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)

Page Range		51260-51261
FR Document		2015-20805
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 Issue 163 (Monday, August 24, 2015)
[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
Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices 51261

grants your request in accordance with This matter concerns alleged false or misrepresentations about its
the law and the public interest. misleading representations that Jubilant membership in any privacy or security
Postal mail addressed to the Clinsys made to consumers concerning program sponsored by the government
Commission is subject to delay due to its participation in the Safe Harbor or any other self-regulatory or standard-
heightened security screening. As a privacy framework agreed upon by the setting organization, including, but not
result, we encourage you to submit your U.S. and the European Union (‘‘EU’’) limited to, the U.S.-EU Safe Harbor
comments online. To make sure that the (‘‘U.S.-EU Safe Harbor Framework’’). Framework and the U.S.-Swiss Safe
Commission considers your online The U.S.-EU Safe Harbor Framework Harbor Framework.
comment, you must file it at https:// allows U.S. companies to transfer data Parts II through VI of the proposed
ftcpublic.commentworks.com/ftc/ outside the EU consistent with EU law. order are reporting and compliance
jubilantclinsysconsent by following the To join the U.S.-EU Safe Harbor provisions. Part II requires Jubilant
instructions on the web-based form. If Framework, a company must self-certify Clinsys to retain documents relating to
this Notice appears at http:// to the U.S. Department of Commerce its compliance with the order for a five-
www.regulations.gov/#!home, you also (‘‘Commerce’’) that it complies with a year period. Part III requires
may file a comment through that Web set of principles and related dissemination of the order now and in
site. requirements that have been deemed by the future to persons with
If you file your comment on paper, the European Commission as providing responsibilities relating to the subject
write ‘‘Jubilant Clinsys, Inc.—Consent ‘‘adequate’’ privacy protection. These matter of the order. Part IV ensures
Agreement; File No. 152 3140’’ on your principles include notice, choice, notification to the FTC of changes in
comment and on the envelope, and mail onward transfer, security, data integrity, corporate status. Part V mandates that
your comment to the following address: access, and enforcement. Commerce Jubilant Clinsys submit an initial
Federal Trade Commission, Office of the maintains a public Web site, compliance report to the FTC, and make
Secretary, 600 Pennsylvania Avenue www.export.gov/safeharbor, where it available to the FTC subsequent reports.
NW., Suite CC–5610 (Annex D), posts the names of companies that have Part VI is a provision ‘‘sunsetting’’ the
Washington, DC 20580, or deliver your self-certified to the U.S.-EU Safe Harbor order after twenty (20) years, with
comment to the following address: Framework. The listing of companies certain exceptions.
Federal Trade Commission, Office of the indicates whether their self-certification The purpose of this analysis is to
Secretary, Constitution Center, 400 7th is ‘‘current’’ or ‘‘not current.’’ facilitate public comment on the
Street SW., 5th Floor, Suite 5610 Companies are required to re-certify proposed order. It is not intended to
(Annex D), Washington, DC 20024. If every year in order to retain their status constitute an official interpretation of
possible, submit your paper comment to as ‘‘current’’ members of the U.S.-EU the proposed complaint or order or to
the Commission by courier or overnight Safe Harbor Framework. modify the order’s terms in any way.
Jubilant Clinsys is a research
service. By direction of the Commission.
organization that provides
Visit the Commission Web site at pharmaceutical, biotechnology and Donald S. Clark,
http://www.ftc.gov to read this Notice medical device companies with services Secretary.
and the news release describing it. The in support of drug and device [FR Doc. 2015–20805 Filed 8–21–15; 8:45 am]
FTC Act and other laws that the development. According to the BILLING CODE 6750–01–P
Commission administers permit the Commission’s complaint, Jubilant
collection of public comments to Clinsys has set forth on its Web site,
consider and use in this proceeding as http://www.clinsys.com/ FEDERAL TRADE COMMISSION
appropriate. The Commission will index.php?option=com_ [File No. 152 3184]
consider all timely and responsive content&view=article&id=8&Itemid=19,
public comments that it receives on or privacy policies and statements about Contract Logix, LLC; Analysis of
before September 16, 2015. You can find its practices, including statements Proposed Consent Order to Aid Public
more information, including routine related to its participation in the U.S– Comment
uses permitted by the Privacy Act, in EU Safe Harbor Framework.
the Commission’s privacy policy, at The Commission’s complaint alleges AGENCY: Federal Trade Commission.
http://www.ftc.gov/ftc/privacy.htm. that Jubilant Clinsys falsely represented ACTION: Proposed Consent Agreement.
Analysis of Proposed Consent Order To that it was a ‘‘current’’ participant in the SUMMARY: The consent agreement in this
Aid Public Comment U.S.-EU Safe Harbor Framework when, matter settles alleged violations of
in fact, from November 2012 through federal law prohibiting unfair or
The Federal Trade Commission April 2015, Jubilant Clinsys was not a
(‘‘FTC’’ or ‘‘Commission’’) has accepted, deceptive acts or practices. The attached
‘‘current’’ participant in the U.S.-EU Analysis to Aid Public Comment
subject to final approval, a consent Safe Harbor Framework. The
agreement applicable to Jubilant describes both the allegations in the
Commission’s complaint alleges that in
Clinsys, Inc. (‘‘Jubilant Clinsys’’). draft complaint and the terms of the
November 2007, Jubilant Clinsys
The proposed consent order has been consent order—embodied in the consent
submitted its self-certification to the
placed on the public record for thirty agreement—that would settle these
U.S.-EU Safe Harbor Framework.
(30) days for receipt of comments by allegations.
Jubilant Clinsys did not renew its self-
interested persons. Comments received certification in November 2012 and DATES: Comments must be received on
during this period will become part of Commerce subsequently updated or before September 16, 2015.
tkelley on DSK3SPTVN1PROD with NOTICES

the public record. After thirty days, the Jubilant Clinsys’ status to ‘‘not current’’ ADDRESSES: Interested parties may file a
Commission will again review the on its public Web site. In May 2015, comment at https://
agreement and the comments received, Jubilant Clinsys removed its Safe Harbor ftcpublic.commentworks.com/ftc/
and will decide whether it should representation from its Web site privacy contractlogixconsent online or on paper,
withdraw from the agreement and take policy. by following the instructions in the
appropriate action or make final the Part I of the proposed order prohibits Request for Comment part of the
agreement’s proposed order. Jubilant Clinsys from making SUPPLEMENTARY INFORMATION section

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Document Created: 2015-12-15 10:54:55
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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Proposed Consent Agreement.
Dates		Comments must be received on or before September 16, 2015.
Contact		Monique F. Einhorn, ((202) 326-2575), Bureau of Consumer Protection, 600 Pennsylvania Avenue NW., Washington, DC 20580.
FR Citation		80 FR 51260