[Federal Register Volume 86, Number 219 (Wednesday, November 17, 2021)]
[Rules and Regulations]
[Pages 64063-64065]
[FR Doc No: 2021-25006]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2021-1045; Special Conditions No. 25-795-SC]

Special Conditions: Airbus Defense and Space S.A., C212-CC/-CD/-
CE/-CF/-DF/-DE Airplanes; Rechargeable Lithium Battery Installations

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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

SUMMARY: These special conditions are issued for the Airbus Defense and
Space S.A. (Airbus) Model C212-CC/-CD/-CE/-CF/-DF/-DE airplanes. This
airplane, as modified by Airbus Defense and Space, Inc., will have a
novel or unusual design feature when compared to the state of
technology envisioned in the airworthiness standards for transport
category airplanes. This design feature is the emergency lighting
installation that contain rechargeable lithium batteries. The
applicable airworthiness regulations do not contain adequate or
appropriate safety standards for this

design feature. These special conditions contain the additional safety
standards that the Administrator considers necessary to establish a
level of safety equivalent to that established by the existing
airworthiness standards.

DATES: This action is effective November 17, 2021. Send comments on or
before January 3, 2022.

ADDRESSES: Send comments identified by Docket No. FAA-2021-1045 using
any of the following methods:
     Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending
your comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: Except for Confidential Business Information (CBI) as
described in the following paragraph, and other information as
described in 14 CFR 11.35, the FAA will post all comments received
without change to http://www.regulations.gov/, including any personal
information you provide. The FAA will also post a report summarizing
each substantive verbal contact received about this proposal.
    Confidential Business Information: Confidential Business
Information (CBI) is commercial or financial information that is both
customarily and actually treated as private by its owner. Under the
Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from
public disclosure. If your comments responsive to this Notice contain
commercial or financial information that is customarily treated as
private, that you actually treat as private, and that is relevant or
responsive to this Notice, it is important that you clearly designate
the submitted comments as CBI. Please mark each page of your submission
containing CBI as ``PROPIN.'' The FAA will treat such marked
submissions as confidential under the FOIA, and the indicated comments
will not be placed in the public docket of this Notice. Submissions
containing CBI should be sent to Nazih Khaouly, Aircraft Systems, AIR-
623, Technical Innovation Policy Branch, Policy and Innovation
Division, Aircraft Certification Service, Federal Aviation
Administration, 2200 South 216th Street, Des Moines, Washington 98198;
telephone and fax<PHONE_NUMBER>; email [email protected]. Comments
the FAA receives, which are not specifically designated as CBI, will be
placed in the public docket for this rulemaking.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov/ at any time. Follow the online instructions
for accessing the docket or go to Docket Operations in Room W12-140 of
the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Nazih Khaouly, Aircraft Systems, AIR-
623, Technical Innovation Policy Branch, Policy and Innovation
Division, Aircraft Certification Service, Federal Aviation
Administration, 2200 South 216th Street, Des Moines, Washington 98198;
telephone and fax<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION: The substance of these special conditions
has been published in the Federal Register for public comment in
several prior instances with no substantive comments received.
Therefore, the FAA has determined that prior public notice and comment
are unnecessary, and finds that, for the same reason, good cause exists
for adopting these special conditions upon publication in the Federal
Register.

Comments Invited

    The FAA invites interested people to take part in this rulemaking
by sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    The FAA will consider all comments received by the closing date for
comments. The FAA may change these special conditions based on the
comments received.

Background

    On December 16, 2019, Airbus Defense and Space, Inc. applied for a
supplemental type certificate for the installation of rechargeable
lithium batteries as part of an emergency lighting installation in the
Airbus Model C212-CC/-CD/-CE/-CF/-DF/-DE airplanes. The Airbus Model
C212-CC/-CD/-CE/-CF/-DF/-DE airplanes are twin-engine, transport
category aircraft, with capacity for 28 passengers, and a maximum
takeoff weight of 16,976 pounds.

Type Certification Basis

    Under the provisions of title 14, Code of Federal Regulations (14
CFR) 21.101, Airbus Defense and Space, Inc. must show that the Airbus
Model C212-CC/-CD/-CE/-CF/-DF/-DE airplanes, as changed, continue to
meet the applicable provisions of the regulations listed in Type
Certificate No. A43EU or the applicable regulations in effect on the
date of application for the change, except for earlier amendments as
agreed upon by the FAA.
    If the Administrator finds that the applicable airworthiness
regulations (e.g., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Airbus Model C212-CC/-CD/-CE/-CF/-
DF/-DE airplanes because of a novel or unusual design feature, special
conditions are prescribed under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the applicant apply for a supplemental type
certificate to modify any other model included on the same type
certificate to incorporate the same novel or unusual design feature,
these special conditions would also apply to the other model under
Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Airbus Model C212-CC/-CD/-CE/-CF/-DF/-DE airplanes must
comply with the fuel vent and exhaust emission requirements of 14 CFR
part 34 and the noise certification requirements of 14 CFR part 36.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type
certification basis under Sec.  21.101.

Novel or Unusual Design Feature

    The Airbus Model C212-CC/-CD/-CE/-CF/-DF/-DE airplanes will
incorporate the following novel or unusual design feature:
    An emergency lighting installation that contains rechargeable
lithium batteries.

Discussion

    Rechargeable lithium batteries are considered to be a novel or
unusual design feature in transport category airplanes, with respect to
the requirements in Sec.  25.1353. This type of battery has certain
failure, operational, and maintenance characteristics that differ
significantly from those of the nickel-cadmium and lead-acid
rechargeable batteries currently approved for installation on transport

category airplanes. These batteries introduce higher energy levels into
airplane systems through new chemical compositions in various battery-
cell sizes and construction. Interconnection of these cells in battery
packs introduces failure modes that require unique design
considerations, such as provisions for thermal management.
    Special Condition 1 requires that each individual cell within a
rechargeable lithium battery be designed to maintain safe temperatures
and pressures. Special Condition 2 addresses these same issues but for
the entire battery. Special Condition 2 requires the battery be
designed to prevent propagation of a thermal event, such as self-
sustained, uncontrolled increases in temperature or pressure from one
cell to adjacent cells.
    Special Conditions 1 and 2 are intended to ensure that the cells
and battery are designed to eliminate the potential for uncontrollable
failures. However, a certain number of failures will occur due to
various factors beyond the control of the designer. Therefore, other
special conditions are intended to protect the airplane and its
occupants if failure occurs.
    Special Conditions 3, 7, and 8 are self-explanatory.
    Special Condition 4 clarifies that the flammable fluid fire-
protection requirements of Sec.  25.863 apply to rechargeable lithium
battery installations. Section 25.863 is applicable to areas of the
airplane that could be exposed to flammable fluid leakage from airplane
systems. Rechargeable lithium batteries contain electrolyte that is a
flammable fluid.
    Special Condition 5 requires each rechargeable lithium battery
installation to not damage surrounding structure or adjacent systems,
equipment, or electrical wiring from corrosive fluids or gases that may
escape in such a way as to cause a major or more severe failure
condition. Special Condition 6 requires each rechargeable lithium
battery installation to have provisions to prevent any hazardous effect
on airplane structure or systems caused by the maximum amount of heat
it can generate due to any failure of it or its individual cells. The
means of meeting special conditions 5 and 6 may be the same, but they
are independent requirements addressing different hazards. Special
Condition 5 addresses corrosive fluids and gases, whereas Special
Condition 6 addresses heat.
    Special Condition 9 requires rechargeable lithium batteries to have
``automatic'' means due to the fast acting nature of lithium battery
chemical reactions. Manual intervention would not be timely or
effective in mitigating the hazards associated with these batteries.
    These conditions apply to all rechargeable lithium battery
installations in lieu of Sec.  25.1353(b)(1) through (4) at amendment
25-123, or Sec.  25.1353(c)(1) through (4) at earlier amendments. These
regulations will remain in effect for other battery installations on
these airplanes.
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Applicability

    As discussed above, these special conditions are applicable to the
Airbus Model C212-CC/-CD/-CE/-CF/-DF/-DE airplanes. Should Airbus
Defense and Space, Inc. apply at a later date for a supplemental type
certificate to modify any other model included on Type Certificate No.
A43EU to incorporate the same novel or unusual design feature, these
special conditions would apply to that model as well.

Conclusion

    This action affects only a certain novel or unusual design feature
on the Airbus Model C212-CC/-CD/-CE/-CF/-DF/-DE airplanes. It is not a
rule of general applicability and affects only the applicant who
applied to the FAA for approval of these features on the airplanes.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

Authority Citation

    The authority citation for these special conditions is as follows:

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

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Airbus Defense and Space S.A. Model
C212-CC/-CD/-CE/-CF/-DF/-DE, as modified by Airbus Defense and Space,
Inc.
    In lieu of Sec.  25.1353(b)(1) through (4) at amendment 25-123, or
Sec.  25.1353(c)(1) through (4) at earlier amendments, each
rechargeable lithium battery installation must:
    1. Be designed to maintain safe cell temperatures and pressures
under all foreseeable operating conditions to prevent fire and
explosion.
    2. Be designed to prevent the occurrence of self-sustaining,
uncontrollable increases in temperature or pressure, and automatically
control the charge rate of each cell to protect against adverse
operating conditions, such as cell imbalance, back charging,
overcharging, and overheating.
    3. Not emit explosive or toxic gases, either in normal operation or
as a result of its failure that may accumulate in hazardous quantities
within the airplane.
    4. Meet the requirements of Sec.  25.863.
    5. Not damage surrounding structure or adjacent systems, equipment,
or electrical wiring from corrosive fluids or gases that may escape in
such a way as to cause a major or more-severe failure condition.
    6. Have provisions to prevent any hazardous effect on airplane
structure or systems caused by the maximum amount of heat it can
generate due to any failure of it or its individual cells.
    7. Have a failure sensing and warning system to alert the flight
crew if its failure affects safe operation of the airplane.
    8. If its function is required for safe operation of the airplane,
have a monitoring and warning feature that alerts the flight crew when
its charge state falls below acceptable levels.
    9. Have a means to automatically disconnect from its charging
source in the event of an over-temperature condition, cell failure or
battery failure.

    Note:  A battery system consists of the battery, battery charger
and any protective, monitoring and alerting circuitry or hardware
inside or outside of the battery. It also includes vents (where
necessary) and packaging. For the purpose of these special
conditions, a battery and battery system are referred to as a
battery.

    Issued in Kansas City, Missouri, on November 10, 2021.
Patrick R. Mullen,
Manager, Technical Innovation Policy Branch, Policy and Innovation
Division, Aircraft Certification Service.
[FR Doc. 2021-25006 Filed 11-16-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: November 5, 2009 (Volume 74, Number 213)]
[Notices]
[Page 57319-57320]
[DOCID:fr05no09-61]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0526]

 Food and Drug Administration's Safe Use Initiative; Availability
of Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
launch of its Safe Use Initiative with the release of a report titled
``FDA's Safe Use Initiative--Collaborating to Reduce Preventable Harm
from Medicines.'' FDA is opening a docket to enable the public to
comment on the report and the initiative. In addition, a safe use Web
site has been created to facilitate transparency as the initiative
moves forward. The initiative proposes a series of next steps,
including working with interested partners--patients, consumers,
caretakers, healthcare practitioners, pharmacists, healthcare systems,
health insurers, drug manufacturers, and other Federal agencies--to
select specific candidate cases of preventable, drug-related harm for
analysis, intervention proposals, and evaluation metrics. The report
identifies some specific areas of concern that could benefit from Safe
Use Initiative partnerships.

DATES: Submit electronic or written comments at any time.

ADDRESSES: Submit written comments on the information in this docket to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857.
Submit electronic comments to http://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
information.

FOR FURTHER INFORMATION CONTACT: Karen Weiss, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg 51, rm. 6122, Silver Spring, MD 20993, 301-796-
5400.

SUPPLEMENTARY INFORMATION:

I. Background

    Tens of millions of people in the United States depend on
prescription

and over-the-counter (OTC) medications to stay healthy. Yet it is
widely known that too many people incur preventable injury and even die
from medication errors or misuse. Preventable injuries can result from
a variety of sources, including informational errors (mistakes made in
prescribing or using a medicine because of inadequate information);
unintended, or accidental exposure; intentional drug misuse and abuse;
and rarely because of manufacturing and/or distribution defects. The
Institute of Medicine (IOM) estimates that 1.5 million preventable
injuries, or adverse drug events, occur in the United States healthcare
system each year,\1,2\ at a cost exceeding $4 billion annually.
Additionally, incorrect use of OTC medications results in thousands of
preventable injuries. Furthermore, unintended exposure to medications
causes a significant number of injuries and deaths, mainly in children.
Between 2003 and 2006 alone, more than 9,000 children were accidentally
exposed to prescription opioid drugs.\3\
---------------------------------------------------------------------------

    \1\ Institute of Medicine of the National Academies, Preventing
Medication Errors, National Academies Press, p. 124, 2007.
    \2\ Ibid, p. 4. The IOM defines an adverse drug event (ADE) as
any injury due to medication. Examples include a wrong dosage
leading to injury (e.g., rash, confusion, or loss of function) or an
allergic reaction occurring in a patient not known to be allergic to
a given medication.
    \3\ Bailey, J.E., E. Campagna, R.C. Dart, ``The Underrecognized
Toll of Prescription Opioid Abuse on Young Children,'' Annals of
Emergency Medicine, 53:4129-24, 2009.
---------------------------------------------------------------------------

    These potentially avoidable injuries and deaths represent our
society's collective failure to adequately manage medication risks.
Because the shortcomings in the healthcare system have been broadly
acknowledged, FDA and many other healthcare stakeholders have been
working hard to improve the way in which the nation's healthcare system
manages medication risks. However, much more needs to be done, and
coordinated cross-sector efforts, involving all stakeholders, would
have the greatest impact.
    To this end, FDA is launching the Safe Use Initiative, through
which it will collaborate with stakeholders--including patients,
consumers, caretakers, healthcare practitioners, pharmacists,
healthcare systems, health insurers, drug manufacturers, and Federal
agencies--to identify specific candidate cases associated with
important, measurable amounts of preventable harm. In the coming
months, FDA plans to develop, through extensive consultation with all
interested public and private stakeholders, a general list of candidate
cases for collaborative analysis and intervention. FDA also intends to
work with federal partners to develop population-based national
estimates of preventable harm from medications, categorized by drug,
drug classes, and therapeutic situations. In addition to opening a
docket to receive public input, FDA plans to hold a series of public
meetings to gather broad public feedback as the candidate list is being
developed. It is FDA's goal to implement a small number of
interventions during the next 12 months.
    For more information, see FDA's Safe Use Web page at http://
www.fda.gov/Drugs/DrugSafety/ucm187806.htm.

II. Submission of Feedback on the Contents of This Docket

    Interested parties may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments on this information.
Submit a single copy of electronic comments or two paper copies of any
mailed comments. Individuals may submit one paper copy. Comments should
be identified with the docket number found in brackets in this
document's heading. Received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
FDA will accept electronic comments or submissions only at http://
www.regulations.gov.

    Dated: October 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26530 Filed 11-4-09; 8:45 am]

BILLING CODE 4160-01-S