4576 Federal Register / Vol. 80, No. 18 / Wednesday, January 28, 2015 / Notices 

subject to final approval, an agreement 

containing a consent order from Focus 

Education, LLC (‘‘Focus Education’’), 

Chief Executive Officer, Michael 

Apstein, and Chief Financial Officer, 

John Able (‘‘Respondents’’). 

The proposed consent order 

(‘‘proposed order’’) has been placed on 

the public record for thirty (30) days for 

receipt of comments by interested 

persons. Comments received during this 

period will become part of the public 

record. After thirty (30) days, the 

Commission will again review the 

agreement and the comments received, 

and will decide whether it should 

withdraw from the agreement or make 

final the agreement’s proposed order. 

This matter involves Focus 

Education’s advertising for the ifocus 

System, which included the Jungle 

Rangers computer game and comic 

book, and information on children’s 

behavior, exercise, and diet. The 

Commission’s complaint alleges that the 

Respondents violated Sections 5(a) and 

12 of the Federal Trade Commission Act 

by making false or unsubstantiated 

representations that playing the ifocus 

System’s Jungle Rangers computer game 

improves children’s focus, memory, 

attention, behavior, and/or school 

performance, including in children with 

ADHD, and that these improvements 

were permanent. The complaint also 

alleges that Respondents violated 

Sections 5(a) and 12 by making false 

representations that scientific studies 

prove these claims. 

The proposed order includes 

injunctive relief that prohibits these 

alleged violations and fences in similar 

and related violations. For purposes of 

the order, ‘‘Covered Product’’ means any 

product, program, device, or service that 

purports to alter the brain’s structure or 

function, improve cognitive abilities, 

behavior, or academic performance, or 

treat or lessen the symptoms of 

cognitive abnormalities or disorders, 

including ADHD. 

Part I of the Order prohibits the 

Respondents from making any 

representation that the ifocus System or 

any substantially similar product 

improves children’s cognitive abilities, 

behavior, or academic performance, 

including in children with ADHD 

unless any such representation is nonmisleading and the Respondents possess 

and rely upon competent and reliable 

scientific evidence. For purposes of this 

Part, competent and reliable scientific 

evidence is defined as ‘‘human clinical 

testing of such product that is sufficient 

in quality and quantity, based on 

standards generally accepted by experts 

in the relevant field, when considered 

in light of the entire body of relevant 

and reliable scientific evidence, to 

substantiate that the representation is 

true. Such testing shall be (1) 

randomized, double-blind, and 

adequately controlled; and (2) 

conducted by researchers qualified by 

training and experience to conduct such 

testing.’’ In addition, competent and 

reliable scientific evidence is subject to 

the preservation requirements set forth 

in Part IV. 

Part II is a fencing-in provision. It 

prohibits the Respondents from making 

any claim about the benefits, 

performance, or efficacy of any Covered 

Product unless the claim is nonmisleading and the Respondents possess 

competent and reliable scientific 

evidence that is sufficient in quality and 

quantity, when considered in light of 

the entire body of relevant and reliable 

scientific evidence, to substantiate that 

the representation is true. For purposes 

of this Part, Covered Product is defined 

as any product, program, device, or 

service that purports to alter the brain’s 

structure or function, improve cognitive 

abilities, behavior, or academic 

performance, or treat or lessen the 

symptoms of cognitive abnormalities or 

disorders, including ADHD. Competent 

and reliable scientific evidence means 

‘‘tests, analyses, research, or studies (1) 

that have been conducted and evaluated 

in an objective manner by qualified 

persons; (2) that are generally accepted 

in the profession to yield accurate and 

reliable results; and (3) as to which, 

when they are human clinical tests or 

studies, all underlying or supporting 

data and documents generally accepted 

by experts in the field as relevant to an 

assessment of such testing as set forth 

Part IV are available for inspection and 

production to the Commission.’’ 

Part III prohibits the Respondents 

from misrepresenting, in relation to the 

advertising of any Covered Product, (1) 

the results of any test, study, or 

research; or (2) that the benefits of any 

such Covered Product are scientifically 

proven. 

Part IV requires the Respondents, for 

human clinical tests or studies, to 

secure and preserve all underlying or 

supporting data and documents 

generally accepted by experts in the 

field as relevant to an assessment of the 

test. There is an exception for a 

‘‘Reliably Reported’’ test, defined as a 

test published in a peer-reviewed 

journal that was not conducted, 

controlled, or sponsored by 

Respondents, affiliates, or others in the 

manufacturing and supply chain. Also, 

the published report must provide 

sufficient information about the test for 

experts in the relevant field to assess the 

reliability of the results. 

Part V contains recordkeeping 

requirements for advertisements and 

substantiation relevant to 

representations covered by Parts I 

through III of the order. 

Parts VI through IX of the proposed 

order require Respondents to: Deliver a 

copy of the order to principals, officers, 

directors, managers, employees, agents, 

and representatives having 

responsibilities with respect to the 

subject matter of the order; notify the 

Commission of changes in corporate 

structure, discontinuance of current 

business or employment, or affiliation 

with any new business or employment 

that might affect compliance obligations 

under the order; and file compliance 

reports with the Commission. 

Part X provides that the order will 

terminate after twenty (20) years, with 

certain exceptions. 

The purpose of this analysis is to 

facilitate public comment on the 

proposed order, and it is not intended 

to constitute an official interpretation of 

the complaint or proposed order, or to 

modify the proposed order’s terms in 

any way. 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. 2015–01516 Filed 1–27–15; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Committee on Vital and Health 

Statistics: Meeting 

Pursuant to the Federal Advisory 

Committee Act, the Department of 

Health and Human Services (HHS) 

announces the following advisory 

committee meeting. 

Name: National Committee on Vital and 

Health Statistics (NCVHS), Full Committee 

Meeting. 

Time and Date: 

February 24, 2015 9:00 a.m.–5:30 p.m. EST 

February 25, 2015 8:30 a.m.–12:00 p.m. EST 

Place: U.S. Department of Health and 

Human Services, Centers for Disease Control 

and Prevention, National Center for Health 

Statistics, 3311 Toledo Road, Auditorium A 

and B, Hyattsville, Maryland 20782, (301) 

458–4524. 

Status: Open. 

Purpose: The purpose of this meeting is to 

review the status of current NCVHS activities 

and to strategically plan for 2015 NCVHS 

objectives and deliverables. The Committee 

will review its ongoing efforts in 

coordinating Subcommittee projects. 

Additional topics will include 

implementation plans for the ACA Review 

Committee process and reviewing the 

summary from the Roundtable on Supporting 

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Federal Register / Vol. 80, No. 18 / Wednesday, January 28, 2015 / Notices 4577 

1These certification criteria are: § 170.314(a)(18), 

(a)(19), (a)(20), (b)(9), (f)(7), (g)(1), (g)(3), (h)(1), 

(h)(2), and (h)(3). 

Community Data Engagement. The Working 

Group on HHS Data Access and Use will 

continue strategic discussions on Building a 

Framework for Guiding Principles for Data 

Access and Use. 

The times shown above are for the full 

Committee meeting. Subcommittee issues 

will be included as part of the Full 

Committee schedule. 

Contact Person for More Information: 

Substantive program information may be 

obtained from Debbie M. Jackson, Acting 

Executive Secretary, NCVHS, National Center 

for Health Statistics, Centers for Disease 

Control and Prevention, 3311 Toledo Road, 

Room 2339, Hyattsville, Maryland 20782, 

telephone (301) 458–4614. Summaries of 

meetings and a roster of committee members 

are available on the NCVHS home page of the 

HHS Web site: http://www.ncvhs.hhs.gov/, 

where further information including an 

agenda will be posted when available. 

Should you require reasonable 

accommodation, please contact the CDC 

Office of Equal Employment Opportunity on 

(301) 458–4EEO (4336) as soon as possible. 

Dated: January 22, 2015. 

James Scanlon, 

Deputy Assistant Secretary for Planning and 

Evaluation (Science and Data Policy), Office 

of the Assistant Secretary for Planning and 

Evaluation. 

[FR Doc. 2015–01536 Filed 1–27–15; 8:45 am] 

BILLING CODE 4151–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Committee on Vital and Health 

Statistics; Meeting Standards 

Subcommittee 

Pursuant to the Federal Advisory 

Committee Act, the Department of 

Health and Human Services (HHS) 

announces the following advisory 

committee meeting. 

Name: National Committee on Vital and 

Health Statistics (NCVHS) Subcommittee on 

Standards 

Time and Date: February 26, 2015, 8:30 

a.m.–5:00 p.m. EST 

Place: U.S. Department of Health and 

Human Services, Centers for Disease Control 

and Prevention, National Center for Health 

Statistics, 3311 Toledo Road, Auditorium A 

and B, Hyattsville, Maryland 20782, (301) 

458–4524. 

Status: Open. 

Purpose: The purpose of this hearing is to 

review and discuss the current status of 

selected administrative simplification topics 

of interest to the National Committee on Vital 

and Health Statistics. 

The objectives of this hearing will be to (1) 

review, discuss and consider for 

recommendations the operating rules 

presented for adoption for four HIPAA 

transactions—Health Care Claims, 

Enrollment/Disenrollment, Premium 

Payment, and Prior Authorization; and (2) 

discuss and consider suggestions of the 

Review Committee evaluation criteria for 

existing standards, code sets, identifiers, and 

operating rules. 

Contact Person for More Information: 

Debbie M. Jackson, Acting Executive 

Secretary, NCVHS, National Center for 

Health Statistics, Centers for Disease Control 

and Prevention, 3311 Toledo Road, Room 

2339, Hyattsville, Maryland 20782, telephone 

(301) 458–4614 or Terri Deutsch, Centers for 

Medicare and Medicaid Services, Office of EHealth Standards and Services, 7500 Security 

Boulevard, Baltimore, Maryland 21244, 

telephone (410) 786–9462. Program 

information as well as summaries of meetings 

and a roster of committee members are 

available on the NCVHS home page of the 

HHS Web site: 

http://www.ncvhs.hhs.gov/, where further 

information including an agenda will be 

posted when available. 

Should you require reasonable 

accommodation, please contact the CDC 

Office of Equal Employment Opportunity on 

(301) 458–4EEO (4336) as soon as possible. 

Dated: January 22, 2015. 

James Scanlon, 

Deputy Assistant Secretary for Planning and 

Evaluation (Science and Data Policy), Office 

of the Assistant Secretary for Planning and 

Evaluation. 

[FR Doc. 2015–01537 Filed 1–27–15; 8:45 am] 

BILLING CODE 4151–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Notice of Availability: Test Tools and 

Test Procedures Approved by the 

National Coordinator for the ONC HIT 

Certification Program 

AGENCY: Office of the National 

Coordinator for Health Information 

Technology (ONC), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: This notice announces the 

availability of test tools and test 

procedures approved by the National 

Coordinator for Health Information 

Technology (the National Coordinator) 

for the testing of EHR technology to the 

2014 Edition Release 2 EHR certification 

criteria under the ONC HIT Certification 

Program. The approved test tools and 

test procedures are identified on the 

ONC Web site at: http://healthit.gov/

policy-researchers-implementers/

testing-and-test-methods. The test tools 

and test procedures for the ‘‘optional— 

transitions of care’’ certification 

criterion (§ 170.314(b)(8)) and the 

optional testing and certification for the 

‘‘view, download, and transmit to 3rd 

party’’ certification criterion 

(§ 170.314(e)(1)) have not yet been 

approved. 

FOR FURTHER INFORMATION CONTACT: 

Alicia Morton, Director, Office of 

Certification, Office of the National 

Coordinator for Health Information 

Technology, 202–549–7851. 

SUPPLEMENTARY INFORMATION: On 

January 7, 2011, the Department of 

Health and Human Services issued a 

final rule establishing a permanent 

certification program for the purposes of 

testing and certifying health information 

technology (‘‘Establishment of the 

Permanent Certification Program for 

Health Information Technology,’’ 76 FR 

1262) (Permanent Certification Program 

final rule). The permanent certification 

program was renamed the ‘‘ONC HIT 

Certification Program’’ in a final rule 

published on September 4, 2012 (77 FR 

54163) (‘‘2014 Edition EHR Certification 

Criteria final rule’’). In the preamble of 

the Permanent Certification Program 

final rule, we stated that when the 

National Coordinator had approved test 

tools and test procedures for 

certification criteria adopted by the 

Secretary ONC would publish a notice 

of availability in the Federal Register 

and identify the approved test tools and 

test procedures on the ONC Web site. 

In the 2014 Edition Release 2 EHR 

Certification Criteria final rule the 

Secretary adopted additional and 

revised certification criteria as part of 

the 2014 Edition EHR certification 

criteria (79 FR 54430). The National 

Coordinator has approved test tools and 

test procedures for testing EHR 

technology to most of these additional 

and revised certification criteria under 

the ONC HIT Certification Program.1

These approved test tools and test 

procedures are identified on the ONC 

Web site at: http://healthit.gov/policyresearchers-implementers/testing-andtest-methods. The test tools and test 

procedures for the ‘‘optional— 

transitions of care’’ certification 

criterion (§ 170.314(b)(8)) and the 

optional testing and certification for the 

‘‘view, download, and transmit to 3rd 

party’’ certification criterion 

(§ 170.314(e)(1)) have not yet been 

approved. Draft test procedures for 

§ 170.314(b)(8) and the optional testing 

and certification for § 170.314(e)(1) are 

available on the Web site listed above. 

Authority: 42 U.S.C. 300jj–11. 

Dated: January 21, 2015. 

Lisa Lewis, 

Acting National Coordinator for Health 

Information Technology. 

[FR Doc. 2015–01535 Filed 1–27–15; 8:45 am] 

BILLING CODE 4150–45–P 

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