Special Local Regulations; Marine Events Within the Captain of the Port Zone Columbia River, 24028-24029 [2019-10890]
Download as PDF
khammond on DSKBBV9HB2PROD with RULES
24028
Federal Register / Vol. 84, No. 101 / Friday, May 24, 2019 / Rules and Regulations
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–2011 for ‘‘Section 503A Bulks
List Final Rule Questions and Answers;
Guidance for Industry; Small Entity
Compliance Guide; Availability.’’
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/201523389.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 SECG to the Division of
Drug Information, Center for Drug
Evaluation and Research, Food and
VerDate Sep<11>2014
16:08 May 23, 2019
Jkt 247001
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 SECG.
FOR FURTHER INFORMATION CONTACT:
Rosilend Lawson, Center for Drug
Evaluation and Research, Office of
Unapproved Drugs and Labeling
Compliance, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 5197, Silver Spring,
MD 20993–0002, 240–402–6223,
Rosilend.Lawson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
www.regulations.gov. Use the FDA
website listed in the previous sentence
to find the most current version of the
guidance.
Dated: May 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–10953 Filed 5–23–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
I. Background
In the Federal Register of February
19, 2019 (84 FR 4696), we issued a final
rule establishing the list of bulk drug
substances that can be used in
compounding under section 503A of the
FD&C Act (the final rule) (21 U.S.C.
353a). The final rule, entitled ‘‘List of
Bulk Drug Substances That Can Be Used
To Compound Drug Products in
Accordance With Section 503A of the
Federal Food, Drug, and Cosmetic Act,’’
is codified at 21 CFR 216.23 and became
effective March 21, 2019.
We examined the economic
implications of the final rule as required
by the Regulatory Flexibility Act (5
U.S.C. 601–612) and, because we do not
have enough information about the
effect of the final rule on small entities,
determined that the final rule will have
a significant economic impact on a
substantial number of small entities. In
compliance with section 212 of the
Small Business Regulatory Enforcement
Fairness Act (Pub. L. 104–121, as
amended by Pub. L. 110–28), we are
making available the SECG to explain
the actions that a small entity must take
to comply with the rule.
We are issuing the SECG consistent
with our good guidance practices
regulation (21 CFR 10.115). The SECG
represents the current thinking of FDA
on the final rule. 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.
Persons with access to the internet
may obtain the SECG at either https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
Frm 00038
Fmt 4700
Special Local Regulations; Marine
Events Within the Captain of the Port
Zone Columbia River
AGENCY:
Coast Guard, DHS.
Notice of enforcement of
regulation.
ACTION:
The Coast Guard will enforce
special local regulations at eight
locations in the Sector Columbia River
Captain of the Port zone during the
dates and times noted in this document.
This action is necessary to prevent
injury and to protect life and property
of the maritime public from the hazards
associated with special marine events.
These regulations prohibit persons and
vessels from entry into, transit through,
mooring, anchoring, or loitering within
the regulated area unless authorized by
the Captain of the Port, Sector Columbia
River or their designated representative.
SUMMARY:
The regulations in 33 CFR
100.1302 will be enforced for the eight
regulated areas identified in the
SUPPLEMENTARY INFORMATION section
below for the dates and times specified
in this document.
DATES:
If
you have questions about this notice of
enforcement, call or email LCDR Dixon
Whitley, Waterways Management
Division, Marine Safety Unit Portland,
Coast Guard; telephone 503–240–9319,
email msupdxwwm@uscg.mil.
FOR FURTHER INFORMATION CONTACT:
The Coast
Guard will enforce special local
regulations established in 33 CFR
100.1302 for the following eight events
during the hours specified on the dates
and at the locations listed in the
following Table:
SUPPLEMENTARY INFORMATION:
II. Electronic Access
PO 00000
[Docket No. USCG–2019–0357]
Sfmt 4700
E:\FR\FM\24MYR1.SGM
24MYR1
Federal Register / Vol. 84, No. 101 / Friday, May 24, 2019 / Rules and Regulations
24029
TABLE—DATES AND TIMES OF ENFORCEMENT OF 33 CFR 100.1302 SPECIAL LOCAL REGULATIONS AT VARIOUS
LOCATIONS IN THE SECTOR COLUMBIA RIVER CAPTAIN OF THE PORT ZONE IN 2019
No.
Date
Event
1 ..............
May 31, 2019, 9
a.m. to 5 p.m.
2 ..............
June 8, 2019–
Rose Fest DragJune 9, 2019, 7
on Boat Races.
a.m. to 4 p.m.
June 28, 2019–
Richland Regatta
June 30, 2019,
Hydroplane
8 a.m. to 7 p.m.
races.
July 13, 2019, 11 The Big Float,
a.m. to 7 p.m.
group innertube float.
3 ..............
4 ..............
Spring Testing
Hydroplane
races.
Sponsor
Location
Tri-Cities Water
Follies Association.
Kennewick, WA. Regulated area includes all navigable waters within
the Columbia River in the vicinity of Columbia Park, commencing at
the Interstate 395 Bridge and continuing up river approximately 2.0
miles and terminating at the northern end of Wade Island.
Portland, OR. Regulated area includes all waters of the Willamette
River shore to shore, bordered on the north by the Hawthorne
Bridge, and on the south by the Marquam Bridge.
Richland, WA. Regulated area includes all navigable waters of the Columbia River in the vicinity of Howard Amon Park, between River
Miles 337 and 338.
Portland, OR. Regulated area includes all navigable waters of the Willamette River, in Portland, Oregon, enclosed by the Hawthorne
Bridge, the Marquam Bridge, and west of a line beginning at the
Hawthorne Bridge at approximate location 45°30′50″ N; 122°40′21″
W, and running south to the Marquam Bridge at approximate location 45°30′27″ N; 122°40′11″ W.
Kennewick, WA. Regulated area includes all navigable waters within
the Columbia River in the vicinity of Columbia Park, commencing at
the Interstate 395 Bridge and continuing up river approximately 2.0
miles and terminating at the northern end of Wade Island.
Perry, WA. Regulated area includes all navigable waters, bank-to-bank
of the Snake River, 500 yards upstream and 500 yards downstream
from the Washington State Highway 261 Bridge at the approximate
position of 46°35′23″ N; 118°13′10″ W.
Pasco, WA. Regulated area includes all navigable waters, bank-tobank of the Columbia River in Pasco, Washington, between river
mile 332 and river mile 335.
Portland, OR. Regulated area includes the western side of the Willamette River extending from Tom McCall Waterfront Park between the
Hawthorne and Marquam Bridges, Portland, OR: Line one starting at
45–30′49″ N/122–40′24″ W then heading east to 45–30′49″ N/122–
40′22″ W then heading south to 45–30′29″ N/122–40′08″ W then
heading west to 45–30′26″ N/122–40′14″ W then heading north ending at 45–30′49″N/122–40′24″ W.
PortlandKaohsiung Sister Association.
Northwest Power
Boat Association.
Human Access
Project.
5 ..............
July 26, 2019–
Kennewick HyTri-Cities Water
July 28, 2019,
droplane Races.
Follies Associa6 a.m. to 6 p.m.
tion.
6 ..............
August 10, 2019,
11 a.m. to 1
p.m.
Swim the Snake
7 ..............
September 7,
2019, 9 a.m. to
10:30 a.m.
September 7,
2019– September 8,
2019, 8 a.m. to
6 p.m.
Columbia Crossing Swim.
Blue Mountain
Resource Conservation and
Development.
3 Rivers Road
Runners.
Portland Dragon
Boat Races.
DragonSports
USA.
8 ..............
All coordinates are listed in reference Datum NAD 1983.
khammond on DSKBBV9HB2PROD with RULES
The special requirements listed in 33
CFR 100.1302 apply to the activation
and enforcement of these special local
regulations. All vessel operators who
desire to enter the designated zone must
obtain permission from the Captain of
the Port or their Designated
Representative. The Coast Guard may be
assisted by other Federal, State, or local
law enforcement agencies in enforcing
this regulation.
In addition to this notice of
enforcement in the Federal Register, the
Coast Guard will provide notification of
this enforcement period via the Local
Notice to Mariners and marine
information broadcasts.
Dated: May 20, 2019.
J.C. Smith,
Captain, U.S. Coast Guard, Captain of the
Port Columbia River.
[FR Doc. 2019–10890 Filed 5–23–19; 8:45 am]
BILLING CODE 9110–04–P
VerDate Sep<11>2014
16:08 May 23, 2019
Jkt 247001
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2019–0288]
Safety Zones; Annual Events in the
Captain of the Port Buffalo Zone
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
The Coast Guard will enforce
certain safety zones located in federal
regulations for Annual Events in the
Captain of the Port Buffalo. This action
is necessary and intended to protect the
safety of life and property on navigable
waters prior to, during, and immediately
after these events. During each
enforcement period, no person or vessel
may enter the respective safety zone
without the permission of the Captain of
the Port Buffalo.
DATES: The regulations in 33 CFR
165.939(b)(1), as listed in Table 165.939,
SUMMARY:
PO 00000
Frm 00039
Fmt 4700
Sfmt 4700
will be enforced from 6:15 a.m. through
10:45 a.m. on July 21, 2019.
The regulations in 33 CFR
165.939(b)(4), as listed in Table 165.939,
will be enforced from 9:15 p.m. through
10:15 p.m. on July 4, 2019.
The regulations in 33 CFR
165.939(b)(6), as listed in Table 165.939,
will be enforced from 8:45 p.m. through
11:45 p.m. on July 27, 2019.
The regulations in 33 CFR
165.939(b)(12), as listed in Table
165.939, will be enforced from 6:45 a.m.
through 10:45 a.m. on July 13, 2019.
The regulations in 33 CFR
165.939(d)(2), as listed in Table 165.939,
will be enforced daily from 9 a.m.
through 6 p.m. August 30, 2019 through
September 2, 2019.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this notice of
enforcement, call or email LT Ryan
Junod, Chief of Waterways Management,
U.S. Coast Guard Marine Safety Unit
Cleveland; telephone (216) 937–0124,
email ryan.s.junod@uscg.mil.
SUPPLEMENTARY INFORMATION: The Coast
Guard will enforce the Safety Zones;
Annual Events in the Captain of the Port
E:\FR\FM\24MYR1.SGM
24MYR1
Agencies
[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Rules and Regulations]
[Pages 24028-24029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10890]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG-2019-0357]
Special Local Regulations; Marine Events Within the Captain of
the Port Zone Columbia River
AGENCY: Coast Guard, DHS.
ACTION: Notice of enforcement of regulation.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard will enforce special local regulations at
eight locations in the Sector Columbia River Captain of the Port zone
during the dates and times noted in this document. This action is
necessary to prevent injury and to protect life and property of the
maritime public from the hazards associated with special marine events.
These regulations prohibit persons and vessels from entry into, transit
through, mooring, anchoring, or loitering within the regulated area
unless authorized by the Captain of the Port, Sector Columbia River or
their designated representative.
DATES: The regulations in 33 CFR 100.1302 will be enforced for the
eight regulated areas identified in the SUPPLEMENTARY INFORMATION
section below for the dates and times specified in this document.
FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email LCDR Dixon Whitley, Waterways
Management Division, Marine Safety Unit Portland, Coast Guard;
telephone 503-240-9319, email [email protected].
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce special local
regulations established in 33 CFR 100.1302 for the following eight
events during the hours specified on the dates and at the locations
listed in the following Table:
[[Page 24029]]
Table--Dates and Times of Enforcement of 33 CFR 100.1302 Special Local Regulations at Various Locations in the
Sector Columbia River Captain of the Port Zone in 2019
----------------------------------------------------------------------------------------------------------------
No. Date Event Sponsor Location
----------------------------------------------------------------------------------------------------------------
1................. May 31, 2019, 9 a.m. Spring Testing Tri-Cities Water Kennewick, WA. Regulated
to 5 p.m. Hydroplane races. Follies Association. area includes all
navigable waters within
the Columbia River in
the vicinity of Columbia
Park, commencing at the
Interstate 395 Bridge
and continuing up river
approximately 2.0 miles
and terminating at the
northern end of Wade
Island.
2................. June 8, 2019-June 9, Rose Fest Dragon Portland-Kaohsiung Portland, OR. Regulated
2019, 7 a.m. to 4 Boat Races. Sister Association. area includes all waters
p.m. of the Willamette River
shore to shore, bordered
on the north by the
Hawthorne Bridge, and on
the south by the Marquam
Bridge.
3................. June 28, 2019-June Richland Regatta Northwest Power Boat Richland, WA. Regulated
30, 2019, 8 a.m. to Hydroplane races. Association. area includes all
7 p.m. navigable waters of the
Columbia River in the
vicinity of Howard Amon
Park, between River
Miles 337 and 338.
4................. July 13, 2019, 11 The Big Float, group Human Access Project Portland, OR. Regulated
a.m. to 7 p.m. inner-tube float. area includes all
navigable waters of the
Willamette River, in
Portland, Oregon,
enclosed by the
Hawthorne Bridge, the
Marquam Bridge, and west
of a line beginning at
the Hawthorne Bridge at
approximate location
45[deg]30'50'' N;
122[deg]40'21'' W, and
running south to the
Marquam Bridge at
approximate location
45[deg]30'27'' N;
122[deg]40'11'' W.
5................. July 26, 2019-July Kennewick Hydroplane Tri-Cities Water Kennewick, WA. Regulated
28, 2019, 6 a.m. to Races. Follies Association. area includes all
6 p.m. navigable waters within
the Columbia River in
the vicinity of Columbia
Park, commencing at the
Interstate 395 Bridge
and continuing up river
approximately 2.0 miles
and terminating at the
northern end of Wade
Island.
6................. August 10, 2019, 11 Swim the Snake...... Blue Mountain Perry, WA. Regulated area
a.m. to 1 p.m. Resource includes all navigable
Conservation and waters, bank-to-bank of
Development. the Snake River, 500
yards upstream and 500
yards downstream from
the Washington State
Highway 261 Bridge at
the approximate position
of 46[deg]35'23'' N;
118[deg]13'10'' W.
7................. September 7, 2019, 9 Columbia Crossing 3 Rivers Road Pasco, WA. Regulated area
a.m. to 10:30 a.m. Swim. Runners. includes all navigable
waters, bank-to-bank of
the Columbia River in
Pasco, Washington,
between river mile 332
and river mile 335.
8................. September 7, 2019- Portland Dragon Boat DragonSports USA.... Portland, OR. Regulated
September 8, 2019, 8 Races. area includes the
a.m. to 6 p.m. western side of the
Willamette River
extending from Tom
McCall Waterfront Park
between the Hawthorne
and Marquam Bridges,
Portland, OR: Line one
starting at 45-30'49'' N/
122-40'24'' W then
heading east to 45-
30'49'' N/122-40'22'' W
then heading south to 45-
30'29'' N/122-40'08'' W
then heading west to 45-
30'26'' N/122-40'14'' W
then heading north
ending at 45-30'49''N/
122-40'24'' W.
----------------------------------------------------------------------------------------------------------------
All coordinates are listed in reference Datum NAD 1983.
The special requirements listed in 33 CFR 100.1302 apply to the
activation and enforcement of these special local regulations. All
vessel operators who desire to enter the designated zone must obtain
permission from the Captain of the Port or their Designated
Representative. The Coast Guard may be assisted by other Federal,
State, or local law enforcement agencies in enforcing this regulation.
In addition to this notice of enforcement in the Federal Register,
the Coast Guard will provide notification of this enforcement period
via the Local Notice to Mariners and marine information broadcasts.
Dated: May 20, 2019.
J.C. Smith,
Captain, U.S. Coast Guard, Captain of the Port Columbia River.
[FR Doc. 2019-10890 Filed 5-23-19; 8:45 am]
BILLING CODE 9110-04-P