Federal Register / Vol. 89, No. 179 / Monday, September 16, 2024 / Rules and Regulations 75489 

administrative sanctions. However, entry of a 

guilty plea can be a sign that a Respondent 

accepts responsibility for complying with the 

EAR and will take greater care to do so in the 

future. In appropriate cases where a 

Respondent is receiving substantial criminal 

penalties, OEE may find that sufficient 

deterrence may be achieved by lesser 

administrative sanctions than would be 

appropriate in the absence of criminal 

penalties. Conversely, OEE might seek greater 

administrative sanctions in an otherwise 

similar case where a Respondent is not 

subjected to criminal penalties. The presence 

of a related criminal or civil disposition may 

distinguish settlements among civil penalty 

cases that appear otherwise to be similar. As 

a result, the factors set forth for consideration 

in civil penalty settlements will often be 

applied differently in the context of a ‘‘global 

settlement’’ of both civil and criminal cases, 

or multiple civil cases, and may therefore be 

of limited utility as precedent for future 

cases, particularly those not involving a 

global settlement. 

M. Future Compliance/Deterrence Effect. 

The impact an administrative enforcement 

action may have on promoting future 

compliance with the regulations by a 

Respondent and similar parties, particularly 

those in the same industry sector. 

N. Other Factors That OEE Deems 

Relevant. On a case-by-case basis, in 

determining the appropriate enforcement 

response and/or the amount of any civil 

monetary penalty, OEE will consider the 

totality of the circumstances to ensure that its 

enforcement response is proportionate to the 

nature of the violation. 

IV. Civil Penalties 

A. Determining What Sanctions Are 

Appropriate in a Settlement 

OEE will review the facts and 

circumstances surrounding an apparent 

violation and apply the Factors Affecting 

Administrative Sanctions in section III of this 

supplement in determining the appropriate 

sanction or sanctions in an administrative 

case, including the appropriate amount of a 

civil monetary penalty where such a penalty 

is sought and imposed. Penalties for 

settlements reached after the initiation of 

litigation will usually be higher than those 

described by these guidelines. 

B. Amount of Civil Penalty 

1. Determining Whether a Case is 

Egregious. In those cases in which a civil 

monetary penalty is considered appropriate, 

the OEE Director will make a determination 

as to whether a case is deemed ‘‘egregious’’ 

for purposes of the base penalty calculation. 

If a case is determined to be egregious, the 

OEE Director also will also determine the 

appropriate base penalty amount within the 

range of base penalty amounts prescribed in 

paragraphs IV.B.2.a.iii and iv of this 

supplement. These determinations will be 

based on an analysis of the applicable factors. 

In making these determinations, substantial 

weight will generally be given to Factors A 

(‘‘willful or reckless violation of law’’), B 

(‘‘awareness of conduct at issue’’), C (‘‘harm 

to regulatory program objectives’’), and D 

(‘‘individual characteristics’’), with particular 

emphasis on Factors A, B, and C. 

A case will be considered an ‘‘egregious 

case’’ where the analysis of the applicable 

factors, with a focus on Factors A, B, and C, 

indicates that the case represents a 

particularly serious violation of the law 

calling for a strong enforcement response. 

2. Monetary Penalties in Egregious Cases 

and Non-Egregious Cases. The civil monetary 

penalty amount shall generally be calculated 

as follows, except that neither the base 

penalty amount nor the penalty amount will 

exceed the applicable statutory maximum: 

a. Base Category Calculation and 

Voluntary Self-Disclosures. 

i. In a non-egregious case, if the apparent 

violation is disclosed through a voluntary 

self-disclosure, the base penalty amount shall 

be up to one-half of the transaction value. 

ii. In a non-egregious case, if the apparent 

violation comes to OEE’s attention by means 

other than a voluntary self-disclosure, the 

base penalty amount shall be up to the 

transaction value. 

iii. In an egregious case, if the apparent 

violation is disclosed through a voluntary 

self-disclosure, the base penalty amount shall 

be an amount up to one-half of the statutory 

maximum penalty applicable to the violation. 

iv. In an egregious case, if the apparent 

violation comes to OEE’s attention by means 

other than a voluntary self-disclosure, the 

base penalty amount shall be an amount up 

to the statutory maximum penalty applicable 

to the violation. 

v. The applicable statutory maximum civil 

penalty per violation of the Export Control 

Reform Act (ECRA) of 2018 is a fine defined 

in ECRA and adjusted in accordance with 

U.S. law, e.g., the Federal Civil Penalties 

Inflation Adjustment Act Improvements Act 

of 2015 (Pub. L. 114–74, sec. 701), which in 

2024 was $364,992, or an amount that is 

twice the value of the transaction that is the 

basis of the violation with respect to which 

the penalty is imposed, whichever is greater. 

The following matrix represents the base 

penalty amount of the civil monetary penalty 

for each category of violation: 

BASE PENALTY MATRIX

Voluntary self-disclosure? 

Egregious case? 

NO YES 

YES ...................................... (1) Up to One-Half of the Transaction Value .................. (3) Up to One-Half of the Applicable Statutory Maximum. 

NO ........................................ (2) Up to the Transaction Value ..................................... (4) Up to the Applicable Statutory Maximum. 

b. Adjustment for Applicable Relevant 

Factors. The base penalty amount of the civil 

monetary penalty will be adjusted to reflect 

applicable Factors for Administrative Action 

set forth in section III of these guidelines. 

The Factors may result in a penalty amount 

that is lower or higher than the base penalty 

amount depending upon whether they are 

aggravating or mitigating and how they, in 

the discretion of OEE, apply in combination 

in a particular case. 

C. Settlement Procedures 

The procedures relating to the settlement 

of administrative enforcement cases are set 

forth in § 766.18 of the EAR. 

Thea D. Rozman Kendler, 

Assistant Secretary for Export 

Administration. 

[FR Doc. 2024–21013 Filed 9–12–24; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 862 

[Docket No. FDA–2024–N–4058] 

Medical Devices; Clinical Chemistry 

and Clinical Toxicology Devices; 

Classification of the Clozapine Test 

System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 


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75490 Federal Register / Vol. 89, No. 179 / Monday, September 16, 2024 / Rules and Regulations 

1FDA notes that the ACTION caption for this final 

order is styled as ‘‘Final amendment; final order,’’ 

rather than ‘‘Final order.’’ Beginning in December 

2019, this editorial change was made to indicate 

that the document amends the Code of Federal 

Regulations. The change was made in accordance 

with the Office of Federal Register’s (OFR) 

interpretations of the Federal Register Act (44 

U.S.C. chapter 15), its implementing regulations (1 

CFR 5.9 and parts 21 and 22), and the ‘‘Document 

Drafting Handbook.’’ 

classifying the clozapine test system 

into class II (special controls). The 

special controls that apply to the device 

type are identified in this order and will 

be part of the codified language for the 

clozapine test system’s classification. 

We are taking this action because we 

have determined that classifying the 

device into class II (special controls) 

will provide a reasonable assurance of 

safety and effectiveness of the device. 

We believe this action will also enhance 

patients’ access to beneficial innovative 

devices. 

DATES: This order is effective September 

16, 2024. The classification was 

applicable on April 16, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Joseph Kotarek, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3504, Silver Spring, 

MD 20993–0002, 301–796–2718, 

Joseph.Kotarek@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

clozapine test system as class II (special 

controls), which we have determined 

will provide a reasonable assurance of 

safety and effectiveness. 

The automatic assignment of class III 

occurs by operation of law and without 

any action by FDA, regardless of the 

level of risk posed by the new device. 

Any device that was not in commercial 

distribution before May 28, 1976, is 

automatically classified as, and remains 

within, class III and requires premarket 

approval unless and until FDA takes an 

action to classify or reclassify the device 

(see 21 U.S.C. 360c(f)(1)). We refer to 

these devices as ‘‘postamendments 

devices’’ because they were not in 

commercial distribution prior to the 

date of enactment of the Medical Device 

Amendments of 1976, which amended 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). 

FDA may take a variety of actions in 

appropriate circumstances to classify or 

reclassify a device into class I or II. We 

may issue an order finding a new device 

to be substantially equivalent under 

section 513(i) of the FD&C Act (see 21 

U.S.C. 360c(i)) to a predicate device that 

does not require premarket approval. 

We determine whether a new device is 

substantially equivalent to a predicate 

device by means of the procedures for 

premarket notification under section 

510(k) of the FD&C Act (21 U.S.C. 

360(k)) and part 807 (21 CFR part 807). 

FDA may also classify a device 

through ‘‘De Novo’’ classification, a 

common name for the process 

authorized under section 513(f)(2) of the 

FD&C Act (see also part 860, subpart D 

(21 CFR part 860, subpart D)). Section 

207 of the Food and Drug 

Administration Modernization Act of 

1997 (Pub. L. 105–115) established the 

first procedure for De Novo 

classification. Section 607 of the Food 

and Drug Administration Safety and 

Innovation Act (Pub. L. 112–144) 

modified the De Novo application 

process by adding a second procedure. 

A device sponsor may utilize either 

procedure for De Novo classification. 

Under the first procedure, the person 

submits a 510(k) for a device that has 

not previously been classified. After 

receiving an order from FDA classifying 

the device into class III under section 

513(f)(1) of the FD&C Act, the person 

then requests a classification under 

section 513(f)(2). 

Under the second procedure, rather 

than first submitting a 510(k) and then 

a request for classification, if the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence, that person requests a 

classification under section 513(f)(2) of 

the FD&C Act. 

Under either procedure for De Novo 

classification, FDA is required to 

classify the device by written order 

within 120 days. The classification will 

be according to the criteria under 

section 513(a)(1) of the FD&C Act. 

Although the device was automatically 

placed within class III, the De Novo 

classification is considered to be the 

initial classification of the device. 

When FDA classifies a device into 

class I or II via the De Novo process, the 

device can serve as a predicate for 

future devices of that type, including for 

510(k)s (see section 513(f)(2)(B)(i) of the 

FD&C Act). As a result, other device 

sponsors do not have to submit a De 

Novo request or premarket approval 

application to market a substantially 

equivalent device (see section 513(i) of 

the FD&C Act, defining ‘‘substantial 

equivalence’’). Instead, sponsors can use 

the 510(k) process, when necessary, to 

market their device. 

II. De Novo Classification 

On May 24, 2019, FDA received 

Saladax Biomedical, Inc.’s request for 

De Novo classification of the MyCare 

Psychiatry Clozapine Assay Kit. FDA 

reviewed the request in order to classify 

the device under the criteria for 

classification set forth in section 

513(a)(1) of the FD&C Act. 

We classify devices into class II if 

general controls by themselves are 

insufficient to provide reasonable 

assurance of safety and effectiveness, 

but there is sufficient information to 

establish special controls that, in 

combination with the general controls, 

provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use (see 21 U.S.C. 

360c(a)(1)(B)). After review of the 

information submitted in the request, 

we determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

has determined that these special 

controls, in addition to the general 

controls, will provide reasonable 

assurance of the safety and effectiveness 

of the device. FDA has determined that 

general controls will provide reasonable 

assurance of the safety and effectiveness 

of the device. 

Therefore, on April 16, 2020, FDA 

issued an order to the requester 

classifying the device into class II. In 

this final order, FDA is codifying the 

classification of the device by adding 21 

CFR 862.3245.1 We have named the 

generic type of device clozapine test 

system, and it is identified as a device 

intended to measure clozapine in 

human specimens. Measurements 

obtained by this device are used in 

monitoring levels of clozapine to ensure 

appropriate therapy in patients with 

treatment-resistant schizophrenia. 

FDA has identified the following risks 

to health associated specifically with 

this type of device and the measures 

required to mitigate these risks in table 

1. 

TABLE 1—CLOZAPINE TEST SYSTEM RISKS AND MITIGATION MEASURES

Identified risks to health Mitigation measures 

Incorrect test results ........................................................... Certain design verification and validation activities and Certain labeling information. 


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Federal Register / Vol. 89, No. 179 / Monday, September 16, 2024 / Rules and Regulations 75491 

TABLE 1—CLOZAPINE TEST SYSTEM RISKS AND MITIGATION MEASURES—Continued 

Identified risks to health Mitigation measures 

Incorrect interpretation of test results ................................ Certain design verification and validation activities and Certain labeling information. 

FDA has determined that special 

controls, in combination with the 

general controls, address these risks to 

health and provide reasonable assurance 

of safety and effectiveness. For a device 

to fall within this classification, and 

thus avoid automatic classification in 

class III, it would have to comply with 

the special controls named in this final 

order. The necessary special controls 

appear in the regulation codified by this 

order. This device is subject to 

premarket notification requirements 

under section 510(k) of the FD&C Act. 

III. Analysis of Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) 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. 

IV. Paperwork Reduction Act of 1995 

This final order establishes special 

controls that refer to previously 

approved collections of information 

found in other FDA regulations and 

guidance. These collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3521). The 

collections of information in part 860, 

subpart D, regarding De Novo 

classification have been approved under 

OMB control number 0910–0844; the 

collections of information in 21 CFR 

part 814, subparts A through E, 

regarding premarket approval, have 

been approved under OMB control 

number 0910–0231; the collections of 

information in part 807, subpart E, 

regarding premarket notification 

submissions, have been approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 820, regarding quality system 

regulation, have been approved under 

OMB control number 0910–0073; and 

the collections of information in 21 CFR 

parts 801 and 809, regarding labeling, 

have been approved under OMB control 

number 0910–0485. 

List of Subjects in 21 CFR Part 862 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 862 is 

amended as follows: 

PART 862—CLINICAL CHEMISTRY 

AND CLINICAL TOXICOLOGY 

DEVICES 

■ 1. The authority citation for part 862 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Add § 862.3245 to subpart D to read 

as follows: 

§ 862.3245 Clozapine test system. 

(a) Identification. A clozapine test 

system is a device intended to measure 

clozapine in human specimens. 

Measurements obtained by this device 

are used in monitoring levels of 

clozapine to ensure appropriate therapy 

in patients with treatment-resistant 

schizophrenia. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Design verification and validation 

must include the following: 

(i) Precision study data that 

demonstrates precision that is clinically 

appropriate, as determined by FDA, for 

the clozapine test system. Precision 

studies must include a minimum of 

three samples containing different 

concentrations of clozapine including 

near medical decision points and 

throughout the expected therapeutic 

range of clozapine. Samples near the 

medical decision points must be clinical 

specimens collected from patients 

taking clozapine; 

(ii) Method comparison data that 

demonstrates accuracy that is clinically 

acceptable, as determined by FDA, for 

the clozapine test system; 

(iii) Data from studies that 

demonstrate that the device is free from 

clinically significant interference, as 

determined by FDA, from commonly coadministered medications that are used 

in patients with treatment-resistant 

schizophrenia; and 

(iv) Data from studies that 

demonstrate that the device is free from 

clinically significant cross-reactivity, as 

determined by FDA, from major 

circulating metabolites found in the 

intended use population. 

(2) The labeling required under 

§ 809.10 of this chapter must include a 

limiting statement conveying that the 

assay should only be used in 

conjunction with information available 

from clinical evaluations and other 

diagnostic procedures and that results 

from the assay alone should not be used 

in making treatment decisions. 

Dated: September 10, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20895 Filed 9–13–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2024–N–4061] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

the Device To Detect or Measure 

Nucleic Acid From Viruses Associated 

With Head and Neck Cancers 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

classifying the device to detect or 

measure nucleic acid from viruses 

associated with head and neck cancers 

into class II (special controls). The 

special controls that apply to the device 

type are identified in this order and will 

be part of the codified language for the 

device to detect or measure nucleic acid 

from viruses associated with head and 

neck cancers’ classification. We are 

taking this action because we have 

determined that classifying the device 

into class II (special controls) will 

provide a reasonable assurance of safety 

and effectiveness of the device. We 

believe this action will also enhance 

patients’ access to beneficial innovative 

devices. 

DATES: This order is effective September 

16, 2024. The classification was 

applicable on May 11, 2020. 

FOR FURTHER INFORMATION CONTACT: Kim 

Davis, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3220, Silver Spring, 

MD 20993–0002, 301–796–1049, 

Kim.Davis@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 


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