[Federal Register Volume 80, Number 234 (Monday, December 7, 2015)]
[Notices]
[Pages 76022-76025]
[FR Doc No: 2015-30772]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1286]

Moving Forward: Collaborative Approaches to Medical Device
Cybersecurity; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``Moving Forward: Collaborative
Approaches to Medical Device Cybersecurity.'' FDA, in collaboration
with the National Health Information Sharing Analysis Center (NH-ISAC),
the Department of Health and Human Services, and the Department of
Homeland Security, seek to bring together diverse stakeholders to
discuss complex challenges in medical device cybersecurity that impact
the medical device ecosystem. The purpose of this workshop is to
highlight past collaborative efforts; increase awareness of existing
maturity models (i.e. frameworks leveraged for benchmarking an
organization's processes) which are used to evaluate cybersecurity
status, standards, and tools in development; and to engage the multi-
stakeholder community in focused discussions on unresolved gaps and
challenges that have hampered progress in advancing medical device
cybersecurity.

DATES: The public workshop will be held January 20-21, 2016, from 9
a.m. to 5:30 p.m. Submit either electronic or written comments on the
public workshop by February 22, 2016.

ADDRESSES: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the
Great Room, (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the
public meeting participants (non-FDA employees) is through Building 1
where routine security check procedures will be performed. For parking
and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions
    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-N-1286 for ``Moving Forward: Collaborative Approaches to
Medical Device Cybersecurity.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Suzanne Schwartz, Food and Drug
Administration, Center for Devices and Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5428, Silver Spring, MD 20993, 301-796-
6937<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Effective medical device cybersecurity to assure device safety and
functionality has become more important with the increasing use of
wireless, Internet- and network-connected devices, and the frequent
electronic exchange of medical device-related health information. As
medical devices become more connected and interoperable, the potential
for exploit of device vulnerabilities, whether intentional or not,
increases. Rather than impacting a single device or single system,
multiple devices or an entire hospital network may be compromised. In
the past, the Healthcare and Public Health (HPH) sector has been the
target of many attempts at intrusion. Protecting the HPH critical
infrastructure from attack by strengthening cybersecurity is a high
priority for the Federal government. Cybersecurity is the subject of
recent Executive Orders focused on enhancing the cybersecurity of
critical infrastructure (E.O. 13636) (Ref. 1) and increasing
cybersecurity information sharing (E.O. 13691) (Ref. 2). Furthermore,
Presidential Policy Directive 21 tasks the Federal government to work
together with the private sector in order to strengthen the security
and resilience of critical infrastructure against physical and cyber
threats (Ref. 3). This public workshop will bring together diverse
stakeholders from the public and private sector to discuss the current
state of medical device cybersecurity, including its evolution over the
past 12 months. Moreover, the workshop plans to provide a vision for
the desired state of medical device cybersecurity through ongoing
collaboration and new partnerships over the next 12 months. Meeting
participants are encouraged to formulate strategies and feasible action
plans to address gaps, such as management of vulnerabilities in legacy
devices. These diverse stakeholders include, but are not limited to:
Medical device manufacturers; healthcare facilities and personnel
(e.g., healthcare providers, biomedical engineers, IT system
administrators); professional and trade organizations including medical
device cybersecurity consortia; patient groups; insurance providers;
cybersecurity researchers; local, State, and Federal Governments; and
information security firms.
    A voluntary, risk-based framework for achieving enhanced
cybersecurity was developed by the National Institute of Standards and
Technology (NIST) in collaboration with external public and private
sector partners (Ref. 4). Since its release in February 2014, the
``Framework for Improving Critical Infrastructure Cybersecurity''
(Framework) has been leveraged by entities within the HPH sector to
better manage and reduce cybersecurity risks. This workshop aims to
highlight some of the ways that the Framework has been employed to
better understand, manage, communicate, and mitigate medical device
cybersecurity risks across the medical device total product lifecycle.
    Medical device cybersecurity vulnerabilities, if exploited, may
result in device malfunction, disruption of healthcare services
including treatment interventions, inappropriate access to patient
information, or compromised electronic health record data integrity.

Such outcomes could have a profound impact on patient care and safety.
In the last few years, HPH sector stakeholders have been engaged in
many collaborative activities that seek to strengthen medical device
cybersecurity and, therefore, enhance patient safety. FDA has
contributed to these efforts through guidance, multi-stakeholder
engagement, outreach, and by hosting a 2014 public workshop on
cybersecurity (Ref. 5). The 2016 public workshop announced in this
Federal Register notice will build upon previous work by featuring some
of the collaborative efforts that address medical device cybersecurity
through education and training, information sharing, standards, risk
assessment, and tools development.
    Though progress is evident, key hurdles continue to impede
maturation of the HPH community's cybersecurity posture. This workshop
seeks to increase awareness among stakeholders and create a common
understanding of potential threats and vulnerabilities, as well as to
present proactive preventative measures that may be universally
employed as best practices and good cyber hygiene. The workshop also
aims to facilitate extensive dialogue and articulate paths forward in
the critical areas of information sharing, coordinated vulnerability
disclosure and vulnerability management, and the Common Vulnerability
Scoring System (CVSS). Information sharing continues to be a challenge
as stakeholders work to define processes to create a trusted
environment. Coordinated vulnerability disclosure is an important
component of information sharing. Proactively identifying, assessing,
and managing medical device vulnerabilities before they are exploited
is one way to protect against potential patient harm. Vulnerabilities
may be identified by the device manufacturer as well as by external
entities such as healthcare facilities, cybersecurity researchers, and
other sectors of critical infrastructure. As described in International
Organization for Standardization/International Electrotechnical
Commission 29147:2014, ``Coordinated disclosure, also known as
responsible disclosure, is a vulnerability disclosure model in which
all stakeholders agree to delay publishing vulnerability details for an
agreed-upon period of time, generally after a patch to mitigate the
vulnerability is available. The model includes steps that simplify the
otherwise-complex, back-and-forth communications between the
vulnerability finder and the affected manufacturer'' (Ref. 6).
Coordinated disclosure is just one aspect of vulnerability management.
Understanding how a vulnerability may affect device functionality,
assessing the vulnerability impact across multiple product types, and
identifying mitigations that may be employed until a permanent fix may
be implemented are all critical components of vulnerability management
that should be addressed throughout the medical device total product
lifecycle. This workshop provides an opportunity for stakeholders to
explore implementation of coordinated vulnerability disclosure and
vulnerability management, including existing standards, models, best
practices, and lessons learned in this area.
    One of the tools that manufacturers or healthcare facilities may
use to assess and manage the impact of vulnerability is CVSS. CVSS is a
risk assessment tool that provides an open and standardized method for
rating information technology vulnerabilities. However, incorporating
CVSS into medical device vulnerability assessments has proven to be a
challenge in that it does not directly incorporate patient risk and
public health impact factors. This workshop encourages robust dialogue
on how CVSS might be adapted for medical devices and how considerations
of the use environment might be incorporated in a more standardized
manner into medical device CVSS scores.

II. Topics for Discussion at the Public Workshop

    The public workshop sessions are designed to incorporate the
following general themes:
     Envisioning a roadmap for coordinated vulnerability
disclosure and vulnerability management as part of the broader effort
to create a trusted environment for information sharing.
    [cir] How might the stakeholder community create incentives to
encourage stakeholder participation?
    [cir] What do individual stakeholders need to understand and be
aware of regarding coordinated disclosure?
    [cir] What current tools and models presently exist that may aid
stakeholders in implementing disclosure and vulnerability management?
    [cir] How can the security researcher community work in
collaboration with HPH stakeholders to identify, assess, and mitigate
vulnerabilities?
     Sharing FDA's current thinking on the implementation of
the Framework in the medical device total product lifecycle.
     Adapting cybersecurity and/or risk assessment tools such
as CVSS for the medical device operational environment.
     Adapting and/or implementing existing cybersecurity
standards for medical devices.
     Understanding the challenges that manufacturers face as
they increase collaboration with external third parties (cybersecurity
researchers, Information Sharing and Analysis Organizations (ISAOs),
and end users), to resolve cybersecurity vulnerabilities that impact
their devices. Note that an ISAO is a group created to gather, analyze,
and disseminate critical infrastructure information (Ref. 7).
     Gaining situational awareness of the current activities in
the HPH sector to enhance medical device cybersecurity.
     Identifying cybersecurity gaps and challenges that persist
in the medical device ecosystem and begin crafting action plans to
address them.
    Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by January 13, 2016, at 4 p.m. Early
registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permits, onsite registration on the day
of the public workshop will be provided beginning at 8 a.m.
    If you need special accommodations due to a disability, please
contact Susan Monahan, Center for Devices and Radiological Health,
Office of Communication and Education,<PHONE_NUMBER> or email:
<EMAIL_ADDRESS>no later than January 7, 2016.
    Please provide complete contact information for each attendee,
including name, title, affiliation, email, and telephone number. Those
without Internet access should contact Susan Monahan to register.
Registrants will receive confirmation after they have been accepted.
You will be notified if you are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. The Webcast link will be available on the registration
Web page after January 13, 2016. Please visit FDA's Medical Devices
News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. Select this
meeting/public workshop from the posted events list. If you have never
attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a

quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. FDA has verified the Web site addresses in this
document, but FDA is not responsible for any subsequent changes to the
Web site after this document publishes in the Federal Register.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see ADDRESSES). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. The Freedom of
Information office address is available on the Agency's Web site at
http://www.fda.gov. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

III. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. Executive Order 13636, ``Improving Critical Infrastructure
Cybersecurity,'' February 19, 2013 (http://www.gpo.gov/fdsys/pkg/FR-2013-02-19/pdf/2013-03915.pdf).
2. Executive Order 13691, ``Promoting Private Sector Cybersecurity
Information Sharing,'' February 13, 2015 (http://www.gpo.gov/fdsys/pkg/FR-2015-02-20/pdf/2015-03714.pdf).
3. Presidential Policy Directive 21, ``Critical Infrastructure
Security and Resilience,'' February 12, 2013 (http://www.whitehouse.gov/the-press-office/2013/02/12/presidential-policy-directive-critical-infrastructure-security-and-resil).
4. National Institute of Standards and Technology (NIST),
``Framework for Improving Critical Infrastructure Cybersecurity,''
version 1, February 12, 2014 (http://www.nist.gov/cyberframework/upload/cybersecurity-framework-021214-final.pdf).
5. Food and Drug Administration, ``Public Workshop--Collaborative
Approaches for Medical Device and Healthcare Cybersecurity, October
21-22, 2014.'' October 11, 2015 (http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm412979.htm).
6. ``ISO/IEC 29147:2014--Information Technology--Security
Techniques--Vulnerability Disclosure,'' (http://www.iso.org/iso/catalogue_detail.htm?csnumber=45170).
7. Department of Homeland Security, ``Frequently Asked Questions
About Information Sharing and Analysis Organizations (ISAOs),''
November 17, 2015 (http://www.dhs.gov/isao-faq).

    Dated: December 2, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-30772 Filed 12-4-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: October 17, 2007 (Volume 72, Number 200)]
[Rules and Regulations]
[Page 58971-58975]
[DOCID:fr17oc07-10]

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Part III

Department of Transportation

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Federal Aviation Administration

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14 CFR Part 33

 Airworthiness Standards; Engine Bird Ingestion; Final Rule

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 33

[Docket No.: FAA-2006-25375; Amendment No. 33-23]
RIN 2120-AI73

Airworthiness Standards; Engine Bird Ingestion

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This final rule amends the aircraft turbine engine type
certification standards to better address the threat flocking birds
present to turbine engine aircraft. These changes will also harmonize
FAA and European Aviation Safety Agency (EASA) bird ingestion standards
for aircraft turbine engines type certificated by the United States and
the EASA countries, and simplify airworthiness approvals for import and
export. The changes are necessary to establish uniform international
standards and provide an acceptable level of safety for aircraft
turbine engines with respect to the current large flocking bird threat.

DATES: This amendment becomes effective on November 16, 2007.

FOR FURTHER INFORMATION CONTACT: Marc Bouthillier, Rulemaking and
Policy Branch, Engine and Propeller Directorate, ANE-111, Federal
Aviation Administration, 12 New England Executive Park, Burlington,
Massachusetts 01803; telephone<PHONE_NUMBER>; facsimile (781) 238-
7199; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules on aviation safety is found in
Title 49 of the United States Code. Subtitle I, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements''. Under that section, the FAA is charged 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, including minimum safety
standards for aircraft engines. This regulation is within the scope of
that authority because it updates the existing regulations for engine
bird ingestion.

Background

    The FAA adopted new regulations under 14 CFR 33.76 on September 5,
2000, to better address the overall bird ingestion threat to turbine
powered aircraft. These requirements were adopted, in part, as a
response to NTSB safety recommendation A-76-64, which recommended an
increase in the level of bird ingestion capability for aircraft
engines.
    Based on comments received during that rulemaking effort, the FAA
decided to pursue additional rulemaking to address larger flocking
birds (mass greater then 1.15 kg/2.5 pounds), since existing engine
certification requirements did not specifically address the threat that
these size birds, or their growing population, present to airplane
operational safety.

Summary of the NPRM

    On July 20, 2006, the FAA published a notice of proposed rulemaking
(NPRM), ``Airworthiness Standards; Engine Bird Ingestion'' (71 FR
41184). The NPRM proposed to amend aircraft turbine engine type
certification standards to reflect recent analysis of the threat
flocking birds present to turbine engine aircraft. The proposed changes
are necessary to establish uniform international standards that provide
an adequate level of safety. The comment period closed September 18,
2006.

Summary of the Final Rule

    The final rule adopts new bird ingestion standards for turbine
aircraft engines under 14 CFR 33.76. It also provides a detailed
description of the rulemaking project including the safety objective
and a discussion of the considerations supporting our selection of this
course of action.
    No changes were made to the final rule from what was proposed in
the NPRM.

Summary of Comments

    The FAA received comments from Transport Canada Civil Aviation
(TCCA) and the National Transportation Safety Board (NTSB).
    TCCA fully supports the intent of the proposal. However, NTSB
expressed concern with the size of the largest bird upon which the rule
is based (8 pounds). NTSB reasoned that flocking birds greater than 8
pounds can exist in the environment, and may have impacted commercial
aircraft in the past. NTSB also expressed concern about using de-rated
takeoff thrust instead of full rated takeoff thrust value for required
tests because full rated thrust can be selected by the flight crew, and
because this power setting may be a more severe case than using de-
rated takeoff thrust. NTSB suggested the required tests be revised to
reflect a worst-case scenario.
    The FAA does not concur with these three comments. The safety
objective of this rule is to address the expected world fleet rate of
catastrophic aircraft events due to multi-engine power loss resulting
from multi-engine ingestion of large flocking birds. The various rule
parameters were carefully selected to achieve this goal by devising
tests that encompass a sufficient percentage of possible parameter
combinations (e.g., bird mass/number, bird speed, engine power setting,
target locations, etc.) that would allow the world fleet to operate at
this very high level of safety. The database of ingestion events used
to determine ingestion rates covers a 30-year period and over 325
million flights. The database analysis enabled the FAA to define the
actual threat experienced in service, including a conservative
adjustment for potential future increases in ingestion rates. The
proposed rule was not intended to encompass the worst possible
combination of factors, as this is problematic to predict, and would be
beyond the capability of current engine technology. We believe
selecting all parameters using a theoretical worst case scenario would
be impractical from a design, manufacture, and operational standpoint.
    NTSB further suggested incorporating pre-existing fan blade service
damage into the required tests because the potential exists for such
damage to occur in normal service. The FAA is not adopting this
suggestion. Engine type certification requirements are intended for and
applied to undamaged products as a baseline. The engine bird ingestion
requirements and type certificate (TC) requirements are similar in this
regard. This revised rule is based on critical ingestion parameters for
the most severe engine bird ingestion events recorded over the past
several decades. As such, substantial margin exists for the normal
ingestion events seen in service, including service acceptable damage
allowed by the Instructions for Continued Airworthiness (ICAs). Also,
current Advisory Circular material for ICA compliance specifies the
type certificate holder evaluate service-acceptable damage criteria
against the type certification requirements, and include appropriate
instructions in the ICAs. The overall positive experience of the world
fleet indicates that this

general approach provides an acceptable level of safety.
    NTSB also suggested that the FAA consider bird ingestion event data
collected since the bird study cutoff date of 1999. NTSB asserts the
30-year data set used is inadequate to assess the risk associated with
bird ingestion. The FAA's decision to proceed with this rulemaking is
based on quantitative and qualitative evaluation of the threat observed
in service over a lengthy period of time. We concluded that the
increasing population of large flocking birds in the environment, and
the increasing number of encounters in service, make it necessary to
expand the scope of the existing requirements. The data from the 30-
year study period covers over 325 million flights and is comprised of
data from actual engine bird ingestion events where the bird species,
size, and number; aircraft and engine model; flight regime, and outcome
are reasonably known. The database covers a broad cross-section of
aircraft type and operations and is considered fully adequate to
establish engine bird ingestion rates from which the critical ingestion
parameters were selected to meet the rule's safety objective. The event
data collected since the study period does not appear to indicate a
change in the basic threat definition or an increase in the actual rate
of occurrence and would not likely affect the outcome of the rulemaking
project.
    Finally, as suggested by TCCA, the FAA has reviewed the new table
included in the amendatory language to ensure it is accurate. The final
rule is adopted as proposed.

Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires
that the FAA consider the impact of paperwork and other information
collection burdens imposed on the public. We have determined that there
is no current or new requirement for information collection associated
with this amendment.

International Compatibility

    In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to comply with
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the maximum extent practicable. The FAA has
determined that there are no ICAO Standards and Recommended Practices
that correspond to these regulations.

Regulatory Evaluation, Regulatory Flexibility Determination,
International Trade Impact Assessment, and Unfunded Mandates Assessment

    Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 directs that each Federal agency
shall propose or adopt a regulation only upon a reasoned determination
that the benefits of the intended regulation justify its costs. Second,
the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires
agencies to analyze the economic impact of regulatory changes on small
entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits
agencies from setting standards that create unnecessary obstacles to
the foreign commerce of the United States. In developing U.S.
standards, this Trade Act requires agencies to consider international
standards and, where appropriate, that they be the basis of U.S.
standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4) requires agencies to prepare a written assessment of the costs,
benefits, and other effects of proposed or final rules that include a
Federal mandate likely to result in the expenditure by State, local, or
tribal governments, in the aggregate, or by the private sector, of $100
million or more annually (adjusted for inflation with base year of
1995). This portion of the preamble summarizes the FAA's analysis of
the economic impacts of this final rule.
    Department of Transportation Order DOT 2100.5 prescribes policies
and procedures for simplification, analysis, and review of regulations.
If the expected cost impact is so minimal that a proposed or final rule
does not warrant a full evaluation, this order permits that a statement
to that effect and the basis for it be included in the preamble if a
full regulatory evaluation of the cost and benefits is not prepared.
Such a determination has been made for this final rule. The reasoning
for this determination follows:
    The NPRM regulatory analysis explained that this rule will have a
minimal cost impact with positive net benefits because the two U.S.
firms to be affected by this rule are already in compliance in order to
sell their products in Europe. No comments were received on the NPRM
regulatory analysis. Therefore, we conclude that this final rule will
have minimal cost impact with positive net benefits and a detailed
regulatory analysis is not required.
    FAA has, therefore, determined that this final rule is not a
``significant'' regulatory action as defined in section 3(f) of
Executive Order 12866, and is not ``significant'' as defined in DOT's
Regulatory Policies and Procedures.

Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA)
establishes ``as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of applicable
statutes, to fit regulatory and informational requirements to the scale
of the businesses, organizations, and governmental jurisdictions
subject to regulation. To achieve this principle, agencies are required
to solicit and consider flexible regulatory proposals and to explain
the rationale for their actions to assure that such proposals are given
serious consideration.'' The RFA covers a wide range of small entities,
including small businesses, not-for-profit organizations, and small
governmental jurisdictions.
    Agencies must perform a review to determine whether a rule will
have a significant economic impact on a substantial number of small
entities. If the agency determines that it will, the agency must
prepare a regulatory flexibility analysis as described in the RFA.
    However, if an agency determines that a rule is not expected to
have a significant economic impact on a substantial number of small
entities, section 605(b) of the RFA provides that the head of the
agency may so certify and a regulatory flexibility analysis is not
required. The certification must include a statement providing the
factual basis for this determination, and the reasoning should be
clear.
    The NPRM Regulatory Flexibility Analysis determined that there were
no small entities that would be affected by this rule. We received no
comments on the NPRM Regulatory Flexibility Analysis and continue to
believe that this final rule will only impact two American
manufacturers neither of which is a small entity. Therefore, as the
Acting FAA Administrator, I certify that this final rule will not have
a significant economic impact on a substantial number of small
entities.

International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39) prohibits Federal
agencies from establishing any standards or engaging in related
activities that create unnecessary obstacles to the foreign commerce of
the United States. Legitimate domestic objectives, such as safety, are
not considered unnecessary obstacles. The statute also requires
consideration of international standards and, where

appropriate, that they be the basis for U.S. standards. The FAA has
assessed the potential effect of this final rule and determined that it
is in accord with the Trade Agreements Act as the final rule uses
European standards as the basis for United States regulation.

Unfunded Mandates Assessment

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement
assessing the effects of any Federal mandate in a proposed or final
agency rule that may result in an expenditure of $100 million or more
(adjusted annually for inflation with the base year 1995) in any one
year by State, local, and tribal governments, in the aggregate, or by
the private sector; such a mandate is deemed to be a ``significant
regulatory action.'' The FAA currently uses an inflation-adjusted value
of $128.1 million in lieu of $100 million.
    This final rule does not contain such a mandate. The requirements
of Title II of the Act do not apply.

Executive Order 13132, Federalism

    The FAA has analyzed this final rule under the principles and
criteria of Executive Order 13132, Federalism. We determined that this
action will not have a substantial direct effect on the States, or the
relationship between the national Government and the States, or on the
distribution of power and responsibilities among the various levels of
government, and therefore does not have federalism implications.

Environmental Analysis

    FAA Order 1050.1E identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined this rulemaking action qualifies for the categorical
exclusion identified in Chapter 3, paragraph 312d, and involves no
extraordinary circumstances.

Regulations That Significantly Affect Energy Supply, Distribution, or
Use

    The FAA has analyzed this final rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (May 18, 2001). We have determined that it is not
a ``significant energy action'' under the executive order because it is
not a ``significant regulatory action'' under Executive Order 12866,
and it is not likely to have a significant adverse effect on the
supply, distribution, or use of energy.

Availability of Rulemaking Documents

    You can get an electronic copy of rulemaking documents using the
Internet by--
    1. Searching the Federal eRulemaking Portal (http://www.regulations.gov
);

    2. Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/
; or

    3. Accessing the Government Printing Office's Web page at http://www.gpoaccess.gov/fr/index.html
.

    You can also get a copy by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling<PHONE_NUMBER>. Make
sure to identify the amendment number or docket number of this
rulemaking.
    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 (Volume 65, Number 70; Pages 19477-78), or you may visit
http://www.regulations.gov.

Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act (SBREFA) of
1996 requires FAA to comply with small entity requests for information
or advice about compliance with statutes and regulations within its
jurisdiction. If you are a small entity and you have a question
regarding this document, you may contact your local FAA official, or
the person listed under the FOR FURTHER INFORMATION CONTACT heading at
the beginning of the preamble. You can find out more about SBREFA on
the Internet at http://www.faa.gov/regulations_policies/rulemaking/sbre_act/
.

List of Subjects in 14 CFR Part 33

    Air Transportation, Aircraft, Aviation Safety, Safety.

The Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends Chapter I of Title 14, Code of Federal Regulations as follows:

PART 33--AIRWORTHINESS STANDARDS: AIRCRAFT ENGINES

0
1. The authority citation for part 33 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

0
2. Amend Sec.  33.76 by revising paragraphs (a) introductory text,
(a)(1), (a)(3), (a)(5), the heading of paragraph (b) introductory text,
and the heading of paragraph (c) introductory text, and adding
paragraph (d) and Table 4 to read as follows:

Sec.  33.76  Bird ingestion.

    (a) General. Compliance with paragraphs (b), (c), and (d) of this
section shall be in accordance with the following:
    (1) Except as specified in paragraph (d) of this section, all
ingestion tests must be conducted with the engine stabilized at no less
than 100-percent takeoff power or thrust, for test day ambient
conditions prior to the ingestion. In addition, the demonstration of
compliance must account for engine operation at sea level takeoff
conditions on the hottest day that a minimum engine can achieve maximum
rated takeoff thrust or power.
* * * * *
    (3) The impact to the front of the engine from the large single
bird, the single largest medium bird which can enter the inlet, and the
large flocking bird must be evaluated. Applicants must show that the
associated components when struck under the conditions prescribed in
paragraphs (b), (c) or (d) of this section, as applicable, will not
affect the engine to the extent that the engine cannot comply with the
requirements of paragraphs (b)(3), (c)(6) and (d)(4) of this section.
* * * * *
    (5) Objects that are accepted by the Administrator may be
substituted for birds when conducting the bird ingestion tests required
by paragraphs (b), (c) and (d) of this section.
* * * * *
    (b) Large single bird. * * *
    (c) Small and medium flocking bird. * * *
    (d) Large flocking bird. An engine test will be performed as
follows:
    (1) Large flocking bird engine tests will be performed using the
bird mass and weights in Table 4, and ingested at a bird speed of 200
knots.
    (2) Prior to the ingestion, the engine must be stabilized at no
less than the mechanical rotor speed of the first exposed stage or
stages that, on a standard day, would produce 90 percent of the sea
level static maximum rated takeoff power or thrust.
    (3) The bird must be targeted on the first exposed rotating stage
or stages at a blade airfoil height of not less than 50 percent
measured at the leading edge.

    (4) Ingestion of a large flocking bird under the conditions
prescribed in this paragraph must not cause any of the following:
    (i) A sustained reduction of power or thrust to less than 50
percent of maximum rated takeoff power or thrust during the run-on
segment specified under paragraph (d)(5)(i) of this section.
    (ii) Engine shutdown during the required run-on demonstration
specified in paragraph (d)(5) of this section.
    (iii) The conditions specified in paragraph (b)(3) of this section.
    (5) The following test schedule must be used:
    (i) Ingestion followed by 1 minute without power lever movement.
    (ii) Followed by 13 minutes at not less than 50 percent of maximum
rated takeoff power or thrust.
    (iii) Followed by 2 minutes between 30 and 35 percent of maximum
rated takeoff power or thrust.
    (iv) Followed by 1 minute with power or thrust increased from that
set in paragraph (d)(5)(iii) of this section, by between 5 and 10
percent of maximum rated takeoff power or thrust.
    (v) Followed by 2 minutes with power or thrust reduced from that
set in paragraph (d)(5)(iv) of this section, by between 5 and 10
percent of maximum rated takeoff power or thrust.
    (vi) Followed by a minimum of 1 minute at ground idle then engine
shutdown. The durations specified are times at the defined conditions.
Power lever movement between each condition will be 10 seconds or less,
except that power lever movements allowed within paragraph (d)(5)(ii)
of this section are not limited, and for setting power under paragraph
(d)(5)(iii) of this section will be 30 seconds or less.
    (6) Compliance with the large flocking bird ingestion requirements
of this paragraph (d) may also be demonstrated by:
    (i) Incorporating the requirements of paragraph (d)(4) and (d)(5)
of this section, into the large single bird test demonstration
specified in paragraph (b)(1) of this section; or
    (ii) Use of an engine subassembly test at the ingestion conditions
specified in paragraph (b)(1) of this section if:
    (A) All components critical to complying with the requirements of
paragraph (d) of this section are included in the subassembly test;
    (B) The components of paragraph (d)(6)(ii)(A) of this section are
installed in a representative engine for a run-on demonstration in
accordance with paragraphs (d)(4) and (d)(5) of this section; except
that section (d)(5)(i) is deleted and section (d)(5)(ii) must be 14
minutes in duration after the engine is started and stabilized; and
    (C) The dynamic effects that would have been experienced during a
full engine ingestion test can be shown to be negligible with respect
to meeting the requirements of paragraphs (d)(4) and (d)(5) of this
section.
    (7) Applicants must show that an unsafe condition will not result
if any engine operating limit is exceeded during the run-on period.
* * * * *

      Table 4 to Sec.   33.76.--Large Flocking Bird Mass and Weight
------------------------------------------------------------------------
                                                              Bird mass
Engine inlet throat area (square meters/square      Bird      and weight
                    inches)                       quantity    (kg (lbs))
------------------------------------------------------------------------
A <  2.50 (3875)...............................         None  ...........
2.50 (3875) < = A <  3.50 (5425)................            1  1.85 (4.08)
3.50 (5425) < = A <  3.90 (6045)................            1  2.10 (4.63)
3.90 (6045) < = A..............................            1  2.50 (5.51)
------------------------------------------------------------------------

    Issued in Washington, DC, on October 5, 2007.
Robert A. Sturgell,
Acting Administrator.
 [FR Doc. E7-20407 Filed 10-16-07; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Notices]
[Pages 3532-3533]
[FR Doc No: 2019-01991]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2018-0319]

Qualification of Drivers; Exemption Applications; Implantable
Cardioverter Defibrillator (ICD)

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of denials.

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

SUMMARY: FMCSA announces its decision to deny applications from four
individuals treated with Implantable Cardioverter Defibrillators (ICDs)
who requested an exemption from the Federal Motor Carrier Safety
Regulations (FMCSRs) prohibiting operation of a commercial motor
vehicle (CMV) in interstate commerce by persons with a current clinical
diagnosis of myocardial infarction, angina pectoris, coronary
insufficiency, thrombosis, or any other cardiovascular disease of a
variety known to be accompanied by syncope, dyspnea, collapse, or
congestive heart failure.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2018-0319 in the keyword box, and click
``Search.'' Next, click the ``Open Docket Folder'' button and choose
the document to review. If you do not have access to the internet, you
may view the docket online by visiting the Docket Management Facility
in Room W12-140 on the ground floor of the DOT West Building, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., ET,
Monday through Friday, except Federal holidays.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. 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
www.dot.gov/privacy.

II. Background

    On November 14, 2018, FMCSA published a FR notice (83 FR 56896)
announcing receipt of applications from four individuals treated with
ICDs and requested comments from the public. These four individuals
requested an exemption from 49 CFR 391.41(b)(4) which prohibits
operation of a CMV in interstate commerce by persons with a current
clinical diagnosis of myocardial infarction, angina pectoris, coronary
insufficiency, thrombosis, or any other cardiovascular disease of a
variety known to be accompanied by syncope, dyspnea, collapse, or
congestive heart failure. The public comment period closed on December
14, 2018, and no comments were received.
    FMCSA has evaluated the eligibility of these applicants and
concluded that granting these exemptions would not provide a level of
safety that would be equivalent to or greater than, the level of safety
that would be obtained by complying with the regulation 49 CFR
391.41(b)(4). A summary of each applicant's medical history related to
their ICD exemption request was discussed in the November 14, 2018,
Federal Register notice and will not be repeated in this notice.
    In reaching the decision to deny these exemption requests, the
Agency considered information from the Cardiovascular Medical Advisory
Criteria, an April 2007 Evidence Report titled ``Cardiovascular Disease
and Commercial Motor Vehicle Driver Safety, and a December 2014 focused
research report titled ``Implantable Cardioverter Defibrillators and
the Impact of a Shock in a Patient When Deployed.'' Copies of the
reports are included in the docket.
    FMCSA has published advisory criteria to assist medical examiners
in determining whether drivers with certain medical conditions are
qualified to operate a CMV in interstate commerce. [Appendix A to Part
391--Medical Advisory Criteria, section D, paragraph 4]. The advisory
criteria for 49 CFR 391.41(b)(4) indicates that coronary artery bypass
surgery and pacemaker implantation are remedial procedures and thus,
not medically disqualifying. Implantable cardioverter defibrillators
are disqualifying due to risk of syncope.

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption if
it finds such an exemption would likely achieve a level of safety that
is equivalent to, or greater then, the level that would be achieved
absent such an exemption.
    The Agency's decision regarding these exemption applications is
based on an individualized assessment of each applicant's medical
information provided by the applicant, available medical and scientific
data concerning ICD's, and public comments received.
    In the case of persons with ICDs, the underlying condition for
which the ICD was implanted places the individual at high risk for
syncope (a transient loss of consciousness) or other unpredictable
events known to result in gradual or sudden incapacitation. ICDs may
discharge, which could result in loss of ability to safely control a
CMV. See the April 2007 Evidence Report on Cardiovascular Disease and
Commercial Motor vehicle Driver Safety, April 2007.\1\ A focused
research report on Implantable Cardioverter Defibrillators and the
Impact of a Shock on a Patient When Deployed completed for the FMCSA in
December of 2014 indicates that the available scientific data on
persons with ICDs and CMV driving does not support that persons with
ICDs who operate CMVs are able to meet an equal or greater level of
safety and upholds the findings of the April 2007 report.
---------------------------------------------------------------------------

    \1\ Now available at http://ntl.bts.gov/lib/30000/30100/30123/Final_CVD_Evidence_Report_v2.pdf.
---------------------------------------------------------------------------

V. Conclusion

    The Agency has determined that the available medical and scientific
literature and research provides insufficient data to enable the Agency
to conclude that granting these exemptions would achieve a level of
safety equivalent to, or greater than, the level of safety maintained
without the exemption. Therefore, the following four applicants have
been denied exemptions from the physical qualification standards in 49
CFR 391.41(b)(4):

Herman L. Bolton (LA)
Robert A. Crawley (MD)
Paul J. Hill (SD)
Johnny L. Walls (AL)

    Each applicant has, prior to this notice, received a letter of
final disposition regarding his/her exemption request. Those decision
letters fully outlined the basis for the denial and constitutes final
action by the Agency. The list published today summarizes the Agency's
recent denials as required under 49 U.S.C. 31315(b)(4).

    Issued on: February 1, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-01991 Filed 2-11-19; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 84, Number 93 (Tuesday, May 14, 2019)]
[Notices]
[Pages 21411-21412]
[FR Doc No: 2019-09878]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2019-0098; Notice No. 2019-05]

Hazardous Materials; Lithium Battery Safety Advisory Committee
Nominations

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
Department of Transportation (DOT).

ACTION: Request for Member Nominations for the Lithium Battery Safety
Advisory Committee.

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

SUMMARY: PHMSA is seeking nominations for individuals to serve as
members on the Lithium Battery Safety Advisory Committee (the
Committee). This is a safety advisory committee mandated by section
333(d) of the FAA Reauthorization Act of 2018 and established in
accordance with the Federal Advisory Committee Act (FACA) of 1972. The
committee will facilitate communication among manufacturers of lithium
ion and lithium metal cells and batteries, manufacturers of products
incorporating both large and small lithium ion and lithium metal
batteries, air carriers, and the Federal Government. This communication
will promote the safe transportation of lithium ion and lithium metal
cells and batteries and improve the effectiveness and economic and
social impacts of related regulation. No later than 180 days after the
establishment of the Committee, the Committee shall submit to the
Secretary and the appropriate committees of Congress a report that
describes and evaluates the steps being taken in the private sector and
by international regulatory authorities to implement and enforce
requirements relating to the safe transportation of bulk shipments of
lithium ion cells and batteries. The Committee will also identify any
areas of regulatory requirements for which there is consensus that
greater attention is needed.

DATES: Nominations must be received on or before June 4, 2019.

ADDRESSES: All nomination material should be emailed to the Advisory
Committee's Program Manager, Lindsey Constantino, at
<EMAIL_ADDRESS>or mailed to the Pipeline and Hazardous
Materials Safety Administration, 1200 New Jersey Avenue SE, PHH-4, E23-
442, Washington, DC 20590, to the attention of Lindsey Constantino,
Advisory Committee Program Manager, PHH-4.

FOR FURTHER INFORMATION CONTACT: Lindsey Constantino, International
Transportation Specialist (PHH-4), U.S. Department of Transportation,
Pipeline and Hazardous Materials Safety Administration, 1200 New Jersey
Avenue SE., East Building, 2nd Floor, Washington, DC 20590-0001,
Telephone<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Advisory Committee Background

    The Committee is a statutorily mandated advisory committee that
provides a mechanism for:
    (a) Facilitating communication among manufacturers of lithium ion
and lithium metal cells and batteries, manufacturers of products
incorporating both large and small lithium ion and lithium metal
batteries, air carriers, and the Federal Government, regarding the safe
transportation of lithium ion and lithium metal cells and batteries and
the effectiveness and economic and social impacts of the regulation of
such transportation.
    (b) Providing the Secretary, the Federal Aviation Administration
(FAA), and PHMSA with timely information about new lithium ion and
metal battery technology and transportation safety practices and
methodologies.
    (c) Providing a forum for the Secretary to distribute information
on this topic, as well as engage Committee members in discussions
concerning the related activities of the Department of Transportation.
    A complete list of duties for the Committee is outlined in section
333(d)(2) of the FAA Reauthorization Act of 2018. This committee is
established in accordance with the Federal Advisory Committee Act, 5
U.S.C. App. 2.

II. Membership

    The Committee will consist of representatives from:
    (a) Large volume manufacturers of lithium ion and lithium metal
cells and batteries;

    (b) domestic manufacturers of lithium ion and lithium metal
batteries or battery packs;
    (c) manufacturers of consumer products powered by lithium ion and
lithium metal batteries;
    (d) manufacturers of vehicles powered by lithium ion and lithium
metal batteries;
    (e) marketers of products powered by lithium ion and lithium metal
batteries;
    (f) cargo air service providers based in the United States;
    (g) passenger air service providers based in the United States;
    (h) pilots and employees of air service providers described in
bullets (f) and (g);
    (i) shippers of lithium ion and lithium metal batteries for air
transportation;
    (j) manufacturers of battery-powered medical devices or batteries
used in medical devices;
    (k) employees of the Department of Transportation, including
employees of FAA and PHMSA;
    (l) representatives of such other Government departments and
agencies as the Secretary determines appropriate; and
    (m) any other individuals the Secretary determines are appropriate
to comply with Federal law.

III. Terms of Participation

     All Group members must be able to attend a minimum of two
meetings each year in Washington, DC, and other designated locations,
or by teleconference.
     Members serve without compensation, although travel
expenses, including per diem, may be eligible for reimbursement
consideration based on budget availability.
     A member appointed for his or her individual views or
advice must be appointed as a Special Government Employee (SGE). Other
members will serve as Representatives or Regular Government Employees.
SGEs are subject to certain Federal conflict of interest laws.

IV. Nomination Procedures

    The PHMSA Administrator, on behalf of the Secretary, is seeking
individual nominations for committee members, preferably executive
level leadership, with diverse experiences and expertise in research
and development; academia; human factors; lithium battery
manufacturing; lithium battery testing; packaging manufacture and
testing; air cargo safety; risk management; or other related experience
in manufacturing or transporting lithium batteries by air. Any
interested person may nominate one or more qualified individuals for
membership on the Committee. Self-nominations are also accepted.
     Nominations must include a current, complete resume
including business and home address, telephone number, email address,
education, relevant professional or business experience, present
occupation, and membership status in other working groups or advisory
committees, past or present.
     Nominations must include a short biography identifying
each nominee's qualifications and expertise.
     Nominations must include an indication of the category the
individual nominated most identifies with, based on the list provided
in paragraph II Membership. If an individual preforms functions in
multiple categories, please choose the most relevant category.
     Nominations should highlight relevant experience on panels
that have dealt with transportation safety, lithium battery safety, air
transportation safety, or detail the nominee's interest in the subject
matter that will be considered by the committee.
     Nominations must acknowledge that the nominee is aware of
the nomination unless self-nominated.

    Signed in Washington, DC, on May 8, 2019.
William S. Schoonover,
Associate Administrator, Pipeline and Hazardous Materials Safety
Administration.
[FR Doc. 2019-09878 Filed 5-13-19; 8:45 am]
 BILLING CODE 4910-60-P