[Federal Register: October 8, 2009 (Volume 74, Number 194)]
[Rules and Regulations]
[Page 51779-51783]
[DOCID:fr08oc09-10]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 110

[Docket No. USCG-2008-1232]
RIN 1625-AA01

Anchorages; New and Revised Anchorages in the Captain of the Port
Portland, OR, Area of Responsibility

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is establishing a new anchorage, modifying
existing anchorages, and revising the regulations governing anchorages
in the Captain of the Port Portland, Oregon, area of responsibility.
These changes are necessary to ensure that there are sufficient
anchorage opportunities in that area, and to clarify the locations of
those anchorage opportunities. In addition, the changes will help
prevent conflicts with navigable channels and other uses of anchorage
waters.

DATES: This rule is effective November 9, 2009.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2008-1232 and are available online by going to
http://www.regulations.gov, inserting USCG-2008-1232 in the ``Keyword''
box, and clicking ``Search.'' This material is 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 rule,
call or e-mail MST1 Jaime Sayers, Waterways Management Division, Coast
Guard Sector Portland, telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On May 26, 2009, we published a notice of proposed rulemaking
(NPRM) entitled ``Anchorages; New and Revised Anchorages in the Captain
of the Port Portland, OR, Area of Responsibility'' in the Federal
Register (74 FR 24718). We received one comment on the proposed rule.
There were no requests made for a public hearing regarding this rule
and none was held. No other documents have been published for this
rulemaking.

Background and Purpose

    The establishment of a new anchorage, modification of existing
anchorages, and revision of the regulations governing anchorages
contained in this rule are necessary to ensure that there are
sufficient anchorage opportunities in the Captain of the Port Portland,
Oregon, area of responsibility, and ensure that the locations of those
opportunities are clear. In addition, the changes will help prevent
conflicts with navigable channels and other uses of anchorage waters.
Currently, there are insufficient anchorage opportunities in the
Captain of the Port Portland, Oregon, area of responsibility, and many
of them conflict with navigable channels and other uses of the
anchorage waters.

Discussion of Comments and Changes

    The one comment made about this proposed rule explained that the
changes being made are the result of a collaborative effort of the
members of the Lower Columbia Region Harbor Safety Committee and that
the Columbia River Bar Pilots fully support the rule as written. No
changes were made as a result of this comment.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

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. The establishment of a new anchorage,
modification of existing anchorages, and revision of the regulations
governing anchorages do not have any significant costs associated with
them.

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 would affect the following entities, some of which
might be small entities: The owners or operators of vessels intending
to transit or anchor in the Captain of the Port Portland, Oregon, area
of responsibility. However, the establishment of a new anchorage,
modification of existing anchorages, and revision of the regulations
governing anchorages that result from this rule will have no economic
impact on small entities because anchorages can still be transited and
used for other maritime activities besides anchoring.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
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.

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).

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.

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.

Taking of Private Property

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

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.

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.

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.

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.

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.

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)(f), of the Instruction. This rule involves the establishment of a
new anchorage, modification of existing anchorages, and revision of
regulations governing anchorages in the Captain of the Port Portland,
Oregon, area of responsibility, which are categorically excluded under
section 2.B.2 Figure 2-1, paragraph 34(f), of the Instruction. An
environmental analysis checklist and categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 110

    Anchorage grounds.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 110 as follows:

PART 110--ANCHORAGE REGULATIONS

0
1. The authority citation for part 110 continues to read as follows:

    Authority: 33 U.S.C. 471, 1221 through 1236, 2030, 2035, 2071;
33 CFR 1.05-1; Department of Homeland Security Delegation No.
0170.1.

0
2. Revise Sec.  110.228 to read as follows:

Sec.  110.228  Columbia River, Oregon and Washington.

    (a) Anchorage grounds.--(1) Astoria North Anchorage. An area
enclosed by a line beginning northeast of Astoria, Oregon, at latitude
46[deg]12'00.79'' N, longitude 123[deg]49'55.40'' W; thence continuing
easterly to latitude 46[deg]12'02.00'' N, longitude 123[deg]49'40.09''
W; thence continuing east-northeasterly to latitude 46[deg]13'14.85''
N, longitude 123[deg]46'27.89'' W; thence continuing south-
southeasterly to latitude 46[deg]13'00.56'' N, longitude
123[deg]46'16.65'' W; thence continuing southwesterly to latitude
46[deg]11'51.79'' N, longitude 123[deg]49'18.08'' W; thence continuing
west-southwesterly to latitude 46[deg]11'46.27'' N, longitude
123[deg]49'43.48'' W; thence continuing west-southwesterly to latitude
46[deg]11'44.98'' N, longitude 123[deg]49'49.44'' W; thence continuing
westerly to latitude 46[deg]11'44.32'' N, longitude 123[deg]49'58.88''
W; thence continuing northeasterly to the point of the beginning.
    (2) Astoria South Anchorage. An area enclosed by a point beginning
east-northeast of Astoria, Oregon, at latitude 46[deg]11'46.95'' N,
longitude 123[deg]49'13.04'' W; thence continuing northeasterly to
latitude 46[deg]13'02.18'' N, longitude 123[deg]45'54.55'' W; thence
continuing easterly to latitude 46[deg]13'05.90'' N, longitude
123[deg]45'41.55'' W; thence continuing southeasterly to latitude
46[deg]12'55.16'' N, longitude 123[deg]45'34.31'' W; thence continuing
southwesterly to latitude 46[deg]12'24.32'' N, longitude
123[deg]46'34.70'' W; thence continuing west-southwesterly to latitude
46[deg]11'37.32'' N, longitude 123[deg]49'03.46'' W; thence continuing
north-northwesterly to the point of the beginning.
    (3) Longview Anchorage. An area enclosed by a line beginning
southeast of Longview, Washington, at latitude 46[deg]06'28.69'' N,
longitude 122[deg]57'38.33'' W; thence continuing northwesterly to
latitude 46[deg]06'41.71'' N, longitude 122[deg]58'01.25'' W; thence
continuing westerly to latitude 46[deg]07'22.55'' N, longitude
122[deg]59'00.81'' W; thence continuing westerly to latitude
46[deg]07'36.21'' N, longitude 122[deg]59'19.29'' W; thence continuing
southwesterly to latitude 46[deg]07''28.44' N, longitude
122[deg]59'31.18'' W; thence continuing easterly to latitude
46[deg]07'14.77'' N, longitude 122[deg]59'12.70'' W; thence continuing
easterly to latitude 46[deg]06'42.01'' N, longitude 122[deg]58'28.41''
W; thence continuing northeasterly to latitude 46[deg]06'34.27'' N,
longitude 122[deg]58'14.21'' W; thence continuing northeasterly to
latitude 46[deg]06'32.19'' N, longitude 122[deg]58'08.77'' W; thence
continuing northeasterly to latitude 46[deg]06'22.44'' N, longitude
122[deg]57'43.27'' W; thence continuing northeasterly to the point of
the beginning.
    (4) Kalama Anchorage. An area to be enclosed by a line beginning
north-northwesterly of Sandy Island at latitude 46[deg]01'20.48'' N,
longitude 122[deg]52'04.32'' W; thence continuing east-southeasterly to
latitude 46[deg]00'57.73'' N, longitude 122[deg]51'35.14'' W; thence
continuing east-southeasterly to latitude 46[deg]00'53.95'' N,
longitude 122[deg]51'30.29'' W; thence continuing southeasterly to
latitude 46[deg]00'35.10'' N, longitude 122[deg]51'15.37'' W; thence
continuing south-southeasterly to latitude 45[deg]59'41.48'' N,
longitude 122[deg]50'52.40'' W; thence continuing southwesterly to
latitude 45[deg]59'38.65'' N, longitude 122[deg]51'05.97'' W; thence
continuing north-northwesterly to latitude 46[deg]00'36.82'' N,
longitude 122[deg]51'45.44'' W; thence continuing west-northwesterly to
latitude 46[deg]01'24.38'' N, longitude 122[deg]52'21.20'' W; thence
continuing northeasterly to the beginning.
    (5) Woodland Anchorage. An area enclosed by a line beginning
northeast of Columbia City, Oregon, at latitude 45[deg]53'55.31'' N,
longitude 122[deg]48'17.35'' W; thence continuing easterly to latitude
45[deg]53'57.11'' N, longitude 122[deg]48'02.16'' W; thence continuing
south-southeasterly to latitude 45[deg]53'21.16'' N, longitude
122[deg]47'44.28''

W; thence continuing westerly to latitude 45[deg]53'20.16'' N,
longitude 122[deg]48'02.37'' W; thence continuing northwesterly to
latitude 45[deg]53'41.50'' N, longitude 12[deg]48'13.53'' W; thence
continuing northerly to the point of beginning.
    (6) Henrici Bar Anchorage. An area enclosed by a line beginning
west-southwesterly of Bachelor Slough, Washington, at latitude
45[deg]47'24.68'' N, longitude 122[deg]46'49.14'' W; thence continuing
east-southeasterly to latitude 45[deg]46'44.95'' N, longitude
122[deg]46'13.23'' W, thence continuing southeasterly to latitude
45[deg]46'25.67'' N, longitude 122[deg]46'00.54'' W; thence continuing
south-southeasterly to latitude 45[deg]46'02.69'' N, longitude
122[deg]45'50.32'' W; thence continuing southerly to latitude
45[deg]45'43.66'' N, longitude 122[deg]45'45.33'' W; thence continuing
southerly to latitude 45[deg]45'37.52'' N, longitude 122[deg]45'44.99''
W; thence continuing westerly to latitude 45[deg]45'37.29'' N,
longitude 122[deg]45'53.06 W; thence continuing north-northwesterly to
latitude 45[deg]46'15.94'' N, longitude 122[deg]46'10.25'' W; thence
continuing west-northwesterly to latitude 45[deg]47'20.20'' N,
longitude 122[deg]46'59.28'' W; thence continuing easterly to the point
of beginning.
    (7) Lower Vancouver Anchorage. An area enclosed by a line beginning
north-northeast of Reeder Point at latitude 45[deg]43'39.18'' N,
longitude 122[deg]45'27.54'' W; thence continuing south-southwesterly
to latitude 45[deg]41'26.95'' N, longitude 122[deg]46'13.83'' W; thence
continuing southerly to latitude 45[deg]40'35.72'' N, longitude
122[deg]46'09.98'' W; thence continuing south-southeasterly to latitude
45[deg]40'23.95'' N, longitude 122[deg]46'04.26'' W; thence continuing
west-southwesterly to latitude 45[deg]40'20.68'' N, longitude
122[deg]46'16.07'' W; thence continuing northwesterly to latitude
45[deg]40'32.85'' N, longitude 122[deg]46'21.98'' W; thence continuing
north-northwesterly to latitude 45[deg]41'01.03'' N, longitude
122[deg]46'26.85'' W; thence continuing northerly to latitude
45[deg]41'29.07'' N, longitude 12[deg]46'26.15'' W; thence continuing
north-northeasterly to latitude 45[deg]43'41.27'' N, longitude
122[deg]45'39.87'' W; thence continuing easterly to the point of the
beginning. The Vancouver lower anchorage will then resume slightly
further upstream at an area north of Kelly point and will be enclosed
by a line starting at latitude 45[deg]40'10.09'' N, longitude
122[deg]45'57.53' W; thence continuing southeasterly to latitude
45[deg]39'42.94'' N, longitude 122[deg]45'44.34'' W; thence continuing
west-southwesterly to latitude 45[deg]39'40.07'' N, longitude
122[deg]45'56.34'' W; thence continuing northwesterly to latitude
45[deg]40'06.75'' N, longitude 122[deg]46'09.30'' W; thence continuing
east-northeasterly to the point of the beginning.
    (8) Kelly Point Anchorage. An area enclosed by a line beginning
northeast of Kelly Point, Oregon, at latitude 45[deg]39'10.32'' N,
longitude 122[deg]45'36.45'' W; thence continuing east-southeasterly to
latitude 45[deg]39'02.10'' N, longitude 122[deg]45'21.67'' W; thence
continuing east-southeasterly to latitude 45[deg]38'59.15'' N,
longitude 122[deg]45'16.38'' W; thence continuing southwesterly to
latitude 45[deg]38'51.03'' N, longitude 122[deg]45'25.57'' W; thence
continuing westerly to latitude 45[deg]38'51.54'' N, longitude
122[deg]45'26.35'' W; thence continuing northwesterly to latitude
45[deg]39'06.27'' N, longitude 122[deg]45'40.50'' W; thence continuing
north-northeasterly to the beginning point.
    (9) Upper Vancouver Anchorage. An area enclosed by a line beginning
north-northeast of Hayden Island at latitude 45[deg]38'43.44'' N,
longitude 122[deg]44'39.50'' W; thence continuing northeasterly to
45[deg]38'26.98'' N, longitude 122[deg]43'25.87'' W; thence continuing
east-northeasterly to latitude 45[deg]38'17.31'' N, longitude
122[deg]42'54.69'' W; thence continuing easterly to latitude
45[deg]38'12.40'' N, longitude 122[deg]42'43.93'' W; thence continuing
east-southeasterly to latitude 45[deg]37'40.53'' N, longitude
122[deg]41'44.08'' W; thence south-southeasterly to latitude
45[deg]37'36.11'' N, longitude 122[deg]41'48.86'' W; thence continuing
west-southwesterly to latitude 45[deg]37'52.20'' N, longitude
122[deg]42'19.50'' W; thence continuing west-southwesterly to latitude
45[deg]38'10.75'' N, longitude 122[deg]43'08.89'' W; thence continuing
southwesterly to latitude 45[deg]38'18.79'' N, longitude
122[deg]43'44.83'' W; thence continuing westerly to latitude
45[deg]38'41.37'' N, longitude 122[deg]44'40.44'' W; thence continuing
northeasterly to the point of beginning.
    (10) Cottonwood Island Anchorage. An area enclosed by a line
beginning west-southwest of Longview, WA at latitude 46[deg]05'56.88''
N, longitude 122[deg]56'53.19'' W; thence continuing easterly to
latitude 46[deg]05'14.06'' N, longitude 122[deg]54'45.71'' W; thence
continuing east-southeasterly to latitude 46[deg]04'57.12'' N,
longitude 122[deg]54'12.41'' W; thence continuing southeasterly to
latitude 46[deg]04'37.55'' N, longitude 122[deg]53'45.80'' W; thence
continuing southeasterly to latitude 46[deg]04'13.72'' N, longitude
122[deg]53'23.66'' W; thence continuing southeasterly to latitude
46[deg]03'54.94'' N, longitude 122[deg]53'11.81'' W; thence continuing
southerly to latitude 46[deg]03'34.96'' N, longitude 122[deg]53'03.17''
W; thence continuing westerly to latitude 46[deg]03'32.06'' N,
longitude 122[deg]53'19.68'' W; thence continuing north-northwesterly
to latitude 46[deg]03'50.84'' N, longitude 122[deg]53'27.81'' W; thence
continuing northwesterly to latitude 46[deg]04'08.10'' N, longitude
122[deg]53'38.70'' W; thence continuing northwesterly to latitude
46[deg]04'29.41'' N, longitude 122[deg]53'58.17'' W; thence continuing
north-northwesterly to latitude 46[deg]04'49.89'' N, longitude
122[deg]54'21.57'' W; thence continuing northwesterly to latitude
46[deg]05'06.95'' N, longitude 122[deg]54'50.65'' W; thence continuing
northwesterly to latitude 46[deg]05'49.77'' N, longitude 122[deg]56'
58.12'' W; thence continuing east-northeasterly to the point of the
beginning.
    (b) Regulations.
    (1) All designated anchorages are intended for the primary use of
deep-draft vessels over 200 feet in length.
    (2) If a vessel under 200 feet in length is anchored in a
designated anchorage, the master or person in charge of the vessel
shall:
    (i) Ensure that the vessel is anchored so as to minimize conflict
with large, deep-draft vessels utilizing or seeking to utilize the
anchorage; and
    (ii) Move the vessel out of the area if requested by the master of
a large, deep-draft vessel seeking to enter or depart the area or if
directed by the Captain of the Port.
    (3) Vessels desiring to anchor in designated anchorages shall
contact the pilot office that manages that anchorage to request an
appropriate position to anchor. Columbia River Bar Pilots manage
Astoria North Anchorage and Astoria South Anchorage. Columbia River
Pilots manage all designated anchorages upriver from Astoria.
    (4) No vessel may occupy a designated anchorage for more than 30
consecutive days without permission from the Captain of the Port.
    (5) No vessel being laid-up or dismantled or undergoing major
alterations or repairs may occupy a designated anchorage without
permission from the Captain of the Port.
    (6) No vessel carrying a Cargo of Particular Hazard listed in Sec.
126.10 of this chapter may occupy a designated anchorage without
permission from the Captain of the Port.
    (7) No vessel in a condition such that it is likely to sink or
otherwise become a hazard to the operation of other vessels shall
occupy a designated anchorage except in an emergency and then only for
such periods as may be authorized by the Captain of the Port.
    (8) Vessels anchoring in Astoria North Anchorage should avoid
placing their anchor in the charted cable area.

    Dated: September 9, 2009.
G.T. Blore,
Rear Admiral, U.S. Coast Guard, Commander, Thirteenth Coast Guard
District.
[FR Doc. E9-24317 Filed 10-7-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 77, Number 232 (Monday, December 3, 2012)]
[Rules and Regulations]
[Pages 71493-71494]
[FR Doc No: 2012-29001]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2012-1193; Airspace Docket No. 12-ANM-26]
RIN 2120-AA66

Amendment of VOR Federal Airway V-8 in the Vicinity of Rifle, CO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule, technical amendment.

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SUMMARY: This action amends VHF Omnidirectional Range (VOR) Federal
Airway V-8 in the vicinity of Rifle, CO, to correct the description
contained in part 71 to ensure it matches the information contained in
the FAA's aeronautical database, matches the depiction on the
associated charts, and to ensure the safety and efficiency of the
National Airspace System (NAS).

DATES: Effective date 0901 UTC December 3, 2012. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace Regulations and
ATC Procedures Group, Office of Mission Support Services, Federal
Aviation Administration, 800 Independence Avenue SW., Washington, DC
20591; telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    After a recent review of aeronautical data, the Aeronautical
Navigation Products Group identified the current VOR Federal airway V-8
description published in FAA Order 7400.9, Airspace Designations and
Reporting Points, did not match the airway information contained in the
FAA's aeronautical database or the charted depiction of the airway.
When V-8 was amended in the Federal Register of September 30, 1993 (58
FR 51010), the airway was realigned over the Rifle, CO, VHF
Omnidirectional Range/Distance Measuring Equipment (VOR/DME) navigation
aid between Grand Junction, CO, and Kremmling, CO. In the Federal
Register of August 9, 2010 (75 FR 47709), V-8 was renamed from the
Findlay, OH, VORTAC to the Flag City, OH, VORTAC. The Rifle, CO, VOR/
DME was inadvertently deleted from the airway description. The FAA
aeronautical database retained the Rifle, CO, VOR/DME in the airway
description correctly and the associated aeronautical charts remain
published accordingly. To overcome any confusion or flight safety
issues associated with conflicting airway description information being
published, the FAA is amending the V-8 legal description to reflect the
airway aligned over the Rifle, CO, VOR/DME. Accordingly, since this is
an administrative correction to update the V-8 description to be in
concert with the FAA's aeronautical database and charting, notice and
public procedures under Title 5 U.S.C. 553(b) are unnecessary.

The Rule

    The FAA amends Title 14 Code of Federal Regulations (14 CFR) part
71 by amending the legal description of VOR Federal airway V-8 in the
vicinity of Rifle, CO. Specifically, the FAA amends V-8 to reflect the
airway aligned over the Rifle, CO, VOR/DME; thus, matching the
information currently contained in the FAA's aeronautical database and
the charted depiction of the airway.
    VOR Federal airways are listed in paragraph 6010 of FAA Order
7400.9W dated August 8, 2012, and effective September 15, 2012, which
is incorporated by reference in 14 CFR 71.1. The VOR Federal airway
listed in this document will be revised subsequently in the Order.
    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.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under Department of Transportation (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, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    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 the 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 an
existing VOR Federal airway within the NAS.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with 311a, FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures.'' 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.

List 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 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 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 7400.9W,
Airspace Designations and Reporting Points, signed August 8, 2012, and
effective September 15, 2012, is amended as follows:

Paragraph 6010 VOR Federal Airways.

    (a) Domestic VOR Federal airways.
* * * * *

V-8

    From INT Seal Beach, CA, 266[deg] and Ventura, CA, 144[deg]
radials; Seal Beach; Paradise, CA; 35 miles, 7 miles wide (3 miles
SE and 4 miles NW of centerline) Hector, CA; Goffs, CA; INT Goffs
033[deg] and Morman Mesa, NV, 196[deg] radials; Morman Mesa; Bryce
Canyon, UT; Hanksville, UT; Grand Junction, CO; Rifle, CO;
Kremmling, CO; Mile High, CO; Akron, CO; Hayes Center, NE; Grand
Island, NE; Omaha, NE; Des Moines, IA; Iowa City, IA; Moline, IL;
Joliet, IL; Chicago Heights, IL; Goshen, IN; Flag City, OH;
Mansfield, OH; Briggs, OH; Bellaire, OH; INT Bellaire 107[deg] and
Grantsville, MD, 285[deg] radials; Grantsville; Martinsburg, WV; to
Washington, DC. The portion outside the United States has no upper
limit.
* * * * *

    Issued in Washington, DC, November 15, 2012.
Paul Gallant,
Acting Manager, Airspace Policy and ATC Procedures Group.
[FR Doc. 2012-29001 Filed 11-30-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)]
[Proposed Rules]
[Pages 46900-46902]
[FR Doc No: 2018-19889]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0771; Product Identifier 2018-CE-029-AD]
RIN 2120-AA64

Airworthiness Directives; GA 8 Airvan (Pty) Ltd Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for GA
8 Airvan (Pty) Ltd Models GA8 and GA8-TC320 airplanes. This proposed AD
results from mandatory continuing airworthiness information (MCAI)
originated by an aviation authority of another country to identify and
correct an unsafe condition on an aviation product. The MCAI describes
the unsafe condition as certain wing strut fittings manufactured with
incorrect grain orientation, which has an unknown effect on fatigue
related concerns. We are issuing this proposed AD to require actions to
address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by November 1,
2018.

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 proposed AD, contact GA
8 Airvan (Pty) Ltd, c/o GippsAero Pty Ltd, Attn: Technical Services,
P.O. Box 881, Morwell Victoria 3840, Australia; telephone: +61 03 5172
1200; fax: +61 03 5172 1201; email:
[email protected]. You may review this referenced
service information at the FAA, Policy and Innovation Division, 901
Locust, Kansas City, Missouri 64106. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

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-2018-
0771; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this proposed AD, the regulatory evaluation, any comments received, and
other information. The street address for Docket Operations (telephone
(800) 647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Doug Rudolph, Aerospace Engineer, FAA,
Small Airplane Standards Branch, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].

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-2018-0771;
Product Identifier 2018-CE-029-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://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

    The Civil Aviation Safety Authority (CASA), which is the aviation
authority for Australia, has issued AD No. AD/GA8/9, Amendment 1, dated
May 29, 2018 (referred to after this as ``the MCAI''), to correct an
unsafe condition for the specified products. The MCAI states:

    Amendment 1 of this [CASA] AD is issued to amend the replacement
times as Service Bulletin GA8-2017-174 Issue 2 changed the mandatory
replacement times for part number GA8-570026-035 strut from 6000
hours time in service or 3 calendar years to 9000 hours time in
service or 5 calendar years, whichever occurs first.
    A manufacturing quality escape has resulted in wing strut
fittings in the effective serial number range to be manufactured
with

incorrect grain orientation. The fatigue implications of the
incorrect grain are not well understood. Therefore, CASA has
mandated a conservative factored fatigue life limit based on the
known fleet data of the affected aircraft. CASA will continue to
gather data for the purposes of managing the fleet removal of these
fittings from service.

You may examine the MCAI on the internet at http://www.regulations.gov
by searching for and locating Docket No. FAA-2018-0771.

Related Service Information Under 1 CFR Part 51

    GippsAero has issued Service Bulletin SB-GA8-2017-174, Issue 2,
dated May 23, 2018. The service information describes procedures for
wing strut and strut fitting inspection and replacement. 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.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Costs of Compliance

    We estimate that this proposed AD would affect 50 airplanes of U.S.
registry. The average labor rate is $85 per work-hour.
    We estimate that it would take about 8 work-hours and $200 for
parts to do the initial inspections of this proposed AD, for a cost of
$880 per airplane and $44,000 for the U.S. operator fleet. We estimate
that it would take about 5 work-hours and $200 for parts to do the
repetitive inspections, for a cost of $625 per airplane and $31,250 for
the U.S. operator fleet per inspection cycle.
    In addition, we estimate that replacing the struts and strut
fittings would take about 10 work-hours and require parts costing
$7,000, for a cost of $7,850 per airplane and $392,500 for the U.S.
operator fleet.
    Reporting the inspection findings would require about 1 work-hour,
for a cost of $85 per airplane and $4,250 for the U.S. operator fleet
per inspection cycle.
    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a currently valid OMB Control Number. The OMB
Control Number for this information collection is 2120-0056. Public
reporting for this collection of information is estimated to be
approximately 1 hour per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, completing and reviewing the collection of
information. All responses to this collection of information are
mandatory as required by this AD; the nature and extent of
confidentiality to be provided, if any. Send comments regarding this
burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to: Information
Collection Clearance Officer, Federal Aviation Administration, 10101
Hillwood Parkway, Fort Worth, TX 76177-1524.

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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to small airplanes, gliders,
balloons, airships, domestic business jet transport airplanes, and
associated appliances to the Director of the Policy and Innovation
Division.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

GA 8 Airvan (Pty) Ltd: Docket No. FAA-2018-0771; Product Identifier
2018-CE-029-AD.

(a) Comments Due Date

    We must receive comments by November 1, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to GA 8 Airvan (Pty) Ltd Models GA8 and GA8-
TC320 airplanes, certificated in any category, with a strut or strut
fitting installed that has a part number and serial number listed in
table 1 of GippsAero Service Bulletin SB-GA8-2017-174, Issue 2,
dated May 23, 2018 (GippsAero SB-GA8-2017-174, Issue 2).

(d) Subject

    Air Transport Association of America (ATA) Code 57: Wings.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) issued by the aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as certain wing
strut fittings manufactured with incorrect grain orientation, which
has an unknown effect on fatigue-related concerns. We are issuing
this AD to detect and address fatigue-related damage to the wing
strut fittings, which could lead to failure of the wing with
consequent loss of control of the airplane.

(f) Actions and Compliance

    Unless already done, do the following actions in paragraphs
(f)(1) through (6) of this AD:
    (1) Within 3 months after the effective date of this AD or
within 100 hours time-in-service (TIS) after the effective date of
this AD, whichever occurs first, with the wing struts removed,
visually inspect each forward and aft wing strut fitting and
fuselage attachment point for cracks, corrosion, and damage. If a
crack, corrosion, or damage is found during the inspection, before
further flight, do the applicable corrective actions (check torque,
restore surface protection, rework areas with fouling, and replace
any part with a crack, corrosion, or damage). Follow the procedures
in Parts C1, C2, and D or E, as applicable, in the Accomplishment
Instructions in GippsAero SB-GA8-2017-174, Issue 2.
    (2) Within 3 months after the effective date of this AD or
within 100 hours TIS after the effective date of this AD, whichever
occurs first, and thereafter at intervals not to exceed 100 hours
TIS, visually inspect each strut and strut fitting for cracks,
corrosion, and damage. If a crack, corrosion, or damage is found
during any of the inspections, before further flight, do the
applicable corrective actions (check torque, restore surface
protection, and replace any part with a crack, corrosion, or
damage). Follow the procedures in Parts B and D or E, as applicable,
in the Accomplishment Instructions of GippsAero SB-GA8-2017-174,
Issue 2.
    (3) Within 1,000 hours TIS after doing the inspections required
in paragraph (f)(1) of this AD and thereafter at intervals not to
exceed 1,000 hours TIS, with the wing struts installed, visually
inspect each forward and aft wing strut, strut fitting, and strut
fitting lug hole for cracks, corrosion, and damage. If a crack,
corrosion, or damage is found during any of the inspections, before
further flight, do the applicable corrective actions (do additional
inspections, replace hardware, and replace any part with a crack,
corrosion, or damage). Follow the procedures in Parts C3 and D or E,
as applicable, in the Accomplishment Instructions of GippsAero SB-
GA8-2017-174, Issue 2.
    (4) To use an eddy current or fluorescent liquid penetrant
inspection method instead of a visual inspection for the
requirements in paragraphs (f)(1) of this AD, the Manager, Small
Airplane Standards Branch, FAA must approve your inspection method,
and the Manager's approval letter must specifically refer to this
AD. Send your approval request to the contact information found in
paragraph (g)(1) of this AD.
    (5) Remove from service each part listed in Parts D and E of
table 3 on or before the part exceeds its specified replacement time
and replace with an airworthy part. On the effective date of this
AD, any part listed in table 3 of GippsAero SB-GA8-2017-174, Issue
2, that has exceeded its replacement time, within 100 hours TIS
after the effective date of this AD or within 12 months after the
effective date of this AD, whichever occurs first, remove the part
from service and replace with an airworthy part. Follow the
replacement procedures in Part D or Part E, as applicable, in the
Accomplishment Instructions of GippsAero SB-GA8-2017-174, Issue 2.
    (6) Within 24 hours after each inspection required in paragraphs
(f)(1) and (2) of this AD, submit a report of the inspection
results, even if no damage is found, to the Civil Aviation Safety
Authority (CASA) and GA 8 Airvan (Pty) Ltd. Use the Document
Compliance Notice of GippsAero SB-GA8-2017-174, Issue 2, and include
in the report the total hours TIS on the airplane and the type of
operation. You may use the contact information found in paragraph
(h) of this AD to contact GA 8 Airvan (Pty) Ltd. To contact CASA,
use the online CASA Defect Reporting Service at the following
internet address: https://drs.casa.gov.au/.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Small Airplane Standards Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to ATTN: Doug Rudolph, Aerospace Engineer,
FAA, Small Airplane Standards Branch, 901 Locust, Room 301, Kansas
City, Missouri 64106; telephone:<PHONE_NUMBER>; fax: (816) 329-
4090; email: [email protected]. Before using any approved AMOC on
any airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must
instead be accomplished using a method approved by the Manager,
Small Airplane Standards Branch, FAA; or CASA.
    (3) Reporting Requirements: A federal agency may not conduct or
sponsor, and a person is not required to respond to, nor shall a
person be subject to a penalty for failure to comply with a
collection of information subject to the requirements of the
Paperwork Reduction Act unless that collection of information
displays a currently valid OMB Control Number. The OMB Control
Number for this information collection is 2120-0731. Public
reporting for this collection of information is estimated to be
approximately 1 hour per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, completing and reviewing the collection
of information. All responses to this collection of information are
voluntary; the nature and extent of confidentiality to be provided,
if any. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for
reducing this burden to: Information Collection Clearance Officer,
Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth,
TX 76177-1524.

(h) Related Information

    Refer to MCAI issued by CASA, AD No. AD/GA8/9, Amendment 1,
dated May 29, 2018. You may examine the MCAI on the internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2018-0771. For service information related to this AD, contact
GA 8 Airvan (Pty) Ltd, c/o GippsAero Pty Ltd, Attn: Technical
Services, P.O. Box 881, Morwell Victoria 3840, Australia; telephone:
+61 03 5172 1200; fax: +61 03 5172 1201; email:
[email protected]. You may review this
referenced service information at the FAA, Policy and Innovation
Division, 901 Locust, Kansas City, Missouri 64106. For information
on the availability of this material at the FAA, call (816) 329-
4148.

    Issued in Kansas City, Missouri, on August 31, 2018.
Melvin J. Johnson,
Deputy Director, Policy & Innovation Division, Aircraft Certification
Service.
[FR Doc. 2018-19889 Filed 9-14-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 90 (Wednesday, May 10, 2023)]
[Notices]
[Pages 30181-30185]
[FR Doc No: 2023-09904]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97437; File No. SR-CboeBZX-2023-020]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.;
Suspension of and Order Instituting Proceedings To Determine Whether To
Approve or Disapprove Proposed Rule Change To Amend the BZX Equities
Fee Schedule To Add and Modify Certain Step-Up Tiers, Add a Non-
Displayed Step-Up Tier and Modify Certain Fee Codes

May 4, 2023.

I. Introduction

    On March 6, 2023, Cboe BZX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Exchange Act'' or ``Act''),\1\ and Rule 19b-4
thereunder,\2\ a proposed rule

change (File Number SR-CboeBZX-2023-020) to amend the BZX Equities Fee
Schedule (``Fee Schedule'') to add and modify certain Step-Up Tiers,
add a Non-Displayed Step-Up Tier and to modify Fee Codes HB, HV and
HY.\3\ The proposed rule change was immediately effective upon filing
with the Commission pursuant to Section 19(b)(3)(A) of the Act.\4\ The
proposed rule change was published for comment in the Federal Register
on March 16, 2023.\5\ The Commission has received no comment letters on
the proposed rule change. Under Section 19(b)(3)(C) of the Act,\6\ the
Commission is hereby: (i) temporarily suspending File Number SR-
CboeBZX-2023-020; and (ii) instituting proceedings to determine whether
to approve or disapprove File Number SR-CboeBZX-2023-020.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Notice, infra note 5, at 16285.
    \4\ 15 U.S.C. 78s(b)(3)(A). A proposed rule change may take
effect upon filing with the Commission if it is designated by the
exchange as ``establishing or changing a due, fee, or other charge
imposed by the self-regulatory organization on any person, whether
or not the person is a member of the self-regulatory organization.''
15 U.S.C. 78s(b)(3)(A)(ii).
    \5\ See Securities Exchange Act Release No. 97108 (March 10,
2023), 88 FR 16285 (``Notice''). The Exchange initially filed the
proposed fee changes on March 1, 2023 (SR-CboeBZX-2023-017).
However, on March 6, 2023, the Exchange withdrew that filing and
submitted SR-CboeBZX-2023-020.
    \6\ 15 U.S.C. 78s(b)(3)(C).
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    The Exchange operates a ``Maker-Taker'' model whereby it pays
credits to Members \7\ that add liquidity and assesses fees to those
that remove liquidity.\8\ The Exchange also offers tiered pricing which
provides Members opportunities to qualify for higher rebates or reduced
fees where certain volume criteria and thresholds are met.\9\ According
to the Exchange, tiered pricing provides an incremental incentive for
Members to strive for higher tier levels, which provides increasingly
higher benefits or discounts for satisfying increasingly more stringent
criteria.\10\
---------------------------------------------------------------------------

    \7\ See BZX Rule 1.5(n). The term ``Member'' shall mean any
registered broker or dealer that has been admitted to membership in
the Exchange. A Member will have the status of a ``member'' of the
Exchange as that term is defined in Section 3(a)(3) of the Act.
Membership may be granted to a sole proprietor, partnership,
corporation, limited liability company or other organization which
is a registered broker or dealer pursuant to Section 15 of the Act,
and which has been approved by the Exchange.
    \8\ See Notice, supra note 5, at 16286.
    \9\ Id.
    \10\ Id.
---------------------------------------------------------------------------

    The Exchange proposes to amend its Fee Schedule to add and modify
certain Step-Up Tiers, add a Non-Displayed Step-Up Tier and to modify
Fee Codes HB, HV and HY, which fee changes became effective on March 6,
2023.\11\ With respect to the Exchange's Step-Up Tiers, the Exchange
currently offers Step-Up Tiers (tiers 1 through 3) that provide Members
an opportunity to receive an enhanced rebate from the standard rebate
for liquidity adding orders that yield fee codes B, V, and Y where they
increase their relative liquidity each month over a predetermined
baseline.\12\ The Exchange now proposes to add a new Tier 1 and
renumber existing Tiers 1 through 3 (existing Step-Up Tiers 1, 2 and 3
would be renumbered to Tiers 2, 3 and 4 respectively, and will be
referred to herein as ``proposed Step-Up Tier'' 2, 3 or 4, as
applicable).\13\ Specifically, proposed Tier 1 would provide for the
following:
---------------------------------------------------------------------------

    \11\ Id.
    \12\ Id. See also Fee Schedule, Footnotes 2, Step-Up Tiers.
    \13\ Id.
---------------------------------------------------------------------------

     Proposed Tier 1 would offer an enhanced rebate of $0.0031
per share for qualifying orders (i.e., orders yielding fee codes B, V,
or Y) where (1) Member has a Step-Up ADAV \14\ from January 2023
>=10,000,000 or Member has a Step-Up Add TCV \15\ from January 2023
>=0.10%; and (2) Member has an ADV \16\ >=0.60% of the TCV.\17\
---------------------------------------------------------------------------

    \14\ ``Step-Up ADAV'' means ADAV in the relevant baseline month
subtracted from current ADAV. See Notice, supra note 5, at 16286.
    \15\ ``Step-Up Add TCV'' means ADAV as a percentage of TCV in
the relevant baseline month subtracted from current ADAV as a
percentage of TCV. ADAV means average daily added volume calculated
as the number of shares added per day. ADAV is calculated on a
monthly basis. TCV means total consolidated volume calculated as the
volume reported by all exchanges and trade reporting facilities to a
consolidated transaction reporting plan for the month for which the
fees apply. Id.
    \16\ ``ADV'' means average daily volume calculated as the number
of shares added or removed, combined, per day. ADV is calculated on
a monthly basis. Id.
    \17\ ``TCV'' means total consolidated volume calculated as the
volume reported by all exchanges and trade reporting facilities to a
consolidated transaction reporting plan for the month for which the
fees apply. The Exchange excludes from its calculation of TCV volume
on any day that the Exchange experiences an Exchange System
Disruption, on any day with a scheduled early market close and the
Russell Reconstitution Day. See Fee Schedule, Definitions.
---------------------------------------------------------------------------

    Proposed Tiers 2 through 4 would have the same criteria and provide
the same enhanced rebate as existing Tiers 1 through 3,
respectively.\18\
---------------------------------------------------------------------------

    \18\ See Notice, supra note 5, at 16286.
---------------------------------------------------------------------------

    The Exchange also proposes to amend footnote 2 to add a Non-
Displayed Step-Up Tier, which will provide Members an opportunity to
receive an enhanced rebate from the standard rebate for liquidity
adding non-displayed orders that yield fee codes HB,\19\ HV,\20\ and HY
\21\ and meet certain required volume-based criteria.\22\ The proposed
criteria for the Non-Displayed Step-Up Tier is as follows:
---------------------------------------------------------------------------

    \19\ Orders yielding Fee Code ``HB'' are non-displayed orders
adding liquidity to BZX (Tape B). See Fee Schedule, Fee Codes and
Associated Fees. To reflect eligibility for the Non-Displayed Step-
Up Tier for Fee Code HB, the Exchange added footnote to 2 to Fee
Code HB.
    \20\ Orders yielding Fee Code ``HV'' are non-displayed orders
adding liquidity to BZX (Tape A). Id. To reflect eligibility for the
Non-Displayed Step-Up Tier for Fee Code HV, the Exchange added
footnote to 2 to Fee Code HV.
    \21\ Orders yielding Fee Code ``HY'' are non-displayed orders
adding liquidity to BZX (Tape C). Id. To reflect eligibility for the
Non-Displayed Step-Up Tier for Fee Code HY, the Exchange added
footnote to 2 to Fee Code HY.
    \22\ See Notice, supra note 5, at 16286.
---------------------------------------------------------------------------

     The proposed Non-Displayed Step-Up Tier would offer an
enhanced rebate of $0.0025 per share for qualifying orders (i.e.,
orders yielding fee codes HB, HV, or HY) where (1) Member has a Step-Up
ADAV from January 2023 >=10,000,000 or Member has a Step-Up Add TCV
from January 2023 >=0.10%; and (2) Member has an ADV >=0.60% of the
TCV.

III. Suspension of the Proposed Rule Change

    Pursuant to Section 19(b)(3)(C) of the Act,\23\ at any time within
60 days of the date of filing of an immediately effective proposed rule
change pursuant to Section 19(b)(1) of the Act,\24\ the Commission
summarily may temporarily suspend the change in the rules of a self-
regulatory organization (``SRO'') 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. As discussed below, the Commission believes a temporary
suspension of the proposed rule change is necessary and appropriate to
allow for additional analysis of the proposed rule change's consistency
with the Act and the rules thereunder.
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78s(b)(3)(C).
    \24\ 15 U.S.C. 78s(b)(1).
---------------------------------------------------------------------------

    In support of the proposal, the Exchange argues that is 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 or incentives to be insufficient.\25\
The Exchange believes that its specific proposal reflects a competitive
pricing structure designed to incentivize market participants to direct
their order flow to the Exchange, which the Exchange believes would

enhance market quality to the benefit of all Members.\26\ The Exchange
states that the Step-Up Tiers in general are designed to provide
Members with additional opportunities to receive enhanced rebates by
increasing their order flow to the Exchange, which further contributes
to a deeper, more liquid market and provides even more execution
opportunities for active market participants.\27\ According to the
Exchange, like other Step-Up Tiers, the proposed Step-Up Tier 1 is
designed to give members an additional opportunity to receive an
enhanced rebate for orders meeting the applicable criteria.\28\
Furthermore, the Exchange states that the proposed Non-Displayed Step-
Up Tier is designed to increase the Members' provision of liquidity to
the Exchange, which increases execution opportunities and provides for
overall enhanced price discovery and price improvement opportunities on
the Exchange.\29\ The Exchange believes that increased overall order
flow benefits all Members by contributing towards a robust and well-
balanced market ecosystem.\30\
---------------------------------------------------------------------------

    \25\ See Notice, supra note 5, at 16287.
    \26\ Id.
    \27\ See Notice, supra note 5, at 16286.
    \28\ Id.
    \29\ Id.
    \30\ Id.
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    Additionally, the Exchange believes the proposed Step-Up Tier 1 and
Non-Displayed Step-Up Tier are reasonable as they serve to incentivize
Members to increase their liquidity-adding, displayed volume (Step-Up
Tier 1) and liquidity-adding, non-displayed volume (Non-Displayed Step-
Up Tier), which benefit all market participants by incentivizing
continuous liquidity and thus, deeper, more liquid markets as well as
increased execution opportunities.\31\ The Exchange states that the
proposed incentives to provide displayed liquidity are designed to
incentivize continuous displayed liquidity, which signals other market
participants to take the additional execution opportunities provided by
such liquidity, while the proposed incentives to provide non-displayed
liquidity will further contribute to a deeper, more liquid market and
provide even more execution opportunities for active market
participants at improved prices.\32\ According to the Exchange, this
overall increase in activity deepens the Exchange's liquidity pool,
offers additional cost savings, supports the quality of price
discovery, promotes market transparency, and improves market quality
for all investors.\33\
---------------------------------------------------------------------------

    \31\ See Notice, supra note 5, at 16287.
    \32\ Id.
    \33\ Id.
---------------------------------------------------------------------------

    The Exchange also believes the proposed Step-Up Tier 1 and Non-
Displayed Step-Up Tier represent an equitable allocation of rebates and
are not unfairly discriminatory because all Members are eligible for
those tiers and would have the opportunity to meet a tier's criteria
and would receive the proposed rebate if such criteria is met.\34\
Further, according to the Exchange, the proposed rebates are
commensurate with the proposed criteria.\35\ The Exchange states that
the rebates reasonably reflect the difficulty in achieving the
applicable criteria as proposed.\36\ The Exchange also states that the
proposed tier/rebate will not adversely impact any Member's ability to
qualify for other reduced fee or enhanced rebate tiers.\37\ Should a
Member not meet the proposed criteria under the modified tier, the
Member will merely not receive that corresponding enhanced rebate.\38\
---------------------------------------------------------------------------

    \34\ Id.
    \35\ Id.
    \36\ Id.
    \37\ Id.
    \38\ Id.
---------------------------------------------------------------------------

    Additionally, the Exchange states that relative volume-based
incentives and discounts have been widely adopted by exchanges,
including the Exchange, and are reasonable, equitable and non-
discriminatory because they are open to all Members on an equal basis
and provide additional benefits or discounts that are reasonably
related to (i) the value to an exchange's market quality and (ii)
associated higher levels of market activity, such as higher levels of
liquidity provision and/or growth patterns.\39\ According to the
Exchange, competing equity exchanges offer similar tiered pricing
structures, including schedules of rebates and fees that apply based
upon members achieving certain volume and/or growth thresholds, as well
as assess similar fees or rebates for similar types of orders, to that
of the Exchange.\40\
---------------------------------------------------------------------------

    \39\ Id.
    \40\ Id.
---------------------------------------------------------------------------

    When exchanges file their proposed rule changes with the
Commission, including fee filings like the Exchange's present proposal,
they are required to provide a statement supporting the proposal's
basis under the Act and the rules and regulations thereunder applicable
to the exchange.\41\ The instructions to Form 19b-4, on which exchanges
file their proposed rule changes, specify that such statement ``should
be sufficiently detailed and specific to support a finding that the
proposed rule change is consistent with [those] requirements.'' \42\
---------------------------------------------------------------------------

    \41\ See 17 CFR 240.19b-4 (Item 3 entitled ``Self-Regulatory
Organization's Statement of the Purpose of, and Statutory Basis for,
the Proposed Rule Change'').
    \42\ Id.
---------------------------------------------------------------------------

    Section 6 of the Act, including Sections 6(b)(4), (5), and (8),
requires the rules of an exchange to (1) provide for the equitable
allocation of reasonable fees among members, issuers, and other persons
using the exchange's facilities; \43\ (2) perfect the mechanism of a
free and open market and a national market system, protect investors
and the public interest, and not be designed to permit unfair
discrimination between customers, issuers, brokers, or dealers; \44\
and (3) not impose any burden on competition not necessary or
appropriate in furtherance of the purposes of the Act.\45\
---------------------------------------------------------------------------

    \43\ 15 U.S.C. 78f(b)(4).
    \44\ 15 U.S.C. 78f(b)(5).
    \45\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

    In temporarily suspending the Exchange's fee change, the Commission
intends to further consider whether the proposal, in particular the
proposed modifications to add and modify certain Step-Up Tiers and add
a Non-Displayed Step-Up Tier, is consistent with the statutory
requirements applicable to a national securities exchange under the
Act. The Commission will consider whether the proposed rule change
satisfies the standards under the Act and the rules thereunder
requiring, among other things, that an exchange's rules provide for the
equitable allocation of reasonable fees among members, issuers, and
other persons using its facilities; not permit unfair discrimination
between customers, issuers, brokers or dealers; and do not impose any
burden on competition not necessary or appropriate in furtherance of
the purposes of the Act.\46\
---------------------------------------------------------------------------

    \46\ See 15 U.S.C. 78f(b)(4), (5), and (8), respectively.
---------------------------------------------------------------------------

    Therefore, the Commission finds that it is appropriate in the
public interest, for the protection of investors, and otherwise in
furtherance of the purposes of the Act, to temporarily suspend the
proposed rule change.\47\
---------------------------------------------------------------------------

    \47\ For purposes of temporarily suspending the proposed rule
change, the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

IV. Proceedings To Determine Whether To Approve or Disapprove the
Proposed Rule Change

    In addition to temporarily suspending the proposal, the Commission
also hereby institutes proceedings pursuant

to Sections 19(b)(3)(C) \48\ and 19(b)(2)(B) of the Act \49\ to
determine whether the proposed rule change should be approved or
disapproved. Institution of proceedings does not indicate that the
Commission has reached any conclusions with respect to any of the
issues involved. Rather, the Commission seeks and encourages interested
persons to provide additional comment on the proposed rule change to
inform the Commission's analysis of whether to approve or disapprove
the proposed rule change.
---------------------------------------------------------------------------

    \48\ 15 U.S.C. 78s(b)(3)(C). Once the Commission temporarily
suspends a proposed rule change, Section 19(b)(3)(C) of the Act
requires that the Commission institute proceedings under Section
19(b)(2)(B) to determine whether a proposed rule change should be
approved or disapproved.
    \49\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

    Pursuant to Section 19(b)(2)(B) of the Act,\50\ the Commission is
providing notice of the grounds for possible disapproval under
consideration:
---------------------------------------------------------------------------

    \50\ 15 U.S.C. 78s(b)(2)(B). Section 19(b)(2)(B) of the Act also
provides that proceedings to determine whether to disapprove a
proposed rule change must be concluded within 180 days of the date
of publication of notice of the filing of the proposed rule change.
See id. The time for conclusion of the proceedings may be extended
for up to 60 days if the Commission finds good cause for such
extension and publishes its reasons for so finding, or if the
exchange consents to the longer period. See id.
---------------------------------------------------------------------------

     Whether the Exchange has demonstrated how the proposal is
consistent with Section 6(b)(4) of the Act, which requires that the
rules of a national securities exchange ``provide for the equitable
allocation of reasonable dues, fees, and other charges among its
members and issuers and other persons using its facilities;'' \51\
---------------------------------------------------------------------------

    \51\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

     Whether the Exchange has demonstrated how the proposal is
consistent with Section 6(b)(5) of the Act, which requires, among other
things, that the rules of a national securities exchange be ``designed
to perfect the operation of a free and open market and a national
market system'' and ``protect investors and the public interest,'' and
not be ``designed to permit unfair discrimination between customers,
issuers, brokers, or dealers;'' \52\ and
---------------------------------------------------------------------------

    \52\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

     Whether the Exchange has demonstrated how the proposal is
consistent with Section 6(b)(8) of the Act, which requires that the
rules of a national securities exchange ``not impose any burden on
competition not necessary or appropriate in furtherance of the purposes
of [the Act].'' \53\
---------------------------------------------------------------------------

    \53\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

    As discussed in Section III above, the Exchange argues that all
Members will be eligible for the proposed new tiers and have the
opportunity to meet the tiers' criteria. The Exchange further states
the proposal provides a reasonable means to incentivize Members to
continue to send certain types of order flow to the Exchange. Because
the proposed Step-Up Tier and Non-Displayed Step-Up Tier are designed
to provide more favorable pricing to Members with volume increases over
specified baseline months, questions are raised as to whether the
Exchange has satisfied its burden to demonstrate that such tiers will,
as the Exchange argues, continue to provide a reasonable means to
incentivize Members to send certain types of order flow to the
Exchange, in a manner consistent with the Act and the rules thereunder
when the specified baseline months remain the same and may continue
indefinitely.
    Under the Commission's Rules of Practice, the ``burden to
demonstrate that a proposed rule change is consistent with the [Act]
and the rules and regulations issued thereunder . . . is on the [SRO]
that proposed the rule change.'' \54\ The description of a proposed
rule change, its purpose and operation, its effect, and a legal
analysis of its consistency with applicable requirements must all be
sufficiently detailed and specific to support an affirmative Commission
finding,\55\ and any failure of an SRO to provide this information may
result in the Commission not having a sufficient basis to make an
affirmative finding that a proposed rule change is consistent with the
Act and the applicable rules and regulations.\56\
---------------------------------------------------------------------------

    \54\ 17 CFR 201.700(b)(3).
    \55\ See id.
    \56\ See id.
---------------------------------------------------------------------------

    The Commission is instituting proceedings to allow for additional
consideration and comment on the issues raised herein, including as to
whether the proposal is consistent with the Act, specifically, with its
requirements that the rules of a national securities exchange provide
for the equitable allocation of reasonable dues, fees, and other
charges among its members, issuers, and other persons using its
facilities; are designed to perfect the operation of a free and open
market and a national market system, and to protect investors and the
public interest; are not designed to permit unfair discrimination
between customers, issuers, brokers, or dealers; and do not impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act; \57\ as well as any other
provision of the Act, or the rules and regulations thereunder.
---------------------------------------------------------------------------

    \57\ See 15 U.S.C. 78f(b)(4), (5), and (8).
---------------------------------------------------------------------------

V. Commission's Solicitation of Comments

    The Commission requests written views, data, and arguments with
respect to the concerns identified above as well as any other relevant
concerns. Such comments should be submitted by May 31, 2023. Rebuttal
comments should be submitted by June 14, 2023. Although there do not
appear to be any issues relevant to approval or disapproval that would
be facilitated by an oral presentation of views, data, and arguments,
the Commission will consider, pursuant to Rule 19b-4, any request for
an opportunity to make an oral presentation.\58\
---------------------------------------------------------------------------

    \58\ 15 U.S.C. 78s(b)(2). Section 19(b)(2) of the Act grants the
Commission flexibility to determine what type of proceeding--either
oral or notice and opportunity for written comments--is appropriate
for consideration of a particular proposal by an SRO. See Securities
Acts Amendments of 1975, Report of the Senate Committee on Banking,
Housing and Urban Affairs to Accompany S. 249, S. Rep. No. 75, 94th
Cong., 1st Sess. 30 (1975).
---------------------------------------------------------------------------

    The Commission asks that commenters address the sufficiency and
merit of the Exchange's statements in support of the proposal, in
addition to any other comments they may wish to submit about the
proposed rule change.
    Interested persons are invited to submit written data, views, and
arguments concerning the proposed rule change, including whether the
proposal 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 protected]. Please include
File No. SR-CboeBZX-2023-020 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CboeBZX-2023-020. 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 website (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 website 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 the filing also will be available for inspection
and copying at the principal office of the Exchange. Do not include
personal identifiable information in submissions; you should submit
only information that you wish to make available publicly. We may
redact in part or withhold entirely from publication submitted material
that is obscene or subject to copyright protection. All submissions
should refer to File Number SR-CboeBZX-2023-020 and should be submitted
on or before May 31, 2023. Rebuttal comments should be submitted by
June 14, 2023.

VI. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(3)(C) of the
Act,\59\ that File Number SR-CboeBZX-2023-020 be and hereby is,
temporarily suspended. In addition, the Commission is instituting
proceedings to determine whether the proposed rule change should be
approved or disapproved.
---------------------------------------------------------------------------

    \59\ 15 U.S.C. 78s(b)(3)(C).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\60\
---------------------------------------------------------------------------

    \60\ 17 CFR 200.30-3(a)(57) and (58).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-09904 Filed 5-9-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Notices]
[Pages 42825-42826]
[FR Doc No: 2015-17684]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0128]

Prescription Drug User Fee Act; Stakeholder Consultation Meetings
on the Prescription Drug User Fee Act Reauthorization; Request for
Notification of Stakeholder Intention To Participate

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for notification of participation.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing
this notice to request that public stakeholders--including patient and
consumer advocacy groups, health care professionals, and scientific and
academic experts--notify FDA of their intent to participate in periodic
consultation meetings on the reauthorization of the Prescription Drug
User Fee Act (PDUFA). The statutory authority for PDUFA expires in
September 2017. At that time, new legislation will be required for FDA
to continue collecting user fees for the prescription drug program. The
Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA
consult with a range of stakeholders in developing recommendations for
the next PDUFA program. The FD&C Act also requires that FDA hold
discussions (at least every month) with patient and consumer advocacy
groups during FDA's negotiations with the regulated industry. The
purpose of this request for notification is to ensure continuity and
progress in these monthly discussions by establishing consistent
stakeholder representation.

DATES: Submit notification of intention to participate in these series
of meetings by August 28, 2015. Stakeholder meetings will be held
monthly. It is anticipated that they will commence in September or
October 2015.

ADDRESSES: Submit notification of intention to participate in monthly
stakeholder meetings by email to<EMAIL_ADDRESS>The
meetings will be held at the FDA campus, 10903 New Hampshire Ave.,
Silver Spring, MD 20993.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301-796-
5003, FAX:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is requesting that public stakeholders--including patient and
consumer advocacy groups, health care professionals, and scientific and
academic experts--notify the Agency of their intent to participate in
periodic stakeholder consultation meetings on the reauthorization of
PDUFA. PDUFA authorizes FDA to collect user fees from the regulated
industry for the process for the review of human drugs. The
authorization for the current program (PDUFA V) expires in September
2017. Without new legislation, FDA will no longer be able to collect
user fees for future fiscal years to fund the human drug review
process.
    Section 736B(d) of the FD&C Act (21 U.S.C. 379h-2(d)) requires that
FDA consult with a range of stakeholders, including representatives
from patient and consumer groups, health care professionals, and
scientific and academic experts, in developing recommendations for the
next PDUFA program. FDA will initiate the reauthorization process by
holding a public meeting on July 15, 2015, where stakeholders and other
members of the public will be given an opportunity to

present their views on the reauthorization. The FD&C Act further
requires that FDA continue meeting with these stakeholders at least
once every month during negotiations with the regulated industry to
continue discussions of stakeholder views on the reauthorization. It is
anticipated that these monthly stakeholder consultation meetings will
commence in September or October 2015.
    FDA is issuing this Federal Register notice to request that
stakeholder representatives from patient and consumer groups, health
care professional associations, as well as scientific and academic
experts, notify FDA of their intent to participate in the periodic
stakeholder consultation meetings on PDUFA reauthorization. FDA
believes that consistent stakeholder representation at these meetings
will be important to ensure progress in these discussions. If you wish
to participate in the stakeholder consultation meetings, please
designate one or more representatives from your organization who will
commit to attending these meetings and preparing for the discussions.
Stakeholders who identify themselves through this notice will be
included in all stakeholder consultation discussions while FDA
negotiates with the regulated industry. If a stakeholder decides to
participate in these monthly meetings at a later time, that stakeholder
may join the remaining monthly stakeholder consultation meetings after
notifying FDA of this intention (see ADDRESSES). These stakeholder
discussions will satisfy the consultation requirement in section
736B(d)(3) of the FD&C Act.

II. Notification of Intent To Participate in Periodic Stakeholder
Consultation Meetings

    If you intend to participate in continued periodic stakeholder
consultation meetings regarding PDUFA reauthorization, please provide
notification by email to<EMAIL_ADDRESS>by August 28,
2015. Your email should contain complete contact information, including
name, title, affiliation, address, email address, phone number, and
notice of any special accommodations required because of disability.
Stakeholders will receive confirmation and additional information about
the first meeting after FDA receives this notification.

    Dated: July 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17684 Filed 7-17-15; 8:45 am]
 BILLING CODE 4164-01-P