7452 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 

§ 870.4100 Extracorporeal circuit and 

accessories for long-term respiratory/

cardiopulmonary failure. 

(a) Identification. An extracorporeal 

circuit and accessories for long-term 

respiratory/cardiopulmonary support 

(>6 hours) is a system of devices and 

accessories that provides assisted 

extracorporeal circulation and 

physiologic gas exchange of the 

patient’s blood in patients with acute 

respiratory failure or acute 

cardiopulmonary failure, where other 

available treatment options have failed, 

and continued clinical deterioration is 

expected or the risk of death is 

imminent. The main devices and 

accessories of the system include, but 

are not limited to, the console 

(hardware), software, and disposables, 

including, but not limited to, an 

oxygenator, blood pump, heat 

exchanger, cannulae, tubing, filters, and 

other accessories (e.g., monitors, 

detectors, sensors, connectors). 

(b) Classification—Class II (special 

controls). The special controls for this 

device are: 

(1) The technological characteristics 

of the device must ensure that the 

geometry and design parameters are 

consistent with the intended use, and 

that the devices and accessories in the 

circuit are compatible; 

(2) The devices and accessories in the 

circuit must be demonstrated to be 

biocompatible; 

(3) Sterility and shelf-life testing must 

demonstrate the sterility of any patientcontacting devices and accessories in 

the circuit and the shelf life of these 

devices and accessories; 

(4) Non-clinical performance 

evaluation of the devices and 

accessories in the circuit must 

demonstrate substantial equivalence of 

the performance characteristics on the 

bench, mechanical integrity, 

electromagnetic compatibility (where 

applicable), software, durability, and 

reliability; 

(5) In vivo evaluation of the devices 

and accessories in the circuit must 

demonstrate their performance over the 

intended duration of use, including a 

detailed summary of the clinical 

evaluation pertinent to the use of the 

devices and accessories to demonstrate 

their effectiveness if a specific 

indication (patient population and/or 

condition) is identified; and 

(6) Labeling must include a detailed 

summary of the non-clinical and in vivo 

evaluations pertinent to use of the 

devices and accessories in the circuit 

and adequate instructions with respect 

to anticoagulation, circuit setup, 

performance characteristics with respect 

to compatibility among different devices 

and accessories in the circuit, and 

maintenance during a procedure. 

Dated: February 8, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–02876 Filed 2–11–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 878 

[Docket No. FDA–2016–N–0237] 

Medical Devices; General and Plastic 

Surgery Devices; Classification of the 

Scalp Cooling System To Reduce the 

Likelihood of Chemotherapy-Induced 

Alopecia 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

scalp cooling system to reduce the 

likelihood of chemotherapy-induced 

alopecia into class II (special controls). 

The special controls that will apply to 

the device are identified in this order 

and will be part of the codified language 

for the scalp cooling system to reduce 

the likelihood of chemotherapy-induced 

alopecia’s classification. The Agency is 

classifying the device into class II 

(special controls) in order to provide a 

reasonable assurance of safety and 

effectiveness of the device. 

DATES: This order is effective February 

12, 2016. The classification was 

applicable on December 8, 2015. 

FOR FURTHER INFORMATION CONTACT: Neil 

Ogden, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G414, Silver Spring, 

MD 20993–0002, 301–796–6397. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 

360c(f)(1)), devices that were not in 

commercial distribution before May 28, 

1976 (the date of enactment of the 

Medical Device Amendments of 1976), 

generally referred to as postamendments 

devices, are classified automatically by 

statute into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

the device is classified or reclassified 

into class I or II, or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the FD&C Act, to a predicate 

device that does not require premarket 

approval. The Agency determines 

whether new devices are substantially 

equivalent to predicate devices by 

means of premarket notification 

procedures in section 510(k) of the 

FD&C Act (21 U.S.C. 360(k)) and part 

807 (21 CFR part 807) of the regulations. 

Section 513(f)(2) of the FD&C Act, as 

amended by section 607 of the Food and 

Drug Administration Safety and 

Innovation Act (Pub. L. 112–144), 

provides two procedures by which a 

person may request FDA to classify a 

device under the criteria set forth in 

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

Under the first procedure, the person 

submits a premarket notification under 

section 510(k) of the FD&C Act for a 

device that has not previously been 

classified and, within 30 days of 

receiving an order classifying the device 

into class III under section 513(f)(1) of 

the FD&C Act, the person requests a 

classification under section 513(f)(2). 

Under the second procedure, rather than 

first submitting a premarket notification 

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

and then a request for classification 

under the first procedure, the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence and requests a classification 

under section 513(f)(2) of the FD&C Act. 

If the person submits a request to 

classify the device under this second 

procedure, FDA may decline to 

undertake the classification request if 

FDA identifies a legally marketed device 

that could provide a reasonable basis for 

review of substantial equivalence with 

the device or if FDA determines that the 

device submitted is not of ‘‘lowmoderate risk’’ or that general controls 

would be inadequate to control the risks 

and special controls to mitigate the risks 

cannot be developed. 

In response to a request to classify a 

device under either procedure provided 

by section 513(f)(2) of the FD&C Act, 

FDA will classify the device by written 

order within 120 days. This 

classification will be the initial 

classification of the device. 

On March 6, 2015, Target Health, Inc. 

(on behalf of Dignitana AB) submitted a 

request for classification of the 

DigniCapTM Scalp Cooling System 

under section 513(f)(2) of the FD&C Act. 

The manufacturer recommended that 

the device be classified into class II (Ref. 

1). 

In accordance with section 513(f)(2) of 

the FD&C Act, FDA reviewed the 


srobinson on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 7453 

request in order to classify the device 

under the criteria for classification set 

forth in section 513(a)(1) of the FD&C 

Act. FDA classifies 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 to provide 

reasonable assurance of the safety and 

effectiveness of the device for its 

intended use. After review of the 

information submitted in the request 

and the medical literature, if applicable, 

FDA determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

believes these special controls will 

provide reasonable assurance of the 

safety and effectiveness of the device. 

Therefore, on December 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 § 878.4360 (21 CFR 

878.4360). 

Following the effective date of this 

final classification order, any firm 

submitting a premarket notification 

(510(k)) for a scalp cooling system to 

reduce the likelihood of chemotherapyinduced alopecia will need to comply 

with the special controls named in this 

final order. 

The device is assigned the generic 

name scalp cooling system to reduce the 

likelihood of chemotherapy-induced 

alopecia, and it is identified as a scalp 

cooling system to reduce the likelihood 

of chemotherapy-induced alopecia 

intended to reduce the frequency and 

severity of alopecia during 

chemotherapy in which alopeciainducing chemotherapeutic agents are 

used. The device is a prescription 

device. 

FDA has identified the following risks 

to health associated with this type of 

device and the measures required to 

mitigate these risks: 

TABLE 1—SCALP COOLING SYSTEM TO REDUCE THE LIKELIHOOD OF CHEMOTHERAPY-INDUCED ALOPECIA RISKS AND

MITIGATION MEASURES

Identified risk Mitigation measure 

Thermal Tissue Damage .......................................................................... Non-clinical Performance Testing. 

Software Verification, Validation, and Hazard Analysis Labeling. 

Electromagnetic Interference/Electrical Shock ......................................... Electromagnetic Compatibility and Electrical Testing Labeling. 

Adverse Tissue Reaction ......................................................................... Biocompatibility. 

Increased Risk of Scalp Metastases ........................................................ Labeling. 

Patient Labeling. 

Use Error .................................................................................................. Labeling. 

Scalp Pain, Headache, and Chills ............................................................ Labeling. 

Patient Labeling. 

FDA believes that the special controls 

in § 878.4360(b)(1) through (6), in 

addition to the general controls, address 

these risks to health and provide 

reasonable assurance of safety and 

effectiveness. 

Scalp cooling systems to reduce the 

likelihood of chemotherapy-induced 

alopecia are prescription devices 

restricted to patient use only upon the 

authorization of a practitioner licensed 

by law to administer or use the device; 

see 21 CFR 801.109 (Prescription 

devices). 

Section 510(m) of the FD&C Act 

provides that FDA may exempt a class 

II device from the premarket notification 

requirements under section 510(k) of the 

FD&C Act, if FDA determines that 

premarket notification is not necessary 

to provide reasonable assurance of the 

safety and effectiveness of the device. 

For this type of device, FDA has 

determined that premarket notification 

is necessary to provide reasonable 

assurance of the safety and effectiveness 

of the device. Therefore, this device 

type is not exempt from premarket 

notification requirements. Persons who 

intend to market this type of device 

must submit to FDA a premarket 

notification, prior to marketing the 

device, which contains information 

about the scalp cooling system to reduce 

the likelihood of chemotherapy-induced 

alopecia they intend to market. 

II. 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. 

III. 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, and the collections of 

information in 21 CFR part 801, 

regarding labeling, have been approved 

under OMB control number 0910–0485. 

IV. Reference 

The following reference is on display 

in the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, and is 

available for viewing by interested 

persons between 9 a.m. and 4 p.m., 

Monday through Friday; it is also 

available electronically at http://

www.regulations.gov. 

1. DEN150010: De novo request per 513(f)(2) 

from Target Health, Inc. (on behalf of 

Dignitana AB), dated March 6, 2015. 

List of Subjects in 21 CFR Part 878 

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 878 is 

amended as follows: 

PART 878—GENERAL AND PLASTIC 

SURGERY DEVICES 

■ 1. The authority citation for 21 CFR 

part 878 continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 878.4360 to subpart E to read 

as follows: 

§ 878.4360 Scalp cooling system to reduce 

the likelihood of chemotherapy-induced 

alopecia. 

(a) Identification. A scalp cooling 

system to reduce the likelihood of 

chemotherapy-induced alopecia is a 

prescription device intended to reduce 


srobinson on DSK5SPTVN1PROD with RULES
7454 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 

the frequency and severity of alopecia 

during chemotherapy in which 

alopecia-inducing chemotherapeutic 

agents are used. 

(b) Classification—Class II (special 

controls). The special controls for this 

device are: 

(1) Non-clinical performance testing 

must demonstrate that the device meets 

all design specifications and 

performance requirements, and that the 

device performs as intended under 

anticipated conditions of use. This 

information must include testing to 

demonstrate accuracy of the 

temperature control mechanism. 

(2) Performance testing must 

demonstrate the electromagnetic 

compatibility and electrical safety of the 

device. 

(3) Software verification, validation, 

and hazard analysis must be performed. 

(4) The patient contacting 

components of the device must be 

demonstrated to be biocompatible. 

Material names must be provided. 

(5) Labeling must include the 

following: 

(i) A statement describing the 

potential risk of developing scalp 

metastasis. 

(ii) Information on the patient 

population and chemotherapeutic 

agents/regimen for which the device has 

been demonstrated to be effective. 

(iii) A summary of the non-clinical 

and/or clinical testing pertinent to use 

of the device. 

(iv) A summary of the device 

technical parameters, including 

temperature cooling range and duration 

of cooling. 

(v) A summary of the device- and 

procedure-related adverse events 

pertinent to use of the device. 

(vi) Information on how the device 

operates and the typical course of 

treatment. 

(6) Patient labeling must be provided 

and must include: 

(i) Relevant contraindications, 

warnings, precautions, and adverse 

effects/complications. 

(ii) Information on how the device 

operates and the typical course of 

treatment. 

(iii) Information on the patient 

population for which there is clinical 

evidence of effectiveness. 

(iv) The potential risks and benefits 

associated with use of the device. 

(v) Postoperative care instructions. 

(vi) A statement describing the 

potential risk of developing scalp 

metastasis. 

Dated: February 8, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–02878 Filed 2–11–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF STATE 

22 CFR Part 41 

[Public Notice: 9439] 

RIN 1400–AD17 

Visas: Documentation of 

Nonimmigrants Under the Immigration 

and Nationality Act, as Amended 

AGENCY: Department of State. 

ACTION: Interim final rule; correction. 

SUMMARY: The Department of State 

published a Federal Register interim 

final rule on February 4, 2016, in 

Volume 81, No. 23, page 5906. The 

document contains an error in the 

Regulatory Findings. This document 

corrects the rule by replacing the text, 

‘‘included elsewhere in this edition of 

the Federal Register’’ with ‘‘published 

in the Federal Register on February 8, 

2016, 81 FR 6430.’’ There is also a 

correction in the ADDRESSES section, to 

provide the correct public notice 

number to find the rule to submit 

comments on www.regulations.gov. 

DATES: This correction is effective on 

February 19, 2016. Written comments 

must be received on or before April 4, 

2016. 

FOR FURTHER INFORMATION CONTACT: 

Paul-Anthony L. Magadia, U.S. 

Department of State, Visa Services, 

Legislation and Regulations Division, 

Washington, DC 20006, 202–485–7641; 

email: magadiapl@state.gov. 

SUPPLEMENTARY INFORMATION: The 

Department of State published an 

interim final rule on February 4, 2016 

(81 FR 5906); this document corrects 

text in the ADDRESSES section and in the 

discussion of Executive Order 12866. 

Correction 

In the FR Doc 2016–02191, appearing 

on page 5906 in the Federal Register of 

February 4, 2016 (81 FR 5906): 

1. In the second column of page 5906, 

third item under ADDRESSES, the term 

‘‘XXXX’’ is corrected to read ‘‘9428.’’ 

2. In the third column of page 5907, 

the first sentence of the discussion 

regarding ‘‘Executive Order 12866: 

Regulatory Review’’ is corrected to read: 

‘‘The costs of this rulemaking are 

discussed in the companion DHS rule, 

RIN 1651–AB09, published in the 

Federal Register on February 8, 2016, 

81 FR 6430.’’ 

Dated: February 9, 2016. 

David S. Newman, 

Director of Legal Affairs, Visa Services, 

Bureau of Consular Affairs, U.S. Department 

of State. 

[FR Doc. 2016–02962 Filed 2–11–16; 8:45 am] 

BILLING CODE 4710–06–P 

PENSION BENEFIT GUARANTY 

CORPORATION 

29 CFR Part 4022 

Benefits Payable in Terminated SingleEmployer Plans; Interest Assumptions 

for Paying Benefits 

AGENCY: Pension Benefit Guaranty 

Corporation. 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

Pension Benefit Guaranty Corporation’s 

regulation on Benefits Payable in 

Terminated Single-Employer Plans to 

prescribe interest assumptions under 

the regulation for valuation dates in 

March 2016. The interest assumptions 

are used for paying benefits under 

terminating single-employer plans 

covered by the pension insurance 

system administered by PBGC. 

DATES: Effective March 1, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Catherine B. Klion (Klion.Catherine@

pbgc.gov), Assistant General Counsel for 

Regulatory Affairs, Pension Benefit 

Guaranty Corporation, 1200 K Street 

NW., Washington, DC 20005, 202–326– 

4024. (TTY/TDD users may call the 

Federal relay service toll-free at 1–800– 

877–8339 and ask to be connected to 

202–326–4024.) 

SUPPLEMENTARY INFORMATION: PBGC’s 

regulation on Benefits Payable in 

Terminated Single-Employer Plans (29 

CFR part 4022) prescribes actuarial 

assumptions—including interest 

assumptions—for paying plan benefits 

under terminating single-employer 

plans covered by title IV of the 

Employee Retirement Income Security 

Act of 1974. The interest assumptions in 

the regulation are also published on 

PBGC’s Web site (http://www.pbgc.gov). 

PBGC uses the interest assumptions in 

Appendix B to Part 4022 to determine 

whether a benefit is payable as a lump 

sum and to determine the amount to 

pay. Appendix C to Part 4022 contains 

interest assumptions for private-sector 

pension practitioners to refer to if they 

wish to use lump-sum interest rates 

determined using PBGC’s historical 

methodology. Currently, the rates in 

Appendices B and C of the benefit 

payment regulation are the same. 


srobinson on DSK5SPTVN1PROD with RULES