[Federal Register: March 22, 2010 (Volume 75, Number 54)]
[Notices]
[Page 13636-13638]
[DOCID:fr22mr10-127]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61710; File No. SR-ISE-2010-02]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Order Approving Proposed Rule Change To Amend Exchange Rules
Related to Cut-Off Time for Contrary Exercise Advice Submissions

March 15, 2010.

I. Introduction

    On January 11, 2010, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange Commission (``Commission''), pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change relating to the cut-off time for
submitting contrary exercise advices to the Exchange. The proposed rule
change was published for comment in the Federal Register on February 8,
2010.\3\ This order approves the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 61458 (February 1,
2010), 75 FR 6237.
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II. Description of the Proposal

    The Exchange has proposed to amend Rule 1100 to extend the cut-off
time to submit contrary exercise advices (``CEAs'') \4\ to the Exchange
to 7:30 p.m. The Exchange also has proposed to make certain non-
substantive changes to reorganize the text of Rule 1100 to more clearly
present the existing requirements and to eliminate duplicative
language.
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    \4\ Contrary exercise advices are also referred to as Expiring
Exercise Declarations in the OCC rules.
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    Pursuant to Rule 805 of the Options Clearing Corporation (``OCC''),
certain options that are in-the-money by a specified amount will be
automatically exercised. This procedure is known as ``Exercise-by-
Exception'' or ``Ex-by-Ex.'' Under the Ex-by-Ex process, options
holders holding option contracts that are in-the-money by a requisite
amount and who wish to have their contracts automatically exercised
need take no

further action. However, under OCC Rule 805, option holders who do not
want their options automatically exercised or who want their options to
be exercised under parameters different than the Ex-by-Ex procedures
must instruct OCC of their ``contrary intention.'' Pursuant to ISE Rule
1100 option holders must also file a CEA with the Exchange notifying
the Exchange of the option holder's contrary intention. ISE Rule 1100
is designed, in part, to deter individuals from taking improper
advantage of late breaking news by requiring evidence of an option
holder's timely decision to exercise or not exercise expiring equity
options. Members satisfy this evidentiary requirement by submitting a
CEA directly to the Exchange, or by electronically submitting the CEA
to the Exchange through OCC's electronic communications system. The
submission of the CEA allows the Exchange to satisfy its regulatory
obligation to verify that the decision to make a contrary exercise was
made timely and in accordance with ISE Rule 1100.
    ISE Rule 1100 currently provides option holders until 5:30 p.m. on
the day prior to expiration to make a final decision to exercise or not
exercise an option that would otherwise either expire or be
automatically exercised. An Exchange member may not accept CEA
instructions from its customer or non-customer accounts after 5:30 p.m.
The current rule, however, gives Exchange members up to 6:30 p.m. to
actually submit these CEA instructions to the Exchange where such
member uses an electronic submission process. Pursuant to the rule, if
members do not employ an electronic submission procedure, they are
required to submit CEAs for non-customer accounts by the 5:30 p.m.
deadline. This 5:30 p.m. deadline for manual submission of CEAs for
non-customer accounts is earlier than the electronic submission
deadline to prevent firms from improperly extending the 5:30 p.m.
deadline to exercise or not exercise an option.\5\ In either case,
whether or not submitting the CEA electronically or manually, the final
decision to issue a CEA instruction must be made at 5:30 p.m.
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    \5\ According to the Exchange, this requirement is based on the
difficulty of monitoring a manual procedure that has different times
for deciding whether or not to exercise the option and for the
submission of the CEA.
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    This current process of submitting CEAs was approved by the
Commission in 2003.\6\ The Exchange represents that in 2003, the Ex-by-
Ex thresholds were $0.75 for customers and $0.25 for broker-dealer
accounts. In 2009, the Ex-by-Ex threshold had narrowed significantly to
$0.01 for all accounts. The Exchange notes that this decrease in the
Ex-by-Ex threshold, coupled with the dramatic increase in option
trading volume from 2003 to 2009, has led to a larger number of CEA
instructions and has increased the burden on firms to process and
submit instructions on a timely basis.
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    \6\ See Securities Exchange Act Release Nos. 47885 (May 16,
2003), 68 FR 28309 (May 23, 2003) (SR-Amex-2001-92); 48505
(September 17, 2003), 68 FR 55680 (September 26, 2003) (SR-ISE-2003-
20); 48640 (October 16, 2003), 68 FR 60757 (October 23, 2003) (SR-
PCX-2003-47); and 48639 (October 16, 2003), 68 FR 60764 (October
23,2003) (SR-Phlx-2003-65).
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    As a result of these concerns, the Exchange has proposed to extend
the current 6:30 p.m. deadline for electronic submission of CEA
instructions to the Exchange by one additional hour, to 7:30 p.m. In
its filing, the Exchange stated that the proposed rule change is
necessary to address concerns expressed by members that, given the
decrease in the Ex-by-Ex threshold and the increase in trading, the
existing deadline for submitting CEAs to the Exchange is problematic
for timely back-office processing. According to the Exchange, the
proposed additional one hour will address this concern by further
enabling firms to more timely manage, process, and submit the
instructions to the Exchange.
    The Exchange also proposes to allow a member to submit a CEA to the
Exchange by 7:30 p.m. on a day when there is a modified close of
trading. The current rule allows a member to submit an electronic CEA
to the Exchange up to 2 hours and 30 minutes after the close of trading
on a day when there is a modified close of trading. The proposed rule
change will make the submission deadline for electronic CEAs on both
regular and modified close expiration days uniform and, according to
the Exchange, this should help to reduce errors.
    The ISE noted in its filing that the proposed rule change does not
change the substantive requirement that option holders make a final
decision by 5:30 p.m. whether to exercise or not exercise an option
that would otherwise either expire or be automatically exercised. The
Exchange represented that it will continue to enforce the 5:30 p.m.
decision making requirement, while also allowing additional time to
process and submit the CEA instructions. As noted in the filing, the
Exchange believes that the proposed rule change will benefit the
marketplace, particularly back-office processing. The Exchange also
represents that the additional processing time and Exchange submission
deadline will not conflict with OCC submission rules or cause any OCC
processing issues.

III. Discussion and Commission's Findings

    After careful review of the proposed rule change, the Commission
finds that the proposed rule change is consistent with the requirements
of the Act and the rules and regulations thereunder applicable to a
national securities exchange.\7\ In particular, the Commission finds
that the proposed rule change is consistent with the provisions of
Section 6(b)(5) of the Act,\8\ which requires, among other things, that
ISE rules must be designed to prevent fraudulent and manipulative acts
and practices, to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
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    \7\ In approving this proposal, the Commission has considered
the proposed rule's impact on efficiency, competition and capital
formation. See 15 U.S.C. 78c(f).
    \8\ 15 U.S.C. 78f(b)(5).
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    The Commission believes that the proposed rule change is
appropriate because, by extending the deadline to submit electronic
CEAs from 6:30 p.m. to 7:30 p.m., the proposal should provide Exchange
members with sufficient additional time to process the CEAs submitted
by options holders which, according to the Exchange, have steadily
increased with the increased options trading volume of recent years and
the narrowing of the Ex-by-Ex threshold. Thus, consistent with Section
6(b)(5) of the Act,\9\ the proposal will foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, by addressing the back-office processing problems noted
by the Exchange that exist under the current 6:30 p.m. deadline for
electronic submission of CEAs.
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    \9\ Id.
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    In approving the proposal, the Commission emphasizes that the
Exchange is not changing the time by which options holders must notify
Exchange members of the contrary intention, which will remain at 5:30
p.m., and will continue to be enforced by the Exchange as it is
currently.

Because the deadline for options holders to make a decision to exercise
or not exercise an expiring option that would otherwise either expire
or be automatically exercised is not changing, the Commission also
believes that proposal will not compromise one key goal of the rule,
which is to prevent individuals from taking improper advantage of late-
breaking news.
    The Commission also notes that the time for submission of CEAs for
non-customer accounts on a manual basis will remain at 5:30 p.m. The
Commission continues to believe that this time difference for manual
submissions is warranted given the potential difficulties in monitoring
compliance with a manual procedure, as noted by the Exchange.\10\
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    \10\ See footnote 5 and accompanying text.
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    The Commission also believes that the Exchange's proposal to change
the deadline for submitting CEAs to the Exchange to 7:30 p.m. on days
when there is a modified close of trading is appropriate. A uniform
deadline for submitting CEAs, irrespective of the closing time, will
eliminate any possibility for error when determining what the
submission deadline is on a modified close expiration day. As described
above, current rules set the deadline on modified close expiration day
at 2 hours and 30 minutes after the close. Since the modified close
time does vary on these modified days, the CEA times could vary as
well, which may have proved confusing to Exchange members. Thus, the
change to a 7:30 p.m. cut-off for all electronic submission of CEAs,
irrespective of the market's closing time, should help to avoid
confusion and reduce the potential for errors. Finally, the Commission
also finds that the Exchange's non-substantive changes to the text of
Rule 1100 to more clearly present the existing requirements and to
eliminate duplicative language is appropriate.
    Based on the above, the Commission believes that the proposed rule
change is consistent with Section 6(b)(5) of the Act \11\ in that it
will prevent fraudulent and manipulative acts and practices, promote
just and equitable principles of trade, foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general,
protect investors and the public interest.
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    \11\ 15 U.S.C. 78f(b)(5).
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    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\12\ that the proposed rule change (SR-ISE-2010-002) be, and it
hereby is, approved.
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    \12\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-6204 Filed 3-19-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 143 (Wednesday, July 27, 2022)]
[Notices]
[Pages 45098-45099]
[FR Doc No: 2022-16114]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 15038-001]

Let It Go, LLC; Notice of Application Accepted for Filing, Intent
To Waive Scoping, Soliciting Motions To Intervene and Protests, Ready
for Environmental Analysis, and Soliciting Comments, Terms and
Conditions, Recommendations, and Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Exemption from Licensing.
    b. Project No.: 15038-001.
    c. Date filed: December 9, 2021.
    d. Applicant: Let It Go, LLC (Let It Go).
    e. Name of Project: Jefferson Mill Hydroelectric Project (Jefferson
Mill Project).
    f. Location: On the Hardware River near the Town of Scottsville,
Albemarle County, Virginia. The project would not occupy Federal land.
    g. Filed Pursuant to: Public Utility Regulatory Policies Act of
1978, 16 U.S.C. 2705, 2708, amended by the Hydropower Regulatory
Efficiency Act of 2013, Public Law 113-23, 127 Stat. 493 (2013).
    h. Applicant Contacts: Aaron Van Duyne III, Let It Go, LLC c/o Van
Duyne, Bruno & Co., P.A.; 18 Hook Mountain Road, Suite 202, P.O. Box
896, Pine Brook, NJ 07058; cpa.com">[email protected]cpa.com; Kevin O'Brien, 809
Bolling Ave, Unit C, Charlottesville, VA 22902;<PHONE_NUMBER> or
[email protected]; and/or Jessica Penrod (lead contact for project
questions), Natel Energy, 2401 Monarch St, Alameda, CA 94501; 415-845-
1933 or [email protected].
    i. FERC Contact: Andy Bernick,<PHONE_NUMBER>, or
[email protected].
    j. Deadline for filing comments, motions to intervene and protests,
terms and conditions, recommendations, and prescriptions: 60 days from
the issuance date of this notice; reply comments are due 105 days from
the issuance date of this notice.
    The Commission strongly encourages electronic filing. Please file
motions to intervene, protests, comments, terms and conditions,
recommendations, and prescriptions using the Commission's eFiling
system at https://ferconline.ferc.gov/FERCOnline.aspx. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at https://ferconline.ferc.gov/QuickComment.aspx. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at [email protected],<PHONE_NUMBER> (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, you may submit a
paper copy. Submissions sent via the U.S. Postal Service must be
addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include docket number 15038-001.
    The Commission's Rules of Practice and Procedure require all
interveners filing documents with the Commission to serve a copy of
that document on each person on the official service list for the
project. Further, if an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. This application has been accepted for filing and is now ready
for environmental analysis.
    l. The proposed project would consist of: (1) an existing 140-foot-
long, 9-foot-high masonry dam that impounds a 1.46-acre reservoir with
a gross volume of 5.3 acre-feet at the normal pool elevation of 320.0
feet North American Vertical Datum of 1988 (NAVD88); (2) a new 12.5-
foot-wide, 4-foot-high intake rack with 0.75-inch spacing to prevent
river debris from entering the intake; (3) a new 14-foot-long, 12-foot-
wide, and 10-foot-high reinforced concrete intake structure, mostly
constructed below-grade and upstream of the dam on the west side of the
river; (4) a new 70-foot-long, 3-foot-diameter penstock; (5) a new eel
ramp for the upstream passage of American eel and sea lamprey; (6) an
existing 3-foot-wide and 0.9-foot-high low-flow notch and 4.6-foot-deep

plunge pool for downstream fish passage; (7) an existing 33-foot-wide,
8-foot-long, 14-foot-high powerhouse with one new 20-kilowatt (kW)
turbine-generator unit; (8) two new 100-foot-long underground utility
trenches (containing conduits for utility power, generator power, and
communications) between the powerhouse and control equipment shed; (9)
a new draft tube that connects the exit of the turbine to the tailrace;
(10) a transmission line connecting the project to the distribution
system owned by the Appalachian Power Company; and (11) appurtenant
facilities. The project is estimated to generate an average of 111,000
kW-hours annually. The applicant proposes to operate the project in a
run-of-river mode.
    m. On February 16, 2022, Let It Go filed a request to waive scoping
to expedite the exemption process, and received support for the waiver
from the U.S. Fish and Wildlife Service, Virginia Marine Resources
Commission, Virginia Department of Historic Resources, and the U.S.
Army Corps of Engineers. Due to the small size and location of this
project, the applicant's close coordination with federal and state
agencies during preparation of the application, and studies completed
during pre-filing consultation, we intend to waive scoping. Based on a
review of the application and resource agency consultation letters
including comments filed to date, Commission staff does not anticipate
that any new issues would be identified through additional scoping.
Based on the issues identified during the pre-filing period, staff's
National Environmental Policy Act (NEPA) document will consider the
potential effects of project construction and operation on geology and
soils, aquatic, terrestrial, threatened and endangered species,
recreation, and cultural and historic resources.
    n. A copy of the application can be viewed on the Commission's
website at https://www.ferc.gov using the ``eLibrary'' link. Enter the
docket number excluding the last three digits in the docket number
field to access the document. For assistance, contact FERC Online
Support.
    Register online at https://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    o. Any qualified applicant desiring to file a competing application
must submit to the Commission, on or before the specified intervention
deadline date, a competing development application, or a notice of
intent to file such an application. Submission of a timely notice of
intent allows an interested person to file the competing development
application no later than 120 days after the specified intervention
deadline date. Applications for preliminary permits will not be
accepted in response to this notice.
    A notice of intent must specify the exact name, business address,
and telephone number of the prospective applicant, and must include an
unequivocal statement of intent to submit a development application. A
notice of intent must be served on the applicant(s) named in this
public notice.
    Anyone may submit comments, a protest, or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, .211, and .214. In determining the appropriate action to
take, the Commission will consider all protests or other comments
filed, but only those who file a motion to intervene in accordance with
the Commission's Rules may become a party to the proceeding. Any
comments, protests, or motions to intervene must be received on or
before the specified comment date for the particular application.
    All filings must: (1) bear in all capital letters the title
``PROTEST,'' ``MOTION TO INTERVENE,'' ``NOTICE OF INTENT TO FILE
COMPETING APPLICATION,'' ``COMPETING APPLICATION,'' ``COMMENTS,''
``REPLY COMMENTS,'' ``RECOMMENDATIONS,'' ``TERMS AND CONDITIONS,'' or
``PRESCRIPTIONS;'' (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person protesting or intervening; and (4) otherwise comply with the
requirements of 18 CFR 385.2001 through 385.2005. Agencies may obtain
copies of the application directly from the applicant. A copy of any
protest or motion to intervene must be served upon each representative
of the applicant specified in the particular application.
    p. Updated procedural schedule and final amendments: The
application will be processed according to the following procedural
schedule. Revisions to the schedule may be made as appropriate.

------------------------------------------------------------------------
            Milestone                           Target date
------------------------------------------------------------------------
Deadline for filing                September 2022.
 interventions, protests,
 comments, recommendations, terms
 and conditions, and fishway
 prescriptions.
Deadline for filing reply          November 2022.
 comments.
------------------------------------------------------------------------

    q. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of this notice
of ready for environmental analysis.

    Dated: July 21, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-16114 Filed 7-26-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 3 (Thursday, January 5, 2023)]
[Rules and Regulations]
[Pages 753-755]
[FR Doc No: 2022-28601]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2022-N-3191]

Medical Devices; Orthopedic Devices; Classification of the Bone
Indentation Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the bone indentation device into class II (special
controls). The special controls that apply to the device type are
identified in this order and will be part of the codified language for
the bone indentation device's classification. We are taking this action
because we have determined that classifying the device into class II
(special controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices.

DATES: This order is effective January 5, 2023. The classification was
applicable on August 19, 2021.

FOR FURTHER INFORMATION CONTACT: Laura Rose, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4435, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the bone indentation device as
class II (special controls), which we have determined will provide a
reasonable assurance of safety and effectiveness. In addition, we
believe this action will enhance patients' access to beneficial
innovation, in part by placing the device into a lower device class
than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in

commercial distribution prior to the date of enactment of the Medical
Device Amendments of 1976, which amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On March 31, 2021, FDA received Active Life Scientific's request
for De Novo classification of the OsteoProbe. FDA reviewed the request
in order to classify the device under the criteria for classification
set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on August 19, 2021, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
888.1600.\1\ We have named the generic type of device bone indentation
device, and it is identified as a device that measures resistance to
indentation in bone.
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    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

     Table 1--Bone Indentation Device Risks and Mitigation Measures
------------------------------------------------------------------------
          Identified risks                    Mitigation measures
------------------------------------------------------------------------
Bone fracture or soft tissue damage.  In vivo performance testing, and
                                       Labeling.
Adverse tissue reaction.............  Biocompatibility evaluation.
Infection, including operator         Shelf-life testing, Sterilization
 exposure to infectious transmission.  validation, Reprocessing
                                       validation, Human factors
                                       testing, and Labeling.
Patient or operator injury due to     Electrical safety testing, and
 electrical hazards.                   Electromagnetic compatibility
                                       testing.
Pain, discomfort, bruising, or        In vivo performance testing, and
 bleeding.                             Labeling.
Inappropriate patient management due  Non-clinical performance testing,
 to inaccurate device output or       In vivo performance testing,
 misinterpretation of device output.  Software verification, validation,
                                       and hazard analysis,
                                      Human factors testing, and
                                       Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. We encourage sponsors to consult with us if they wish to
use a non-animal testing method they believe is suitable, adequate,
validated, and feasible. We will consider if such an alternative method
could be assessed for equivalency to an animal test method. This device
is subject to premarket notification requirements under section 510(k)
of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in 21 CFR part 860, subpart D, regarding De Novo
classification have been approved under OMB control number 0910-0844;
the collections of information in 21 CFR part 814, subparts A through
E, regarding premarket approval, have been approved under OMB control
number 0910-0231; the collections of information in part 807, subpart
E, regarding premarket notification submissions, have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 820, regarding quality system regulation, have been
approved under OMB control number 0910-0073; and the collections of
information in 21 CFR parts 801, regarding labeling, have been approved
under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 888

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
888 is amended as follows:

PART 888--ORTHOPEDIC DEVICES

0
1. The authority citation for part 888 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  888.1600 to subpart B to read as follows:

Sec.  888.1600  Bone indentation device.

    (a) Identification. A bone indentation device is a device that
measures resistance to indentation in bone.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) In vivo performance testing must demonstrate that the device
performs as intended under anticipated conditions of use. Testing must
evaluate the risk of bone fracture, soft tissue damage, pain,
discomfort, bruising, or bleeding.
    (2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use,
including an evaluation of the accuracy and precision of the device
with respect to resistance to bone indentation.
    (3) Human factors testing must demonstrate that the intended
user(s) can correctly use the device, based on the instructions for
use.
    (4) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (5) Performance testing must demonstrate:
    (i) The sterility of the patient-contacting components of the
device; and
    (ii) Validation of reprocessing instructions for any reusable
components of the device.
    (6) Performance data must support the shelf life of the device by
demonstrating continued sterility and device functionality over the
identified shelf life.
    (7) Software verification, validation, and hazard analysis must be
performed.
    (8) Performance data must be provided to demonstrate the
electromagnetic compatibility (EMC) and electrical safety of the
device.
    (9) Labeling must include:
    (i) Instructions for use;
    (ii) Validated methods and instructions for reprocessing of any
reusable components;
    (iii) A shelf life for any sterile components;
    (iv) Information regarding limitations of the clinical significance
of the device output; and
    (v) A detailed summary of the accuracy and precision of the device.

    Dated: December 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28601 Filed 1-4-23; 8:45 am]
BILLING CODE 4164-01-P


            Pesticide Reregistration Performance Measures and Goals;
                            Annual Progress Report;
                               Fiscal Year 2014
           Docket identification (ID) number:  EPA-HQ-OPP-2014-0125

I.  Introduction
      The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136a et seq.) requires EPA to publish information about EPA's annual achievements in meeting its performance measures and goals for pesticide reregistration.  This report addresses EPA's achievements in this area during fiscal year 2014.  This report discusses the integration of tolerance reassessment with the reregistration process, and describes the status of various regulatory activities associated with reregistration and tolerance reassessment.  The report also presents total numbers of products reregistered and products registered under the "fast-track" provisions of FIFRA.
II.  Background
      EPA must establish and publish in the Federal Register its annual performance measures and goals for pesticide reregistration, tolerance reassessment, and expedited registration, under section 4(l) of FIFRA, 7 U.S.C. 136a-1(l).  Specifically, such measures and goals are to include:
 The status of reregistration.
 The number of products reregistered, canceled, or amended.
 The number and type of data requests of Data Call-In (DCI) notices under FIFRA section 3(c)(2)(B) issued to support product reregistration by active ingredient.
 Progress in reducing the number of unreviewed, required reregistration studies.
 The aggregate status of tolerances reassessed.
 The number of applications for registration submitted under FIFRA section 4(k)(3) (which provides for expedited processing and review of certain applications) that were approved or disapproved.
 The future schedule for reregistrations in the current and succeeding fiscal year.
 The projected year of completion of the reregistrations under FIFRA section 4.
	FIFRA required EPA to conduct a comprehensive pesticide reregistration program -- a complete review of the human health and environmental effects of older pesticides originally registered before November 1, 1984.  Pesticides meeting today's scientific and regulatory standards could be declared "eligible" for reregistration.  To be eligible, an older pesticide must have a substantially complete data base, and must not cause unreasonable adverse effects to human health or the environment when used according to Agency approved label directions and precautions.
	In addition, all pesticides with food uses must meet the safety standard of section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) 21 U.S.C. 346a.  Under FFDCA, EPA must make a determination that pesticide residues remaining in or on food are "safe"; that is, "that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue" from dietary and other sources.  In determining allowable levels of pesticide residues in food, EPA must, among other requirements, perform a comprehensive assessment of each pesticide's risks, considering:
 Aggregate exposure (from food, drinking water, and residential uses).
 Cumulative effects from all pesticides sharing a common mechanism of toxicity.
 Possible increased susceptibility of infants and children.
 Possible endocrine or estrogenic effects.
	The 1996 FFDCA amendments also required the reassessment of all existing tolerances (pesticide residue limits in food) and tolerance exemptions within 10 years, to ensure that they met the safety standard of the law.  EPA was directed to give priority to the review of those pesticides that appeared to pose the greatest risk to public health. The Agency completed the last of 9,721 required tolerance reassessment decisions in September 2007, ensuring that all pesticides used on food in the United States meet the law's safety standard.  EPA's approach to tolerance reassessment under FFDCA was described fully in the Agency's document, "Raw and Processed Food Schedule for Pesticide Tolerance Reassessment" (62 FR 42020, August 4, 1997) (FRL-5734-6).
	The Pesticide Registration Improvement Act (PRIA) of 2003 became effective on March 23, 2004 (Pub. Law 108-199, Div. G, Title V, Sec. 501, 118 Stat. 419).  Among other things, PRIA amended FIFRA section 4(g)(2) to require EPA to complete Reregistration Eligibility Decisions (REDs) for pesticides with food uses/tolerances by August 3, 2006, and to complete all non-food use REDs by October 3, 2008.  The Agency completed REDs for the last of 613 reregistration pesticide cases in September 2008, meeting the PRIA deadline.  REDs are available on the Agency's Pesticide Chemical Search web page at https://iaspub.epa.gov/apex/pesticides/f?p=chemicalsearch:1.
III.  Program Accountability
	Through this summary of performance measures and goals for pesticide reregistration, tolerance reassessment, and expedited registration, EPA describes progress made during FY 2014 in each of the program areas specified in FIFRA section 4(l).
A.  Status of Reregistration
	The last reregistration eligibility decisions for 613 reregistration cases (representing pesticide active ingredients or groups of pesticide active ingredients) were completed in FY 2008.  Product reregistration was not completed in FY 2014; the Agency's progress towards completion is discussed in detail below. During FY 2014, as in the intervening years, the Agency focused on implementing the reregistration eligibility decisions as applicable to individual pesticide products.
B.  Product Reregistration; Numbers of Products Reregistered, Canceled, and Amended
	At the end of the reregistration process, after EPA has issued a RED and declared a pesticide reregistration case eligible for reregistration, individual end-use products that contain pesticide active ingredients included in the case still must be reregistered. This concluding part of the reregistration process is called "product reregistration."
	In issuing a completed RED document, EPA sends registrants a DCI notice requesting any product-specific data and specific revised labeling needed to complete reregistration for each of the individual pesticide products covered by the RED.  Based on the results of EPA's review of these data and labeling, products found to meet FIFRA and FFDCA standards may be reregistered.
	A variety of outcomes are possible for pesticide products completing this final phase of the reregistration process.  Ideally, in response to the DCI, the pesticide producer, or registrant, will submit the required product-specific data and revised labeling, which EPA will review and find acceptable.  At that point, the Agency may reregister the pesticide product.  However, some products contain multiple active ingredients and receive multiple DCI's issued at different times.  Products containing multiple active ingredients may require more than one round of label revisions depending on the timing of the  REDs and DCIs.  A product with multiple active ingredients could not be fully reregistered until the last active ingredient in its formulation was determined to be eligible for reregistration and all requirements of the applicable REDs satisfied (e.g., label changes, data requirements).  In other situations, the Agency may temporarily suspend a product's registration if the registrant has not submitted required product-specific studies within the time frame specified. The Agency may cancel a product's registration because the registrant did not pay the required registration maintenance fee.  Alternatively, the registrant may request a voluntary cancellation of their end-use product registration.
	1.  Product reregistration actions in FY 2014.  EPA counts each of the post-RED product outcomes described above as a product reregistration action.  A single pesticide product may be the subject of several product reregistration actions within the same year.  For example, a product's registration initially may be amended, then the product may be reregistered, or the product may first be suspended and later it may be voluntarily canceled.  During FY 2014, with a goal of 900 total product reregistration actions, the EPA completed the product reregistration actions detailed in Table 1.

        TABLE 1. -- PRODUCT REREGISTRATION ACTIONS COMPLETED IN FY 2014
                          (AS OF SEPTEMBER 30, 2014)

                                    Actions
                                                                        FY 2014
Product reregistration actions
                                                                             65
Product amendment actions
                                                                            166
Product cancellation actions
                                                                             61
Product suspension actions
                                                                              4
Total actions
                                                                            296

	2.  Status of the product reregistration universe for FY 2014.  EPA also keeps track of the status of the universe of products subject to reregistration, that is, the overall number of products reregistered, amended, canceled, and sent for suspension, as well as the number of products with actions pending, as of the end of the fiscal year. This overall status information is not "cumulative" -- it is not derived from summing up a series of annual actions.  Adding annual actions would result in a larger overall number since each individual product is subject to multiple actions -- it can be amended, reregistered, and/or canceled, over time.  Instead, the "big picture" status information in Table 2 should be considered a snapshot in time.  As registrants and EPA make marketing and regulatory decisions in the future, the status of individual products may change, and numbers in this table are expected to fluctuate.
TABLE 2. -- STATUS OF THE UNIVERSE OF PRODUCTS SUBJECT TO PRODUCT REREGISTRATION, FOR FY 2014 (AS OF SEPTEMBER 30, 2014)

                                    Status
                                                                        FY 2014
Products reregistered
                                                                          5,081
Products amended
                                                                          3,229
Products canceled
                                                                         10,866
Products sent for suspension
                                                                             40
Total products with actions completed
                                                                         19,216
Products with actions pending
                                                                          5,368
Total products in product reregistration universe
                                                                         24,584

      At the end of FY 2014, 5,368 products had product reregistration decisions pending.  Some pending products awaited science reviews, label reviews, or reregistration decisions by EPA.  Others were not yet ready for product reregistration actions, but were associated with more recently completed REDs.  Their product-specific data were not yet due to be submitted to or reviewed by the Agency.
	The universe of products in product reregistration has increased in some years and decreased in other years.  In past years, when such changes occurred, an increase resulted from products associated with the most recently completed REDs, while a decrease was due to fluctuations in numbers of products associated with product-specific Data Call-Ins (PDCIs).
	3.  Product reregistration goal in FY 2015.  EPA's goal is to complete 600 product reregistration actions during FY 2015.  Additional information is available on EPA's Reregistration and Other Review Programs Predating Pesticide Registration Review web page at https://www.epa.gov/pesticide-reevaluation/reregistration-and-other-review-programs-predating-pesticide-registration.
C.  Applications for Registration Requiring Expedited Processing; Numbers Approved and Disapproved

	By law, EPA must expedite its processing of certain types of applications for pesticide product registration, i.e., applications for end-use products that would be identical or substantially similar to a currently registered product (me-too products); amendments to current product registrations that do not require review of scientific data; and products for public health pesticide uses.  During FY 2014, EPA considered and approved the numbers of applications for registration requiring expedited processing (also known as "fast track" applications) shown in Table 3.
                       TABLE 3. -- FAST TRACK APPLICATIONS APPROVED IN FY 2014
                               Application Type
                                                                        FY 2014
Me-too product registrations/Fast track
                                                                            239
Amendments/Fast track
                                                                          2,234
Total applications processed by fast track means
                                                                          2,473

	For those applications not approved, the Agency generally notifies the registrant of any deficiencies in the application that need to be corrected or addressed before the application can be approved.  Applications may have been withdrawn after discussions with the Agency, but none were formally "denied" during FY 2014.
	On a financial accounting basis, EPA devoted 22.8 full-time equivalents (FTEs) in FY 2014 to reviewing and processing applications for fast track me-too product registrations and label amendments.  The Agency spent approximately $3.3 million in FY 2014 in direct costs (i.e., time on task, not including administrative expenses, computer systems, management overhead, and other indirect costs) on expedited processing and reviews.
D.  Projected Year of Completion of Reregistrations
	EPA completed the last reregistration eligibility decisions in FY 2008.  The Agency plans to complete product reregistration for conventional pesticides in FY 2019 and antimicrobial pesticides in FY 2024.
IV. Can I Comment on this Report?
      EPA does not expect these reports to lead to any public particular action and therefore is not seeking particular public comment. However, EPA welcomes input from stakeholders and the general public. Written comments, identified by the docket identification number EPA-HQ-OPP-2014-0125, and received by EPA on or before 60 days after date of publication in the Federal Register, will be taken into consideration in the event that EPA determines that further action is warranted.
      Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2014-0125, by one of the following methods:
      ::  Federal eRulemaking Portal:  http://www.regulations.gov.  Follow the on-line instructions for submitting comments.  Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
      ::  Mail:  Office of Pesticide Programs (OPP) Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
 	:: Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/where-send-comments-epa-dockets.
      Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

V.  For Further Information Contact
      Ramé Cromwell, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>


[Federal Register Volume 77, Number 145 (Friday, July 27, 2012)]
[Rules and Regulations]
[Pages 44110-44113]
[FR Doc No: 2012-18199]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 29

[Docket No. FAA-2012-0785; Special Conditions No. 29-027-SC]

Special Conditions: Agusta S.p.A. Model AW139 and AB139
Helicopter, Installation of a Search and Rescue (SAR) Automatic Flight
Control System (AFCS)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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

SUMMARY: These special conditions are issued for the Agusta S.p.A.
(Agusta) Model AW139 and AB139 helicopters. These model helicopters, as
modified by Agusta, will have novel or unusual design features
associated with installing an optional SAR AFCS. The applicable
airworthiness standards do not contain adequate or appropriate safety
standards for this design feature. These special conditions contain the
additional safety standards the Administrator considers necessary to
show a level of safety equivalent to that established by the existing
airworthiness standards.

DATES: The effective date of these special conditions is July 18, 2012.
We must receive your comments by September 25, 2012.

ADDRESSES: Send comments identified by docket number [FAA-2012-0785]
using any of the following methods:
     Federal eRegulations Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery of Courier: Deliver comments to the ``Mail''
address between 9 a.m., and 5 p.m., Monday through Friday, except
Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://regulations.gov, including any personal information
the commenter provides. Using the search function of the docket Web
site, anyone can find and read the electronic form of all comments
received into any FAA docket, including the name of the individual
sending the comment (or signing the comment for an association,
business, labor union, etc.). DOT's complete Privacy Act Statement can
be found in the Federal Register published on April 11, 2000 (65 FR
19477-19478), as well as at http://DocketsInfo.dot.gov.
    Docket: You can read the background documents or comments received
at http://www.regulations.gov. Follow the online instructions for
accessing the docket or go to the Docket Operations in Room @12-140 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: FAA, Aircraft Certification Service,
Rotorcraft Directorate, Regulations and Policy Group (ASW-111), Attn:
Stephen Barbini, 2601 Meacham Blvd., Fort Worth, Texas 76137; telephone
(817) 222-5196; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Reason for No Prior Notice and Comment Before Adoption

    The substance of these special conditions has been subjected to the
notice and comment period previously and has been derived without
substantive change from those previously issued. It is unlikely that
prior public comment would result in a significant change from the
substance contained herein. Further, a delay in the effective date of
these special conditions would significantly delay issuance of the
design approval and thus delivery of the helicopter, which is imminent.
Therefore, the FAA has determined that prior public notice and comment
are unnecessary, impracticable, and contrary to the public interest,
and finds good cause exists for adopting these special conditions upon
issuance. The FAA is requesting comments to allow interested persons to
submit views that may not have been submitted in response to the prior
opportunities for comment.

Comments Invited

    While we did not precede this with a notice of proposed special
conditions, we invite interested people to take part in this action by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive by the closing date for
comments. We will consider comments filed late if it is possible to do
so without incurring additional expense or delay. We may change these
special conditions based on the comments we receive.

Background and Discussion

    On November 11, 2008, Agusta applied for a change to Type
Certificate (TC) No. R00002RD to install an optional SAR AFCS in the
Model AB139 and AW139 helicopters. The AB139 and AW139 models are
transport category helicopters certificated to Category A and Category
B requirements, and instrument flight certificated under the
requirements of Appendix B to 14 CFR part 29, Amendment 29-40.
    There is a need to use dedicated AFCS upper modes, in which a fully
coupled autopilot provides operational SAR profiles, for SAR operations
conducted over water in offshore areas clear of obstructions. The SAR
modes enable the helicopter pilot to fly fully coupled maneuvers, to
include predefined search patterns during cruise flight, and to
transition from cruise flight to a stabilized hover and departure
(transition from hover to cruise flight). The SAR AFCS also includes an
auxiliary crew control that allows another crewmember (such as a hoist
operator) to have limited authority to control the helicopter's
longitudinal and lateral position during hover operations.
    Flight operations conducted over water at night may have an
extremely limited visual horizon with little visual reference to the
surface even when conducted under Visual Meteorological Conditions.
Consequently, the certification requirements for SAR modes must meet
Appendix B to 14 CFR part 29 for helicopter instrument flight. While
this appendix prescribes airworthiness criteria for instrument flight,
it does not consider operations below instrument flight minimum speed
(VMINI), whereas the SAR modes allow for coupled operations
at low speed, all-azimuth flight to zero airspeed (hover).
    Since SAR operations have traditionally been a public use mission,
the use of SAR modes in civil operations requires special airworthiness
standards (special conditions) to maintain a level of safety

consistent with Category A and Instrument Flight Rule (IFR)
certification. In this regard, 14 CFR part 29 lacks adequate
airworthiness standards for AFCS SAR mode certification to include
flight characteristics, performance, and installed equipment and
systems.

Type Certification Basis

    Under 14 CFR 21.101, Agusta must show the AW139 and AB139 model
helicopters, as changed, continue to meet either the applicable
provisions of the rules incorporated by reference in TC No. R00002RD or
the applicable regulations in effect on the date of application for the
change, depending on the significance of the change as defined by 14
CFR 21.101. The regulations incorporated by reference in the TC are
commonly referred to as the ``original type certification basis.'' The
regulations incorporated by reference in R00002RD are as follows:
    (a) 14 CFR 21.29 and Part 29, Amendments 29-1 through 29-45.
    (b) Appendix B to Part 29, Amendment 29-40.
    (c) 14 CFR part 36, Appendix H, Amendment 36-1 through Amendment
36-25.
    (d) Special Condition No. 29-0010-SC, High Intensity Radiated
Fields (HIRF), dated Feb. 19, 2004.
    (e) Equivalent Level of Safety Findings issued against:
    (1) 14 CFR 29.1305, as documented in AB139 FAA Memo dated Dec. 20,
2004.
    (2) 14 CFR 29.1321, as documented in AB139 FAA Memo dated Dec. 20,
2004.

Regulatory Basis for Special Conditions

    If the Administrator finds the applicable airworthiness standards
(i.e., 14 CFR part 29) do not contain adequate or appropriate safety
standards for the Agusta model AW139 and AB139 helicopters because of a
novel or unusual design feature, special conditions are prescribed
under 14 CFR 21.16.
    The FAA issues special conditions, as defined in Sec.  11.19, under
Sec.  11.38, and they become part of the type certification basis under
Sec.  21.101.
    Special conditions are initially applicable to the model for which
they are issued. Should the TC for that model be amended later to
include any other model that incorporates the same novel or unusual
design feature, or should any other model already included on the same
TC be modified to incorporate the same novel or unusual design feature,
these special conditions would also apply to the other model.

Novel or Unusual Design Features

    The Agusta model AW139 and AB139 helicopters will incorporate the
following novel or unusual design features:
    The SAR system is composed of a navigation computer with SAR modes,
an AFCS that provides coupled SAR functions, hoist operator control, a
hover speed reference system, and two radio altimeters. The AFCS
coupled SAR functions include:
    (a) Hover hold at selected height above the surface.
    (b) Ground speed hold.
    (c) Transition down and hover to a waypoint under guidance from the
navigation computer.
    (d) SAR pattern, transition down, and hover near a target over
which the helicopter has flown.
    (e) Transition up, climb, and capture a cruise height.
    (f) Capture and track SAR search patterns generated by the
navigation computer.
    (g) Monitor the preselected hover height with automatic increase in
collective if the aircraft height drops below the safe minimum height.
    These SAR modes are intended to be used over large bodies of water
in areas clear of obstructions. Further, use of the modes that
transition down from cruise to hover will include operation at
airspeeds below VMINI.
    The SAR system only entails navigation, flight control, and coupled
AFCS operation of the helicopter. The system does not include the
additional equipment that may be required for over water flight or
external loads to meet other operational requirements.

Applicability

    These special conditions apply to the Agusta Model AW139 and AB139
helicopters. Should Agusta apply at a later date for a change to the TC
to include another model incorporating the same novel or unusual design
feature, these special conditions would apply to that model as well
under the provisions of Sec.  21.101(d).

Conclusion

    This action affects only certain novel or unusual design features
on two model helicopters (i.e., AW139 and AB139 helicopters). It is not
a rule of general applicability.

List of Subjects in 14 CFR Part 29

    Aircraft, Aviation safety.

0
The authority citation for these special conditions is as follows:

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

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Agusta Model AW139 and AB139
helicopters when the optional Search and Rescue (SAR) Automatic Flight
Control System (AFCS) is installed:
    In addition to the part 29 certification requirements for Category
A and helicopter instrument flight (Appendix B), the following
additional requirements must be met for certification of the SAR AFCS:
    (a) SAR Flight Modes. The coupled SAR flight modes must provide:
    (1) Safe and controlled flight in three axes (lateral and
longitudinal position/speed and height/vertical speed) at all airspeeds
from instrument flight minimum speed (VMINI) to a hover
within the maximum demonstrated wind envelope.
    (2) Automatic transition to the helicopter instrument flight
(Appendix B) envelope as part of the normal SAR mode sequencing.
    (3) A pilot-selectable Go-Around mode that safely interrupts any
other coupled mode and automatically transitions the helicopter to the
instrument flight (Appendix B) envelope.
    (4) A means to prevent unintended flight below a safe minimum
height. Pilot-commanded descent below the safe minimum height is
acceptable provided the alerting requirements in (b)(7)(i) alert the
pilot of this descent below safe minimum height.
    (b) SAR Mode System Architecture. To support the integrity of the
SAR modes, the following system architecture is required:
    (1) A system for limiting the engine power demanded by the AFCS
when any of the automatic piloting modes are engaged, so full authority
digital engine control power limitations, such as torque and
temperature, are not exceeded.
    (2) A system providing the aircraft height above the surface and
final pilot-selected height at a location on the instrument panel in a
position acceptable to the FAA that will make it plainly visible to and
usable by any pilot at their station.
    (3) A system providing the aircraft heading and the pilot-selected
heading at a location on the instrument panel in a position acceptable
to the FAA that will make it plainly visible to and usable by any pilot
at their station.
    (4) A system providing the aircraft longitudinal and lateral ground
speeds

and the pilot-selected longitudinal and lateral ground speeds when used
by the AFCS in the flight envelope where airspeed indications become
unreliable. This information must be presented at a location on the
instrument panel in a position acceptable to the FAA that is plainly
visible to and usable by any pilot at their station.
    (5) A system providing wind speed and wind direction when automatic
piloting modes are engaged or transitioning from one mode to another.
    (6) A system that monitors for flight guidance deviations and
failures, and contains an alerting function that provides the flight
crew with enough information to take appropriate corrective action.
    (7) The alerting system must provide visual or aural alerts, or
both, to the flight crew under any of the below conditions:
    (i) When the stored or pilot-selected safe minimum height is
reached.
    (ii) When a SAR mode system malfunction occurs.
    (iii) When the AFCS changes modes automatically from one SAR mode
to another.

For normal transitions from one SAR mode to another, a single visual or
aural alert may suffice. For a SAR mode malfunction or a mode having a
time-critical component, the flight crew alerting system must activate
early enough to allow the flight crew to take timely and appropriate
action. The alerting system means must be designed to alert the flight
crew in order to minimize crew errors that could create an additional
hazard.
    (8) The SAR system hoist operator control is considered a flight
control with limited authority and must comply with the following:
    (i) The hoist operator control must be designed and located to
provide for convenient operation and to prevent confusion and
inadvertent operation.
    (ii) The helicopter must be safely controllable by the hoist
operator control throughout the range of that control.
    (iii) The hoist operator control may not interfere with the safe
operation of the helicopter.
    (iv) Pilot and copilot flight controls must be able to smoothly
override the limited control authority of the hoist operator control,
without exceptional piloting skill, alertness, or strength, and without
the danger of exceeding any other limitation because of the override.
    (9) The reliability of the AFCS must be related to the effects of
its failure. The occurrence of any failure condition that would prevent
continued safe flight and landing must be extremely improbable. For any
failure condition of the AFCS which is not shown to be extremely
improbable:
    (i) The helicopter must be safely controllable and capable of
continued safe flight without exceptional piloting skill, alertness, or
strength. Additional unrelated probable failures affecting the control
system must be evaluated.
    (ii) The AFCS must be designed so that it cannot create a hazardous
deviation in the flight path or produce hazardous loads on the
helicopter during normal operation or in the event of a malfunction or
failure, assuming corrective action begins within an appropriate period
of time. Where multiple systems are installed, subsequent malfunction
conditions must be evaluated in sequence unless their occurrence is
shown to be improbable.
    (10) A functional hazard assessment and a system safety assessment
must be provided to the FAA that addresses the failure conditions
associated with SAR operations.
    (i) For SAR catastrophic failure conditions, changes may be
required to the following:
    (A) System architecture.
    (B) Software and complex electronic hardware design assurance
levels.
    (C) High Intensity Radiated Field (HIRF) test levels.
    (D) Instructions for continued airworthiness.
    (ii) The assessments must consider all the systems required for SAR
operations to include the AFCS, all associated AFCS sensors (for
example, radio altimeter), and primary flight displays. Electrical and
electronic systems with SAR catastrophic failure conditions (for
example, AFCS) must comply with the Sec.  29.1317(a)(4) HIRF
requirements.
    (c) SAR Mode Performance Requirements.
    (1) Demonstrate the SAR modes for the requested flight envelope,
including the following minimum sea-state and wind conditions:
    (i) Sea State: Wave height of 2.5 meters (8.2 feet), considering
both short and long swells.
    (ii) Wind: 25 knots headwind; 17 knots for all other azimuths.
    (2) The selected hover height and hover velocity must be captured
(to include the transition from one captured mode to another captured
mode) accurately and smoothly and not exhibit any significant overshoot
or oscillation.
    (3) The minimum use height (MUH) for the SAR modes must be no more
than the maximum loss of height following any single failure or any
combination of failures not shown to be extremely improbable, plus an
additional 15 feet. The MUH is the minimum height at which any SAR AFCS
mode may be engaged.
    (4) The SAR mode system must be usable up to the maximum certified
gross weight of the aircraft or to the lower of the following weights:
    (i) Maximum emergency flotation weight.
    (ii) Maximum hover Out-of-Ground Effect (OGE) weight.
    (iii) Maximum demonstrated weight.
    (d) Flight Characteristics.
    (1) The basic aircraft must meet all of the part 29 airworthiness
criteria for helicopter instrument flight (Appendix B).
    (2) For SAR mode coupled flight below VMINI, at the
maximum demonstrated winds, the helicopter must be able to maintain any
required flight condition and make a smooth transition from any flight
condition to any other flight condition without requiring exceptional
piloting skill, alertness, or strength, and without exceeding the limit
load factor. This requirement also includes aircraft control through
the hoist operator's control.
    (3) For SAR modes at airspeeds below VMINI, the
following requirements of Appendix B to part 29 must be met and will be
used as an extension to the IFR certification envelope of the basic
aircraft:
    (i) Static Longitudinal Stability: the requirements of paragraph IV
of Appendix B are not applicable.
    (ii) Static Lateral-Directional Stability: The requirements of
paragraph V of Appendix B are not applicable.
    (iii) Dynamic Stability: The requirements of paragraph VI of
Appendix B are replaced with the following two paragraphs:
    (A) Any oscillation must be damped and any aperiodic response must
not double in amplitude in less than 10 seconds. This requirement must
also be met with degraded upper mode(s) of the AFCS. An ``upper mode''
is a mode that utilizes a fully coupled autopilot to provide an
operational SAR profile.
    (B) After any upset, the AFCS must return the aircraft to the last
commanded position within 10 seconds or less.
    (4) With any of the upper mode(s) of the AFCS engaged, the pilot
must be able to manually recover the aircraft and transition to the
normal (Appendix B) IFR flight profile envelope without exceptional
skill, alertness, or strength.
    (e) One-Engine Inoperative (OEI) Performance Information.
    (1) The following performance information must be provided in the

Rotorcraft Flight Manual Supplement (RFMS):
    (i) OEI performance information and emergency procedures, providing
the maximum weight that will provide a minimum clearance of 15 feet
above the surface, following failure of the critical engine in a hover.
The maximum weight must be presented as a function of the hover height
for the temperature and pressure altitude range requested for
certification. The effects of wind must be reflected in the hover
performance information.
    (ii) Hover OGE performance with the critical engine inoperative for
OEI continuous and time-limited power ratings for those weights,
altitudes, and temperatures for which certification is requested.

    Note: These OEI performance requirements do not replace
performance requirements that may be needed to comply with the
airworthiness or operational standards (14 CFR 29.865 or 14 CFR part
133) for external loads or human external cargo.

    (f) RFMS.
    (1) The RFMS must contain, at a minimum:
    (i) Limitations necessary for safe operation of the SAR system to
include:
    (A) Minimum crew requirements.
    (B) Maximum SAR weight.
    (C) Engagement criteria for each of the SAR modes to include MUH
(as determined in paragraph (c)(3)).
    (ii) Normal and emergency procedures for operation of the SAR
system (to include operation of the hoist operator control), with AFCS
failure modes, AFCS degraded modes, and engine failures.
    (iii) Performance information:
    (A) OEI performance and height-loss.
    (B) Hover OGE performance information, utilizing OEI continuous and
time-limited power ratings.
    (C) The maximum wind envelope demonstrated in flight test.
    (g) Flight Demonstration.
    (1) Before approval of the SAR system, an acceptable flight
demonstration of all the coupled SAR modes is required.
    (2) The AFCS must provide fail-safe operations during coupled
maneuvers. The demonstration of fail-safe operations must include a
pilot workload assessment associated with manually flying the aircraft
to an altitude greater than 200 feet above the surface and an airspeed
of at least the best rate of climb airspeed (Vy).
    (3) For any failure condition of the SAR system not shown to be
extremely improbable, the pilot must be able to make a smooth
transition from one flight mode to another without exceptional piloting
skill, alertness, or strength.
    (4) Failure conditions that are not shown to be extremely
improbable must be demonstrated by analysis, ground testing, or flight
testing. For failures demonstrated in flight, the following normal
pilot recovery times are acceptable:
    (i) Transition modes (Cruise-to-Hover/Hover-to-Cruise) and Hover
modes: Normal pilot recognition plus 1 second.
    (ii) Cruise modes: Normal pilot recognition plus 3 seconds.
    (5) All AFCS malfunctions must include evaluation at the low-speed
and high-power flight conditions typical of SAR operations.
Additionally, AFCS hard-over, slow-over, and oscillatory malfunctions,
particularly in yaw, require evaluation. AFCS malfunction testing must
include a single or a combination of failures (e.g., erroneous data
from and loss of the radio altimeter, attitude, heading, and altitude
sensors) that are not shown to be extremely improbable.
    (6) The flight demonstration must include the following
environmental conditions:
    (i) Swell into wind.
    (ii) Swell and wind from different directions.
    (iii) Cross swell.
    (iv) Swell of different lengths (short and long swell).

    Issued in Fort Worth, Texas, on July 18, 2012.
Kimberly K. Smith,
Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2012-18199 Filed 7-26-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 38 (Monday, February 27, 2012)]
[Notices]
[Pages 11525-11526]
[FR Doc No: 2012-4435]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

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

    Docket Numbers: EC12-68-000.
    Applicants: Stephentown Regulation Services LLC.
    Description: Request of Stephentown Regulation Services LLC.
    Filed Date: 2/16/12.
    Accession Number: 20120216-5217.
    Comments Due: 5 p.m. ET 2/28/12.

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

    Docket Numbers: ER10-2131-001.
    Applicants: Grand Ridge Energy LLC.
    Description: Supplement to June 20, 2011 Triennial Report of of
Grand Ridge Energy LLC.
    Filed Date: 2/17/12.
    Accession Number: 20120217-5087.
    Comments Due: 5 p.m. ET 3/9/12.

    Docket Numbers: ER10-2137-001.
    Applicants: Beech Ridge Energy LLC.
    Description: Supplement to June 20, 2011 Triennial Report of Beech
Ridge Energy LLC.
    Filed Date: 2/17/12.
    Accession Number: 20120217-5086.
    Comments Due: 5 p.m. ET 3/9/12.

    Docket Numbers: ER10-2138-001; ER10-2139-001.
    Applicants: Grand Ridge Energy II LLC, Grand Ridge Energy III LLC.
    Description: Supplement to June 20, 2011 Triennial Report of Grand
Ridge Energy II LLC, et al.
    Filed Date: 2/17/12.
    Accession Number: 20120217-5088.
    Comments Due: 5 p.m. ET 3/9/12.

    Docket Numbers: ER10-2140-001.
    Applicants: Grand Ridge Energy IV LLC.
    Description: Supplement to June 20, 2011 Triennial Report of Grand
Ridge Energy IV LLC.
    Filed Date: 2/17/12.
    Accession Number: 20120217-5089.
    Comments Due: 5 p.m. ET 3/9/12.

    Docket Numbers: ER10-2141-001.
    Applicants: Grand Ridge Energy V LLC.
    Description: Supplement to June 20, 2011 Triennial Report of Grand
Ridge Energy V LLC.
    Filed Date: 2/17/12.
    Accession Number: 20120217-5084.
    Comments Due: 5 p.m. ET 3/9/12.

    Docket Numbers: ER12-161-002.
    Applicants: Bishop Hill Energy LLC.
    Description: Change in Status Notice of Bishop Hill Energy LLC.
    Filed Date: 2/17/12.
    Accession Number: 20120217-5128.
    Comments Due: 5 p.m. ET 3/9/12.

    Docket Numbers: ER12-667-001.
    Applicants: ITC Midwest LLC.
    Description: Supplemental Filing of ITC Midwest--Northern States
Power 205 Filing to be effective 2/21/2012.
    Filed Date: 2/17/12.
    Accession Number: 20120217-5037.
    Comments Due: 5 p.m. ET 3/9/12.

    Docket Numbers: ER12-1113-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.,
International Transmission Company.
    Description: ITC-DTE River Rouge to be effective 4/17/2012 under
ER12-1113.
    Filed Date: 2/17/12.
    Accession Number: 20120217-5034.
    Comments Due: 5 p.m. ET 3/9/12.

    Docket Numbers: ER12-1114-000.
    Applicants: ITC Midwest LLC.
    Description: Filing of a Transmission Agreement to be effective 2/
29/2012.
    Filed Date: 2/17/12.
    Accession Number: 20120217-5047.
    Comments Due: 5 p.m. ET 3/9/12.

    Docket Numbers: ER12-1115-000.
    Applicants: PacifiCorp.
    Description: BPA AC Intertie Agreement 6th Revised to be effective
4/18/2012.
    Filed Date: 2/17/12.
    Accession Number: 20120217-5072.
    Comments Due: 5 p.m. ET 3/9/12.

    Docket Numbers: ER12-1117-000.
    Applicants: Consolidated Edison Company of New York.
    Description: Revisions to PASNY/EDDS tariffs to be effective 2/20/
2012.
    Filed Date: 2/17/12.
    Accession Number: 20120217-5073.
    Comments Due: 5 p.m. ET 3/9/12.

    Docket Numbers: ER12-1118-000.
    Applicants: Southern California Edison Company.
    Description: Amended SGIA SCE-FlexEnergy, LLC Lamb Canyon Project
to be effective 2/18/2012.
    Filed Date: 2/17/12.
    Accession Number: 20120217-5075.
    Comments Due: 5 p.m. ET 3/9/12.

    Docket Numbers: ER12-1119-000.
    Applicants: Southern California Edison Company.
    Description: Amended Expedited Service and Interconnection
Agreement Wintec Energy, Ltd., Wintec V to be effective 2/18/2012.
    Filed Date: 2/17/12.
    Accession Number: 20120217-5076.
    Comments Due: 5 p.m. ET 3/9/12.

    Docket Numbers: ER12-1120-000.
    Applicants: ITC Midwest LLC.
    Description: ITC Midwest LLC submits tariff filing per
35.13(a)(2)(iii: Filing of Interconnection Agreement to be effective 4/
19/2012.
    Filed Date: 2/17/12.
    Accession Number: 20120217-5090.
    Comments Due: 5 p.m. ET 3/9/12.

    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 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: February 17, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-4435 Filed 2-24-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)]
[Rules and Regulations]
[Pages 45824-45826]
[FR Doc No: 2018-18881]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31208; Amdt. No. 3813]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule establishes, amends, suspends, or removes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures (ODPs) for operations at certain
airports. These regulatory actions are needed because of the adoption
of new or revised criteria, or because of changes occurring in the
National Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective September 11, 2018. The compliance date
for each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of September 11, 2018.

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001.
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Navigation Products, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169, or
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center at nfdc.faa.gov to
register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedure
Standards Branch (AFS-420), Flight Technologies and Programs Divisions,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125)
Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14 of the Code of
Federal Regulations, Part 97 (14 CFR part 97), by establishing,
amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS.
The complete regulatory description of each SIAP and its associated
Takeoff Minimums or ODP for an identified airport is listed on FAA form
documents which are incorporated by reference in this amendment under 5
U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA
forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when
required by an entry on 8260-15A.
    The large number of SIAPs, Takeoff Minimums and ODPs, their complex
nature, and the need for a special format make publication in the
Federal

Register expensive and impractical. Further, airmen do not use the
regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead
refer to their graphic depiction on charts printed by publishers of
aeronautical materials. Thus, the advantages of incorporation by
reference are realized and publication of the complete description of
each SIAP, Takeoff Minimums and ODP listed on FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAPs, Takeoff Minimums and ODPs with their
applicable effective dates. This amendment also identifies the airport
and its location, the procedure, and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPS, Takeoff
Minimums and/or ODPS as identified in the amendatory language for part
97 of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums and ODP as Amended in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flight safety relating directly to published aeronautical charts.
    The circumstances that created the need for some SIAP and Takeoff
Minimums and ODP amendments may require making them effective in less
than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPs contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPs and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find that notice and
public procedure under 5 U.S.C. 553(b) are impracticable and contrary
to the public interest and, where applicable, under 5 U.S.C. 553(d),
good cause exists for making some SIAPs effective in less than 30 days.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26,1979); and
(3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference,
Navigation (Air).

    Issued in Washington, DC, on August 10, 2018.
Rick Domingo,
Executive Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by
establishing, amending, suspending, or removing Standard Instrument
Approach Procedures and/or Takeoff Minimums and Obstacle Departure
Procedures effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114,
40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Effective 13 September 2018

Berryville, AR, Carroll County, RNAV (GPS) RWY 7, Amdt 1
Berryville, AR, Carroll County, RNAV (GPS) RWY 25, Amdt 1
Mountain Home, AR, Baxter County, ILS OR LOC RWY 5, Amdt 1
Mountain Home, AR, Baxter County, Takeoff Minimums and Obstacle DP,
Amdt 4
Mountain Home, AR, Baxter County, VOR-A, Amdt 10A, CANCELED
Casa Grande, AZ, Casa Grande Muni, ILS OR LOC RWY 5, Amdt 7
Casa Grande, AZ, Casa Grande Muni, RNAV (GPS) RWY 5, Amdt 1
Casa Grande, AZ, Casa Grande Muni, RNAV (GPS) RWY 23, Orig
Fort Huachuca Sierra Vista, AZ, Sierra Vista Muni-Libby AAF, Takeoff
Minimums and Obstacle DP, Amdt 4
El Monte, CA, San Gabriel Valley, NDB OR GPS-C, Amdt 1A, CANCELED
El Monte, CA, San Gabriel Valley, Takeoff Minimums and Obstacle DP,
Amdt 7
El Monte, CA, San Gabriel Valley, VOR-A, Orig
El Monte, CA, San Gabriel Valley, VOR OR GPS-A, Amdt 7A, CANCELED
Palm Springs, CA, Jacqueline Cochran Rgnl, RNAV (GPS) RWY 35, Amdt 1
San Francisco, CA, San Francisco Intl, ILS OR LOC RWY 28R, ILS RWY 28R
(SA CAT I), ILS RWY 28R (CAT II), ILS RWY 28R (CAT III), Amdt 15
San Francisco, CA, San Francisco Intl, RNAV (GPS) RWY 28L, Amdt 7
San Francisco, CA, San Francisco Intl, RNAV (GPS) Z RWY 28R, Amdt 7
San Francisco, CA, San Francisco Intl, RNAV (RNP) Y RWY 28R, Amdt 5
South Lake Tahoe, CA, Lake Tahoe, Takeoff Minimums and Obstacle DP,
Amdt 8
Ellijay, GA, Gilmer County, RNAV (GPS) RWY 3, Orig
Ellijay, GA, Gilmer County, RNAV (GPS) RWY 21, Orig
Ellijay, GA, Gilmer County, Takeoff Minimums and Obstacle DP, Orig
Rome, GA, Richard B Russell Regional--J H Towers Field, ILS OR LOC RWY
1, Amdt 1
Rome, GA, Richard B Russell Regional--J H Towers Field, RNAV (GPS) RWY
1, Amdt 1
Rome, GA, Richard B Russell Regional--J H Towers Field, RNAV (GPS) RWY
7, Amdt 1
Rome, GA, Richard B Russell Regional--J H Towers Field, RNAV (GPS) RWY
19, Amdt 1
Rome, GA, Richard B Russell Regional--J H Towers Field, RNAV (GPS) RWY
25, Amdt 1
Rome, GA, Richard B Russell Regional--J H Towers Field, Takeoff
Minimums and Obstacle DP, Amdt 4
Rome, GA, Richard B Russell Regional--J H Towers Field, VOR/DME RWY 1,
Amdt 9, CANCELED
Rome, GA, Richard B Russell Regional--J H Towers Field, VOR/DME RWY 19,
Amdt 9, CANCELED
Albia, IA, Albia Muni, Takeoff Minimums and Obstacle DP, Amdt 4
Oelwein, IA, Oelwein Muni, RNAV (GPS) RWY 13, Orig-A
Oelwein, IA, Oelwein Muni, VOR OR GPS-A, Amdt 3B, CANCELED
Sibley, IA, Sibley Muni, NDB OR GPS RWY 35, Amdt 1B, CANCELED

Sibley, IA, Sibley Muni, RNAV (GPS)-A, Orig
Waterloo, IA, Waterloo Rgnl, ILS OR LOC RWY 12, Amdt 10
Waterloo, IA, Waterloo Rgnl, LOC BC RWY 30, Amdt 12
Waterloo, IA, Waterloo Rgnl, RNAV (GPS) RWY 6, Amdt 1
Waterloo, IA, Waterloo Rgnl, RNAV (GPS) RWY 12, Amdt 1
Waterloo, IA, Waterloo Rgnl, RNAV (GPS) RWY 18, Amdt 1
Waterloo, IA, Waterloo Rgnl, RNAV (GPS) RWY 24, Amdt 1
Waterloo, IA, Waterloo Rgnl, RNAV (GPS) RWY 30, Amdt 1
Waterloo, IA, Waterloo Rgnl, RNAV (GPS) RWY 36, Amdt 1
Waterloo, IA, Waterloo Rgnl, VOR RWY 6, Amdt 3B
Waterloo, IA, Waterloo Rgnl, VOR RWY 12, Amdt 10B
Waterloo, IA, Waterloo Rgnl, VOR RWY 18, Amdt 9
Waterloo, IA, Waterloo Rgnl, VOR RWY 24, Amdt 16C
Waverly, IA, Waverly Muni, VOR-A, Amdt 4
Chicago, IL, Chicago O'Hare Intl, RNAV (GPS) PRM Y RWY 28L (CLOSE
PARALLEL), Orig-A
Chicago, IL, Chicago O'Hare Intl, RNAV (GPS) Y RWY 28L, Orig-A
Chicago, IL, Chicago O'Hare Intl, RNAV (GPS) Z RWY 28L, Orig-C
Harrisburg, IL, Harrisburg-Raleigh, RNAV (GPS) RWY 24, Amdt 2A
Evansville, IN, Evansville Rgnl, RADAR-1, Amdt 7A
Evansville, IN, Evansville Rgnl, VOR RWY 4, Amdt 7A
South Bend, IN, South Bend Intl, ILS OR LOC RWY 9R, Amdt 10
South Bend, IN, South Bend Intl, ILS OR LOC RWY 27L, ILS RWY 27L SA CAT
I, ILS RWY 27L SA CAT II, Amdt 36
South Bend, IN, South Bend Intl, RNAV (GPS) RWY 9L, Amdt 1
South Bend, IN, South Bend Intl, RNAV (GPS) RWY 18, Amdt 1B
South Bend, IN, South Bend Intl, RNAV (GPS) RWY 27L, Orig-B
South Bend, IN, South Bend Intl, RNAV (GPS) RWY 27R, Amdt 1
South Bend, IN, South Bend Intl, VOR RWY 18, Amdt 7E
Kingman, KS, Kingman Airport--Clyde Cessna Field, RNAV (GPS) RWY 18,
Amdt 1
Kingman, KS, Kingman Airport--Clyde Cessna Field, RNAV (GPS) RWY 36,
Amdt 1
Indian Head, MD, Maryland, RNAV (GPS) RWY 2, Amdt 1B
Cheboygan, MI, Cheboygan County, Takeoff Minimums and Obstacle DP, Amdt
3A
New Hudson, MI, Oakland Southwest, Takeoff Minimums and Obstacle DP,
Amdt 2A
Starkville, MS, George M Bryan, RNAV (GPS) RWY 18, Amdt 2B
Newark, NJ, Newark Liberty Intl, GLS RWY 4L, Amdt 1
Newark, NJ, Newark Liberty Intl, GLS RWY 4R, Amdt 1
Newark, NJ, Newark Liberty Intl, GLS RWY 22R, Amdt 1
Trenton, NJ, Trenton Mercer, ILS OR LOC RWY 6, Amdt 10D
Trenton, NJ, Trenton Mercer, RNAV (GPS) RWY 34, Orig-C
Belen, NM, Belen Rgnl, RNAV (GPS) RWY 21, Orig-A
Belen, NM, Belen Rgnl, Takeoff Minimums and Obstacle DP, Amdt 1B
Belen, NM, Belen Rgnl, VOR-A, Amdt 1B
New York, NY, LaGuardia, LOC RWY 31, Amdt 3C
New York, NY, LaGuardia, VOR-H, Amdt 3C
New York, NY, Stewart Intl, RNAV (GPS) RWY 9, Amdt 1D
New York, NY, Stewart Intl, RNAV (GPS) RWY 16, Amdt 1C
Wellsville, NY, Wellsville Muni Arpt, Tarantine Fld, LOC/DME RWY 28,
Amdt 4, CANCELED
Wellsville, NY, Wellsville Muni Arpt, Tarantine Fld, RNAV (GPS) RWY 10,
Amdt 1
Wellsville, NY, Wellsville Muni Arpt, Tarantine Fld, RNAV (GPS) RWY 28,
Amdt 1
Dayton, OH, Dayton-Wright Brothers, NDB-A, Amdt 3
Piqua, OH, Piqua Airport--Hartzell Field, RNAV (GPS) RWY 8, Orig-D
Piqua, OH, Piqua Airport--Hartzell Field, RNAV (GPS) RWY 26, Orig-C
Piqua, OH, Piqua Airport--Hartzell Field, VOR RWY 26, Amdt 6D
Piqua, OH, Piqua Airport--Hartzell Field, VOR-A, Amdt 13C
Eugene, OR, Mahlon Sweet Field, ILS OR LOC RWY 16L, Amdt 2A
Eugene, OR, Mahlon Sweet Field, ILS OR LOC RWY 16R, ILS RWY 16R SA CAT
I, ILS RWY 16R CAT II, ILS RWY 16R CAT III, Amdt 38A
Eugene, OR, Mahlon Sweet Field, RNAV (GPS) Y RWY 16L, Amdt 4
Eugene, OR, Mahlon Sweet Field, RNAV (GPS) Y RWY 16R, Amdt 3
Eugene, OR, Mahlon Sweet Field, RNAV (GPS) Y RWY 34L, Amdt 4
Eugene, OR, Mahlon Sweet Field, RNAV (GPS) Y RWY 34R, Amdt 4
Eugene, OR, Mahlon Sweet Field, Takeoff Minimums and Obstacle DP, Amdt
7B
Eugene, OR, Mahlon Sweet Field, VOR-A, Amdt 7B
Eugene, OR, Mahlon Sweet Field, VOR OR TACAN RWY 16R, Amdt 5C
Eugene, OR, Mahlon Sweet Field, VOR OR TACAN RWY 34L, Amdt 6
Hermiston, OR, Hermiston Muni, RNAV (GPS)-B, Amdt 1
Hermiston, OR, Hermiston Muni, VOR-A, Amdt 4
Columbia, SC, Jim Hamilton L B Owens, GPS RWY 31, Orig-B, CANCELED
Columbia, SC, Jim Hamilton L B Owens, LOC RWY 31, Amdt 2
Columbia, SC, Jim Hamilton L B Owens, RNAV (GPS) RWY 13, Orig
Columbia, SC, Jim Hamilton L B Owens, RNAV (GPS) RWY 31, Orig
Pine Ridge, SD, Pine Ridge, RNAV (GPS) RWY 12, Orig
Pine Ridge, SD, Pine Ridge, RNAV (GPS) RWY 30, Orig-C
Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, RNAV (GPS) Y RWY 13R,
Amdt 3
Odessa, TX, Odessa-Schlemeyer Field, Takeoff Minimums and Obstacle DP,
Amdt 3A
Antigo, WI, Langlade County, RNAV (GPS) RWY 27, Amdt 1
Stevens Point, WI, Stevens Point Muni, RNAV (GPS) RWY 3, Orig-B

[FR Doc. 2018-18881 Filed 9-10-18; 8:45 am]
 BILLING CODE 4910-13-P