[Federal Register Volume 82, Number 116 (Monday, June 19, 2017)]
[Notices]
[Pages 27840-27841]
[FR Doc No: 2017-12601]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0345]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Data To Support Drug Product Communications as Used by
the Food and Drug Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on a generic clearance to collect information
to support communications used by FDA about drug products.

DATES: Submit either electronic or written comments on the collection
of information by August 18, 2017.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 18, 2017. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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-2014-N-0345 for ``Data to Support Drug Product Communications as
Used by the Food and Drug Administration.'' Received comments, those
filed in a timely manner (see ADDRESSES), 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Data To Support Drug Product Communications as Used by the Food and
Drug Administration; OMB Control Number 0910-0695--Extension

    Testing of messages in advance of a communication campaign provides
an important role in improving FDA communications. The methods to be
employed include individual indepth interviews, general public focus
group interviews, intercept interviews, self-administered surveys,
gatekeeper surveys, and professional clinician focus group interviews.
The qualitative methods to be used serve the narrowly defined need for
direct and informal opinion on a specific topic and have two major
purposes: To obtain information that is useful in formulating policies
and regulatory decisions and for developing variables and measures for
formulating the basic objectives of risk communication campaigns, and
to assess the potential effectiveness of messages and materials in
reaching and successfully communicating with their intended audiences.
    FDA will use these methods to test and help refine messages and
other communications but will generally conduct further research before
making important decisions. FDA will use this mechanism to test
messages about regulated drug products on a variety of subjects related
to consumer, patient, or health care professional perceptions and about
use of drug products and related materials, including but not limited
to, direct-to-consumer prescription drug promotion, physician labeling
of prescription drugs, medication guides, over-the-counter drug
labeling, emerging risk communications, patient labeling, online sale
of medical products, and consumer and professional education. Annually,
FDA projects about 45 communication studies using the variety of test
methods listed in this document.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
                                                 Number of     responses per   Total annual     Average burden per response (in hours)      Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interviews/Surveys..........................          19,822               1          19,822  0.24 (14 minutes).........................           4,757
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12601 Filed 6-16-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: June 12, 2009 (Volume 74, Number 112)]
[Rules and Regulations]
[Page 27913-27915]
[DOCID:fr12jn09-5]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0226; Directorate Identifier 2007-SW-35-AD;
Amendment 39-15930; AD 2009-12-07]
RIN 2120-AA64

Airworthiness Directives; Agusta S.p.A. Model A109E, A109S, A119,
and AW119MKII Helicopters

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for Agusta
S.p.A. (Agusta) Model A109E, A109S, A119, and AW119MKII helicopters.
This AD results from mandatory continuing airworthiness information
(MCAI) originated by an aviation authority of another country to
identify and correct an unsafe condition on an aviation product. The
European Aviation Safety Agency (EASA), the Technical Agent for the
aviation authority of Italy, with which we have a bilateral agreement,
has issued an MCAI AD which states that two cases of cracks on a
certain cargo hook lever (lever) have been reported by the manufacturer
of the cargo hook. This lever is a critical structural component of the
cargo hook, and a crack could result in inadvertent loss of the cargo
hook load. This AD requires actions that are intended to address the
unsafe condition caused by cracks in the cargo hook lever.

DATES: This AD becomes effective on July 17, 2009.
    The incorporation by reference of certain publications is approved
by the Director of the Federal Register as of July 17, 2009.

ADDRESSES: You may examine the AD docket on the Internet at http://
regulations.gov or in person at the Docket Operations office, U.S.
Department of Transportation, M-30, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC between 9 a.m. and
5 p.m. Monday through Friday, except Federal holidays.
    You may get the service information identified in this AD from
Agusta, Via Giovanni Agusta, 520 21017 Cascina Costa di Samarate (VA),
Italy, telephone 39 0331-229111, fax 39 0331-229605/222595, or at
http://customersupport.agusta.com/technical_advice.php.
    Examining the AD Docket: The AD docket contains the Notice of
proposed rulemaking (NPRM), the economic evaluation, any comments
received, and other information. The street address and operating hours
for the Docket Operations office (telephone<PHONE_NUMBER>) are in the
ADDRESSES section of this AD. Comments will be available in the AD
docket shortly after they are received.

FOR FURTHER INFORMATION CONTACT: John Strasburger, Aviation Safety
Engineer, FAA, Rotorcraft Directorate, Regulations and Policy Group,
2601 Meacham Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued an NPRM to amend 14 CFR part 39 to include an AD that
would apply to the Agusta Model A109E, A109S, A119, and AW119MKII
helicopters on March 4, 2009. That NPRM was published in the Federal
Register on March 23, 2009 (74 FR 12096). That NPRM proposed to require
actions that are intended to detect a crack in the cargo hook lever and
prevent the inadvertent loss of the cargo hook load. You may obtain
further information by examining the MCAI and any related service
information in the AD docket.

Comments

    By publishing the NPRM, we gave the public an opportunity to
participate in developing this AD. However, we received no comment on
the NPRM or on our determination of the cost to the public. Therefore,
based on our review and evaluation of the available data, we have
determined that air safety and the public interest require adopting the
AD as proposed.

Relevant Service Information

    Agusta has issued Alert Bollettino Tecnico (ABT) No. 109EP-78, ABT
No. 109S-12, and ABT No. 119-21, all dated June 6, 2007. The actions
described in the MCAI are intended to correct the same unsafe condition
as that identified in the service information.

Differences Between This AD and the MCAI

    We have reviewed the MCAI and, in general, agree with its
substance. However, we have made the following changes:
     Excluded the August 31, 2007 compliance date because that
date has passed;
     Excluded the Model A109LUH from the applicability and do
not reference Agusta ABT No. 109L-006 because the Model A109LUH
helicopter is not on the U.S. type certificate, H7EU;
     Added the Model AW119MKII to the applicability;
     Required the use of a 10-power or higher magnifying glass
to accomplish the visual inspections; and
     Excluded the kit installation part number (P/N), relying
instead on the cargo hook and lever P/N.
    These differences are highlighted in the ``Differences Between this
AD and the MCAI'' section in this AD.

Costs of Compliance

    We estimate that this AD will affect about 26 helicopters on the
U.S.

Registry with the cargo hook. We also estimate that it will take about
10 minutes to inspect each cargo hook for a crack, and about 1 work-
hour to replace a cracked cargo hook. The average labor rate is $80 per
work-hour. Required parts will cost about $3,677 per cargo hook. Based
on these figures, we estimate the cost of this AD on U.S. operators to
be $97,647 per year, assuming that each affected helicopter requires
five inspections per week, and that two cargo hooks are replaced each
year.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2009-12-07 Agusta S.p.A.: Amendment 39-15930; Docket No. FAA-2009-
0226; Directorate Identifier 2007-SW-35-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective on July
17, 2009.

Other Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Model A109E, A109S, A119, and AW119MKII
helicopters with cargo hook, part number (P/N) 528-010-01, and cargo
hook lever, P/N 232-028-00, installed, certificated in any category.

Reason

    (d) The mandatory continuing airworthiness information (MCAI)
states that two cases of cracks in the lever, P/N 232-028-00, have
been reported by the manufacturer of the cargo hook. The lever is a
component of the cargo hook, P/N 528-010-01. This lever is a
critical structural component of the cargo hook, and a crack could
result in inadvertent loss of the cargo hook load.

Actions and Compliance

    (e) Before each cargo hook operation, visually inspect the cargo
hook lever, P/N 232-028-00, for any crack. Use a 10-power or higher
magnifying glass and inspect in the area depicted in Figures 1 and 2
of the following Agusta Alert Bollettino Tecnico (ABT), all dated
June 6, 2007:
    (1) ABT No. 109EP-78 for Model A109E helicopters;
    (2) ABT No. 109S-12 for Model A109S helicopters; or
    (3) ABT No. 119-21 for Model A119 helicopters.
    (f) If a crack is found in the lever, do not use the cargo hook
until the entire cargo hook is replaced with an airworthy cargo hook
with an uncracked lever.

Differences Between This AD and the MCAI

    (g) This AD differs from the MCAI AD in that we:
    (1) Exclude the August 31, 2007 compliance date because that
date has passed;
    (2) Exclude the Model A109LUH from the applicability and do not
reference Agusta ABT No. 109L-006 because the Model A109LUH
helicopter is not on the U.S. type certificate, H7EU;
    (3) Add the Model AW119MKII to the applicability;
    (4) Require the use of a 10-power or higher magnifying glass to
accomplish the visual inspections; and
    (5) Exclude the kit installation P/N, relying instead on the
cargo hook and lever P/N.

Other Information

    (h) Alternative Methods of Compliance (AMOCs): The Manager,
Safety Management Group, FAA, has the authority to approve AMOCs for
this AD, if requested using the procedures found in 14 CFR 39.19.
Send information to ATTN: John Strasburger, Aviation Safety
Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA,
2601 Meacham Blvd., Fort Worth, TX 76137; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

Related Information

    (i) EASA Emergency AD No. 2007-0160-E, dated June 7, 2007,
contains related information.

Air Transport Association of America (ATA) Tracking Code

    (j) Air Transport Association of America (ATA) Code 2550: Cargo
Compartments.

Material Incorporated by Reference

    (k) You must use the specified portions of the service
information identified in Table 1 to do the actions required.
    (1) The Director of the Federal Register approved the
incorporation by reference of the service information identified in
Table 1 under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Agusta, Via Giovanni Agusta, 520 21017 Cascina Costa di Samarate
(VA), Italy, telephone 39 0331-229111, fax 39 0331-229605/222595, or
at http://customersupport.agusta.com/technical_advice.php.
    (3) You may review copies at the FAA, Office of the Regional
Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas; or at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/
federal-register/cfr/ibr-locations.html.

                                   Table 1--Material Incorporated by Reference
----------------------------------------------------------------------------------------------------------------
     Agusta Alert Bollettino Tecnico                    Date                        For helicopter model
----------------------------------------------------------------------------------------------------------------
No. 109EP-78............................  June 6, 2007...................  A109E

No. 109S-12.............................  June 6, 2007...................  A109S
No. 119-21..............................  June 6, 2007...................  A119
----------------------------------------------------------------------------------------------------------------

    Issued in Fort Worth, Texas on May 21, 2009.
Mark R. Schilling,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. E9-13566 Filed 6-11-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Proposed Rules]
[Pages 41021-41022]
[FR Doc No: 2018-17767]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2018-0769; Airspace Docket No. 18-ASW-10]
RIN 2120-AA66

Proposed Amendment of VOR Federal Airways V-18, V-102, and V-278
in the Vicinity of Guthrie, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend VHF Omnidirectional Range (VOR)
Federal airways V-18, V-102, and V-278 in the vicinity of Guthrie, TX.
The modifications are necessary due to the planned decommissioning of
the Guthrie, TX, VOR/Tactical Air Navigation (VORTAC) navigation aid
(NAVAID), which provides navigation guidance for portions of the
affected air traffic service (ATS) routes. The Guthrie VORTAC is being
decommissioned as part of the FAA's VOR Minimum Operational Network
(MON) program.

DATES: Comments must be received on or before October 1, 2018.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2018-0769; Airspace Docket No. 18-ASW-10 at the beginning of your
comments. You may also submit comments through the internet at http://www.regulations.gov.
    FAA Order 7400.11B, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11B at NARA, call<PHONE_NUMBER>, or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace Policy Group,
Office of Airspace Services, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

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

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2018-0769; Airspace Docket No. 18-ASW-10) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2018-0769; Airspace Docket No. 18-ASW-10.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

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

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace
Designations and Reporting Points, dated August 3, 2017, and effective
September 15, 2017. FAA Order

7400.11B is publicly available as listed in the ADDRESSES section of
this document. FAA Order 7400.11B lists Class A, B, C, D, and E
airspace areas, air traffic service routes, and reporting points.

Background

    The FAA is planning decommissioning activities for the Guthrie, TX,
VORTAC in 2019 as one of the candidate VORs identified for
discontinuance by the FAA's VOR MON program and listed in the final
policy statement notice, ``Provision of Navigation Services for the
Next Generation Air Transportation System (NextGen) Transition to
Performance-Based Navigation (PBN) (Plan for Establishing a VOR Minimum
Operational Network),'' published in the Federal Register of July 26,
2016 (81 FR 48694), Docket No. FAA-2011-1082. Although the VOR portion
of the Guthrie, TX, VORTAC NAVAID is planned for decommissioning, the
Distance Measuring Equipment (DME) portion is being retained. The ATS
routes effected by the Guthrie VORTAC are VOR Federal airways V-18, V-
102, and V-278.
    With the planned decommissioning of the Guthrie VORTAC, the
remaining ground-based NAVAID coverage in the area is insufficient to
enable the continuity of the affected airways. As such, proposed
modifications to V-18, V-102, and V-278 would result in gaps in the
route structures. To overcome the gaps, instrument flight rules (IFR)
traffic could use adjacent VOR Federal airways V-14 and V-114 between
the Lubbock, TX, VORTAC and Wichita Falls, TX, VORTAC; Federal airways
V-14, V-114, and V-355 between the Lubbock, TX, VORTAC and Bowie, TX,
VORTAC; or Federal airways V-62 and V-66 between the Lubbock, TX,
VORTAC and Millsap, TX, VORTAC to circumnavigate the affected area.
Additionally, IFR traffic could file point to point through the
affected area using fixes that will remain in place, or receive air
traffic control (ATC) radar vectors through the area. Visual flight
rules pilots who elect to navigate via the airways through the affected
area could also take advantage of the adjacent VOR Federal airways or
ATC services listed previously.

The Proposal

    The FAA is proposing an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 by modifying VOR Federal airways V-18, V-
102, and V-278. The planned decommissioning of the Guthrie, TX, VORTAC
has made these actions necessary. The proposed VOR Federal airway
changes are outlined below.
    V-18: V-18 currently extends between the Guthrie, TX, VORTAC and
the Charleston, SC, VORTAC. The FAA proposes to remove the airway
segment between the Guthrie, TX, VORTAC and the Millsap, TX, VORTAC.
The unaffected portions of the existing airway would remain as charted.
    V-102: V-102 currently extends between the Salt Flat, TX, VORTAC
and the Wichita Falls, TX, VORTAC. The FAA proposes to remove the
airway segment between the Lubbock, TX, VORTAC and the Wichita Falls,
TX, VORTAC. The unaffected portions of the existing airway would remain
as charted.
    V-278: V-278 currently extends between the Texico, NM, VORTAC and
the Vulcan, AL, VORTAC. The FAA proposes to remove the airway segment
between the Plainview, TX, VOR/DME and the Bowie, TX, VORTAC. The
unaffected portions of the existing airway would remain as charted.
    VOR Federal airways are published in paragraph 6010(a) of FAA Order
7400.11B dated August 3, 2017, and effective September 15, 2017, which
is incorporated by reference in 14 CFR 71.1. The VOR Federal airways
listed in this document would be subsequently published in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

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

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B,
Airspace Designations and Reporting Points, dated August 3, 2017 and
effective September 15, 2017, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways.

* * * * *

V-18 [Amended]

    From Millsap, TX; Glen Rose, TX; Cedar Creek, TX; Quitman, TX;
Belcher, LA; Monroe, LA; Magnolia, MS; Meridian, MS; Crimson, AL;
Vulcan, AL; Talladega, AL; Atlanta, GA; Colliers, SC; to Charleston,
SC.
* * * * *

V-102 [Amended]

    From Salt Flat, TX; Carlsbad, NM; Hobbs, NM; to Lubbock, TX.
* * * * *

V-278 [Amended]

    From Texico, NM; to Plainview, TX. From Bowie, TX; Bonham, TX;
Paris, TX; Texarkana, AR; Monticello, AR; Greenville, MS; Sidon, MS;
Bigbee, MS; to Vulcan, AL.

    Issued in Washington, DC, on August 13, 2018.
Rodger A. Dean Jr.,
Manager, Airspace Policy Group.
[FR Doc. 2018-17767 Filed 8-16-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: May 12, 2009 (Volume 74, Number 90)]
[Rules and Regulations]
[Page 22095-22100]
[DOCID:fr12my09-6]

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

Coast Guard

33 CFR Part 100

[Docket No. USCG-2009-0106]
RIN 1625-AA08

Special Local Regulation for Marine Events; Temporary Change of
Dates for Recurring Marine Events in the Fifth Coast Guard District

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is temporarily changing the enforcement period
of special local regulations for recurring marine events in the Fifth
Coast Guard District. These regulations apply to only five recurring
marine events that conduct on-water activities such as power boat
races, swimming competitions, and harbor celebrations. Special local
regulations are necessary to provide for the safety of life on
navigable waters during the events. This action is intended to restrict
vessel traffic in portions of the Chester River, MD; Rappahannock
River, VA; Elizabeth River, Southern Branch, VA; North Atlantic Ocean,
Ocean City, MD; and Pasquotank, River, Elizabeth, NC during each event.

DATES: Effective May 15, 2009, through July 12, 2009.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2009-0106 and are available online by going to
http://www.regulations.gov, selecting the Advanced Docket Search option
on the right side of the screen, inserting USCG-2009-0106 in the Docket
ID box, pressing Enter, and then clicking on the item in the Docket ID
column. 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
temporary rule, call Dennis Sens, Project Manager, Fifth Coast Guard
District, Prevention Division, at<PHONE_NUMBER> or e-mail at
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On March 25, 2009, we published a notice of proposed rulemaking
(NPRM) entitled Special Local Regulation for Marine Events; Temporary
Change of Dates for Recurring Marine Events in the Fifth Coast Guard
District in the Federal Register (74 FR 12769). We received no comments
on the proposed rule. No public meeting was requested, and none was
held.
    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. The necessary information
regarding change of dates for these

annual recurring marine events were not provided to the Coast Guard in
sufficient time. The potential dangers posed by high speed power boat
races conducted on the waterways with other vessel traffic makes
special local regulations necessary. Delaying the effective date would
be contrary to the public interest, since immediate action is needed to
ensure the safety of the event participants, support vessels, spectator
craft and other vessels transiting the event area. However, advance
notifications will be made to users of the affected waterways via
marine information broadcasts, local notice to mariners, commercial
radio stations and area newspapers.

Background and Purpose

    Marine events are frequently held on the navigable waters within
the boundary of the Fifth Coast Guard District. The on-water activities
that typically comprise marine events include sailing regattas, power
boat races, swim races and holiday parades. For a description of the
geographical area of each Coast Guard Sector Marine Inspection Zone and
Captain of the Port Zone, please see 33 CFR 3.25.
    This regulation proposes to temporarily change the enforcement
period of special local regulations for recurring marine events within
the Fifth Coast Guard District. This proposed regulation applies to
five marine events in 33 CFR 100.501, Table to Sec.  100.501.
    Annually, the District of Columbia Aquatics Club sponsors the
``Maryland Swim for Life'', on the waters of the Chester River near
Chestertown, MD. The regulation at 33 CFR 100.501 is effective annually
for the Maryland Swim for Life marine event. The event is an open water
swimming competition held on the waters of the Chester River, near
Chestertown, Maryland. Approximately 150 swimmers will start from
Rolph's Wharf and swim up-river 2.5 miles then swim down-river
returning back to Rolph's Wharf. A large fleet of support vessels
accompanies the swimmers. Therefore, to ensure the safety of
participants and support vessels, 33 CFR 100.501 would be enforced for
the duration of the event. This temporary final rule changes the period
of enforcement for this event from the third Saturday in June or July
to 5:30 a.m. until 2:30 p.m. on July 11, 2009. During that period,
vessels may not enter the regulated area unless they receive permission
from the Coast Guard Patrol Commander. Vessel traffic may be allowed to
transit the regulated area only when the Patrol Commander determines it
is safe to do so.
    On June 6, 2009, the Rappahannock River Boaters Association (RRBA)
will sponsor the ``2009 RRBA Spring Radar Shootout'', on the waters of
the Rappahannock River near Layton, Virginia. The regulation at 33 CFR
100.501 is effective annually for this river boat race marine event.
The event consists of approximately 35 powerboats participating in
high-speed competitive races, traveling along a 3-mile straight line
race course. Participating boats race individually within the
designated course. A fleet of spectator vessels is anticipated to
gather nearby to view the competition. Due to the need for vessel
control during the event, vessel traffic will be temporarily restricted
to provide for the safety of participants, spectators and transiting
vessels. The regulation at 33 CFR 100.501 would be enforced for the
duration of the event. This temporary final rule changes the period of
enforcement for this event from the last Saturday in June to 12 p.m.
until 5 p.m. on June 6, 2009, or rain date June 7, 2009. During that
period, vessels may not enter the regulated area unless they receive
permission from the Coast Guard Patrol Commander.
    Norfolk Festevents Ltd., Norfolk, VA, sponsors the annual ``Norfolk
Harborfest Celebration'', on the waters of the Elizabeth River between
Norfolk and Portsmouth, VA. The regulation at 33 CFR 100.501 is
effective annually for Norfolk Harborfest marine event. This annual
celebration of Norfolk Harbor consists of a variety of on the water
activities that include an Opening Ceremony--Parade of Sail; jet ski,
water ski, wake board demonstrations; Fire boat demonstrations; Lazy
Lizzie Anything That Floats Parade and Race; Dinghy Parade; Search and
Rescue demonstrations by USCG & USN; and Quick and Dirty Boat Race.
Evening fireworks displays will be fired from barges on the Elizabeth
River as part of the Harborfest celebration. A large fleet of spectator
vessels is anticipated to view the Harborfest activities. Therefore, to
ensure the safety of participants, spectators and transiting vessels,
33 CFR 100.501 would be enforced for the duration of the event. This
temporary final rule changes the period of enforcement for this event
from the first Friday, Saturday and Sunday in June to 9 a.m. on July 3,
2009 until 11 p.m. on July 5, 2009. During that period, vessels may not
enter the regulated area unless they receive permission from the Coast
Guard Patrol Commander. Vessel traffic will be allowed to transit the
regulated area between the water events, when the Patrol Commander
determines it is safe to do so.
    The Offshore Performance Association (OPA) Racing LLC annually
sponsors the ``Offshore Grand Prix'', on the waters of the North
Atlantic Ocean near Ocean City, MD. The regulation at 33 CFR 100.501 is
effective annually for the Ocean City offshore race marine event. The
event is conducted on the waters of the North Atlantic Ocean along the
shoreline near Ocean City, MD. The event consists of approximately 50
V-hull and twin-hull inboard hydroplanes racing in heats counter-
clockwise around an oval race course. A fleet of spectator vessels is
anticipated to gather nearby to view the competition. Therefore, to
ensure the safety of participants, spectators and transiting vessels,
33 CFR 100.501 would be enforced for the duration of the event. This
temporary final rule changes the period of enforcement for this event
from the first Friday and Saturday in June to 10 a.m. on May 30, 2009
until 5 p.m. on May 31, 2009. During that period, vessels may not enter
the regulated area unless they receive permission from the Coast Guard
Patrol Commander. Due to the need for vessel control during the event,
vessel traffic will be temporarily restricted to provide for the safety
of participants, spectators and transiting vessels.
    The Carolina Cup Regatta, Inc. annually sponsors a power boat race
on the waters of the Pasquotank River near Elizabeth City, NC. The
regulation at 33 CFR 100.501 is effective annually for this power boat
race marine event. The event consists of approximately 25 inboard
hydroplanes racing in counter clockwise heats around an oval race
course. A fleet of spectator vessels is anticipated to gather nearby to
view the competition. Therefore, to ensure the safety of participants,
spectators and transiting vessels, 33 CFR 100.501 will be enforced for
the duration of the event. This temporary final rule changes the period
of enforcement for this event from the second Saturday and Sunday in
June to 9 a.m. on May 16, 2009 until 5 p.m. on May 17, 2009. During
that period, vessels may not enter the regulated area unless they
receive permission from the Coast Guard Patrol Commander. Due to the
need for vessel control during the event, vessel traffic will be
temporarily restricted to provide for the safety of participants,
spectators and transiting vessels.

Discussion of Comments and Changes

    The Coast Guard did not receive comments in response to the notice
of proposed rulemaking (NPRM) published

in the Federal Register. Accordingly, the Coast Guard is establishing
temporary special local regulations on specified waters of the Chester
River, Rappahannock River, Elizabeth River, Pasquotank River and North
Atlantic Ocean.

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.
    Although this rule prevents traffic from transiting a portion of
certain waterways during specified events, the effect of this
regulation will not be significant due to the limited duration that the
regulated area will be in effect and the extensive advance
notifications that will be made to the maritime community via marine
information broadcasts, local radio stations and area newspapers so
mariners can adjust their plans accordingly. Additionally, this
rulemaking does not change the permanent regulated areas that have been
published in 33 CFR 100.501, Table to Sec.  100.501. In some cases,
vessel traffic may be able to transit the regulated area when the Coast
Guard Patrol Commander deems it is safe to do so.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule would affect the following entities, some of which
might be small entities: The owners or operators of vessels intending
to transit or anchor in the areas where marine events are being held.
This regulation will not have a significant impact on a substantial
number of small entities because it will be enforced only during marine
events that have been permitted by the Coast Guard Captain of the Port.
The Captain of the Port will ensure that small entities are able to
operate in the areas where events are occurring when it is safe to do
so. In some cases, vessels will be able to safely transit around the
regulated area at various times, and, with the permission of the Patrol
Commander, vessels may transit through the regulated area. Before the
enforcement period, the Coast Guard will issue maritime advisories so
mariners can adjust their plans accordingly.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

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

Federalism

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

Unfunded Mandates Reform Act

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

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

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

Indian Tribal Governments

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

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a 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 0023.1 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(h), of the Instruction. This rule involves implementation of
regulations within 33 CFR Part 100 that apply to organized marine
events on the navigable waters of the United States that may have
potential for negative impact on the safety or other interest of
waterway users and shore side activities in the event area. The
category of water activities includes but is not limited to sail boat
regattas, boat parades, power boat racing, swimming events, crew
racing, and sail board racing.
    Under figure 2-1, paragraph (34)(h), 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 100

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

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  33 U.S.C. 1233.

0
2. In Sec.  100.501, amend Table to Sec.  100.501, as follows:
0
a. Suspend line numbers 21, 37, 38, 40, and 54 from May 15, 2009
through July 12, 2009.
0
b. Add temporary line numbers 58, 59, 60, 61, and 62, from May 15, 2009
through July 12, 2009 to the end of the table to read as follows:

Sec.  100.501   Special Local Regulations; Marine Events in the Fifth
Coast Guard District.

     Table to Sec.   100.501--All Coordinates Listed in the Table to Sec.   100.501 Reference Datum NAD 1983
----------------------------------------------------------------------------------------------------------------
     Number              Date                  Event                Sponsor                   Location
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                     Coast Guard Sector Baltimore--COTP Zone
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
58.............  5:30 a.m. to 2:30     Maryland Swim for     District of Columbia  The waters of the Chester
                  p.m. July 11, 2009.   Life.                 Aquatics Club.        River from shoreline to
                                                                                shoreline, bounded on the
                                                                                south by a line drawn at
                                                                                latitude 39[deg]10'16'' N,
                                                                                near the Chester River
                                                                                Channel Buoy 35 (LLN-26795)
                                                                                and bounded on the north at
                                                                                latitude 39[deg]12'30'' N by
                                                                                the Maryland S.R. 213
                                                                                Highway Bridge.
----------------------------------------------------------------------------------------------------------------
                                   Coast Guard Sector Hampton Roads--COTP Zone
----------------------------------------------------------------------------------------------------------------
59.............  12 p.m. to 5 p.m.     RRBA Spring Radar     Rappahannock River    The waters of the
                  June 6, 2009; rain    Shootout.             Boaters Association   Rappahannock River, adjacent
                  date: June 7, 2009.                         (RRBA).               to Layton, VA, from
                                                                                shoreline to shoreline,
                                                                                bounded on the west by a
                                                                                line running along longitude
                                                                                076[deg]58'30'' W, and
                                                                                bounded on the east by a
                                                                                line running along longitude
                                                                                076[deg]56'00'' W.

60.............  9 a.m. July 3, 2009   Norfolk Harborfest..  Norfolk Festevents,   The waters of the Elizabeth
                  to 11 p.m. July 5,                          Ltd.                  River and its branches from
                  2009.                                                             shore to shore, bounded to
                                                                                the northwest by a line
                                                                                drawn across the Port
                                                                                Norfolk Reach section of the
                                                                                Elizabeth River between the
                                                                                northern corner of the
                                                                                landing at Hospital Point,
                                                                                Portsmouth, Virginia,
                                                                                latitude 36[deg]50'51.0'' N,
                                                                                longitude 076[deg]18'09.0''
                                                                                W and the north corner of
                                                                                the City of Norfolk Mooring
                                                                                Pier at the foot of Brooks
                                                                                Avenue located at latitude
                                                                                36[deg]51'00.0'' N,
                                                                                longitude 076[deg]17'52.0'';
                                                                                W; bounded on the southwest
                                                                                by a line drawn from the
                                                                                southern corner of the
                                                                                landing at Hospital Point,
                                                                                Portsmouth, Virginia, at
                                                                                latitude 36[deg]50'50.0'' N,
                                                                                longitude 076[deg]18'10.0''
                                                                                W, to the northern end of
                                                                                the eastern most pier at the
                                                                                Tidewater Yacht Agency
                                                                                Marina, located at latitude
                                                                                36[deg]50'29.0'' N,
                                                                                longitude 076[deg]17'52.0''
                                                                                W; bounded to the south by a
                                                                                line drawn across the Lower
                                                                                Reach of the Southern Branch
                                                                                of the Elizabeth River,
                                                                                between the Portsmouth
                                                                                Lightship Museum located at
                                                                                the foot of London
                                                                                Boulevard, in Portsmouth,
                                                                                Virginia at latitude
                                                                                36[deg]50'10.0'' N,
                                                                                longitude 076[deg]17'47.0''
                                                                                W, and the northwest corner
                                                                                of the Norfolk Shipbuilding
                                                                                & Drydock, Berkley Plant,
                                                                                Pier No. 1, located at
                                                                                latitude 36[deg]50'08.0'' N,
                                                                                longitude 076[deg]17'39.0''
                                                                                W; and to the southeast by
                                                                                the Berkley Bridge which
                                                                                crosses the Eastern Branch
                                                                                of the Elizabeth River
                                                                                between Berkley at latitude
                                                                                36[deg]50'21.5'' N,
                                                                                longitude 076[deg]17'14.5''
                                                                                W, and Norfolk at latitude
                                                                                36[deg]50'35.0'' N,
                                                                                longitude 076[deg]17'10.0''
                                                                                W.
61.............  10 a.m. May 30, 2009  Ocean City Maryland   Offshore Performance  The waters of the Atlantic
                  to 5 p.m. May 31,     Offshore Grand Prix.  Association, OPA      Ocean commencing at a point
                  2009.                                       Racing, LLC.          on the shoreline at latitude
                                                                                38[deg]25'42'' N, longitude
                                                                                075[deg]03'06'' W; thence
                                                                                east southeast to latitude
                                                                                38[deg]25'30'' N, longitude
                                                                                075[deg]02'12'' W, thence
                                                                                south southwest parallel to
                                                                                the Ocean City shoreline to
                                                                                latitude 38[deg]19'12'' N,
                                                                                longitude 075[deg]03'48'' W;
                                                                                thence west northwest to the
                                                                                shoreline at latitude
                                                                                38[deg]19'30'' N, longitude
                                                                                075[deg]05'00'' W. The
                                                                                waters of the Atlantic Ocean
                                                                                bounded by a line drawn from
                                                                                a position along the
                                                                                shoreline near Ocean City,
                                                                                MD at latitude
                                                                                38[deg]22'25.2'' N,
                                                                                longitude 075[deg]03'49.4''
                                                                                W, thence easterly to
                                                                                latitude 38[deg]22'00.4'' N,
                                                                                longitude 075[deg]02'34.8''
                                                                                W, thence southwesterly to
                                                                                latitude 38[deg]19'35.9'' N,
                                                                                longitude 075[deg]03'35.4''
                                                                                W, thence westerly to a
                                                                                position near the shoreline
                                                                                at latitude 38[deg]20'05''
                                                                                N, longitude
                                                                                075[deg]04'48.4'' W, thence
                                                                                northerly along the
                                                                                shoreline to the point of
                                                                                origin.
----------------------------------------------------------------------------------------------------------------
                                  Coast Guard Sector North Carolina--COTP Zone
----------------------------------------------------------------------------------------------------------------
62.............  9 a.m. May 16, 2009   Carolina Cup Regatta  The Carolina Cup      The waters of the Pasquotank
                  to 5 p.m. May 17,                           Regatta Inc.          River, adjacent to Elizabeth
                  2009.                                                             City, NC, from shoreline to
                                                                                shoreline, bounded on the
                                                                                west by the Elizabeth City
                                                                                Draw Bridge and bounded on
                                                                                the east by a line
                                                                                originating at a point along
                                                                                the shoreline at latitude
                                                                                36[deg]17'54'' N, longitude
                                                                                076[deg]12'00'' W, thence
                                                                                southwesterly to latitude
                                                                                36[deg]17'35'' N, longitude
                                                                                076[deg]12'18'' W at Cottage
                                                                                Point.
----------------------------------------------------------------------------------------------------------------

    Dated: April 27, 2009.
Fred M. Rosa, Jr.,
Rear Admiral, U.S. Coast Guard Commander, Fifth Coast Guard District.
[FR Doc. E9-11056 Filed 5-11-09; 8:45 am]

BILLING CODE 4910-15-P


 Forwarded by Deborah Nagle/ DC/ USEPA/ US on 12/ 20/ 2002 10: 27 AM  Mike McCullough < Mike. McCullough@ epa. state. oh. us> 12/ 20/ 2002 08: 31 AM To: Peter Howe/ R5/ USEPA/ US@ EPA cc: Deborah Nagle/ DC/ USEPA/ US@ EPA, Tom Wall/ DC/ USEPA/ US@ EPA Subject: Re: 316( b) Help needed  From Deborah Nagle Peter,

As best we can determine, the evaluation of 316( b) demonstrations in Ohio for existing power plants assumed 100 percent mortality for all fish eggs and larvae unless a site specific study demonstrated that some other mortality rate was more appropriate.

Mike McCullough Division of Surface Water Ohio EPA >>> < Howe. Peter@ epamail. epa. gov> 12/ 17/ 02 02: 41PM >>> Gentlemen, would you please answer Deb's questions listed in her E Mail attached below related to 316( b) entrainment for your State or refer it to those in your State agency who is responsible for this issue. You can just reply to this message. THANKS.

 Forwarded by Peter Howe/ R5/ USEPA/ US on 12/ 17/ 02 01: 32 PM

316b < 316b@ tetratech f fx. com> Sent: 12/ 16/ 2002 04: 04 PM To: Bruce Kent/ P2/ R8/ USEPA/ US@ EPA, Caroline Ejimofor/ R4/ USEPA/ US@ EPA, Ericp Nelson/ R1/ USEPA/ US@ EPA, Evelyn MacKnight/ R3/ USEPA/ US@ EPA, Isaac Chen/ R6/ USEPA/ US@ EPA, John Dunn/ WWPD/ R7/ USEPA/ US@ EPA, Karrie Jo Shell/ R4/ USEPA/ US@ EPA, Terry Oda/ R9/ USEPA/ US@ EPA, Larry Merrill/ R3/ USEPA/ US@ EPA, Mark Stein/ R1/ USEPA/ US@ EPA, Moses Chang/ R2/ USEPA/ US@ EPA, Paulette Johnsey/ R6/ USEPA/ US@ EPA, Peter Howe/ R5/ USEPA/ US@ EPA, Phil Colarusso/ R1/ USEPA/ US@ EPA, Philip Sweeney/ R2/ USEPA/ US@ EPA, Robyn Stuber/ R9/ USEPA/ US@ EPA cc: Tom Wall/ DC/ USEPA/ US@ EPA, Deborah Nagle/ DC/ USEPA/ US@ EPA Subject: 316( b) Help needed  From Deborah Nagle I need some help from the field, concerning entrainment survival. We have been reviewing and critiqueing multiple entrainment survival studies for the 316( b) Phase II NODA. It is very important for us to know if States consider entrainment survival when making 316( b) determinations. For each State in your Region, I need you to apply one of the answers below:

ANSWERS 1. Does not consider entrainment survival at all 2. Assumes entrainment survival is 0% ( 100% mortality) 3. Assumes entrainment survival is X% ( fill in the number for X)

I need this information quickly this week if possible. Send partial information instead of waiting until you have information for all your states. Thanks for your help.

 Deborah


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Date: May 23, 2002 Memorandum SUBJECT: Addendum to EPA March 8, 2002: Pronamide. Tolerance Reassesment Eligibility Decision (TRED).

FROM: Gary Bangs, Risk Assessor Reregistration Branch 3 Health Effects Division (7509C)

THROUGH: Steve Knizner, Chief Reregistration Branch 3 Health Effects Division (7509C)

TO: Cecelia Watson, Chemical Review Manager Special Review and Reregistration Division (7508C)

PC Code: Pronamide 101701.

DPBarcode: D282842 PURPOSE: Pronamide Revised Aggregate Risk Estimates After Application of Labeling Changes to Eliminate Use on Residential Turf 2 Pronamide Revised Aggregate Risk Estimates After Application of Labeling Changes to Eliminate Use on Residential Turf Cancellation of the single label allowing application of pronamide to home lawns and recreational turf will make children's oral non dietary exposures unlikely. However, since the registrant wants to retain use on golf courses and athletic fields, the potential for low and highcontact exposures for adults still exists. Based on the use pattern of pronamide (the elimination of selected grasses from golf course and professional playing field turf) it is anticipated that children would rarely be exposed to pronamide residues. Labels should strongly encourage watering in to reduce residues, and management practices to restrict entry until the pronamide product is watered into the turf. Given these proposed restrictions on the use of pronamide on turf, the high contact dermal exposure scenario is not considered likely and would result in an overestimate of player exposure.

Short term Aggregate Risk Estimates The short term food, water, and low contact dermal (golfing) pronamide exposures were aggregated in the Risk Assessment, and the estimated environmental concentrations (EECs) modeled using Sci Grow and PRZM EXAMS did not exceed the drinking water level of concern (DWLOC) . Therefore, risk estimates for all pathways of exposure are not of concern for pronamide in the short term when pronamide use is restricted per the label changes cited above.

Chronic Aggregate Risk Estimates The chronic risk estimates would remain the same for all populations as stated in the Risk Assessment, as there are no anticipated long term non dietary exposure scenarios for pronamide. All aggregate food and water estimates do not exceed the level of concern.

Cancer Risk Estimates Aggregate cancer risk estimates will be reduced by restricting non agricultural uses to turf for sod and seed, ornamental landscaping, industrial sites, professional athletic fields, and golf courses. Golfing is believed to be a representative scenario for likely exposures to the public. The cancer risk estimate for golfing a single day per year is about the same as the dietary cancer risk estimate, or 1 x 10 7 . When both dietary and non dietary risk are added, the cancer risk estimate is 2.2 x 10 7 . The DWLOC for the aggregated dietary and golfing cancer risks is 1.06 ppb. Without golf course exposure (i. e., no recreational turf uses at all), the cancer DWLOC of 1.2 ppb is based on dietary exposure alone. The Tier 2 PRZM EXAMS 37 year mean EECs are 0.535 4.35 ppb. This modeling was based on the maximum label rates for pronamide, whereas typical rates for many crops are 25% 50% less. No targeted water monitoring data were available, but USGS water monitoring data showed maximum pronamide levels of 0.82 ppb in ground water and 0.365 ppb in surface water. Further refinement of drinking water modeling estimates and/ or targeted monitoring of water sources in high pronamide use areas would provide more confidence in the risk assessment. 3 Risk Characterization The cancer risk estimate for playing on treated turf used the turf residues averaged over 14 days, which is how long pronamide takes to dissipate to negligible levels. A single day's exposure was used, based on the national average rate of golfing of 18 times per year, or about every 2 weeks. The residential/ recreational exposure estimates are based on a default dermal absorption value of 100%, therefore, a dermal absorption study would help to reduce these risk estimates. Additional label language encouraging prompt watering in of the product would help to reduce available residues (as shown in the submitted turf residue study) and thereby also reduce risks.