Carrot Neurotechnology, Inc.; Analysis of Proposed Consent Order To Aid Public Comment, 57614-57616 [2015-24220]

Download as PDF 57614 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices Judith Ingram, Press Officer, Telephone: (202) 694–1220. Shawn Woodhead Werth, Secretary and Clerk of the Commission. Thursday, October 1, 2015 at 10:00 a.m. DATE AND TIME: 999 E Street NW., Washington, DC (Ninth Floor). PLACE: This meeting will be open to the public. STATUS: FEDERAL RESERVE SYSTEM Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Shawn Woodhead Werth, Secretary and Clerk, at (202)694–1040, at least 72 hours prior to the meeting date. PERSON TO CONTACT FOR INFORMATION: Judith Ingram, Press Officer, Telephone: (202) 694–1220. Shawn Woodhead Werth, Secretary and Clerk of the Commission. [FR Doc. 2015–24501 Filed 9–22–15; 4:15 pm] BILLING CODE 6715–01–P FEDERAL ELECTION COMMISSION Sunshine Act Meeting Federal Election Commission. Tuesday, September 29, 2015 At 10:00 a.m. And Thursday, October 1, 2015 At The Conclusion Of The Open Meeting. DATE AND TIME: 999 E Street NW., Washington, DC. This meeting will be closed to the public. STATUS: Compliance matters pursuant to 52 U.S.C. 30109. Internal personnel rules and internal rules and practices. Information the premature disclosure of which would be likely to have a considerable adverse effect on the implementation of a proposed Commission action. * * * * * tkelley on DSK3SPTVN1PROD with NOTICES ITEMS TO BE DISCUSSED: VerDate Sep<11>2014 16:45 Sep 23, 2015 BILLING CODE 6210–01–P BILLING CODE 6715–01–P Draft Advisory Opinion 2015–07: Hillary for America Draft Advisory Opinion 2015–08: Repledge State and Local Ballot Measures and the Ban on Foreign National Contributions Notice of Proposed Rulemaking on Reporting Multistate Independent Expenditures in Presidential Primary Elections Commission Documents/Public Disclosure Policies Management and Administrative Matters PLACE: [FR Doc. 2015–24265 Filed 9–23–15; 8:45 am] [FR Doc. 2015–24403 Filed 9–22–15; 4:15 pm] ITEMS TO BE DISCUSSED: AGENCY: Board of Governors of the Federal Reserve System, September 21, 2015. Michael J. Lewandowski, Associate Secretary of the Board. PERSON TO CONTACT FOR INFORMATION: Jkt 235001 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 October 19, 2015. A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690–1414: 1. Edgewater Bancorp, Inc., Saint Joseph, Michigan; to become a bank holding company following the conversion of its subsidiary, Edgewater Bank, Saint Joseph, Michigan, from a federal savings bank to a Michigan statechartered bank. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than October 9, 2015. A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198–0001: 1. J.C. Long and Carol V. Long, as trustees of the W.C. Long, Jr., Living Trust, all of Wellington, Kansas; to retain voting shares of Tri-County Financial Corporation, and thereby indirectly retain voting shares of The Bank of Commerce, both in Wellington, Kansas. Board of Governors of the Federal Reserve System, September 21, 2015. Michael J. Lewandowski, Associate Secretary of the Board. [FR Doc. 2015–24266 Filed 9–23–15; 8:45 am] BILLING CODE 6210–01–P FEDERAL TRADE COMMISSION [File No. 142 3132] Carrot Neurotechnology, Inc.; Analysis of Proposed Consent Order To Aid Public Comment Federal Trade Commission. Proposed Consent Agreement. AGENCY: ACTION: The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached SUMMARY: E:\FR\FM\24SEN1.SGM 24SEN1 tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices 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 October 19, 2015. ADDRESSES: Interested parties may file a comment at https:// ftcpublic.commentworks.com/ftc/ carrotneurotechconsent online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write ‘‘Carrot Neurotechnology, Inc.—Consent Agreement; File No. 1423132’’ on your comment and file your comment online at https:// ftcpublic.commentworks.com/ftc/ carrotneurotechconsent by following the instructions on the web-based form. If you prefer to file your comment on paper, write ‘‘Carrot Neurotechnology, Inc.—Consent Agreement; File No. 1423132’’ 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 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 September 17, 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 October 19, 2015. Write ‘‘Carrot Neurotechnology, Inc.—Consent Agreement; File No. 1423132’’ on your VerDate Sep<11>2014 16:45 Sep 23, 2015 Jkt 235001 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/ carrotneurotechconsent by following the instructions on the web-based form. If this Notice appears at http:// www.regulations.gov/#!home, you also 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). PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 57615 may file a comment through that Web site. If you file your comment on paper, write ‘‘Carrot Neurotechnology, Inc.— Consent Agreement; File No. 1423132’’ 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 October 19, 2015. You can find more information, including routine uses permitted by the Privacy Act, in the Commission’s privacy policy, at http://www.ftc.gov/ftc/privacy.htm. Analysis of Proposed Consent Order To Aid Public Comment The Federal Trade Commission (‘‘Commission’’) has accepted, subject to final approval, an agreement containing a consent order as to Carrot Neurotechnology, Inc., Adam Goldberg, and Aaron Seitz (hereafter ‘‘respondents’’). The proposed consent order (‘‘order’’) has been placed on the public record for 30 days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will again review the order and the comments received, and will decide whether it should withdraw the order or make it final. This matter involves the respondents’ advertising for the Ultimeyes software application. The Commission’s complaint alleges that the respondents violated Sections 5(a) and 12 of the Federal Trade Commission Act (‘‘FTC Act’’), 15 U.S.C. 45(a), 52, by representing, either falsely or without adequate substantiation, that Ultimeyes substantially improves users’ vision, including that it: improves the vision of users, including people of all ages, genders, and visual abilities; improves vision with real world benefits, E:\FR\FM\24SEN1.SGM 24SEN1 tkelley on DSK3SPTVN1PROD with NOTICES 57616 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices including benefits across a broad range of activities ranging from athletics to more routine lifestyle activities, such as reading, watching TV, and driving; improves vision on average by 31% and two lines on the Snellen eye chart, and improves contrast sensitivity by 100%; and reverses, delays, or corrects aging eye or presbyopia, including, but not limited to, by improving night vision, improving users’ ability to read in dim light, and diminishing the need for glasses or other visual aids. The complaint also alleges that the respondents violated Sections 5(a) and 12 by making the false or misleading representation that scientific testing proves that Ultimeyes improves vision in the above ways. The order includes injunctive relief that prohibits these alleged violations and fences in similar and related violations. The order applies to marketing claims for any Covered Product or Service, defined as any Device within the meaning of Sections 12 and 15 of the FTC Act, 15 U.S.C. 52, 55, or any program or service that is: (1) Intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or (2) intended to affect the structure or any function of the body of man or other animals; and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes. As additional fencing-in relief, the order requires the respondents to follow appropriate recordkeeping and compliance reporting requirements, as well as document preservation requirements for human clinical studies that it conducts or sponsors on any Covered Product or Service. Part I prohibits any representation that a Covered Product or Service improves users’ vision, unless it is nonmisleading and supported by competent and reliable scientific evidence. Such evidence must consist of human clinical testing of the Covered Product or Service 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 (1) be randomized, double-blind, and adequately controlled; and (2) be conducted by researchers qualified by training and experience to conduct such testing. In addition, the respondents VerDate Sep<11>2014 16:45 Sep 23, 2015 Jkt 235001 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, performance, efficacy, safety, or side effects of any Covered Product or Service, unless it is non-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 and evaluated in an objective manner by qualified persons; and that are generally accepted in the profession to yield accurate and reliable results. When that evidence consists of human clinical tests or studies, the respondents 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 respondents 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 respondent or by any supplier of the respondents. 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 respondents from misrepresenting, including through the use of a name, endorsement, depiction, or illustration, the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research, or that any benefits of a product, program, or service are scientifically proven. Part V requires the respondents to disclose, when triggered by certain representations as to scientific support or endorsements in connection with the advertisement or sale of any product, program, or service, any material connections to any person that has PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 conducted, authored, or participated in any test, study, or research of the product, program, or service; and all material connections between a person providing an endorsement and respondents or any other person manufacturing, labeling, advertising, promoting, offering for sale, selling, or distributing such product, program, or service. Part VI provides the respondents will pay an equitable monetary payment of $150,000 and contains other provisions related to the payment. Part VII requires the respondents to provide sufficient customer information to administer redress. Part VIII contains recordkeeping requirements for advertisements and substantiation relevant to representations covered by Parts I through III, as well as order acknowledgments covered by Part IX. Parts IX through XI require the respondents 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 XII provides that, with exceptions, the order will terminate in twenty years. The purpose of this analysis is to facilitate public comment on the order, and it is not intended to constitute an official interpretation of the complaint or order, or to modify the order’s terms in any way. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. 2015–24220 Filed 9–23–15; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–10137 and CMS–10237] Agency Information Collection Activities: Submission for OMB Review; Comment Request ACTION: Notice. The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the SUMMARY: E:\FR\FM\24SEN1.SGM 24SEN1

Agencies

[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)]
[Notices]
[Pages 57614-57616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24220]


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FEDERAL TRADE COMMISSION

[File No. 142 3132]


Carrot Neurotechnology, Inc.; 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

[[Page 57615]]

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 October 19, 2015.

ADDRESSES: Interested parties may file a comment at https://ftcpublic.commentworks.com/ftc/carrotneurotechconsent online or on 
paper, by following the instructions in the Request for Comment part of 
the SUPPLEMENTARY INFORMATION section below. Write ``Carrot 
Neurotechnology, Inc.--Consent Agreement; File No. 1423132'' on your 
comment and file your comment online at https://ftcpublic.commentworks.com/ftc/carrotneurotechconsent by following the 
instructions on the web-based form. If you prefer to file your comment 
on paper, write ``Carrot Neurotechnology, Inc.--Consent Agreement; File 
No. 1423132'' 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 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 September 17, 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 October 19, 
2015. Write ``Carrot Neurotechnology, Inc.--Consent Agreement; File No. 
1423132'' 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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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/carrotneurotechconsent 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 ``Carrot Neurotechnology, 
Inc.--Consent Agreement; File No. 1423132'' 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 October 19, 2015. You can find more 
information, including routine uses permitted by the Privacy Act, in 
the Commission's privacy policy, at http://www.ftc.gov/ftc/privacy.htm.

Analysis of Proposed Consent Order To Aid Public Comment

    The Federal Trade Commission (``Commission'') has accepted, subject 
to final approval, an agreement containing a consent order as to Carrot 
Neurotechnology, Inc., Adam Goldberg, and Aaron Seitz (hereafter 
``respondents'').
    The proposed consent order (``order'') has been placed on the 
public record for 30 days for receipt of comments by interested 
persons. Comments received during this period will become part of the 
public record. After 30 days, the Commission will again review the 
order and the comments received, and will decide whether it should 
withdraw the order or make it final.
    This matter involves the respondents' advertising for the Ultimeyes 
software application. The Commission's complaint alleges that the 
respondents violated Sections 5(a) and 12 of the Federal Trade 
Commission Act (``FTC Act''), 15 U.S.C. 45(a), 52, by representing, 
either falsely or without adequate substantiation, that Ultimeyes 
substantially improves users' vision, including that it: improves the 
vision of users, including people of all ages, genders, and visual 
abilities; improves vision with real world benefits,

[[Page 57616]]

including benefits across a broad range of activities ranging from 
athletics to more routine lifestyle activities, such as reading, 
watching TV, and driving; improves vision on average by 31% and two 
lines on the Snellen eye chart, and improves contrast sensitivity by 
100%; and reverses, delays, or corrects aging eye or presbyopia, 
including, but not limited to, by improving night vision, improving 
users' ability to read in dim light, and diminishing the need for 
glasses or other visual aids. The complaint also alleges that the 
respondents violated Sections 5(a) and 12 by making the false or 
misleading representation that scientific testing proves that Ultimeyes 
improves vision in the above ways.
    The order includes injunctive relief that prohibits these alleged 
violations and fences in similar and related violations. The order 
applies to marketing claims for any Covered Product or Service, defined 
as any Device within the meaning of Sections 12 and 15 of the FTC Act, 
15 U.S.C. 52, 55, or any program or service that is: (1) Intended for 
use in the diagnosis of disease or other condition, or in the cure, 
mitigation, treatment, or prevention of disease, in man or other 
animals; or (2) intended to affect the structure or any function of the 
body of man or other animals; and which does not achieve any of its 
principal intended purposes through chemical action within or on the 
body of man or other animals and which is not dependent upon being 
metabolized for the achievement of any of its principal intended 
purposes. As additional fencing-in relief, the order requires the 
respondents to follow appropriate recordkeeping and compliance 
reporting requirements, as well as document preservation requirements 
for human clinical studies that it conducts or sponsors on any Covered 
Product or Service.
    Part I prohibits any representation that a Covered Product or 
Service improves users' vision, unless it is non-misleading and 
supported by competent and reliable scientific evidence. Such evidence 
must consist of human clinical testing of the Covered Product or 
Service 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 (1) 
be randomized, double-blind, and adequately controlled; and (2) be 
conducted by researchers qualified by training and experience to 
conduct such testing. In addition, the respondents 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, 
performance, efficacy, safety, or side effects of any Covered Product 
or Service, unless it is non-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 and evaluated in an objective manner by qualified persons; 
and that are generally accepted in the profession to yield accurate and 
reliable results. When that evidence consists of human clinical tests 
or studies, the respondents 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 respondents 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 respondent or by any supplier of the 
respondents. 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 respondents from misrepresenting, including 
through the use of a name, endorsement, depiction, or illustration, the 
existence, contents, validity, results, conclusions, or interpretations 
of any test, study, or research, or that any benefits of a product, 
program, or service are scientifically proven.
    Part V requires the respondents to disclose, when triggered by 
certain representations as to scientific support or endorsements in 
connection with the advertisement or sale of any product, program, or 
service, any material connections to any person that has conducted, 
authored, or participated in any test, study, or research of the 
product, program, or service; and all material connections between a 
person providing an endorsement and respondents or any other person 
manufacturing, labeling, advertising, promoting, offering for sale, 
selling, or distributing such product, program, or service.
    Part VI provides the respondents will pay an equitable monetary 
payment of $150,000 and contains other provisions related to the 
payment.
    Part VII requires the respondents to provide sufficient customer 
information to administer redress.
    Part VIII contains recordkeeping requirements for advertisements 
and substantiation relevant to representations covered by Parts I 
through III, as well as order acknowledgments covered by Part IX.
    Parts IX through XI require the respondents 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 XII provides that, with exceptions, the order will terminate 
in twenty years.
    The purpose of this analysis is to facilitate public comment on the 
order, and it is not intended to constitute an official interpretation 
of the complaint or order, or to modify the order's terms in any way.

    By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2015-24220 Filed 9-23-15; 8:45 am]
BILLING CODE 6750-01-P