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]


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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