[Federal Register Volume 77, Number 125 (Thursday, June 28, 2012)]
[Rules and Regulations]
[Pages 38473-38474]
[FR Doc No: 2012-15754]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2012-0196; Airspace Docket No. 12-AWP-2]

Amendment of Class E Airspace; Fairfield, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends Class E airspace at Travis Air Force Base
(AFB), Fairfield, CA. The projected decommissioning of the Travis VHF
Omni-Directional Radio Range (VOR) has made this action necessary for
the safety and management of Instrument Flight Rules (IFR) operations
at the airport.

DATES: Effective date, 0901 UTC, September 20, 2012. The Director of
the Federal Register approves this incorporation by reference action
under 1 CFR part 51, subject to the annual revision of FAA Order 7400.9
and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On April 18, 2012, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to amend controlled airspace at
Fairfield, CA (77 FR 23171). Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. Two comments were received in favor of the
airspace amendment. Except for a minor editorial change, this rule is
the same as published in the NPRM.
    Class E airspace designations are published in paragraph 6004, of
FAA Order 7400.9V dated August 9, 2011, and effective September 15,
2011, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by amending Class E airspace designated as an extension to
Class D surface area at Travis AFB, Fairfield, CA. Airspace
reconfiguration is necessary due to the

projected decommissioning of the Travis VOR, and enhances the safety
and management of IFR operations at the airport.
    The FAA has determined this regulation only involves an established
body of technical regulations for which frequent and routine amendments
are necessary to keep them operationally current. Therefore, this
regulation: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under 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 this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. The FAA's authority to
issue rules regarding aviation safety is found in Title 49 of the U.S.
Code. Subtitle 1, Section 106 discusses the authority of the FAA
Administrator. Subtitle VII, Aviation Programs, describes in more
detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it amends
controlled airspace at Travis AFB, Fairfield, CA.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9V, Airspace Designations and
Reporting Points, dated August 9, 2011, and effective September 15,
2011 is amended as follows:

Paragraph 6004 Class E airspace designated as an extension to a
class D surface area.

* * * * *

AWP CA E4 Fairfield, CA [Amended]

Fairfield, Travis AFB, CA
    (Lat. 38[deg]15'46'' N., long. 121[deg]55'39'' W.)

    That airspace extending upward from the surface within 1.8 miles
each side of the Travis AFB 047[deg] bearing, extending from the
4.3-mile radius of Travis AFB to 8.7 miles northeast of Travis AFB,
and within 1.8 miles each side of the Travis AFB 227[deg] bearing
extending from the 4.3-mile radius of the airport to 8.7 miles
southwest of Travis AFB, and within 3.7 miles northwest and 1.8
miles southeast of the Travis AFB 236[deg] bearing extending from
the 4.3-mile radius of the airport to 5.6 miles southwest of Travis
AFB.

    Issued in Seattle, Washington, on June 15, 2012.
John Warner,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2012-15754 Filed 6-27-12; 8:45 am]
BILLING CODE 4910-13-P


--------------------------------------------------------------------------------
Final Review Checklist for ICR Desk Officers  -  New, renewal and revision ICR Packages
INSTRUCTIONS: Complete Final Review Checklist for all new, renewal and revision ICRs. Provide checklist to Team Lead with the final ICR package.

ICR Information
ICR Title
Procedures for Implementing the National Environmental Policy Act (NEPA) and Assessing the Environmental Effects Abroad of EPA Actions (Renewal)
EPA ICR Number
2243.10
OMB Control Number
2020-0033
ICR Desk Officer
Aaron Jackson

Supporting Statement

                            Comments for Team Lead

The Supporting Statement contains all major sections listed in the template.

The title of the ICR is consistent with what it has been in the past or the ICR Owner has provided an explanation as to why it has changed.

All Terms of Clearance from the previous ICR have been addressed.

Section 3(b) includes the following information about the 1[st] FR Notice - publication date, FR citation, description of the comments received (if any), and EPA's response to the comments.
Public comments were previously requested via the Federal Register on June 28, 2022, during a 60-day comment period

Section 3(c) includes a description of the consultations conducted for this specific renewal package.

Sections 6(b) and (c) include updated, loaded wage rates.

Section 6(f) includes a detailed explanation of the reason for change and whether this change is a program change or an adjustment.
Note: If the ICRAS has both a program change and an adjustment, the change in hours and costs must be split accordingly between the two types of change.

Section 6(g) includes the proper template language.

                                       x
The document contains tracked changes for all changes made.
                            Clean version provided

The document has one-inch margins, Times New Roman/12 point font.

The document contains page numbers.

The document is type is ".docx".

The document name is in the following format - ####ss## if no changes were made or ####ss##initialsdate (e.g., 2000.01ck9-25-19) if changes were made.
                         Changes in respondent burden
Federal Register Notice

                            Comments for Team Lead
                              Header Information

The document cites the correct (6560-50-P) billing code in the top right corner.

The document cites the correct FRL Number.

The ICR title matches exactly what is in the Supporting Statement.

                                    Summary
                                       x
The document cites the correct ICR Number, OMB Control Number, expiration date, and publication date of the 1[st] FR Notice.
                      1[st] FRN had the wrong ICR Number

The summary section does not include any legal citations (i.e., CFR or USC references).

                           Supplementary Information

The Abstract includes a comprehensive, but brief, description of the information collection.

The form numbers listed are consistent with the form numbers listed in ICRAS, Part 2.
                   No forms associated with this collection

The hour and cost burden matches exactly what is in the Supporting Statement and the total cost burden is split between labor costs and non-labor costs (capital and O&M costs)

The Changes in the Estimates section addresses the amount of change, whether the change is an adjustment or program change, and a high-level explanation of the change.

                            Formatting, Edits, Etc.

All of the standard template language is included and has not been changed.

The document contains tracked changes for all changes made.

All blue instructional language has been removed from the document.

The document has one-inch margins, Times New Roman/12 point font.

The document contains page numbers and is 4 pages or less in length.

The document is type is ".docx".

 ☐
The document name is in the following format - ####fr## if no changes were made or ####fr##initialsdate (e.g., 2000.01ck9-25-19) if changes were made.

ICRAS Entry

                            Comments for Team Lead
                                    Part 1

The ICR title matches exactly what is in the Supporting Statement.

If program changes are being made, Type of Request is "revision a currently approved collection."
N/A
                                    Part 2

There is a separate IC for each "Affected Public" type and each "Obligation to Respond" type.

The number of ICs is the same as the previous ICR or the ICR Owner has provided an explanation as to why it has changed.

Each form associated with the ICR was uploaded as a separate file with a unique form number.  The files from the last ICR renewal were deleted and replaced for forms that were updated.
No Forms associated with this collection

The Annual Cost Burden includes only capital and O&M costs (not labor costs).

The change in burden was correct split among the Program Change and Adjustment columns.

The Annual Number of Responses, Annual Hour Burden and Annual Cost Burden in the Summary of Burden table matches exactly what is in the supporting statement.

                                     Files
                                       x
All files were uploaded into ICRAS, including the Supporting Statement, FR Notice, Supplemental Tables/Documents, and Typesetting Request
      Should I request the Typesetting Request, or does Courtney do that?


[Federal Register Volume 86, Number 153 (Thursday, August 12, 2021)]
[Notices]
[Pages 44477-44478]
[FR Doc No: 2021-17149]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Applications for Modifications to
Special Permit

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
Transportation (DOT).

ACTION: List of applications for modification of special permits.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations, notice is hereby given
that the Office of Hazardous Materials Safety has received the
application described herein. Each mode of transportation for which a
particular special permit is requested is indicated by a number in the
``Nature of Application'' portion of the table below as follows: 1--
Motor vehicle, 2--Rail freight, 3--Cargo vessel, 4--Cargo aircraft
only, 5--Passenger-carrying aircraft.

DATES: Comments must be received on or before August 27, 2021.

ADDRESSES: Record Center, Pipeline and Hazardous Materials Safety
Administration U.S. Department of Transportation, Washington, DC 20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Donald Burger, Chief, Office of
Hazardous Materials Safety General Approvals and Permits Branch,
Pipeline and Hazardous Materials Safety Administration, U.S. Department
of Transportation, East Building, PHH-13, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Copies of the applications are available for
inspection in the Records Center, East Building, PHH-13, 1200 New
Jersey Avenue Southeast, Washington, DC.
    This notice of receipt of applications for special permit is
published in accordance with part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on August 5, 2021.
Donald P. Burger,
Chief, General Approvals and Permits Branch.

                                              Special Permits Data
----------------------------------------------------------------------------------------------------------------
                                                                                Nature of the special permits
       Application No.                 Applicant          Regulation(s) affected              thereof
----------------------------------------------------------------------------------------------------------------
14206-M......................  Hexagon Digital Wave LLC  180.205, 172.203(a),      To modify the special permit
                                                          172.301(c).               to authorize DOT-SP 14157
                                                                                and DOT-SP 13488 cylinders.
                                                                                (modes 1, 2, 3, 4, 5)
14287-M......................  Troxler Electronic        173.465, 173.410,         To modify the special permit
                                Laboratories, Inc.        173.411, 173.412,         to authorize additional
                                                          173.415.                  portable nuclear gauges.
                                                                                (modes 1, 3, 4)
20336-M......................  Geotek Coring Inc.......  173.3(d)................  To modify the special permit
                                                                                to authorize up to 36
                                                                                salvage cylinders in an ISO
                                                                                container. (modes 1, 3)
21139-M......................  KULR Technology           172.200, 172.700(a).....  To modify the special permit
                                Corporation.                                        to authorize the
                                                                                transportation of lithium
                                                                                batteries transported for
                                                                                purposes of recycling,
                                                                                reuse, refurbishment,
                                                                                repurposing, or evaluation.
                                                                                (modes 1, 2)
21195-M......................  Panasonic Energy          173.185(c)..............  To modify the special permit
                                Corporation of America.                             to authorize additional
                                                                                packaging. (mode 1)
21249-M......................  Romeo Systems, Inc......  172.101(j)..............  To modify the special permit
                                                                                to authorize the use of two
                                                                                additional production
                                                                                modules. (mode 4)
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2021-17149 Filed 8-11-21; 8:45 am]
BILLING CODE P


[Federal Register Volume 88, Number 147 (Wednesday, August 2, 2023)]
[Notices]
[Page 50896]
[FR Doc No: 2023-16352]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4715-DR; Docket ID FEMA-2023-0001]

Guam; Amendment No. 1 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the territory of Guam (FEMA-4715-DR), dated May 25, 2023, and
related determinations.

DATES: This amendment was issued May 28, 2023.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the territory of Guam is hereby amended to include Individual
Assistance for the following areas among those areas determined to have
been adversely affected by the event declared a major disaster by the
President in his declaration of May 25, 2023.

    The territory of Guam for Individual Assistance (already
designated for emergency protective measures [Category B], including
direct federal assistance under the Public Assistance program).
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-16352 Filed 8-1-23; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 79, Number 77 (Tuesday, April 22, 2014)]
[Notices]
[Pages 22499-22501]
[FR Doc No: 2014-09123]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0374]

Postmarketing Requirements for the Class-Wide Extended-Release/
Long-Acting Opioid Analgesics; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to obtain stakeholder input on the design and conduct of the
postmarketing requirements (PMRs) for the class-wide extended-release/
long-acting (ER/LA) opioid analgesic drug products to further assess
the serious risks of misuse, abuse, hyperalgesia, addiction, overdose,
and death associated with their long-term use.
    FDA is seeking input on these issues from stakeholders, including
patients, academia, researchers, State and other Federal regulators,
health care organizations, health care providers, the pharmaceutical
industry, and others from the general public.

DATES: The public meeting will be held on May 19 and 20, 2014, from 8
a.m. to 5 p.m. Individuals who wish to present at the meeting must
register by May 9, 2014. See section III under the SUPPLEMENTARY
INFORMATION section for information on how to register to speak at the
meeting.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Participants must enter
through Building 1 and undergo security screening. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit either electronic or written comments by June 19, 2014.
Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. Identify all comments with the docket number found in brackets
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Janelle Derbis, Center for Drug
Evaluation and Research, Food and Drug Administration, 20 North
Michigan Ave., Suite 510, Chicago, IL 60602,<PHONE_NUMBER>, FAX: 312-
886-

1682, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is committed to improving the safe and appropriate use of ER/LA
opioid analgesics and preserving appropriate access for those patients
who rely on these medications to manage their pain. In May 2012, FDA
hosted a scientific workshop to discuss the assessment of analgesic
treatment of chronic pain, during which presenters raised concerns
about the safe and appropriate use of opioid analgesics.\1\ Over the
past 2 years, FDA has reviewed numerous submissions to Agency dockets,
including citizen petitions and comments to petitions, and relevant
literature about the benefits and risks associated with opioid drug
products, including the serious risks of misuse, abuse, hyperalgesia,
addiction, overdose, and death associated with the long-term use of ER/
LA opioid analgesics. FDA has concluded that more data are needed
regarding these serious risks.
---------------------------------------------------------------------------

    \1\ Assessment of Analgesic Treatment of Chronic Pain: A
Scientific Workshop (see http://www.fda.gov/Drugs/NewsEvents/ucm283979.htm). Information and comments from that workshop are
available at www.regulations.gov, Docket No. FDA-2012-N-0067.
---------------------------------------------------------------------------

    FDA described these data requirements in its September 10, 2013,
letter to all new drug application (NDA) applicants for ER/LA opioid
analgesics. Data are needed to address the following issues:
     The incidence of and risk factors for misuse, abuse,
addiction, overdose, and death associated with long-term use of opioids
for chronic pain.
     Validated measures of misuse, abuse, addiction, overdose,
and death.
     Validated coded medical terminologies used to identify
misuse, abuse, addiction, overdose, and death.
     Validated definitions of ``doctor/pharmacy shopping'' as
outcomes suggestive of misuse, abuse, and addiction.
     The serious risk of developing hyperalgesia following use
of ER/LA opioid analgesics for at least 1 year to treat chronic pain.
    In the September 10, 2013, letter, FDA informed the ER/LA opioid
analgesic NDA application holders of the requirement to conduct
postapproval studies (also referred to as postmarketing requirements or
PMRs) and established milestone dates for completion of those studies,
which include observational studies and a clinical trial (see section
II for more details). The deadline for the applicants' final protocol
submissions is August 2014.

II. Purpose and Scope of Meeting

    The purpose of this public meeting is to obtain stakeholder input
on the design and conduct of the PMRs (described in the following
paragraph) for the ER/LA opioid analgesic drug products to assess the
serious risks of misuse, abuse, hyperalgesia, addiction, overdose, and
death associated with their long-term use. FDA and NDA applicants will
consider stakeholder input when preparing final protocols to be
submitted by August 2014.
    The PMRs described in FDA's September 10, 2013, letter to NDA
applicants of ER/LA opioid analgesics are as follows:
    (1) PMR  2065-1: Conduct one or more studies to provide
quantitative estimates of the serious risks of misuse, abuse,
addiction, overdose, and death associated with long-term use of opioid
analgesics for management of chronic pain among patients prescribed ER/
LA opioid products. Include an assessment of risk relative to efficacy.
    These studies should address at a minimum the following specific
aims:
    a. Estimate the incidence of misuse, abuse, addiction, overdose,
and death associated with long-term use of opioids for chronic pain.
Stratify misuse and overdose by intentionality wherever possible.
Examine the effect of product/formulation, dose and duration of opioid
use, prescriber specialty, indication, and other clinical factors
(e.g., concomitant psychotropic medications, personal or family history
of substance abuse, and history of psychiatric illness) on the risk of
misuse, abuse, addiction, overdose, and death.
    b. Evaluate and quantify other risk factors for misuse, abuse,
addiction, overdose, and death associated with long-term use of opioids
for chronic pain, including, but not limited to, the following:
Demographic factors, psychosocial/behavioral factors, medical factors,
and genetic factors. Identify confounders and effect modifiers of
individual risk factor/outcome relationships. Stratify misuse and
overdose by intentionality wherever possible.
    (2) PMR  2065-2: Develop and validate measures of the
following opioid-related adverse events: Misuse, abuse, addiction,
overdose, and death (based on the Department of Health and Human
Services' definition, or any agreed upon definition), which will be
used to inform the design and analysis for PMR  2065-1 and any
future postmarketing safety studies and clinical trials to assess these
risks. This can be achieved by conducting an instrument development
study or a validation study of an algorithm based on secondary data
sources.
    (3) PMR  2065-3: Conduct a study to validate coded medical
terminologies (e.g., ICD9, ICD10, and SNOMED) used to identify the
following opioid-related adverse events: Misuse, abuse, addiction,
overdose, and death in any existing postmarketing databases to be
employed in the studies. Stratify misuse and overdose by intentionality
wherever possible. These validated codes will be used to inform the
design and analysis for PMR  2065-1.
    (4) PMR  2065-4: Conduct a study to define and validate
``doctor/pharmacy shopping'' as outcomes suggestive of misuse, abuse,
and addiction. These validated codes will be used to inform the design
and analysis for PMR  2065-1.
    (5) PMR  2065-5: Conduct a clinical trial to estimate the
serious risk for the development of hyperalgesia following use of ER/LA
opioid analgesics for at least 1 year to treat chronic pain. We
strongly encourage you to use the same trial to assess the development
of tolerance following use of ER/LA opioid analgesics. Include an
assessment of risk relative to efficacy.

III. Attendance and Registration

    Attendance is free and will be on a first-come, first-served basis.
Individuals who wish to present at the public meeting must register on
or before May 9, 2014, at https://erlaopioidpmrmeeting.eventbrite.com.
In section II, FDA has listed the PMRs. You should identify which
PMR(s) you wish to address in your presentation, or whether your
comments apply to all PMRs, so FDA can consider that in organizing the
presentations. FDA will do its best to accommodate requests to speak
and will determine the amount of time allotted to each presenter and
the approximate time that each oral presentation is scheduled to begin.
An agenda and additional meeting background material will be available
approximately 2 weeks before the meeting at http://www.fda.gov/Drugs/NewsEvents/ucm384489.htm.
    Individuals who wish to attend the meeting but do not wish to make
a presentation should register by May 12, 2014. Onsite registration on
the day of the meeting will be based on space availability.
    If you need special accommodations due to a disability, please
contact Janelle Derbis (see FOR FURTHER

INFORMATION CONTACT) at least 7 days in advance.
    A live Web cast of this meeting will be viewable at https://collaboration.fda.gov/opmr/ on the day of the meeting. A video record
of the meeting will be available at the same Web address for 1 year.

IV. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. To ensure
consideration, submit comments by June 19, 2014. Received comments may
be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

V. Transcripts

    As soon as possible after a transcript of the public meeting is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see ADDRESSES). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.

    Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09123 Filed 4-21-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)]
[Rules and Regulations]
[Pages 37542-37545]
[FR Doc No: 2015-16251]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2015-0436]
RIN 1625-AA00

Safety Zone; Three Rivers Regatta/Three River Regatta and
Fireworks, Ohio River, Mile 0.5 to Mile 0.5 on the Allegheny River and
Mile 0.5 on the Monongahela River; Pittsburgh, PA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone from
mile 0.5 Ohio River up-bound to mile 0.5 on the Allegheny River and
mile 0.5 on the Monongahela River, extending the entire width of the
rivers. This action is necessary to ensure public safety due to the
inherent hazards associated with launching fireworks from a barge and
the explosive nature of the fireworks display. During the enforcement
period, entry into, transiting, or anchoring in the safety zone is
prohibited to all vessels not registered with the sponsor as
participants or official patrol vessels, unless specifically authorized
by the Captain of the Port (COTP) Pittsburgh or a designated
representative.

DATES: This rule is effective and will be enforced with actual notice
on July 3, 2015 from 12:00 p.m. to 10:00 p.m., on July 4, 2015 from
12:00 p.m. to 10:00 p.m. and on July 5, 2015 from 12:00 p.m. to 10:00
p.m.

ADDRESSES: Documents mentioned in this preamble are part of docket
USCG-2015-0436. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the

Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Ariana Mohnke, Marine Safety Unit Pittsburgh, U.S. Coast
Guard, at telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If
you have questions on viewing or submitting material to the docket,
call Cheryl F. Collins, Program Manager, Docket Operations, telephone
(202) 366-9826.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    On June 11, 2015, we published a final rule entitled ``Annual
fireworks displays and other events in the Eighth Coast Guard District
requiring safety zones'' in the Federal Register (79 FR 222398). In
that rulemaking, the Coast Guard established a permanent safety zone
for the annual ``Three Rivers Regatta/Three River Regatta and
Fireworks'', listed in Table no. 1 to 33 CFR 165.801 at Line no. 43. On
June 15, 2015, we published a notice of proposed rulemaking (NPRM)
entitled ``Three Rivers Regatta/Three River Regatta and Fireworks'' in
the Federal Register. We received no comments on the proposed rule. No
public meeting was requested, and none was held.
    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not using the NPRM process with respect to this rule
because it is unnecessary and contrary to public interest.
    On May 20, 2015, the sponsor notified the Coast Guard that it
intended to hold the event on July 3-5, 2015 at a location from mile
0.5 Ohio River up-bound to mile 0.5 on the Allegheny River and mile 0.5
on the Monongahela River, extending the entire width of the rivers.
According to Table no. 1 to 33 CFR 165.801, the event is to be held
during two days the week of July 4th and is to be located at: Ohio
River, Mile 0.0-0.5, Allegheny River, Mile 0.0-0.5, and Monongahela
River, Mile 0.0-0.5. After full review of the event information and
location, the Coast Guard determined that the published annual event
differs from the intended dates and location for the event being held
this year. A safety zone is necessary. Therefore, to mitigate the
potential danger to spectators and participants, the Coast Guard is
establishing a temporary safety zone. Any delay or cancellation of the
event in order to allow for a notice and comment period is contrary to
the public interest in not having the event occur on the dates and in
the location proposed by the sponsor and advertised to the public and
could potentially interfere with contractual obligations. Completing
the full NPRM process would be impracticable. Delaying this rule by
completing the full NPRM process would unnecessarily delay the safety
zone and be contrary to public interest because the safety zone is
needed to protect transiting vessels, spectators, and the personnel
involved in the display from the hazards associated with fireworks
displays taking place over the waterway.
    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. Delaying this rule would be
unnecessary as this event is a recurring event and mariners familiar
with the waterway are aware that the regatta and celebrations related
to Independence Day activities occur yearly on this waterway. This year
the event will occur over the course of three days, as opposed to the
published time period of two days, as per the Federal Register. In
addition, the event will take place very near to the published
location, approximately 0.1 miles distant from the published location
in the Federal Register. Delaying this rule would be contrary to the
public interest of ensuring the safety of spectators and vessels during
the event and immediate action is necessary to prevent possible loss of
life or property. Also a delay or cancellation of the event in order to
allow for publication in the Federal Register is contrary to the
public's interest in having this event occur as scheduled. Broadcast
Notices to Mariners (BNM) and information sharing with the waterway
users will update mariners of the restrictions, requirements, and
enforcement times during this temporary situation.

B. Basis and Purpose

    This regulation is necessary to ensure the safety of vessels,
spectators and participants from hazards associated with and resulting
from the 2015 Three Rivers Regatta/Three River Regatta and Fireworks
events. Based on the inherent hazards associated with a fireworks show
and an on-water regatta event, the COTP Pittsburgh has determined that
a fireworks display and a marine regatta pose a significant risk to
watercraft, participant safety, spectator safety, public safety and
property. The combination of increased numbers of recreational vessels
and potential debris falling on passing or anchored spectator vessels
has the potential to result in serious injuries or fatalities. This
regulation temporarily establishes a zone to restrict vessel movement
through and around the location of the regatta and the fireworks
display in order to reduce the risks associated with these events.
    The legal basis and authorities for this rule are found in 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, which
collectively authorize the Coast Guard to establish and define
regulatory safety zones.

C. Discussion of the Final Rule

    The Coast Guard is establishing a safety zone for the 2015 Three
Rivers Regatta/Three River Regatta and Fireworks from mile 0.5 Ohio
River up-bound to mile 0.5 on the Allegheny River and mile 0.5 on the
Monongahela River, extending the entire width of the rivers. This
temporary safety zone will be enforced with actual notice from 12:00
p.m. to 10:00 p.m. on July 3-5, 2015, daily. Additionally, prior to the
fireworks displays, there will be boat races and therefore, for the
safety of those involved in the boat races as well as the general
public attempting to transit through this location, a safety zone will
be enforced. The public will be informed of the enforcement periods by
local notice to mariners. Should there be any subsequent changes or
shortening of enforcement periods, the public will be notified via
broadcast notice to mariners.
    This rule establishing a temporary safety zone is necessary to
ensure the safety of spectators and vessels from hazards associated
with the event.
    Deviation from this temporary safety zone is prohibited unless
specifically authorized by the COTP Pittsburgh, or a designated
representative. Deviation requests will be considered and reviewed on a
case-by-case basis.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking.

Below we summarize our analyses based on a number of these statutes or
executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. It is not
``significant'' under the regulatory policies and procedures of the
Department of Homeland Security (DHS). This rule is limited in scope
and will be in effect for a limited time period. The temporary safety
zone will be in effect for ten hours on each of three consecutive days.
The Coast Guard expects minimum adverse impact to mariners from the
zone's activation as the event has been advertised to the public. Also,
mariners may request authorization from the COTP Pittsburgh or the
designated representative to transit the zone. Notifications to the
marine community will be made through local notice to mariners and
broadcast notice to mariners. The impacts on routine navigation are
expected to be minimal.

2. 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 rule
will not have a significant economic impact on a substantial number of
small entities. This rule will affect the following entities, some of
which may be small entities: The owners or operators of vessels
intending to transit from mile 0.5 Ohio River up-bound to mile 0.5 on
the Allegheny River and mile 0.5 on the Monongahela River, extending
the entire width of the rivers from 12:00 p.m. to 10:00 p.m. on July 3,
2015 and July 4, 2015 and July 5, 2015. This safety zone will not have
a significant economic impact on a substantial number of small entities
because this rule is limited in scope, will only be in effect for a
limited time period, and notifications to the marine community will be
made to those that could be operating in the area during the event.
Additionally, waterway users can use the portions of the channel not
affected by the safety zone. Deviation from the rule may be requested
and will be considered on a case-by-case basis by the COTP or a
designated representative.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

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

5. Federalism

    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 rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

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

7. Unfunded Mandates Reform Act

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

8. Taking of Private Property

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

9. Civil Justice Reform

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

10. Protection of Children

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

11. Indian Tribal Governments

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

12. Energy Effects

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

13. Technical Standards

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

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
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 rule establishes a temporary safety zone from mile
0.5 Ohio River up-bound to mile 0.5 on the Allegheny River and mile 0.5
on the Monongahela River, extending the entire width of the rivers.
This rule is categorically excluded from further review under paragraph
34(g) of figure 2-1 of the Commandant Instruction an environmental
analysis checklist supporting this determination and a Categorical
Exclusion Determination are available in the docket where indicated
under ADDRESSES. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this rule.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
2. A new temporary Sec.  165.T08-0436 is added to read as follows:

Sec.  165.T08-0436  Safety Zone; Three Rivers Regatta/Three River
Regatta and Fireworks, Ohio River mile 0.5 to mile 0.5 on the Allegheny
River and mile 0.5 on the Monongahela River; Pittsburgh, PA.

    (a) Location. The following area is a safety zone: Ohio River mile
0.5 to mile 0.5 on the Allegheny River and mile 0.5 on the Monongahela
River.
    (b) Effective date. This rule is effective, and will be enforced
through actual notice, from July 3, 2015 through July 5, 2015 from
12:00 p.m. through 10:00 p.m., daily.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into this zone is prohibited unless
authorized by the COTP Pittsburgh or a designated representative.
    (2) Persons or vessels requiring entry into or passage through the
zone must request permission from the COTP Pittsburgh or a designated
representative. The COTP Pittsburgh representative may be contacted at
412-221-0807.
    (3) All persons and vessels shall comply with the instructions of
the COTP Pittsburgh or their designated representative. Designated COTP
representatives include United States Coast Guard commissioned,
warrant, and petty officers.
    (d) Information broadcasts. The COTP Pittsburgh or a designated
representative will inform the public through broadcast notices to
mariners of the enforcement period for the safety zone as well as any
changes in the planned schedule.

    Dated: June 15, 2015.
L.N. Weaver,
Commander, U.S. Coast Guard, Captain of the Port.
[FR Doc. 2015-16251 Filed 6-30-15; 8:45 am]
 BILLING CODE 9110-04-P