10330 Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Rules and Regulations 

databases. As such, these special 

conditions address these vulnerabilities. 

The digital systems architecture for 

the Boeing Model 767–2C series 

airplanes is composed of several 

connected networks. This network 

architecture is used for a diverse set of 

functions providing data connectivity 

between systems, including: 

1. Airplane control, communication, 

display, monitoring and navigation 

systems, 

2. operator business and 

administrative support systems, 

3. passenger entertainment systems, 

and 

4. access by systems external to the 

airplane. 

The Model 767–2C series airplane 

electronic-system network architecture 

allows connection to airplane electronic 

systems and networks, and access from 

airplane external sources (e.g., operator 

networks, wireless devices, Internet 

connectivity, service-provider satellite 

communications, electronic flight bags, 

etc.) to the previously isolated airplane 

electronic assets. 

This design may result in networksecurity vulnerabilities from intentional 

or unintentional corruption of data and 

systems required for the safety, 

operations, and maintenance of the 

airplane. The existing regulations and 

guidance material did not anticipate this 

type of system architecture, or external 

wired and wireless electronic access to 

airplane electronic systems. 

Furthermore, regulations, and current 

system safety-assessment policy and 

techniques, do not address potential 

security vulnerabilities, which could be 

caused by unauthorized access to 

airplane electronic systems and 

networks. 

Special conditions have been applied 

on past airplane programs to require 

consideration of related security 

vulnerabilities. These special conditions 

are similar to those previously applied, 

except that the scope has been adjusted 

to be consistent with those features 

unique to the Model 767–2C series 

airplane. 

Applicability 

As discussed above, these special 

conditions apply to Boeing Model 767– 

2C series airplanes. Should Boeing 

apply later for a change to the type 

certificate to include another model 

incorporating the same novel or unusual 

design feature, the special conditions 

would apply to that model as well. 

Conclusion 

This action affects only certain novel 

or unusual design features on one model 

series of airplane. It is not a rule of 

general applicability. 

The substance of these special 

conditions has been subjected to the 

notice and comment period in several 

prior instances, and has been derived 

without substantive change from those 

previously issued. It is unlikely that 

prior public comment would result in a 

significant change from the substance 

contained herein. Therefore, because a 

delay would significantly affect the 

certification of the airplane, the FAA 

has determined that prior public notice 

and comment are unnecessary and 

impracticable, and good cause exists for 

adopting these special conditions upon 

publication in the Federal Register. 

The FAA is requesting comments to 

allow interested persons to submit 

views that may not have been submitted 

in response to the prior opportunities 

for comment described above. 

List of Subjects in 14 CFR Part 25 

Aircraft, Aviation safety, Reporting 

and recordkeeping requirements. 

The authority citation for these 

special conditions is as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701, 

44702, 44704. 

The Special Conditions 

Accordingly, pursuant to the 

authority delegated to me by the 

Administrator, the following special 

conditions are issued as part of the typecertification basis for Boeing Model 

767–2C series airplanes. 

1. The applicant must ensure airplane 

electronic-system security protection 

from access by unauthorized sources 

external to the airplane, including those 

possibly caused by maintenance 

activity. 

2. The applicant must ensure that 

electronic-system security threats are 

identified and assessed, and that 

effective electronic-system security 

protection strategies are implemented to 

protect the airplane from all adverse 

impacts on safety, functionality, and 

continued airworthiness. 

3. The applicant must establish 

appropriate procedures to allow the 

operator to ensure that continued 

airworthiness of the airplane is 

maintained, including all post typecertification modifications that may 

have an impact on the approved 

electronic-system security safeguards. 

Issued in Renton, Washington, on February 

19, 2015. 

John J. Piccola, Jr., 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2015–03970 Filed 2–25–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 884 

[Docket No. FDA–2014–M–1957] 

Medical Devices; Obstetrical and 

Gynecological Devices; Classification 

of the Assisted Reproduction Embryo 

Image Assessment System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

Assisted Reproduction Embryo Image 

Assessment System 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 Assisted Reproduction 

Embryo Image Assessment System 

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 

26, 2015. The classification was 

applicable June 6, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Michael Bailey, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G120, Silver Spring, 

MD 20993–0002, 301–796–6530. 

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), 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. 


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Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Rules and Regulations 10331 

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), the 

person requests a classification under 

section 513(f)(2) of the FD&C Act. 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 August 3, 2012, FDA issued an 

order classifying the EEVA System into 

class III, because it was not substantially 

equivalent to a device that was 

introduced or delivered for introduction 

into interstate commerce for commercial 

distribution before May 28, 1976, or a 

device which was subsequently 

reclassified into class I or class II. On 

August 23, 2012, Auxogyn, Inc., 

submitted a de novo request for 

classification of the EEVA 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 

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, 

FDA determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

believes these special controls, in 

addition to general controls, will 

provide reasonable assurance of the 

safety and effectiveness of the device. 

Therefore, on June 6, 2014, FDA 

issued an order to the requestor 

classifying the device into class II. FDA 

is codifying the classification of the 

device by adding § 884.6195 (21 CFR 

884.6195). 

Following the effective date of this 

final classification administrative order, 

any firm submitting a premarket 

notification (510(k)) for an Assisted 

Reproduction Embryo Image 

Assessment System will need to comply 

with the special controls named in the 

final administrative order. 

The device is assigned the generic 

name Assisted Reproduction Embryo 

Image Assessment System, and it is 

identified as a prescription device that 

is designed to obtain and analyze light 

microscopy images of developing 

embryos. This device provides 

information to aid in the selection of 

embryo(s) for transfer when there are 

multiple embryos deemed suitable for 

transfer or freezing. 

FDA has identified the following risks 

to health associated with this type of 

device and the measures required to 

mitigate these risks in Table 1: 

TABLE 1—ASSISTED REPRODUCTION EMBRYO IMAGE ASSESSMENT SYSTEM RISKS AND MITIGATION MEASURES

Identified risk Mitigation measures 

Damage or Destruction of the Embryo .................................................... Non-Clinical Performance Testing. 

Software Verification, Validation & Hazard Analysis. 

Clinical Testing. 

Electromagnetic Compatibility Testing. 

Electrical Safety Testing. 

Labeling. 

Training. 

Infection (Contamination of Device, Labware, and Incubator) ................. Cleaning and Disinfection Validation. 

Labeling. 

Training. 

Incorrect Embryo Development Prediction ............................................... Non-Clinical Performance Testing. 

Software Verification, Validation & Hazard Analysis. 

Clinical Testing. 

Labeling. 

Training. 

Electromagnetic Interference/Electrical Safety Issues ............................. Electromagnetic Compatibility Testing. 

Electrical Safety Testing. 

Labeling. 

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

Training. 

FDA believes that the following 

special controls, in addition to the 

general controls, address these risks to 

health and provide reasonable assurance 

of safety and effectiveness: 

• Clinical performance testing must 

demonstrate a reasonable assurance of 

the safety and effectiveness of the 

device to predict embryo 

development. Classification 

performance (sensitivity and 

specificity) and predictive accuracy 

(Positive Predictive Value and 

Negative Predictive Value) must be 


rmajette on DSK2VPTVN1PROD with RULES
10332 Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Rules and Regulations 

assessed at the subject and embryo 

levels. 

• Software validation, verification, and 

hazard analysis must be provided. 

• Non-clinical performance testing data 

must demonstrate the performance 

characteristics of the device. Testing 

must include the following: 

Æ Total light exposure and output 

testing; 

Æ a safety analysis must be performed 

based on maximum (worst-case) 

light exposure to embryos, which 

also includes the safety of the light 

wavelength(s) emitted by the 

device; 

Æ simulated-use testing; 

Æ Mouse Embryo Assay testing to 

assess whether device operation 

impacts growth and development of 

mouse embryos to the blastocyst 

stage; 

Æ cleaning and disinfection 

validation of reusable components; 

Æ package integrity and transit 

testing; 

Æ hardware fail-safe validation; 

Æ electrical equipment safety and 

electromagnetic compatibility 

testing; and 

Æ prediction algorithm 

reproducibility. 

• Labeling must include the following: 

Æ A detailed summary of clinical 

performance testing, including any 

adverse events; 

Æ specific instructions, warnings, 

precautions, and training needed 

for safe use of the device; 

Æ appropriate electromagnetic 

compatibility information; 

Æ validated methods and instructions 

for cleaning and disinfection of 

reusable components; and 

Æ information identifying compatible 

cultureware and explain how they 

are used with the device. 

An Assisted Reproduction Embryo 

Image Assessment System is a 

prescription device 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 Assisted Reproduction 

Embryo Image Assessment System they 

intend to market. 

II. 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 administrative 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 has been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

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

through Friday. 

1. K120427: De Novo Request from Auxogyn, 

Inc., dated August 23, 2012. 

List of Subjects in 21 CFR Part 884 

Medical devices, Obstetrical and 

Gynecological devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 884 is 

amended as follows: 

PART 884—OBSTETRICAL AND 

GYNECOLOGICAL DEVICES 

■ 1. The authority citation for 21 CFR 

part 884 continues to read as follows: 

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

360j, 371. 

■ 2. Section 884.6195 is added to 

subpart G to read as follows: 

§ 884.6195 Assisted Reproduction Embryo 

Image Assessment System. 

(a) Identification. An Assisted 

Reproduction Embryo Image 

Assessment System is a prescription 

device that is designed to obtain and 

analyze light microscopy images of 

developing embryos. This device 

provides information to aid in the 

selection of embryo(s) for transfer when 

there are multiple embryos deemed 

suitable for transfer or freezing. 

(b) Classification. Class II (special 

controls). The special control(s) for this 

device are: 

(1) Clinical performance testing must 

demonstrate a reasonable assurance of 

safety and effectiveness of the device to 

predict embryo development. 

Classification performance (sensitivity 

and specificity) and predictive accuracy 

(Positive Predictive Value and Negative 

Predictive Value) must be assessed at 

the subject and embryo levels. 

(2) Software validation, verification, 

and hazard analysis must be provided. 

(3) Non-clinical performance testing 

data must demonstrate the performance 

characteristics of the device. Testing 

must include the following: 

(i) Total light exposure and output 

testing; 

(ii) A safety analysis must be 

performed based on maximum (worstcase) light exposure to embryos, which 

also includes the safety of the light 

wavelength(s) emitted by the device; 

(iii) Simulated-use testing; 

(iv) Mouse Embryo Assay testing to 

assess whether device operation impacts 

growth and development of mouse 

embryos to the blastocyst stage; 

(v) Cleaning and disinfection 

validation of reusable components; 

(vi) Package integrity and transit 

testing; 

(vii) Hardware fail-safe validation; 

(viii) Electrical equipment safety and 

electromagnetic compatibility testing; 

and 

(ix) Prediction algorithm 

reproducibility. 

(4) Labeling must include the 

following: 

(i) A detailed summary of clinical 

performance testing, including any 

adverse events; 

(ii) Specific instructions, warnings, 

precautions, and training needed for 

safe use of the device 

(iii) Appropriate electromagnetic 

compatibility information; 

(iv) Validated methods and 

instructions for cleaning and 

disinfection of reusable components; 

and 

(v) Information identifying compatible 

cultureware and explain how they are 

used with the device. 


rmajette on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Rules and Regulations 10333 

Dated: February 20, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03934 Filed 2–25–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 57 

[TD 9711] 

RIN 1545–BM52 

Health Insurance Providers Fee 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final and temporary 

regulations. 

SUMMARY: This document contains 

temporary regulations that provide rules 

for the definition of a covered entity for 

purposes of the fee imposed by section 

9010 of the Patient Protection and 

Affordable Care Act, as amended. The 

temporary regulations are necessary to 

clarify certain terms in section 9010. 

The temporary regulations affect 

persons engaged in the business of 

providing health insurance for United 

States health risks. The text of the 

temporary regulations also serves as the 

text of the proposed regulations (REG– 

143416–14) published in the Proposed 

Rules section in this issue of the Federal 

Register. 

DATES: Effective Date: These regulations 

are effective on February 26, 2015. 

Applicability Date: For dates of 

applicability, see §§ 57.10 and 57.10T. 

FOR FURTHER INFORMATION CONTACT: 

Rachel S. Smith, (202) 317–6855 (not a 

toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

Section 9010 of the Patient Protection 

and Affordable Care Act (PPACA), 

Public Law 111–148 (124 Stat. 119 

(2010)), as amended by section 10905 of 

PPACA, and as further amended by 

section 1406 of the Health Care and 

Education Reconciliation Act of 2010, 

Public Law 111–152 (124 Stat. 1029 

(2010)) (collectively, the Affordable Care 

Act or ACA) imposes an annual fee on 

covered entities that provide health 

insurance for United States health risks. 

All references in this preamble to 

section 9010 are references to the ACA. 

Section 9010 did not amend the Internal 

Revenue Code (Code) but contains 

cross-references to specified Code 

sections. Unless otherwise indicated, all 

other references to subtitles, chapters, 

subchapters, and sections in this 

preamble are references to subtitles, 

chapters, subchapters, and sections in 

the Code and related regulations. All 

references to ‘‘fee’’ in this preamble are 

references to the fee imposed by section 

9010. 

On November 27, 2013, the Treasury 

Department and the IRS issued the 

Health Insurance Providers Fee 

regulations as final regulations (TD 

9643). On August 12, 2014, the Treasury 

Department and the IRS issued Notice 

2014–47, 2014–35 IRB 522, to provide 

further guidance for the 2014 fee year on 

the definition of a covered entity. The 

temporary regulations provide further 

guidance on the definition of a covered 

entity for the 2015 fee year and 

subsequent fee years. 

General Overview 

Section 9010(a) imposes an annual fee 

on each covered entity engaged in the 

business of providing health insurance. 

The fee is due by the annual date 

specified by the Secretary, but in no 

event later than September 30th of each 

calendar year in which a fee must be 

paid (fee year). 

Section 9010(b) requires the Secretary 

to determine the annual fee for each 

covered entity based on the ratio of the 

covered entity’s net premiums written 

for health insurance for any United 

States health risk that are taken into 

account for the calendar year 

immediately before the fee year (data 

year) to the aggregate net premiums 

written for health insurance of United 

States health risks of all covered entities 

that are taken into account during the 

data year. In calculating the fee, the 

Secretary must determine each covered 

entity’s net premiums written for United 

States health risks based on reports 

submitted to the Secretary by the 

covered entity and through the use of 

any other source of information 

available to the Secretary. 

Section 9010(c)(1) defines a covered 

entity as any entity that provides health 

insurance for any United States health 

risk during each fee year. Section 

9010(c)(2) excludes the following 

entities from being covered entities: (A) 

Any employer to the extent that the 

employer self-insures its employees’ 

health risks; (B) any governmental 

entity; (C) any entity (i) that is 

incorporated as a nonprofit corporation 

under a State law, (ii) no part of the net 

earnings of which inures to the benefit 

of any private shareholder or individual, 

no substantial part of the activities of 

which is carrying on propaganda, or 

otherwise attempting, to influence 

legislation (except as otherwise 

provided in section 501(h)), and which 

does not participate in, or intervene in, 

any political campaign on behalf of (or 

in opposition to) any candidate for 

public office, and (iii) more than 80 

percent of the gross revenues of which 

is received from government programs 

that target low income, elderly, or 

disabled populations under titles XVIII, 

XIX, and XXI of the Social Security Act; 

and (D) any entity that is described in 

section 501(c)(9) (a voluntary 

employees’ beneficiary association 

(VEBA)) and is established by an entity 

(other than by an employer or 

employers) for purposes of providing 

health care benefits. 

Section 9010(c)(3)(A) provides a 

controlled group rule under which all 

persons treated as a single employer 

under section 52(a) or (b) or section 

414(m) or (o) are treated as a single 

covered entity. Section 9010(c)(4) 

provides that, if more than one person 

is liable to pay the fee on a single 

covered entity by reason of the 

application of the controlled group rule, 

then all such persons are jointly and 

severally liable for payment of the fee. 

Section 57.2(c)(1) of the Health 

Insurance Providers Fee regulations 

defines the term controlled group to 

mean a group of two or more persons, 

including at least one person that is a 

covered entity, that is treated as a single 

employer under section 52(a), 52(b), 

414(m), or 414(o). Section 57.2(c)(3)(ii) 

further provides that a person is treated 

as being a member of the controlled 

group if it is a member of the group at 

the end of the day on December 31st of 

the data year. 

Explanation of Provisions 

Following the publication of the final 

regulations in TD 9643, the Treasury 

Department and the IRS received 

questions about how to apply the 

exclusions under section 9010(c)(2) to 

the general definition of a covered 

entity. The Treasury Department and 

the IRS also received questions about 

whether covered entities must report 

information on net premiums written 

for certain members of a controlled 

group. Notice 2014–47 was 

subsequently issued to resolve those 

questions for the 2014 fee year. The 

temporary regulations adopt the general 

approach of Notice 2014–47 to resolve 

those questions for the 2015 fee year 

and each subsequent fee year. 

Application of Exclusions Under 

Section 9010(c)(2) 

Notice 2014–47 provided that, for the 

2014 fee year, the Treasury Department 

and the IRS would not treat any entity 

as a covered entity if it would be 


rmajette on DSK2VPTVN1PROD with RULES