[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4351-4353]
[FR Doc No: 2017-00629]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0040]

How To Prepare a Pre-Request for Designation; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``How to
Prepare a Pre-Request for Designation (Pre-RFD).'' The purpose of this
guidance is to explain the Pre-RFD process at the FDA Office of
Combination Products (OCP), describe and help a sponsor understand the
type of information that the sponsor should include in a Pre-RFD, and
assist sponsors in obtaining a preliminary assessment from FDA through
the Pre-RFD process. The Pre-RFD process is available to provide
informal, non-binding feedback regarding the regulatory identity or
classification of a human medical product as a drug, device, biological
product, or combination product. In addition, this informal process
provides information about a non-combination or combination product's
assignment to the appropriate Agency Center (Center for Drug Evaluation
and Research (CDER), Center for Devices and Radiological Health (CDRH),
or Center for Biologics Evaluation and Research (CBER)) for premarket
review and regulation. This draft guidance is not final nor is it in
effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 13, 2017. Submit either written or electronic
comments on this collection of information by March 14, 2017.

ADDRESSES: 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-2017-D-0040 for ``How to Prepare a Pre-Request for Designation
(Pre-RFD); Draft Guidance for Industry.'' 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.
    Submit comments on information collection issues to the Office of
Management and Budget in the following ways:
     Fax to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>, or email to
<EMAIL_ADDRESS>All comments should be identified with the
title, ``How to Prepare a Pre-Request for Designation (Pre-RFD); Draft
Guidance for Industry.''
    Submit written requests for single copies of the draft guidance
document entitled ``How to Prepare a Pre-Request for Designation (Pre-
RFD)'' to the Office of Combination Products, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request, or fax your request to 301-847-
8619. See the SUPPLEMENTARY

INFORMATION section for information on electronic access to the draft
guidance.

FOR FURTHER INFORMATION CONTACT: Leigh Hayes, Office of Combination
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 5129, Silver Spring, MD 20993-0002, or via email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Since its establishment on December 24, 2002, OCP has served as a
resource for sponsors at various stages of development of their
product. Sponsors often seek OCP feedback on whether their medical
product will be regulated as a drug, a device, a biologic, or a
combination product, and which FDA medical product Center (CDER, CBER,
or CDRH) will regulate it, if it is a non-combination product, or will
have the primary jurisdiction for the premarket review and regulation
of the product, if it is a combination product.
    There are two ways that a sponsor can receive such feedback from
OCP. One option is to submit an RFD to receive a formal, binding
determination for the sponsor's product with respect to classification
and/or center assignment that may be changed under conditions specified
in section 563 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-2) and 21 CFR 3.9 in the regulations. The RFD process is
codified in 21 CFR part 3, and OCP has issued a guidance about this
process (see ``How to Write a Request for Designation'' at http://www.fda.gov/RegulatoryInformation/Guidances/ucm126053.htm). A second
more flexible option is for a sponsor to submit an inquiry to OCP to
receive a preliminary jurisdictional assessment, which is not binding.
    Many sponsors seek to utilize the flexibility of more approachable
ways to interact with OCP and the medical product Agency Centers to
obtain feedback from the Agency before submitting a marketing
application to FDA. Over time, these informal methods of obtaining
feedback have become increasingly customary with sponsors, and for
some, even preferable to the formal RFD process. Accordingly, FDA is
enhancing the transparency and consistency of this process, which will
now be called the ``Pre-Request for Designation (Pre-RFD) Program.''
    This draft guidance describes this structured process with clear
recommendations for sponsors wishing to submit Pre-RFDs. It also
provides the process for review of Pre-RFDs by FDA staff, the general
timeframes for sponsors to receive feedback from OCP, and the process
for scheduling teleconferences and meetings in relation to a Pre-RFD.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on how to prepare
a Pre-RFD. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (the PRA) (44 U.S.C. 3501-3502),
Federal Agencies must obtain approval from the Office of Management and
Budget (OMB) for each collection of information they conduct or
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3)
and 5 CFR 1320.3(c) and includes Agency requests or requirements that
members of the public submit reports, keep records, or provide
information to a third party. Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing notice of the proposed
collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Draft Guidance for Industry; How To Prepare a Pre-Request for
Designation (Pre-RFD)

    This draft guidance describes how to prepare a Pre-RFD. The
guidance provides recommendations regarding the information that should
be submitted in a Pre-RFD request and procedures that should be
followed for meetings or conference calls between OCP, the Centers, and
industry representatives or sponsors.
    The proposed collections of information are necessary to allow the
Agency to receive Pre-RFD requests in order to implement this voluntary
submission program.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total  annual    burden per
            Activity                respondents   responses  per     responses     response  (in    Total hours
                                                     respondent                       hours)
----------------------------------------------------------------------------------------------------------------
Pre-RFD submissions.............             136               1             136              12           1,632
Pre-RFD meetings................             136               1             136               1             136
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,768
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Respondents are product sponsors and industry representatives
subject to FDA's laws and regulations. FDA estimates that it will
receive approximately 136 Pre-RFDs annually. The Agency reached this
estimate through its experience with the formal Request for Designation
(RFD) program, by reviewing the number of informal, pre-RFD inquiries
from sponsors that the Agency received over the past 3 years. Based on
FDA's experience with

these informal, Pre-RFD inquiries, FDA expects the proposed Pre-RFD
program to be utilized as a viable program in the future and expects
that the number of Pre-RFDs will increase initially to approximately
180 submissions.
    FDA estimates from past experience with informal Pre-RFD inquiries
that the complete process involved with preparing the Pre-RFD
submission takes approximately 12 hours and an additional 1 hour for
meetings.
    This average is based upon estimates by FDA administrative and
technical staff who are familiar with the information collection
relating to informal, Pre-RFD inquiries, who have consulted and advised
sponsors and industry representatives on the information collection,
and who have reviewed the documentation submitted.
    Therefore, the total reporting burden hours is estimated to be
1,768 hours.

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                 Total burden
                    Number of respondents                           hours         Hourly  wage      Total cost
                                                                  annualized          rate          annualized
----------------------------------------------------------------------------------------------------------------
136..........................................................              13           $33.26       $58,803.68
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Assuming an hourly wage plus benefit rate of $33.26,\1\ the result
is a cost of $432.38 per respondent. The estimated submission cost of
$432.38 multiplied by 136 submissions per year equals $58,803.68, which
is the estimated aggregated industry reporting cost annualized.
---------------------------------------------------------------------------

    \1\ Wage is based on the 2015 Bureau of Labor Statistic's
survey, National Industry Specific Occupational Employment and Wage
Estimate, for standard occupational code 13-1041, compliance officer
in pharmaceutical and medicine manufacturing (http://www.bls.gov/oes/current/oes131041.htm).
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    This draft guidance also refers to previously approved information
collections found in FDA regulations. The collections of information in
21 CFR part 3 are approved under OMB control number 0910-0523.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/RegulatoryInformation/Guidances/ucm534661.htm.

    Dated: January 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00629 Filed 1-12-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 102 (Friday, May 28, 2021)]
[Notices]
[Page 28825]
[FR Doc No: 2021-11363]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

    Docket Numbers: RP21-832-000.
    Applicants: Tapstone Energy, LLC, FP Wheeler Midstream, LLC.
    Description: Joint Petition for Limited Waiver of Capacity Release
Regulations, et al. of Tapstone Energy, LLC, et al.
    Filed Date: 5/19/21.
    Accession Number: 20210519-5150.
    Comments Due: 5 p.m. ET 6/1/21.

    Docket Numbers: RP21-833-000.
    Applicants: ETC Tiger Pipeline, LLC.
    Description: Sec.  4(d) Rate Filing: Filed Agreements Housekeeping
to be effective 6/21/2021.
    Filed Date: 5/21/21.
    Accession Number: 20210521-5054.
    Comments Due: 5 p.m. ET 6/2/21.

    Docket Numbers: RP21-834-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: Amendment to a Negotiated Rate
Agreement Filing--La Frontera Holdings, LLC to be effective 6/1/2021.
    Filed Date: 5/21/21.
    Accession Number: 20210521-5218.
    Comments Due: 5 p.m. ET 6/2/21.

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

    Dated: May 24, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-11363 Filed 5-27-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 171 (Tuesday, September 6, 2022)]
[Rules and Regulations]
[Pages 54349-54351]
[FR Doc No: 2022-19106]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2022-1147; Special Conditions No. 25-829-SC]

Special Conditions: L2 Consulting Services, Inc., Bombardier
Model BD-700-1A10 and BD-700-1A11 Airplanes; Electronic System Security
Protection From Unauthorized External Access

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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SUMMARY: These special conditions are issued for the Bombardier Model
BD-700-1A10 and BD-700-1A11 airplanes. These airplanes, as modified by
L2 Consulting Services, Inc., will have a novel or unusual design
feature when compared to the state of technology envisioned in the
airworthiness standards for airplanes. This design feature is
associated with the installation of an electronic network system
architecture that will allow increased connectivity to and access from
external network sources, (e.g., operator networks, wireless devices,
internet connectivity, service provider satellite communications,
electronic flight bags, etc.) to the airplane's previously isolated
electronic assets (networks, systems, and databases). 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 on L2 Consulting Services, Inc., on
September 6, 2022. Send comments on or before October 21, 2022.

ADDRESSES: Send comments identified by Docket No. FAA-2022-1147 using
any of the following methods:
     Federal eRegulations Portal: Go to https://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 title 14, Code of Federal Regulations (14 CFR) 11.35, the
FAA will post all comments received without change to https://www.regulations.gov/, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact received about these special conditions.
    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 these special
conditions contain commercial or financial information that is
customarily treated as private, that you actually treat as private, and
that is relevant or responsive to these special conditions, 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 these special conditions. Send submissions containing CBI to
Thuan T. Nguyen, Aircraft Information Systems, AIR-622, Technical
Innovation Policy Branch, Policy and Innovation Division, Aircraft
Certification Service, Federal Aviation Administration, 2200 South
216th Street, Des Moines, Washington 98198; telephone;<PHONE_NUMBER>;
email [email protected]. Comments the FAA receives, which are not
specifically designated as CBI, will be placed in the public docket for
these special conditions.
    Docket: Background documents or comments received may be read at
https://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: Thuan T. Nguyen, Aircraft Information
Systems, AIR-622, Technical Innovation Policy Branch, Policy and
Innovation Division, Aircraft Certification Service, Federal Aviation
Administration, 2200 South 216th Street, Des Moines, Washington 98198;
telephone;<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 finds, pursuant to 14 CFR 11.38(b), that new
comments are unlikely, and notice and comment prior to this publication
are unnecessary.

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 October 1, 2021, L2 Consulting Services, Inc., applied for a
supplemental type certificate for the installation of an electronic
network system architecture that will allow increased connectivity to
and access from external network sources, (e.g., operator networks,
wireless devices, internet connectivity, service provider satellite
communications, electronic flight bags, etc.) to the airplane's
previously isolated electronic assets (networks, systems, and
databases). The Bombardier Model BD-700-1A10 and BD-700-1A11 airplanes
are twin-engine, transport category airplanes, executive-interior
business jets with a maximum takeoff weight of 93,500 pounds (42,410
Kg) and a maximum seating capacity of seventeen passengers and two crew
members.

Type Certification Basis

    Under the provisions of title 14, Code of Federal Regulations (14
CFR) 21.101, L2 Consulting Services Inc., must show that the Bombardier
Model BD-700-1A10 and BD-700-1A11 airplanes, as changed, continue to
meet the applicable provisions of the regulations listed in Type
Certificate No. T00003NY, 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 Bombardier Model BD-700-1A10 and
BD-700-1A11 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 Bombardier Model BD-700-1A10 and BD-700-1A11 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 Bombardier Model BD-700-1A10 and BD-700-1A11 airplanes will
incorporate a novel or unusual design feature, which is the
installation of an electronic network system architecture that will
allow increased connectivity to and access from external network
sources, (e.g., operator networks, wireless devices, internet
connectivity, service provider satellite communications, electronic
flight bags, etc.) to the airplane's previously isolated electronic
assets (networks, systems, and databases).

Discussion

    The Bombardier Model BD-700-1A10 and BD-700-1A11 airplanes
electronic system architecture and network configuration is novel or
unusual for commercial transport airplanes because it may allow
increased connectivity to and access from aircraft external network
sources, airline operations, and maintenance networks, to the
airplane's control domain and airline information services domain. The
airplane's control domain and airline information services domain
perform functions required for the safe operation and maintenance of
the airplane. Previously, these domains had very limited connectivity
with external network sources. This data network and design integration
creates a potential for unauthorized persons to access the aircraft
control domain and airline information services domain, and presents
security vulnerabilities related to the introduction of computer
viruses and worms, user errors, and intentional sabotage of airplane
electronic assets (networks, systems, and databases) critical to the
safety and maintenance of the airplane.
    The existing FAA regulations did not anticipate these networked
airplane-system architectures. Furthermore, these regulations and the
current guidance material do not address potential security
vulnerabilities, which could be exploited by unauthorized access to
airplane networks, databuses, and servers. Therefore, these special
conditions ensure that the security (i.e., confidentiality, integrity,
and availability) of airplane systems is not compromised by
unauthorized wired or wireless electronic connections. This includes
ensuring that the security of the airplane's systems is not compromised
during maintenance of the airplane's electronic systems. These special
conditions also require the applicant to provide appropriate
instructions to the operator to maintain all electronic-system
safeguards that have been implemented as part of the original network
design so that this feature does not allow or introduce security
threats.
    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
Bombardier Model BD-700-1A10 and BD-700-1A11 airplanes. Should L2
Consulting Services, Inc., apply at a later date for a supplemental
type certificate to modify any other model included on Type Certificate
No. T00003NY 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 Bombardier Model BD-700-1A10 and BD-700-1A11 airplanes. It is not a
rule of general applicability and affects only the applicant who
applied to the FAA for approval of this feature on the airplane.

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

0
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 Bombardier Model BD-700-1A10 and BD-
700-1A11 airplanes, as modified by L2 Consulting Services,

Inc., for airplane electronic-unauthorized external access.
    1. The applicant must ensure airplane electronic system security
protection from access by unauthorized sources external to the
airplane, including those possibly caused by maintenance activity.
    2. The applicant must ensure that electronic system security
threats are identified and assessed, and that effective electronic
system security protection strategies are implemented to protect the
airplane from all adverse impacts on safety, functionality, and
continued airworthiness.
    3. The applicant must establish appropriate procedures to allow the
operator to ensure that continued airworthiness of the airplane is
maintained, including all post type certification modifications that
may have an impact on the approved electronic system security
safeguards.

    Issued in Kansas City, Missouri, on August 30, 2022.
Patrick R. Mullen,
Manager, Technical Innovation Policy Branch, Policy and Innovation
Division, Aircraft Certification Service.
[FR Doc. 2022-19106 Filed 9-2-22; 8:45 am]
BILLING CODE 4910-13-P