Meeting of the National Preparedness and Response Science Board, 11441 [2015-04303]
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Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices
as compared to an examination by a
dermatologist.10
Thus, the orders impose a high level
of substantiation despite lacking
evidence that the marketing claims
require such substantiation, and the
complaints’ vague claim construction
obscures this flawed approach.11
Despite the assurances in the majority’s
statement as to what the orders require,
the complaints imply—and the majority
appears to agree 12—that reasonable
consumers expected the apps to
substitute for professional medical care.
This disconnect raises the possibility
that the Commission may use vague
complaints to impose very high
substantiation standards on healthrelated apps even if the advertising
claims for those apps are more modest.
This approach concerns me. Healthrelated apps have enormous potential to
improve access to health information for
underserved populations and to enable
individuals to monitor more effectively
their own well-being, thereby improving
health outcomes. Health-related apps
need not be as accurate as professional
care to provide significant value for
many consumers. The Commission
should not subject such apps to overly
stringent substantiation requirements,
so long as developers adequately convey
the limitations of their products. In
particular, the Commission should be
very wary of concluding that consumers
interpret marketing for health-related
apps as claiming that those apps
substitute for professional medical care,
unless we can point to express claims,
clearly implied claims, or extrinsic
evidence. If the Commission continues
to adopt such conclusions without any
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10 When
the FTC cannot ‘‘conclude with
confidence’’ that a specific implied claim is being
made—for example, if the ad contains ‘‘conflicting
messages’’—the FTC ‘‘will not find the ad to make
the implied claim unless extrinsic evidence allows
us to conclude that such a reading of the ad is
reasonable.’’ In re Thompson Med. Co., 104 F.T.C.
648, 788–89 (1984).
11 These onerous substantiation requirements
cannot be defended as ‘‘fencing-in.’’ The FTC does
not traditionally fence in companies by requiring a
heightened level of substantiation. Instead, past
FTC decisions fence in companies by extending the
scope of a substantiation requirement beyond the
specific product, parties, or type of conduct
involved in the actual violation. See Federal Trade
Commission v. Springtech 77376, LLC, et al.
(‘‘Cedarcide Industries’’), Matter No. X120042,
Dissenting Statement of Commissioner Maureen K.
Ohlhausen at 3 (July 16, 2013). Requiring past
violators to meet a higher burden of substantiation
would not fence them in—it would only make it
more difficult for them to make truthful claims that
could be useful to consumers. Id.
12 ‘‘Commissioner Ohlhausen . . . believes . . .
that it is not reasonable to read the ads as claiming
that the automated assessment is as accurate as a
dermatologist. We disagree.’’ Statement of
Chairwoman Ramirez, Commissioner Brill, and
Commissioner McSweeny at 1.
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evidence of consumers’ actual
interpretations, and thus requires a very
high level of substantiation for healthrelated apps, we are likely to chill
innovation in such apps, limit the
potential benefits of this innovation,
and ultimately make consumers worse
off.13
I therefore respectfully dissent.
[FR Doc. 2015–04348 Filed 3–2–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Preparedness
and Response Science Board
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the National Preparedness and
Response Science Board (NPRSB), also
known as the National Biodefense
Science Board, will be holding a public
teleconference.
DATES: The NPRSB will hold a public
meeting on March 30, 2015, from 1:00
p.m. to 2:00 p.m. EST. The agenda is
subject to change as priorities dictate.
ADDRESSES: Individuals who wish to
participate should send an email to
NPRSB@HHS.GOV with ‘‘NPRSB
Registration’’ in the subject line. The
meeting will occur by teleconference.
To attend via teleconference and for
further instructions, please visit the
NPRSB Web site at WWW.PHE.GOV/
NPRSB.
FOR FURTHER INFORMATION CONTACT:
Please submit an inquiry via the NPRSB
Contact Form located at www.phe.gov/
NBSBComments.
SUPPLEMENTARY INFORMATION: Pursuant
to section 319M of the Public Health
Service Act (42 U.S.C. 247d–7f) and
section 222 of the Public Health Service
Act (42 U.S.C. 217a), HHS established
the NPRSB. The Board shall provide
expert advice and guidance to the
Secretary on scientific, technical, and
SUMMARY:
13 See, e.g., Scott Gottlieb and Coleen Klasmeier,
‘‘Why Your Phone Isn’t as Smart as It Could Be,’’
Wall Street Journal (Aug. 7, 2014) (blaming heavy
regulation of consumer-directed health apps and
devices for smartphones that are ‘‘purposely
dumbed down’’ and ‘‘products that are never
created because mobile-tech entrepreneurs choose
to direct their talents elsewhere’’), available at
https://online.wsj.com/articles/scott-gottlieb-andcoleen-klasmeier-why-your-phone-isnt-as-smart-asit-could-be-1407369163.
PO 00000
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11441
other matters of special interest to HHS
regarding current and future chemical,
biological, nuclear, and radiological
agents, whether naturally occurring,
accidental, or deliberate. The NPRSB
may also provide advice and guidance
to the Secretary and/or the Assistant
Secretary for Preparedness and
Response (ASPR) on other matters
related to public health emergency
preparedness and response.
Background: This public meeting via
teleconference will be dedicated to the
NPRSB’s deliberation and vote on the
findings from the ASPR Future
Strategies Working Group. Subsequent
agenda topics will be added as priorities
dictate. Any additional agenda topics
will be available on the NPRSB March
30, 2015, meeting Web page, available at
WWW.PHE.GOV/NPRSB.
Availability of Materials: The meeting
agenda and materials will be posted
prior to the meeting on the March 30th
meeting Web page at WWW.PHE.GOV/
NPRSB.
Procedures for Providing Public Input:
Members of the public are invited to
attend by teleconference via a toll-free
call-in phone number which is available
on the NPRSB Web site at
WWW.PHE.GOV/NPRSB. All members
of the public are encouraged to provide
written comment to the NPRSB. All
written comments must be received
prior to March 29, 2015, and should be
sent by email to NPRSB@HHS.GOV with
‘‘NPRSB Public Comment’’ as the
subject line. Public comments received
by close of business one week prior to
each teleconference will be distributed
to the NPRSB in advance.
Dated: February 24, 2015.
Nicole Lurie,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2015–04303 Filed 3–2–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee on Immunization
Practices (ACIP)
Correction: This notice was published
in the Federal Register on January 30,
2015, Volume 80, Number 20, Page
5116–5117. Due to inclement weather in
the Atlanta, Georgia area, the first day
of the meeting scheduled for February
25 and 26, 2015 was not held. The
second day of the meeting will take
place as follows:
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03MRN1
Agencies
[Federal Register Volume 80, Number 41 (Tuesday, March 3, 2015)]
[Notices]
[Page 11441]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-04303]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the National Preparedness and Response Science Board
AGENCY: Office of the Secretary, Department of Health and Human
Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: As stipulated by the Federal Advisory Committee Act, the
Department of Health and Human Services (HHS) is hereby giving notice
that the National Preparedness and Response Science Board (NPRSB), also
known as the National Biodefense Science Board, will be holding a
public teleconference.
DATES: The NPRSB will hold a public meeting on March 30, 2015, from
1:00 p.m. to 2:00 p.m. EST. The agenda is subject to change as
priorities dictate.
ADDRESSES: Individuals who wish to participate should send an email to
NPRSB@HHS.GOV with ``NPRSB Registration'' in the subject line. The
meeting will occur by teleconference. To attend via teleconference and
for further instructions, please visit the NPRSB Web site at
WWW.PHE.GOV/NPRSB.
FOR FURTHER INFORMATION CONTACT: Please submit an inquiry via the NPRSB
Contact Form located at www.phe.gov/NBSBComments.
SUPPLEMENTARY INFORMATION: Pursuant to section 319M of the Public
Health Service Act (42 U.S.C. 247d-7f) and section 222 of the Public
Health Service Act (42 U.S.C. 217a), HHS established the NPRSB. The
Board shall provide expert advice and guidance to the Secretary on
scientific, technical, and other matters of special interest to HHS
regarding current and future chemical, biological, nuclear, and
radiological agents, whether naturally occurring, accidental, or
deliberate. The NPRSB may also provide advice and guidance to the
Secretary and/or the Assistant Secretary for Preparedness and Response
(ASPR) on other matters related to public health emergency preparedness
and response.
Background: This public meeting via teleconference will be
dedicated to the NPRSB's deliberation and vote on the findings from the
ASPR Future Strategies Working Group. Subsequent agenda topics will be
added as priorities dictate. Any additional agenda topics will be
available on the NPRSB March 30, 2015, meeting Web page, available at
WWW.PHE.GOV/NPRSB.
Availability of Materials: The meeting agenda and materials will be
posted prior to the meeting on the March 30th meeting Web page at
WWW.PHE.GOV/NPRSB.
Procedures for Providing Public Input: Members of the public are
invited to attend by teleconference via a toll-free call-in phone
number which is available on the NPRSB Web site at WWW.PHE.GOV/NPRSB.
All members of the public are encouraged to provide written comment to
the NPRSB. All written comments must be received prior to March 29,
2015, and should be sent by email to NPRSB@HHS.GOV with ``NPRSB Public
Comment'' as the subject line. Public comments received by close of
business one week prior to each teleconference will be distributed to
the NPRSB in advance.
Dated: February 24, 2015.
Nicole Lurie,
Assistant Secretary for Preparedness and Response.
[FR Doc. 2015-04303 Filed 3-2-15; 8:45 am]
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