82 FR 46243 - Moonlight Slumber, LLC; Analysis To Aid Public Comment
FEDERAL TRADE COMMISSION Federal Register Volume 82, Issue 191 (October 4, 2017)
Federal Register Volume 82, Issue 191 (October 4, 2017)
| Page Range | 46243-46245 | |
| FR Document | 2017-21289 |
[Federal Register Volume 82, Number 191 (Wednesday, October 4, 2017)] [Notices] [Pages 46243-46245] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21289] ----------------------------------------------------------------------- FEDERAL TRADE COMMISSION [File No. 162 3128] Moonlight Slumber, LLC; Analysis 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 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 30, 2017. ADDRESSES: Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write: ``In the Matter of Moonlight Slumber, LLC, File No. 1623128'' on your comment, and file your comment online at https://ftcpublic.commentworks.com/ftc/moonlightslumberconsent by following the instructions on the web-based form. If you prefer to file your comment on paper, write ``In the Matter of Moonlight Slumber, LLC, File No. 1623128'' 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: Amanda Kostner (202-326-2880) and Jock Chung (202-326-2984), 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 [[Page 46244]] consent agreement containing a 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 28, 2017), on the World Wide Web, at https://www.ftc.gov/news-events/commission-actions. You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before October 30, 2017. Write ``In the Matter of Moonlight Slumber, LLC, File No. 1623128'' 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 https://www.ftc.gov/policy/public-comments. 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/moonlightslumberconsent 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 prefer to file your comment on paper, write ``In the Matter of Moonlight Slumber, LLC, File No. 1623128'' 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. Because your comment will be placed on the publicly accessible FTC Web site at https://www.ftc.gov, you are solely responsible for making sure that your comment does not include any sensitive or confidential information. In particular, your comment should not include any sensitive personal information, such as your or anyone else'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, such as medical records or other individually identifiable health information. In addition, your comment should not include any ``trade secret or any commercial or financial information which . . . is privileged or confidential''--as provided by 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)--including in particular competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names. Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled ``Confidential,'' and must comply with FTC Rule 4.9(c). 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). Your comment will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your comment has been posted on the public FTC Web site--as legally required by FTC Rule 4.9(b)--we cannot redact or remove your comment from the FTC Web site, unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule 4.9(c), and the General Counsel grants that request. Visit the FTC 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 30, 2017. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy. 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 from Moonlight Slumber, LLC (``respondent''). 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 (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make final the agreement's proposed order. This matter involves the deceptive environmental and health claims respondent made regarding its baby mattresses. According to the FTC complaint, respondent made unsubstantiated representations that its mattresses are organic, natural, or plant-based and that its mattresses will not emit any substance, including volatile organic compounds, or off gas; claimed that testing proved that its mattresses do not emit volatile organic compounds; and represented that its mattresses have been certified by Green Safety Shield, yet failed to disclose that it has a material connection to the Green Safety Shield seal. Consumers likely interpret such seals as a claim that an independent third party certified the product. The complaint alleges that all of these claims are deceptive in violation of Section 5(a) of the FTC Act. The proposed consent order contains five provisions designed to prevent respondent from engaging in similar acts and practices in the future. Part I prohibits misleading representations regarding whether any mattress, blanket, pillow, pad, foam-containing product, or sleep- related product is organic, natural, or plant-based; regarding the emissions from such product; and regarding the general environmental and health benefits of such product. The order requires respondent to possess competent and reliable evidence, including scientific evidence when appropriate, to substantiate these representations. Part II prohibits misleading representations regarding emissions- free and VOC-free claims. The order requires competent and reliable scientific evidence to substantiate that a product does not emit more than a trace level of emissions of the substance about which the claim is made. The order defines ``emission'' to include all emissions (not just VOCs that cause smog). This definition reflects the Commission's Enforcement Policy Statement and consumer expectations: Consumers are likely concerned about the potential health effects from exposure to chemical emissions found in indoor air, not just [[Page 46245]] VOCs that affect outdoor air quality. Consistent with the Green Guides, the order defines ``trace level of emissions'' for claims for a substance to mean that (1) emissions of the substance do not result in inhalation concentrations of that substance higher than background levels in the typical residential home; (2) emissions of the substance do not cause material harm that consumers typically associate with that substance, including harm to the environment or human health; and (3) the substance has not been added intentionally to the covered product. Part III prohibits respondent from mispresenting the results of any tests or studies, or from misrepresenting that any product benefit is scientifically or clinically proven. Parts IV and V prohibit respondent from misrepresenting certifications or failing to adequately disclose a material connection to a party making a representation, e.g., an endorser. Parts VI through X are reporting and compliance provisions. Part VI mandates that respondent acknowledge receipt of the order, distribute the order to certain employees and agents, and secure acknowledgments from recipients of the order. Part VII requires that respondent submit compliance reports to the FTC within ninety (90) days of the order's issuance and submit additional reports when certain events occur. Part VIII requires that respondent create and retain certain records for five (5) years. Part IX provides for the FTC's continued compliance monitoring of respondent's activity during the order's effective dates. Part X is a provision ``sunsetting'' the order after twenty (20) years, with certain exceptions. The purpose of the analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the proposed order or to modify its terms in any way. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. 2017-21289 Filed 10-3-17; 8:45 am] BILLING CODE 6750-01-P
![Federal Register / Vol. 82, No. 191 / Wednesday, October 4, 2017 / Notices 46243
The Relevant Geographic Market development, manufacture, or sale of interpretation of the proposed Order or
The relevant geographic market for the relevant products. The provisions of to modify its terms in any way.
point-of-care blood gas testing systems the Consent Agreement ensure that By direction of the Commission.
and point-of-care cardiac marker testing Siemens and Quidel become Donald S. Clark,
systems is the United States. These independent, viable, and effective
Secretary.
products are medical devices regulated competitors in the respective markets in
[FR Doc. 2017–21290 Filed 10–3–17; 8:45 am]
by the U.S. Food and Drug order to maintain the competition that
currently exists. BILLING CODE 6750–01–P
Administration (‘‘FDA’’). Medical
devices sold outside of the United Siemens is a global conglomerate with
States, but not approved for sale in the a healthcare division that is one of the
FEDERAL TRADE COMMISSION
United States, do not provide viable world’s largest suppliers of technology
competitive alternatives for U.S. to the healthcare industry and a leader [File No. 162 3128]
consumers. in medical imaging and laboratory
diagnostics. Siemens currently supplies Moonlight Slumber, LLC; Analysis To
Competitive Effects of the Acquisition a benchtop blood gas testing system, Aid Public Comment
The proposed Acquisition would and Alere’s handheld system will be AGENCY: Federal Trade Commission.
likely result in significant competitive highly complementary to Siemens’
ACTION: Proposed consent agreement.
harm to consumers in the markets for portfolio in the United States. Siemens
point-of-care blood gas testing systems has the expertise, U.S. sales SUMMARY: The consent agreement in this
and point-of-care cardiac marker testing infrastructure, and resources to restore matter settles alleged violations of
systems. In each relevant market, the competition that otherwise would federal law prohibiting unfair or
customers are able to leverage Abbott have been lost pursuant to the proposed deceptive acts or practices. The attached
and Alere against each other to obtain Acquisition. Analysis to Aid Public Comment
better prices and improved products. By Based in San Diego, California, Quidel describes both the allegations in the
eliminating this direct and substantial develops, manufactures, and markets complaint and the terms of the consent
head-to-head competition, the proposed point-of-care diagnostic testing order—embodied in the consent
Acquisition likely would allow the solutions globally. The company has agreement—that would settle these
combined firm to exercise market power expertise with immunoassay testing and allegations.
unilaterally, resulting in higher prices, currently focuses on infectious diseases,
reduced innovation, and less choice for women’s and general health, and DATES: Comments must be received on
consumers. gastrointestinal diseases. The or before October 30, 2017.
acquisition of Alere’s point-of-care ADDRESSES: Interested parties may file a
Entry Conditions
cardiac marker testing business will comment online or on paper, by
Entry in the relevant markets would complement Quidel’s portfolio of rapid following the instructions in the
not be timely, likely, or sufficient in diagnostic testing solutions. Moreover, Request for Comment part of the
magnitude, character, and scope to deter Quidel’s chairman was co-inventor of SUPPLEMENTARY INFORMATION section
or counteract the anticompetitive effects Alere’s point-of-care cardiac marker below. Write: ‘‘In the Matter of
of the proposed Acquisition. New entry Moonlight Slumber, LLC, File No.
testing system, providing Quidel with
would require significant investment of 1623128’’ on your comment, and file
additional understanding and
time and money for product research your comment online at https://
background of the divestiture business.
and development, regulatory approval ftcpublic.commentworks.com/ftc/
The parties must accomplish the
by the FDA, and establishment of a U.S. moonlightslumberconsent by following
divestitures no later than thirty days
sales and service infrastructure. Such the instructions on the web-based form.
development efforts are difficult, time- after the consummation of the Proposed
Acquisition. If the Commission If you prefer to file your comment on
consuming, and expensive, and often paper, write ‘‘In the Matter of Moonlight
fail to result in a competitive product determines that either Siemens or
Quidel is not an acceptable acquirer, or Slumber, LLC, File No. 1623128’’ on
reaching the market. your comment and on the envelope, and
that the manner of the divestitures is not
The Consent Agreement acceptable, the proposed Order requires mail your comment to the following
the parties to unwind the sale of rights address: Federal Trade Commission,
The Consent Agreement eliminates
to Siemens and/or Quidel and then Office of the Secretary, 600
the competitive concerns raised by the
divest the products to a Commission- Pennsylvania Avenue NW., Suite CC–
proposed Acquisition by requiring Alere
approved acquirer(s) within six months 5610 (Annex D), Washington, DC 20580,
to divest: (1) Its point-of-care blood gas
of the date the Order becomes final. or deliver your comment to the
testing business, including its Ottawa,
The Commission has agreed to following address: Federal Trade
Canada facilities, to Siemens; and (2) its
appoint a Monitor to ensure that Abbott Commission, Office of the Secretary,
point-of-care cardiac marker testing
business, including its San Diego, and Alere comply with all of their Constitution Center, 400 7th Street SW.,
California facility, to Quidel. Alere must obligations pursuant to the Consent 5th Floor, Suite 5610 (Annex D),
divest all assets and rights to research, Agreement and to keep the Commission Washington, DC 20024.
develop, manufacture, market, and sell informed about the status of the transfer FOR FURTHER INFORMATION CONTACT:
its point-of-care blood gas testing and of the rights and assets to Siemens and Amanda Kostner (202–326–2880) and
point-of-care cardiac marker testing Quidel. The proposed Order further Jock Chung (202–326–2984), Bureau of
sradovich on DSK3GMQ082PROD with NOTICES
product lines, including all related allows the Commission to appoint a Consumer Protection, 600 Pennsylvania
intellectual property and other trustee in the event the parties fail to Avenue NW., Washington, DC 20580.
confidential business information. divest the products as required. SUPPLEMENTARY INFORMATION: Pursuant
Further, Siemens and Quidel intend to The purpose of this analysis is to to Section 6(f) of the Federal Trade
hire substantially all of Alere’s facilitate public comment on the Commission Act, 15 U.S.C. 46(f), and
employees whose responsibilities Consent Agreement, and it is not FTC Rule 2.34, 16 CFR 2.34, notice is
primarily relate to the research, intended to constitute an official hereby given that the above-captioned
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![Federal Register / Vol. 82, No. 191 / Wednesday, October 4, 2017 / Notices 46245
VOCs that affect outdoor air quality. DEPARTMENT OF HEALTH AND 2. Email your request, including your
Consistent with the Green Guides, the HUMAN SERVICES address, phone number, OMB number,
order defines ‘‘trace level of emissions’’ and CMS document identifier, to
for claims for a substance to mean that Centers for Medicare & Medicaid Paperwork@cms.hhs.gov.
(1) emissions of the substance do not Services 3. Call the Reports Clearance Office at
result in inhalation concentrations of [Document Identifiers: CMS–10110]
(410) 786–1326.
that substance higher than background FOR FURTHER INFORMATION CONTACT:
levels in the typical residential home; Agency Information Collection William Parham at (410) 786–4669.
(2) emissions of the substance do not Activities: Submission for OMB SUPPLEMENTARY INFORMATION: Under the
cause material harm that consumers Review; Comment Request Paperwork Reduction Act of 1995 (PRA)
typically associate with that substance, (44 U.S.C. 3501–3520), federal agencies
AGENCY: Centers for Medicare &
including harm to the environment or must obtain approval from the Office of
Medicaid Services, HHS.
human health; and (3) the substance has Management and Budget (OMB) for each
ACTION: Notice. collection of information they conduct
not been added intentionally to the
SUMMARY: The Centers for Medicare & or sponsor. The term ‘‘collection of
covered product.
Medicaid Services (CMS) is announcing information’’ is defined in 44 U.S.C.
Part III prohibits respondent from an opportunity for the public to 3502(3) and 5 CFR 1320.3(c) and
mispresenting the results of any tests or comment on CMS’ intention to collect includes agency requests or
studies, or from misrepresenting that information from the public. Under the requirements that members of the public
any product benefit is scientifically or Paperwork Reduction Act of 1995 submit reports, keep records, or provide
clinically proven. Parts IV and V (PRA), federal agencies are required to information to a third party. Section
prohibit respondent from publish notice in the Federal Register 3506(c)(2)(A) of the PRA (44 U.S.C.
misrepresenting certifications or failing concerning each proposed collection of 3506(c)(2)(A)) requires federal agencies
to adequately disclose a material information, including each proposed to publish a 30-day notice in the
connection to a party making a extension or reinstatement of an existing Federal Register concerning each
representation, e.g., an endorser. collection of information, and to allow proposed collection of information,
a second opportunity for public including each proposed extension or
Parts VI through X are reporting and reinstatement of an existing collection
compliance provisions. Part VI comment on the notice. Interested
persons are invited to send comments of information, before submitting the
mandates that respondent acknowledge collection to OMB for approval. To
regarding the burden estimate or any
receipt of the order, distribute the order comply with this requirement, CMS is
other aspect of this collection of
to certain employees and agents, and information, including the necessity and publishing this notice that summarizes
secure acknowledgments from utility of the proposed information the following proposed collection(s) of
recipients of the order. Part VII requires collection for the proper performance of information for public comment:
that respondent submit compliance the agency’s functions, the accuracy of 1. Type of Information Collection
reports to the FTC within ninety (90) the estimated burden, ways to enhance Request: Revision of a currently
days of the order’s issuance and submit the quality, utility, and clarity of the approved collection; Title of
additional reports when certain events information to be collected; and the use Information Collection: Manufacturer
occur. Part VIII requires that respondent of automated collection techniques or Submission of Average Sales Prices
create and retain certain records for five other forms of information technology to (ASP) Data for Medicare Part B Drugs;
(5) years. Part IX provides for the FTC’s minimize the information collection Use: In accordance with Section 1847A
continued compliance monitoring of burden. of the Social Security Act (the Act),
respondent’s activity during the order’s Medicare Part B covered drugs and
DATES: Comments on the collection(s) of
effective dates. Part X is a provision biologicals not paid on a cost or
information must be received by the prospective payment basis are paid
‘‘sunsetting’’ the order after twenty (20) OMB desk officer by November 3, 2017. based on the average sales price (ASP)
years, with certain exceptions. ADDRESSES: When commenting on the of the drug or biological, beginning in
The purpose of the analysis is to aid proposed information collections, Calendar Year (CY) 2005. The ASP data
public comment on the proposed order. please reference the document identifier reporting requirements are specified in
It is not intended to constitute an or OMB control number. To be assured Section 1927 of the Act. The reported
official interpretation of the proposed consideration, comments and ASP data are used to establish the
order or to modify its terms in any way. recommendations must be received by Medicare payment amounts. Form
the OMB desk officer via one of the Number: CMS–10110 (OMB control
By direction of the Commission. following transmissions: OMB, Office of number: 0938–0921); Frequency:
Donald S. Clark, Information and Regulatory Affairs, Quarterly; Affected Public: Business or
Secretary. Attention: CMS Desk Officer, Fax other For-profits; Number of
[FR Doc. 2017–21289 Filed 10–3–17; 8:45 am] Number: (202) 395–5806 OR Email: Respondents: 180; Total Annual
BILLING CODE 6750–01–P
OIRA_submission@omb.eop.gov. Responses: 720; Total Annual Hours:
To obtain copies of a supporting
9360. (For policy questions regarding
statement and any related forms for the
this collection contact Felicia Eggleston
proposed collection(s) summarized in
at 410–786–9287.)
sradovich on DSK3GMQ082PROD with NOTICES
this notice, you may make your request
using one of following: Dated: September 28, 2017.
1. Access CMS’ Web site address at William N. Parham, III,
Web site address at https:// Director, Paperwork Reduction Staff, Office
www.cms.gov/Regulations-and- of Strategic Operations and Regulatory
Guidance/Legislation/ Affairs.
PaperworkReductionActof1995/PRA- [FR Doc. 2017–21249 Filed 10–3–17; 8:45 am]
Listing.html. BILLING CODE 4120–01–P
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Document Created: 2018-10-25 09:55:53
Document Modified: 2018-10-25 09:55:53
| 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 October 30, 2017. | |
| Contact | Amanda Kostner (202-326-2880) and Jock Chung (202-326-2984), Bureau of Consumer Protection, 600 Pennsylvania Avenue NW., Washington, DC 20580. | |
| FR Citation | 82 FR 46243 |
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