General Rules and Regulations, Securities Exchange Act of 1934, 18987 [2023-06701]
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18987
Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Rules and Regulations
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RUSSIA
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License review policy
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Aviatech Supply Ltd., a.k.a., the following two aliases:
-Aviatech; and
-Aviatechexport Ltd.
630123, Aeroport St. Build.1A, 3rd
Floor, Novosibirsk, Russia.
Aviazapchast PLC, 48, Ivana Franko
Street, Moscow, 121351, Russia.
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License requirement
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[FR Doc. 2023–06663 Filed 3–28–23; 4:15 pm]
BILLING CODE 3510–33–P
SECURITIES AND EXCHANGE
COMMISSION
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88 FR [INSERT FR PAGE
NUMBER]
3/30/2023
For all items subject to
the EAR. (See § 744.11
of the EAR)
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Presumption of denial ......
88 FR [INSERT FR PAGE
NUMBER ] 3/30/2023.
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BILLING CODE 0099–10–P
General Rules and Regulations,
Securities Exchange Act of 1934
CFR Correction
This rule is being published by the
Office of the Federal Register to correct
an editorial or technical error that
appeared in the most recent annual
revision of the Code of Federal
Regulations.
■ In Title 17 of the Code of Federal
Regulations, Part 240, revised as of
April 1, 2022, in section 240.13e–100,
reinstate the paragraphs at the end of
the section following ‘‘Item 16.
Exhibits’’ to read as follows:
§ 240.13e–100 Schedule 13E–3,
Transaction statement under section 13(e)
of the Securities Exchange Act of 1934 and
Rule 13e–3 (§ 240.13e–3) thereunder.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA–2021–N–0310]
RIN 0910–AI32
Medical Devices; Orthopedic Devices;
Classification of Spinal Spheres for
Use in Intervertebral Fusion
Procedures
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA or Agency) is
issuing a final rule to classify spinal
spheres for use in intervertebral fusion
procedures (an unclassified,
preamendments device) into class III for
which FDA is separately requiring the
lllllllllllllllllllll filing of a premarket approval
application (PMA). FDA has determined
(Signature)
lllllllllllllllllllll that general controls and special
controls together are insufficient to
(Name and title)
lllllllllllllllllllll provide reasonable assurance of safety
and effectiveness for this device.
(Date)
DATES
: This rule is effective May 1,
Instruction to Signature: The
2023.
statement must be signed by the filing
person or that person’s authorized
ADDRESSES: For access to the docket to
representative. If the statement is signed read background documents or
SUMMARY:
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Signature. After due inquiry and to
the best of my knowledge and belief, I
certify that the information set forth in
this statement is true, complete and
correct.
lotter on DSK11XQN23PROD with RULES1
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VerDate Sep<11>2014
15:57 Mar 29, 2023
Jkt 259001
PO 00000
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Presumption of denial ......
[FR Doc. 2023–06701 Filed 3–29–23; 8:45 am]
17 CFR Part 240
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For all items subject to
the EAR. (See § 744.11
of the EAR)
on behalf of a person by an authorized
representative (other than an executive
officer of a corporation or general
partner of a partnership), evidence of
the representative’s authority to sign on
behalf of the person must be filed with
the statement. The name and any title of
each person who signs the statement
must be typed or printed beneath the
signature. See § 240.12b–11 with respect
to signature requirements.
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Thea D. Rozman Kendler,
Assistant Secretary for Export
Administration.
Federal Register citation
Frm 00023
Fmt 4700
Sfmt 4700
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comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this final rule, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Constance Soves, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1656, Silver Spring,
MD 20993–0002, 301–796–6951,
Constance.Soves@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the
Final Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used
Acronyms in This Document
III. Background
A. History of This Rulemaking
B. Summary of Comments to the Proposed
Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA
Response
A. Introduction
B. Description of Comments and FDA
Response
VI. Effective/Compliance Dates
VII. Economic Analysis of Impacts
A. Introduction
B. Summary of Costs and Benefits
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With
Indian Tribal Governments
XII. Reference
I. Executive Summary
A. Purpose of the Final Rule
FDA is classifying spinal spheres for
use in intervertebral fusion procedures
(spinal spheres), which are unclassified,
preamendments devices, into class III. A
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[Federal Register Volume 88, Number 61 (Thursday, March 30, 2023)]
[Rules and Regulations]
[Page 18987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06701]
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SECURITIES AND EXCHANGE COMMISSION
17 CFR Part 240
General Rules and Regulations, Securities Exchange Act of 1934
CFR Correction
This rule is being published by the Office of the Federal Register
to correct an editorial or technical error that appeared in the most
recent annual revision of the Code of Federal Regulations.
0
In Title 17 of the Code of Federal Regulations, Part 240, revised as of
April 1, 2022, in section 240.13e-100, reinstate the paragraphs at the
end of the section following ``Item 16. Exhibits'' to read as follows:
Sec. 240.13e-100 Schedule 13E-3, Transaction statement under section
13(e) of the Securities Exchange Act of 1934 and Rule 13e-3 (Sec.
240.13e-3) thereunder.
* * * * *
Signature. After due inquiry and to the best of my knowledge and
belief, I certify that the information set forth in this statement is
true, complete and correct.
-----------------------------------------------------------------------
(Signature)
-----------------------------------------------------------------------
(Name and title)
-----------------------------------------------------------------------
(Date)
Instruction to Signature: The statement must be signed by the
filing person or that person's authorized representative. If the
statement is signed on behalf of a person by an authorized
representative (other than an executive officer of a corporation or
general partner of a partnership), evidence of the representative's
authority to sign on behalf of the person must be filed with the
statement. The name and any title of each person who signs the
statement must be typed or printed beneath the signature. See Sec.
240.12b-11 with respect to signature requirements.
[FR Doc. 2023-06701 Filed 3-29-23; 8:45 am]
BILLING CODE 0099-10-P
