Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Rules and Regulations 48413 

International/MemorandaofUnderstanding/ 

index.htm. 

202See § 23.160(c)(3)(i). 

203See § 23.160(c)(3)(ii). As discussed above, the 

Commission’s Final Margin Rule is based on the 

BCBS/IOSCO Framework; therefore, the 

Commission expects that the relevant foreign 

margin requirements would conform to such 

Framework at minimum in order to be deemed 

comparable in outcome to the Commission’s 

corresponding margin requirements. 

204See § 23.160(c)(3)(iii). See also 

§ 23.160(c)(3)(iv) (indicating the Commission would 

also consider any other relevant facts and 

circumstances). 205See § 23.160(c)(4). 

authorities, as noted above, are 

responsible for supervising FCs as part 

of their ongoing prudential regulation 

and supervision of such FCs, will 

enforce the RTS, which are directly 

applicable in the Member States, and 

will take all measures necessary to 

ensure that those rules are 

implemented. Thus, the Commission 

finds that the EC, through the competent 

authorities, has the necessary powers to 

supervise, investigate, and discipline 

entities for compliance with its margin 

requirements and recognizes the 

relevant competent authorities’ ongoing 

efforts to detect and deter violations of, 

and ensure compliance with, the margin 

requirements applicable in the EU. 

V. Conclusion 

As detailed above, the Commission 

has noted several differences between 

the Final Margin Rule and the EU 

margin rules. However, having 

considered the scope and objectives of 

the margin requirements for uncleared 

swaps under the laws of the EU,202

whether such margin requirements 

achieve comparable outcomes to the 

Commission’s corresponding margin 

requirements,203 and the ability of the 

Member State competent authorities to 

supervise and enforce compliance with 

the margin requirements for noncentrally cleared OTC derivatives under 

the laws of the EU,204 the Commission 

has determined that the EU margin rules 

are comparable in outcome to the Final 

Margin Rule. 

As noted above, the Final Margin 

Rule’s regulatory objective is to ensure 

the safety and soundness of CSEs in 

order to offset the greater risk to CSEs 

and the financial system arising from 

the use of swaps that are not cleared. 

The EU margin rules require 

counterparties to apply robust riskmitigation techniques to their bilateral 

relationships to reduce counterparty 

credit risk and to mitigate the potential 

systemic risk that could arise. Moreover, 

the EU margin rules achieve comparable 

outcomes to the Final Margin Rule in 

the following specific areas: The 

products and entities subject to the EU’s 

margin requirements; the treatment of 

inter-affiliate derivative transactions; 

the methodologies for calculating the 

amounts of initial and variation margin; 

the process and standards for approving 

models for calculating initial and 

variation margin models; the timing and 

manner in which initial and variation 

margin must be collected and/or paid; 

any threshold levels or amounts; risk 

management controls for the calculation 

of initial and variation margin; eligible 

collateral for initial and variation 

margin; the requirements of custodial 

arrangements, including segregation of 

margin and rehypothecation; margin 

documentation requirements; and the 

cross-border application of the EU’s 

margin regime. Finally, based on the 

long history of regulatory cooperation 

between the Commission and Member 

State competent authorities with 

supervisory and enforcement authority 

under the RTS, the Commission finds 

that the EC, through the competent 

authorities, has the necessary powers to 

supervise, investigate, and discipline 

entities for compliance with its margin 

requirements, and recognizes the 

relevant authorities’ ongoing efforts to 

detect and deter violations of, and 

ensure compliance with, the margin 

requirements applicable in the EU. 

Accordingly, a CSE that is subject to 

both the Final Margin Rule and the EU’s 

margin rules with respect to an 

uncleared swap that is also a noncentrally cleared OTC derivative may 

rely on substituted compliance for all 

aspects of the Final Margin Rule and the 

Cross-Border Margin Rule. Any such 

CSE that, in accordance with this 

comparability determination, complies 

with the EU margin rules, would be 

deemed to be in compliance with the 

Final Margin Rule but would remain 

subject to the Commission’s 

examination and enforcement 

authority.205

Issued in Washington, DC, on October 13, 

2017, by the Commission. 

Christopher J. Kirkpatrick, 

Secretary of the Commission. 

Appendix to Comparability 

Determination for the European Union: 

Margin Requirements for Uncleared 

Swaps for Swap Dealers and Major 

Swap Participants—Commission Voting 

Summary 

On this matter, Chairman Giancarlo and 

Commissioners Quintenz and Behnam voted 

in the affirmative. No Commissioner voted in 

the negative. 

[FR Doc. 2017–22616 Filed 10–17–17; 8:45 am] 

BILLING CODE 6351–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 862 

[Docket No. FDA–2017–N–5160] 

Medical Devices; Clinical Chemistry 

and Clinical Toxicology Devices; 

Classification of the Organophosphate 

Test System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the organophosphate 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 organophosphate 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, 

in part by reducing regulatory burdens. 

DATES: This order is effective October 

18, 2017. The classification was 

applicable on August 8, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Steven Tjoe, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4550, Silver Spring, 

MD, 20993–0002, 301–796–5866. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

organophosphate test system as class II 

(special controls), which we have 

determined will provide a reasonable 

assurance of safety and effectiveness. In 

addition, we believe this action will 

enhance patients’ access to beneficial 

innovation, in part by reducing 

regulatory burdens by placing the 

device into a lower device class than the 

automatic class III assignment. 

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 


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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 (the 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 to a 

predicate device that does not require 

premarket approval (see 21 U.S.C. 

360c(i)). We determine whether a new 

device is substantially equivalent to a 

predicate by means of the procedures 

for premarket notification under section 

510(k) of the FD&C Act (21 U.S.C. 360(k) 

and 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. Section 207 of the Food and 

Drug Administration Modernization Act 

of 1997 established the first procedure 

for De Novo classification (Pub. L. 105– 

115). Section 607 of the Food and Drug 

Administration Safety and Innovation 

Act modified the De Novo application 

process by adding a second procedure 

(Pub. L. 112–144). 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 

within class III, the De Novo 

classification is considered to be the 

initial classification of the device. 

We believe this De Novo classification 

will enhance patients’ access to 

beneficial innovation, in part by 

reducing regulatory burdens. 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 21 

U.S.C. 360c(f)(2)(B)(i)). As a result, other 

device sponsors do not have to submit 

a De Novo request or premarket 

approval (PMA) application in order to 

market a substantially equivalent device 

(see 21 U.S.C. 360c(i), defining 

‘‘substantial equivalence’’). 

Instead, sponsors can use the less 

burdensome 510(k) process, when 

necessary, to market their device. 

II. De Novo Classification 

For this device, FDA issued an order 

on May 2, 2013, finding the 

Quantitation of Organophosphate 

Metabolites in Urine by LC/MS/MS 

(liquid chromatography-tandem mass 

spectrometry (the two ‘‘MS’’ next to 

each other denote ‘‘tandem’’)) not 

substantially equivalent to a predicate 

not subject to PMA. Thus, the device 

remained in class III in accordance with 

section 513(f)(1) of the FD&C Act when 

we issued the order. 

On May 31, 2013, Elizabeth Hamelin, 

on behalf of the Centers for Disease 

Control and Prevention, Division of 

Laboratory Sciences/National Center for 

Environmental Health, submitted a 

request for classification of the 

Quantitation of Organophosphate 

Metabolites in Urine by LC/MS/MS. 

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 general controls, 

will provide reasonable assurance of the 

safety and effectiveness of the device. 

Therefore, on August 8, 2013, FDA 

issued an order to the requestor 

classifying the device into class II. FDA 

is codifying the classification of the 

device by adding 21 CFR 862.3652. We 

have named the generic type of device 

organophosphate test system, and it is 

identified as a device intended to 

measure organophosphate metabolites 

quantitatively in human urine from 

individuals who have signs and 

symptoms consistent with 

cholinesterase poisoning. The data 

obtained by this device is intended to 

aid in the confirmation and 

investigation of organophosphate 

exposure. 

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—ORGANOPHOSPHATE TEST SYSTEM RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures 

False Positive .................................. (1) The distribution of these devices is limited to laboratories with experienced personnel who are trained 

to measure and evaluate organophosphate exposure and guide public health response. 

(2) Analytical testing must demonstrate the device has appropriate performance characteristics, including 

adequate precision and accuracy across the measuring range and near medical decision points. 

False Negative ................................ (1) The distribution of these devices is limited to laboratories with experienced personnel who are trained 

to measure and evaluate organophosphate exposure and guide public health response. 

(2) Analytical testing must demonstrate the device has appropriate performance characteristics, including 

adequate precision and accuracy across the measuring range and near medical decision points. 

Public Health Risk from Incorrect 

Test Results.

(1) The distribution of these devices is limited to laboratories with experienced personnel who are trained 

to measure and evaluate organophosphate exposure and guide public health response. 

(2) Analytical testing must demonstrate the device has appropriate performance characteristics, including 

adequate precision and accuracy across the measuring range and near medical decision points. 


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Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Rules and Regulations 48415 

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. In order 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). 

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. 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– 

3520). The collections of information in 

part 807, subpart E, regarding premarket 

notification submissions have been 

approved under OMB control number 

0910–0120. 

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 § 862.3652 to subpart D to read 

as follows: 

§ 862.3652 Organophosphate test system. 

(a) Identification. An 

organophosphate test system is a device 

intended to measure organophosphate 

metabolites quantitatively in human 

urine from individuals who have signs 

and symptoms consistent with 

cholinesterase poisoning. The data 

obtained by this device is intended to 

aid in the confirmation and 

investigation of organophosphate 

exposure. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The distribution of these devices is 

limited to laboratories with experienced 

personnel who are trained to measure 

and evaluate organophosphate exposure 

and guide public health response. 

(2) Analytical testing must 

demonstrate the device has appropriate 

performance characteristics, including 

adequate precision and accuracy across 

the measuring range and near medical 

decision points. 

Dated: October 13, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–22590 Filed 10–17–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF DEFENSE 

Department of the Navy 

32 CFR Part 706 

Certifications and Exemptions Under 

the International Regulations for 

Preventing Collisions at Sea, 1972 

AGENCY: Department of the Navy, DoD. 

ACTION: Final rule. 

SUMMARY: The Department of the Navy 

(DoN) is amending its certifications and 

exemptions under the International 

Regulations for Preventing Collisions at 

Sea, 1972, as amended (72 COLREGS), 

to reflect that the Deputy Assistant 

Judge Advocate General 

(DAJAG)(Admiralty and Maritime Law) 

has determined that USS MICHAEL 

MONSOOR (DDG 1001) is a vessel of 

the Navy which, due to its special 

construction and purpose, cannot fully 

comply with certain provisions of the 72 

COLREGS without interfering with its 

special function as a naval ship. The 

intended effect of this rule is to warn 

mariners in waters where 72 COLREGS 

apply. 

DATES: This rule is effective October 18, 

2017 and is applicable beginning 

October 3, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Lieutenant Commander Kyle Fralick, 

(Admiralty and Maritime Law), Office of 

the Judge Advocate General, Department 

of the Navy, 1322 Patterson Ave. SE., 

Suite 3000, Washington Navy Yard, DC 

20374–5066, telephone 202–685–5040. 

SUPPLEMENTARY INFORMATION: Pursuant 

to the authority granted in 33 U.S.C. 

1605, the DoN amends 32 CFR part 706. 

This amendment provides notice that 

the DAJAG (Admiralty and Maritime 

Law), under authority delegated by the 

Secretary of the Navy, has certified that 

USS MICHAEL MONSOOR (DDG 1001) 

is a vessel of the Navy which, due to its 

special construction and purpose, 

cannot fully comply with the following 

specific provisions of 72 COLREGS 

without interfering with its special 

function as a naval ship: Annex I 

paragraph 2(a)(i), pertaining to the 

location of the forward masthead light at 

a height not less than 6 meters above the 

hull; Annex I, paragraph 2(g) pertaining 

to the placement of sidelights above the 

hull of the vessel; Rule 30(a)(i) and 

Annex I, paragraph 2(k) pertaining to 

the vertical separation between anchor 

lights, and the location of the forward 

anchor light at a height of not less than 

6 meters above the hull; Annex I, 

paragraph 3(a), pertaining to the 

horizontal separation between the 

forward and after masthead lights; 

Annex I, paragraph 2(i)(iii), pertaining 

to the vertical spacing of task lights; and 

Annex I, paragraph 3(c), pertaining to 

the task lights placed at a horizontal 

distance of not less than 2 meters from 

the fore and aft centerline of the vessel. 

The DAJAG (Admiralty and Maritime 

Law) has also certified that the lights 

involved are located in closest possible 

compliance with the applicable 72 

COLREGS requirements. 

Moreover, it has been determined, in 

accordance with 32 CFR parts 296 and 

701, that publication of this amendment 

for public comment prior to adoption is 

impracticable, unnecessary, and 

contrary to public interest since it is 

based on technical findings that the 

placement of lights on this vessel in a 

manner differently from that prescribed 

herein will adversely affect the vessel’s 

ability to perform its military functions. 

List of Subjects in 32 CFR Part 706 

Marine safety, Navigation (water), 

Vessels. 

For the reasons set forth in the 

preamble, the DoN amends part 706 of 

title 32 of the Code of Federal 

Regulations as follows: 

PART 706—CERTIFICATIONS AND 

EXEMPTIONS UNDER THE 

INTERNATIONAL REGULATIONS FOR 

PREVENTING COLLISIONS AT SEA, 

1972 

■ 1. The authority citation for part 706 

continues to read as follows: 

Authority: 33 U.S.C. 1605. 

■ 2. Section 706.2 is amended by: 

■ a. In Table One, adding in 

alphanumerical order by vessel number, 

an entry for USS MICHAEL MONSOOR 

(DDG 1001); 


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