[Federal Register Volume 82, Number 119 (Thursday, June 22, 2017)]
[Rules and Regulations]
[Pages 28397-28399]
[FR Doc No: 2017-12799]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0078; Directorate Identifier 2015-SW-026-AD;
Amendment 39-18933; AD 2017-13-03]
RIN 2120-AA64

Airworthiness Directives; Bell Helicopter Textron Canada Limited
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for Bell
Helicopter Textron Canada Limited (Bell) Model 429 helicopters. This AD
requires adding an identification number to life-limited rod ends that
do not have a serial number (S/N). The actions of this AD are intended
to address an unsafe condition on these products.

DATES: This AD is effective July 27, 2017.

    The Director of the Federal Register approved the incorporation by
reference of a certain document listed in this AD as of July 27, 2017.

ADDRESSES: For service information identified in this final rule,
contact Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir,
Mirabel, Quebec J7J1R4; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax
(450) 433-0272; or at http://www.bellcustomer.com/files/. You may
review the referenced service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0078.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0078; or in person at the Docket Operations Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the Transport Canada AD, any incorporated-by-
reference service information, the economic evaluation, any comments
received, and other information. The street address for the Docket
Operations Office (phone:<PHONE_NUMBER>) is U.S. Department of
Transportation, Docket Operations Office, M-30, West Building Ground
Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Matt Fuller, Senior Aviation Safety
Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101
Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On February 17, 2017, at 82 FR 10976, the Federal Register
published our notice of proposed rulemaking (NPRM), which proposed to
amend 14 CFR part 39 by adding an AD that would apply to Bell Model 429
helicopters, S/N 57001 through 57260, with a pylon restraint spring
assembly (spring assembly) forward rod end (rod end) part number (P/N)
427-010-210-105 installed. The NPRM proposed to require cleaning and
marking each rod end with the S/N of the spring assembly. The NPRM also
proposed prohibiting the installation of rod end P/N 427-010-210-105 on
any helicopter unless it has been marked in accordance with the
proposed requirements. The proposed requirements were intended to
prevent a rod end from remaining in service after reaching its life
limit. This condition could result in failure of a rod end and
subsequent loss of control of a helicopter.
    Transport Canada, which is the aviation authority for Canada, has
issued AD No. CF-2015-15, dated June 25, 2015, to correct an unsafe
condition for Bell Model 429 helicopters, S/Ns 57001 through 57260.
Transport Canada advises that, per its regulations, life-limited parts
must be marked with their P/N and S/N. Transport Canada further states
that the spring assembly rod end P/N 427-010-210-105 has a life limit
of 5,000 hours; however, it is not serialized, causing difficulties in
tracking its accumulated air time. According to Transport Canada, this
condition could result in a rod end remaining in service beyond its
life limit. Therefore, the Transport Canada AD requires adding
identification markings on each spring assembly rod end.

Comments

    We gave the public the opportunity to participate in developing
this AD, but we did not receive any comments on the NPRM.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Canada and are approved for operation in the United States. Pursuant to
our bilateral agreement with Canada, Transport Canada, its technical
representative, has notified us of the unsafe condition described in
its AD. We are issuing this AD because we evaluated all information
provided by Transport Canada and determined the unsafe condition exists
and is likely to exist or develop on other helicopters of the same type
design and that air safety and the public interest require adopting the
AD requirements as proposed.

Related Service Information Under 1 CFR Part 51

    Bell Helicopter has issued Alert Service Bulletin 429-15-19, dated
February 26, 2015. This service information specifies procedures for
permanently marking each forward and aft rod end with the S/N of the
spring assembly. This service information applies to certain serial-
numbered helicopters, as subsequent helicopters will have these actions
performed during the manufacturing process.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Other Related Service Information

    We also reviewed Bell Model 429 Maintenance Manual BHT-429-MM-1,
Chapter 4, Airworthiness Limitations Schedule, Revision 24, approved
June 12, 2015, which specifies airworthiness life limits and inspection
intervals for parts installed on Model 429 helicopters.

Costs of Compliance

    We estimate that this AD will affect 70 helicopters of U.S.
Registry. We estimate that operators may incur the following costs in
order to comply with this AD. Labor costs are estimated at $85 per
work-hour. Marking the rod ends will take about 0.5 work-hour for a
total estimated cost of $43 per helicopter and $3,010 for the U.S.
fleet. Replacing a rod end that has exceeded its life limit will take
about 3 work-hours and required parts will cost about $4,100 for an
estimated replacement cost of $4,355 per rod end.

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;

    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979);
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction; and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2017-13-03 Bell Helicopter Textron Canada Limited: Amendment 39-
18933; Docket No. FAA-2017-0078; Directorate Identifier 2015-SW-026-
AD.

(a) Applicability

    This AD applies to Model 429 helicopters, serial number 57001
through 57260, with a pylon restraint spring assembly (spring
assembly) forward rod end (rod end) part number (P/N) 427-010-210-
105 installed, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a rod end remaining in
service after reaching its life limit. This condition could result
in failure of a rod end and subsequent loss of control of a
helicopter.

(c) Effective Date

    This AD becomes effective July 27, 2017.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    (1) Within 140 hours time-in-service, clean and identify each
forward rod end with the spring assembly serial number in accordance
with the Accomplishment Instructions, paragraphs 3 through 5, and 7
through 8, of Bell Helicopter Alert Service Bulletin 429-15-19,
dated February 26, 2015.
    (2) Do not install a forward rod end P/N 427-010-210-105 on any
helicopter unless it has been marked with a serial number in
accordance with paragraph (e)(1) of this AD.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Matt Fuller, Senior Aviation
Safety Engineer, Safety Management Group, Rotorcraft Directorate,
FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone (817) 222-
5110; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    (1) Bell Model 429 Maintenance Manual BHT-429-MM-1, Chapter 4,
Airworthiness Limitations Schedule, Revision 24, approved June 12,
2015, which is not incorporated by reference, contains additional
information about the subject of this AD. For service information
identified in this AD, contact Bell Helicopter Textron Canada
Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J1R4; telephone
(450) 437-2862 or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at http://www.bellcustomer.com/files/. You may review the referenced service
information at the FAA, Office of the Regional Counsel, Southwest
Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.
    (2) The subject of this AD is addressed in Transport Canada AD
No. CF-2015-15 dated June 25, 2015. You may view the Transport
Canada AD on the Internet at http://www.regulations.gov in Docket
No. FAA-2017-0078.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 5101, Standard
Practices/Structures.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Bell Helicopter Alert Service Bulletin 429-15-19, dated
February 26, 2015.
    (ii) Reserved.
    (3) For Bell Helicopter service information identified in this
AD, contact Bell Helicopter Textron Canada Limited, 12,800 Rue de
l'Avenir, Mirabel, Quebec J7J1R4; telephone<PHONE_NUMBER> or (800)
363-8023; fax<PHONE_NUMBER>; or at http://www.bellcustomer.com/files/.
    (4) You may view this service information at FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-
321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Fort Worth, Texas, on June 2, 2017.
Lance T. Gant,
Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2017-12799 Filed 6-21-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: November 25, 2005 (Volume 70, Number 226)]
[Notices]
[Page 71114]
[DOCID:fr25no05-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP06-17-000]

Colorado Interstate Gas Company; Notice of Application

November 18, 2005.
    Take notice that Colorado Interstate Gas Company (CIG), P.O. Box
1087, Colorado Springs, Colorado 80944, filed in Docket No. CP06-17-000
on October 31, 2005, an application pursuant to section 7(b) of the
Natural Gas Act (NGA), for authorization for CIG to abandon, by
removal, its Sanford Compressor Station and Gas Sweetening Plant,
comprised of three 880 horsepower (ISO) reciprocal compressor units and
miscellaneous gas processing and sweetening facilities, located in
Hutchinson County, Texas, all as more fully set forth in the
application which is on file with the Commission and open to public
inspection. This filing may be also viewed on the Web at http://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, call<PHONE_NUMBER> or TTY, (202) 208-
3676.
    Any questions regarding this application should be directed to
Richard Derryberry, Director, Regulatory Affairs, Colorado Interstate
Gas Company, P.O. Box 1087, Colorado Springs, Colorado 80944 at (719)
520-3788 or by fax at<PHONE_NUMBER>.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under the ``e-Filing''
link.
    Comment Date: December 9, 2005.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-6490 Filed 11-23-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Rules and Regulations]
[Pages 27699-27702]
[FR Doc No: 2018-12760]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2018-N-1928]

Medical Devices; Immunology and Microbiology Devices;
Classification of the Brain Trauma Assessment Test

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the brain trauma assessment test 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 brain trauma
assessment test'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, in part by reducing
regulatory burdens.

DATES: This order is effective June 14, 2018. The classification was
applicable on February 14, 2018.

FOR FURTHER INFORMATION CONTACT: Erin Cutts, Center for Devices and
Radiological Health, Food and Drug

Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5618, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the brain trauma assessment test
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 reducing regulatory burdens 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 (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 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 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). 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 shall
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.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. 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 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    On August 28, 2017, Banyan Biomarkers, Inc., submitted a request
for De Novo classification of the Banyan BTI. 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 February 14, 2018, FDA issued an order to the
requester classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 866.5830. We have named
the generic type of device brain trauma assessment test, and it is
identified as a device that consists of reagents used to detect and
measure brain injury biomarkers in human specimens. The measurements
aid in the evaluation of patients with suspected mild traumatic brain
injury in conjunction with other clinical information to assist in
determining the need for head imaging per current standard of care.
    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--Brain Trauma Assessment Test Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Inaccurate test results that provide     General controls and special
 false positive or false negative         control (1) (21 CFR
 results.                                 866.5830(b)(1)).
Failure to correctly interpret test      General controls and special
 results can lead to false positive or    control (2) (21 CFR
 false negative results.                  866.5830(b)(2)).
------------------------------------------------------------------------

    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. 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. 3501-3520). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' 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; and the collections of information in 21 CFR
parts 801 and 809, regarding labeling, have been approved under OMB
control number 0910-0485.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, 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
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

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

0
2. Add Sec.  866.5830 to subpart F to read as follows:

Sec.  866.5830   Brain trauma assessment test.

    (a) Identification. A brain trauma assessment test is a device that
consists of reagents used to detect and measure brain injury biomarkers
in human specimens. The measurements aid in the evaluation of patients
with suspected mild traumatic brain injury in conjunction with other
clinical information to assist in determining the need for head imaging
per current standard of care.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The 21 CFR 809.10(b) compliant labeling must include detailed
descriptions of and results from performance testing conducted to
evaluate precision, accuracy, linearity, analytical sensitivity,
interference, and cross-reactivity. This information must include the
following:
    (i) Performance testing of device precision must, at minimum, use
one unmodified clinical specimen from the intended use population with
concentration of the brain injury biomarker(s) near the medical
decision point. Contrived specimens that have been generated from
pooling of multiple samples or spiking of purified analyte to cover the
measuring range may be used, but the contrived samples must be prepared
to mimic clinical specimens as closely as possible. This testing must
evaluate repeatability and reproducibility using a protocol from an
FDA-recognized standard.
    (ii) Device performance data must be demonstrated through a
clinical study and must include the following:
    (A) Data demonstrating clinical validity including the clinical
sensitivity and specificity, and positive and negative predictive value
of the test in the intended use population of patients with suspected
mild traumatic brain injury (i.e., Glasgow Coma Score (GCS) of 13-15),
or equivalent standard of care for determination of severity of
traumatic brain injury (TBI).
    (B) Study must be performed using the operators and in settings
that are representative of the types of operators and settings for
which the device is intended to be used.
    (C) All eligible subjects must meet the well-defined study
inclusion and exclusion criteria that define the intended use
population. The prevalence of diseased or injured subjects in the study
population must reflect the prevalence of the device's intended use
population, or alternatively, statistical measures must be used to
account for any bias due to enrichment of subpopulations of the
intended use population.
    (D) All eligible subjects must have undergone a head computerized
tomography (CT) scan or other appropriate clinical diagnostic standard
used to determine the presence of an intracranial lesion as part of
standard of care and must also be evaluated by the subject device. All
clinical diagnostic standards used in the clinical study must follow
standard clinical practice in the United States.
    (E) Relevant demographic variables and baseline characteristics
including medical history and neurological history. In addition, head
injury characteristics, neurological assessments, and physical evidence
of trauma must be provided for each subject. This information includes
but is not limited to the following: Time since head injury, time from
head injury to CT scan, time from head injury to blood draw, GCS score
or equivalent, experience of loss of consciousness, presence of
confusion, episodes of vomiting, post-traumatic amnesia
characteristics, presence of post-traumatic seizures, drug or alcohol
intoxication, mechanism of injury, acute intracranial lesion type,
neurosurgical lesion, and cranial fracture.
    (F) Each CT scan or other imaging result must be independently
evaluated in a blinded manner by at least two board-certified
radiologists to determine whether it is positive or negative as defined
by the presence or absence of acute intracranial lesions. This
independent review must be conducted without access to test results of
the device. Prior to conducting the review, the criteria and procedures
to be followed for scoring the images must be established, including
the mechanism for determining consensus.
    (G) All the clinical samples must be tested with the subject device
blinded to the TBI status and the neurological-lesion-status of the
subject.
    (H) Details on how missing values in data are handled must be
provided.
    (I) For banked clinical samples, details on storage conditions and
storage period must be provided. In addition, a specimen stability
study must be conducted for the duration of storage to demonstrate
integrity of archived clinical samples. The samples evaluated in the
assay test development must not be used to establish the clinical
validity of the assays.
    (iii) Performance testing of device analytical specificity must
include the most commonly reported concomitant medications present in
specimens from the intended use population. Additionally, potential
cross-reacting endogenous analytes must be evaluated at the highest
concentration reported in specimens from the intended use population.
    (iv) Expected/reference values generated by testing a statistically
appropriate number of samples from apparently healthy normal
individuals.

    (2) The 21 CFR 809.10(a) and (b) compliant labeling must include
the following limitations:
    (i) A limiting statement that this device is not intended to be
used a stand-alone device but as an adjunct to other clinical
information to aid in the evaluation of patients who are being
considered for standard of care neuroimaging.
    (ii) A limiting statement that reads ``A negative result is
generally associated with the absence of acute intracranial lesions. An
appropriate neuroimaging method is required for diagnosis of acute
intracranial lesions.''
    (iii) As applicable, a limiting statement that reads ``This device
is for use by laboratory professionals in a clinical laboratory
setting.''

    Dated: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12760 Filed 6-13-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31986-31988]
[FR Doc No: 2016-11881]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77841; File No. SR-ISEMercury-2016-11]

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

May 16, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on May 2, 2016, ISE Mercury, LLC (the ``Exchange'' or ``Mercury'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change, as described in Items I, II, and III below, which
Items have been prepared by the self-regulatory organization. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    Mercury proposes to amend its Schedule of Fees proposes to amend
its Schedule of Fees [sic] to add the definitions of ``Mercury
Appointed Market Maker'' and ``Mercury Appointed Order Flow Provider''
effective May 2, 2016, which would increase opportunities for Market
Makers to qualify for the Exchange's Member Volume Program (``MVP'').
The text of the proposed rule change is available on the Exchange's
Internet Web site at http://www.ise.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    Mercury proposes to amend its Schedule of Fees to add the
definitions of Mercury Appointed Market Maker and Mercury Appointed
Order Flow Provider effective May 2, 2016, which would increase
opportunities for members to qualify for the Exchange's MVP.\3\
---------------------------------------------------------------------------

    \3\ The MVP tiers are determined by a member's average daily
volume of Priority Customer Regular Orders, in Penny and Non-Penny
Pilot Symbols traded on the Exchange.
---------------------------------------------------------------------------

    Specifically, the Exchange proposes to allow a Mercury Appointed
Order Flow Provider (``MOFP'') \4\ to designate a Mercury Appointed
Market Maker (``MAMM'') \5\ for purposes of Section I, Table 4 of the
Fee Schedule.\6\ MOFPs and MAMMs would effectuate the designation by
each sending an email to the Exchange by the 5th day of the month with
their designations.\7\ The Exchange would view the corresponding emails
as acceptance of such an appointment and would only recognize one such
designation for each party once every 6 months, which designation would
remain in effect until the Exchange receives an email from either party
indicating that the appointment has been terminated.\8\ The proposed
new concepts would be applicable to, and included in, Section

I, Table 4 of the ISE Mercury Fee Schedule, as described below, and are
designed to increase opportunities for firms to qualify for the
Exchange's MVP.\9\
---------------------------------------------------------------------------

    \4\ A ``MOFP'' is an Electronic Access Member who has been
appointed by a Mercury Market Maker pursuant to Section I, Table 4
of the ISE Mercury Fee Schedule.
    \5\ A ``MAMM'' is a Mercury Market Maker who has been appointed
by an Electronic Access Member pursuant to Section I, Table 4 of the
ISE Mercury Fee Schedule.
    \6\ See proposed ISE Mercury Fee Schedule, Preface.
    \7\ See proposed ISE Mercury Fee Schedule, Section 1, Table 4.
Members should direct their emails designating a MAMM/MOFP to
<EMAIL_ADDRESS>    \8\ See id.
    \9\ See proposed ISE Mercury Fee Schedule, Section 1, Table 4.
---------------------------------------------------------------------------

    ISE Mercury introduced the MVP fee and rebate tiers for Market
Maker and Priority Customer \10\ orders based on the average daily
volume (``ADV'') that a member executes in Priority Customer
orders.\11\ The Exchange assesses fees and rebates for Market Maker and
Priority Customer orders based on five tiers of Total Affiliated
Priority Customer ADV, as described in Table 4 of the Fee Schedule:
\12\ 0-19,999 contracts (``Tier 1''), 20,000-39,999 contracts (``Tier
2''), 40,000-59,999 contracts (``Tier 3''), 60,000-79,999 contracts
(``Tier 4''), and 80,000 or more contracts (``Tier 5'').\13\ As is the
case on ISE Mercury's affiliated exchanges--the International
Securities Exchange, LLC (``ISE'') and ISE Gemini, LLC (``ISE
Gemini'')--the Exchange's ADV calculation includes volume executed by
affiliated members. In particular, the Exchange aggregates all eligible
volume from affiliated members in determining applicable tiers,
provided that there is at least 75% common ownership between the
members as reflected on the member's Form BD, Schedule A. While this
method of aggregating volume is beneficial to large firms with multiple
affiliated members, the Exchange believed that it was also important to
give smaller firms the ability to compete for more favorable fees and
rebates.
---------------------------------------------------------------------------

    \10\ A ``Priority Customer'' is a person or entity that is not a
broker/dealer in securities, and does not place more than 390 orders
in listed options per day on average during a calendar month for its
own beneficial account(s), as defined in ISE Mercury Rule
100(a)(37A).
    \11\ See Exchange Act Release No. 77409 (March 21, 2016), 81 FR
16240 (March 25, 2016) (SR-ISE Mercury-2016-05).
    \12\ The Total Affiliated Priority Customer ADV category
includes all Priority Customer volume executed on the Exchange in
all symbols and order types, including volume executed in the Price
Improvement Mechanism, Facilitation, and Qualified Contingent Cross
mechanisms.
    \13\ The highest tier threshold attained applies retroactively
in a given month to all eligible traded contracts and applies to all
eligible market participants. Any day that the market is not open
for the entire trading day or the Exchange instructs members in
writing to route their orders to other markets may be excluded from
the ADV calculation; provided that the Exchange will only remove the
day for members that would have a lower ADV with the day included.
---------------------------------------------------------------------------

    The Exchange then adopted ADV tiers that are based on preferenced
volume \14\--i.e., volume directed to a specific Market Maker as
provided in Supplementary Material .03 to Rule 713.\15\ In particular,
the Exchange gives Market Makers volume credit for 100% of eligible
traded volume preferenced to that member,\16\ regardless of the actual
allocation that the Market Maker receives (``the Preferenced Volume
Program.''). For example, assume Market Maker ABC is quoting at the
national best bid or offer (``NBBO'') and receives a Preferenced Order
for 10 contracts from an unaffiliated firm for the account of a
Priority Customer. If there are other Market Makers quoting at the
NBBO, Market Maker ABC may receive an allocation of 4 contracts--i.e.,
40% of the order. Rather than counting only the 4 contracts executed
towards the Market Maker's volume total, the Exchange now proposes to
give that Market Maker credit for the full 10 contracts preferenced to
it. This is the same credit the member would receive if the 10
contracts were sent to the exchange by an affiliated member. The
Exchange notes that even though Market Maker ABC receives full credit
for all 10 contracts when executing 4 contracts, Market Makers that
execute the remaining 6 contracts will still receive credit for those 6
contracts.
---------------------------------------------------------------------------

    \14\ See Exchange Act release No. 77412 (March 21, 2016), 81 FR
16238 (March 25, 2016) (SR-ISE Mercury-2016-06).
    \15\ An EAM may designate a ``Preferred Market Maker'' on orders
it enters into the System (``Preferenced Orders''). Supplementary
Material .03 to Rule 713 describes the Exchange's rules concerning
Preferenced Orders.
    \16\ ``Eligible volume'' refers to volume that would otherwise
count towards to applicable volume tier. In the case of ADV
thresholds based on Total Affiliated Priority Customer ADV, as
currently implemented on ISE Mercury, all Priority Customer volume
would be ``eligible.''
---------------------------------------------------------------------------

    The proposed rule would replace the Preferenced Volume Program, but
all other aspects of the MVP, including its five tiers of Total
Affiliated Priority Customer ADV, will remain in effect. The Exchange
proposes to modify its Fee Schedule to include the newly introduced
concepts of a MOFP and MAMM. The proposal would be available to all
MOFPs and MAMMs as defined in the Fee Schedule. Specifically, the
proposed changes would enable any MOFP to qualify its MAMM for credits
under the MVP. In this regard, the proposed change would enable a MAMM
to enter a relationship with a MOFP and receive volume credit from that
MOFP.\17\ Thus, the proposed changes would (1) enable members that are
not currently eligible for the MVP to avail themselves of the MVP and
(2) assist firms that are currently eligible for the MVP to potentially
achieve a higher MVP tier, thus qualifying for lower fees or higher
rebates.
---------------------------------------------------------------------------

    \17\ The Market Maker (i.e., MAMM) would still receive volume
credit from its affiliates.
---------------------------------------------------------------------------

    The Exchange believes these proposed changes would incentivize
firms to direct their order flow to the Exchange to the benefit of all
market participants. As proposed, the Exchange would only process one
designation of a MOFP and MAMM every 6 months, which designation would
remain in effect unless or until either party informs the Exchange of
its termination.\18\ The Exchange believes that this requirement would
impose a measure of exclusivity and would enable MAMMs to rely upon the
MOFP's transaction volume executed on the Exchange, which is beneficial
to all Exchange participants.
---------------------------------------------------------------------------

    \18\ A MOFP may not have more than one MAMM selected at any
given time.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\19\ in general, and furthers the
objectives of Sections 6(b)(4) and (5) of the Act,\20\ in particular,
because it provides for the equitable allocation of reasonable dues,
fees, and other charges among its members, issuers and other persons
using its facilities and does not unfairly discriminate between
customers, issuers, brokers or dealers.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78f(b).
    \20\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The proposal is reasonable, equitable and not unfairly
discriminatory for the following reasons. First, this rule filing is
substantially similar NYSE MKT LLC's fee filing to modify NYSE Amex's
Option Fee Schedule.\21\ As such, the proposal would be available to
all Electronic Access Members (``EAMs'') and Market Makers.
Additionally, the designations are completely voluntary and members may
elect to accept this appointment or not. In addition, the proposed
changes would enable firms that are not currently eligible for the MVP
to avail themselves of the MVP as well as to assist firms that are
currently eligible for the MVP to potentially achieve a higher MVP
tier, thus qualifying for lower fees or higher rebates. The Exchange
believes these proposed changes would incentivize firms to direct their
order flow to the Exchange. Specifically, the proposed changes would
enable any qualifying member (i.e. a MAMM) by virtue of designating a
MOFP to aggregate its Priority Customer volume with that of the MOFP,
which would enhance the MAMM's potential to qualify for lower fees or
higher rebates under the MVP. The Exchange believes these proposed
changes would incentivize MOFPs and

MAMMs to direct their order flow to the Exchange, which would increase
orders routed to the Exchange and benefit all market participants by
expanding liquidity, providing more trading opportunities and tighter
spreads, including those market participants that opt not to become a
MAMM and therefore may be ineligible to earn the credits under the MVP.
---------------------------------------------------------------------------

    \21\ Exchange Act Release No. 77370 (March 15, 2016), 81 FR
15136 (March 21, 2016) (SR-NYSEMKT-2016-35).
---------------------------------------------------------------------------

    The proposal is also reasonable, equitable and not unfairly
discriminatory because the Exchange would only process one designation
of a MOFP and MAMM every 6 months, which requirement would impose a
measure of exclusivity while allowing MAMM's to rely upon, and
potentially increase, the MOFP's transaction volume executed on the
Exchange to the benefit of all Exchange participants.
    Finally, the Exchange believes the proposal is reasonable,
equitable and not unfairly discriminatory as it may encourage an
increase in orders routed to the Exchange, which would expand liquidity
and provide more trading opportunities and tighter spreads to the
benefit of all market participants.

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

    In accordance with Section 6(b)(8) of the Act,\22\ the Exchange
does not believe that the proposed rule change will impose any burden
on intermarket or intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. To the contrary,
the Exchange believes that the proposed rule change will increase
competition by allowing smaller Market Makers to compete for more
favorable fees and rebates. As currently implemented, Market Makers
that are affiliated with an order router are advantaged relative to
other firms in achieving volume based fees and rebates. Although the
Exchange continues to believe that counting volume across affiliated
members is appropriate, a Market Maker that has a similar relationship,
without common ownership, should be able to compete for and receive
similar benefits. The proposed rule change is designed to level the
playing field between these members and their competitors that already
benefit from affiliated volume. The Exchange operates in a highly
competitive market in which market participants can readily direct
their order flow to competing venues. For the reasons described above,
the Exchange believes that the proposed fee change reflects this
competitive environment.
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

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

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act,\23\ and subparagraph (f)(2) of Rule 19b-4
thereunder,\24\ because it establishes a due, fee, or other charge
imposed by ISE Mercury.
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \24\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISEMercury-2016-11 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISEMercury-2016-11. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISEMercury-2016-11, and
should be submitted on or before June 10, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\25\
---------------------------------------------------------------------------

    \25\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-11881 Filed 5-19-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: November 26, 2007 (Volume 72, Number 226)]
[Proposed Rules]
[Page 65911-65913]
[DOCID:fr26no07-10]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-0224; Directorate Identifier 2007-NM-188-AD]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 737-100, -200, -300, -400,
and -500 Series Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Boeing Model 737-100, -200, -300, -400, and -500 series
airplanes. This proposed AD would require repetitive inspections for
fatigue cracking in the longitudinal floor beam web, upper chord, and
lower chord located at certain body stations, and repair if necessary.
This proposed AD results from several reports of cracks in the center
wing box longitudinal floor beams, upper chord, and lower chord. We are
proposing this AD to detect and correct fatigue cracking of the upper
and lower chords and web of the longitudinal floor beams, which could
result in rapid loss of cabin pressure.

DATES: We must receive comments on this proposed AD by January 10,
2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the instructions for submitting comments.

     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Boeing
Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Management Facility

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Nancy Marsh, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6440; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2007-0224;
Directorate Identifier 2007-NM-188-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,

economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov
, including any personal information you provide. We

will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We have received several reports of fatigue cracks in the center
wing box longitudinal floor beams on certain Boeing Model 737-100, -
200, -300, -400, and -500 series airplanes. The cracks were found in
the longitudinal floor beam web, upper chord, and lower chord at left
buttock line (LBL) 24.8, right buttock line (RBL) 24.8, LBL 45.5 and
RBL 45.5, between Station (STA) 656 and STA 727B. The airplanes had
accumulated between 17,000 and 70,000 total flight cycles. These
fatigue cracks are attributed to cyclic pressurization loads, fuel
loads, and passenger loads. Fatigue cracking of the upper and lower
chords and web of the longitudinal floor beams, if not corrected, could
result in rapid loss of cabin pressure.

Related Rulemaking

    On December 30, 1998, we issued AD 98-11-04 R1, amendment 39-10984
(64 FR 987) applicable to Boeing Model 737-100 and -200 series
airplanes. That AD requires revising the FAA-approved maintenance
program to include inspections that will give no less than the required
damage tolerance rating for each structural significant item (SSI) if
they are not effective for the SSI, and repair of cracked structure.
Certain actions in this proposed AD are considered alternative methods
of compliance (AMOCs) for paragraphs (b) and (c) of AD 98-11-04 R1.

Relevant Service Information

    We have reviewed Boeing Service Bulletin 737-57-1296, dated June
13, 2007. The service bulletin describes procedures for the following:
     Detailed inspections for any crack in the upper chord of
the longitudinal floor beam at LBL 24.8 and RBL 24.8, between STA 656
and STA 685.
     High frequency eddy current inspections for any crack in
the lower chord of the longitudinal floor beam at LBL 24.8 and RBL
24.8, between STA 660 and STA 666.
     Detailed inspections for any crack in the longitudinal
floor beam web at LBL 24.8, RBL 24.8, LBL 45.5, and RBL 45.5, between
STA 705 and STA 715.
     Detailed inspections for any crack in the horizontal
flange of the upper chord of the longitudinal floor beam at LBL 24.8,
RBL 24.8, LBL 45.5, and RBL 45.5, at STA 727B.
    The compliance times specified are as follows:
    For Groups 1 and 2 airplanes: Before the accumulation of 20,000
total flight cycles, or within 6,000 flight cycles after the service
bulletin date, whichever occurs later. Repeat the inspections
thereafter at intervals not to exceed 6,000 flight cycles.
    For Group 3 airplanes: Before the accumulation of 20,000 total
flight cycles, or within 7,000 flight cycles after the service bulletin
date, whichever occurs later. Repeat the inspections thereafter at
intervals not to exceed 7,000 flight cycles.
    If a crack is found, the service bulletin recommends contacting
Boeing before further flight for repair instructions. If no crack is
found, the procedures in the service bulletin specify repeating the
inspections. Accomplishing the actions specified in the service
information is intended to adequately address the unsafe condition.

FAA's Determination and Requirements of the Proposed AD

    We have evaluated all pertinent information and identified an
unsafe condition that is likely to exist or develop on other airplanes
of this same type design. For this reason, we are proposing this AD,
which would require accomplishing the actions specified in the service
information described previously, except as discussed under
``Difference Between the Proposed AD and Service Information.''

Difference Between the Proposed AD and Service Information

    The service bulletin specifies to contact the manufacturer for
instructions on how to repair certain conditions, but this proposed AD
would require repairing those conditions in one of the following ways:
     Using a method that we approve; or
     Using data that meet the certification basis of the
airplane, and that have been approved by an Authorized Representative
for the Boeing Commercial Airplanes Delegation Option Authorization
Organization whom we have authorized to make those findings.

Costs of Compliance

    There are about 2,852 airplanes of the affected design in the
worldwide fleet. This proposed AD would affect about 652 airplanes of
U.S. registry. The proposed inspection would take approximately 13 work
hours per airplane, at an average labor rate of $80 per work hour.
Based on these figures, the estimated cost of the proposed inspection
for U.S. operators is $678,080, or $1,040 per airplane, per inspection
cycle.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The Federal Aviation Administration (FAA) amends Sec.  39.13 by
adding the following new airworthiness directive (AD):

Boeing: Docket No. FAA-2007-0224; Directorate Identifier 2007-NM-
188-AD.

Comments Due Date

    (a) The FAA must receive comments on this AD action by January
10, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Boeing Model 737-100, -200, -300, -400,
and -500 series airplanes, certificated in any category; as
identified in Boeing Service Bulletin 737-57-1296, dated June 13,
2007.

Unsafe Condition

    (d) This AD results from several reports of cracks in the center
wing box longitudinal floor beams, upper chord, and lower chord. We
are issuing this AD to detect and correct fatigue cracking of the
upper and lower chords and web of the longitudinal floor beams,
which could result in rapid loss of cabin pressure.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Repetitive Inspections

    (f) Do the various inspections for fatigue cracks in the
longitudinal floor beam web, upper chord, and lower chord, located
at the applicable body stations specified in the Accomplishment
Instructions of Boeing Service Bulletin 737-57-1296, dated June 13,
2007, by doing all the actions specified in the Accomplishment
Instructions of the service bulletin, except as provided by
paragraph (g) of this AD. Do the inspections at the time specified
in paragraph (f)(1) or (f)(2) of this AD, as applicable.
    (1) For Groups 1 and 2 airplanes as identified in the service
bulletin: Do the inspections at the applicable initial compliance
time listed in paragraph 1.E., ``Compliance,'' of the service
bulletin; except, where the service bulletin specifies a compliance
time after the date on the service bulletin, this AD requires
compliance within the specified compliance time after the effective
date of this AD. Repeat the inspections thereafter at the intervals
specified in paragraph 1.E., ``Compliance,'' of the service
bulletin.
    (2) For Group 3 airplanes as identified in the service bulletin:
Do the inspections at the applicable initial compliance time listed
in paragraph 1.E., ``Compliance,'' of the service bulletin; except,
where the service bulletin specifies a compliance time after the
date on the service bulletin, this AD requires compliance within the
specified compliance time after the effective date of this AD.
Repeat the inspections thereafter at the intervals specified in
paragraph 1.E., ``Compliance,'' of the service bulletin.
    (g) If any crack is found during any inspection required by this
AD, and Boeing Service Bulletin 737-57-1296, dated June 13, 2007,
specifies contacting Boeing for repair instructions: Before further
flight, repair using a method approved in accordance with the
procedures specified in paragraph (h) of this AD.

Alternative Methods of Compliance (AMOCs)

    (h)(1) The Manager, Seattle ACO, FAA, has the authority to
approve AMOCs for this AD, if requested in accordance with the
procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD, if it is approved by an
Authorized Representative for the Boeing Commercial Airplanes
Delegation Option Authorization Organization who has been authorized
by the Manager, Seattle ACO, to make those findings. For a repair
method to be approved, the repair must meet the certification basis
of the airplane.

    Issued in Renton, Washington, on November 13, 2007.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E7-22928 Filed 11-23-07; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 100 (Tuesday, May 24, 2016)]
[Notices]
[Pages 32819-32820]
[FR Doc No: 2016-12116]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736

Ombudsman Matter Management System, OMB Control No. 3235-XXXX, SEC
File No. 270-797

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'' or ``SEC'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this new collection of information to the Office of Management
and Budget for approval.
    Members of the public who contact the Ombudsman for assistance
currently do so by traditional mail, electronic mail, telephone, and
facsimile. To make it easier for retail investors and others to contact
the Ombudsman electronically, the Commission is developing the
Ombudsman Matter Management System (``OMMS''), a new, electronic data
collection system for the receipt, collection and analysis of
inquiries, complaints, and recommendations from retail investors
directed to the SEC Ombudsman and the Office of the Investor Advocate,
and invites comment on OMMS. Through OMMS, members of the public may
request assistance from the Ombudsman and staff using a web-based form
(the ``OMMS Form'') tailored to gather information about matters within
the scope of the Ombudsman's function and streamline the inquiry and
response process.
    The OMMS Form will facilitate communication with the Ombudsman via
an electronic series of basic

questions with user-friendly response features such as radio buttons,
drop-down menu responses, pop-up explanation bubbles, Web page links,
fillable narrative text fields, and document upload options. In
addition, the OMMS Form incorporates functionality that, depending upon
certain responses, pre-populates specific fields, and prompts the user
to provide additional information. By eliciting specific information
from the user, the OMMS Form will facilitate communication between the
user and the Ombudsman, reduce response and resolution times, and
maximize Ombudsman staff resources available for recording, processing,
and responding to matters. The requested information collection is
voluntary and will not change the contact methods currently available.
    The Commission expects that OMMS will be operative and the OMMS
Form publicly available through the Commission's Web site, https://www.sec.gov.
    The Commission estimates that the total reporting burden for using
the OMMS Form will be 250 hours. The calculation of this estimate
depends on how many members of the public use the form each year and
the estimated time it takes to complete the forms: 500 respondents x 30
minutes per submission = 250 burden hours. The estimates of average
burden hours are made solely for the purposes of the Paperwork
Reduction Act. The total estimated one-time cost to the federal
government of creating OMMS and the OMMS Form is $400,000.
    An agency may not conduct or sponsor a collection of information
unless it displays a currently valid control number. No person shall be
subject to any penalty for failing to comply with a collection of
information subject to the PRA that does not display a valid Office of
Management and Budget control number.
    Written comments are invited on all aspects of this proposed
information collection request, in particular: (a) Whether this
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
users, including through the use of automated collection techniques or
other forms of information technology.
    Consideration will be given to comments and suggestions submitted
in writing within 60 days of this publication. Please direct your
written comments to Pamela Dyson, Director/Chief Information Officer,
Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F Street
NE., Washington, DC 20549; or send an email to<EMAIL_ADDRESS>
    Dated: May 18, 2016.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-12116 Filed 5-23-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Proposed Rules]
[Pages 40299-40300]
[FR Doc No: 2019-17368]

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

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-0466; Airspace Docket No. 19-ACE-8]
RIN 2120-AA66

Proposed Amendment of Class E Airspace; Marshalltown, IA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend Class E airspace extending
upward from 700 feet above the surface at Marshalltown Municipal
Airport, Marshalltown, IA. The FAA is proposing this action as the
result of an airspace review caused by the decommissioning of the
Elmwood VHF omnidirectional range (VOR) navigation aid, which provided
navigation guidance for the instrument procedures at these airports, as
part of the VOR Minimum Operational Network (MON) Program. Airspace
redesign is necessary for the safety and management of instrument
flight rules (IFR) operations at this airport.

DATES: Comments must be received on or before September 30, 2019.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2019-0466; Airspace Docket No. 19-ACE-8, at the beginning of your
comments. You may also submit comments through the internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order 7400.11C, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11C at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Rebecca Shelby, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would

amend Class E airspace extending upward from 700 feet above the surface
at Marshalltown Municipal Airport, Marshalltown, IA, to support IFR
operations at this airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2019-0466;
Airspace Docket No. 19-ACE-8.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11C, Airspace
Designations and Reporting Points, dated August 13, 2018, and effective
September 15, 2018. FAA Order 7400.11C is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11C lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by amending Class E airspace extending
upward from 700 feet above the surface to within a 6.5-mile radius
(increased from a 6.4-mile radius) of Marshalltown Municipal Airport,
Marshalltown, IA.
    This action is necessary due to an airspace review caused by the
decommissioning of the Elmwood VOR, which provided guidance information
for the instrument procedures at these airports, as part of the VOR MON
Program.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11C, dated August 13, 2018, and effective September 15,
2018, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    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, is
non-controversial and unlikely to result in adverse or negative
comments. 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. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11C,
Airspace Designations and Reporting Points, dated August 13, 2018, and
effective September 15, 2018, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ACE IA E5 Marshalltown, IA [Amended]

Marshalltown Municipal Airport, IA
    (Lat. 42[deg]06'46'' N, long. 92[deg]55'04'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Marshalltown Municipal Airport.

    Issued in Fort Worth, Texas, on August 7, 2019.
John Witucki,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2019-17368 Filed 8-13-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Rules and Regulations]
[Pages 26667-26669]
[FR Doc No: 2012-10720]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30840; Amdt. No. 3477]

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

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures 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 May 7, 2012. 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 May 7, 2012.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 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 are available online free of charge. Visit
nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff
Minimums and ODP copies may be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Richard A. Dunham III, Flight
Procedure Standards Branch (AFS-420) Flight Technologies and Programs
Division, 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, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and
Sec.  97.20 of Title 14 of the Code of Federal Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but 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 contained in FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAP and the corresponding effective dates. This
amendment also identifies the airport and its location, the procedure
and the amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP as amended in the transmittal. For safety and
timeliness of change considerations, this amendment incorporates only
specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
    The SIAPs, as modified by FDC P-NOTAM, and contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these changes to
SIAPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts. The circumstances which created the need for all
these SIAP amendments requires making them effective in less than 30
days.
    Because of the close and immediate relationship between these SIAPs
and safety in air commerce, I find that notice

and public procedure before adopting these SIAPs are impracticable and
contrary to the public interest and, where applicable, that good cause
exists for making these SIAPs effective in less than 30 days.

Conclusion

    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, and
Navigation (Air).

    Issued in Washington, DC, on April 27, 2012.
Ray Towles,
Deputy 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
amending Standard Instrument Approach 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(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

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

Sec. Sec.  97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.35  [Amended]

    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

    * * * Effective Upon Publication

--------------------------------------------------------------------------------------------------------------------------------------------------------
      AIRAC Date           State             City                 Airport          FDC No.      FDC Date                      Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
31-May-12.............  MO           St Louis............  Lambert-St Louis           2/1136      4/20/12  ILS OR LOC RWY 6, Amdt 1C
                                                            Intl.
31-May-12.............  MO           Columbia............  Columbia Rgnl.......       2/1214      4/20/12  RNAV (GPS) RWY 31, Orig
31-May-12.............  AK           Soldotna............  Soldotna............       2/1292      4/20/12  VOR A, Amdt 7
31-May-12.............  MT           Billings............  Billings Logan Intl.       2/1298      4/20/12  VOR/DME RWY 28R, Amdt 14
31-May-12.............  KY           Covington...........  Cincinnati/Northern        2/1417      4/20/12  ILS OR LOC RWY 18R, ILS RWY 18R (CAT II),
                                                            Kentucky Intl.                                  Amdt 1A
31-May-12.............  KY           Covington...........  Cincinnati/Northern        2/1418      4/20/12  ILS OR LOC RWY 36C, ILS RWY 36C (CAT II), ILS
                                                            Kentucky Intl.                                  RWY 36C (CAT III), Amdt 41A
31-May-12.............  KY           Covington...........  Cincinnati/Northern        2/1419      4/20/12  ILS OR LOC RWY 36L, ILS RWY 36L (CAT II),
                                                            Kentucky Intl.                                  Amdt 1A
31-May-12.............  KY           Covington...........  Cincinnati/Northern        2/1420      4/20/12  ILS OR LOC RWY 36R, ILS RWY 36R (CAT II), ILS
                                                            Kentucky Intl.                                  RWY 36R (CAT III), Amdt 8A
31-May-12.............  TN           Memphis.............  Memphis Intl........       2/1439      4/11/12  ILS OR LOC RWY 36R, ILS RWY 36R (CAT II0),
                                                                                ILS RWY 36R (CAT III), Amdt 3B
31-May-12.............  TN           Memphis.............  Memphis Intl........       2/1441      4/11/12  ILS OF LOC RWY 36L, ILS RWY 36L (CAT II), ILS
                                                                                RWY 36L (CAT III), Amdt 14C
31-May-12.............  TN           Memphis.............  Memphis Intl........       2/1442      4/11/12  ILS OR LOC RWY 36C, ILS RWY 36C (CAT II), ILS
                                                                                RWY 36C (CAT III), Amdt 3B
31-May-12.............  OH           Batavia.............  Clermont County.....       2/1617      4/20/12  NDB RWY 22, Amdt 1
31-May-12.............  OH           Batavia.............  Clermont County.....       2/1623      4/20/12  VOR B, Amdt 7
31-May-12.............  MN           Mankato.............  Mankato Rgnl........       2/1869      4/20/12  RNAV (GPS) RWY 22, Orig
31-May-12.............  TN           Memphis.............  Memphis Intl........       2/1907      4/11/12  RNAV (RNP) Y RWY 18L, Orig-B
31-May-12.............  TN           Memphis.............  Memphis Intl........       2/1908      4/11/12  RNAV (GPS) Z RWY 18C, Amdt 2
31-May-12.............  TN           Memphis.............  Memphis Intl........       2/1909      4/11/12  RNAV (RNP) Y RWY 18C, Orig-A
31-May-12.............  TN           Memphis.............  Memphis Intl........       2/1910      4/11/12  RNAV (GPS) Z RWY 18R, Amdt 2
31-May-12.............  TN           Memphis.............  Memphis Intl........       2/1911      4/11/12  ILS OR LOC RWY 18R, Amdt 14A
31-May-12.............  TN           Memphis.............  Memphis Intl........       2/1913      4/11/12  ILS OR LOC RWY 18L, Amdt 2B
31-May-12.............  TN           Memphis.............  Memphis Intl........       2/1918      4/11/12  RNAV (GPS) Z RWY 18L, Amdt 2
31-May-12.............  TN           Memphis.............  Memphis Intl........       2/1919      4/11/12  RNAV (RNP) Y RWY 18R, Orig-B
31-May-12.............  TN           Memphis.............  Memphis Intl........       2/1920      4/11/12  RNAV (RNP) X RWY 18L, Orig-B
31-May-12.............  TN           Memphis.............  Memphis Intl........       2/1921      4/11/12  RNAV (RNP) X RWY 18R, Orig-B
31-May-12.............  TN           Memphis.............  Memphis Intl........       2/1922      4/11/12  ILS OR LOC RWY 18C, Amdt 1B
31-May-12.............  WI           Milwaukee...........  General Mitchell           2/2232      4/20/12  ILS OR LOC RWY 1L, ILS RWY 1L (CAT II), ILS
                                                            Intl.                                           RWY 1L (CAT III), Amdt 9A

31-May-12.............  WY           Cheyenne............  Cheyenne Rgnl/Jerry        2/3058      4/20/12  ILS OR LOC RWY 27, Amdt 34B
                                                            Olson Field.
31-May-12.............  PA           Perkasie............  Pnnridge............       2/3117      4/11/12  RNAV (GPS) RWY 26, Orig
31-May-12.............  PA           Perkasie............  Pnnridge............       2/3154      4/11/12  NDB OR GPS A, Amdt 2
31-May-12.............  PA           Perkasie............  Pnnridge............       2/3164      4/11/12  RNAV (GPS) RWY 8, Amdt 1
31-May-12.............  VA           Luray...............  Luray Caverns.......       2/4789      4/20/12  RNAV (GPS) RWY 4, Orig
31-May-12.............  VA           Luray...............  Luray Caverns.......       2/4790      4/20/12  NDB A, Amdt 7
31-May-12.............  VA           Luray...............  Luray Caverns.......       2/4791      4/20/12  VOR/DME B, Amdt 3
31-May-12.............  VA           Luray...............  Luray Caverns.......       2/4792      4/20/12  RNAV (GPS) RWY 22, Amdt 1
31-May-12.............  UT           Milford.............  Milford Muni/Den And       2/5298      4/20/12  RNAV (GPS) RWY 16, Orig
                                                            Judy Briscoe Field.
31-May-12.............  LA           New Orleans.........  Louis Armstrong New        2/5888      4/20/12  ILS OR LOC RWY 10, ILS RWY 10 (CAT II), ILS
                                                            Orleans Intl.                                   RWY 10 (CAT III), Amdt 2B
31-May-12.............  IL           Chicago.............  Chicago O'Hare Intl.       2/6031      4/11/12  ILS OR LOC RWY 4R, Amdt 6L
31-May-12.............  MN           Cloquet.............  Cloquet Carlton.....       2/6430      4/20/12  NDB RWY 35, Amdt 4
31-May-12.............  WI           Racine..............  John H Batten.......       2/8815      4/11/12  ILS OR LOC RWY 4, Amdt 4C
31-May-12.............  TX           Houston.............  George Bush                2/8871      4/20/12  ILS OR LOC RWY 26R, ILS RWY 26R (SA CAT I),
                                                            Intercontinental/                               ILS RWY 26R (CAT II), ILS RWY 26R (CAT III),
                                                            Houston.                                        Amdt 3
31-May-12.............  TX           Houston.............  George Bush                2/8872      4/20/12  ILS OR LOC RWY 26L, ILS RWY 26L (SA CAT I),
                                                            Intercontinental/                               ILS RWY 26L (CAT II), ILS RWY 26L (CAT III),
                                                            Houston.                                        Amdt 20
31-May-12.............  TX           Houston.............  George Bush                2/8874      4/20/12  ILS OR LOC RWY 27, ILS RWY 27 (SA CAT I), ILS
                                                            Intercontinental/                               RWY 27 (CAT II), ILS RWY 27 (CAT III), Amdt
                                                            Houston.                                        9
31-May-12.............  CA           Lakeport............  Lampson Field.......       2/9212      4/20/12  RNAV (GPS) A, Orig
31-May-12.............  OH           Toledo..............  Toledo Express......       2/9345      4/20/12  ILS OR LOC RWY 25, Amdt 7A
31-May-12.............  OH           Toledo..............  Toledo Express......       2/9347      4/20/12  RNAV (GPS) RWY 25, Amdt 2
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[FR Doc. 2012-10720 Filed 5-4-12; 8:45 am]
BILLING CODE 4910-13-P