International Traffic in Arms Regulations: Revisions to Definition and Controls Related to Defense Services; Extension of Comment Period, 78278 [2024-22041]
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78278
Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Proposed Rules
ddrumheller on DSK120RN23PROD with PROPOSALS1
control measures are implemented to
address device system hazards, such as
Failure Modes Effects Analysis and/or
Hazard Analysis and Critical Control
Points summaries and their impact on
assay performance.
(v) Final release criteria to be used for
manufactured assay lots with
appropriate evidence that lots released
at the extremes of the specification will
meet the identified analytical and
clinical performance characteristics as
well as stability.
(vi) Stability studies for reagents must
include documentation of an assessment
of real-time stability for multiple reagent
lots using the indicated specimen types
and must use acceptance criteria that
ensure that analytical and clinical
performance characteristics are met
when stability is assigned based on the
extremes of the acceptance range.
(vii) All stability protocols, including
acceptance criteria.
(viii) Detailed documentation of
analytical performance studies
conducted as appropriate to the
technology, specimen types tested, and
intended use of the device, including
limit of detection (LoD), linearity,
precision, endogenous and exogenous
interferences, cross-reactivity, carryover,
matrix equivalency, sample and
reagents stability, and as applicable,
upper and lower limits of quantitation
(ULoQ and LLoQ, respectively).
Samples selected for use must be from
subjects with clinically relevant
circulating genotypes in the United
States. Cross-reactivity studies must
include samples from HBV nucleic acid
negative subjects with other viral or
non-viral causes of liver disease,
including autoimmune hepatitis,
alcoholic liver disease, chronic hepatitis
C virus (HCV), primary biliary cirrhosis,
and nonalcoholic steatohepatitis, when
applicable. The effect of each identified
nucleic-acid isolation and purification
procedure on detection must be
evaluated.
(ix) For devices with associated
software or instrumentation,
documentation must include a detailed
description of device software,
including software applications and
hardware-based devices that incorporate
software. The detailed description must
include documentation of verification,
VerDate Sep<11>2014
16:25 Sep 24, 2024
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validation, and hazard analysis and risk
assessment activities, including an
assessment of the impact of threats and
vulnerabilities on device functionality
and end users/patients as part of
cybersecurity review.
(x) Detailed documentation of
performance from a clinical study with
a design and number of clinical samples
(appropriately statistically powered)
that is appropriate for the intended use
of the device as well as conducted in the
appropriate settings by the intended
users. The samples must include
prospective (sequential) samples for
each claimed specimen type and, as
appropriate, additional characterized
clinical samples. Samples must be
sourced from geographically diverse
areas.
Dated: September 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–21932 Filed 9–24–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF STATE
22 CFR Parts 120 and 121
[Public Notice: 12552; DOS–2024–0023]
RIN 1400–AF29
International Traffic in Arms
Regulations: Revisions to Definition
and Controls Related to Defense
Services; Extension of Comment
Period
Department of State.
Proposed rule; extension of
comment period.
AGENCY:
ACTION:
The Department of State is
extending the comment period for a
proposed rule published July 29, 2024.
The original comment period required
submission of comments on or before
September 27, 2024. In response to
requests from the public, the
Department extends the comment
period through October 15, 2024.
DATES: The comment period for the
proposed rule published July 29, 2024,
at 89 FR 60980, is extended. Comments
should be received on or before October
15, 2024.
SUMMARY:
PO 00000
Frm 00019
Fmt 4702
Sfmt 9990
Interested parties may
submit comments by one of the
following methods:
• Email: DDTCPublicComments@
state.gov with the subject line:
‘‘Regulatory Change: Defense Service
Definition’’.
• Internet: At www.regulations.gov,
search for this notice, by docket number
DOS–2024–0023. Additional
instructions regarding submission of
comments can be found in the
document published at 89 FR 60980,
July 29, 2024.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Sarah Heidema, Director, Office of
Defense Trade Controls Policy,
Department of State, telephone (202)
663–1282; email
DDTCCustomerService@state.gov.
ATTN: Revisions to Definition and
Controls Related to Defense Services.
On July
29, 2024, the Department of State
published a proposed rule proposing
revisions to the definition of defense
service at 22 CFR 120.32 of the
International Traffic in Arms
Regulations (22 CFR parts 120 through
130) and to the United States Munitions
List at 22 CFR 121.1 (89 FR 60980). On
the same day, the Department of
Commerce published a complementary
proposed rule proposing changes to
existing restrictions under the Export
Administration Regulations (15 CFR
parts 730 through 744) on military and
intelligence end uses and end users and
related controls on certain activities of
U.S. persons, as well as the proposed
addition of a military-support end-user
control (89 FR 60985). In response to
requests from the public received by the
Department of Commerce, and due to
their plan to extend the comment period
for their complementary proposed rule
for 15 more days, as published via
separate notice, the Department of State
is similarly extending the comment
period for its proposed rule for 15 days.
SUPPLEMENTARY INFORMATION:
Stanley L. Brown,
Acting Assistant Secretary, Bureau of
Political-Military Affairs, Department of
State.
[FR Doc. 2024–22041 Filed 9–23–24; 4:15 pm]
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[Federal Register Volume 89, Number 186 (Wednesday, September 25, 2024)]
[Proposed Rules]
[Page 78278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22041]
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DEPARTMENT OF STATE
22 CFR Parts 120 and 121
[Public Notice: 12552; DOS-2024-0023]
RIN 1400-AF29
International Traffic in Arms Regulations: Revisions to
Definition and Controls Related to Defense Services; Extension of
Comment Period
AGENCY: Department of State.
ACTION: Proposed rule; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Department of State is extending the comment period for a
proposed rule published July 29, 2024. The original comment period
required submission of comments on or before September 27, 2024. In
response to requests from the public, the Department extends the
comment period through October 15, 2024.
DATES: The comment period for the proposed rule published July 29,
2024, at 89 FR 60980, is extended. Comments should be received on or
before October 15, 2024.
ADDRESSES: Interested parties may submit comments by one of the
following methods:
Email: [email protected] with the subject line:
``Regulatory Change: Defense Service Definition''.
Internet: At www.regulations.gov, search for this notice,
by docket number DOS-2024-0023. Additional instructions regarding
submission of comments can be found in the document published at 89 FR
60980, July 29, 2024.
FOR FURTHER INFORMATION CONTACT: Sarah Heidema, Director, Office of
Defense Trade Controls Policy, Department of State, telephone (202)
663-1282; email [email protected]. ATTN: Revisions to
Definition and Controls Related to Defense Services.
SUPPLEMENTARY INFORMATION: On July 29, 2024, the Department of State
published a proposed rule proposing revisions to the definition of
defense service at 22 CFR 120.32 of the International Traffic in Arms
Regulations (22 CFR parts 120 through 130) and to the United States
Munitions List at 22 CFR 121.1 (89 FR 60980). On the same day, the
Department of Commerce published a complementary proposed rule
proposing changes to existing restrictions under the Export
Administration Regulations (15 CFR parts 730 through 744) on military
and intelligence end uses and end users and related controls on certain
activities of U.S. persons, as well as the proposed addition of a
military-support end-user control (89 FR 60985). In response to
requests from the public received by the Department of Commerce, and
due to their plan to extend the comment period for their complementary
proposed rule for 15 more days, as published via separate notice, the
Department of State is similarly extending the comment period for its
proposed rule for 15 days.
Stanley L. Brown,
Acting Assistant Secretary, Bureau of Political-Military Affairs,
Department of State.
[FR Doc. 2024-22041 Filed 9-23-24; 4:15 pm]
BILLING CODE 4710-25-P
