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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations
on that firms knowledge that such device was being prescribed or used by health care providers for such use. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he or she received the article, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses.
Dated: July 14, 2021.
Janet Woodcock, Acting Commissioner of Food and Drugs.
Dated: July 22, 2021.
Xavier Becerra, Secretary, Department of Health and Human Services.
FR Doc. 202115980 Filed 73021; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HOMELAND
SECURITY
Coast Guard 33 CFR Part 165
Docket Number USCG20210480
RIN 1625AA00

Safety Zone; Lake of the Ozarks, Mile Markers 7, 10.5, 13, 16, 22, 26, 34, and 42, Lake of the Ozarks, MO
Coast Guard, DHS.
Temporary final rule.

AGENCY:
ACTION:

The Coast Guard is establishing temporary safety zones in all navigable waters extending 420 feet in all directions around fireworks barges at eight different locations on the Lake of the Ozarks. These safety zones are needed to protect personnel, vessels, and the marine environment from potential hazards created by the fireworks displays. Entry of vessels or persons into these zones is prohibited unless specifically authorized by the Captain of the Port Sector Upper Mississippi River or a designated representative.

SUMMARY:

This rule is effective on August 10, 2021 at 10 p.m. to 10:30 p.m.
ADDRESSES: To view documents mentioned in this preamble as being available in the docket, go to https
www.regulations.gov, type USCG2021
0480 in the search box and click Search. Next, in the Document Type column, select Supporting & Related Material.

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DATES:

VerDate Sep<11>2014

16:00 Jul 30, 2021

Jkt 253001

If you have questions on this rule, call or email Lieutenant Commander Stephanie Moore, Sector Upper Mississippi River Waterways Management Division, U.S.
Coast Guard; telephone 3142692560, email Stephanie.R.Moore@uscg.mil.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking Section U.S.C. United States Code
II. Background Information and Regulatory History The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4a of the Administrative Procedure Act APA 5
U.S.C. 553b. 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.
553bB, the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking NPRM
with respect to this rule because it is impracticable. We must establish this safety zone by August 10, 2021 and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.
Under 5 U.S.C. 553d3, the Coast Guard finds that good cause exists for making this rule effective less than 30
days after publication in the Federal Register. Delaying the effective date of this rule would be contrary to the public interest because immediate action is needed to respond to the potential safety hazards associated with the fireworks displays on August 10, 2021.
III. Legal Authority and Need for Rule The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034
previously 33 U.S.C. 1231. The Captain of the Port Sector Upper Mississippi River COTP has determined that potential hazards associated with the fireworks displays on August 10, 2021 will be a safety concern for anyone on the Lake of the Ozarks at the designated launch locations. This rule resulted from a marine event notification stating that there will be fireworks displays to celebrate a bicentinneal birthday on the Lake of the Ozarks. This rule is needed to protect personnel, vessels, and the marine environment in the navigable
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waters within the safety zone before, during, and after the fireworks display.
IV. Discussion of the Rule This rule establishes safety zones on August 10, 2021 from 10 p.m. until 10:30 p.m. The safety zones will be located on all navigable waters extending 420 feet in all directions around fireworks barges at the following locations on the Lake of the Ozarks at 1 mile marker 7 38 1235.20 N 92
4502.57 W, 2 mile marker 10.5 38
0121.93 N 92 4738.93 W, 3 mile marker 13 38 1101.86 N 92 4119.32
W, 4 mile marker 16 38 0854.89 N
92 3829.53 W, 5 mile marker 22 38
0854.89 N 92 4118.95 W, 6 mile marker 26 38 0725.22 N 92 4258.65
W, 7 mile marker 34 38 0725.22 N
92 4734.59 W and 8 mile marker 42
38 0855 N 92 5223.30 W. The duration of these zones is intended to protect personnel, vessels, and the marine environment in these navigable waters before, during, and after the fireworks displays. No vessel or person will be permitted to enter the safety zones without obtaining permission from the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S.
Coast Guard assigned to units under the operational control of USCG Sector Upper Mississippi River. The COTP or a designated representative will inform the public of the enforcement date and times for these safety zones, as well as any emergent safety concerns that may delay the enforcement of the zones.
V. 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 and Executive orders, and we discuss First Amendment rights of protestors.
A. Regulatory Planning and Review Executive Orders 12866 and 13563
direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits.
This rule has not been designated a significant regulatory action, under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget OMB.
This regulatory action determination is based on size, location, and duration of the temporary safety zones. This action involves fireworks displays at multiple designated locations on the
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