80 FR 51260 - Jubilant Clinsys, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

FEDERAL TRADE COMMISSION

Federal Register Volume 80, Issue 163 (August 24, 2015)

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.

[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Pages 51260-51261]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20805]


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FEDERAL TRADE COMMISSION

[File No. 152 3140]


Jubilant Clinsys, Inc.; Analysis of Proposed Consent Order To Aid 
Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed Consent Agreement.

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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 September 16, 2015.

ADDRESSES: Interested parties may file a comment at https://ftcpublic.commentworks.com/ftc/jubilantclinsysconsent online or on 
paper, by following the instructions in the Request for Comment part of 
the SUPPLEMENTARY INFORMATION section below. Write ``Jubilant Clinsys, 
Inc.--Consent Agreement; File No. 152 3140'' on your comment and file 
your comment online at https://ftcpublic.commentworks.com/ftc/jubilantclinsysconsent by following the instructions on the web-based 
form. If you prefer to file your comment on paper, write ``Jubilant 
Clinsys, Inc.--Consent Agreement; File No. 152 3140'' 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: Monique F. Einhorn, ((202) 326-2575), 
Bureau of Consumer Protection, 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 August 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 September 16, 
2015. Write ``Jubilant Clinsys, Inc.--Consent Agreement; File No. 152 
3140'' 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,

[[Page 51261]]

grants your request in accordance with the law and the public interest.
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    \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).
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    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/jubilantclinsysconsent 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 ``Jubilant Clinsys, Inc.--
Consent Agreement; File No. 152 3140'' 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 September 16, 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 (``FTC'' or ``Commission'') has 
accepted, subject to final approval, a consent agreement applicable to 
Jubilant Clinsys, Inc. (``Jubilant Clinsys'').
    The proposed consent 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 days, the Commission will again review the 
agreement and the comments received, and will decide whether it should 
withdraw from the agreement and take appropriate action or make final 
the agreement's proposed order.
    This matter concerns alleged false or misleading representations 
that Jubilant Clinsys made to consumers concerning its participation in 
the Safe Harbor privacy framework agreed upon by the U.S. and the 
European Union (``EU'') (``U.S.-EU Safe Harbor Framework''). The U.S.-
EU Safe Harbor Framework allows U.S. companies to transfer data outside 
the EU consistent with EU law. To join the U.S.-EU Safe Harbor 
Framework, a company must self-certify to the U.S. Department of 
Commerce (``Commerce'') that it complies with a set of principles and 
related requirements that have been deemed by the European Commission 
as providing ``adequate'' privacy protection. These principles include 
notice, choice, onward transfer, security, data integrity, access, and 
enforcement. Commerce maintains a public Web site, www.export.gov/safeharbor, where it posts the names of companies that have self-
certified to the U.S.-EU Safe Harbor Framework. The listing of 
companies indicates whether their self-certification is ``current'' or 
``not current.'' Companies are required to re-certify every year in 
order to retain their status as ``current'' members of the U.S.-EU Safe 
Harbor Framework.
    Jubilant Clinsys is a research organization that provides 
pharmaceutical, biotechnology and medical device companies with 
services in support of drug and device development. According to the 
Commission's complaint, Jubilant Clinsys has set forth on its Web site, 
http://www.clinsys.com/index.php?option=com_content&view=article&id=8&Itemid=19, privacy 
policies and statements about its practices, including statements 
related to its participation in the U.S-EU Safe Harbor Framework.
    The Commission's complaint alleges that Jubilant Clinsys falsely 
represented that it was a ``current'' participant in the U.S.-EU Safe 
Harbor Framework when, in fact, from November 2012 through April 2015, 
Jubilant Clinsys was not a ``current'' participant in the U.S.-EU Safe 
Harbor Framework. The Commission's complaint alleges that in November 
2007, Jubilant Clinsys submitted its self-certification to the U.S.-EU 
Safe Harbor Framework. Jubilant Clinsys did not renew its self-
certification in November 2012 and Commerce subsequently updated 
Jubilant Clinsys' status to ``not current'' on its public Web site. In 
May 2015, Jubilant Clinsys removed its Safe Harbor representation from 
its Web site privacy policy.
    Part I of the proposed order prohibits Jubilant Clinsys from making 
misrepresentations about its membership in any privacy or security 
program sponsored by the government or any other self-regulatory or 
standard-setting organization, including, but not limited to, the U.S.-
EU Safe Harbor Framework and the U.S.-Swiss Safe Harbor Framework.
    Parts II through VI of the proposed order are reporting and 
compliance provisions. Part II requires Jubilant Clinsys to retain 
documents relating to its compliance with the order for a five-year 
period. Part III requires dissemination of the order now and in the 
future to persons with responsibilities relating to the subject matter 
of the order. Part IV ensures notification to the FTC of changes in 
corporate status. Part V mandates that Jubilant Clinsys submit an 
initial compliance report to the FTC, and make available to the FTC 
subsequent reports. Part VI is a provision ``sunsetting'' the order 
after twenty (20) years, with certain exceptions.
    The purpose of this analysis is to facilitate public comment on the 
proposed order. It is not intended to constitute an official 
interpretation of the proposed complaint or order or to modify the 
order's terms in any way.

    By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2015-20805 Filed 8-21-15; 8:45 am]
BILLING CODE 6750-01-P