Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 11437 

FOR FURTHER INFORMATION CONTACT: For 

additional information about the 

information collection, contact Cathy 

Williams at (202) 418–2918. 

SUPPLEMENTARY INFORMATION: 

OMB Control Number: 3060–1174. 

Title: Section 73.503, Licensing 

requirements and service; Section 

73.621, Noncommercial educational TV 

stations; Section 73.3527, Local public 

inspection file of noncommercial 

educational stations. 

Form Number: Not applicable. 

Type of Review: Extension of a 

currently approved collection. 

Respondents: Not for profit 

institutions. 

Number of Respondents and 

Responses: 2,200 respondents and 

30,800 responses. 

Frequency of Response: 

Recordkeeping requirement; Annual 

reporting requirement; One-time 

reporting requirement; Third party 

disclosure requirement. 

Estimated Time per Response: 0.25– 

1.5 hours. 

Total Annual Burden: 17,050 hours. 

Total Annual Cost to Respondents: 

$330,000. 

Obligation to Respond: Required to 

obtain or retain benefits. The statutory 

authority for this collection of 

information is contained in 47 U.S.C. 

151, 152, 154(i), 303, 307 and 308. 

Nature and Extent of Confidentiality: 

There is no assurance of confidentiality 

provided to respondents. 

Privacy Impact Assessment: No 

impact(s). 

Needs and Uses: On April 25, 2012, 

the Commission adopted a Notice of 

Proposed Rulemaking (‘‘NPRM’’) in MB 

Docket 12–106, FCC 12–43, In the 

Matter of Noncommercial Educational 

Station Fundraising for Third-Party 

Non-Profit Organizations. Under the 

Commission’s existing rules, a 

noncommercial educational (‘‘NCE’’) 

broadcast station may not conduct 

fundraising activities to benefit any 

entity besides the station itself if the 

activities would substantially alter or 

suspend regular programming. The 

NPRM proposes to relax the rules to 

allow NCE stations to spend up to one 

percent of their total annual airtime 

conducting on-air fundraising activities 

that interrupt regular programming for 

the benefit of third-party non-profit 

organizations. 

A final rulemaking has not been 

adopted by the Commission to date. The 

Commission would like to keep this 

collection in OMB’s inventory. We will 

receive OMB final approval once the 

final rulemaking is adopted by the 

Commission. 

Federal Communications Commission. 

Marlene H. Dortch, 

Secretary. Office of the Secretary, Office of 

the Managing Director. 

[FR Doc. 2015–04338 Filed 3–2–15; 8:45 am] 

BILLING CODE 6712–01–P 

FEDERAL RESERVE SYSTEM 

Formations of, Acquisitions by, and 

Mergers of Bank Holding Companies 

The companies listed in this notice 

have applied to the Board for approval, 

pursuant to the Bank Holding Company 

Act of 1956 (12 U.S.C. 1841 et seq.) 

(BHC Act), Regulation Y (12 CFR part 

225), and all other applicable statutes 

and regulations to become a bank 

holding company and/or to acquire the 

assets or the ownership of, control of, or 

the power to vote shares of a bank or 

bank holding company and all of the 

banks and nonbanking companies 

owned by the bank holding company, 

including the companies listed below. 

The applications listed below, as well 

as other related filings required by the 

Board, are available for immediate 

inspection at the Federal Reserve Bank 

indicated. The applications will also be 

available for inspection at the offices of 

the Board of Governors. Interested 

persons may express their views in 

writing on the standards enumerated in 

the BHC Act (12 U.S.C. 1842(c)). If the 

proposal also involves the acquisition of 

a nonbanking company, the review also 

includes whether the acquisition of the 

nonbanking company complies with the 

standards in section 4 of the BHC Act 

(12 U.S.C. 1843). Unless otherwise 

noted, nonbanking activities will be 

conducted throughout the United States. 

Unless otherwise noted, comments 

regarding each of these applications 

must be received at the Reserve Bank 

indicated or the offices of the Board of 

Governors not later than March 27, 

2015. 

A. Federal Reserve Bank of Kansas 

City (Dennis Denney, Assistant Vice 

President) 1 Memorial Drive, Kansas 

City, Missouri 64198–0001: 

1. UniBanc Corp., Maywood, 

Nebraska; to acquire 100 percent of the 

voting shares of Bank of Stapleton, 

Stapleton, Nebraska: 

In connection with this proposal, 

UniBanc Corp. has applied to acquire 

Stapleton Investment Company, and 

thereby engage in general insurance 

activities in a town greater than 5,000 in 

population, pursuant to section 

225.28(b)(11)(iii)(A). 

Board of Governors of the Federal Reserve 

System, February 25, 2015. 

Michael J. Lewandowski, 

Associate Secretary of the Board. 

[FR Doc. 2015–04375 Filed 3–2–15; 8:45 am] 

BILLING CODE 6210–01–P 

FEDERAL TRADE COMMISSION 

[File No. 132 3211] 

Health Discovery Corporation; 

Analysis of Proposed Consent Order 

To Aid Public Comment 

AGENCY: Federal Trade Commission. 

ACTION: Proposed consent agreement. 

SUMMARY: The consent agreement in this 

matter settles alleged violations of 

federal law prohibiting unfair or 

deceptive acts or practices. The attached 

Analysis to Aid Public Comment 

describes both the allegations in the 

draft complaint and the terms of the 

consent order—embodied in the consent 

agreement—that would settle these 

allegations. 

DATES: Comments must be received on 

or before March 25, 2015. 

ADDRESSES: Interested parties may file a 

comment at https://ftcpublic.comment

works.com/ftc/melappsconsent/ online 

or on paper, by following the 

instructions in the Request for Comment 

part of the SUPPLEMENTARY INFORMATION

section below. Write ‘‘Health Discovery 

Corporation—Consent Agreement; File 

No. 1323211’’ on your comment and file 

your comment online at https:// 

ftcpublic.commentworks.com/ftc/ 

melappsconsent/ by following the 

instructions on the web-based form. If 

you prefer to file your comment on 

paper, write ‘‘Health Discovery 

Corporation—Consent Agreement; File 

No. 1323211’’ on your comment and on 

the envelope, and mail your comment to 

the following address: Federal Trade 

Commission, Office of the Secretary, 

600 Pennsylvania Avenue NW., Suite 

CC–5610 (Annex D), Washington, DC 

20580, or deliver your comment to the 

following address: Federal Trade 

Commission, Office of the Secretary, 

Constitution Center, 400 7th Street SW., 

5th Floor, Suite 5610 (Annex D), 

Washington, DC 20024. 

FOR FURTHER INFORMATION CONTACT: 

Karen Mandel, Bureau of Consumer 

Protection, (202) 326–2491, 600 

Pennsylvania Avenue NW., Washington, 

DC 20580. 

SUPPLEMENTARY INFORMATION: Pursuant 

to Section 6(f) of the Federal Trade 

Commission Act, 15 U.S.C. 46(f), and 

FTC Rule 2.34, 16 CFR 2.34, notice is 

mstockstill on DSK4VPTVN1PROD with NOTICES

11438 Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 

1 In particular, the written request for confidential 

treatment that accompanies the comment must 

include the factual and legal basis for the request, 

and must identify the specific portions of the 

comment to be withheld from the public record. See 

FTC Rule 4.9(c), 16 CFR 4.9(c). 

hereby given that the above-captioned 

consent agreement containing consent 

order to cease and desist, having been 

filed with and accepted, subject to final 

approval, by the Commission, has been 

placed on the public record for a period 

of thirty (30) days. The following 

Analysis to Aid Public Comment 

describes the terms of the consent 

agreement, and the allegations in the 

complaint. An electronic copy of the 

full text of the consent agreement 

package can be obtained from the FTC 

Home Page (for February 23, 2015), on 

the World Wide Web, at http:// 

www.ftc.gov/os/actions.shtm. 

You can file a comment online or on 

paper. For the Commission to consider 

your comment, we must receive it on or 

before March 25, 2015. Write ‘‘Health 

Discovery Corporation—Consent 

Agreement; File No. 1323211’’ on your 

comment. Your comment—including 

your name and your state—will be 

placed on the public record of this 

proceeding, including, to the extent 

practicable, on the public Commission 

Web site, at http://www.ftc.gov/os/ 

publiccomments.shtm. As a matter of 

discretion, the Commission tries to 

remove individuals’ home contact 

information from comments before 

placing them on the Commission Web 

site. 

Because your comment will be made 

public, you are solely responsible for 

making sure that your comment does 

not include any sensitive personal 

information, like anyone’s Social 

Security number, date of birth, driver’s 

license number or other state 

identification number or foreign country 

equivalent, passport number, financial 

account number, or credit or debit card 

number. You are also solely responsible 

for making sure that your comment does 

not include any sensitive health 

information, like medical records or 

other individually identifiable health 

information. In addition, do not include 

any ‘‘[t]rade secret or any commercial or 

financial information which . . . is 

privileged or confidential,’’ as discussed 

in Section 6(f) of the FTC Act, 15 U.S.C. 

46(f), and FTC Rule 4.10(a)(2), 16 CFR 

4.10(a)(2). In particular, do not include 

competitively sensitive information 

such as costs, sales statistics, 

inventories, formulas, patterns, devices, 

manufacturing processes, or customer 

names. 

If you want the Commission to give 

your comment confidential treatment, 

you must file it in paper form, with a 

request for confidential treatment, and 

you have to follow the procedure 

explained in FTC Rule 4.9(c), 16 CFR 

4.9(c).1 Your comment will be kept 

confidential only if the FTC General 

Counsel, in his or her sole discretion, 

grants your request in accordance with 

the law and the public interest. 

Postal mail addressed to the 

Commission is subject to delay due to 

heightened security screening. As a 

result, we encourage you to submit your 

comments online. To make sure that the 

Commission considers your online 

comment, you must file it at https:// 

ftcpublic.commentworks.com/ftc/ 

melappsconsent/ by following the 

instructions on the web-based form. If 

this Notice appears at http:// 

www.regulations.gov/#!home, you also 

may file a comment through that Web 

site. 

If you file your comment on paper, 

write ‘‘Health Discovery Corporation— 

Consent Agreement; File No. 1323211’’ 

on your comment and on the envelope, 

and mail your comment to the following 

address: Federal Trade Commission, 

Office of the Secretary, 600 

Pennsylvania Avenue NW., Suite CC– 

5610 (Annex D), Washington, DC 20580, 

or deliver your comment to the 

following address: Federal Trade 

Commission, Office of the Secretary, 

Constitution Center, 400 7th Street SW., 

5th Floor, Suite 5610 (Annex D), 

Washington, DC 20024. If possible, 

submit your paper comment to the 

Commission by courier or overnight 

service. 

Visit the Commission Web site at 

http://www.ftc.gov to read this Notice 

and the news release describing it. The 

FTC Act and other laws that the 

Commission administers permit the 

collection of public comments to 

consider and use in this proceeding as 

appropriate. The Commission will 

consider all timely and responsive 

public comments that it receives on or 

before March 25, 2015. For information 

on the Commission’s privacy policy, 

including routine uses permitted by the 

Privacy Act, see http://www.ftc.gov/ftc/ 

privacy.htm. 

Analysis of Proposed Consent Order To 

Aid Public Comment 

The Federal Trade Commission 

(‘‘FTC’’ or ‘‘Commission’’) has accepted, 

subject to final approval, an agreement 

containing a consent order as to Health 

Discovery Corporation (hereafter ‘‘the 

company’’). 

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 

proposed order and the comments 

received, and will decide whether it 

should withdraw or make final the 

agreement’s proposed order. 

This matter involves the company’s 

advertising for the MelApp mobile 

device software application. The 

Commission’s complaint alleges that the 

company violated Sections 5(a) and 12 

of the Federal Trade Commission Act by 

representing that MelApp accurately 

analyses moles and other skin lesions 

for melanoma and increases consumers’ 

chances of detecting melanoma in early 

stages, because such claims were false 

or misleading, or were not substantiated 

at the time the representations were 

made. The complaint also alleges that 

the company violated Sections 5(a) and 

12 by making the false or misleading 

representation that scientific testing 

proves that MelApp accurately detects 

melanoma. 

The proposed order includes 

injunctive relief that prohibits these 

alleged violations and fences in similar 

and related violations. The proposed 

order covers any Device, as the term is 

used within the meaning of Sections 12 

and 15 of the FTC Act, 15 U.S.C. 52, 55. 

As additional fencing-in relief, the 

proposed order requires the company to 

follow appropriate recordkeeping and 

compliance reporting requirements, as 

well as document preservation 

requirements for human clinical studies 

that it conducts or sponsors on the 

Device. 

Part I prohibits any representation 

that a Device detects or diagnoses 

melanoma or risk factors of melanoma, 

or increases users’ chances of detecting 

melanoma in early stages, unless it is 

non-misleading and supported by 

competent and reliable scientific 

evidence. Such evidence must consist of 

human clinical testing of the Device that 

is sufficient in quality and quantity, 

based on standards generally accepted 

by experts in the field, is blinded, 

conforms to actual use conditions, 

includes a representative range of skin 

lesions, and is conducted by researchers 

qualified by training and experience to 

conduct such testing. In addition, the 

company must maintain all underlying 

or supporting data that experts in the 

relevant field generally would accept as 

relevant to an assessment of such 

testing. 

Part II prohibits any representation 

about the health benefits or health 

efficacy of a Device, unless it is nonmstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 11439 

1The Commission has voted to accept for public 

comment a consent agreement with the sole 

respondent in In the Matter of Health Discovery 

Corporation (addressing the MelApp mobile app). 

In FTC v. Avrom Boris Lasarow, et al. (addressing 

the Mole Detective mobile app), the Commission 

has authorized the filing of a federal court 

complaint against four defendants and approved a 

proposed settlement with two of those defendants, 

Kristi Zuhlke Kimball and New Consumer 

Solutions LLC. 

2See MelApp Complaint ¶ 6(A). 

3See Mole Detective Complaint ¶¶ 18(A)–(B), 

18(D); Ex. A–2. 

4FTC Policy Statement Regarding Advertising 

Substantiation, 104 F.T.C. 839 (1984) (appended to 

Thompson Med. Co., 104 F.T.C. 648 (1984)) (‘‘[W]e 

reaffirm our commitment to the underlying legal 

requirement of advertising substantiation—that 

advertisers and ad agencies have a reasonable basis 

for advertising claims before they are 

disseminated.’’), aff’d, 791 F.2d 189, 193 & 196 

(D.C. Cir. 1986), cert. denied, 479 U.S. 1086 (1987). 

5Based on our application of the factors set out 

in Pfizer, 81 F.T.C. 23, 64 (1970), if these advertisers 

make future claims that any device detects or 

diagnoses melanoma, or increases a user’s chances 

of detecting melanoma in its early stages, the orders 

would require that such claims be substantiated by 

human clinical testing. The orders specify that such 

Continued 

misleading and supported by competent 

and reliable scientific evidence that is 

sufficient in quality and quantity based 

on standards generally accepted in the 

relevant scientific fields, 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, 

competent and reliable scientific 

evidence means tests, analyses, 

research, or studies that have been 

conducted by a qualified person in an 

objective manner and are generally 

accepted in the profession to yield 

accurate and reliable results. When that 

evidence consists of a human clinical 

trial, the company must maintain all 

underlying or supporting data and 

documents that experts in the relevant 

field generally would accept as relevant 

to an assessment of such testing. 

Part III triggered when the human 

clinical testing requirement in Parts I or 

II applies, requires the company to 

secure and preserve all underlying or 

supporting data and documents 

generally accepted by experts in the 

relevant field as relevant to an 

assessment of the test, such as protocols, 

instructions, participant-specific data, 

statistical analyses, and contracts with 

the test’s researchers. There is an 

exception for a ‘‘Reliably Reported’’ test, 

defined as a test that is published in a 

peer-reviewed journal and that was not 

conducted, controlled, or sponsored by 

any proposed respondent or supplier. 

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 IV prohibits the company from 

misrepresenting, including through the 

use of a product or service name, 

endorsement, depiction, or illustration, 

the existence, contents, validity, results, 

conclusions, or interpretations of any 

test, study, or research, or that any 

benefits of such product or service are 

scientifically proven, including, but not 

limited to, that studies, research, testing, 

or trials prove that a product or service 

detects or diagnoses a disease or the 

risks of a disease. 

Part V provides the company will pay 

an equitable monetary payment of 

Seventeen Thousand Six Hundred 

Ninety-three Dollars ($17,693). 

Part VI contains recordkeeping 

requirements for advertisements and 

substantiation relevant to 

representations covered by Parts I 

through III, as well as order receipts 

covered by Part VII. 

Parts VII through IX require the 

company to deliver a copy of the order 

to officers, employees, and 

representatives having managerial 

responsibilities with respect to the 

order’s subject matter, notify the 

Commission of changes in corporate 

structure that might affect compliance 

obligations, and file compliance reports 

with the Commission. 

Part X provides that, with exceptions, 

the order will terminate in twenty years. 

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, 

Commissioner Ohlhausen dissenting. 

Donald S. Clark, 

Secretary. 

Statement of Chairwoman Ramirez, 

Commissioner Brill, and Commissioner 

McSweeny 

In the Matter of Health Discovery 

Corporation, File No. 132 3211, and 

FTC v. Avrom Boris Lasarow, et al., 

File No. 132 3210 

February 23, 2015 

Today the Commission is announcing 

actions in two matters challenging the 

advertising for the mobile apps MelApp 

and Mole Detective.1 Both of these apps 

claimed to provide an automated 

analysis of moles and skin lesions for 

symptoms of melanoma and increase 

consumers’ chances of detecting 

melanoma in its early stages. 

Advertising for MelApp stated that it 

used ‘‘patent protected state-of-the-art 

mathematical algorithms and imagebased pattern recognition technology to 

analyze the uploaded image [of a skin 

lesion],’’ to ‘‘provide a risk analysis of 

the uploaded picture being a 

melanoma’’ and ‘‘assist[ ] in the early 

detection of melanoma.’’ 2 Advertising 

for Mole Detective stated that it ‘‘is the 

first and only app to calculate 

symptoms of melanoma right on the 

phone,’’ and that it could ‘‘analyze[] 

your mole using the dermatologist 

ABCDE method and give[] you a risk 

factor based on the symptoms your mole 

may or may not be showing,’’ ‘‘increase 

the chance of detecting skin cancer in 

early stages,’’ and ‘‘save[] lives through 

the early detection of potentially fatal 

melanoma,’’ using ‘‘shape recognition 

software.’’ 3

The claims that these apps would 

provide an accurate, automated analysis 

of skin lesions were the central selling 

points for both MelApp and Mole 

Detective, and these claims needed to be 

substantiated.4 Although Commissioner 

Ohlhausen does not appear to disagree 

with this assessment, she believes the 

Commission’s complaint needs to 

articulate a comparative reference point 

for any ‘‘accuracy’’ claim to set an 

appropriate level of substantiation in 

the accompanying orders. Absent 

extrinsic evidence, she believes it is 

reasonable to read the ads as claiming 

that the automated assessment is more 

accurate than unaided self-assessment, 

and that it is not reasonable to read the 

ads as claiming that the automated 

assessment is as accurate as a 

dermatologist. 

We disagree. We think the powerful 

language of the advertising, such as that 

quoted above, is clear on its face, so no 

extrinsic evidence of consumer 

interpretation is needed to support the 

challenged representations that the apps 

accurately analyze moles for symptoms 

of melanoma and increase the chance of 

detecting skin cancer in its early stages. 

Because the defendants and the 

respondent lacked substantiation for 

those claims, we have reason to believe 

they violated Section 5. Thus, it is not 

necessary to hypothesize about what 

implied claims, such as the accuracy 

relative to different types of 

assessments, consumers may have read 

into the advertising. 

Commissioner Ohlhausen also 

suggests that the orders would, de facto, 

require any future app the advertisers 

market to be as accurate as a 

dermatologist or biopsy. Again, we 

respectfully disagree. The orders do not 

prescribe a particular level of accuracy 

the apps must achieve prior to being 

marketed; rather, they require scientific 

testing demonstrating accuracy at a level 

appropriate to the claims being made.5

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11440 Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 

testing must be blinded, conform to actual use 

conditions, include a representative range of skin 

lesions, and be conducted by researchers qualified 

by training and experience to conduct such testing. 

These conditions are designed to ensure the 

accuracy and reliability of testing used to support 

a narrow and clearly defined set of claims relating 

specifically to the detection and diagnosis of 

melanoma, a serious and progressively deadly 

disease. 

If these advertisers make other claims about the 

health benefits or efficacy of any product or service, 

the orders require such claims to be non-misleading 

and supported by competent and reliable scientific 

evidence. The orders further describe what 

constitutes competent and reliable scientific 

evidence and make it quite clear that the evidence 

required is directly tied to the claim made, 

expressly or implicitly, by the advertiser. 

1See Statement of Commissioner Maureen K. 

Ohlhausen Dissenting in Part and Concurring in 

Part In the Matter of GeneLink, Inc. and foru 

International Corp., (Jan. 7, 2014); Concurring 

Statement of Commissioner Maureen K. Ohlhausen, 

POM Wonderful, Docket No. 9344, at 3 (Jan. 10, 

2013). These statements are available at http://

www.ftc.gov/about-ftc/biographies/maureen-kohlhausen#speeches. 

2Concurring Statement of Commissioner 

Maureen K. Ohlhausen, POM Wonderful, at 3. 

3 I agree with the majority that the companies 

claimed, without substantiation, that the apps’ 

automated risk assessments were more accurate 

than a user’s unaided self-assessment using the 

ABCDE factors, and I therefore would support 

complaints narrowly challenging this claim. 

Further, I would support orders prohibiting claims 

that an app ‘‘detects melanoma or risk factors of 

melanoma, thereby increasing, as compared to 

unaided self-assessment, users’ chances of detecting 

melanoma in early stages,’’ unless substantiated by 

competent and reliable scientific evidence. 

4Mole Detective Order at 5. The MelApp Order 

includes a similar prohibition. See MelApp Order 

at 3. 

5Mole Detective Order at 5; MelApp Order at 3. 

6Under Pfizer, the Commission determines the 

level of evidence an advertiser must have to 

substantiate its product efficacy claims by 

examining six factors: (1) The type of product 

advertised; (2) the type of claim; (3) the benefits of 

a truthful claim; (4) the cost of developing 

substantiation for the claim; (5) the consequences 

of a false claim; and (6) the amount of 

substantiation that experts in the field would 

require. Pfizer, Inc., 81 F.T.C. 23, 64 (1970). 

7Statement of Chairwoman Ramirez, 

Commissioner Brill, and Commissioner McSweeny 

at 2. 

8Mole Detective Complaint ¶ 23. The MelApp 

complaint contains similar language. See MelApp 

Complaint at 4. 

9Because the ads do not expressly quantify (in 

absolute terms or by comparison) the accuracy or 

efficacy of the apps, any purported claims by the 

ads about accuracy or efficacy must be implied, not 

express. 

Thus, if scientific testing demonstrates 

that the app is accurate 60% of the time, 

the advertisers would be able to make a 

60% accuracy claim. It would be 

incumbent upon these marketers to 

make sure that their advertising 

conveyed that level of accuracy and did 

not suggest a stronger level of science to 

reasonable consumers. 

Technologies such as health-related 

mobile apps have the potential to 

provide tremendous conveniences and 

benefits to consumers. However, the 

same rules of the road apply to all 

media and technologies—advertisers 

must have substantiation to back up 

their claims. The Commission will 

continue to hold advertisers accountable 

for the promises they make to 

consumers, especially when they 

pertain to diseases and other serious 

health conditions. 

For the foregoing reasons, we have 

reason to believe that the complaint 

allegations and proposed relief reached 

by consent of the settling parties are 

appropriate. 

Dissenting Statement of Commissioner 

Maureen K. Ohlhausen 

In the Matter of Health Discovery 

Corporation, File No. 132–3211 and 

FTC v. Avrom Boris Lasarow, et al., 

File No. 132–3210 

February 23, 2015 

These matters are another example of 

the Commission using an unduly 

expansive interpretation of advertising 

claims to justify imposing an 

inappropriately high substantiation 

requirement on a relatively safe 

product.1 As I have previously stated, 

‘‘We must keep in mind . . . that if we 

are too quick to find stronger claims 

than the ones reasonable consumers 

actually perceive, then we will 

inadvertently, but categorically, require 

an undue level of substantiation for 

those claims.’’ 2 Because I fear this 

course of action will inhibit the 

development of beneficial products and 

chill the dissemination of useful health 

information to consumers, I dissent. 

I do not dispute that companies must 

have adequate substantiation to support 

the claims that they make, and I thus 

would have supported complaints and 

substantiation requirements based on 

the app developers’ claims that their 

apps automatically assessed cancer risk 

more accurately than a consumer’s 

unaided self-assessment using the 

ABCDE factors.3

However, the complaints and orders 

in these cases go further, demanding a 

high level of substantiation for a wide 

range of potential advertising claims. 

Specifically, the orders require rigorous, 

well-accepted, blinded, human clinical 

tests to substantiate any claim that the 

app increases consumers’ chances of 

detecting skin cancer in the early 

stages.4 Both orders also impose the 

same high substantiation standard on 

any claim that an app ‘‘detects or 

diagnoses melanoma or risk factors of 

melanoma.’’ 5 The orders could thus be 

read to require the app developers to 

demonstrate that their apps assess 

cancer risk as well as dermatologists, 

even if their ads make much more 

limited claims. 

Substantiation requirements must 

flow from the claims made by the 

advertiser. Under Pfizer, the 

Commission should require a high level 

of substantiation if the advertiser 

expressly claimed or implied that the 

apps provide dermatologist-level 

accuracy and efficacy, and a lower level 

of substantiation if the advertiser claims 

a lower level of capability.6 The 

majority’s statement appears to agree 

with that approach: 

‘‘[I]f scientific testing demonstrates that 

the app is accurate 60% of the time, the 

advertisers would be able to make a 

60% accuracy claim. It would be 

incumbent upon these marketers to 

make sure that their advertising 

conveyed that level of accuracy and did 

not suggest a stronger level of science to 

reasonable consumers.’’ 7

Yet, having acknowledged that the 

app developers need only ensure that 

their advertising conveys the 

appropriate level of accuracy, the 

majority still supports complaints that 

do not specify what claimed level of 

accuracy their advertisements conveyed 

to consumers. Instead, the complaints 

describe the allegedly unlawful 

advertising claims amorphously. The 

Mole Detective complaint, for example, 

characterizes the defendants’ ads as 

claiming that the app ‘‘accurately 

analyzes moles for the ABCDE 

symptoms of melanoma; and/or 

increases consumers’ chances of 

detecting skin cancer in early stages.’’ 8

This amorphous claim construction 

leaves two unresolved questions: 

‘‘Accurate compared to what?’’ and 

‘‘Increases chances compared to what?’’ 

We must know how reasonable 

consumers answered those questions— 

and thus establish what claims 

consumers likely took from the ads— 

before we can determine whether 

defendants provided the appropriate 

level of substantiation for those claims.9

There is little reason to think that 

consumers interpreted the ads to 

promise early detection as accurate and 

efficacious as a dermatologist. The ads 

never claim that the apps substitute for 

a dermatologist exam. In fact, the ads 

describe the apps as tools to enhance 

self-assessment in conjunction with 

visits to dermatologists, and both apps 

emphasize the importance of regular 

dermatologist visits. Without extrinsic 

evidence, I do not have reason to believe 

that a reasonable consumer would take 

away the implied claim that using these 

apps would increase their chances of 

detecting skin cancer in the early stages 

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Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 11441 

10When 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). 

11These 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. 

13See, 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 

http://online.wsj.com/articles/scott-gottlieb-andcoleen-klasmeier-why-your-phone-isnt-as-smart-asit-could-be-1407369163. 

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 

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] 

BILLING CODE 6750–01–P 

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] 

BILLING CODE P 

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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