48762 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Rules and Regulations 

9 5 U.S.C. 603(a), 604(a). 

10 44 U.S.C. 3506. 

this requirement. As explained above, 

the adjustments required for years 

subsequent to 2017 are not subject to the 

requirements of the Administrative 

Procedure Act. Moreover, the 2017 

adjustments are made according to a 

statutory formula that does not provide 

for agency discretion. Accordingly, a 

delay in effectiveness of the 2017 

adjustments is not required. 

IV. Regulatory Requirements 

Regulatory Flexibility Act 

Because no notice of proposed 

rulemaking is required, the Regulatory 

Flexibility Act does not require an 

initial or final regulatory flexibility 

analysis.9

Paperwork Reduction Act 

In accordance with the Paperwork 

Reduction Act of 1995,10 NASA 

reviewed this interim final rule. No 

collections of information pursuant to 

the Paperwork Reduction Act are 

contained in the interim final rule. 

List of Subjects in 14 CFR Parts 1264 

and 1271 

Claims, Lobbying, Penalties. 

For the reasons stated in the 

preamble, the National Aeronautics and 

Space Administration adopts as final 

the interim rule amending 14 CFR parts 

1264 and 1271 which published on June 

26, 2017, at 82 FR 28760, with the 

following changes: 

PART 1264—IMPLEMENTATION OF 

THE PROGRAM FRAUD CIVIL 

PENALTIES ACT OF 1986 

■ 1. The authority citation for part 1264 

continues to read as follows: 

Authority: 31 U.S.C. 3809, 51 U.S.C. 

20113(a). 

§ 1264.102 [Amended] 

■ 2. In § 1264.102, paragraphs (a) and 

(b), remove the number ‘‘$10,781’’ and 

add in its place the number ‘‘$10,957.’’ 

PART 1271—NEW RESTRICTIONS ON 

LOBBYING 

■ 3. The authority citation for part 1271 

continues to read as follows: 

Authority: Section 319, Pub. L. 101–121 

(31 U.S.C. 1352); Pub. L. 97–258 (31 U.S.C. 

6301 et seq.) 

§ 1271.400 [Amended] 

■ 4. In § 1271.400: 

■ a. In paragraphs (a) and (b) remove the 

words ‘‘not less than $18,936 and not 

more than $189,361’’ and add in their 

place the words ‘‘not less than $19,246 

and not more than $192,459.’’ 

■ b. In paragraph (e), remove the two 

occurrences of ‘‘$18,936’’ and add in 

their place ‘‘$19,246’’ and remove 

‘‘189,361’’ and add in its place 

‘‘$192,459’’. 

Appendix A to Part 1271 [Amended] 

■ 5. In appendix A to part 1271, in the 

paragraph following paragraph (3) and 

in the last paragraph of the appendix, 

remove the words ‘‘not less than 

$18,936 and not more than $189,361’’ 

and add in their place the words ‘‘not 

less than $19,246 and not more than 

$192,459’’. 

Nanette J. Smith, 

NASA Federal Register Liaison Officer. 

[FR Doc. 2017–22847 Filed 10–19–17; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2017–N–5371] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

the Device To Detect and Identify 

Microbial Pathogen Nucleic Acids in 

Cerebrospinal Fluid 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the device to detect and 

identify microbial pathogen nucleic 

acids in cerebrospinal fluid into class II 

(special controls). The special controls 

that will apply to the device type are 

identified in this order and will be part 

of the codified language for the device 

to detect and identify microbial 

pathogen nucleic acids in cerebrospinal 

fluid’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 

20, 2017. The classification was 

applicable on October 8, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Sconce, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4524, Silver Spring, 

MD, 20993–0002, 301–796–6679, 

kimberly.sconce@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

device to detect and identify microbial 

pathogen nucleic acids in cerebrospinal 

fluid 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. 

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 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. 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 


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Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Rules and Regulations 48763 

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 April 9, 2015, BioFire Diagnostics, 

LLC submitted a request for De Novo 

classification of the FilmArray®

Meningitis/Encephalitis (ME) Panel. 

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 October 8, 2015, 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 866.3970. We 

have named the generic type of device, 

device to detect and identify microbial 

pathogen nucleic acids in cerebrospinal 

fluid, and it is identified as a qualitative 

in vitro device intended for the 

detection and identification of 

microbial-associated nucleic acid 

sequences from patients suspected of 

meningitis or encephalitis. A device to 

detect and identify microbial pathogen 

nucleic acids in cerebrospinal fluid is 

intended to aid in the diagnosis of 

meningitis or encephalitis when used in 

conjunction with clinical signs and 

symptoms and other clinical and 

laboratory findings. 

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—DEVICE TO DETECT AND IDENTIFY MICROBIAL PATHOGEN NUCLEIC ACIDS IN CEREBROSPINAL FLUID RISKS AND

MITIGATION MEASURES

Identified risks Mitigation measures 

Incorrect identification or lack of identification of a pathogenic microorganism by the device can 

lead to improper patient management.

Special Controls (1), (2), (3), (4), and (5). 

Failure to correctly interpret test results ......................................................................................... Special Controls (6), (7), (8), and (9). 

Failure to correctly operate the instrument ..................................................................................... Special Control (10). 

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 

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 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 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 § 866.3970 to subpart D to read 

as follows: 

§ 866.3970 Device to detect and identify 

microbial pathogen nucleic acids in 

cerebrospinal fluid. 

(a) Identification. A device to detect 

and identify microbial pathogen nucleic 

acids in cerebrospinal fluid is a 

qualitative in vitro device intended for 

the detection and identification of 

microbial-associated nucleic acid 


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48764 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Rules and Regulations 

sequences from patients suspected of 

meningitis or encephalitis. A device to 

detect and identify microbial pathogen 

nucleic acids in cerebrospinal fluid is 

intended to aid in the diagnosis of 

meningitis or encephalitis when used in 

conjunction with clinical signs and 

symptoms and other clinical and 

laboratory findings. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Premarket notification 

submissions must include detailed 

device description documentation, 

including the device components, 

ancillary reagents required but not 

provided, and a detailed explanation of 

the methodology, including primer/ 

probe sequence, design, and rationale 

for sequence selection. 

(2) Premarket notification 

submissions must include detailed 

documentation from the following 

analytical studies: Analytical sensitivity 

(limit of detection), inclusivity, 

reproducibility, interference, cross 

reactivity, and specimen stability. 

(3) Premarket notification 

submissions must include detailed 

documentation from a clinical study. 

The study, performed on a study 

population consistent with the intended 

use population, must compare the 

device performance to results obtained 

from well-accepted comparator 

methods. 

(4) Premarket notification 

submissions must include detailed 

documentation for device software, 

including, but not limited to, software 

applications and hardware-based 

devices that incorporate software. 

(5) The Intended Use statement in the 

device labeling must include a 

statement that the device is intended to 

be used in conjunction with standard of 

care culture. 

(6) A detailed explanation of the 

interpretation of results and acceptance 

criteria must be included in the device’s 

21 CFR 809.10(b)(9) compliant labeling. 

(7) The device labeling must include 

a limitation stating that the negative 

results do not preclude the possibility of 

central nervous system infection. 

(8) The device labeling must include 

a limitation stating that device results 

are not intended to be used as the sole 

basis for diagnosis, treatment, or other 

patient management decisions. 

(9) The device labeling must include 

a limitation stating that positive results 

do not mean that the organism detected 

is infectious or is the causative agent for 

clinical symptoms. 

(10) As part of the risk management 

activities performed as part of your 21 

CFR 820.30 design controls, you must 

document an appropriate end user 

device training program that will be 

offered as part of your efforts to mitigate 

the risk of failure to correctly operate 

the instrument. 

Dated: October 13, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–22769 Filed 10–19–17; 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 (72 COLREGS), to reflect that 

the Deputy Assistant Judge Advocate 

General (DAJAG) (Admiralty and 

Maritime Law) has determined that 

certain vessels of the VIRGINIA SSN 

Class are vessels of the Navy which, due 

to their special construction and 

purpose, cannot fully comply with 

certain provisions of the 72 COLREGS 

without interfering with their special 

function as a naval ships. The intended 

effect of this rule is to warn mariners in 

waters where 72 COLREGS apply. 

DATES: This rule is effective October 20, 

2017 and is applicable beginning 

September 30, 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 

certain vessels of the SSN Class are 

vessels of the Navy which, due to their 

special construction and purpose, 

cannot fully comply with the following 

specific provisions of 72 COLREGS 

without interfering with their special 

function as a naval ship: Rule 23(a) and 

Annex I, paragraph 2(a)(i), pertaining to 

the vertical placement of the masthead, 

light and Annex I, paragraph 2(f)(i), 

pertaining to the masthead light being 

above and clear of all other lights and 

obstructions; Rule 30 (a), Rule 21(e), and 

Annex I, paragraph 2(k), pertaining to 

the vertical separation of the anchor 

lights, vertical placement of the forward 

anchor light above the hull, and the arc 

of visibility of all around lights; Rule 23 

(a) and Annex I, paragraph 3(b), 

pertaining to the location of the 

sidelights; and Rule 21(c), pertaining to 

the location and arc of visibility of the 

sternlight. 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 these vessels in 

a manner differently from that 

prescribed herein will adversely affect 

these vessels’ ability to perform their 

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 alpha 

numerical order, by vessel number, an 

entry for USS INDIANA (SSN 789); 

■ b. In Table Three, adding, in alpha 

numerical order, by vessel number, an 

entry for USS INDIANA (SSN 789); and 

■ c. In Table Four: 

■ i. In paragraph 25, adding, in alpha 

numerical order, by vessel number, an 

entry for USS INDIANA (SSN 789); and 

■ ii. In paragraph 26, adding, in alpha 

numerical order, by vessel number, an 

entry for USS INDIANA (SSN 789). 

The additions read as follows: 

§ 706.2 Certifications of the Secretary of 

the Navy under Executive Order 11964 and 

33 U.S.C. 1605. 

* * * * * 


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