[Federal Register Volume 88, Number 120 (Friday, June 23, 2023)]
[Notices]
[Pages 41107-41108]
[FR Doc No: 2023-13331]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-2204]

Formal Dispute Resolution and Administrative Hearings of Final
Administrative Orders Under Section 505G of the Federal Food, Drug, and
Cosmetic Act; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Formal
Dispute Resolution and Administrative Hearings of Final Administrative
Orders Under Section 505G of the Federal Food, Drug, and Cosmetic
Act.'' This draft guidance provides recommendations for industry and
review staff on the formal dispute resolution and administrative
hearings procedures for resolving scientific and/or medical disputes
between the Center for Drug Evaluation and Research (CDER) and
requestors and sponsors of drugs that will be subject to a final
administrative order (final order) under section 505G of the Federal
Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments on the draft
guidance by August 22, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2023-D-2204 for ``Formal Dispute Resolution and Administrative
Hearings of Final Administrative Orders Under Section 505G of the
Federal Food, Drug, and Cosmetic Act.'' 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 draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jung Lee, Center for Drug Evaluation
and Research (HFD-600), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5494, Silver Spring, MD 20993, 301-796-
3599.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Formal Dispute Resolution and Administrative Hearings of
Final

Administrative Orders Under Section 505G of the Federal Food, Drug, and
Cosmetic Act.'' This draft guidance provides recommendations for
industry and review staff on the formal dispute resolution and
administrative hearings procedures for resolving scientific and/or
medical disputes between CDER and requestors \1\ and sponsors \2\ of
drugs that will be subject to a final order under section 505G of the
FD&C Act (21 U.S.C. 355h).
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    \1\ Requestor is defined in section 505G(q)(3) of the FD&C Act
as any person or group of persons marketing, manufacturing,
processing, or developing a drug.
    \2\ Sponsor is defined in section 505G(q)(2) of the FD&C Act as
any person marketing, manufacturing, or processing a drug that is
listed pursuant to section 510(j) of the FD&C Act and is or will be
subject to an administrative order under section 505G of the FD&C
Act.
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    Section 505G of the FD&C Act was added by the Coronavirus Aid,
Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136), which
was enacted on March 27, 2020. After FDA issues a final order in
accordance with section 505G(b)(2) of the FD&C Act, FDA must afford
eligible requestors or sponsors the opportunity for formal dispute
resolution (FDR) and hearings on disputes over the final order. This
draft guidance describes the FDR procedures for eligible requestors or
sponsors that wish to appeal a scientific and/or medical issue related
to a final order. This draft guidance also outlines the procedures for
an administrative hearing related to a final order. Finally, as
required by section 505G(l)(4) of the FD&C Act, this draft guidance
describes the procedures for consolidated proceedings for FDR and
hearings to resolve the scientific and/or medical disputes.
    In support of the CARES Act, FDA agreed to specific performance
goals and procedures described in the document ``Over-the-Counter
Monograph User Fee Program Performance Goals and Procedures--Fiscal
Years 2018-2022,'' commonly referred to as the OMUFA commitment letter
(the document can be accessed at https://www.fda.gov/media/106407/download, and the document with updated goal dates for fiscal years
2021-2025 can be accessed at https://www.fda.gov/media/146283/download). The OMUFA commitment letter specifies that FDA will revise
the guidance for industry and review staff entitled ``Formal Dispute
Resolution: Sponsor Appeals Above the Division Level'' (existing FDR
guidance), available at https://www.fda.gov/media/126910/download, to
include circumstances and procedures under which FDR may be used with
respect to final orders under section 505G of the FD&C Act. In
addition, consistent with the statutory requirement under 505G(l)(4),
the OMUFA commitment letter explains that FDA will issue guidance on
its views regarding best practices for consolidated proceedings for
appeals.
    For administrative efficiency, rather than amend the existing FDR
guidance to include FDR procedures for final orders and issue a
separate guidance for consolidated proceedings for appeals, FDA is
issuing this single draft guidance. This draft guidance addresses the
process for resolving scientific and/or medical disputes of final
orders, including FDR, administrative hearings, and consolidated
proceedings. FDA has incorporated recommendations from the existing FDR
guidance as appropriate.
    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 ``Formal
Dispute Resolution and Administrative Hearings of Final Administrative
Orders Under Section 505G of the Federal Food, Drug, and Cosmetic
Act.'' 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

    Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act
of 1995 does not apply to collections of information made under section
505G of the FD&C Act. The information collections made in this guidance
implement the provisions of the following subsections of 505G:
    (1) Section 505G(l)(4), which requires FDA to issue guidance that
specifies the consolidated proceedings for appeal and the procedures
for such proceedings where appropriate;
    (2) Section 505G(b)(2)(A)(iv)(III), which requires that FDA afford
requesters of drugs that will be subject to final administrative orders
the opportunity for formal dispute resolution up to the level of the
Director of CDER;
    (3) Section 505G(b)(3) and section 505G(b)(4)(E), which allow
persons who participated in each stage of FDR with respect to a drug to
request a hearing concerning a final administrative order with respect
to such drug. Under Section 505G(b)(3)(C)(ii), a single hearing may be
conducted if more than one request is submitted with respect to the
same administrative order; and
    (4) Section 505G(j), which requires that all submissions must be in
electronic format.
    Therefore, clearance by the Office of Management and Budget under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) is not
required for these collections of information.
    In addition, this guidance does refer to previously approved FDA
collections of information. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information for OTC monograph products, OTC monograph order
requests, and the OTC Monograph User Fee Program have been approved
under OMB control number 0910-0340.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: June 16, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13331 Filed 6-22-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 181 (Thursday, September 17, 2020)]
[Proposed Rules]
[Pages 58014-58016]
[FR Doc No: 2020-20481]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0845; Product Identifier 2020-NM-102-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Airbus SAS Model A320-271N, A321-211 and A321-271N
airplanes. This proposed AD was prompted by reports of missing overhead
stowage compartment (OHSC) X-fixation brackets or brackets that were
incorrectly installed during assembly. This proposed AD would require a
special detailed inspection of the OHSC X-fixation brackets for missing
or incorrectly installed brackets, and installation or replacement if
necessary; or modification of each OHSC; as specified in a European
Union Aviation Safety Agency (EASA) AD, which will be incorporated by
reference. The FAA is proposing this AD to address the unsafe condition
on these products.

DATES: The FAA must receive comments on this proposed AD by November 2,
2020.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material incorporated by reference (IBR) in this AD, contact
the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49
221 8999 000; email<EMAIL_ADDRESS>internet www.easa.europa.eu.
You may find this IBR material on the EASA website at https://ad.easa.europa.eu. You may view this IBR 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>. It is also available in the AD
docket on the internet at https://www.regulations.gov by searching for
and locating Docket No. FAA-2020-0845.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0845; 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 NPRM, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2020-0845;
Product Identifier 2020-NM-102-AD'' at the beginning of your comments.
The most helpful comments reference a specific portion of the proposal,
explain the reason for any recommended change, and include supporting
data. The FAA will consider all comments received by the closing date
and may amend this proposal because of those comments.
    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
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this proposed AD.

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 NPRM 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 NPRM, 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 they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Sanjay Ralhan, Aerospace Engineer, Large Aircraft Section,
International Validation Branch, FAA, 2200 South 216th St., Des Moines,
WA 98198; telephone and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
Any commentary that the FAA receives which is not specifically
designated as CBI will be placed in the public docket for this
rulemaking.

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0122, dated May 29, 2020
(``EASA AD 2020-0122'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for certain Airbus SAS Model A320-271N, A321-211 and A321-
271N airplanes.
    This proposed AD was prompted by reports of missing OHSC X-fixation
brackets or brackets that were incorrectly installed during assembly.
The FAA is proposing this AD to address this condition, which could
lead to OHSC failure under certain loading conditions, and possibly
result in injury to occupants and impede egress during an emergency
evacuation. See the MCAI for additional background information.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2020-0122 requires a special detailed inspection of the
OHSC X-fixation brackets for missing or incorrectly installed brackets,
and corrective actions (installation or replacement) if necessary; or
modification of each OHSC by installing new X-fixation brackets and re-
identifying the OHSC housing. 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.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the FAA
evaluated all the relevant information and determined the unsafe
condition described previously is likely to exist or develop in other
products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in EASA AD 2020-0122 described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2020-0122
will be incorporated by reference in the FAA final rule. This proposed
AD would, therefore, require compliance with EASA AD 2020-0122 in its
entirety, through that incorporation, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Using common terms that are the same as the heading of a particular
section in the EASA AD does not mean that operators need comply only
with that section. For example, where the AD requirement refers to
``all required actions and compliance times,'' compliance with this AD
requirement is not limited to the section titled ``Required Action(s)
and Compliance Time(s)'' in the EASA AD. Service information specified
in EASA AD 2020-0122 that is required for compliance with EASA AD 2020-
0122 will be available on the internet at https://www.regulations.gov
by searching for and locating Docket No. FAA-2020-0845 after the FAA
final rule is published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 31 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
               Labor cost                   Parts cost         Cost per product         Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Up to 29 work-hours x $85 per hour = Up               $0  Up to $2,465..............  Up to $76,415.
 to $2,465.
----------------------------------------------------------------------------------------------------------------

                  Estimated Costs for Optional Actions
------------------------------------------------------------------------
           Labor cost                 Parts cost       Cost per product
------------------------------------------------------------------------
Up to 36 work-hours x $85 per     Up to $539,060....  Up to $542,120.
 hour = Up to $3,060.
------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition action that would be required based on the results of any
required actions. The FAA has no way of determining the number of
aircraft that might need this on-condition action:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
               Labor cost                   Parts cost        product
------------------------------------------------------------------------
Up to 29 work-hours x $85 per hour = Up              * $             * $
 to $2,465..............................
------------------------------------------------------------------------
* The FAA has received no definitive data that would enable us to
  provide parts cost estimates for the on-condition action specified in
  this proposed AD.

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

    The FAA 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) 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 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

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 (AD):

Airbus SAS: Docket No. FAA-2020-0845; Product Identifier 2020-NM-
102-AD.

(a) Comments Due Date

    The FAA must receive comments by November 2, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus SAS Model A320-271N, A321-211 and
A321-271N airplanes, certificated in any category, as identified in
European Union Aviation Safety Agency (EASA) AD 2020-0122, dated May
29, 2020 (``EASA AD 2020-0122'').

(d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
furnishings.

(e) Reason

    This AD was prompted by reports of missing overhead stowage
compartment (OHSC) X-fixation brackets or brackets that were
incorrectly installed during assembly. The FAA issuing this AD to
address this condition, which could lead to OHSC failure under
certain loading conditions, and possibly result in injury to
occupants and impede egress during an emergency evacuation.

(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, EASA AD 2020-0122.

(h) Exceptions to EASA AD 2020-0122

    (1) Where EASA AD 2020-0122 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2020-0122 does not apply
to this AD.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2020-0122
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation 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 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the Large Aircraft Section, International Validation
Branch, send it to the attention of the person identified in
paragraph (k)(2) of this AD. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district 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, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2020-0122 that contains RC procedures and
tests: Except as required by paragraph (j)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(k) Related Information

    (1) For information about EASA AD 2020-0122, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email<EMAIL_ADDRESS>internet www.easa.europa.eu. You
may find this EASA AD on the EASA website at https://ad.easa.europa.eu. 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>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2020-0845.
    (2) For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
    Issued on September 11, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-20481 Filed 9-16-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Pages 48392-48393]
[FR Doc No: 2015-19831]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Aviation
Medical Examiner Program

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. This collection is necessary in order to determine
applicants' qualifications for certification as Aviation Medical
Examiners (AMEs).

DATES: Written comments should be submitted by October 13, 2015.

ADDRESSES: Send comments to the FAA at the following address: Ronda
Thompson, Room 300, Federal Aviation Administration, ASP-110, 950
L'Enfant Plaza SW., Washington, DC 20024.

FOR FURTHER INFORMATION CONTACT: Ronda Thompson at<PHONE_NUMBER>, or
by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0604.
    Title: Aviation Medical Examiner Program.
    Form Numbers: FAA Form 8520-2.
    Type of Review: Renewal of an information collection.
    Background: 14 CFR part 183 describes the requirements for
delegating to private physicians the authority to conduct physical
examinations on persons wishing to apply for their airmen medical
certificate. This collection of information is for the purpose of
obtaining essential information concerning the applicants' professional
and personal qualifications. The FAA

uses the information to screen and select the designees who serve as
aviation medical examiners.
    Respondents: Approximately 450 applicants annually.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 30 minutes.
    Estimated Total Annual Burden: 225 hours.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on August 4, 2015.
Ronda Thompson,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, ASP-110.
[FR Doc. 2015-19831 Filed 8-11-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 17 (Wednesday, January 26, 2022)]
[Rules and Regulations]
[Pages 3923-3926]
[FR Doc No: 2022-01540]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0009; Project Identifier MCAI-2021-01459-R;
Amendment 39-21914; AD 2022-02-17]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters Deutschland GmbH
(AHD) Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Airbus Helicopters Deutschland GmbH (AHD) Model MBB-BK 117 C-2, MBB-BK
117 D-2, and MBB-BK 117 D-3 helicopters. This AD was prompted by
reports of engine flame out following prolonged operations in falling
snow on helicopters with an inlet barrier filter (IBF) system
installed. This AD requires revising the existing Rotorcraft Flight
Manual (RFM) for your helicopter, as specified in a European Union
Aviation Safety Agency (EASA) AD, which is incorporated by reference.
The FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD becomes effective February 10, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of February 10,
2022.
    The FAA must receive comments on this AD by March 14, 2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For EASA material incorporated by reference (IBR) in this final
rule, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. For Airbus Helicopters service
information identified in this final rule, contact Airbus Helicopters,
2701 North Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-
0000 or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at https://www.airbus.com/helicopters/services/technical-support.html. You may
view this material at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX
76177. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. Service information that is IBRed is also
available in the AD docket at https://www.regulations.gov by searching
for and locating Docket No. FAA-2022-0009.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0009; 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
EASA AD, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Hal Jensen, Aerospace Engineer,
Operational Safety Branch, Compliance & Airworthiness Division, FAA,
950 L'Enfant Plaza N SW, Washington, DC 20024; telephone (202) 267-
9167; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA Emergency AD 2021-0289-E, dated
December 23, 2021 (EASA AD 2021-0289-E), to correct an unsafe condition
for all Airbus Helicopters Deutschland GmbH (AHD), formerly Eurocopter
Deutschland GmbH; and Airbus Helicopters Inc., formerly American
Eurocopter LLC, Model MBB-BK117 C-2, D-2, D-3, and D-3m helicopters,
all variants, all serial numbers.
    This AD was prompted by reports of engine flame out following
prolonged operations in falling snow with the IBF system installed. The
FAA is issuing this AD to prevent partial icing of an IBF engine intake
and engine flame out. The unsafe condition, if not addressed, could
result in engine failure and reduced control of the helicopter,
possibly resulting in damage to the

helicopter or injury to occupants. See EASA AD 2021-0289-E for
additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0289-E requires amending the RFM by incorporating the
applicable RFM temporary revision (TR), to amend the IBF system
limitations and emergency procedures sections, to include a restriction
to operation in falling or blowing snow.
    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.

Other Related Service Information

    The FAA reviewed Airbus Helicopters Service Bulletin SB MBB-BK117
C-2-71-005, Revision 5, dated May 31, 2017; and Airbus Helicopters
Service Bulletin SB MBB[hyphen]BK117 D[hyphen]2-71-001, Revision 1,
dated August 2, 2017. This service information specifies procedures for
installing an IBF system.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA of the
unsafe condition described in its AD. The FAA is issuing this AD after
evaluating all pertinent information and determining that the unsafe
condition exists and is likely to exist or develop on other helicopters
of the same type design.

Requirements of This AD

    This AD requires accomplishing the actions specified in EASA AD
2021-0289-E, described previously, as IBRed, except for any differences
identified as exceptions in the regulatory text of this AD and except
as discussed under ``Differences Between this AD and the EASA AD.''

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result,
EASA AD 2021-0289-E will be IBRed in this FAA final rule. This AD
would, therefore, require compliance with EASA AD 2021-0289-E in its
entirety through that incorporation, except for any differences
identified as exceptions in the regulatory text of this AD. Using
common terms that are the same as the heading of a particular section
in EASA AD 2021-0289-E does not mean that operators need comply only
with that section. For example, where the AD requirement refers to
``all required actions and compliance times,'' compliance with this AD
requirement is not limited to the section titled ``Required Action(s)
and Compliance Time(s)'' in EASA AD 2021-0289-E. Service information
referenced in EASA AD 2021-0289-E for compliance will be available at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2022-0009.

Differences Between This AD and the EASA AD

    EASA AD 2021-0289-E applies to Model MBB-BK117 D-3m helicopters,
whereas this AD does not because that model is not FAA type-
certificated. EASA AD 2021-0289-E defines ``Retrofit SB'' as, ``AH
Service Bulletin (SB) MBB-BK117 C-2-71-005, SB MBB-BK117 D-2-71-001 and
SB MBB-BK117 D-3-71-001, as applicable, installing the IBF system,''
whereas this AD redefines ``Retrofit SB'' because SB MBB-BK117 D-3-71-
001 has not been issued.
    EASA AD 2021-0289-E requires operators to ``inform all flight
crews'' of revisions to the RFM, and thereafter to ``operate the
helicopter accordingly.'' However, this AD does not specifically
require those actions.
    14 CFR 91.9 requires that no person may operate a civil aircraft
without complying with the operating limitations specified in the RFM.
Therefore, including a requirement in this AD to operate the helicopter
according to the revised RFM would be redundant and unnecessary.
Additionally, FAA regulations mandate compliance with only the
operating limitations section of the flight manual. Some of the flight
manual changes required by this AD apply to the emergency procedures
section of the existing RFM for your helicopter. Compliance with such
requirements in an AD is impracticable to demonstrate or track on an
ongoing basis; therefore, requirements to operate the aircraft in such
a manner are unenforceable. Nonetheless, the FAA recommends that flight
crews of the helicopters listed in the applicability be made aware of
the flight manual changes and that they operate in accordance with the
revised emergency procedures.
    In this AD, the existing RFM for your helicopter may be revised and
the logbook entry for that action may be made by the owner/operator
(pilot) holding at least a private pilot certificate, whereas the EASA
AD does not mention this allowance. This action must be entered into
the aircraft records showing compliance with this AD in accordance with
14 CFR 43.9(a)(1) through (4) and 14 CFR 91.417(a)(2)(v). The record
must be maintained as required by 14 CFR 91.417 or 135.439.

Interim Action

    The FAA considers this AD interim action. If final action is later
identified, the FAA might consider further rulemaking then.

Justification for Immediate Adoption and Determination of the Effective
Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies foregoing notice and comment prior to adoption of this rule
because the affected component is part of the propulsion system that is
critical to the power of the helicopter. Partial icing of the affected
component could result in engine flame out, engine failure, reduced
control of the helicopter, and subsequent damage to the helicopter or
injury to occupants. In light of this, required actions must be
accomplished within 14 days or 40 hours time-in-service, whichever
occurs first after the effective date of this AD. This compliance time
is shorter than the time necessary for the public to comment and for
publication of the final rule. Accordingly, notice and opportunity for
prior public comment are impracticable and contrary to the public
interest pursuant to 5 U.S.C. 553(b)(3)(B).
    In addition, the FAA finds that good cause exists pursuant to 5
U.S.C. 553(d) for making this amendment effective in less than 30 days,
for the same reasons the FAA found good cause to forego notice and
comment.

Comments Invited

    The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2022-0009; Project Identifier MCAI-
2021-01459-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this final rule because of those comments.
    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
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this final rule.

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 AD 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 AD, 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 they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent to Hal
Jensen, Aerospace Engineer, Operational Safety Branch, Compliance &
Airworthiness Division, FAA, 950 L'Enfant Plaza N SW, Washington, DC
20024; telephone<PHONE_NUMBER>; email [email protected]. Any
commentary that the FAA receives that is not specifically designated as
CBI will be placed in the public docket for this rulemaking.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because the FAA has determined
that it has good cause to adopt this rule without prior notice and
comment, RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 213 helicopters of U.S.
Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates the following costs to comply with
this AD.
    Revising the existing RFM for your helicopter takes about 1 work-
hour for an estimated cost of about $85 per helicopter and up to about
$18,105 for the U.S. fleet.

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, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

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:

2022-02-17 Airbus Helicopters Deutschland GmbH (AHD): Amendment 39-
21914; Docket No. FAA-2022-0009; Project Identifier MCAI-2021-01459-
R.

(a) Effective Date

    This airworthiness directive (AD) is effective February 10,
2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Helicopters Deutschland GmbH (AHD)
Model MBB-BK 117 C-2, MBB-BK 117 D-2, and MBB-BK 117 D-3
helicopters, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code: 7160, Engine Air
Intake System.

(e) Unsafe Condition

    This AD was prompted by reports of engine flame out following
prolonged operations in falling snow with the inlet barrier filter
(IBF) system installed. The FAA is issuing this AD to prevent
partial icing of an IBF engine intake and engine flame out. The
unsafe condition, if not addressed, could result in engine failure
and reduced control of the helicopter, possibly resulting in damage
to the helicopter or injury to occupants.

(f) Compliance

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

(g) Requirements

    Comply with all required actions and compliance times specified
in, and in accordance with, European Union Aviation Safety Agency
(EASA) Emergency AD 2021-0289-E, dated December 23, 2021 (EASA AD
2021-0289-E).

(h) Exceptions to EASA AD 2021-0289-E

    (1) Where EASA AD 2021-0289-E defines Retrofit SB, replace the
text ``AH Service Bulletin (SB) MBB-BK117 C-2-71-005, SB MBB-BK117
D-2-71-001 and SB MBB-BK117 D-3-71-001, as applicable, installing
the IBF system,'' with ``AH Service Bulletin (SB) MBB-BK117 C-2-71-
005 and SB MBB-BK117 D-2-71-001, as applicable, installing the IBF
system; and for Model MBB-BK 117 D-3 helicopters, in accordance with
a method approved by the Manager, General Aviation & Rotorcraft
Section, International Validation Branch, FAA; or EASA; or Airbus
Helicopters' EASA Design Organization

Approval (DOA). If approved by the DOA, the approval must include
the DOA-authorized signature.''
    (2) Where EASA AD 2021-0289-E requires compliance in terms of
flight hours, this AD requires using hours time-in-service.
    (3) Where EASA AD 2021-0289-E refers to its effective date, this
AD requires using the effective date of this AD.
    (4) Where paragraph (1) of EASA AD 2021-0289-E specifies to
``inform all flight crews, and, thereafter, operate the helicopter
accordingly,'' this AD does not require those actions.
    (5) The action required by paragraphs (1) and (2) of EASA AD
2021-0289-E may be performed by the owner/operator (pilot) holding
at least a private pilot certificate and must be entered into the
aircraft records showing compliance with this AD in accordance with
14 CFR 43.9(a)(1) through (4) and 14 CFR 91.417(a)(2)(v). The record
must be maintained as required by 14 CFR 91.417 or 135.439.
    (6) This AD does not mandate compliance with the ``Remarks''
section of EASA AD 2021-0289-E.

(i) Special Flight Permit

    Special flight permits may be permitted provided that there are
no passengers on board.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation 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 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (k) of
this AD. Information may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    For more information about this AD, contact Hal Jensen,
Aerospace Engineer, Operational Safety Branch, Compliance &
Airworthiness Division, FAA, 950 L'Enfant Plaza N SW, Washington, DC
20024; telephone<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) European Union Aviation Safety Agency (EASA) Emergency AD
2021-0289-E, dated December 23, 2021.
    (ii) [Reserved]
    (3) For EASA AD 2021-0289-E, contact EASA, Konrad-Adenauer-Ufer
3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet www.easa.europa.eu. You may find the
EASA material on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket at https://www.regulations.gov by searching
for and locating Docket No. FAA-2022-0009.
    (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 13, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-01540 Filed 1-24-22; 11:15 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 97 (Friday, May 18, 2018)]
[Notices]
[Pages 23272-23273]
[FR Doc No: 2018-10612]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG18-87-000.
    Applicants: Pratt Wind, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Pratt Wind, LLC.
    Filed Date: 5/14/18.
    Accession Number: 20180514-5991.
    Comments Due: 5 p.m. ET 6/4/18.

    Docket Numbers: EG18-88-000.
    Applicants: Stoneray Power Partners, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Stoneray Power Partners, LLC.
    Filed Date: 5/14/18.
    Accession Number: 20180514-6023.
    Comments Due: 5 p.m. ET 6/4/18.

    Docket Numbers: EG18-89-000.
    Applicants: Copenhagen Wind Farm, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Copenhagen Wind Farm, LLC.
    Filed Date: 5/14/18.
    Accession Number: 20180514-6033.
    Comments Due: 5 p.m. ET 6/4/18.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER18-1581-000.
    Applicants: Tucson Electric Power Company.
    Description: Compliance filing: Order No. 842 Compliance Filing to
be effective 5/15/2018.
    Filed Date: 5/14/18.
    Accession Number: 20180514-5011.
    Comments Due: 5 p.m. ET 6/4/18.

    Docket Numbers: ER18-1582-000.
    Applicants: UNS Electric, Inc.
    Description: Compliance filing: Order No. 842 Compliance Filing to
be effective 5/15/2018.
    Filed Date: 5/14/18.
    Accession Number: 20180514-5012.
    Comments Due: 5 p.m. ET 6/4/18.

    Docket Numbers: ER18-1584-000.
    Applicants: Mississippi Power Company.
    Description: Request for Waiver of MRA Cost Based Tariff Volume No.
1 for Period I of Mississippi Power Company.
    Filed Date: 5/14/18.
    Accession Number: 20180514-5999.
    Comments Due: 5 p.m. ET 6/4/18.

    Docket Numbers: ER18-1586-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2018-05-14_SA 3114 Walnut
Bend Solar-EAI GIA (J552) to be effective 4/30/2018.
    Filed Date: 5/14/18.
    Accession Number: 20180514-6017.
    Comments Due: 5 p.m. ET 6/4/18.

    Docket Numbers: ER18-1587-000.
    Applicants: Tyr Energy, LLC.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revisions to be effective 5/15/2018.
    Filed Date: 5/14/18.
    Accession Number: 20180514-6022.
    Comments Due: 5 p.m. ET 6/4/18.

    Docket Numbers: ER18-1589-000.
    Applicants: Monongahela Power Company, PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Monongahela Power Company
submits OIA SA No. 4717 to be effective 7/13/2018.
    Filed Date: 5/14/18.
    Accession Number: 20180514-6041.
    Comments Due: 5 p.m. ET 6/4/18.

    Docket Numbers: ER18-1590-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: Revisions to Extend Tariff
Administration between SPP and SPA through 07/31/2018 to be effective
4/1/2018.
    Filed Date: 5/14/18.
    Accession Number: 20180514-6042.
    Comments Due: 5 p.m. ET 6/4/18.

    Docket Numbers: ER18-1592-000.
    Applicants: West Penn Power Company, PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: West Penn Power Company
submits OIA SA No. 4976 to be effective 7/13/2018.
    Filed Date: 5/14/18.
    Accession Number: 20180514-6046.
    Comments Due: 5 p.m. ET 6/4/18.

    Docket Numbers: ER18-1593-000.
    Applicants: Avista Corporation.
    Description: Compliance filing: Avista Corp OATT Order 842
Compliance Filing to be effective 5/15/2018.
    Filed Date: 5/14/18.
    Accession Number: 20180514-6049.
    Comments Due: 5 p.m. ET 6/4/18.

    Docket Numbers: ER18-1594-000.
    Applicants: Public Service Company of Colorado.
    Description: Compliance filing: OATT--Order No. 842 Compliance--
LGIP-SGIP to be effective 5/15/2018.
    Filed Date: 5/14/18.
    Accession Number: 20180514-6069.
    Comments Due: 5 p.m. ET 6/4/18.

    Docket Numbers: ER18-1597-000.
    Applicants: PJM Interconnection, L.L.C.

    Description: Sec.  205(d) Rate Filing: Original ISA, SA No. 5072;
Queue No. AB2-129 to be effective 4/16/2018.
    Filed Date: 5/14/18.
    Accession Number: 20180514-6094.
    Comments Due: 5 p.m. ET 6/4/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or 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 14, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-10612 Filed 5-17-18; 8:45 am]
 BILLING CODE 6717-01-P