[Federal Register Volume 88, Number 202 (Friday, October 20, 2023)]
[Notices]
[Pages 72489-72491]
[FR Doc No: 2023-23162]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1137]

Development and Licensure of Vaccines To Prevent COVID-19;
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 we) is announcing the
availability of a revised guidance for industry entitled ``Development
and Licensure of Vaccines to Prevent COVID-19.'' This guidance revises
the guidance of the same name, which was announced in the Federal
Register on August 3, 2020. FDA is issuing this guidance to assist the
Agency and sponsors in the clinical development and licensure of
vaccines for the prevention of COVID-19. Additionally, this guidance
provides an overview of key considerations to satisfy regulatory
requirements set forth in the investigational new drug application
(IND) regulations and in the licensing regulations for chemistry,
manufacturing, and controls (CMC), and nonclinical and clinical data
through development and licensure, and for post-licensure safety
evaluation of COVID-19 preventive vaccines. FDA is also announcing the
withdrawal of an FDA guidance document related to COVID-19.

DATES: The announcement of the guidance is published in the Federal
Register on October 20, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2020-D-1137 for ``Development and Licensure of Vaccines to Prevent
COVID-19.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
two self-addressed adhesive labels to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jessica Gillum, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a revised guidance for
industry entitled ``Development and Licensure of Vaccines to Prevent
COVID-19.'' The recommendations described in the guidance are expected
to assist the Agency and sponsors in the clinical development and
licensure of vaccines for the prevention of COVID-19.
    Due to the COVID-19 public health emergency, there was an urgent
need to develop safe and effective vaccines to prevent COVID-19 and
work collaboratively with industry and other partners to accelerate
those efforts. To help address those needs, in June 2020, FDA issued a
guidance entitled ``Development and Licensure of Vaccines to Prevent
COVID-19'' (the ``June 2020 guidance'') to assist sponsors in the
clinical development and licensure of vaccines for the prevention of
COVID-19. The June 2020 guidance, which was announced in the Federal
Register on August 3, 2020 (85 FR 46641), explained that we expected
the recommendations would continue to apply outside the context of the
COVID-19 public health emergency, and that FDA would replace that
guidance with any appropriate changes based on public comments and our
experience with implementation. In addition, in the Federal Register of
March 13, 2023 (88 FR 15417), FDA listed the June 2020 guidance as one
of the guidances the Agency was revising to continue in effect for 180
days after the COVID-19 public health emergency declaration issued
under the Public Health Service Act expired on May 11, 2023, during
which time FDA planned to further revise those guidances. Consistent
with what we said in the Federal Register of March 13, 2023, FDA is
issuing this revised final guidance.
    We are issuing this revised guidance consistent with our good
guidance practices (GGP) regulation (Sec.  10.115 (21 CFR 10.115)). We
are implementing this guidance without prior public comment because we
have determined that prior public participation is not feasible or
appropriate (see Sec.  10.115(g)(2) and section 701(h)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
371(h)(1)(C)). We made this determination because the revisions to the
guidance acknowledge the current epidemiology of COVID-19 or reflect
current recommendations provided to sponsors and immediate
implementation is required to facilitate the development of vaccines to
protect the public health. Specifically, we are issuing this guidance
to ensure that sponsors are aware of our current recommendations to
expedite the timely development of vaccines to prevent COVID-19. In
addition, we note that interested parties have had the opportunity to
comment on the June 2020 guidance. Although this guidance document is
being implemented immediately, it remains subject to comment in
accordance with FDA's GGP regulation (Sec.  10.115(g)(3)(D)).
    The revised guidance provides an overview of key considerations to
satisfy regulatory requirements set forth in the IND regulations in
part 312 (21 CFR part 312) and licensing regulations in part 601 (21
CFR part 601) for CMC, and nonclinical and clinical data through
development and licensure, and for post-licensure safety evaluation of
COVID-19 preventive vaccines. FDA is committed to supporting all
scientifically sound approaches to attenuating the clinical impact of
COVID-19. There are many candidate COVID-19 vaccines currently in
development, and FDA recognizes that the considerations presented do
not represent all the considerations necessary to satisfy statutory and
regulatory requirements applicable to the licensure of vaccines
intended to prevent COVID-19. The nature of a particular vaccine and
its intended use may impact specific data needs.
    We received numerous comments on the June 2020 guidance. Those
comments were considered and the revisions in this guidance reflect the
responses to the comments as appropriate. Changes to the guidance from
the June 2020 guidance include removal of reference to the COVID-19
public health emergency and revisions to the nonclinical data section
to take into consideration that enhanced respiratory disease has not
occurred with clinical use of COVID-19 vaccines. The clinical trials
section has been revised to reflect that at this stage of the pandemic
only very young children are likely to be serologically na[iuml]ve and,
in recognition of the available data on vaccine effectiveness, to
recommend that sponsors provide appropriate justification for
statistical criteria for clinical disease efficacy studies. In
addition, editorial changes were made to improve clarity. The revised
guidance announced in this notice replaces the June 2020 guidance.
    The revised guidance represents the current thinking of FDA on the
development and licensure of vaccines to prevent COVID-19. 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.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in part 312 have been approved under OMB control number 0910-0014; the
collections of information in 21 CFR part 58 regarding good laboratory
practice for nonclinical laboratory studies have been approved under
OMB control number 0910-0119; the collections of information in 21 CFR
part 50 have been approved under OMB control number 0910-0130; the
collections of information in 21 CFR parts 210, 211 and 610 have been
approved under OMB control number 0910-0139; the collections of
information in 21 CFR part 600 have been approved under OMB control

numbers 0910-0308 and 0910-0291 (Form FDA 3500A); the collections of
information in part 601 have been approved under OMB control number
0910-0338; the collections of information in FDA's guidance entitled
``Establishment and Operation of Clinical Trial Data Monitoring
Committees'' have been approved under OMB control number 0910-0581;
and, the collections of information in FDA's guidance entitled
``Emergency Use Authorization of Medical Products and Related
Authorities'' have been approved under OMB control number 0910-0595.

III. Emergency Use Authorization for Vaccines To Prevent COVID-19
Guidance

    In October 2020, FDA first issued a guidance entitled ``Emergency
Use Authorization for Vaccines to Prevent COVID-19'' (Vaccine EUA
guidance) to provide sponsors of requests for emergency use
authorization (EUA) for COVID-19 vaccines with recommendations
regarding the data and information needed to support the issuance of an
EUA under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an
investigational vaccine to prevent COVID-19. Although, the guidance
stated that it was intended to remain in effect only for the duration
of the public health emergency related to COVID-19 declared under the
Public Health Service Act, in the Federal Register of March 13, 2023
(88 FR 15417 at 15421), FDA listed the guidance as one of the COVID-19-
related guidances the Agency was revising to continue in effect for 180
days after the COVID-19 public health emergency declared under the PHS
Act expired on May 11, 2023, during which time FDA planned to further
revise those guidances. However, circumstances have changed since the
end of the declared public health emergency on May 11, 2023. FDA has
reviewed the Vaccine EUA guidance and determined that the guidance is
no longer needed, as the Agency has shifted its focus toward
communicating directly with individual manufacturers. Accordingly, the
EUA guidance will no longer be in effect after the publication of the
guidance for immediate implementation announced in this notice,
``Development and Licensure of Vaccines to Prevent COVID-19.''

IV. Electronic Access

    Persons with access to the internet may obtain the document at
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.

    Dated: October 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23162 Filed 10-19-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 28 (Thursday, February 10, 2022)]
[Rules and Regulations]
[Pages 7679-7681]
[FR Doc No: 2022-02753]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 87, No. 28 / Thursday, February 10, 2022 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0696; Project Identifier MCAI-2021-00032-T;
Amendment 39-21923; AD 2022-03-06]
RIN 2120-AA64

Airworthiness Directives; Airbus Canada Limited Partnership (Type
Certificate Previously Held by C Series Aircraft Limited Partnership
(CSALP); Bombardier, Inc.) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-500-
1A11 airplanes. This AD was prompted by reports of loose or
disconnected powerplant FIREX interconnection hoses. This AD requires
replacing certain existing FIREX hose assemblies with a newly designed
FIREX hose assembly, as specified in a Transport Canada Civil Aviation
(TCCA) AD, which is incorporated by reference. The FAA is issuing this
AD to address the unsafe condition on these products.

DATES: This AD is effective March 17, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publications listed in this AD as of March 17,
2022.

ADDRESSES: For TCCA material incorporated by reference (IBR) in this
AD, contact TCCA, Transport Canada National Aircraft Certification, 159
Cleopatra Drive, Nepean, Ontario K1A 0N5, Canada; telephone 888-663-
3639; email [email protected]; internet https://tc.canada.ca/en/aviation.
You may view this material at the FAA, Airworthiness Products Section,
Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call 206-
231-3195. It is also available in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0696.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0696; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
mandatory continuing airworthiness information (MCAI), any comments
received, and other information. The address for Docket Operations is
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Elizabeth Dowling, Aerospace Engineer,
Mechanical Systems and Administrative Services Section, FAA, New York
ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    TCCA, which is the aviation authority for Canada, has issued TCCA
AD CF-2021-01, dated January 8, 2021 (TCCA AD CF-2021-01) (also
referred to as the Mandatory Continuing Airworthiness Information, or
the MCAI), to correct an unsafe condition for certain Airbus Canada
Limited Partnership Model BD-500-1A10 and BD-500-1A11 airplanes.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Airbus Canada
Limited Partnership Model BD-500-1A10 and BD-500-1A11 airplanes. The
NPRM published in the Federal Register on August 25, 2021 (86 FR
47424). The NPRM was prompted by reports of loose powerplant FIREX
interconnection hoses, and in one instance a hose was found
disconnected. An investigation by the manufacturer determined that if
the instructions for connecting the FIREX hose are not followed
properly, hoses can become loose or disconnected. The NPRM proposed to
require replacing certain existing FIREX hose assemblies with a newly
designed FIREX hose assembly, as specified in TCCA AD CF-2021-01.
    The FAA is issuing this AD to address the possibility that fire
extinguishing agent may not be effectively applied should a fire occur
within a powerplant assembly that has a partially or completely
disconnected FIREX hose, which could result in the inability to put out
a fire in the engine. See the MCAI for additional background
information.

Discussion of Final Airworthiness Directive

Comments

    The FAA received a comment from Air Line Pilots Association,
International, who supported the NPRM without change.
    The FAA received an additional comment from Delta Air Lines. The
following presents the comment received on the NPRM and the FAA's
response.

Request To Withdraw the Proposed AD

    Delta Air Lines (DAL) requested that the FAA withdraw the proposed
AD. DAL stated that it had already accomplished the required actions of
paragraph (g) of the proposed AD by accomplishing the actions specified
in Airbus Canada Limited Partnership Service Bulletin (SB) BD500-262003
Issue 002, dated January 7, 2020.
    The FAA does not agree with the request to withdraw this AD. Even
though DAL is the only current U.S. operator of the applicable
airplanes, the AD must still be issued in case of any future imports of
the airplanes.

Conclusion

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

Related Service Information Under 1 CFR Part 51

    TCCA AD CF-2021-01 describes procedures for replacing certain
existing

FIREX hose assemblies on each powerplant with a newly designed FIREX
hose assembly with provisions for the installation of safety cables at
each end, in order to prevent the hose from becoming loose or
disconnected. This material is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 36 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
5 work-hours x $85 per hour = $425...........................         $13,012          $13,437         $483,732
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected operators. The FAA does not control warranty coverage for
affected operators. As a result, the FAA has included all known costs
in the cost estimate.

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2022-03-06 Airbus Canada Limited Partnership (Type Certificate
Previously Held by C Series Aircraft Limited Partnership (CSALP);
Bombardier, Inc.): Amendment 39-21923; Docket No. FAA-2021-0696;
Project Identifier MCAI-2021-00032-T.

(a) Effective Date

    This airworthiness directive (AD) is effective March 17, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Canada Limited Partnership (type
certificate previously held by C Series Aircraft Limited Partnership
(CSALP); Bombardier, Inc.) Model BD-500-1A10 and BD-500-1A11
airplanes, certificated in any category, as identified in Transport
Canada Civil Aviation (TCCA) AD CF-2021-01, dated January 8, 2021
(TCCA AD CF-2021-01).

(d) Subject

    Air Transport Association (ATA) of America Code 26, Fire
protection.

(e) Reason

    This AD was prompted by reports of loose or disconnected
powerplant FIREX interconnection hoses. The FAA is issuing this AD
to address the possibility that fire extinguishing agent may not be
effectively applied should a fire occur within a powerplant assembly
that has a partially or completely disconnected FIREX hose, which
could result in the inability to put out a fire in the engine.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, TCCA AD CF-2021-01.

(h) Exceptions to TCCA AD CF-2021-01

    (1) Where TCCA AD CF-2021-01 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where TCCA AD CF-2021-01 refers to ``hours air time,'' this
AD requires using ``flight hours.''

(i) No Reporting Requirement

    Although the service information referenced in TCCA AD CF-2021-
01 specifies to submit certain information to the manufacturer, this
AD does not include that requirement.

(j) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 39.19, send your request to your principal
inspector or responsible Flight Standards Office, as appropriate. If
sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; tax<PHONE_NUMBER>. Before
using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch,

FAA; or TCCA; or Airbus Canada Limited Partnership's TCCA Design
Approval Organization (DAO). If approved by the DAO, the approval
must include the DAO-authorized signature.

(k) Related Information

    For more information about this AD, contact Elizabeth Dowling,
Aerospace Engineer, Mechanical Systems and Administrative Services
Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
[email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Transport Canada Civil Aviation AD CF-2021-01, dated January
8, 2021.
    (ii) [Reserved]
    (3) For TCCA AD CF-2021-01, contact Transport Canada National
Aircraft Certification, 159 Cleopatra Drive, Nepean, Ontario K1A
0N5, Canada; telephone<PHONE_NUMBER>; email [email protected]; internet
https://tc.canada.ca/en/aviation.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on January 20, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-02753 Filed 2-9-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 178 (Thursday, September 13, 2012)]
[Proposed Rules]
[Pages 56585-56586]
[FR Doc No: 2012-22530]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0901; Directorate Identifier 2012-NE-19-AD]
RIN 2120-AA64

Airworthiness Directives; Turbomeca S.A. Turboshaft Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Turbomeca S.A. Arriel 1A1, 1A2, 1B, 1C, 1C1, 1C2, 1D, 1D1, 1E2, 1K1,
1S, and 1S1 turboshaft engines. This proposed AD was prompted by
several reports of uncommanded in-flight shutdown (IFSD) on Arriel 1
engines. This proposed AD would require performing a high gas generator
speed (NG) rating vibration check. We are proposing this AD to prevent
an uncommanded in-flight shut-down of the engine, which could result in
an emergency landing.

DATES: We must receive comments on this proposed AD by November 13,
2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Frederick Zink, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; email:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2012-0901;
Directorate Identifier 2012-NE-19-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2012-0117, dated July 3, 2012 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    Several cases of uncommanded in-flight shut-down (IFSD) have
been reported on ARRIEL 1 engines. Results of subsequent
investigations showed that some Gas Generator (GG) rear bearing
failures have occurred following ``Level 3'' maintenance operations
on the GG Assembly. Some of these maintenance operations may have
created an unbalanced condition of the GG rotating assembly and,
ultimately, failure of the GG rear bearing.
    This condition, if not detected and corrected, could lead to an
uncommanded engine in-flight shut down and may ultimately lead to an
emergency landing.

You may obtain further information by examining the MCAI in the AD
docket.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of France
and is approved for operation in the United States. Pursuant to our
bilateral agreement with the European Community, EASA has notified us
of the unsafe condition described in the MCAI referenced above. We are
proposing this AD because we evaluated all information provided by EASA
and determined the unsafe condition exists and is likely to exist or
develop on other products of the same type design.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 1,445 products of U.S. registry. We also estimate
that it would take about 1 work-hour per product to comply with this
proposed AD. The average labor rate is $85 per work-hour. Based on
these figures, we estimate the cost of the proposed AD on U.S.

operators to be $122,825. Our cost estimate is exclusive of possible
warranty coverage.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Turbomeca S.A.: Docket No. FAA-2012-0901; Directorate Identifier
2012-NE-19-AD.

(a) Comments Due Date

    We must receive comments by November 13, 2012.

(b) Affected Airworthiness Directives (ADs)

    None.

(c) Applicability

    This AD applies to all Turbomeca S.A. ARRIEL 1A1, 1A2, 1B, 1C,
1C1, 1C2, 1D, 1D1, 1E2, 1K1, 1S, and 1S1 turboshaft engines.

(d) Reason

    This AD was prompted by several reports of uncommanded in-flight
shutdown on Arriel 1 engines. We are issuing this AD to prevent an
uncommanded in-flight shutdown of the engine, which could result in
an emergency landing.

(e) Actions and Compliance

    Unless already done, from the effective date of this AD, do the
following. After any Level 3 maintenance action on the gas generator
(GG) rotating assembly and before returning the engine to service,
accomplish a high GG speed (NG) rating vibration check.

(f) Definition

    Level 3 maintenance on the GG rotating assembly is when the
Module 03 is removed from the helicopter for implementation of deep
maintenance operation to be performed in accordance with the
applicable maintenance instructions.

(g) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, may approve AMOCs for
this AD. Use the procedures found in 14 CFR 39.19 to make your
request.

(h) Related Information

    (1) For more information about this AD, contact Frederick Zink,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; email<EMAIL_ADDRESS>phone:<PHONE_NUMBER>; fax: 781-
238-7199.
    (2) Refer to Mandatory Continuing Airworthiness Information AD
2012-0117, dated July 3, 2012, for related information.

    Issued in Burlington, Massachusetts, on September 5, 2012.
Colleen M. D'Alessandro,
Assistant Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2012-22530 Filed 9-12-12; 8:45 am]
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[Federal Register Volume 80, Number 102 (Thursday, May 28, 2015)]
[Notices]
[Pages 30448-30449]
[FR Doc No: 2015-12863]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RD15-2-000]

Commission Information Collection Activities (FERC-725G); Comment
Request

AGENCY: Federal Energy Regulatory Commission, Energy.

ACTION: Notice of information collection and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, 44 U.S.C. 3507(a)(1)(D) and the Office of Management and
Budget's implementing regulations, the Federal Energy Regulatory
Commission (Commission or FERC) is soliciting public comment on the
information collection, FERC-725G (Mandatory Reliability Standards for
the Bulk-Power System: PRC Standards), as modified in this docket. The
Commission previously published a notice in the Federal Register (80 FR
13528, 3/16/2015) requesting public comments. The Commission received
no comments and is making this notation in its submittal to OMB.

DATES: Comments regarding the proposed revision to this information
collection must be received on or before June 29, 2015.

ADDRESSES: Comments, identified by Docket Number RD15-2, may be filed
in the following ways:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance, contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-725G (Mandatory Reliability Standards for the Bulk-
Power System: PRC Standards).
    OMB Control No.: 1902-0252.
    Type of Request: Three-year extension of the FERC-725G information
collection requirements as modified in Docket No. RD15-2.
    Abstract: The Commission is submitting Reliability Standard PRC-
006-2 to OMB under FERC-725G \1\ for review of the reporting and
recordkeeping requirements.
---------------------------------------------------------------------------

    \1\ In 2012, the Commission initially approved Reliability
Standard PRC-006-1. Automatic Underfrequency Load Shedding and Load
Shedding Plans Reliability Standards, Order No. 763, 139 FERC ]
61,098, order granting clarification, 140 FERC ] 61,164 (2012). The
Commission included Reliability Standard PRC-006-1 under FERC-725A
(OMB Control No. 1902-0244). The entire burden associated with
Reliability Standard PRC-006-2 (for new requirements as well as
those unchanged from PRC-006-1) will be added to FERC-725G. In the
future, the burden (an estimated 12,672 hours) associated with
Reliability Standard PRC-006-1 will be removed from FERC-725A, to
remove the temporary double counting of those hours.
---------------------------------------------------------------------------

    The Commission requires the information collected by the FERC-725G
to implement the statutory provisions of section 215 of the Federal
Power Act (FPA).\2\ On August 8, 2005, Congress enacted into law the
Electricity Modernization Act of 2005, which is Title XII, Subtitle A,
of the Energy Policy Act of 2005 (EPAct 2005).\3\ EPAct 2005 added a
new section 215 to the FPA, which required a Commission-certified
Electric Reliability Organization (ERO) to develop mandatory and
enforceable Reliability Standards, which are subject to Commission
review and approval. Once approved, the Reliability Standards may be
enforced by the ERO subject to Commission oversight, or the Commission
can independently enforce Reliability Standards.\4\
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    \2\ 16 U.S.C. 824o (2012).
    \3\ Energy Policy Act of 2005, Pub. L. 109-58, Title XII,
Subtitle A, 119 Stat. 594, 941 (codified at 16 U.S.C. 824o).
    \4\ 16 U.S.C. 824o(e)(3).
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    On February 3, 2006, the Commission issued Order No. 672,
implementing section 215 of the FPA.\5\ Pursuant to Order No. 672, the
Commission certified one organization, North American Electric
Reliability Corporation (NERC),

as the ERO.\6\ The Reliability Standards developed by the ERO and
approved by the Commission apply to users, owners and operators of the
Bulk-Power System as set forth in each Reliability Standard.
---------------------------------------------------------------------------

    \5\ Rules Concerning Certification of the Electric Reliability
Organization; and Procedures for the Establishment, Approval, and
Enforcement of Electric Reliability Standards, Order No. 672, FERC
Stats. & Regs. ] 31,204, order on reh'g, Order No. 672-A, FERC
Stats. & Regs. ] 31,212 (2006).
    \6\ North American Electric Reliability Corp., 116 FERC ]
61,062, order on reh'g and compliance, 117 FERC ] 61,126 (2006),
order on compliance, 118 FERC ] 61,190, order on reh'g, 119 FERC ]
61,046 (2007), aff'd sub nom. Alcoa Inc. v. FERC, 564 F.3d 1342
(D.C. Cir. 2009).
---------------------------------------------------------------------------

    In Order No. 763, the Commission approved Reliability Standard PRC-
006-1, but directed NERC to include explicit language in a subsequent
version of the Reliability Standard clarifying that applicable entities
are required to implement corrective actions identified by the planning
coordinator in accordance with a schedule established by the same
planning coordinator.
    NERC filed a petition on December 15, 2014 requesting approval of
proposed Reliability Standard PRC-006-2 addressing the Commission's
directive in Order No. 763. The NERC petition states that the
``[p]roposed Reliability Standard PRC-006-2, through proposed new
Requirement R15, and proposed enhanced language of the existing
Requirements R9 and R10, requires the Planning Coordinator to develop a
schedule for implementation of any necessary corrective actions, and
requires that the applicable entities will implement these corrective
actions according to the schedule established by the Planning
Coordinator.''
    Reliability Standard PRC-006-2 was approved on 3/4/2015 in a
Delegated Order.\7\
---------------------------------------------------------------------------

    \7\ The Order in Docket No. RD15-2 is available at http://elibrary.ferc.gov/idmws/common/opennat.asp?fileID=13793463.
---------------------------------------------------------------------------

    Type of Respondents: Planning coordinators, UFLS entities (as they
are defined in the proposed Reliability Standard) and transmission
owners that own elements identified in the underfrequency load shedding
programs established by the planning coordinators.
    Estimate of Annual Burden: \8\ Our estimate below regarding the
number of respondents is based on the NERC compliance registry as of
May 5, 2015. According to the NERC compliance registry, there are 80
planning coordinators. The individual burden estimates are based on the
time needed to gather data, develop corrective action plans and
schedules to perform assessments of the underfrequency load shedding
programs. Additionally, documentation and the review of underfrequency
load shedding program results by supervisors and management is included
in the administrative estimations. These are consistent with estimates
for similar tasks in other Commission approved standards.
---------------------------------------------------------------------------

    \8\ The Commission defines ``burden'' as the total time, effort,
or financial resources expended by persons to generate, maintain,
retain, or disclose or provide information to or for a federal
agency. For additional information, see 5 CFR 1320.3.
---------------------------------------------------------------------------

    Estimates for the additional burden and cost imposed by the order
in Docket No. RD15-2-000 follow.\9\
---------------------------------------------------------------------------

    \9\ The only changes to Requirements R9 and R10 and associated
measures and evidence retention in Reliability Standard PRC-006-2
(from PRC-006-1) were enhancements to the language which do not
impact the cost of implementation. The modifications provide
additional clarity and do not affect burden or cost.
    \10\ The number of respondents is based on the NERC compliance
registry as January 30, 2015.
    \11\ The estimates for cost per hour (salary plus benefits) are
based on the May 2013 figures of the Bureau of Labor and Statistics
(posted as of February 9, 2015 at http://bls.gov/oes/current/naics3_221000.htm).
     $72.92/hour [($84.96 + $60.87)/2], the average of the
salary plus benefits for a manager ($84.96/hour) and an electrical
engineer ($60.87/hour), is used for the hourly cost for the
reporting requirements associated with Requirement R15 and Measure
M15.
     $29.01/hour, the salary plus benefits for a file clerk,
is used for the hourly cost for the evidence retention requirements
associated with Requirement R15 and Measure M15.
    \12\ The requirements include: Requirement R15 and Measure M15
and evidence retention (planning coordinator that conducts
underfrequency load shedding design assessment under Requirements
R4, R5, or R12 and determines underfrequency load shedding program
does not meet the performance characteristics in Requirement R3,
develops corrective action plans and schedule for implementation by
UFLS entities within its area).

                                                            FERC-725G, as Modified in RD15-2
                                                             [Due to approval of PRC-006-2]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Annual
                                                            number of      Total
                                      Number and type of    responses    number of    Average  burden per    Total annual burden     Total annual cost
                                       respondent \10\         per       responses     response  (hours)           (hours)                  \11\
                                                            respondent
                                    (1)..................          (2)  (1)*(2)=(3)  (4)..................  (3)*(4)=(5)..........  ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting and recordkeeping         80 planning                      1           80  52 hrs. (47 hrs. for   4,160 hrs. (3,760      $285,783 ($274,179
 requirements \12\.                  coordinators.                                    reporting              hrs. for reporting     for reporting
                                                                                requirements, and 5    requirements, and      requirements, and
                                                                                hrs. for record        400 hrs. for record    $11,604 for record
                                                                                retention              retention              retention
                                                                                requirements).         requirements).         requirements).
    Total.........................  80 planning            ...........  ...........  .....................  4,160................  $285,783.
                                     coordinators.
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    Dated: May 21, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-12863 Filed 5-27-15; 8:45 am]
 BILLING CODE 6717-01-P