[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Pages 33887-33888]
[FR Doc No: 2023-11148]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-1618]

Generally Accepted Scientific Knowledge in Applications for Drug
and Biological Products: Nonclinical Information; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Generally
Accepted Scientific Knowledge in Applications for Drug and Biological
Products: Nonclinical Information.'' This draft guidance is intended to
assist sponsors in determining whether it may be appropriate to rely on
generally accepted scientific knowledge (GASK) to fulfill certain legal
and regulatory requirements applicable to the new drug application
(NDA) or biologics licensing application (BLA) in question. When final,
this guidance will represent the Agency's current thinking on this
topic.

DATES: Submit either electronic or written comments on the draft
guidance by July 24, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-1618 for ``Generally Accepted Scientific Knowledge in
Applications for Drugs and Biological Products: Nonclinical
Information.'' 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, or 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
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: Kristiana Brugger, Office of
Regulatory Policy, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6262,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Diane Maloney, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Generally Accepted Scientific Knowledge in Applications for
Drugs and Biological Products: Nonclinical Information.'' This guidance
describes two types of instances in which it may be appropriate to rely
on GASK to meet certain nonclinical safety requirements for NDAs and
BLAs, regardless of regulatory pathway for approval or licensure (e.g.,
an NDA under section 505(b)(1) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 355(b)(1)) or an NDA pursuant to section
505(b)(2) of the FD&C Act; or a BLA under section 351(a) of the Public
Health Service Act (PHS Act) (42 U.S.C. 262(a)) or a BLA under section
351(k) of the PHS Act). The information that supports the nonclinical
safety of a drug or biological product and that must be submitted in
the application can include references to GASK, when appropriate,
instead of or in addition to, specific studies conducted with respect
to the drug or biological product. In such cases, therefore, it might
be unnecessary to conduct certain nonclinical studies. This guidance
does not address the use of GASK in other contexts (e.g., clinical
studies).
    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 ``Generally
Accepted Scientific Knowledge in Applications for Drug and Biological
Products: Nonclinical Information.'' 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. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312, investigational new drug
applications, have been approved under OMB control number 0910-0014.
The collections of information in 21 CFR part 314, NDAs and abbreviated
new drug applications, have been approved under OMB control number
0910-0001, and the collections of information in 21 CFR part 601, BLAs,
have been approved under OMB control number 0910-0338.

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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: May 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11148 Filed 5-24-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 25 (Monday, February 7, 2011)]
[Notices]
[Page 6612]
[FR Doc No: 2011-2619]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice Announcing Filing Priority for Preliminary Permit
Applications

January 28, 2011.

------------------------------------------------------------------------
                                                             Project No.
------------------------------------------------------------------------
FFP Missouri 13, LLC.......................................    13763-000
Grays Hydro, LLC...........................................    13772-000
------------------------------------------------------------------------

    On January 27, 2011, the Commission held a drawing to determine
priority between two competing preliminary permit applications with
identical filing times. In the event that the Commission concludes that
neither of the applicants' plans is better adapted than the other to
develop, conserve, and utilize in the public interest the water
resources of the region at issue, the priority established by this
drawing will serve as the tiebreaker. Based on the drawing, the order
of priority is as follows:

1. FFP Missouri 13, LLC--Project No. 13763-000
2. Grays Hydro, LLC--Project No. 13772-000

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-2619 Filed 2-4-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 30, 2010 (Volume 75, Number 167)]
[Proposed Rules]
[Page 52914-52916]
[DOCID:fr30au10-21]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0865; Directorate Identifier 2010-SW-061-AD]
RIN 2120-AA64

Airworthiness Directives; Bell Helicopter Textron Canada Limited
Models 206A, 206B, 206L, 206L-1, 206L-3, and 206L-4 Helicopters

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    It has been determined that new tail rotor disc assembly Part
Number (P/N) 101584-1 or -2, sold through Bell Helicopter Spares
beginning March 2009, as an alternate to P/N 32721-1, does not
conform to the approved configuration. Operating a helicopter with
disk assembly P/N 101584-1 or -2 installed may result in loss of
control of the helicopter.

The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by October 14,
2010.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
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 Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Sharon Miles, Aerospace Engineer, FAA,
Rotorcraft Directorate, 2601 Meacham Blvd., Fort Worth, Texas 76137;
telephone:<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-2010-0865;
Directorate Identifier 2010-SW-061-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 because of 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 we
receive about this proposed AD.

Discussion

    Transport Canada, which is the aviation authority for Canada, has
issued AD No. CF-2010-07, dated February 24, 2010 (referred to after
this as ``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    It has been determined that new tail rotor disc assembly Part
Number (P/N) 101584-1 or -2, sold through Bell Helicopter Spares

beginning March 2009, as an alternate to P/N 32721-1, does not
conform to the approved configuration. Operating a helicopter with
disk assembly P/N 101584-1 or -2 installed may result in loss of
control of the helicopter.
    This directive mandates the removal from service tail rotor disc
assembly P/N 101584-1 and -2.

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

Relevant Service Information

    Bell Helicopter has issued Alert Service Bulletin No. 206-09-123,
REV A, dated June 10, 2009, and Alert Service Bulletin No. 206L-09-157,
REV A, dated June 10, 2009. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of the 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 our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Differences Between This Proposed AD and the MCAI or Service
Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a Note within the proposed AD.

Costs of Compliance

    We estimate that this proposed AD will affect 2,847 products of
U.S. registry. We also estimate that it would take about 1 work-hour
per product to comply with the basic requirements of this proposed AD.
The average labor rate is $85 per work-hour. Required parts would cost
about $260 per product.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $982,215 or $345 per product.

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, 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

    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:

Bell Helicopter Textron Canada Limited: Docket No. FAA-2010-0865;
Directorate Identifier 2010-SW-061-AD.

Comments Due Date

    (a) We must receive comments by October 14, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to the following model and serial number
airplanes, certificated in any category.

------------------------------------------------------------------------
               Model                          Serial No. (S/N)
------------------------------------------------------------------------
206A..............................  004 through 660 and 672 through 715.
206B..............................  All S/Ns including those converted
                                     from Model 206A.
206L..............................  45004 through 45153 and 46601
                                     through 46617.
206L-1............................  45154 through 45790.
206L-3............................  51001 through 51612.
206L-4............................  All S/Ns.
------------------------------------------------------------------------

Subject

    (d) Air Transport Association of America (ATA) Code 65: Tail
Rotor Drive.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    It has been determined that new tail rotor disc assembly Part
Number (P/N) 101584-1 or -2, sold through Bell Helicopter Spares
beginning March 2009, as an alternate to P/N 32721-1, does not
conform to the approved configuration. Operating a helicopter with
disk assembly P/N 101584-1 or -2 installed may result in loss of
control of the helicopter.
    This directive mandates the removal from service tail rotor disc
assembly P/N 101584-1 and -2.

Actions and Compliance

    (f) Unless already done, do the following actions following Bell
Helicopter Alert Service Bulletin No. 206-09-123, REV A, dated June
10, 2009; and Bell Helicopter Alert Service Bulletin No. 206L-09-
157, REV A, dated June 10, 2009, as applicable.
    (1) Check the helicopter maintenance records to determine if a
disc assembly, part number (P/N) 101584-1 or -2, is installed. Do
this check within the next 30 days after the effective date of this
AD or within the next 100 hours time-in-service (TIS) after the
effective date of this AD, whichever occurs first.
    (2) If, during the maintenance records check required in
paragraph (f)(1) of this AD,

you cannot positively determine that a P/N 101584-1 or -2 disc
assembly is not installed, within the next 30 days after the
effective date of this AD or within the next 100 hours TIS after the
effective date of this AD, whichever occurs first, inspect the tail
rotor driveshaft system to determine if P/N 101584-1 or -2 is
installed.
    (3) If, during the maintenance records check required in
paragraph (f)(1) of this AD or during the inspection required in
paragraph (f)(2) of this AD, you can positively determine that a P/N
101584-1 or -2 disc assembly is not installed, no further action is
required. Before further flight, make an entry in the log book
showing compliance with this AD.
    (4) If, during the maintenance records check required in
paragraph (f)(1) of this AD or during the inspection required in
paragraph (f)(2) of this AD, you can positively determine that a P/N
101584-1 or -2 disc assembly is installed, within the next 30 days
after the effective date of this AD or within the next 100 hours TIS
after the effective date of this AD, whichever occurs first, replace
disc assembly P/N 101584-1 or -2 with disc assembly P/N 32721-1.
    (5) As of the effective date of this AD, do not install disc
assembly P/N 101584-1 or -2.

FAA AD Differences

    Note:  This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Sharon Miles, Aerospace Engineer, FAA,
Rotorcraft Directorate, 2601 Meacham Blvd., Fort Worth, Texas 76137;
telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. Before using any
approved AMOC on any airplane to which the AMOC applies, notify your
appropriate principal inspector (PI) in the FAA Flight Standards
District Office (FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI Transport Canada, AD No. CF-2010-07, dated
February 24, 2010; Bell Helicopter Alert Service Bulletin No. 206-
09-123, REV A, dated June 10, 2009; and Bell Helicopter Alert
Service Bulletin No. 206L-09-157, REV A, dated June 10, 2009, for
related information.

    Issued in Fort Worth, Texas, on August 19, 2010.
Mark R. Schilling,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2010-21589 Filed 8-27-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 85 (Tuesday, May 3, 2022)]
[Proposed Rules]
[Pages 26143-26145]
[FR Doc No: 2022-09488]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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

Federal Register / Vol. 87, No. 85 / Tuesday, May 3, 2022 / Proposed
Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 29

[Docket No. FAA-2022-0183; Notice No. 29-22-01-SC]

Special Conditions: The Boeing Company, Leonardo S.p.a. Model
AW139 Helicopter; Use of New Hovering Out of Ground Effect Utility
Power on the Model AW139 Helicopter

AGENCY: Federal Aviation Administration (FAA), Transportation (DOT).

ACTION: Notice of proposed special conditions.

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

SUMMARY: This action proposes special conditions for the Leonardo
S.p.a. (Leonardo) Model AW139 helicopter. This helicopter as modified
by The Boeing Company (Boeing) will have a novel or unusual design
feature when compared to the state of technology envisioned in the
airworthiness standards for helicopters. This design feature
incorporates a 2.5-minute all engines operating (AEO) power restricted
for use at helicopter operating speeds below 60 knots indicated
airspeed (KIAS), and hovering out of ground effect (HOGE). This power
is referred to as 2.5-minute HOGE utility power (HUP), or 2.5-minute
HUP. The 2.5-minute HUP is greater than the transmission power
limitations associated with takeoff and AEO. The applicable
airworthiness regulations do not contain adequate or appropriate safety
standards for this design feature. These proposed special conditions
contain the additional safety standards that the Administrator
considers necessary to establish a level of safety equivalent to that
established by the existing airworthiness standards.

DATES: Send comments on or before June 17, 2022.

ADDRESSES: Send comments identified by Docket No. FAA-2022-0183 using
any of the following methods:
     Federal eRegulations Portal: Go to https://www.regulations.gov/ and follow the online instructions for sending
your comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: Except for Confidential Business Information (CBI) as
described in the following paragraph, and other information as
described in title 14, Code of Federal Regulations (14 CFR), Sec.
11.35, the FAA will post all comments received without change to
https://www.regulations.gov/, including any personal information you
provide. The FAA will also post a report summarizing each substantive
verbal contact received about these proposed special conditions.
    Confidential Business Information: Confidential Business
Information (CBI) is commercial or financial information that is both
customarily and actually treated as private by its owner. Under the
Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from
public disclosure. If your comments responsive to this Notice contain
commercial or financial information that is customarily treated as
private, that you actually treat as private, and that is relevant or
responsive to this Notice, it is important that you clearly designate
the submitted comments as CBI. Please mark each page of your submission
containing CBI as ``PROPIN.'' The FAA will treat such marked
submissions as confidential under the FOIA, and the indicated comments
will not be placed in the public docket of this Notice. Submissions
containing CBI should be sent to Dorina Mihail, Propulsion and Energy
Section, AIR-624, Technical Innovation Policy Branch, Policy and
Innovation Division, Aircraft Certification Service, Federal Aviation
Administration, 1200 District Avenue, Burlington, MA 01803; telephone
781-238-7153; fax<PHONE_NUMBER>; email [email protected]. Comments
the FAA receives, which are not specifically designated as CBI, will be
placed in the public docket for this rulemaking.
    Docket: Background documents or comments received may be read at
https://www.regulations.gov/ at any time. Follow the online
instructions for accessing the docket or go to Docket Operations in
Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Dorina Mihail, Propulsion and Energy
Section, AIR-624, Technical Innovation Policy Branch, Policy and
Innovation Division, Aircraft Certification Service, Federal Aviation
Administration, 1200 District Avenue, Burlington, MA 01803; telephone
781-238-7153; fax<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. The most helpful comments reference a
specific portion of the special conditions, explain the reason for any
recommended change, and include supporting data.
    The FAA will consider all comments received by the closing date for
comments. The FAA may change these special conditions based on the
comments received.

Background

    On September 18, 2020, Boeing applied for a supplemental type
certificate for performance envelope expansion of the Leonardo Model
AW139 helicopter. The AW139 helicopter as changed, is a medium twin-
engine 14 CFR part 29 transport category B helicopter with a 15,521
pounds (7040 Kg) maximum takeoff weight and a maximum seating capacity
of nine passengers and two crew. This helicopter takeoff and landing
altitude is 10,000 feet density altitude (Hd), and the forward flight
altitude is 11,000 feet Hd. This helicopter has the capability for
Category II instrument landing system (ILS) approaches. The Model AW139
helicopter as changed will be equipped with two PT6C-67C1 engines. The
Model AW139 helicopter as

changed will have a 2.5-minute HUP for use in HOGE that exceeds the
transmission power limitations associated with takeoff and AEO.

Type Certification Basis

    Under the provisions of 14 CFR 21.101, Boeing must show that the
Leonardo Model AW139 helicopter, as changed, continues to meet the
applicable provisions of the regulations listed in Type Certificate No.
R00002RD, or the applicable regulations in effect on the date of
application for the change, except for earlier amendments as agreed
upon by the FAA. The proposed certification basis for this supplemental
type certificate is as follows:
    14 CFR 21.29 and part 29, Amendment 29-1 through Amendment 29-45
with 14 CFR 29.25, 29.143, 29.173, 29.175, 29.177 at Amendment 29-51,
and 14 CFR 29.773 at Amendment 29-57.
    Equivalent Level of Safety Findings issued against:
    14 CFR 29.1305, as documented in the AB139 FAA Memo, dated December
20, 2004.
    If the Administrator finds that the applicable airworthiness
regulations (e.g., 14 CFR part 29) do not contain adequate or
appropriate safety standards for the Leonardo Model AW139 helicopter
because of a novel or unusual design feature, special conditions are
prescribed under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the applicant apply for a supplemental type
certificate to modify any other model included on the same type
certificate to incorporate the same novel or unusual design feature,
these special conditions would also apply to the other model under
Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Leonardo Model AW139 helicopter must comply with the
noise certification requirements of 14 CFR part 36.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type
certification basis under Sec.  21.101.

Novel or Unusual Design Feature

    The Leonardo Model AW139 helicopter will incorporate a novel or
unusual design feature which is a 2.5-minute AEO power that is greater
than the transmission takeoff power limitations associated with takeoff
and AEO. This power is restricted for use when HOGE and at helicopter
operating speeds below 60 KIAS. The applicable airworthiness
regulations do not contain adequate or appropriate safety standards for
this design feature.

Discussion

    The design feature will incorporate a 2.5-minute HUP that allows
the pilot to enter HOGE, operate in HOGE, and depart from HOGE at high
altitudes and ambient atmospheric temperatures. The use of the 2.5-
minute HUP is limited to periods of no longer than 2.5 minutes each
use, under AEO conditions, at helicopter operating speeds below 60 KIAS
and HOGE. Use of the 2.5-minute HUP is not part of, or combined with a
takeoff operation.
    Helicopter operation at the 2.5-minute HUP will use the engine
power higher than the rated maximum continuous power and limits but
lower than the rated takeoff power and limits and do not exceed the 5
minute takeoff rating for which the engines are type certificated.
Existing part 33 regulations for the engines are adequate for the
proposed helicopter 2.5-minute HUP.
    Use of the 2.5-minute HUP exceeds the helicopter transmission power
limitations associated with takeoff and AEO. Existing part 29
regulations do not recognize helicopter operation that exceeds the
transmission power limitations associated with takeoff and AEO. The
special conditions that the FAA proposes to address the use of the 2.5-
minute HUP on this model of helicopter, as modified by Boeing, are as
follows.
    The Rotorcraft Flight Manual must specify that the use of the 2.5-
minute HUP is limited to periods no longer than 2.5 minutes each, under
AEO conditions, at helicopter operating speeds below 60 KIAS and HOGE.
Additionally, the Rotorcraft Flight Manual must specify that use of the
2.5-minute HUP is not part of, or combined with, a takeoff operation.
    The requirement added to Sec.  29.49(c) provides for the
development of helicopter performance data for 2.5-minute HUP
utilization.
    The testing requirement added to Sec.  29.923(d) consists of two
applications of 2.5-minute HUP torque and the maximum speed per 10-hour
cycle. The 10-hour cycle represents a run of 10 hours in length that is
repeated 20 times, for a total of (at least) 200 hours of endurance
testing as required by Sec.  29.923(a). Therefore, the testing added to
Sec.  29.923(d) provides for 40 applications of the 2.5-minute HUP
during the 200-hour endurance test specified in Sec.  29.923(a). This
testing is added to Sec.  29.923(d) ``Endurance tests; 90 percent of
maximum continuous run,'' since the 2.5-minute HUP is not part of, or
combined with, a takeoff operation, as stated in these special
conditions and is expected to be used during mid-mission.
    The flight-test requirement added to Sec.  29.1049 is intended to
address the hovering cooling provisions at the 2.5-minute HUP and HOGE
following thermal stabilization at maximum weight, mission
representative power, maximum altitude, and ambient temperatures
specified in Sec.  29.1043(b). The flight-test continues with cycling
in and out of the HUP mode, in a manner representative of the intended
use of the 2.5-minute HUP, per the instructions specified in the
Rotorcraft Flight Manual. The repeated successive HUP applications and
time duration between HUP cycles result in the most critical condition
for the cooling provisions required by Sec.  29.1041(a) and (b). The
flight-test continues with departing the hover and transitioning to a
maximum continuous power climb at the best rate of climb speed. Climb
is continued for 5 minutes after the highest temperatures are observed
or until the service ceiling is reached.
    The requirements added to Sec.  29.1305 are means for the pilot to
identify when the 2.5-minute HUP level is achieved, when the event
begins, and when the time interval expires. These means will assist the
pilot in managing the 2.5-minute HUP short time duration in a pilot
high-workload environment.
    The requirements added to Sec.  29.1521 are similar to the
powerplant limitations for takeoff operations in Sec.  29.1521(b),
modified to reflect the 2.5-minute HUP.
    The requirement added to Sec.  29.1587(b)(8) will require
publishing the performance data developed under paragraph (b) of these
special conditions in the Rotorcraft Flight Manual. These data must be
clearly referenced to the appropriate hover charts and specify that
they are not to be used for take-off or landing determinations.
    These proposed special conditions contain the additional safety
standards that the Administrator considers necessary to establish a
level of safety equivalent to that established by the existing
airworthiness standards.

Applicability

    As discussed above, these proposed special conditions are
applicable to the Leonardo Model AW139 helicopter. Should Boeing apply
at a later date for a supplemental type certificate to modify any other
model included on Type Certificate No. R00002RD, to incorporate the
same novel or unusual design feature, these special conditions would
apply to that model as well.

Conclusion

    This action affects only a certain novel or unusual design feature
on the Leonardo Model AW139 helicopter. It is not a rule of general
applicability and affects only the applicant who applied to the FAA for
approval of this feature on the helicopter.

List of Subjects in 14 CFR Part 29

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

Authority Citation

    The authority citation for these special conditions is as follows:

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

The Proposed Special Conditions

    Accordingly, the Federal Aviation Administration (FAA) proposes the
following special conditions as part of the type certification basis
for the Leonardo S.p.a. Model AW139 helicopter, as modified by The
Boeing Company.
    (a) The Rotorcraft Flight Manual must state the following:
    (1) Use of the 2.5-minute Hovering Out of Ground Effect (HOGE)
Utility Power (2.5-minute HUP) is limited to a period no longer than
2.5 minutes each, under all engine operating (AEO) conditions, at
helicopter operating speeds below 60 knots indicated airspeed (KIAS)
and HOGE.
    (2) Use of the 2.5-minute HUP is not part of, or combined with, a
takeoff operation.
    (b) In addition to the requirements of Sec.  29.49(c), the out-of-
ground effect hover performance must be determined over the ranges of
weight, altitude, and temperatures for which certification is requested
with the 2.5-minute HUP.
    (c) In addition to the requirements of Sec.  29.923(d) when
performing the endurance test, the 2.5 minute all engines operating
must be performed using two applications of 2.5-minute HUP torque and
the maximum speed for use with 2.5-minute HUP torque, per 10-hour
cycle.
    (d) In addition to the requirements of Sec.  29.1049, the hovering
cooling provisions at the 2.5-minute HUP must be shown as follows--
    (1) Conduct a thermal stabilization at maximum weight, mission
representative power, maximum altitude, and ambient temperatures
specified in Sec.  29.1043(b); following stabilization, increase power
to the 2.5-minute HUP and HOGE for a duration of 2.5 minutes (150
seconds).
    (2) Cycle in and out the HUP mode in a manner representative of the
intended use of the 2.5-minute HUP, and per the instructions specified
in the Rotorcraft Flight Manual, if any. The HUP cycles should account
for repeated successive HUP applications and time duration between HUP
cycles resulting in the most critical condition for the cooling
provisions required by Sec.  29.1041(a) and (b).
    (3) Following the tests in paragraphs (d)(1) and (2) of these
special conditions, depart the hover and transition to a maximum
continuous power climb at the best rate of climb speed. Continue the
climb until 5 minutes after the highest temperatures are observed or
until the service ceiling is reached.
    (e) In addition to the requirements of Sec.  29.1305, the pilot
must have the means to identify the 2.5-minute HUP time limit
associated with its use as follows--
    (1) When the power level is achieved,
    (2) when the event begins, and
    (3) when the time interval expires.
    These indications must be clear and unambiguous to the pilot and
must not cause pilot confusion. The use of these indications must be
evaluated in operationally relevant scenarios in accordance with Sec.
29.1523 for crew workload.
    (f) In addition to the requirements of Sec.  29.1521, the use of
the 2.5-minute HUP must be limited by the following:
    (1) The maximum rotational speed, which may not be greater than--
    (i) The maximum value determined by the rotor design, or
    (ii) The maximum value demonstrated during the type tests.
    (2) The maximum allowable turbine inlet or turbine outlet gas
temperature (for turbine engines).
    (3) The maximum allowable power or torque for each engine,
considering the power input limitations of the transmission with all
engines operating.
    (4) The maximum allowable power or torque for each engine
considering the power input limitations of the transmission with one
engine inoperative;
    (5) The time limit for the use of the power corresponding to the
limitations established in paragraphs (f)(1) through (4) of these
special conditions.
    (6) The maximum allowable engine and transmission oil temperatures,
if the time limit established in paragraph (f)(5) of these special
conditions exceeds 2 minutes.
    (7) Use of 2.5-minute HUP is limited to HOGE only.
    (g) In addition to the requirements of Sec.  29.1587(b)(8), the
Rotorcraft Flight Manual must contain the out-of-ground effect hover
performance determined under paragraph (b) of these special conditions,
and the maximum safe wind demonstrated under the ambient conditions for
the data presented. In addition, the Rotorcraft Flight Manual must
include the maximum weight for each altitude and temperature condition
at which the rotorcraft can safely hover out-of-ground-effect in winds
not less than 17 knots from all azimuths. These data must be clearly
referenced to the appropriate hover charts and specify that they are
not to be used for take-off or landing determinations.

    Issued in Kansas City, Missouri, on April 28, 2022.
Patrick R. Mullen,
Manager, Technical Innovation Policy Branch, Policy and Innovation
Division, Aircraft Certification Service.
[FR Doc. 2022-09488 Filed 5-2-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 56 (Tuesday, March 24, 2015)]
[Notices]
[Pages 15651-15652]
[FR Doc No: 2015-06623]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74528; File No. SR-ISE-2015-10]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Amend the Schedule of Fees

March 18, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on March 13, 2015, the International Securities Exchange, LLC (the
``Exchange'' or the ``ISE'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change, as described
in Items I, II, and III below, which items have been prepared by the
self-regulatory organization. The Commission is publishing this notice
to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE proposes to amend the Schedule of Fees to expand low
latency Ethernet fees to non-members. The text of the proposed rule
change is available on the Exchange's Web site (http://www.ise.com), at
the principal office of the Exchange, and at the Commission's Public
Reference Room.\3\
---------------------------------------------------------------------------

    \3\ The text of the proposed rule change is marked to show
changes made by ISE-2015-11.
---------------------------------------------------------------------------

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in sections A, B and C below, of the
most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange charges an Ethernet fee for its four different
Ethernet connection options, which is $1,000 per month for a 1 Gigabit
(``Gb'') connection, $4,500 per month for a 10 Gb connection, $8,000
per month for a 10 Gb low latency connection, and $15,000 per month for
a 40 Gb low latency connection. These Ethernet connectivity options
provide access to both the ISE and the ISE's sister exchange, ISE
Gemini, LLC (``ISE Gemini'').\4\ While the 1 Gb and 10 Gb Ethernet fees
apply to both members and non-members, the 10 Gb low latency and 40 Gb
low latency fees apply only to members. The Exchange now proposes to
amend the Schedule of Fees to apply the low latency Ethernet fee to
non-members as well. The Exchange designates this filing to become
effective on March 16, 2015.
---------------------------------------------------------------------------

    \4\ Market participants pay the same fees regardless of whether
they choose to connect to both exchanges or solely to the ISE.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\5\ in general, and Section
6(b)(4) of the Act,\6\ in particular, in that it is designed to provide
for the equitable allocation of reasonable dues, fees, and other
charges among its members and other persons using its facilities. The
Exchange believes that it is reasonable, equitable, and not unfairly
discriminatory to extend the low latency Ethernet fees to non-members.
Market participants that establish connectivity to the Exchange will
continue to pay the same fee based on the Ethernet options that they
choose, and there will be no discrimination between the fees charged
for members and non-members. While these low latency connections will
likely continue to be of primary interest to Exchange members, the
Exchange believes that these options should be available to interested
non-members as well. Furthermore, the Exchange notes that the proposed
rule change does not modify the fees applicable to these premium low
latency Ethernet options, which will remain at their current

levels. The low latency Ethernet fees described in this filing remain
consistent with the Exchange's connectivity costs, including costs for
software and hardware enhancements, and resources dedicated to
development, quality assurance, and support.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f.
    \6\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,\7\ the Exchange does
not believe that the proposed rule change will impose any burden on
intermarket or intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The proposed
rule change amends the Schedule of Fees to apply low latency Ethernet
fees to non-members in addition to members, and is not intended to have
any competitive effect. The Exchange operates in a highly competitive
market in which market participants can readily direct their order flow
to competing venues. In such an environment, the Exchange must
continually review, and consider adjusting, its fees to remain
competitive with other exchanges. For the reasons described above, the
Exchange believes that the proposed fee changes reflect this
competitive environment.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \8\ and subparagraph (f)(2) of Rule 19b-4
thereunder,\9\ because it establishes a due, fee, or other charge
imposed by ISE.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \9\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2015-10 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-ISE-2015-10. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the ISE. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2015-10 and should be
submitted by April 14, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-06623 Filed 3-23-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 34 (Tuesday, February 23, 2021)]
[Notices]
[Pages 10955-10958]
[FR Doc No: 2021-03583]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-10017-76-OMS]

Privacy Act of 1974; System of Records

AGENCY: Office of Mission Support (OMS), Environmental Protection
Agency (EPA).

ACTION: Notice of a new system of records.

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

SUMMARY: The U.S. Environmental Protection Agency's (EPA), Office of
Mission Support is giving notice that it proposes to create a new
system of records pursuant to the provisions of the Privacy Act of
1974. Fleet Access (FA) is being created to comply with United States
Code (U.S.C.) 175 Federal Motor Vehicle Expenditure Control and the
General Services Administration (GSA)

Federal Management Regulation (FMR) B-15 requiring all federal agencies
store and maintain vehicle asset data collected in a Fleet Management
Information System (FMIS).

DATES: Persons wishing to comment on this system of records notice must
do so by March 25, 2021. New routine uses for this new system of
records will be effective March 25, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OMS-2020-0137, by one of the following methods:
    Regulations.gov: www.regulations.gov. Follow the online
instructions for submitting comments.
    Email<EMAIL_ADDRESS>    Fax:<PHONE_NUMBER>.
    Mail: OMS Docket, Environmental Protection Agency, Mail Code:
2822T, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    Hand Delivery: OMS Docket, EPA/DC, WJC West Building, Room 3334,
1301 Constitution Ave. NW, Washington, DC 20460. Such deliveries are
only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OMS-
2020-0137. The EPA policy is that all comments received will be
included in the public docket without change and may be made available
online at www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Controlled Unclassified Information (CUI) or other information for
which disclosure is restricted by statute. Do not submit information
that you consider to be CUI or otherwise protected through
www.regulations.gov. The www.regulations.gov website is an ``anonymous
access'' system for EPA, which means the EPA will not know your
identity or contact information unless you provide it in the body of
your comment. Each agency determines submission requirements within
their own internal processes and standards. EPA has no requirement of
personal information. If you send an email comment directly to the EPA
without going through www.regulations.gov your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the internet. If you
submit an electronic comment, the EPA recommends that you include your
name and other contact information in the body of your comment. If the
EPA cannot read your comment due to technical difficulties and cannot
contact you for clarification, the EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses. For
additional information about the EPA public docket, visit the EPA
Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CUI or other information
for which disclosure is restricted by statute. Certain other material,
such as copyrighted material, will be publicly available only in hard
copy. Publicly available docket materials are available either
electronically in www.regulations.gov or in hard copy at the OMS
Docket, EPA/DC, WJC West Building, Room 3334, 1301 Constitution Ave.
NW, Washington, DC 20460. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OMS Docket is<PHONE_NUMBER>.
    Out of an abundance of caution for members of the public and our
staff, the EPA Docket Center and Reading Room are closed to the public,
with limited exceptions, to reduce the risk of transmitting COVID-19.
Our Docket Center staff will continue to provide remote customer
service via email, phone, and webform. We encourage the public to
submit comments via https://www.regulations.gov/ or email, as there may
be a delay in processing mail and faxes. Hand deliveries and couriers
may be received by scheduled appointment only. For further information
on EPA Docket Center services and the current status, please visit us
online at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: General questions about the Fleet
Access system should be made in writing to: James Cunningham, (202)
564-7212<EMAIL_ADDRESS>Jackie Brown,<PHONE_NUMBER>,
<EMAIL_ADDRESS>and Jonathan Barnes,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Fleet Access stores vehicle level data such
as license plate, VIN, make, model, acquisition value/and or lease
rates as well as designations regarding alternative fuel, energy, and
sustainability mandates. Fleet Access is used to produce an end-of-year
report known as the Federal Automotive Statistical Tool Report (FAST
Report) submitted jointly to the Department of Energy (DOE), the
General Services Administration (GSA), and the Idaho National Lab
(INL). The FAST report summarizes each vehicle's yearly data with
respect to fuel, mileage, maintenance, acquisition, and disposal. Fleet
Access also serves as a comprehensive standardized vehicle reservation
system used by agency staff needing to reserve and utilize fleet
vehicles for official agency business. Vehicle registration features of
Fleet Access requires system users register personal business
information in order to reserve agency fleet assets.

SYSTEM NAME AND NUMBER:
    Fleet Access (FA)--EPA-85.

SECURITY CLASSIFICATION:
    Unclassified.

SYSTEM LOCATION:
    AgileFleet (Fleet Access Service Provider): 14101 Willard Rd.,
Suite A, Chantilly, VA 20151; AgileFleet (Fleet Access Datacenter): 600
West 7th Street, Los Angeles, CA 900021, System Managers: 1200
Pennsylvania Ave. NW, Washington, DC 20460.

SYSTEM MANAGER(S):
    James Cunningham, IT Project Manager, 1200 Pennsylvania Ave. NW,
Washington, DC 20460, Mail code 3101M, [email protected], 202-
564-7212.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    40 U.S.C. 175--Federal Motor Vehicle Expenditure Control; Sections
15301 and 15302 of the Consolidated Omnibus Budget Reconciliation Act
of 1986 (Pub. L. 99-272) (40 U.S.C. 17502 and 17503); and General
Services Administration (GSA) FMR B-15.

PURPOSE(S) OF THE SYSTEM:
    Fleet Access (FA) is a contractor owned and operated system used by
EPA to comply with the General Services Administration (GSA) FMR B-15
requirement that each federal agency store and maintain vehicle asset
data collected in a Fleet Management Information System (FMIS). The FA
system serves two primary purposes: First, to store vehicle level data
such as license plate, VIN, make, model, acquisition value/lease rates,
designations regarding alternative fuel, energy and sustainability
mandates. Which is used to produce the Federal Automotive Statistical
Tool Report (FAST Report) as an end of year report. This end of year
report is submitted jointly to the Department of Energy (DOE), the GSA,
and the Idaho National

Lab (INL). The FAST report summarizes each vehicle's annual data with
respect to fuel, mileage, maintenance, acquisition, and disposal. And
second, it is used by EPA's Fleet program management, regional, local
staff and support contractors as a standardized vehicle reservation
system to reserve and utilize fleet vehicles for official agency
business.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    The categories of individuals covered by this system include EPA
employees and EPA Contractors.

CATEGORIES OF RECORDS IN THE SYSTEM:
    PII collected includes: Last Name, First Name, Work Phone Number,
Work Email Address, Driver's License Expiration Date, and Profile
Picture.

RECORD SOURCE CATEGORIES:
    Fleet Access is a data management system that allows authorized EPA
employees and contractors to store/maintain vehicle asset data and
reserve agency vehicles across various programs/regions. PII
information is collected directly from the user via an online
registration form.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND PURPOSES OF SUCH USES:
    The following new or modified routine uses apply to this system
because the use of the record is necessary for the efficient conduct of
government. The routine uses are related to and compatible with the
original purpose for which the information was collected.
    A. Disclosure of Law Enforcement Purposes: Information may be
disclosed to the appropriate Federal, State, local, tribal, or foreign
agency responsible for investigating, prosecuting, enforcing, or
implementing a statute, rule, regulation, or order, if the information
is relevant to a violation or potential violation of civil or criminal
law or regulation within the jurisdiction of the receiving entity.
    B. Disclosure Incident to Requesting Information: Information may
be disclosed to any source from which additional information is
requested (to the extent necessary to identify the individual, inform
the source of the purpose of the request, and to identify the type of
information requested,) when necessary to obtain information relevant
to an agency decision concerning retention of an employee or other
personnel action (other than hiring), retention of a security
clearance, the letting of a contract, or the issuance or retention of a
grant or other benefit.
    C. Disclosure to Requesting Agency: Disclosure may be made to a
Federal, State, local, foreign, or tribal or other public authority of
the fact that this system of records contains information relevant to
the retention of an employee, the retention of a security clearance,
the letting of a contract, or the issuance or retention of a license,
grant or other benefit. The other agency or licensing organization may
then make a request supported by the written consent of the individual
for the entire record if it so chooses. No disclosure will be made
unless the information has been determined to be sufficiently reliable
to support a referral to another office within the agency or to another
Federal agency for criminal, civil, administrative, personnel or
regulatory action.
    D. Disclosure of Office of Management and Budget: Information may
be disclosed to the Office of Management and Budget (OMB) at any stage
in the legislative coordination and clearance process in connection
with private relief legislation as set forth in OMB Circular No. A-19.
    E. Disclosure to Congressional Offices: Information may be
disclosed to a congressional office from the record of an individual in
response to an inquiry from the congressional office made at the
request of the individual.
    F. Disclosure to Department of Justice: Information may be
disclosed to the Department of Justice, or in a proceeding before a
court, adjudicative body, or other administrative body before which the
Agency is authorized to appear, when:
    1. The Agency, or any component thereof;
    2. Any employee of the Agency in his or her official capacity;
    3. Any employee of the Agency in his or her individual capacity
where the Department of Justice or the Agency have agreed to represent
the employee; or
    4. The United States, if the Agency determines that litigation is
likely to affect the Agency or any of its components, is a party to
litigation or has an interest in such litigation, and the use of such
records by the Department of Justice or the Agency is deemed by the
Agency to be relevant and necessary to the litigation provided,
however, that in each case it has been determined that the disclosure
is compatible with the purpose for which the records were collected.
    G. Disclosure of National Archives: Information may be disclosed to
the National Archives and Records Administration in records management
inspections.
    H. Disclosure to Contractors, Grantees, and Others: Information may
be disclosed to contractors, grantees, consultants, or volunteers
performing or working on a contract, service, grant, cooperative
agreement, job, or other activity for the Agency and who have a need to
have access to the information in the performance of their duties or
activities for the Agency. When appropriate, recipients will be
required to comply with the requirements of the Privacy Act of 1974 as
provided in 5 U.S.C. 552a(m).
    I. Disclosures of Administrative Claims, Complaints and Appeals:
Information from this system of records may be disclosed to an
authorized appeal grievance examiner, formal complaints examiner, equal
employment opportunity investigator, arbitrator or other person
properly engaged in investigation or settlement of an administrative
grievance, complaint, claim, or appeal filed by an employee, but only
to the extent that the information is relevant and necessary to the
proceeding. Agencies that may obtain information under this routine use
include, the Office of Personnel Management, Office of Special Counsel,
Merit Systems Protection Board, Federal Labor Relations Authority,
Equal Employment Opportunity Commission and Office of Government
Ethics.
    J. Disclosure to the Office of Personnel Management: Information
from this system of records may be disclosed to the Office of Personnel
Management pursuant to that agency's responsibility for evaluation and
oversight of Federal personnel management.
    K. Disclosure in Connection with Litigation: Information from this
system of records may be disclosed in connection with litigation or
settlement discussions regarding claims by or against the Agency,
including public filing with a court, to the extent that disclosure of
the information is relevant and necessary to the litigation or
discussions and except where court orders are otherwise required under
section (b)(11) of the Privacy Act of 1974, 5 U.S.C. 552a(b)(11).
    L. Disclosure to Persons or Entities in Response to an Actual of
Suspected Breach of Personally Identifiable Information: To appropriate
agencies, entities, and persons when (1) the Agency suspects or has
confirmed that there has been a breach of the system of records, (2)
the Agency has determined that as a result of the suspected or
confirmed breach there is a risk of harm to individuals, the Agency
(including its information systems, programs, and operations), the
Federal Government, or national security; and (3) the disclosure

made to such agencies, entities, and persons is reasonably necessary to
assist in connection with the Agency's efforts to respond to the
suspected or confirmed breach or to prevent, minimize, or remedy such
harm.
    M. Disclosure to assist another agency in its efforts to respond to
a breach: To another Federal agency or Federal entity, when the Agency
determines that information from this system of records is reasonably
necessary to assist the recipient agency or entity in (1) responding to
a suspected or confirmed breach or (2) preventing, minimizing, or
remedying the risk of harm to individuals, the recipient agency or
entity (including its information systems, programs, and operations),
the Federal Government, or national security, resulting from a
suspected or confirmed breach.

POLICIES AND PRACTICES FOR STORAGE OF RECORDS:
    The information collected within Fleet Access is maintained and
stored in a database hosted by Aptum, a DataCenter Service Provider
located at 600 West 7th Street, Los Angeles, California 900021 in
accordance to the EPA record retention schedule 00-90-Administrative
Support Databases. And EPA Record Schedule 1009--Motor Vehicles and
Personal Property.

POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:
    Records for Fleet Access are retrievable by User ID and Last Name.

POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:
    Fleet Access complies with EPA Records Schedule 0090-Administrative
Support Databases and EPA Record Schedule 1009--Motor Vehicles and
Personal Property. Personnel information is retained for as long as the
user or administrator determines necessary, generally, as long as the
individual is employed by the EPA and requires vehicle reservation
access. If a person no longer needs to reserve a vehicle for agency
business, their user information is deleted permanently, in accordance
with EPA Record Schedule 1009. Vehicle data is stored for a minimum of
3 years.

ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:
    Security controls used to protect personal sensitive data in Fleet
Access are commensurate with those required for an information system
rated moderate for confidentiality, integrity, and availability, as
prescribed in NIST Special Publication, 800-53, ``Recommended Security
Controls for Federal Information Systems,'' Revision 4.
    1. Administrative Safeguards: Personnel are required to complete
annual agency Information Security and Privacy training. Personnel are
instructed to lock their computers when they leave their desks.
    2. Technical Safeguards: Access to Fleet Access is restricted to
authorized users via login by username and password. All application
passwords are encrypted in the database. User passwords cannot be seen
by the administrators. The application is web-based, and user sessions
encrypted. Authorized users are defined by an application administrator
from within the application. Permission structures are currently role-
based and are applied individually by an application administrator as
needed.
    3. Physical Safeguards: Equipment used for the purposes of hosting
the Fleet Access is in a secure facility. Access to the secure facility
is restricted to employees displaying valid identification badges.
Access to the Network Operations Center is limited to authorized,
network administrators and requires successful validation by additional
authentication mechanisms. Access to the secure facility is logged.
Power to the facility is insured by both battery backup and diesel
generator. Fire suppression systems are in place.
    The facility is staffed 24-hours-a-day, seven days a week.

RECORD ACCESS PROCEDURES:
    Individuals seeking access to information in this system of records
about themselves are required to provide adequate identification (e.g.,
driver's license, military identification card, employee badge or
identification card). Additional identity verification procedures may
be required, as warranted. Requests must meet the requirements of EPA
regulations that implement the Privacy Act of 1974, at 40 CFR part 16.

CONTESTING RECORD PROCEDURES:
    Requests for correction or amendment must identify the record to be
changed and the corrective action sought. Complete EPA Privacy Act
procedures are described in EPA's Privacy Act regulations at 40 CFR
part 16.

NOTIFICATION PROCEDURE:
    Any individual who wants to know whether this system of records
contains a record about him or her, should make a written request to
the Attn: Agency Privacy Officer, MC 2831T, 1200 Pennsylvania Ave. NW,
Washington, DC 20460<EMAIL_ADDRESS>
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
    None.

HISTORY:
    None.

Vaughn Noga,
Senior Agency Official for Privacy.
[FR Doc. 2021-03583 Filed 2-22-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Proposed Rules]
[Pages 96413-96415]
[FR Doc No: 2016-31644]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 87 and 1068

[EPA-HQ-OAR-2014-0828; FRL-9957-73-OAR]

Reconsideration of Finding That Greenhouse Gas Emissions From
Aircraft Cause or Contribute to Air Pollution That May Reasonably Be
Anticipated To Endanger Public Health and Welfare

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final action denying petition for reconsideration.

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

SUMMARY: This action provides notice that the U.S. Environmental
Protection Agency (EPA) Administrator, Gina McCarthy, denied a petition
for reconsideration of the final Finding that Greenhouse Gas Emissions
from Aircraft Cause or Contribute to Air Pollution that May Reasonably
Be Anticipated to Endanger Public Health and Welfare, published in the
Federal Register on August 15, 2016.

DATES: The EPA took final action to deny the petition for
reconsideration on December 21, 2016.

FOR FURTHER INFORMATION CONTACT: Lesley Jantarasami, Office of
Atmospheric Programs, Climate Change Division, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW., Mail Code 6207-A, Washington DC
20460; Telephone number:<PHONE_NUMBER>; Email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. How can I get copies of this document and other related information?

    This Federal Register document, the petition for reconsideration
and the EPA's response addressing the petition for reconsideration are
available in the docket under Docket ID No. EPA-HQ-OAR-2014-0828.
    Docket. The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OAR-2014-0828. Publicly available docket materials
are available either electronically through http://www.regulations.gov
or in hard copy at the EPA Docket Center (EPA/DC), EPA WJC West, Room
3334, 1301 Constitution Ave. NW., Washington, DC. The EPA Docket Center
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is

(202) 566-1744, and the telephone number for the Air Docket is (202)
566-1742. This action, the petition for reconsideration and the EPA's
response addressing the petition can also be found on the EPA's Web
site at https://www.epa.gov/regulations-emissions-vehicles-and-engines/final-rule-finding-greenhouse-gas-emissions-aircraft.
    Electronic access. You may access this Federal Register document
electronically from the Government Printing Office under the ``Federal
Register'' listings at FDSys (http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=FR).

II. Judicial Review

    Section 307(b)(1) of the Clean Air Act (CAA) indicates which
Federal Court of Appeals have venue over petitions for review of final
EPA actions. This section provides, in part, that the petitions for
review must be filed in the Court of Appeals for the District of
Columbia Circuit if: (i) The agency action consists of ``nationally
applicable regulations promulgated, or final action taken, by the
Administrator;'' or (ii) such actions are locally or regionally
applicable, if ``such action is based on a determination of nationwide
scope or effect and if in taking such action the Administrator finds
and publishes that such action is based on such a determination.''
    The EPA has determined that its action denying the petition for
reconsideration is nationally applicable for purposes of CAA section
307(b)(1) because it affects the final Finding that Greenhouse Gas
Emissions from Aircraft Cause or Contribute to Air Pollution that May
Reasonably Be Anticipated to Endanger Public Health and Welfare, and
that finding triggers the EPA's statutory duty to promulgate aircraft
engine emission standards under CAA section 231, which are nationally
applicable regulations and for which judicial review will be available
only in the U.S. Court of Appeals for the District of Columbia Circuit.
Moreover, EPA already determined that the subject finding was
nationally applicable, see 81 FR 54422 (Aug. 15, 2016), and that
finding has in fact been challenged in the U.S. Court of Appeals for
the District of Columbia Circuit. In the alternative, even if this
action were considered to be only locally or regionally applicable, the
Administrator has determined that it has nationwide scope and effect
within the meaning of CAA section 307(b)(1) both because EPA has
determined that the final finding has nationwide scope and effect
within the meaning of CAA section 307(b)(1), see 81 FR 54422 (Aug. 15,
2016), and because it concerns risks from GHG pollution and
contributions to such pollution that occur across the nation.
    Thus, any petition for judicial review of the EPA's decision to
deny the petition for reconsideration described in this document must
be filed in the U.S. Court of Appeals for the District of Columbia
Circuit by February 28, 2017.

III. Description of Action

    On July 25, 2016, EPA Administrator McCarthy signed the action
entitled ``Finding that Greenhouse Gas Emissions from Aircraft Cause or
Contribute to Air Pollution that May Reasonably Be Anticipated to
Endanger Public Health and Welfare.'' That action included two findings
under section 231(a)(2)(A) of the CAA. These findings were that: (1)
Concentrations of six well-mixed greenhouse gases (GHGs) in the
atmosphere endanger the public health and welfare of current and future
generations (the endangerment finding), and (2) GHGs emitted from
certain classes of engines used in certain aircraft \1\ are
contributing to the air pollution--the mix of those six GHGs in the
atmosphere--that endangers public health and welfare (the cause or
contribute finding, or contribution finding). The Administrator made
these findings using the same definitions of ``air pollution'' and
``air pollutant'' as were used in earlier findings under CAA section
202(a)(1) regarding motor vehicle GHG emissions (the 2009 Findings),
namely the combined mix of six key well-mixed GHGs: carbon dioxide
(CO2), methane, nitrous oxide, hydrofluorocarbons (HFCs),
perfluorocarbons (PFCs), and sulfur hexafluoride (SF6).
While the 2009 Findings under CAA section 202(a)(1) relate to GHG
emissions from new motor vehicles and new motor vehicle engines, these
findings under CAA section 231(a)(2)(A) relate to GHG emissions from
certain classes of engines used in certain aircraft. These findings
were published in the Federal Register on August 15, 2016 (81 FR
54422), and became effective on September 14, 2016 (2016 Findings).
---------------------------------------------------------------------------

    \1\ The contribution finding concludes that GHG emissions from
certain classes of engines used in ``U.S. covered aircraft''
contribute to the air pollution that endangers public health and
welfare. The finding defines ``U.S. covered aircraft'' to be
subsonic jet aircraft with a maximum takeoff mass (MTOM) greater
than 5,700 kilograms and subsonic propeller driven aircraft (e.g.,
turboprops) with a MTOM greater than 8,618 kilograms. This
contribution finding for engines used in U.S. covered aircraft
results in the vast majority (89 percent) of total U.S. aircraft GHG
emissions being included in this determination.
---------------------------------------------------------------------------

    The Biogenic CO2 Coalition (Petitioner) submitted a
petition dated October 14, 2016 asking the EPA to reconsider the 2016
Findings with respect to the Agency's treatment of biogenic carbon
dioxide (CO2) emissions from short-cycle annual herbaceous
crops. CAA section 307(d)(7)(B) states that ``[o]nly an objection to a
rule or procedure which was raised with reasonable specificity during
the period for public comment (including any public hearing) may be
raised during judicial review. If the person raising an objection can
demonstrate to the Administrator that it was impracticable to raise
such objection within such time or if the grounds for such objection
arose after the period for public comment (but within the time
specified for judicial review) and if such objection is of central
relevance to the outcome of the rule, the Administrator shall convene a
proceeding for reconsideration of the rule and provide the same
procedural rights as would have been afforded had the information been
available at the time the rule was proposed.''
    The EPA carefully reviewed the petition for reconsideration and
evaluated all the information presented on the issues raised, along
with information contained in the docket for the 2016 Findings, in
reaching a decision on the petition. The EPA has concluded that the
petition does not meet the criteria for reconsideration in CAA section
307(d)(7)(B). In a letter to the petitioner, the EPA Administrator,
Gina McCarthy, denied the petition for reconsideration. The letter
included an enclosure, a Reconsideration Response document entitled
``Response to the Biogenic CO2 Coalition's Petition for
Reconsideration of the Final Finding that Greenhouse Gas Emissions from
Aircraft Cause or Contribute to Air Pollution that May Reasonably Be
Anticipated to Endanger Public Health and Welfare,'' that articulates
in detail the rationale for the EPA's final responses to the petition
for reconsideration and the EPA Administrator's denial of that
petition. These documents are all available in the docket for this
action.

IV. Conclusion

    For the reasons discussed in the letter to the petitioner and the
Reconsideration Response document, the petition to reconsider the final
Finding that Greenhouse Gas Emissions from Aircraft Cause or Contribute
to Air Pollution that May Reasonably Be Anticipated to Endanger Public
Health and Welfare is denied.

    Dated: December 21, 2016.
Gina McCarthy,
Administrator.
[FR Doc. 2016-31644 Filed 12-29-16; 8:45 am]
 BILLING CODE 6560-50-P