: Notice of interpretation.

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

SUMMARY: FRA is issuing this notice of interpretation to inform
interested parties of its application and enforcement of the harassment
or intimidation provisions contained in 49 CFR part 225, specifically
relating to situations in which a supervisor or other railroad official
accompanies an injured employee into an examination room. This notice
of interpretation informs the regulated community as to when such
behavior constitutes harassment or intimidation calculated to
discourage or prevent the reporting of an accident, incident, injury or
illness. This document is not intended to address or impact statutory
provisions related to providing ``prompt medical attention,'' as
enforcement of those provisions fall within the jurisdiction of the
U.S. Department of Labor.

FOR FURTHER INFORMATION CONTACT: Douglas H. Taylor, Staff Director,
Operating Practices Division, Office of Safety Assurance and
Compliance, FRA, 1200 New Jersey Avenue, SE., RRS-11, Mail Stop 25,
Washington, DC 20590 (telephone<PHONE_NUMBER>); or Zeb Schorr, Trial
Attorney, Office of Chief Counsel, FRA, 1200 New Jersey Avenue SE.,
RCC-11, Mail Stop 10, Washington, DC 20590 (telephone<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 225.33(a) of Title 49 of the Code of Federal Regulations
requires each railroad to ``adopt and comply with a written Internal
Control Plan'' addressing the railroad's policies and procedures
regarding accident/incident reporting. This section further requires
that such Internal Control Plans include, at a minimum, a ``policy
statement declaring the railroad's commitment * * * to the principle,
in absolute terms, that harassment or intimidation of any person that
is calculated to discourage or prevent such person from receiving
proper medical treatment or from reporting such accident, incident,
injury or illness will not be permitted or tolerated * * *.'' The FRA
Guide for Preparing Accident/Incident Reports also notes that ``many
railroad

employees fail to disclose their injuries to the railroad or fail to
accept reportable treatment from a physician because they wish to avoid
potential harassment from management or possible discipline that is
sometimes associated with the reporting of such injuries.'' FRA Guide,
Ch. 1, p.8. The FRA Guide goes on to state that supervisory personnel
and mid-level managers in some instances ``are urged to engage in
practices which may undermine or circumvent the reporting of injuries
and illnesses.'' Id.
    FRA is aware of incidents in which a supervisor or other railroad
official (hereinafter collectively referred to as the ``supervisor'')
has accompanied an injured employee into an examination room, or other
room in which the injured employee received medical treatment
(hereinafter collectively referred to as the ``examination room'').
While FRA is concerned that injured employees in such situations may
not receive complete or prompt medical treatment, responsibility for
ensuring that such treatment is afforded has been assigned by Congress
to the Department of Labor. FRA is concerned that when accompanied by a
supervisor an injured employee may be discouraged or otherwise
prevented from reporting an accident, incident, injury or illness.
Similarly, a supervisor may influence the type or extent of medical
treatment afforded the employee in an effort to affect the
reportability of that injury. Although concerns have been expressed as
to the need for a railroad to determine the extent of an employee's
injuries, FRA does not believe that such concerns outweigh the
potential pitfalls and problems associated with the practice of having
supervisors accompany injured employees while they receive care from
their physicians. Moreover, physicians are in the best position to
evaluate the health of injured employees and the presence of a
supervisor during such examinations would not, in most cases, add any
value to the treatment of an employee and would, in general, be a
distraction to both the employee and the physician.
    The purpose of this document is to articulate a general principle
regarding what behavior constitutes harassment or intimidation in
violation of Sec.  225.33(a)(1) in the particular context of
supervisors accompanying injured employees in examination rooms. The
interpretation contained in this notice reflects the longstanding
position of FRA regarding this practice. This document is not intended
to address or impact the meaning or application of the statutory
provisions contained in 49 U.S.C. 20109 related to providing ``prompt
medical attention,'' as enforcement and application of those provisions
fall within the jurisdiction of the U.S. Department of Labor.

II. Interpretation

A. General Principle

    Harassment and intimidation occur in violation of Sec.
225.33(a)(1) when a railroad supervisor accompanies an injured employee
into an examination room, unless one or more of the exceptions listed
in section II(B) of this notice exists.

B. Exceptions

    FRA recognizes that there are limited circumstances in which it is
appropriate, and indeed preferable, for a supervisor to accompany an
injured employee into an examination room. Thus, FRA believes that
limited exceptions to the general principle articulated in section
II(A) of this notice are necessary. Consequently, FRA recognizes the
following limited exceptions:
    (1) The injured employee issues a voluntary invitation to the
supervisor to accompany him or her in the examination room. The injured
employee must issue this invitation freely, without coercion, duress,
or intimidation. For example, an injured employee may seek the
attendance of a supervisor where the supervisor is a friend. This
exception does not encompass invitations issued by third parties,
including physicians, unless the invitations are made pursuant to the
request of the injured employee.
    (2) The injured employee is unconscious or otherwise unable to
effectively communicate material information to the physician and the
supervisor's input is needed to provide such material information to
the physician. In these circumstances, the supervisor is assisting the
injured employee in providing information to the physician so that the
injured employee may receive appropriate and responsive medical
treatment.

    Issued in Washington, DC, on March 24, 2009.
Jo Strang,
Acting Deputy Administrator, Federal Railroad Administration.
[FR Doc. E9-6953 Filed 3-27-09; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register: April 11, 2008 (Volume 73, Number 71)]
[Notices]
[Page 19919-19921]
[DOCID:fr11ap08-120]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57627; File No. SR-NYSE-2008-19]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
and Amendment No. 1 To Amend NYSE Rule 46 To Permit the Appointment of
Qualified Exchange Employees To Act as Floor Governors

April 4, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 14, 2008, the New York Stock Exchange, LLC (``NYSE'' 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 prepared by NYSE. On April 4, 2008
the Exchange filed Amendment No. 1 to the proposed rule change. NYSE
has designated this proposal as concerned solely with the
administration of a self-regulatory organization, pursuant to Section
19(b)(3)(A)(iii) of the Act and Rule 19b-4(f)(3) thereunder,\3\ which
renders the proposed rule change effective upon filing. 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.
    \3\ 17 CFR 240.19b-4(f)(3).
---------------------------------------------------------------------------

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

    The Exchange proposes to amend NYSE Rule 46 to permit the
appointment of qualified Exchange employees to act as Floor Governors.
The text of the proposed rule change is available at http://
www.nyse.com, the Exchange and 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, NYSE 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 Exchange 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
    NYSE Rule 46 currently provides a process for the Exchange to
appoint NYSE members as Floor Officials. NYSE Rule 2(a) states that the
term ``member,'' when referring to a natural person, means a natural
person associated with a member organization who has been approved by
the Exchange and designated by such member organization to effect
transactions on the Floor of the Exchange or any facility thereof.
Floor Officials are delegated certain authority from the Board of
Directors of the Exchange to supervise and regulate active openings and
unusual situations that arise in connection with the making of bids,
offers or transactions on the trading Floor, and to review and approve
certain trading actions, such as trades to be effected at wide
variations in price and delayed openings and trading halts.\4\
---------------------------------------------------------------------------

    \4\ See NYSE Rules 37, 47, 48, 60, 64, 75, 79A, 85, 90, 91, 93,
100, 103, 103A, 103B, 104, 107A, 110, 111, 112, 115A, 122, 123A,
123C, 123D, 127, 128B, 284, 325, 476A, 903 and 906.
---------------------------------------------------------------------------

    Floor Officials have traditionally been drawn from the ranks of
experienced NYSE Floor members and serve in a volunteer capacity in
addition to their regular obligations as either brokers or specialists.
Within the broad category of ``Floor Official,'' there are several
ranks reflecting the experience of the member serving, including (in
ascending order of seniority) Floor Official, Senior Floor Official,
Floor Governor, and Executive Floor Governor. Under NYSE Rule 46, more
senior-level Floor Officials may take any action that a lower-level
Floor Official is authorized to take.
    Floor Officials at all ranks are appointed by the NYSE's Chairman
and Board of Directors, in consultation with the Executive Floor
Governors and NYSE Regulation Board, which advises on the fitness of
the individuals designated. In connection with the NYSE Regulation
Board's advisory function, NYSE Regulation staff gives a mandatory
education program to the prospective officials, which all candidates
for Floor Official (including Floor Governors) must complete. NYSE
Regulation also administers a qualifying examination to newly-named
Floor Officials, who must pass the exam prior to being recommended by
the NYSE Regulation Board for appointment.
    As the NYSE's trading Floor has downsized from five trading rooms
to two, a number of highly-experienced members have left the Floor as a
result of retirement, layoffs and restructurings within their member
organizations. Because of these departures, the available pool of
experienced members who can serve as senior-level Floor Officials
(particularly Floor Governors) has shrunk commensurately.
    During this same time, the Exchange has hired several former
members who, while they were active on the Floor, served as senior-
level Floor Officials.\5\ The Exchange believes that these individuals
have the necessary business and rule knowledge that would enable them
to act as Floor Governors if the need arose, but are restricted by the
provision in NYSE Rule 46 that states that Floor Governors must be
``members'' of the Exchange. In order to broaden the pool of
experienced individuals who can participate in and supervise unusual
trading situations on the Floor, the Exchange is proposing an amendment
to NYSE Rule 46 that would permit the Exchange to designate qualified
Exchange employees, who would have the same authority as Floor
Governors, in addition to appointing active members as Floor Governors.
To avoid any conflicts of interest between business interests and
regulatory interests, the proposed amendment also provides that the
Exchange may not appoint employees of NYSE Regulation as Floor
Governors.
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    \5\ For example, one such individual served as an Executive
Floor Governor, while two others served as Floor Governors.
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    The proposed amendment would preserve the Exchange's flexibility to
appoint both qualified members and qualified staff to act as Floor
Governors. In addition, and as importantly, the amendment would not
change either the selection or the qualification processes: qualified
Exchange employees (like qualified members) would need to be appointed
by the Exchange's chairman in consultation with the Executive Floor
Governors and NYSE Regulation Board of Directors and approved by the
NYSE Board of Directors; and they would need to complete the mandatory
education program and, if necessary, the qualifications exam.\6\ By
retaining these processes, the Exchange intends to limit the
appointment of Exchange employees to only those employees who meet the
standards that the Exchange currently expects of member Floor
Governors.
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    \6\ The Exchange notes that under NYSE Regulation policy, former
Floor Governors employed by the Exchange and appointed as qualified
Exchange employees under Rule 46 would not need to retake the
qualifying examination. This is consistent with the treatment of
members being promoted to Floor Governor from Floor Official
positions; such members are deemed to be qualified for the position
after completing the mandatory education program, and are exempt
from retaking the examination.
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    Because the proposed amendment adds a new category of Floor
Official (qualified Exchange employee), the Exchange is proposing to
add new supplementary material, Rule 46.20, to clarify that qualified
Exchange employees are authorized to take any action that a Floor
Governor may take. Because all Floor Governors are also empowered to
take any action that a Floor Official may take, the rule further
clarifies that qualified Exchange employees may also take any action
that a Floor Official may take.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
and furthers the objectives of Section 6(b)(5) of the Act,\7\ in that
it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to remove
impediments to, and perfect the mechanisms of, a free and open market
and a national market system, and, in general, to protect investors and
the public interest.
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    \7\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is concerned solely with the
administration of the Exchange and has, therefore, become effective
pursuant to Section 19(b)(3)(A)(iii) of the Act \8\ and Rule 19b-
4(f)(3) \9\ thereunder. At any time within 60 days of the filing of
such proposed rule change, the Commission may summarily abrogate such
rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for

the protection of investors, or otherwise in furtherance of the
purposes of the Act.\10\
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(3).
    \10\ For purposes of calculating the 60-day period within which
the Commission may summarily abrogate the proposed rule change under
Section 19(b)(3)(C) of the Act, the Commission considers the period
to commence on April 4, 2008, the date on which NYSE filed Amendment
No. 1. See 15 U.S.C. 78s(b)(3)(C).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, 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-NYSE-2008-19 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-NYSE-2008-19. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of NYSE. 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-NYSE-2008-19 and should be
submitted on or before May 2, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
Florence E. Harmon,
Deputy Secretary.
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    \11\ 17 CFR 200.30-3(a)(12).
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 [FR Doc. E8-7699 Filed 4-10-08; 8:45 am]

BILLING CODE 8011-01-P