[Federal Register Volume 87, Number 105 (Wednesday, June 1, 2022)]
[Rules and Regulations]
[Pages 32988-32990]
[FR Doc No: 2022-11699]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2022-N-0713]

Medical Devices; Cardiovascular Devices; Classification of the
Coronary Artery Disease Risk Indicator Using Acoustic Heart Signals

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the coronary artery disease risk indicator using acoustic heart signals
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 coronary artery disease risk indicator using
acoustic heart signals' classification. We are taking this action
because we have determined that classifying the device into class II
(special controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices.

DATES: This order is effective June 1, 2022. The classification was
applicable on November 24, 2020.

FOR FURTHER INFORMATION CONTACT: Kimberly Crowley, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2531, Silver Spring, MD, 20993-0002, 301-
796-6017, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the coronary artery disease risk
indicator using acoustic heart signals as class II (special controls),
which we have determined will provide a reasonable assurance of safety
and effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by placing the
device into a lower device class than the automatic class III
assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order

within 120 days. The classification will be according to the criteria
under section 513(a)(1) of the FD&C Act. Although the device was
automatically placed within class III, the De Novo classification is
considered to be the initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On November 4, 2019, FDA received Acarix A/S's request for De Novo
classification of the CADScor System. 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 November 24, 2020, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
870.1420.\1\ We have named the generic type of device coronary artery
disease risk indicator using acoustic heart signals, and it is
identified as a device that records heart sounds including murmurs and
vibrations to calculate a patient-specific risk of presence of coronary
artery disease, as an aid in cardiac analysis and diagnosis.
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    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

  Table 1--Coronary Artery Disease Risk Indicator Using Acoustic Heart
                  Signals Risks and Mitigation Measures
------------------------------------------------------------------------
         Identified risks                    Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction...........  Biocompatibility evaluation,
                                     Labeling, and Usability testing.
Skin burn/irritation..............  Electrical safety testing, and
                                     Electromagnetic compatibility
                                     testing.
False positive leading to           Software verification, validation,
 unnecessary medical procedures.     and hazard analysis; Usability
                                     testing; Acoustic performance
                                     testing; Clinical performance
                                     testing; and Labeling.
False negative leading to failure   Software verification, validation,
 to detect coronary artery disease.  and hazard analysis; Usability
                                     testing; Acoustic performance
                                     testing; Clinical performance
                                     testing; and Labeling.
Delay in calculation due to device  Software verification, validation,
 failure resulting in a delay of     and hazard analysis; Clinical
 treatment.                          performance testing; Usability
                                     testing; Acoustic performance
                                     testing; and Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

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

IV. Paperwork Reduction Act of 1995

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

List of Subjects in 21 CFR Part 870

    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
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for part 870 continues to read as follows:

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

0
2. Add Sec.  870.1420 to subpart B to read as follows:

Sec.  870.1420  Coronary artery disease risk indicator using acoustic
heart signals.

    (a) Identification. A coronary artery disease risk indicator using
acoustic heart signals is a device that records heart sounds including
murmurs and vibrations to calculate a patient-specific risk of presence
of coronary artery disease, as an aid in cardiac analysis and
diagnosis.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Clinical performance testing must fulfill the following:
    (i) Testing must include a discussion of the patient population and
any statistical techniques used for analyzing the data; and
    (ii) Testing must be representative of the intended use population
for the device. Any selection criteria or sample limitations must be
fully described and justified.
    (2) Acoustic performance testing must evaluate microphone
sensitivity, sound acquisition bandwidth, and amplitude accuracy. The
acoustic sensor specifications and mechanism used to capture heart
sounds must be described.
    (3) A scientific justification for the validity of the algorithm(s)
must be provided. This justification must fulfill the following:
    (i) All inputs and outputs of the algorithm must be fully
described;
    (ii) The procedure for segmenting, characterizing, and classifying
the acoustic signal must be fully described; and
    (iii) This justification must include verification of the algorithm
calculations and validation using an independent data set.
    (4) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (5) Software verification, validation, and hazard analysis must be
performed.
    (6) Human factors/usability testing must demonstrate that the user
can correctly use the device, including device placement, based solely
on reading the directions for use.
    (7) Performance data must demonstrate the electromagnetic
compatibility and electrical safety of the device.
    (8) Labeling must include the following:
    (i) A description of what the device measures and outputs to the
user;
    (ii) Instructions for proper placement of the device;
    (iii) Instructions on care and cleaning of the device;
    (iv) Warnings identifying sensor acquisition factors that may
impact measurement results and instructions for mitigating these
factors; and
    (v) The expected performance of the device for all intended use
populations and environments.

    Dated: May 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-11699 Filed 5-31-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 54 (Wednesday, March 20, 2013)]
[Rules and Regulations]
[Pages 17097-17099]
[FR Doc No: 2013-06442]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0023]
RIN 1625-AA00

Safety Zone; Lake Havasu Triathlon; Lake Havasu City, AZ

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone within
the navigable waters of Lake Havasu and the London Bridge Channel for
the Lake Havasu Triathlon. This temporary safety zone is necessary to
provide safety for the swimmers, crew, rescue personnel, and other
users of the waterway. Persons and vessels are prohibited from entering
into, transiting through, or anchoring within this safety zone unless
authorized by the Captain of the Port or his designated representative.

DATES: This rule is effective from 6 a.m. until 10 a.m. on March 23,
2013.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2013-0023 and are available online
by going to http://www.regulations.gov, inserting USCG-2013-0023 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, 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 FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or email Petty Officer Bryan Gollogly, Waterways
Management, U.S. Coast Guard Sector San Diego; Coast Guard; telephone
619-278-7656, email<EMAIL_ADDRESS>If you have
questions on viewing the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

A. Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because delay would be impracticable. The
Coast Guard did not receive the necessary information from the event
sponsor until recently and the sponsor is anticipating this event
taking place as scheduled. Because of these time constraints, it is
impracticable that the Coast Guard issue an NPRM. Immediate action is
necessary to ensure the safety of vessels, spectators, participants,
and others in the vicinity of the marine event on the date and times
this rule will be in effect.
    Under 5 U.S.C. 553(d)(3), for the same reasons mentioned above, the
Coast Guard finds that good cause exists for making this rule effective
less than 30 days after publication in the Federal Register. Delaying
the effective date would be impracticable and contrary to the public
interest, since immediate action is needed to ensure the public's
safety and the Coast Guard was provided with information regarding this
event with insufficient time to delay the effective date.

B. Basis and Purpose

    The Havasu Triathlon will consist of 600 participants. The
waterside swim course consists of 1500 meters in Lake Havasu and the
London Bridge Channel. The course requires a safety zone while the
swimmers are on the course, thus restricting vessel traffic within the
north London Bridge Channel and a small portion of Lake Havasu for four
hours. There will be four safety vessels provided by the sponsor to
enforce the safety zone. Before the effective period, the Coast Guard
will publish a Local Notice to Mariners (LNM).

C. Discussion of Rule

    The Coast Guard is establishing a safety zone that will be
effective from 6 a.m. until 10 a.m. on March 23, 2013. The limits of
the safety zone will include the portion of the London Bridge Channel
north of the London Bridge and all navigable waters of Lake Havasu
encompassed by the following coordinates; 34[deg]28'40'' N,
114[deg]21'43'' W, 34[deg]28'19'' N, 114[deg]21'42'' W, 34[deg]28'39''
N, 114[deg]21'19'' W, 34[deg]28'20'' N, 114[deg]20'49'' W and
34[deg]28'16'' N, 114[deg]20'54'' W
    The safety zone is necessary to provide for the safety of swimmers,
crew, rescue personnel, and other users of the waterway. Persons and
vessels will be prohibited from entering into, transiting through, or
anchoring within the safety zone unless authorized by the Captain of
the Port, or his designated representative.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    We expect the economic impact of this rule to be so minimal that a
full Regulatory Evaluation is unnecessary. The safety zone is of a
limited duration, four hours, and is limited to a relatively small
geographic area.

2. Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule will affect the following entities, some of which may be
small entities: the owners and operators of pleasure craft engaged in
recreational activities and sightseeing.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons. Vessel
traffic will be restricted for a limited period of only two hours early
in the day when traffic is light. Before the effective period, the
Coast Guard will publish a Local Notice to Mariners (LNM).

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in

understanding the rule so that they can better evaluate its effects on
them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

8. Taking of Private Property

    This rule will not affect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

13. Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction. This rule involves establishment of a
safety zone.
    An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security Measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add temporary Sec.  165.T11-474 to read as follows:

Sec.  165.T11-474  Safety Zone; Lake Havasu Triathlon; Lake Havasu
City, AZ.

    (a) Location. The limits of the safety zone will include the
portion of the London Bridge Channel north of the London Bridge and all
navigable waters of Lake Havasu encompassed by the following
coordinates; 34[deg]28'40'' N, 114[deg]21'43'' W, 34[deg]28'19'' N,
114[deg]21'42'' W, 34[deg]28'39'' N, 114[deg]21'19'' W, 34[deg]28'20''
N, 114[deg]20'49'' W and 34[deg]28'16'' N, 114[deg]20'54'' W.
    (b) Effective Period. This section will be effective from 6 a.m.
until 10 a.m. on March 23, 2013. Before the effective

period, the Coast Guard will publish a Local Notice to Mariners (LNM).
    (c) Definitions. The following definition applies to this section:
designated representative means any commissioned, warrant, or petty
officer of the Coast Guard on board Coast Guard, Coast Guard Auxiliary,
and local, state, and federal law enforcement vessels who have been
authorized to act on the behalf of the Captain of the Port.
    (d) Regulations. (1) Entry into, transit through or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port of San Diego or his designated representative.
    (2) Mariners requesting permission to transit through the safety
zone may request authorization to do so from local law enforcement.
Local law enforcement may be contacted on VHF marine Channel 16.
    (3) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port or his designated representative.
    (4) Upon being hailed by U.S. Coast Guard patrol personnel by
siren, radio, flashing a light, or other means, the operator of a
vessel shall proceed as directed.
    (5) The Coast Guard may be assisted by other federal, state, or
local agencies.

    Dated: March 6, 2013.
S.M. Mahoney,
Captain, U.S. Coast Guard, Acting, Captain of the Port San Diego.
[FR Doc. 2013-06442 Filed 3-19-13; 8:45 am]
BILLING CODE 9110-04-P


The use of the maximum observed residue value from the available field trials is not considered appropriate for generating risk estimates in the EFED's assessment because it is ultimately an estimate representative of a single exposure scenario at best ( i. e., consumption of lettuce contaminated with cypermethrin), whereas it is likely that there will be numerous scenarios in which exposure estimates may be well above this maximum EEC on lettuce. To account for potential variability and uncertainty, the EFED's model, T REX, calculates EECs and risk quotients based on upper bound residue concentrations as presented by Hoerger and Kenaga ( 1972) and modified by Fletcher et al. ( 1994). These concentrations are determined using nomograms that relate application rate of a pesticide to residues remaining on dietary items of terrestrial organisms ( based on the foliar dissipation half lives of a chemical). The exposure estimates in the EFED's RED for cypermethrin are expected to be the most accurate and conservative estimates available, since they are based on a foliar half life that represents the 90% upper confidence limit of the mean half life for data from actual foliar dissipation studies ( Willis and McDowell 1987).

FMC, Comment Appendix 4: Assessment of the potential risk to honeybees and earthworms from cypermethrin applications. The FMC conducted preliminary risk assessments for these organisms to address the gap, using the scenarios: cotton, lettuce and pecans.   The EU uses the hazard quotient ( QH) in a Tier 1 risk assessment to take into consideration the exposure in the environment, as opposed to laboratory toxicity honeybee testing. QH = Application rate ( g a. i./ ha)/ Toxicity endpoint ( µ g/ honeybee). 47   The QH, ORAL = 112.4/ 0.172 = 654, moderate toxicity; the QH, CONTACT = 112.4/ 0.023 = 4,887, extremely high. They indicate that the label states that " This product is highly toxic to bees exposed to direct treatment or residues on blooming crops or weed. Do not apply this product or allow it to drift to blooming crops if bees are visiting the treatment area."   Cotton and honeybees have a mutually beneficial relationship. The crop should be monitored for honeybee activity prior to cypermethrin application to avoid unnecessary risk. Lettuce is a self pollinating plant, in most agricultural fields, minimal exposure of cypermethrin to honeybees occur. Pecans are pollinated by the wind and they are not considered a food source by the honeybees, therefore, the exposure to cypermethrin will also be minimal.   Cypermethrin is very toxic to earthworms ( LC50 = 26.09 µ g/ cm2). The FMC indicated that in soil, the exposure is reduced. In a 2 week study, using artificial soil, with concentrations ranging from 0.1 100 mg a. i./ Kg dry soil, the LC50 > 100 mg a. i./ Kg dry soil, and NOEC = 100 mg a. i./ Kg dry soil.   Since the Agency does not have guidance to evaluate earthworms, the FMC used the European Amnex III guideline ( SANCO/ 10329/ 2002) for a Tier II assessment. Three issues were factored in: the toxicity of the chemical, the calculation of the exposure in the soil, and the ratio or hazard quotient.   The registrant conducted the analysis according to the guideline, that states that when the log KOW is > 2 ( in this case it is 6.54, from Laskowski, 2000), the LC50 is adjusted to the toxicity of natural soils by dividing the endpoint by two. Then, the corrected LC50 = 50 mg a. i./ kg dry soil.   The EECs in soil are based on the application rate without consideration of degradation, EEC = application rate, 112.4 g a. i./ ha x 6 x percentage that reaches the soil x factor ( not described).   The EEC is 0.90 mg/ Kg, then the RQ = 0.018. It is below 0.5, therefore, no risk is anticipated following exposure to cypermethrin applied to soil at a rate of 6X the recommended single application rate.

Response to Comment Appendix 4: The EFED has reviewed FMC's " Assessment of the Potential Risk to Honeybees and Earthworms from Cypermethrin Applications." While the EFED appreciates FMC's attempt to further characterize risk to earthworms and honey bees, it disagrees with the conclusion that cypermethrin poses minimal risk to earthworms and honeybees if used according to the label requirements. The EFED asserts that concern for honeybees and earthworms is warranted because the evidence currently available to the Agency is not sufficient for precluding risk to these organisms. For instance, the studies which FMC points to as evidence of low toxicity to earthworms under " realistic exposure conditions" ( i. e., in the presence of soil) have not been submitted or reviewed by the EFED, whereas the evidence that suggests high toxicity is currently available to the Agency. If the registrant would like the Agency to incorporate the data into a future risk assessment, then the studies must be submitted for review. Upon receiving these data, they will be evaluated and addressed during Registration Review. 48 For honeybees, FMC assumes that spray drift to non target plants from agricultural applications is negligible and only considers risk to honey bees actively foraging on targeted crops or weeds treated with cypermethrin. However, drift to non target plants off site could also pose risks even if in relatively low amounts because the toxicity to honey bees is extremely high. In addition, even if bees aren't actively foraging during an application, it is reasonable to expect that residues on plants could remain high enough so as to induce toxic effects to bees foraging shortly after application. Given the timing ( i. e., the seasons) and number of applications of cypermethrin, it appears that exposure and risk to honey bees and non target insects is likely.


[Federal Register Volume 76, Number 218 (Thursday, November 10, 2011)]
[Notices]
[Pages 70183-70184]
[FR Doc No: 2011-29106]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65684; File No. SR-EDGA-2011-35]

Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
Amendments to the EDGA Exchange, Inc. Fee Schedule

November 4, 2011.
    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 October 24, 2011, the EDGA Exchange, Inc. (the ``Exchange'' or
the ``EDGA'') 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

    The Exchange proposes to amend its fees and rebates applicable to
Members \3\ of the Exchange pursuant to EDGA Rule 15.1(a) and (c). All
of the changes described herein are applicable to EDGA Members. The
text of the proposed rule change is available on the Exchange's
Internet Web site at http://www.directedge.com.
---------------------------------------------------------------------------

    \3\ A Member is any registered broker or dealer, or any person
associated with a registered broker or dealer, that has been
admitted to membership in the Exchange.
---------------------------------------------------------------------------

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

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

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

Purpose
    Currently, a rebate of $0.0027 per share is provided to Members who
add liquidity on the EDGX Exchange, Inc. (``EDGX'') via an EDGA-
originated ROUC routing strategy, as defined in Exchange Rule
11.9(b)(3)(a), during Regular Trading Hours.\4\ This situation yields
Flag P. The Exchange proposes to apply Flag P's rebate to the Pre-
Opening Session \5\ and Post-Closing Session \6\ so that Members may
earn the same rebate for adding liquidity on EDGX as they earn during
Regular Trading Hours, which is defined as ``pre & post market'' in
EDGA's fee schedule.
---------------------------------------------------------------------------

    \4\ See EDGA Exchange Rule 1.5(w).
    \5\ See EDGA Exchange Rule 1.5(q).
    \6\ See EDGA Exchange Rule 1.5(p).
---------------------------------------------------------------------------

    The Exchange proposes to implement this amendment to its fee
schedule on October 24, 2011.
Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\7\ in general, and
furthers the objectives of Section 6(b)(4),\8\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its members and other persons using its
facilities.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f.
    \8\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that the rebate for Flag P of $0.0027 per
share is an equitable allocation of reasonable dues, fees, and other
charges. During the Pre-Opening Session and the Post-Closing Session,
the ROUC strategy is the only means for Members to post liquidity to an
away exchange. The ROUC routing strategy checks the System for
available shares and then is sent sequentially to destinations on the
System routing table, Nasdaq OMX BX, and NYSE. If shares remain
unexecuted after routing, they are posted to EDGX. The rebate is
designed to incentivize Members to also route through EDGA during the
Pre-Opening Session and the Post-Closing Session to reach multiple
sources of liquidity before routing to other low cost destinations, and
thereby potentially increases volume on EDGA to the extent an order
using the ROUC routing strategy executes on EDGA. The rebate allows
Members to reach multiple sources of liquidity by routing order flow
through EDGA rather than going directly to various venues. The rebate
also provides Members with a flat rate of $0.0027 per share rebate if
the ROUC routing strategy posts to EDGX. When the Exchange's routing
broker/dealer, Direct Edge ECN LLC d/b/a DE Route (``DE Route'')
achieves certain tiers on EDGX, it is able to pass through a better
rebate than if it had not achieved a tier.\9\ For example, if the
Member had routed to EDGX directly and the order had added liquidity to
EDGX, the Member could receive rebates ranging from $0.0023-$0.0034,
depending on if a volume threshold were satisfied.\10\ The $0.0027 per
share rebate thus represents a rate in between these various tiered and
non-tiered rebates provided for adding liquidity to EDGX. This allows
EDGA Members to share in potential volume tier savings realized by DE
Route when it achieves certain tiers.
---------------------------------------------------------------------------

    \9\ See EDGX fee schedule, footnote 1.
    \10\ Id.
---------------------------------------------------------------------------

    This type of rate is also similar to EDGA's rate for removing
liquidity from LavaFlow (Flag U). The standard removal rate of $0.0029
per share is reduced to $0.0023 per share for orders routed to LavaFlow
that achieve certain volume thresholds, as EDGA Members are able to
share in potential volume tier savings realized by EDGA when routing to
LavaFlow.\11\ This rebate is also comparable to other rebates offered
by the Exchange that add liquidity, such as the ROOC \12\ routing
strategy, which yields Flags 8 and 9.\13\ For Flags 8 and

9, the Exchange passes through the default rebate (i.e., non-tier) from
the primary listing market (i.e., NYSE Arca, NYSE Amex) to Members
because DE Route does not generally achieve a favorable tier rate. This
rate is also consistent with the processing of similar routing
strategies by EDGA's competitors where EDGA takes into account the
rates that it is charged or rebated when routing to other low cost
destinations.\14\ Finally, as another example, when EDGA routes to a
primary exchange's opening cross, (Flag O), the Exchange passes through
the tier savings that DE Route achieves on an away exchange to its
Members.\15\ This tier savings takes the form of a cap of Members' fees
at $10,000 per month for using Flag O.
---------------------------------------------------------------------------

    \11\ See footnote 6 of the EDGA fee schedule.
    \12\ See EDGA Exchange Rule 11.9(b)(3)(n).
    \13\ See the EDGA Fee Schedule where Flag 8 offers a rebate of
$.0015 where a member routes an order to NYSE Amex using the ROOC
routing strategy and adds liquidity, and Flag 9 offers a rebate of
$.0021 where a member routes an order to NYSE Arca using the ROOC
routing strategy and adds liquidity.
    \14\ See also BATS BZX fee schedule, describing Discounted
Destination Specific Routing (``One Under'') to NYSE, NYSE ARCA and
NASDAQ. See Securities Exchange Act Release No. 62858, 75 FR 55838
(September 14, 2010) (SR-BATS-2010-023) (modifying the BATS fee
schedule in order to amend the fees for its BATS + NYSE Arca
destination specific routing option to continue to offer a ``one
under'' pricing model).
    \15\ See footnote 5 of the EDGA fee schedule.
---------------------------------------------------------------------------

    The Exchange believes that the rebate of $0.0027 is reasonable as
it is consistent with how other exchanges pass through charges or
rebates for orders routed to a different exchange that add liquidity.
For example, when Nasdaq routes to Nasdaq PSX, Nasdaq passes back
Nasdaq PSX's standard charge of $0.0027 per share. When NYSE Arca
routes to NYSE, NYSE Arca passes back the standard NYSE rebate of
$0.0015 per share. These rebates generally approximate what the
originating exchange receives from the exchange that is routed to plus
or minus a certain differential. EDGA's pricing is consistent with this
premise.
    The Exchange believes that the proposed rebate is non-
discriminatory in that it applies uniformly to all Members.
    The Exchange also notes that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive. The proposed rule change reflects a competitive pricing
structure designed to incent market participants to direct their order
flow to the Exchange. The Exchange believes that the proposed rates are
equitable and non-discriminatory in that they apply uniformly to all
Members. The Exchange believes the fees and credits remain competitive
with those charged by other venues and therefore continue to be
reasonable and equitably allocated to Members.

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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) of the Act \16\ and Rule 19b-4(f)(2) \17\ thereunder. 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.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(3)(A).
    \17\ 17 CFR 19b-4(f)(2).
---------------------------------------------------------------------------

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-EDGA-2011-35 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-EDGA-2011-35. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the 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-EDGA-2011-35 and should be
submitted on or before December 1, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-29106 Filed 11-9-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 173 (Friday, September 6, 2013)]
[Notices]
[Page 54899]
[FR Doc No: 2013-21680]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0297]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Prevention of Salmonella Enteritidis
in Shell Eggs During Production--Recordkeeping and Registration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled, ``Prevention of Salmonella
Enteritidis in Shell Eggs During Production--Recordkeeping and
Registration,'' has been approved by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On May 20, 2013, the Agency submitted a
proposed collection of information entitled ``Prevention of Salmonella
Enteritidis in Shell Eggs During Production--Recordkeeping and
Registration,'' to OMB for review and clearance under 44 U.S.C. 3507.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. OMB has now approved the information
collection and has assigned OMB control number 0910-0660. The approval
expires on August 31, 2016. A copy of the supporting statement for this
information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: September 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21680 Filed 9-5-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Rules and Regulations]
[Pages 53983-53985]
[FR Doc No: 2018-23399]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2018-0369; Airspace Docket No. 18-ASO-8]
RIN 2120-AA66

Amendment of Class E Airspace, Augusta, GA, and Establishment of
Class E Airspace, Waynesboro, GA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace extending upward from 700
feet above the surface in Augusta, GA, by recognizing the name change
of Augusta Regional Airport at Bush Field (formerly Augusta Regional at
Bush Field Airport); removing Burke County Airport and Millen Airport
from the airspace designation and establishing these two airports under
Waynesboro, GA, designation; and updating the geographic coordinates of
Daniel Field, Augusta, GA, and Millen Airport, Waynesboro, GA. This
action accommodates airspace reconfiguration due to the decommissioning
of the Millen non-directional radio beacon (NDB) and cancellation of
the NDB approach at Millen Airport. Controlled airspace is necessary
for the safety and management of instrument flight rules (IFR)
operations at these airports.

DATES: Effective 0901 UTC, January 3, 2019. The Director of the Federal
Register approves this incorporation by reference action under title 1
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: 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, call<PHONE_NUMBER>, 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: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Avenue, College Park, GA 30337; 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 amends Class E airspace, at Augusta, GA, and establishes Class E
airspace at Waynesboro, GA, to support airspace reconfiguration due to
the decommissioning of the Millen non-directional radio beacon (NDB)
and cancellation of the NDB approach at Millen Airport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (83 FR 39384, August 9, 2018) for Docket No. FAA-2018-0369 to
amend Class E airspace area extending upward from 700 feet or more
above the surface, and establish Class E airspace area extending upward
from 700 feet or more above the surface at Burke County Airport and
Millen Airport, Waynesboro, GA as the Millen NDB has been
decommissioned and the NDB approach cancelled.
    Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received.
    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 part 71.1. The Class
E airspace designation listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends 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 Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR)
amends part 71 by amending Class E airspace extending upward from 700
feet above the surface in Augusta, GA, by recognizing the name change
of Augusta Regional Airport at Bush Field (formerly Augusta Regional at
Bush Field Airport); removing Burke County Airport and Millen Airport
from the airspace designation and establishing these two airports under
Waynesboro, GA, designation due to the cancellation of the Millen NDB
and cancellation of the associated approach; and updating the
geographic coordinates of Daniel Field, Augusta, GA, to be in concert
with the FAA's aeronautical database.
    Class E airspace extending upward from 700 feet above the surface
is established at Burke County Airport, Waynesboro, GA, within a 6.7-
mile (increased from a 6.6-mile) radius of the airport.
    Class E airspace extending upward from 700 feet above the surface
is established at Millen airport within a 7.4-mile (increased from a
7.3-mile) radius of the airport. The geographic coordinates are
adjusted to be in concert with the FAA's aeronautical database.

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.
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
only affects air traffic procedures and air navigation, it is certified
that this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 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 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 Federal Aviation
Administration 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.

* * * * *

ASO GA E5 Augusta, GA [Amended]

Augusta Regional Airport at Bush Field, GA
    (Lat. 33[deg]22'12'' N, long. 81[deg]57'52'' W)
Daniel Field
    (Lat. 33[deg]28'00'' N, long. 82[deg]02'22'' W)
Emory NDB
    (Lat. 33[deg]27'46'' N, long. 81[deg]59'49'' W)

    That airspace extending upward from 700 feet above the surface
within an 8.6-mile radius of Augusta Regional Airport at Bush Field,
and within 3.2 miles either side of the 168[deg] bearing from the
airport extending from the 8.6-mile radius to 12.5 miles south of
the airport, and within a 7-mile radius of Daniel Field, and within
8 miles west and 4 miles east of the 349[deg] bearing from the Emory
NDB extending from the 7-mile radius to 16 miles north of the Emory
NDB.

ASO GA E5 Waynesboro, GA [New]

Burke County Airport, GA
    (Lat. 33[deg]02'29'' N, long. 82[deg]00'10'' W)
Millen Airport

    (Lat. 32[deg]53'35'' N, long. 81[deg]57'55'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.7-mile radius of Burke County Airport, and within a 7.4-
mile radius of Millen Airport.

    Issued in College Park, Georgia, on October 17, 2018.
Ken Brissenden,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2018-23399 Filed 10-25-18; 8:45 am]
 BILLING CODE 4910-13-P