[Federal Register Volume 84, Number 187 (Thursday, September 26, 2019)]
[Rules and Regulations]
[Page 50760]
[FR Doc No: 2019-20424]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2019-0240; FRL-10000-01-Region 9]

Designation of Areas for Air Quality Planning Purposes:
California; Coachella Valley 8-Hour Ozone Nonattainment Area;
Reclassification to Extreme; Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; correction.

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SUMMARY: On July 10, 2019, the Environmental Protection Agency (EPA)
published in the Federal Register a rule entitled ``Designation of
Areas for Air Quality Planning Purposes; California; Coachella Valley
8-Hour Ozone Nonattainment Area; Reclassification to Extreme.'' That
publication inadvertently included the incorrect docket number for the
rule. This document corrects that error.

DATES: This document is effective on September 26, 2019.

FOR FURTHER INFORMATION CONTACT: Tom Kelly, Air Planning Office (AIR-
2), EPA Region IX,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On July 10, 2019 (84 FR 32841), the EPA
published a final rule entitled ``Designation of Areas for Air Quality
Planning Purposes; California; Coachella Valley 8-Hour Ozone
Nonattainment Area; Reclassification to Extreme'' that granted a
request from the State of California to reclassify the Coachella Valley
nonattainment area from ``Severe-15'' to ``Extreme'' for the 1997 ozone
national ambient air quality standards. That publication incorrectly
identified the docket number, which could make it difficult for members
of the public to locate documents related to the reclassification. This
document corrects the docket number in that rule.
    In FR Doc. 2019-14612, published July 10, 2019 (84 FR 32841), make
the following corrections:
    1. On page 32841, in the third column, correct the docket number
for ``Designation of Areas for Air Quality Planning Purposes;
California; Coachella Valley 8-Hour Ozone Nonattainment Area;
Reclassification to Extreme'' to read: ``[EPA-OAR-R09-2019-0240; FRL-
9996-12-Region 9]''
    2. On page 32842, in the first column, correct the first sentence
of the ADDRESSES caption to read:
    ``The EPA has established a docket for this action under Docket ID
No. EPA-R09-OAR-2019-0240''.

    Dated: September 6, 2019.
Deborah Jordan,
Acting Regional Administrator, Region IX.
[FR Doc. 2019-20424 Filed 9-25-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Rules and Regulations]
[Page 18234]
[FR Doc No: 2013-06864]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1005

[Docket No. FDA-2007-N-0091; (formerly 2007N-0104)]

Service of Process on Manufacturers; Manufacturers Importing
Electronic Products Into the United States; Agent Designation; Change
of Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending a final
rule that appeared in the Federal Register of April 9, 2007 (72 FR
17397 at 17401) to reflect changes to the Center for Devices and
Radiological Health's address. This action is editorial in nature and
is intended to improve the accuracy of the Agency's regulations.

DATES: This rule is effective March 26, 2013

FOR FURTHER INFORMATION CONTACT: Prince P. Kangoma, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 66, rm. G628B,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is making technical amendments in the
Agency's regulations under 21 CFR 1005.25(b) as a result of an office
relocation. The former address was 9200 Corporate Blvd., Rockville, MD
20850. The new address is 10903 New Hampshire Ave., Silver Spring, MD
20993-0002. Designation of agent by manufacturers of electronic
products offering such products for importation into the United States
must be addressed to the Center for Devices and Radiological Health,
Document Mail Center--WO66-G609. Publication of this document
constitutes final action of these changes under the Administrative
Procedures Act (5 U.S.C. 553). Notice and public procedures are
unnecessary because FDA is merely updating nonsubstantive content.

List of Subjects in 21 CFR Part 1005

    Administrative practice and procedure; Electronic product; Imports;
Radiation protection; Surety bonds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
1005 is amended as follows:

PART 1005--IMPORTATION OF ELECTRONIC PRODUCTS

0
1. The authority citation for 21 CFR part 1005 continues to read as
follows:

    Authority:  21 U.S.C. 360ii, 360mm.

Sec.  1005.25  [Amended]

0
2. Section 1005.25(b) is amended by removing ``Center for Devices and
Radiological Health (HFZ-240), 9200 Corporate Blvd., Rockville, MD
20850'' and by adding in its place ``Center for Devices and
Radiological Health, 10903 New Hampshire Ave., Document Mail Center--
WO66-G609, Silver Spring, MD 20993-0002''.

    Dated: March 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06864 Filed 3-25-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)]
[Notices]
[Pages 18912-18913]
[FR Doc No: 2017-08178]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]

Reducing the Risk of Preventable Adverse Drug Events Associated
With Hypoglycemia in the Older Population; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration's (FDA) Center for Drug
Evaluation and Research (CDER), Professional Affairs and Stakeholder
Engagement Staff (PASES), is announcing a 1-day public workshop
entitled ``Reducing the Risk of Preventable Adverse Drug Events
Associated with Hypoglycemia in the Older Population.'' The purpose of
this workshop is to discuss the importance of individualized glycemic
control targets for older patients with diabetes; to reduce the risk of
serious hypoglycemia; identify and discuss medication safety efforts,
both those that are part of the Safe Use Initiative and those external
to FDA, that are of direct relevance and importance to older patients
living with the disease; discuss future areas of research which could
be explored to reduce the risk of serious hypoglycemia in older
diabetic patients; and disseminate the results of this discussion to
inform patients, patient advocates, and health care practitioners.

DATES: The public workshop will be held on September 12, 2017, from 9
a.m. to 4 p.m.

ADDRESSES: The public workshop will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop
participants (non-FDA employees) is through Building 1, where routine
security check procedures will be performed. For parking and security
information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Scott Winiecki, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA CDER, PASES, is announcing a 1-day public workshop entitled
``Reducing the Risk of Preventable Adverse Drug Events associated with
Hypoglycemia in the Older Population.'' The purpose of this workshop is
to: (1) Discuss the importance of individualized glycemic control
targets for older patients with diabetes, in order to reduce the risk
of serious hypoglycemia; (2) identify and discuss medication safety
efforts, both those that are part of the Safe Use Initiative and those
external to FDA, that are of direct relevance and importance to older
patients living with the disease; (3) discuss future areas of research
which could be explored to reduce the risk of serious hypoglycemia in
older diabetic patients; and (4) disseminate the results of this
discussion to inform patients, patient advocates, and health care
practitioners.

II. Topics for Discussion at the Public Workshop

    The symposium will feature presentations on the scope of
hypoglycemia-related adverse drug events in the older population, the
risks and benefits of various degrees of glycemic control, factors
affecting patient centered care, research into effective diabetes
management, and the concept and translation of individualized glycemic
targets to minimize adverse events in practice settings. Presenters
will represent multidisciplinary backgrounds from government, academia,
patient safety groups, health care industry, and clinicians. There will
be opportunities for collaboration between speakers and attendees as
well as question and answer sessions.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the
following Web site: http://wcms.fda.gov/FDAgov/Drugs/NewsEvents/ucm538666.htm?SSContributor=true. Please provide complete contact
information for each attendee, including name, title, affiliation,
address, email, and telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by August 29, 2017, midnight Eastern Time. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization. If time
and space permit,

onsite registration on the day of the public workshop will be provided
beginning at 7:30 a.m.
    For those without Internet access, please contact Scott Winiecki,
(see FOR FURTHER INFORMATION CONTACT) to register. If you need special
accommodations due to a disability, please contact Scott Winiecki no
later than September 1, 2017.
    Transcripts: A transcript of the public workshop will be accessible
at https://www.regulations.gov approximately 30 days after the
workshop. It may also be viewed at the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

    Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08178 Filed 4-21-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: August 24, 2010 (Volume 75, Number 163)]
[Rules and Regulations]
[Page 51938-51940]
[DOCID:fr24au10-10]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2010-0234]
RIN 1625-AA09

Drawbridge Operation Regulation; Taunton River, Fall River and
Somerset, MA

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard has changed the drawbridge operation
regulations

that govern the operation of the Brightman Street (Rt-6) Bridge at mile
1.8, across the Taunton River between Fall River and Somerset,
Massachusetts. This final rule will help relieve the bridge owner from
the burden of crewing the bridge at times when there have been few
requests to open the bridge. In addition, we are also removing some
obsolete language from the regulations, the operation regulations for
the Bristol County Bridge at mile 10.3, because that bridge has
subsequently been replaced with a fixed highway bridge.

DATES: This rule is effective September 23, 2010.

ADDRESSES: Comments and related materials received from the public, as
well as documents mentioned in this preamble as being available in the
docket, are part of docket USCG-2010-0234 and are available online by
going to http://www.regulations.gov, inserting USCG-2010-0234 in the
``Keyword'' box, and then 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 Mr. John W. McDonald, Project Officer, First Coast Guard
District Bridge Branch,<PHONE_NUMBER><EMAIL_ADDRESS>If you
have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On June 8, 2010, we published a notice of proposed rulemaking
(NPRM) entitled Drawbridge Operation Regulations Taunton River in the
Federal Register (75 FR 32351). We received no comments on the proposed
rule. No public meeting was requested, and none was held.

Basis and Purpose

    The Brightman Street (Rt-6) Bridge at mile 1.8, across the Taunton
River between Fall River and Somerset, Massachusetts, has a vertical
clearance in the closed position of 27 feet at mean high water and 31
feet at mean low water. The drawbridge operation regulations are listed
at 33 CFR 117.619.
    The bridge is required under the existing regulations to open on
signal as follows:
    At all times from April 1 through May 31 and from September 1
through November 1.
    From June 1 through August 31, the draw need not open for pleasure
craft from 7 a.m. to 9:30 a.m. and 4 p.m. through 6:30 p.m., Monday
through Friday, except holidays. The draw is required to open on signal
for commercial vessels at any time during the June 1 through August 31
time period.
    From November 1 through March 31, the bridge is required to open on
signal 6 a.m. through 6 p.m. and from 6 p.m. through 6 a.m. the bridge
shall open after a one-hour advance notice is given.
    The owner of the bridge, Massachusetts Department of
Transportation, has been crewing the bridge in excess of the time
required in the existing regulations during the winter months, November
1 through March 31. They have been crewing the bridge from 5 a.m.
through 9 p.m. with a one-hour advance notice required from 9 p.m.
through 5 a.m. This allows the bridge owner to crew the bridge in two
eight-hour shifts rather than one eight-hour shift plus four hours of
overtime.
    The bridge owner has subsequently requested a change to the
regulations to allow them to crew the bridge year round from 5 a.m.
through 9 p.m., daily, with a one-hour advance notice from 9 p.m.
through 5 a.m.
    The bridge owner provided bridge logs which indicated few requests
to open the draw after 9 p.m. In addition, the NRG power plant (Montop
Electric) which formerly operated upstream from the bridge has closed
permanently which will eliminate most, if not all, commercial vessel
transits.
    The bridge opening logs for the past three years, 2007, 2008, and
2009, indicated few requests to open the bridge after 9 p.m. year round
for vessel traffic.
    There were 11 requests to open the bridge after 9 p.m. in 2009, 9
requests to open after 9 p.m. in 2008, and 14 requests to open after 9
p.m. in 2007.
    Under this proposed rule the bridge would open on signal year round
from 5 a.m. to 9 p.m. and between 9 p.m. and 5 a.m., after a one-hour
advance notice is given by calling the number posted at the bridge.
    The Coast Guard believes this proposed rule is reasonable, and if
implemented, should continue to meet the present and future needs of
navigation.

Discussion of Comments and Changes

    The Coast Guard received no comments in response to the notice of
proposed rulemaking. As a result, no changes have been made to this
final rule.

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. This conclusion is based upon the fact
that this final rule expands the time period the bridge is crewed in
the winter months and extends the winter schedule to year round based
on historic infrequent use between 9 p.m. and 5 a.m.

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 conclusion is based upon the fact that the vessel
operators that normally frequent this waterway will still be able to
obtain bridge openings after 9 p.m. by simply providing a one-hour
advance notice by calling the number posted at the bridge.

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.

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 (adjusted for
inflation) 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 cause 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 would not create an
environmental risk to health or risk to safety that might
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
guides the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
that 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 (32)(e), of the Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule.

List of Subjects in 33 CFR Part 117

    Bridges.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. Section 117.619 is revised to read as follows:

Sec.  117.619  Taunton River.

    (a) The Brightman Street (Route-6) Bridge at mile 1.8, between Fall
River and Somerset, shall operate as follows:
    (b) The draw shall open on signal between 5 a.m. and 9 p.m., daily.
From 9 p.m. through 5 a.m. the draw shall open on signal after at least
a one-hour advance notice is given by calling the number posted at the
bridge.
    (c) From June 1 through August 31, the draw need not open for the
passage of pleasure craft from 7 a.m. to 9:30 a.m. and from 4 p.m. to
6:30 p.m., Monday through Friday, except holidays. The draw shall open
for commercial vessels at all times.
    (d) From 6 p.m. on December 24 to midnight on December 25, and from
6 p.m. on December 31 to midnight on January 1, the draw shall open on
signal if at least a two-hour advance notice is given by calling the
number posted at the bridge.
    (e) The owner of the bridge shall provide and keep in good legible
condition clearance gauges located on both upstream and downstream
sides of the draw with figures not less than twelve inches in height,
designed, installed and maintained according to the provisions of Sec.
118.160 of this chapter.

    Dated: August 10, 2010.
Daniel A. Neptun,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2010-20922 Filed 8-23-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: December 10, 2008 (Volume 73, Number 238)]
[Notices]
[Page 75092-75094]
[DOCID:fr10de08-45]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0480 ; FRL-8379-5]

Agency Information Collection Activities; Proposed Renewal and
Consolidation of Several Currently Approved Collections; Comment
Request; Pesticide Registration Fees Program; EPA ICR No. 2330.01, OMB
Control No. 2070-new

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew and

consolidate several existing approved Information Collection Requests
(ICRs) to the Office of Management and Budget (OMB). Before submitting
the consolidated ICR to OMB for review and approval, EPA is soliciting
comments on specific aspects of this information collection. The
consolidated ICR, entitled: ``Pesticide Registration Fees Program'' and
identified by EPA ICR No. 2330.01 and OMB Control No. 2070-new, will
consolidate the following currently approved ICRs: ``Product
Registration Maintenance Fees'' (EPA ICR No. 1214.07, OMB Control No.
2070-0100) and ``Pesticide Registration Fee Waivers (PRIA)'' (EPA ICR
No. 2147.03, OMB Control No. 2070-0167).

DATES: Comments must be received on or before February 9, 2009.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0480, by one of the following methods:
     Federal Portal: http://www.regulations.gov. Follow the on-
line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2008-0480. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Rame Cromwell, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What Information is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits
comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What Should I Consider when I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the collection activity.
    7. Make sure to submit your comments by the deadline identified
under DATES.
    8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

III. What Do I Need to Know About PRA?

    An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information subject to PRA approval
unless it displays a currently valid OMB control number. The OMB
control numbers for EPA's regulations in title 40 of the Code of
Federal Regulations (CFR), after appearing in the preamble of the final
rule, are further displayed either by publication in the Federal
Register or by other appropriate means, such as on the related
collection instruments or form, if applicable. The display of OMB
control numbers for certain EPA regulations is consolidated in a list
at 40 CFR 9.1.
    PRA defines burden to mean the total time, effort, or financial
resources

expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements
which have subsequently changed; train personnel to be able to respond
to a collection of information; search data sources; complete and
review the collection of information; and transmit or otherwise
disclose the information.

IV. What ICR Does this Request Apply to?

    Title: Pesticide Registration Fees Program.
    ICR numbers: EPA ICR No. 2330.01, OMB Control No. 2070-new.
    ICR status: This ICR reflects the consolidation of the following
currently approved ICRs: ``Product Registration Maintenance Fees'' (EPA
ICR No. 1214.07, OMB Control No. 2070-0100; scheduled to expire on
November 30, 2010) and ``Pesticide Registration Fee Waivers (PRIA)''
(EPA ICR No. 2147.03, OMB Control No. 2070-0167; scheduled to expire on
October 31, 2010).
    Affected entities: Entities potentially affected by this ICR are
pesticide registrants holding currently active registrations under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3
and section 24(c), which are subject to this information collection
activity. These include pesticide companies and state governments,
which may be identified by pesticide and other agricultural chemical
manufacturing (North American Industrial Classification System (NAICS)
code 325320) and regulation of agricultural marketing and commodities
(NAICS code 9641).
    Abstract: The proposed consolidation information collection reports
the paperwork burden hours and costs for State initiated under either
Pesticide Registration Fee Waivers (PRIA) or Pesticide Product
Registration Maintenance Fee. PRIA authorizes EPA to process requests
for waivers of fees. The ICR covers the collection activities
associated with requesting a fee waiver and involves requesters
submitting a waiver request, information to demonstrate eligibility for
the waiver, and certification of eligibility. Waivers are available for
small businesses, for minor uses, and for actions solely associated
with the Inter-Regional Project Number 4 (IR-4). State and Federal
agencies are exempt from the payment of fees. Maintenance fees are
collected from pesticides registrants as required by law. Respondents
complete and submit EPA Form 8570-30 indicating the respondent's
liability for the registration maintenance fee. Annually the Agency
provides registrants a list of the registered products currently
registered with the Agency. Registrants are provided the opportunity to
review the list, determine its accuracy, and remit payment of
maintenance fee. The list of products has space identified for making
those products to be supported and those products that are to be
cancelled. The registrants are also instructed to identify any products
on the list which they believe to be transferred to another company and
to add to the list any products which the company believes to be
registered that are not the Agency-provided list. The failure to pay
the required fee for a product will result in cancellation of that
product's registration.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average a
combined 2,109 hours annually. The consolidated ICR, a copy of which is
available in the docket, provides a detailed explanation of this
estimate, which is only briefly summarized here:
    Estimated total number of potential respondents: 2,109.
    Frequency of response: Annual.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 10,013 hours.
    Estimated total annual costs: $647,703. This ICR does not involve
any capital investment or maintenance and operational costs.

V. Are There Changes in the Estimates from the Last Approvals?

    The consolidation of these ICRs will not result in a change of the
10,013 hours in the total estimated combined respondent burden that is
currently approved by OMB.

VI. What is the Next Step in the Process for this ICR?

    EPA will consider the comments received and amend the consolidated
ICR as appropriate. The final ICR package will then be submitted to OMB
for review and approval pursuant to 5 CFR 1320.12. EPA will issue
another Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to
announce the submission of the ICR to OMB and the opportunity for the
public to submit additional comments for OMB consideration.
    If you have any questions about this ICR or the approval process,
please contact the person listed under FOR FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: December 2, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E8-29219 Filed 12-9-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 83, Number 82 (Friday, April 27, 2018)]
[Notices]
[Pages 18623-18624]
[FR Doc No: 2018-08908]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2013-0124; FMCSA-2013-0125]

Qualification of Drivers; Exemption Applications; Hearing

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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

SUMMARY: FMCSA announces its decision to renew exemptions for 3
individuals from the hearing requirement in the Federal Motor Carrier
Safety Regulations (FMCSRs) for interstate commercial motor vehicle
(CMV) drivers. The exemptions enable these hard of hearing and deaf
individuals to continue to operate CMVs in interstate commerce.

DATES: The exemptions were applicable on March 27, 2018. The exemptions
expire on March 27, 2020. Comments must be received on or before May
29, 2018.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2013-0124; FMCSA-2013-0125
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
e.t., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number(s) for this notice. Note that all comments received will
be posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE,
Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments online.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these

comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
e.t., Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for five years if it finds ``such exemption would likely achieve a
level of safety that is equivalent to or greater than the level that
would be achieved absent such exemption.'' The statute also allows the
Agency to renew exemptions at the end of the five-year period. FMCSA
grants exemptions from the FMCSRs for a two-year period to align with
the maximum duration of a driver's medical certification.
    The physical qualification standard for drivers regarding hearing
found in 49 CFR 391.41(b)(11) states that a person is physically
qualified to driver a CMV if that person first perceives a forced
whispered voice in the better ear at not less than 5 feet with or
without the use of a hearing aid or, if tested by use of an audiometric
device, does not have an average hearing loss in the better ear greater
than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a
hearing aid when the audiometric device is calibrated to American
National Standard (formerly ASA Standard) Z24.5--1951.
    49 CFR 391.41(b)(11) was adopted in 1970, with a revision in 1971
to allow drivers to be qualified under this standard while wearing a
hearing aid, 35 FR 6458, 6463 (April 22, 1970) and 36 FR 12857 (July 3,
1971).
    The 3 individuals listed in this notice have requested renewal of
their exemptions from the hearing standard in 49 CFR 391.41(b)(11), in
accordance with FMCSA procedures. Accordingly, FMCSA has evaluated
these applications for renewal on their merits and decided to extend
each exemption for a renewable two-year period.

II. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

III. Basis for Renewing Exemptions

    In accordance with 49 U.S.C. 31136(e) and 31315, each of the 3
applicants has satisfied the renewal conditions for obtaining an
exemption from the hearing requirement. The 3 drivers in this notice
remain in good standing with the Agency. In addition, for Commercial
Driver's License (CDL) holders, the Commercial Driver's License
Information System (CDLIS) and the Motor Carrier Management Information
System (MCMIS) are searched for crash and violation data. For non-CDL
holders, the Agency reviews the driving records from the State Driver's
Licensing Agency (SDLA). These factors provide an adequate basis for
predicting each driver's ability to continue to safely operate a CMV in
interstate commerce. Therefore, FMCSA concludes that extending the
exemption for each of these drivers for a period of two years is likely
to achieve a level of safety equal to that existing without the
exemption.
    As of March 27, 2018, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 3 individuals have satisfied the renewal
conditions for obtaining an exemption from the hearing requirement in
the FMCSRs for interstate CMV drivers: Marquarius Boyd, (MS); Keith
Craig Drown, (ID); and James Gooch, (KS).
    The drivers were included in docket numbers FMCSA-2013-0124 and
FMCSA-2013-0125. Their exemptions are applicable as of March 27, 2018,
and will expire on March 27, 2020.

IV. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must report any crashes or accidents as defined in 49
CFR 390.5; and (2) report all citations and convictions for
disqualifying offenses under 49 CFR part 383 and 49 CFR 391 to FMCSA;
and (3) each driver prohibited from operating a motorcoach or bus with
passengers in interstate commerce. The driver must also have a copy of
the exemption when driving, for presentation to a duly authorized
Federal, State, or local enforcement official. In addition, the
exemption does not exempt the individual from meeting the applicable
CDL testing requirements. Each exemption will be valid for two years
unless rescinded earlier by FMCSA. The exemption will be rescinded if:
(1) The person fails to comply with the terms and conditions of the
exemption; (2) the exemption has resulted in a lower level of safety
than was maintained before it was granted; or (3) continuation of the
exemption would not be consistent with the goals and objectives of 49
U.S.C. 31136(e) and 31315.

V. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VI. Conclusion

    Based upon its evaluation of the 3 exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the hearing
requirement in 49 CFR 391.41 (b)(11). In accordance with 49 U.S.C.
31136(e) and 31315, each exemption will be valid for two years unless
revoked earlier by FMCSA.

    Issued on: April 23, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-08908 Filed 4-26-18; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)]
[Rules and Regulations]
[Pages 37540-37542]
[FR Doc No: 2015-16261]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2015-0450]
RIN 1625-AA11

Regulated Navigation Area; 4th of July, Biscayne Bay, Miami, FL

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a regulated navigation area on
Biscayne Bay in Miami, Florida, for multiple 4th of July fireworks
displays throughout the Miami area. This regulation is necessary to
protect the public from hazards associated with boating traffic
expected during 4th of July firework displays throughout the Miami
area. To ensure the public's safety, all vessels within the regulated
navigation area are: Required to transit the regulated navigation area
at no more than 15 knots; subject to control by the Coast Guard members
with law enforcement authority; and required to follow the instructions
of all law enforcement officials in the area.

DATES: This rule is effective from July 4 until July 5, 2015 and will
be enforced from 7 p.m. on July 4 until 2 a.m. on July 5, 2015.

ADDRESSES: Documents indicated in this preamble are part of docket
USCG-2015-0450. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in room W12-140 on the ground
floor of the Department of Transportation West Building, 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 email Petty Officer John Jennings, Sector Miami Prevention
Department, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Cheryl Collins, Program Manager, Docket Operations, telephone
(202) 366-9826.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
RNA Regulated Navigation Area

I. Regulatory History and Information

    The Coast Guard is issuing this 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 NPRM with respect to this temporary
rule because information was recently received regarding the location
of fireworks displays throughout the Miami area. As a result, it was
impracticable to issue this rule with opportunity to comment because
the Coast Guard did not receive notice of Fourth of July firework
displays in time to publish a NPRM.
    Historically, there is increased vessel traffic on the waters of
Biscayne Bay during Fourth of July fireworks displays in the Miami
area. Vessel congestion, especially where vessels cross navigational
channels to return to their home marinas at high rates of speed has
resulted in accidents that caused severe injury and death. This RNA is
necessary to better protect the public on this congested waterway.
Under these circumstances, it would be contrary to the public interest
in maintaining safety in Biscayne Bay to delay the effective date of
the temporary final rule.
    For the same reason discussed above, under 5 U.S.C. 553(d)(3), the
Coast Guard finds that good cause exists for making this rule effective
less than 30 days after publication in the Federal Register.

II. Basis and Purpose

    The legal basis for the rule is the Coast Guard's authority to
establish regulated navigation areas and other limited access areas: 33
U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Department of Homeland Security Delegation No. 0170.1.
    The purpose of the rule is to ensure the safe transit of vessels
and to protect persons, vessels, and the marine environment within the
regulated navigation area during 4th of July festivities.

III. Discussion of the Temporary Final Rule

    This temporary final rule will designate a regulated navigation
area encompassing all waters within one nautical mile of the center of
the Intracoastal Waterway to the east and 2\1/2\ nautical miles to the
west from Black Point extending 10 nautical miles north to the
Rickenbacker Causeway Bridge; then encompassing all navigable waters of
the Intracoastal Waterway between the Rickenbacker Causeway Bridge
north to the Julia Tuttle Causeway Bridge, Miami, Florida. The
regulated navigation area will be enforced from 7 p.m. July 4, 2015,
until 2 a.m. July 5, 2015.
    All vessels within the regulated navigation area are: (1) Required
to transit the area at no more than 15 knots; (2) subject to control by
the Coast Guard; and (3) required to follow the

instructions of all law enforcement officials in the area.
    The regulated navigation area is necessary to ensure the safety of
the public during a time of heightened vessel traffic in the
aforementioned areas. Each year numerous vessels congregate in the
waters of Biscayne Bay during launching of the 4th of July fireworks
displays. The close proximity and increased crossing situations of
numerous vessels within the regulated navigation area during 4th of
July poses a hazardous condition.
    The regulated navigation area will result in vessels transiting at
a reduced speed, thereby significantly reducing the threat of vessel
collisions. Requiring vessels within the regulated navigation area to
transit at no more than 15 knots will also enable law enforcement
officials to identify, respond to, query, and stop operators who may
pose a hazard to other vessels in the area. Nothing in this regulation
alleviates vessel operators from their duty to comply with all other
federal, state, and local laws in the area.

IV. Regulatory Analyses

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

A. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    The economic impact of this rule is not significant for the
following reasons: (1) the regulated navigation area will be enforced
for only seven hours; (2) the regulated navigation area does not
prohibit vessels from transiting the area; (3) vessels will still be
able operate in surrounding waters that are not encompassed within the
regulated navigation area without being subject to all the restrictions
imposed by the regulated navigation area; and (4) advance notification
of the regulated navigation area will be made to the local maritime
community via Local Notice to Mariners and Broadcast Notice to
Mariners.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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 may affect the following entities, some of which may be
small entities: the owners or operators of vessels intending to transit
the regulated navigation area from 7 p.m. July 4, 2015 until 2 a.m.
July 5, 2015. For the reasons discussed in the Regulatory Planning and
Review section above, this rule will not have a significant economic
impact on a substantial number of small entities.

C. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    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.

D. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

E. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on 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. We have analyzed this rule under that Order and have
determined that it does not have implications for federalism.

F. 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.

G. 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 (adjusted for
inflation) 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.

H. Taking of Private Property

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

I. 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.

J. 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.

K. 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.

L. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

M. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

N. 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 involves establishing a regulated navigation area to ensure
the safe transit of vessels and to protect persons, vessels, and the
marine environment within the regulated navigation area for the 4th of
July which will be enforced for seven hours. This rule is categorically
excluded, under figure 2-1, paragraph (34)(g), of the Instruction. An
environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this rule.

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. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Revise Sec.  165.779 to read as follows:

Sec.  165.779  Regulated Navigation Area; 4th of July, Biscayne Bay,
Miami, FL.

    (a) Regulated area. The regulated navigation area encompasses all
waters of Biscayne Bay between the Julia Tuttle Causeway Bridge and
Black Point contained within an imaginary line connecting the following
points: beginning at Point 1 in position 25[deg]48'38'' N.,
80[deg]10'40'' W.; thence east to Point 2 in position 25[deg]48'38''
N., 80[deg]10'30'' W.; thence southwest to Point 3 in position
25[deg]46'41'' N., 80[deg]10'54'' W.; thence southeast to Point 4 in
position 25[deg]46'17'' N., 80[deg]10'43'' W.; thence southwest to
Point 5 in position 25[deg]45'05'' N., 80[deg]10'50'' W.; thence
southeast to Point 6 in position 25[deg]44'47'' N., 80[deg]10'44'' W.;
thence southeast to Point 7 in position 25[deg]43'29'' N.,
80[deg]09'37'' W.; thence southwest to Point 8 in position
25[deg]42'39'' N., 80[deg]10'35'' W.; thence southwest to Point 9 in
position 25[deg]31'11'' N., 80[deg]13'06'' W.; thence northwest to
Point 10 in position 25[deg]31'31'' N., 80[deg]17'48'' W.; thence
northeast to Point 11 in position 25[deg]43'25'' N., 80[deg]13'17'' W.;
thence northeast to Point 12 in position 25[deg]43'59'' N.,
80[deg]12'04'' W.; thence northeast to Point 13 in position
25[deg]44'46'' N., 80[deg]11'23'' W.; thence northeast to Point 14 in
position 25[deg]46'10'' N., 80[deg]10'59'' W.; thence northwest to
Point 15 in position 25[deg]46'20'' N., 80[deg]11'04'' W.; thence
northeast to Point 16 in position 25[deg]46'44'' N., 80[deg]10'59'' W.;
thence northwest to Point 17 in position 25[deg]47'15'' N.,
80[deg]11'06'' W.; thence northeast to Point 18 in position
25[deg]47'24'' N., 80[deg]11'00'' W.; thence north to Point 19 in
position 25[deg]47'36'' N., 80[deg]11'00'' W.; thence back to origin.
All coordinates are North American Datum 1983.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the
Captain of the Port Miami in the enforcement of the regulated area.
    (c) Regulations. (1) All vessels within the regulated area are
required to transit at no more than 15 knots, are subject to control by
the Coast Guard, and must follow the instructions of designated
representatives.
    (2) At least 48 hours prior to the enforcement period, the Coast
Guard will provide notice of the regulated area via Local Notice to
Mariners and Broadcast Notice to Mariners. The Coast Guard will also
provide notice of the regulated area by on-scene designated
representatives.
    (d) Enforcement period. This rule will be enforced from 7 p.m. on
July 4, 2015 until 2 a.m. on July 5, 2015.

    Dated: June 22, 2015.
Scott A. Buschman,
Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard
District.
[FR Doc. 2015-16261 Filed 6-30-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: September 11, 2007 (Volume 72, Number 175)]
[Notices]
[Page 51812-51813]
[DOCID:fr11se07-53]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. DI07-12-000]

Ken Howard; Notice of Petition for Declaratory Order and
Soliciting Comments, Motions to Intervene, and Protests

September 4, 2007.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Petition for Declaratory Order.
    b. Docket No.: DI07-12-000.
    c. Date Filed: August 15, 2007.
    d. Applicant: Ken Howard.
    e. Name of Project: Keene Channel/Howard Micro-Hydro Project.
    f. Location: The Keene Channel/Howard Micro-Hydro Project is
located on an unnamed stream on Kupreanof Island, near Petersburg,
Alaska, affecting T. 6 S., R. 80 E., sec. 6, Copper River Meridian. The
project does not occupy any tribal or federal lands.
    g. Filed Pursuant to: Section 23(b)(1) of the Federal Power Act, 16
U.S.C. 817(b).
    h. Applicant Contact: Ken Howard, P.O. Box 2067, Petersburg,
Alaska, 99833; Telephone:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>
    i. FERC Contact: Any questions on this notice should be addressed
to Henry Ecton<PHONE_NUMBER>, or E-mail<EMAIL_ADDRESS>    j. Deadline for filing comments and/or motions: October 4, 2007.
    All documents (original and eight copies) should be filed with:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. Comments, protests, and interventions may be
filed electronically via the Internet in lieu of paper. Any questions,
please contact the Secretary's Office. See, 18 CFR 385.2001(a)(1)(iii)
and the instructions on the Commission's Web site at: http://www.ferc.gov
.

    Please include the docket number (DI07-12-000) on any protests,
comments and/or motions filed.

    k. Description of Project: The existing project consists of: (1) A
30-inch-long weir in the unnamed stream, forming a small reservoir; (2)
a 6-inch-diameter, 550-foot-long PVC pipe; (3) a 1-kW Stream Engine
turbine, connected to a battery bank through a Zantex 4848 inverter;
and (4) appurtenant facilities. The facility is not connected to an
interstate grid.
    When a Petition for Declaratory Order is filed with the Federal
Energy Regulatory Commission, the Federal Power Act requires the
Commission to investigate and determine if the interests of interstate
or foreign commerce would be affected by the project. The Commission
also determines whether or not the project: (1) Would be located on a
navigable waterway; (2) would occupy or affect public lands or
reservations of the United States; (3) would utilize surplus water or
water power from a government dam; or (4) if applicable, has involved
or would involve any construction subsequent to 1935 that may have
increased or would increase the project's head or generating capacity,
or have otherwise significantly modified the project's pre-1935 design
or operation.
    l. Locations of the application: Copies of this filing are on file
with the Commission and are available for public inspection. This
filing may be viewed on the web at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or TTY,

contact<PHONE_NUMBER>.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, and/or Motions to Intervene--Anyone may
submit comments, a protest, or a motion to intervene in accordance with
the requirements of Rules of Practice and Procedure, 18 CFR 385.210,
.211, .214. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``PROTESTS'', AND/
OR ``MOTIONS TO INTERVENE'', as applicable, and the Docket Number of
the particular application to which the filing refers. A copy of any
motion to intervene must also be served upon each representative of the
applicant specified in the particular application.
    p. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the applicant's representatives.

Kimberly D. Bose,
Secretary. 3 DI07-12-000
 [FR Doc. E7-17856 Filed 9-10-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 91 (Thursday, May 10, 2018)]
[Notices]
[Pages 21781-21782]
[FR Doc No: 2018-09931]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1415]

Framework for Assessment of Drug-Drug Interactions for
Therapeutic Proteins; Establishment of a Public Docket; Request for
Information and Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for
information and comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is
establishing a public docket to assist with its development of a
policy/guidance document on the assessment of drug-drug interactions
(DDIs) for therapeutic proteins (TPs). The Agency split the 2012 DDI
draft guidance into two draft guidance documents published in October
2017: ``In Vitro Metabolism- and Transporter-Mediated Drug-Drug
Interaction Studies'' and ``Clinical Drug Interaction Studies--Study
Design, Data Analysis, and Clinical Implications.'' The two guidance
documents focus on enzyme- and transporter-based DDIs and do not
include a discussion on TPs, which was originally included in the 2012
guidance. The Agency is currently revisiting the framework for
assessment of DDIs for TPs outlined in the draft 2012 DDI guidance to
offer timely and actionable information pertaining to DDIs for TPs and
is seeking public input to assist in updating or creating a new
framework.

DATES: Although you can comment at any time, to ensure that the Agency
considers your comment in our development of recommendations, submit
either electronic or written information and comments by July 9, 2018.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-1415 for ``Framework for Assessment of Drug-Drug
Interactions for Therapeutic Proteins.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    Regarding human prescription drugs: Julie Chronis, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3203, Silver Spring, MD 20993-0002, 301-
796-1200.
    Regarding human prescription biological products: Stephen Ripley,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Concurrent use of more than one prescription drug is common. A
Centers for Disease Control and Prevention survey reports that about 20
percent of U.S. adults take three or more prescription drugs; and among
adults age 65 and older, 40 percent take five or more medications.\1\
Taking more than one drug at a time can result in DDIs which can result
in toxicities or loss of efficacy. It is impractical to evaluate the
impact of every possible drug combination. Therefore, the FDA

follows a systematic risk-based approach for DDI assessment.
---------------------------------------------------------------------------

    \1\ Centers for Disease Control and Prevention's National Health
and Nutrition Examination Survey: https://www.cdc.gov/nchs/data/hus/hus16.pdf#079.
---------------------------------------------------------------------------

    Two draft guidance documents, when finalized, which are intended to
assist drug developers in the planning and evaluation of the DDI
potential of their drug during development were published in October
2017 entitled ``Clinical Drug Interaction Studies--Study Design, Data
Analysis, and Clinical Implications,'' and ``In Vitro Metabolism- and
Transporter-Mediated Drug-Drug Interaction Studies.'' \2\ These two
draft guidances replaced the 2012 draft guidance entitled ``Drug
Interaction Studies--Study Design, Data Analysis, Implications for
Dosing, and Labeling Recommendations.'' The 2017 draft guidance
documents focus on enzyme- and transporter-based DDIs; however, they do
not discuss TPs.
---------------------------------------------------------------------------

    \2\ ``Clinical Drug Interaction Studies--Study Design, Data
Analysis, and Clinical Implications'' can be found at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM292362.pdf; provide comments to this guidance using
docket number FDA-2017-D-596.
    ``In Vitro Metabolism- and Transporter-Mediated Drug-Drug
Interaction Studies'' can be found at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM581965.pdf; provide comments to this guidance using docket number
FDA-2017-D-5961.
---------------------------------------------------------------------------

    The 2012 guidance recommended DDI assessment for TPs in three
scenarios: (1) For cytokine or cytokine modulators, (2) for a known or
suspected mechanism of DDI not related to effects on Cytochrome P450
enzymes or transporters, and (3) for when a TP is used in combination
with another drug. The Agency now plans to revisit the previous
framework for the assessment of DDIs for TPs that was included in the
2012 draft guidance. We are seeking public input on the revision and
development of a framework to address DDIs for TPs with the goal of
publishing this framework in a short policy/guidance document.

II. Additional Issues for Consideration and Request for Information

    Interested persons are invited to provide detailed information and
comments on the approach to the DDI assessment of TPs. Please read the
information above regarding the submission of comments and confidential
information. FDA is particularly interested in responses to the
following overarching questions:
    1. In what scenarios/circumstances and for which classes of TPs
should DDI assessment be performed? Please provide rationale for your
suggestions including available data and scientific principles to
inform the considerations.
    2. For circumstances when DDI assessments are necessary:
    a. What types of assessments can be useful (e.g., in vitro studies,
dedicated clinical studies, population pharmacokinetic analyses,
physiologically based pharmacokinetic analyses)? Please discuss the
challenges and limitations with each type of assessment, and, as
necessary, organize any discussions by the class of TP.
    b. What are the study design considerations (e.g., population,
analytes) for the types of assessments discussed in bullet 2a. above?
Please describe the rationale for any design considerations proposed.
    FDA will consider all information and comments submitted.

    Dated: May 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09931 Filed 5-9-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 29 (Friday, February 11, 2011)]
[Notices]
[Pages 7891-7893]
[FR Doc No: 2011-3035]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63857; File No. SR-BATS-2011-004]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Related to
Fees for Use of BATS Exchange, Inc.

February 7, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on January 31, 2011, BATS Exchange, Inc. (the ``Exchange'' or
``BATS'') 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 Exchange. The
Exchange has designated the proposed rule change as one establishing or
changing a due, fee, or other charge imposed by the Exchange under
Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposed rule change effective upon
filing with the Commission. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    The Exchange proposes to modify its fee schedule applicable to
Members \5\ and non-members of the Exchange pursuant to BATS Rules
15.1(a) and (c). While changes to the fee schedule pursuant to this
proposal will be effective upon filing, the changes will become
operative on February 1, 2011.
---------------------------------------------------------------------------

    \5\ A Member is any registered broker or dealer that has been
admitted to membership in the Exchange.
---------------------------------------------------------------------------

    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to modify its fee schedule effective February
1, 2011, in order to: (i) Adjust fees for ``logical'' ports used for
order entry or receipt of Exchange data; and (ii) adjust the fees for
orders executed at other options exchanges through Exchange-offered
routing strategies in order to more closely reflect the Exchange's cost
of executing orders at such away markets.

(i) Fees for Logical Ports
    The Exchange proposes to raise the fee for each pair \6\ of logical
ports from $250 each month to $400 each month. A logical port is also
commonly referred to as a TCP/IP port, and represents a port
established by the Exchange within the Exchange's system for trading
and billing purposes. Each logical port established is specific to a
Member or non-member and grants that Member or non-member the ability
to operate a specific application, such as FIX order entry or PITCH
data receipt.
---------------------------------------------------------------------------

    \6\ Each pair of ports consists of one port at the Exchange's
primary data center and one port at the Exchange's secondary data
center.
---------------------------------------------------------------------------

    The proposed fee increase for each pair of logical ports is
designed to help offset increasing infrastructure costs associated with
the implementation of internally developed real-time latency monitoring
on all FIX order entry ports. The latency monitoring offered by the
Exchange beginning February 1, 2011 will be similar to that provided by
other exchanges through outside vendors, except that the Exchange does
not currently propose to charge any additional fees for latency
monitoring on FIX ports.
    As proposed, the change applies to Members that obtain ports for
direct access to the Exchange, Sponsored Participants \7\ sponsored by
Members to receive direct access to the Exchange, non-member service
bureaus that act as a conduit for orders entered by Exchange Members
that are their customers, and market data recipients. While the
proposal would represent an increase in the monthly fee assessed by the
Exchange for all logical ports (including logical ports unaffected by
the Exchange's offering of latency monitoring on FIX ports), the
Exchange's overall connectivity fees remain lower than those of its
primary competitors.
---------------------------------------------------------------------------

    \7\ A ``Sponsored Participant'' is as a firm that is sponsored
by a Member of the Exchange to access the Exchange and that meets
the criteria of Exchange Rule 11.3.
---------------------------------------------------------------------------

(ii) Routing Pricing
    The Exchange proposes to adjust its fees for options order routing.
Rather than continuing to subsidize its Members' routing strategies,
the Exchange proposes to adjust routing fees to more closely reflect
the Exchange's cost of executing those orders at away markets.
Specifically, the Exchange proposes to assess the following per
contract fees for Customer orders that are routed to the named away
exchange: $0.06 for all orders in non-``Make/Take'' issues,\8\ if
applicable, routed to NYSE Amex, NYSE Arca, the Boston Options
Exchange, the Chicago Board Options Exchange, the International
Securities Exchange, or NASDAQ OMX PHLX; $0.30 for all orders routed to
the Chicago Board Options Exchange 2, the International Securities
Exchange in Make/Take issues, or NASDAQ OMX PHLX in Make/Take issues;
and $0.50 for all orders routed to Nasdaq Options Market or NYSE Arca
in Make/Take issues. The Exchange also proposes to assess a routing fee
of $0.55 per contract for all Firm and Market Maker orders that are
routed to any away exchange pursuant to the order routing strategies
offered by the Exchange.
---------------------------------------------------------------------------

    \8\ As defined on the fee schedule, Make/Take pricing refers to
executions at the identified Exchange under which ``Post Liquidity''
or ``Maker'' rebates (``Make'') are credited by that exchange and
``Take Liquidity'' or ``Taker'' fees (``Take'') are charged by that
exchange.
---------------------------------------------------------------------------

    The Exchange believes that the proposed routing fees are
competitive, fair and reasonable, and non-discriminatory in that they
approximate the cost to the Exchange of executing routed orders at an
away market and are similar to those fees charged by other exchanges.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6 of the Act.\9\
Specifically, the Exchange believes that the proposed rule change is
consistent with Section 6(b)(4) of the Act,\10\ in that it provides for
the equitable allocation of reasonable dues, fees and other charges
among members and other persons using any facility or system which the
Exchange operates or controls.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    With respect to the increase in logical port fees, the Exchange
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 Exchange
believes that its fees are competitive with those charged by other
venues, and that its fees for connectivity are still less expensive
than its primary competitors. In addition, at the same time as the
Exchange is increasing its fee per logical port, the Exchange is making
available to its Members real-time latency monitoring without any
additional fee. Accordingly, the Exchange believes that the increase to
port fees will help the Exchange to continue to maintain and improve
its infrastructure, while also encouraging Exchange customers to
request and enable only the ports that are necessary for their
operations related to the Exchange.
    With respect to the increase in routing fees for BATS Options,
although routing options are available to all Members, Members are not
required to use the Exchange's routing services, but instead, the
Exchange's routing services are completely optional. Members can manage
their own routing to different options exchanges or can utilize a
myriad of other routing solutions that are available to market
participants. Finally, the Exchange believes that the proposed rates
are equitable in that they apply uniformly to all Members and non-
members.

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

    The Exchange does not believe that the proposed rule change imposes
any burden on competition.

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

    No written comments were solicited or received.

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

    Pursuant to Section 19(b)(3)(A)(ii) of the Act \11\ and Rule 19b-
4(f)(2) thereunder,\12\ the Exchange has designated this proposal as
establishing or changing a due, fee, or other charge applicable to the
Exchange's Members and non-members, which renders the proposed rule
change effective upon filing.\13\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \12\ 17 CFR 240.19b-4(f)(2).
    \13\ See Section 916 of the Dodd-Frank Wall Street Reform and
Consumer Protection Act of 2010, which amended paragraph (A) of
Section 19(b)(3) of the Act by inserting the phrase ``on any person,
whether or not the person is a member of the self-regulatory
organization'' after ``due, fee or other charge imposed by the self-
regulatory organization.'' As a result, all SRO rule proposals
establishing or changing dues, fees, or other charges are
immediately effective upon filing regardless of whether such dues,
fees, or other charges are imposed on members of the SRO, non-
members, or both.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the 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.

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BATS-2011-004 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-BATS-2011-004. This file
number should be included on the subject line if e-mail 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-BATS-2011-004 and should be
submitted on or before March 4, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-3035 Filed 2-10-11; 8:45 am]
BILLING CODE 8011-01-P