Risk Management and Financial Assurance for OCS Lease and Grant Obligations; Correction, 47080-47081 [2024-11914]
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47080
Federal Register / Vol. 89, No. 106 / Friday, May 31, 2024 / Rules and Regulations
the device into the United States in the
future. We do not have enough
information to quantify these benefits.
The destruction of refused devices
will lessen the costs incurred to export
and return refused devices to the
country of origin (the current procedure
for refused devices valued at $2,500 or
less). Express couriers and the U.S.
Postal Service (USPS) will incur
quantified cost savings from exporting
and returning fewer refused devices,
respectively.
Quantified costs of the final rule will
include the costs to FDA to destroy,
rather than return, refused devices
valued at $2,500 or less, and the
additional costs to store these devices at
IMFs prior to destruction. FDA will
additionally incur one-time costs to
update its electronic OASIS and SERIO;
revise its RPM, IOM, and additional
FDA and inter-Agency procedures; and
train employees on the new procedures.
Express couriers will incur one-time
costs to read and understand the rule.
If our assumptions do not hold, FDA
may incur additional costs, including
costs to purchase equipment to destroy
refused devices, costs to train
employees administering the
destruction of refused devices, costs to
notify separately the owners or
consignees of refused devices, and costs
to prepare for hearings on destruction
that the owners or consignees of refused
devices request. We have developed a
comprehensive Economic Analysis of
Impacts that assesses the impacts of the
final rule. The full analysis of economic
impacts is available in the docket for
this rule (Ref. 1) and at https://
www.fda.gov/about-fda/economicsstaff/regulatory-impact-analyses-ria.
IX. Analysis of Environmental Impact
We have determined under 21 CFR
25.30(h) that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
khammond on DSKJM1Z7X2PROD with RULES
X. Paperwork Reduction Act of 1995
This final rule contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
XI. Federalism
We have analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. FDA has
determined that the rule does not
contain policies that have substantial
direct effects on the States, on the
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16:00 May 30, 2024
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relationship between the National
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Accordingly, we
conclude that the rule does not contain
policies that have federalism
implications as defined in the Executive
order and, consequently, a federalism
summary impact statement is not
required.
XII. Consultation and Coordination
With Indian Tribal Governments
We have analyzed this rule in
accordance with the principles set forth
in Executive Order 13175. We have
determined that the rule does not
contain policies that have substantial
direct effects 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.
Accordingly, we conclude that the rule
does not contain policies that have
Tribal implications as defined in the
Executive order and, consequently, a
Tribal summary impact statement is not
required.
XIII. Reference
The following reference is on display
with the Dockets Management Staff (see
ADDRESSES) and is available for viewing
by interested persons between 9 a.m.
and 4 p.m., Monday through Friday; it
also available electronically at https://
www.regulations.gov. Although FDA
verified the website addresses in this
document, please note that websites are
subject to change over time.
1. FDA. Administrative Destruction:
Regulatory Impacts Analysis, Regulatory
Flexibility Analysis, Unfunded Mandates
Reform Act Analysis, 2023. https://
www.fda.gov/about-fda/reports/
economic-impact-analyses-fdaregulations.
List of Subjects in 21 CFR Part 1
Cosmetics, Drugs, Exports, Food
labeling, Imports, Labeling, Reporting,
and recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, the Food and Drug
Administration amends 21 CFR part 1 as
follows:
321, 331, 332, 333, 334, 335a, 342, 343, 350c,
350d, 350j, 352, 355, 360b, 360ccc, 360ccc–
1, 360ccc–2, 362, 371, 374, 381, 382, 384a,
387, 387a, 387c, 393, and 2223; 42 U.S.C.
216, 241, 243, 262, 264, 271.
2. In § 1.94, revise paragraphs (a) and
(c) to read as follows:
■
§ 1.94 Hearing on refusal of admission or
destruction.
(a) If it appears that the article may be
subject to refusal of admission or that
the article is a drug or device that may
be subject to destruction under section
801(a) of the Federal Food, Drug, and
Cosmetic Act, the division director shall
give the owner or consignee a written or
electronic notice to that effect, stating
the reasons therefor. The notice shall
specify a place and a period of time
during which the owner or consignee
shall have an opportunity to introduce
testimony. Upon timely request giving
reasonable grounds therefor, such time
and place may be changed. Such
testimony shall be confined to matters
relevant to the admissibility or
destruction of the article, and may be
introduced orally or in writing.
*
*
*
*
*
(c) If the article is a drug or device
that may be subject to destruction under
section 801(a) of the Federal Food, Drug,
and Cosmetic Act, the division director
may give the owner or consignee a
single written or electronic notice that
provides the notice of refusal of
admission and the notice of destruction
of an article described in paragraph (a)
of this section. The division director
may also combine the hearing on refusal
of admission with the hearing on
destruction of the article described in
paragraph (a) of this section into a single
proceeding.
Dated: May 17, 2024.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2024–11564 Filed 5–30–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF THE INTERIOR
Bureau of Ocean Energy Management
30 CFR Parts 550, 556, and 590
[Docket No. BOEM–2023–0027]
RIN 1010–AE14
PART 1—GENERAL ENFORCEMENT
REGULATIONS
Risk Management and Financial
Assurance for OCS Lease and Grant
Obligations; Correction
1. The authority citation for part 1
continues to read as follows:
AGENCY:
■
Authority: 15 U.S.C. 1333, 1453, 1454,
1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C.
PO 00000
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Bureau of Ocean Energy
Management, Interior.
ACTION: Final rule; correction.
E:\FR\FM\31MYR1.SGM
31MYR1
Federal Register / Vol. 89, No. 106 / Friday, May 31, 2024 / Rules and Regulations
This document makes a
technical correction in the preamble to
the final rule titled, Risk Management
and Financial Assurance for OCS Lease
and Grant Obligations, which the
Department of the Interior published in
the Federal Register on April 24, 2024.
This correction clarifies that the
effective date of the rule is June 29,
2024.
SUMMARY:
As of May 31, 2024, the rule
published on April 24, 2024 (89 FR
31544), effective June 24, 2024, is
corrected to be effective June 29, 2024.
This correction is effective June 29,
2024.
DATES:
FOR FURTHER INFORMATION CONTACT:
Kelley Spence, Office of Regulations,
BOEM, 45600 Woodland Road, Sterling,
Virginia 20166, at email address
Kelley.Spence@boem.gov or at
telephone number (984) 298–7345; and
Karen Thundiyil, Chief, Office of
Regulations, BOEM, 1849 C Street NW,
Washington, DC 20240, at email address
Karen.Thundiyil@boem.gov or at
telephone number (202) 742–0970.
Individuals in the United States who are
deaf, deafblind, hard of hearing, or have
a speech disability may dial 711 (TTY,
TDD, or TeleBraille) to access
telecommunications relay services for
contacting the contacts listed in this
section. These services are available 24
hours a day, 7 days a week, to leave a
message or question with the above
individual. You will receive a reply
during normal business hours.
Individuals outside the United States
should use the relay services offered
within their country to make
international calls to the point-ofcontact in the United States.
The final
rule published April 24, 2024, at 89 FR
31544, contained an incorrect effective
date. It stated the effective date is June
24, 2024. This document corrects the
effective date to June 29, 2024. This
document also makes a correction to
§ 556.901(h).
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with RULES
Corrections
In FR Doc. 2024–08309 appearing on
page 31544 in the Federal Register of
Wednesday, April 24, 2024, the
following corrections are made:
Preamble
1. On page 31544, in the first column,
in the DATES section, the first sentence
is corrected to read ‘‘This final rule is
effective on June 29, 2024.’’
VerDate Sep<11>2014
16:00 May 30, 2024
Jkt 262001
4335 or email Stephanie.E.Lopez@
uscg.mil.
Regulations
§ 556.901
[Corrected]
2. On page 31595, in the first column,
in § 556.901, paragraph (h) introductory
text is corrected to read as follows:
‘‘(h) During the first 3 years from June
29, 2024, you may, upon receipt of a
demand letter for supplemental
financial assurance under this section,
request that the Regional Director allow
you to provide, in three equal
installments payable according to the
schedule provided under this paragraph
(h), the full amount of supplemental
financial assurance required.’’
■
Elizabeth Klein,
Director, Bureau of Ocean Energy
Management.
[FR Doc. 2024–11914 Filed 5–30–24; 8:45 am]
BILLING CODE 4310–MR–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2023–0532]
RIN 1625–AA09
Drawbridge Operation Regulation;
Sloop Channel, Nassau County, NY
Coast Guard, DHS.
Temporary interim rule.
AGENCY:
ACTION:
The Coast Guard is
temporarily modifying the operating
schedule that governs the Meadowbrook
State Parkway Bridge across Sloop
Channel, mile 12.8, at Nassau County,
NY. The bridge is currently operating
under single leaf openings to complete
a bridge rehabilitation; however, during
repairs, the Meadowbrook State
Parkway Bridge experienced electrical
failure in the submarine cables. Until
the bridge repairs are complete the
bridge openings must be minimized.
DATES: This temporary interim rule is
effective May 31, 2024 through 12:01
a.m. on January 2, 2025.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov. Type the docket
number (USCG–2023–0532) in the
‘‘SEARCH’’ box and click ‘‘SEARCH’’. In
the Document Type column, select
‘‘Supporting & Related Material.’’
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
interim rule, call or email, Coast Guard
Bridge Management Specialist,
Stephanie Lopez at telephone 212–514–
SUMMARY:
PO 00000
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47081
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SUPPLEMENTARY INFORMATION:
I. Table of Abbreviations
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Pub. L. Public Law
§ Section
U.S.C. United States Code
NYSDOT New York State Department of
Transportation
TFR Temporary Final Rule
II. Background Information and
Regulatory History
On September 19, 2023, the Coast
Guard issued a general deviation to
NYSDOT allowing the bridge owner,
NYSDOT, to deviate from the current
operating schedule in 33 CFR
117.799(h) for the Meadowbrook State
Parkway Bridge. This deviation allowed
the bridge to operate under single leaf
operations from September 20, 2023, to
March 17, 2024, in order to perform
bridge deck replacement.
Since the actual scope of the work
would take longer than the allowable
time limit of the General Deviation, the
Coast Guard published a notice of
proposed rulemaking (NPRM) on
October 3, 2023, entitled ‘‘Drawbridge
Operation Regulation; Sloop Channel,
Nassau County, NY,’’ in the Federal
Register (88 FR 68033). There we stated
why we issued the NPRM and invited
comments on our proposed regulatory
action related to the rehabilitation of the
Meadowbrook State Parkway Bridge.
During the comment period that ended
November 2, 2023, we received no
comments.
On February 23, 2024, the Coast
Guard published a Temporary Final
Rule (TFR) entitled ‘‘Drawbridge
Operation Regulation; Sloop Channel,
Nassau County, NY,’’ in the Federal
Register (89 FR 13911). There we stated
why we issued the TFR and
implemented the change to the
operating schedule for maintenance of
the bridge.
The Coast Guard is issuing this
Temporary Interim 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), the Coast Guard finds that good
cause exists for not publishing a notice
E:\FR\FM\31MYR1.SGM
31MYR1
Agencies
[Federal Register Volume 89, Number 106 (Friday, May 31, 2024)]
[Rules and Regulations]
[Pages 47080-47081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11914]
=======================================================================
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DEPARTMENT OF THE INTERIOR
Bureau of Ocean Energy Management
30 CFR Parts 550, 556, and 590
[Docket No. BOEM-2023-0027]
RIN 1010-AE14
Risk Management and Financial Assurance for OCS Lease and Grant
Obligations; Correction
AGENCY: Bureau of Ocean Energy Management, Interior.
ACTION: Final rule; correction.
-----------------------------------------------------------------------
[[Page 47081]]
SUMMARY: This document makes a technical correction in the preamble to
the final rule titled, Risk Management and Financial Assurance for OCS
Lease and Grant Obligations, which the Department of the Interior
published in the Federal Register on April 24, 2024. This correction
clarifies that the effective date of the rule is June 29, 2024.
DATES: As of May 31, 2024, the rule published on April 24, 2024 (89 FR
31544), effective June 24, 2024, is corrected to be effective June 29,
2024. This correction is effective June 29, 2024.
FOR FURTHER INFORMATION CONTACT: Kelley Spence, Office of Regulations,
BOEM, 45600 Woodland Road, Sterling, Virginia 20166, at email address
[email protected] or at telephone number (984) 298-7345; and Karen
Thundiyil, Chief, Office of Regulations, BOEM, 1849 C Street NW,
Washington, DC 20240, at email address [email protected] or at
telephone number (202) 742-0970. Individuals in the United States who
are deaf, deafblind, hard of hearing, or have a speech disability may
dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay
services for contacting the contacts listed in this section. These
services are available 24 hours a day, 7 days a week, to leave a
message or question with the above individual. You will receive a reply
during normal business hours. Individuals outside the United States
should use the relay services offered within their country to make
international calls to the point-of-contact in the United States.
SUPPLEMENTARY INFORMATION: The final rule published April 24, 2024, at
89 FR 31544, contained an incorrect effective date. It stated the
effective date is June 24, 2024. This document corrects the effective
date to June 29, 2024. This document also makes a correction to Sec.
556.901(h).
Corrections
In FR Doc. 2024-08309 appearing on page 31544 in the Federal
Register of Wednesday, April 24, 2024, the following corrections are
made:
Preamble
1. On page 31544, in the first column, in the DATES section, the
first sentence is corrected to read ``This final rule is effective on
June 29, 2024.''
Regulations
Sec. 556.901 [Corrected]
0
2. On page 31595, in the first column, in Sec. 556.901, paragraph (h)
introductory text is corrected to read as follows:
``(h) During the first 3 years from June 29, 2024, you may, upon
receipt of a demand letter for supplemental financial assurance under
this section, request that the Regional Director allow you to provide,
in three equal installments payable according to the schedule provided
under this paragraph (h), the full amount of supplemental financial
assurance required.''
Elizabeth Klein,
Director, Bureau of Ocean Energy Management.
[FR Doc. 2024-11914 Filed 5-30-24; 8:45 am]
BILLING CODE 4310-MR-P