National Committee on Vital and Health Statistics: Meeting, 4576-4577 [2015-01536]
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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
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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.
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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]
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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
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: https://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.
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:
https://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]
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[FR Doc. 2015–01536 Filed 1–27–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Committee on Vital and Health
Statistics; Meeting Standards
Subcommittee
Office of the National
Coordinator for Health Information
Technology (ONC), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
mstockstill on DSK4VPTVN1PROD with NOTICES
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
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Notice of Availability: Test Tools and
Test Procedures Approved by the
National Coordinator for the ONC HIT
Certification Program
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: https://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
SUMMARY:
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Certification, Office of the National
Coordinator for Health Information
Technology, 202–549–7851.
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: https://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.
SUPPLEMENTARY INFORMATION:
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]
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1 These 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).
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Agencies
[Federal Register Volume 80, Number 18 (Wednesday, January 28, 2015)]
[Notices]
[Pages 4576-4577]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01536]
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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
[[Page 4577]]
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: https://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