[Federal Register Volume 83, Number 143 (Wednesday, July 25, 2018)]
[Notices]
[Pages 35277-35278]
[FR Doc No: 2018-15870]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2544]

Use of Liquids and/or Soft Foods as Vehicles for Drug
Administration: General Considerations for Selection and In Vitro
Methods for Product Quality Assessments; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Use of
Liquids and/or Soft Foods as Vehicles for Drug Administration: General
Considerations for Selection and In Vitro Methods for Product Quality
Assessments.'' This draft guidance applies to orally administered drug
products and provides recommendations to sponsors who will use or
recommend use of liquids and/or soft foods as vehicles for drug
administration in investigational new drug applications (INDs), new
drug applications (NDAs), Biologics License Applications (BLAs), as
applicable, and in supplements to these applications.

DATES: Submit either electronic or written comments on the draft
guidance by September 24, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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-2544 for ``Use of Liquids and/or Soft Foods as Vehicles for
Drug Administration: General Considerations for Selection and In Vitro
Methods for Product Quality Assessments.'' 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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Mamta Gautam-Basak, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 21, Rm. 2508, Silver Spring, MD 20993, 301-796-
0712.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Use of Liquids and/or Soft Foods as Vehicles for Drug
Administration: General Considerations for Selection and In Vitro
Methods for Product Quality Assessments.'' In the absence of
availability of a dosage form that is appropriate for the targeted
patient population (e.g., pediatric, geriatric), small amounts of
liquids and/or soft foods can be used as described in the FDA-approved
product labeling for immediate ingestion as the suitable vehicle(s) for
oral administration of the specific drug product.
    Generally, drug products mixed in small amounts of liquids (5 to 15
milliliters) or soft foods are used in pediatric and other patient
populations who are unable to swallow solid oral dosage forms. Liquids
and/or soft foods that are shown not to alter performance of the drug
product, and are deemed compatible and suitable for use in the targeted
patient populations, are considered suitable for use as vehicles with
the specific drug product.
    This draft guidance addresses the approaches recommended for
suitability determination of vehicles intended for use with specific
drug products by providing the following:
     Considerations for selection of liquids and/or soft foods
as vehicles.
     Standardized in vitro methodology and data recommendations
for drug product quality assessments to qualify vehicle(s) for drug
product administration.
     Recommendations to communicate acceptable (qualified)
vehicles in drug product labeling. If certain foods are found
unacceptable, they should also be included in the labeling.
    This draft guidance and the methods it describes do not replace
existing guidance documents that address food-effect assessments on the
drug product or dosage form, or stability testing conducted to support
a shelf-life determination. For those drug products marketed with a
vehicle for administration (i.e., the vehicle is copackaged with the
drug product), the recommendations regarding selection and methods
provided in this draft guidance are applicable, but additional
considerations and recommendations may also apply.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Use of
Liquids and/or Soft Foods as Vehicles for Drug Administration: General
Considerations for Selection and In Vitro Methods for Product Quality
Assessments.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
The collections of information in 21 CFR part 312 (INDs) have been
approved under 0910-0014, the collections of information in 21 CFR part
314 (NDAs and ANDAs) have been approved under 0910-0001, and the
collections of information in 21 CFR 201.56 and 201.57 (Prescription
Drug Product Labeling) have been approved under 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: July 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15870 Filed 7-24-18; 8:45 am]
 BILLING CODE 4164-01-P


approval. For an employer using FRA's part 243 web portal, the web
portal will prompt the employer to provide the required information in
this section. Each employer shall state in its submission whether, at
the time of filing, it:
* * * * *
    (4) Uses any combination of paragraphs (a)(1) through (3) of this
section.
    (b) [Reserved]
* * * * *
0
9. Section 243.109 is amended by revising the section heading, the
introductory heading in paragraph (a), and paragraph (a)(2) to read as
follows:

Sec.  243.109   Initial and refresher training program submission,
review, and approval process.

    (a) Initial and refresher programs.
* * * * *
    (2) An employer's initial program, as required by Sec.  243.101(a)
or (b), or an employer's refresher program, as required by Sec.
243.201(e), must be submitted to the Associate Administrator and is
considered approved and may be implemented immediately upon submission.
Following submission, the Associate Administrator will review the
program and inform the employer as to whether the program conforms to
this part. If the Associate Administrator determines that all or part
of the program does not conform, the Associate Administrator will
inform the employer of the specific deficiencies. The deficient
portions of the non-conforming program may remain in effect until
approval of the revised program, unless FRA provides notification
otherwise. An employer shall resubmit the portion of its program, as
revised to address specific deficiencies, within 90 days after the date
of any notice of deficiencies from the Associate Administrator. A
failure to resubmit the program with the necessary revisions shall be
considered a failure to implement a program under this part. The
Associate Administrator may extend this 90-day period upon written
request.
* * * * *
0
10. Section 243.111 is amended by revising paragraphs (a), (c)(3), and
(e), and removing paragraphs (c)(5) through (7) to read as follows:

Sec.  243.111   Approval of programs filed by training organizations or
learning institutions.

    (a) A training organization or learning institution that provides
training services for safety-related railroad employees, including
providing such training services to independent students who enroll
with such training organization or learning institution and who will
rely on the training services provided to qualify to become safety-
related railroad employees, must submit its program to FRA for review
and approval unless:
    (1) The program is approved as a model program under Sec.  243.105
or an employer program under Sec.  243.101; and
    (2) The training organization or learning institution submits an
informational filing to its previously approved program containing the
information required in paragraph (c) of this section.
* * * * *
    (c) * * *
    (3) The training organization or learning institution's primary
telephone number and point of contact; and
* * * * *
    (e) Previously approved programs require an informational filing
when modified. The training organization or learning institution shall
review its previously approved training program and modify it
accordingly when new safety-related Federal railroad laws, regulations,
or orders are issued, or new safety-related technologies, procedures,
or equipment are introduced into the workplace and result in new
knowledge requirements, safety-related tasks, or in modifications of
existing safety-related duties. A training organization or learning
institution that modifies its

training program for these described reasons shall submit an
informational filing to the Associate Administrator not later than 30
days after the end of the calendar year in which the modification
occurred, unless FRA advises otherwise. Programs modified in accordance
with this paragraph are considered approved upon modification and may
be implemented immediately. Any program deficiencies noted by the
Associate Administrator shall be addressed as specified in this
section. A training organization or learning institution may transfer
an approved program to another training organization or learning
institution, or an employer, and that transfer will require the
acquiring entity to file an informational filing unless the acquiring
entity is making substantial additions or revisions to the previously
approved program, which will require FRA review under paragraph (f) of
this section. The filing shall contain a summary description of
sufficient detail so that FRA can associate the changes with the
training organization's or learning institution's previously approved
program, and shall include:
* * * * *
0
11. Section 243.113 is revised to read as follows:

Sec.  243.113   Electronic and written program submission requirements.

    (a) Each employer, training organization, or learning institution
to which this part applies is required to file by electronic means at
FRA's part 243 web portal any program submissions required under this
part in accordance with the requirements of this section. FRA's part
243 web portal will prompt users to submit all required training
program information. Each organization, business, or association that
develops an optional model program in accordance with Sec.  243.105 is
required to file by electronic means at FRA's part 243 web portal the
program in accordance with the requirements of this section.
    (b) Before any person's first program submission electronically at
FRA's part 243 web portal, the person must register for access at the
portal, https://safetydata.fra.dot.gov/Part243/. Users must provide the
following information to complete registration:
    (1) The name of the employer, organization, learning institution,
business, or association;
    (2) The names of two individuals, including job titles, who will be
the person's points of contact and will be the only individuals allowed
access to FRA's secure document submission site;
    (3) The mailing addresses for the person's points of contact;
    (4) The person's system or main headquarters address located in the
United States;
    (5) The email addresses for the person's points of contact; and
    (6) The daytime telephone numbers for the person's points of
contact.
    (c) A person that electronically submits an initial program,
informational filing, or new portions or revisions to an approved
program required by this part at FRA's part 243 web portal shall be
considered to have provided their consent for FRA to electronically
store any materials required by this part and to receive approval or
disapproval notices from FRA by email.

Subpart C--Program Implementation and Oversight Requirements

0
12. Section 243.201 is amended by revising paragraphs (a), (b), (c)(2),
(d) introductory text and (d)(1), and (e)(1) and (2), and adding
paragraphs (e)(3) and (f) to read as follows:

Sec.  243.201   Employee qualification requirements.

    (a)(1) Each employer must permit only employees appropriately
trained and qualified to perform safety-related service.
    (2) In addition to any required knowledge-based training, an
employer may limit a safety-related railroad employee's training to
only the relevant Federal requirements that apply to the safety-related
tasks that the employer authorizes the employee to perform.
    (3) Each employer conducting operations subject to this part shall
either:
    (i) Declare the designation of each of its existing safety-related
railroad employees by occupational category or subcategory, and only
permit designated employees to perform safety-related service in that
occupational category or subcategory; or
    (ii) For an employer that does not designate employees by
occupational category or subcategory, retain a record for each employee
identifying the list of Federal railroad safety laws, regulations, and
orders that cover the work the person is designated as qualified to
perform.
    (b) An employer commencing operations shall declare the designation
of each of its existing safety-related railroad employees by
occupational category or subcategory before beginning operations, and
only permit designated employees to perform safety-related service in
that category or subcategory. Any person designated shall have met the
requirements for newly hired employees or those assigned new safety-
related duties in accordance with paragraph (c) of this section.
    (c) * * *
    (2) If the training curriculum includes OJT, the employee shall
demonstrate, to the satisfaction of a designated instructor, OJT
proficiency by successfully completing the safety-related tasks
necessary to become a qualified member of the occupational category or
subcategory. However, as part of the OJT process and before completing
any of the formal training, including classroom training and OJT, and
passing the field evaluation, a person may perform such tasks under the
direct onsite observation of any qualified person, provided the
qualified person has been advised of the circumstances and is capable
of intervening if an unsafe act or non-compliance with Federal railroad
safety laws, regulations, or orders is observed. An employee designated
to provide formal training to other employees, and who is not a
designated instructor, shall be qualified on the safety-related topics
or tasks in accordance with the employer's training program and the
requirements of this part.
    (d) Employees previously trained or qualified, but not by the
current employer: If an employee has received relevant training or
qualification for a particular occupational category or subcategory
through participation in a FRA-required training program completed by
an entity other than the employee's current employer, that training
shall satisfy the requirements of this part:
    (1) Provided that:
    (i) A current record of training is obtained from that other
entity; or
    (ii) When a current record of training is unavailable from that
other entity, an employer performs testing to ensure the employee has
the knowledge necessary to be a member of that category or subcategory
of safety-related railroad employee. Testing shall include an oral or
written examination, as well as the ability to inspect, identify, and
initiate corrective action necessary for compliance with Federal
railroad safety laws, regulations, or orders, as well as any relevant
railroad rules and procedures promulgated to implement those Federal
railroad safety laws, regulations, or orders. A designated instructor
must make the final determination as to whether the employee has the
knowledge, skills, and abilities to become a member of an occupational
category; and
* * * * *

    (e) * * *
    (1) Beginning January 1, 2022, each Class I railroad, and each
intercity or commuter passenger railroad conducting operations subject
to this part with 400,000 total employee work hours annually or more,
shall deliver refresher training at an interval not to exceed three
calendar years from the date of an employee's last training event,
except where refresher training is specifically required more
frequently in accordance with this chapter. If the last training event
occurs before FRA's approval of the employer's training program, the
employer shall provide refresher training either within three calendar
years from that prior training event or no later than December 31,
2024.
    (2) Beginning May 1, 2023, each employer conducting operations
subject to this part not covered by paragraph (e)(1) of this section
shall deliver refresher training at an interval not to exceed three
calendar years from the date of an employee's last training event,
except where refresher training is specifically required more
frequently in accordance with this chapter. If the last training event
occurs before FRA's approval of the employer's training program, the
employer shall provide refresher training either within three calendar
years from that prior training event or no later than December 31,
2025.
    (3) Each employer shall ensure that, as part of each employee's
refresher training:
    (i) An employee is advised of changes to any rule, practice, or
procedure relevant to the employee's assigned duties;
    (ii) An employee must not be allowed to test out of refresher
training; and
    (iii) The employee is trained and qualified on the application of
any Federal railroad safety laws, regulations, and orders the person is
required to comply with, as well as any relevant railroad rules and
procedures promulgated to implement those Federal railroad safety laws,
regulations, and orders. An employer must consider developing refresher
training to address railroad-wide or industry-wide safety concerns, or
those safety concerns that address an individual employee's weaknesses.
To ensure an employee is trained and qualified, rather than repeating
initial training, an employer is permitted to consider refresher
training as a limited and carefully tailored review of:
    (A) All the required steps of a complicated safety-related task;
    (B) Existing rules or procedures that were initially learned but
rarely used; and
    (C) Safety-related tasks that address skill gaps that the employer
identified in the workforce through efficiency testing, periodic
oversight, annual reviews, accident/incident data, FRA inspection data,
or other performance measuring metrics.
    (f) An employer must consider ways to provide remedial training and
retesting of any employee who fails to successfully pass any training
or testing. Under this part, a failure of any test or training does not
bar the person from successfully completing the training or testing at
a later date.
0
13. Section 243.203 is amended by revising paragraphs (b)(2) and (6),
and (c) to read as follows:

Sec.  243.203  Records.

* * * * *
    (b) * * *
    (2) Occupational category or subcategory designations, or other
suitable designations, for which the employee is deemed qualified;
* * * * *
    (6) The employee's OJT performance, which shall include the unique
name or identifier of the OJT program component in accordance with
Sec.  243.103, the date the OJT program component was successfully
completed, and the identification of the designated instructor(s)
determining that the employee successfully completed all OJT training
necessary to be considered qualified to perform the safety-related
tasks identified with the occupational categories or subcategories, or
other suitable terminology, for which the employee is designated in
accordance with the program required by this part;
* * * * *
    (c) Record accessibility for other than individual employee
records. Except for records demonstrating the qualification status of
each safety-related railroad employee as described in paragraph (b) of
this section or otherwise specified in this part, each annual review
required by this part shall be accessible for three calendar years
after the end of the calendar year to which the annual review relates,
and each test, inspection, or other event record required by this part
shall be accessible for one calendar year after the end of the calendar
year to which the event relates. Each employer shall make these records
accessible at one headquarters location within the United States,
including, but not limited to, a railroad's system headquarters, a
holding company's headquarters, a joint venture's headquarters, a
contractor's principal place of business or other headquarters located
where the contractor is incorporated. This requirement does not
prohibit an employer with divisions from also maintaining any of these
records at any division headquarters.
* * * * *
0
14. Section 243.205 is amended by revising paragraphs (a), (c)
introductory text, (d), (e)(1), (g) introductory text, (h), and (i) to
read as follows:

Sec.  243.205   Periodic oversight.

    (a) General. As part of the program required in accordance with
this part, an employer shall adopt and comply with a program to conduct
periodic oversight tests or inspections to determine if safety-related
railroad employees comply with Federal railroad safety laws,
regulations, and orders particular to FRA-regulated personal and work
group safety. The program of periodic oversight shall commence on the
day the employer files its program with FRA pursuant to Sec.
243.101(a) or on the day the employer commences operations pursuant to
Sec.  243.101(b). The data gathered through the testing or inspection
components of the program shall be used to determine whether systemic
performance gaps exist, and to determine if modifications to the
training component of the program are appropriate to close those gaps.
* * * * *
    (c) Railroad oversight. Each railroad shall identify supervisory
employees, by category or subcategory, responsible for conducting
periodic oversight tests or inspections for the safety-related railroad
employees that it authorizes to perform safety-related duties on its
property, except a railroad is not required to:
* * * * *
    (d) Operational test exception for a railroad. A railroad is not
required to perform operational tests or inspections of safety-related
railroad employees employed by a contractor.
    (e) * * *
    (1) When oversight test or inspection sessions are scheduled
specifically to determine if safety-related employees are in compliance
with Federal railroad safety laws, regulations, and orders particular
to FRA-regulated personal and work group safety; or
* * * * *
    (g) Contractor oversight. Each contractor shall conduct periodic
oversight tests or inspections of its safety-related railroad employees
provided:
* * * * *

    (h) Oversight divided by agreement. (1) Notwithstanding the
requirements of paragraphs (c) and (g) of this section, a railroad and
a contractor may agree that the contractor will provide the oversight
by specifying in the program that the railroad has trained the
contractor employees responsible for training and oversight; or
    (2) Notwithstanding the requirements of this section that assign
specific periodic oversight responsibilities to a railroad or a
contractor, a railroad and a contractor may agree to a different
periodic oversight responsibility arrangement.
    (i) Detailed records required. Each employer that conducts periodic
oversight in accordance with this section must keep a record of the
date, time, place, and result of each test or inspection. The records
shall specify each person administering tests or inspections, and each
person tested. The record shall also provide a method to record whether
the employee complied with the monitored duties, and any interventions
used to remediate non-compliance. Modifications of the program required
by Sec.  217.9 of this chapter may be used in lieu of this oversight
program, provided a railroad specifies it has done so in its program
submitted in accordance with this part.
* * * * *

    Issued in Washington, DC, under the authority set forth in 49
CFR 1.89(b).
Amitabha Bose,
Administrator.
[FR Doc. 2022-21277 Filed 9-30-22; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 88, Number 96 (Thursday, May 18, 2023)]
[Notices]
[Pages 31840-31841]
[FR Doc No: 2023-10622]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Availability of Draft Air Tour Management Plans and
Draft Environmental Assessments (EA) and Public Meetings

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

ACTION: Notice.

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SUMMARY: The FAA, in cooperation with the National Park Service (NPS),
has initiated development of ATMPs for Haleakal[amacr] National Park,
Hawai[revaps]i Volcanoes National Park, Mount Rushmore National
Memorial, and Badlands National Park (collectively referred to as the
Parks) pursuant to the National Parks Air Tour Management Act of 2000
and its implementing regulations. This notice announces the public
availability of the draft ATMPs and draft EAs for comment and the dates
of the public meetings for each of the Parks. The purpose of the public
meetings is to review the draft ATMPs with the public. The draft ATMPs
provide acceptable and effective measures to mitigate or prevent the
significant adverse impacts, if any, of commercial air tour operations
upon the Parks' natural and cultural resources and visitor experiences,
as well as on tribal lands. In accordance with section 106 of the
National Historic Preservation Act, the FAA and the NPS are also
seeking public comment on the potential of the draft ATMPs to cause
adverse effects to historic properties.

DATES:

Comment Period Dates

    For Haleakal[amacr] and Hawai[revaps]i Volcanoes National Parks,
comments must be received on or before June 16, 2023, by 8:00 p.m. HST.
For Mount Rushmore National Memorial and Badlands National Park,
comments must be received on or before June 16, 2023, by 11:59 MDT.
    Comments will be received on the NPS Planning, Environment and
Public Comment System (PEPC) website. Each park's website link is
below:

 Haleakal[amacr] National Park--https://parkplanning.nps.gov/HaleakalaATMP
 Hawai[revaps]i Volcanoes National Park--https://parkplanning.nps.gov/HawaiiVolcanoesATMP
 Mount Rushmore National Memorial--https://parkplanning.nps.gov/MountRushmoreATMP

 Badlands National Park--https://parkplanning.nps.gov/BadlandsATMP

    Before including your address, phone number, email address, or
other personal identifying information in your comment, be advised that
your entire comment--including your personal identifying information--
may be made publicly available at any time. While you can ask in your
comment to withhold from public review your personal identifying
information, we cannot guarantee that we will be able to do so.

Public Meeting Dates

    The meetings will be held virtually at the dates and times listed
below. Questions will be accepted during the public meeting for each
Park through a separate form. The link for the question form is
provided below for each meeting.

 Badlands National Park
    [cir] Wednesday, May 24, 2023 (6:00 p.m.-7:30 p.m. MDT)
    [cir] Join meeting: https://faavideo.zoomgov.com/j/1600068134
     Passcode: 246810
     To join using the ``Zoom Cloud Meetings'' app, please use
the meeting ID and passcode below:
    [cir] Meeting ID:<PHONE_NUMBER>
    [cir] Passcode: 246810
     To join using phone audio only, please use:
    [cir] Call 1-888-924-3239
    [cir] Meeting ID:<PHONE_NUMBER>
    [cir] Passcode: 246810
    [cir] Submit questions for the meeting: https://forms.gle/6msA7mFayKq13ch49
 Haleakal[amacr] National Park
    [cir] Thursday, May 25, 2023 (6:00 p.m.-7:30 p.m. HST)
    [cir] Join meeting: https://faavideo.zoomgov.com/j/1614722433
     Passcode: 246810
     To join using the ``Zoom Cloud Meetings'' app, please use
the meeting ID and passcode below:
    [cir] Meeting ID:<PHONE_NUMBER>
    [cir] Passcode: 246810
     To join using phone audio only, please use:
    [cir] Call 1-888-924-3239
    [cir] Meeting ID:<PHONE_NUMBER>
    [cir] Passcode: 246810
    [cir] Submit questions for the meeting: https://forms.gle/nCCQcSniKrBTz2RXA
 Mount Rushmore National Memorial
    [cir] Thursday, June 1, 2023 (6:00 p.m.-7:30 p.m. MDT)
    [cir] Join meeting: https://faavideo.zoomgov.com/j/1615600109
     Passcode: 246810
     To join using the ``Zoom Cloud Meetings'' app, please use
the meeting ID and passcode below:
    [cir] Meeting ID:<PHONE_NUMBER>
    [cir] Passcode: 246810
     To join using phone audio only, please use:
    [cir] Call 1-888-924-3239
    [cir] Meeting ID:<PHONE_NUMBER>
    [cir] Passcode: 246810
    [cir] Submit questions for the meeting: https://forms.gle/Jm5cT4DHhfta8fnP9
 Hawai[revaps]i Volcanoes National Park
    [cir] Wednesday, June 7, 2023 (6:00 p.m.-7:30 p.m. HST)
    [cir] Join meeting: https://faavideo.zoomgov.com/j/1615197156
     Passcode: 246810
     To join using the ``Zoom Cloud Meetings'' app, please use
the meeting ID and passcode below:
    [cir] Meeting ID:<PHONE_NUMBER>
    [cir] Passcode: 246810
     To join using phone audio only, please use:
     Call 1-888-924-3239
     Meeting ID:<PHONE_NUMBER>
     Passcode: 246810
    [cir] Submit questions for the meeting: https://forms.gle/NK67Ue1cGg25twoZ6

ADDRESSES: The meetings will be held virtually. Members of the public
who wish to observe the virtual meetings can access the live meeting
through the links provided in this notice on the day of the event. The
meeting links will also be available at Air Tour Management Plan
[verbar] Federal Aviation Administration (faa.gov) and on the NPS PEPC
websites for each Park.
    Contact: Any request for reasonable accommodation related to
providing public comments on the draft ATMPs or draft EAs should be
sent to the person listed on the Parks' PEPC sites. The U.S. Department
of Transportation and U.S. Department of the Interior are committed to
providing equal access to the meetings for all participants. If you
need alternative formats or services because of a disability, such as
sign language, interpretation, or other ancillary aids, please contact
the person listed in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Sandra Fox,<PHONE_NUMBER>,
faa.gov">[email protected]faa.gov.

SUPPLEMENTARY INFORMATION: The FAA is issuing this notice pursuant to
the National Parks Air Tour Management Act of 2000 (Pub. L. 106-181)
and its implementing regulations contained in Title 14, Code of Federal
Regulations, part 136, subpart B, National Parks Air Tour Management.
The objectives of the ATMPs are to develop acceptable and effective
measures to mitigate or prevent the significant adverse impacts, if
any, of commercial air tour operations upon the natural resources,
cultural resources, and visitor experiences of the Parks as well as on
tribal lands. The FAA and the NPS are inviting comment from the public,
Federal and state agencies, tribes, Native Hawaiian Organizations, and
other interested parties on the draft ATMPs and draft EAs for
Haleakal[amacr] National Park, Hawai[revaps]i Volcanoes National Park,
Mount Rushmore National Memorial, and Badlands National Park.
    The FAA and the NPS have determined that each ATMP constitutes a
Federal undertaking subject to compliance with Section 106 of the
National Historic Preservation Act and its implementing regulations (36
CFR part 800). The FAA and the NPS have consulted with tribes, Native
Hawaiian Organizations, State and Tribal Historic Preservation
Officers, and other interested parties to identify historic properties
and assess the potential effects of ATMPs on them.
    The meetings will be open to the public. Members of the public who
wish to observe the virtual meetings can access the livestream from the
links and websites provided in this notice.
    The FAA and the NPS request that comments be as specific as
possible in response to the draft ATMPs and draft EAs. All written
comments become part of the official record. Written comments on the
draft ATMPs and draft EAs can be submitted via PEPC or sent to the
mailing addresses provided on the Parks' PEPC sites. Comments will not
be accepted by fax, email, or any other way than those specified above.

    Issued in Washington, DC, on May 15, 2023.
Sandra Fox,
Environmental Protection Specialist, FAA Office of Environment &
Energy.
[FR Doc. 2023-10622 Filed 5-17-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 178 (Thursday, September 13, 2012)]
[Notices]
[Pages 56692-56693]
[FR Doc No: 2012-22519]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67799; File No. SR-NYSEArca-2012-86]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending Certain
NYSE Arca Rules To Replace References to ``NYSE Amex'' With ``NYSE
MKT'' Reflecting the Recent Name Change of NYSE Amex LLC to NYSE MKT
LLC

September 7, 2012.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on August 28, 2012, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend certain NYSE Arca rules to replace
references to ``NYSE Amex'' with ``NYSE MKT'' to reflect the recent
name change of NYSE Amex LLC to NYSE MKT LLC. The text of the proposed
rule change is available on the Exchange's Web site at www.nyse.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 self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those 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 amend certain NYSE Arca rules to replace
references to ``NYSE Amex'' with ``NYSE MKT'' to reflect the recent
name change of NYSE Amex LLC to NYSE MKT LLC.\4\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 67037 (May 21,
2012), 77 FR 31415 (May 25, 2012) (SR-NYSEAmex-2012-32).
---------------------------------------------------------------------------

    The Exchange proposes to replace references to NYSE Amex in NYSE
Arca Rule 6.96 with references to NYSE MKT. The Exchange also proposes
to replace a reference to American Stock Exchange, a predecessor of
NYSE Amex, in NYSE Arca Rule 5.25 with a reference to NYSE MKT.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Securities Exchange Act of 1934 (the
``Act''),\5\ in general, and Section 6(b)(5) of the Act,\6\ in
particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, to protect investors and the
public interest. The Exchange is proposing to replace references to
NYSE Amex with NYSE MKT, which would reflect the current name of NYSE
MKT and is, therefore, in the public interest.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \7\ and Rule 19b-4(f)(6) thereunder.\8\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \8\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \9\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b4(f)(6)(iii),\10\[sic] the
Commission may designate a shorter time if such action is consistent
with the protection of investors and the public interest.
---------------------------------------------------------------------------

    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2012-86 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-NYSEArca-2012-86. This
file number should be included on the subject line if email is used.
    To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room on
official business days between the hours of 10 a.m. and 3 p.m. Copies
of such filing also will be available for inspection and copying at the
principal offices 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-NYSEArca-2012-86, and should be submitted on or before
October 4, 2012.
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-22519 Filed 9-12-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 92 (Monday, May 15, 2017)]
[Proposed Rules]
[Pages 22299-22301]
[FR Doc No: 2017-09693]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2017-0318]
RIN 1625-AA00

Safety Zone; Missouri River Miles 616-617, Council Bluffs, IA,
and Omaha, NE

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to establish a safety zone on the
Missouri River between miles 616 and 617. This action is necessary to
provide for the safety of life on these navigable waters near Council
Bluffs, IA and Omaha, NE during high speed boat races on July 7, 8, and
9, 2017. This proposed rulemaking would prohibit persons and vessels
from being in the safety zone unless authorized by the Captain of the
Port Upper Mississippi River or a designated representative. We invite
your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before June 14, 2017.

ADDRESSES: You may submit comments identified by docket number USCG-
2017-0318 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email LCDR Sean Peterson, Chief of
Prevention, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Upper Mississippi River
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On April 4, 2017, Coast Guard Sector Upper Mississippi River
received an application for a marine event from International Outboard
Grand Prix for the Grand Prix of Omaha and Regatta Festival. The event
is scheduled to take place over three days, July 7, 8, and 9, 2017, on
the Missouri River between the cities of Omaha, NE and Council Bluffs,
IA. High speed boat practices and races will take place during the
hours of 3 to 5 p.m. on July 7, 11:30 a.m. to 6 p.m. on July 8, and 11
a.m. to 5:30 p.m. on July 9.
    Hazards from this race include impediment of the navigational
channel and high speed vessels participating in the race. The Captain
of the Port Upper Mississippi River (COTP) has determined that
potential hazards associated with the race would be a safety concern
for anyone transiting through the race course.
    The purpose of this proposed rulemaking is to ensure the safety of
vessels and the navigable waters between miles 616 and 617 before,
during, and after the scheduled event. The Coast Guard proposes this
proposed rulemaking under authority in 33 U.S.C. 1231.

III. Discussion of Proposed Rule

    The COTP proposes to establish a safety zone from 3 p.m. on July 7,
2017 through 5.30 p.m. on July 9, 2017. The zone would be enforced from
3 to 5 p.m. on July 7, 2017, 11:30 a.m. to 6 p.m. on July 8, 2017, and
11 a.m. to 5:30 p.m. on July 9, 2017. The safety zone would cover all
navigable waters between miles 616 and 617 on the Missouri River in
Council Bluffs, IA and Omaha, NE. The duration of the zone is intended
to ensure the safety of vessels and participants on the navigable
waters before, during, and after the scheduled high speed boat
practices and races. No vessel or person would be permitted to enter
the safety zone without obtaining permission from the COTP or a
designated representative. The regulatory text we are proposing appears
at the end of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive Orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive Orders and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This NPRM has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, the NPRM has not been reviewed by the Office of Management
and Budget.
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. This proposed
rule would have minimal impact on waterway traffic because it would be
in effect for two hours on the first day and six and a half hours on
both the second and third days, during daylight hours and restricts
transit in and through a section of the Missouri River extending one
mile. Moreover, the Coast Guard would issue a Broadcast Notice to
Mariners (BNM) via VHF-FM marine channel 16 about the zone, and the
proposed rule would allow vessels to seek permission to enter the zone.
The racing events on July 8 and 9, 2017, will take place in heats,
allowing time for vessels affected by the closure to transit the area
between heats when deemed safe by on-scene representatives of the COTP.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 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
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A. above this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this proposed rule would economically affect it.
    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 proposed 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
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would 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. If
you believe this proposed rule would have implications for federalism
or Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. 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 proposed rule would not
result in such an expenditure, we do discuss the effects of the rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed 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 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a safety
zone lasting for two hours on the first day and six and a half hours on
both the second and third days that would prohibit entry over a one
mile area of river. Normally such actions are categorically excluded
from further review under paragraph 34(g) of Figure 2-1 of Commandant
Instruction M16475.lD. A preliminary environmental analysis checklist
and Record of Environmental Consideration 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 proposed rule.

G. 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.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this proposed
rulemaking. If you submit a comment, please include the docket number
for this proposed rulemaking, indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material

cannot be submitted using http://www.regulations.gov, contact the
person in the FOR FURTHER INFORMATION CONTACT section of this document
for alternate instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

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 proposes
to amend 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. Add Sec.  165.T08-0318 to read as follows:

Sec.  165.T08-0318  Safety Zone; Missouri River between miles 616 and
617, Council Bluffs, IA and Omaha, NE.

    (a) Location. The following area is a safety zone: All navigable
waters of the Missouri River between miles 616 and 617, from surface to
bottom, Council Bluffs, IA and Omaha, NE.
    (b) Definitions. As used in this section, a ``designated
representative'' means a Coast Guard Patrol Commander, including a
Coast Guard coxswain, petty officer, or other officer operating a Coast
Guard vessel and a Federal, State, and local officer designated by or
assisting the Captain of the Port Upper Mississippi River (COTP) in the
enforcement of the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative via VHF-FM channel 16, or through Coast Guard Sector
Upper Mississippi River at<PHONE_NUMBER>. Those in the safety zone must
comply with all lawful orders or directions given to them by the COTP
or the COTP's designated representative.
    (d) Enforcement period. This section will be enforced from 3 p.m.
to 5 p.m. on July 7, 2017, 11:30 a.m. to 6 p.m. on July 8, 2017, and 11
a.m. to 5:30 p.m. on July 9, 2017.
    (e) Informational broadcasts. The COTP or a designated
representative will inform the public through broadcast notices to
mariners of the enforcement period for the safety zone.

    Dated: May 4, 2017.
M.L. Malloy,
Captain, U.S. Coast Guard, Captain of the Port Sector Upper
Mississippi.
[FR Doc. 2017-09693 Filed 5-12-17; 8:45 am]
BILLING CODE 9110-04-P