50530 Federal Register / Vol. 82, No. 210 / Wednesday, November 1, 2017 / Rules and Regulations 

APPENDIX B TO PART 24—CUSTOMS COBRA USER FEES AND LIMITATIONS IN 19 CFR 24.23 

19 U.S.C. 58c 19 CFR 24.23 Customs COBRA user 

fee/limitation 

FY14 Base fee/ 

limitation (subject 

to adjustment in 

accordance with 

the FAST Act) 

(b)(9)(A) (ii) ............................ (b)(1)(i)(A) .............................. Fee: Express Consignment Carrier/Centralized Hub Facility 

Fee, Per Individual Waybill/Bill of Lading Fee.

$1 

(b)(9)(B)(i) .............................. (b)(1)(i)(B)(2) ......................... Limitation: Minimum Express Consignment Carrier/Centralized Hub Facility Fee.0.35 

(b)(9)(B)(i) .............................. (b)(1)(i)(B)(2) ......................... Limitation: Maximum Express Consignment Carrier/Centralized Hub Facility Fee.1 

(a)(9)(B)(i); .............................

(b)(8)(A)(i) ..............................

(b)(1)(i)(B)(1) ......................... Limitation: Minimum Merchandise Processing Fee .............. 25 

(a)(9)(B)(i); .............................

(b)(8)(A)(i) ..............................

(b)(1)(i)(B)(1) ......................... Limitation: Maximum Merchandise Processing Fee ............. 485 

(b)(8)(A)(ii) ............................. (b)(1)(ii) .................................. Fee: Surcharge for Manual Entry or Release ....................... 3 

(a)(10)(C)(i) ............................ (b)(2)(i) ................................... Fee: Informal Entry or Release; Automated and Not Prepared by CBP Personnel.2 

(a)(10)(C)(ii) ........................... (b)(2)(ii) .................................. Fee: Informal Entry or Release; Manual and Not Prepared 

by CBP Personnel.

6 

(a)(10)(C)(iii) .......................... (b)(2)(iii) ................................. Fee: Informal Entry or Release; Automated or Manual; Prepared by CBP Personnel.9 

(b)(9)(A)(ii) ............................. (b)(4) ...................................... Fee: Express Consignment Carrier/Centralized Hub Facility 

Fee, Per Individual Waybill/Bill of Lading Fee.

1 

PART 111—CUSTOMS BROKERS 

■ 5. The general authority citation for 

part 111 and the specific authority 

citation for § 111.96 continue to read as 

follows: 

Authority: 19 U.S.C. 66, 1202 (General 

Note 3(i), Harmonized Tariff Schedule of the 

United States), 1624, 1641. 

* * * * * 

Section 111.96 also issued under 19 U.S.C. 

58c, 31 U.S.C. 9701. 

* * * * * 

§ 111.19 [Amended] 

■ 6. In § 111.19(c): 

■ a. Remove the phrase ‘‘100 and 138’’ 

in the first sentence; and 

■ b. Remove the amounts ‘‘100’’ and 

‘‘138’’ in each place that they appear. 

§ 111.96 [Amended] 

■ 7. In § 111.96(c): 

■ a. In the first sentence, remove the 

words ‘‘of 138’’ and add in their place 

the words ‘‘specified in § 24.22(h) of 

this chapter’’; and 

■ b. Remove the figure ‘‘138’’ in each 

place that it appears. 

Ronald D. Vitiello, 

Acting Deputy Commissioner, U.S. Customs 

and Border Protection. 

Approved: October 30, 2017. 

Timothy E. Skud, 

Deputy Assistant Secretary of the Treasury. 

[FR Doc. 2017–23878 Filed 10–31–17; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2017–N–5995] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

the BCR–ABL Quantitation Test 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the BCR–ABL quantitation 

test 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 

BCR–ABL quantitation test’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 November 

1, 2017. The classification was 

applicable on July 22, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Ryan Lubert, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4545, Silver Spring, 

MD 20993–0002, 240–402–6357, 

ryan.Lubert@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

BCR–ABL quantitation test 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 

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 (21 

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

does not require premarket approval. 


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Federal Register / Vol. 82, No. 210 / Wednesday, November 1, 2017 / Rules and Regulations 50531 

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 and part 807 (21 

U.S.C. 360(k) and 21 CFR part 807, 

respectively). 

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 

placed 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 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 

On January 19, 2016, Asuragen, Inc., 

submitted a request for De Novo 

classification of the QuantideX qPCR 

BCR–ABL IS 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 general controls, 

will provide reasonable assurance of the 

safety and effectiveness of the device. 

Therefore, on July 22, 2016, 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 866.6060. We 

have named the generic type of device 

BCR–ABL quantitation test, and it is 

identified as a reverse transcriptionquantitative polymerase chain reaction 

(RT-qPCR) test for the quantitation of 

BCR–ABL1 expressed on the 

International Scale (IS) and control 

transcripts in total RNA from whole 

blood of diagnosed t(9;22) positive 

chronic myeloid leukemia (CML) 

patients during monitoring of treatment 

with tyrosine kinase inhibitors. This test 

is not intended for the diagnosis of 

CML. 

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—BCR–ABL QUANTITATION TEST RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures/21 CFR section 

False negative results .............................................................................. Special Controls (1) and (2) (21 CFR 866.6060(b)(1) and (2)). 

False positive results ................................................................................ Special Controls (1) and (2) (21 CFR 866.6060(b)(1) and (2)). 

Lack of traceability of results .................................................................... Special Control (3) (21 CFR 866.6060(b)(3)). 

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) 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. 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 

the guidance document ‘‘De Novo 

Classification Process (Evaluation of 

Automatic Class III Designation)’’ have 

been approved under OMB control 

number 0910–0844; the collections of 

information in 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; and the collections of 

information in 21 CFR parts 801 and 

809, regarding labeling have been 

approved under OMB control number 

0910–0485. 


sradovich on DSK3GMQ082PROD with RULES
50532 Federal Register / Vol. 82, No. 210 / Wednesday, November 1, 2017 / Rules and Regulations 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, 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 866 is 

amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for part 866 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 866.6060 to subpart G to read 

as follows: 

§ 866.6060 BCR–ABL quantitation test. 

(a) Identification. A BCR–ABL 

quantitation test is identified as a 

reverse transcription-quantitative 

polymerase chain reaction (RT-qPCR) 

test for the quantitation of BCR–ABL1 

expressed on the International Scale (IS) 

and control transcripts in total RNA 

from whole blood of diagnosed t(9;22) 

positive chronic myeloid leukemia 

(CML) patients during monitoring of 

treatment with tyrosine kinase 

inhibitors. This test is not intended for 

the diagnosis of CML. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Premarket notification 

submissions must include the following 

information: 

(i) The indication for use must 

indicate the variant(s) for which the 

assay was designed and validated, for 

example BCR–ABL e13a2 and/or e14a2. 

(ii) A detailed description of all 

components in the test, including the 

following: 

(A) A detailed description of the test 

components, all required reagents, 

instrumentation and equipment, 

including illustrations or photographs of 

non-standard equipment or methods; 

(B) Detailed documentation of the 

device software including, but not 

limited to, standalone software 

applications and hardware-based 

devices that incorporate software; 

(C) Methodology and protocols for 

control procedures for the assay to allow 

reporting on the International Scale; 

(D) A description of the result 

outputs, analytical sensitivity of the 

assay, and the range of values that will 

be reported; and 

(E) A description of appropriate 

internal and external controls that are 

recommended or provided. The 

description must identify those control 

elements that are incorporated into the 

testing procedure. 

(iii) Information that demonstrates the 

performance characteristics of the test, 

including: 

(A) For indications for use based on 

a threshold established in a predicate 

device of this generic type, device 

performance data from either a method 

comparison study to the predicate 

device or through a clinical study 

demonstrating clinical validity using 

well-characterized prospectively or 

retrospectively obtained clinical 

specimens, as appropriate, 

representative of the intended use 

population; 

(B) For indications for use based on a 

threshold not established in a predicate 

device of this generic type, device 

performance data from a clinical study 

demonstrating clinical validity using 

well-characterized prospectively or 

retrospectively obtained clinical 

specimens, as appropriate, 

representative of the intended use 

population; 

(C) Device reproducibility data 

generated, using a minimum of three 

sites, of which at least two sites must be 

external sites, with two operators at 

each site. Each site must conduct a 

minimum of three runs per operator 

over non-consecutive days evaluating a 

minimum of five different BCR–ABL 

concentrations that span and are well 

distributed over the measuring range 

and include MR3 (0.1 percent IS). 

Results shall be reported as the standard 

deviation and percentage coefficient of 

variation for each level tested. 

Prespecified acceptance criteria must be 

provided and followed; 

(D) Device precision data using 

clinical samples to evaluate the withinlot, between-lot, within-run, between 

run, and total variation; 

(E) Device linearity data using a 

dilution panel created from clinical 

samples; 

(F) Device analytic sensitivity data, 

including limit of blank, limit of 

detection, and limit of quantification; 

(G) Device specificity data, including 

interference and cross-contamination; 

and 

(H) Device stability data, including 

real-time stability of samples under 

various storage times, temperatures, and 

freeze-thaw conditions. 

(iv) Identification of risk mitigation 

elements used by your device, including 

a detailed description of all additional 

procedures, methods, and practices 

incorporated into the instructions for 

use that mitigate risks associated with 

testing using your device. 

(2) Your 21 CFR 809.10 compliant 

labeling must include the following: 

(i) The intended use in your 21 CFR 

809.10(a)(2) and (b)(2) complaint 

labeling must include an indication for 

use statement that reads ‘‘This test is not 

intended for the diagnosis of CML’’; and 

(ii) A detailed description of the 

performance studies conducted to 

comply with paragraph (b)(1)(iii) of this 

section and a summary of the results. 

(3) Your device output must include 

results on the International Scale (IS) 

and your assay must include multipoint 

calibration controls traceable to a 

relevant international reference panel 

(e.g., the World Health Organization 

International Genetic Reference Panel 

for quantitation of BCR–ABL mRNA). 

Dated: October 26, 2017. 

Lauren Silvis, 

Chief of Staff. 

[FR Doc. 2017–23742 Filed 10–31–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE INTERIOR 

25 CFR Chapters I through III and V 

through VII 

30 CFR Chapters II, IV, V, VII, and XII 

36 CFR Chapter I 

43 CFR Subtitles A and B 

50 CFR Chapters I and IV 

[178D0102DM, DS6CS00000, 

DLSN00000.000000, DX.6CS25] 

Final Report: Review of the 

Department of the Interior Actions That 

Potentially Burden Domestic Energy 

AGENCY: Office of the Secretary, Interior. 

ACTION: Availability of Final Report. 

SUMMARY: The Department of the 

Interior (Interior or the Department) is 

announcing the availability of and 

publishing in its entirety the Final 

Report: Review of the Department of the 

Interior Actions that Potentially Burden 

Domestic Energy prepared pursuant to 

Executive Order 13783, ‘‘Promoting 

Energy Independence and Economic 

Growth.’’ 

DATES: November 1, 2017. 

ADDRESSES: The report is available 

online at: https://www.doi.gov/sites/ 

doi.gov/files/uploads/interior_energy_

actions_report_final.pdf. 

FOR FURTHER INFORMATION CONTACT: 

Mark Lawyer, 202–208–5257, mark_

lawyer@ios.doi.gov. 

SUPPLEMENTARY INFORMATION: Executive 

Order 13783, ‘‘Promoting Energy 

Independence and Economic Growth,’’ 

82 FR 16093 (March 31, 2017), declared 

a national policy of promoting clean and 


sradovich on DSK3GMQ082PROD with RULES