78278 Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Proposed Rules 

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, 

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 

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: 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. 

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. 

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 


ddrumheller on DSK120RN23PROD with PROPOSALS1