Federal Register / Vol. 82, No. 191 / Wednesday, October 4, 2017 / Notices 46243 

The Relevant Geographic Market 

The relevant geographic market for 

point-of-care blood gas testing systems 

and point-of-care cardiac marker testing 

systems is the United States. These 

products are medical devices regulated 

by the U.S. Food and Drug 

Administration (‘‘FDA’’). Medical 

devices sold outside of the United 

States, but not approved for sale in the 

United States, do not provide viable 

competitive alternatives for U.S. 

consumers. 

Competitive Effects of the Acquisition 

The proposed Acquisition would 

likely result in significant competitive 

harm to consumers in the markets for 

point-of-care blood gas testing systems 

and point-of-care cardiac marker testing 

systems. In each relevant market, 

customers are able to leverage Abbott 

and Alere against each other to obtain 

better prices and improved products. By 

eliminating this direct and substantial 

head-to-head competition, the proposed 

Acquisition likely would allow the 

combined firm to exercise market power 

unilaterally, resulting in higher prices, 

reduced innovation, and less choice for 

consumers. 

Entry Conditions 

Entry in the relevant markets would 

not be timely, likely, or sufficient in 

magnitude, character, and scope to deter 

or counteract the anticompetitive effects 

of the proposed Acquisition. New entry 

would require significant investment of 

time and money for product research 

and development, regulatory approval 

by the FDA, and establishment of a U.S. 

sales and service infrastructure. Such 

development efforts are difficult, timeconsuming, and expensive, and often 

fail to result in a competitive product 

reaching the market. 

The Consent Agreement 

The Consent Agreement eliminates 

the competitive concerns raised by the 

proposed Acquisition by requiring Alere 

to divest: (1) Its point-of-care blood gas 

testing business, including its Ottawa, 

Canada facilities, to Siemens; and (2) its 

point-of-care cardiac marker testing 

business, including its San Diego, 

California facility, to Quidel. Alere must 

divest all assets and rights to research, 

develop, manufacture, market, and sell 

its point-of-care blood gas testing and 

point-of-care cardiac marker testing 

product lines, including all related 

intellectual property and other 

confidential business information. 

Further, Siemens and Quidel intend to 

hire substantially all of Alere’s 

employees whose responsibilities 

primarily relate to the research, 

development, manufacture, or sale of 

the relevant products. The provisions of 

the Consent Agreement ensure that 

Siemens and Quidel become 

independent, viable, and effective 

competitors in the respective markets in 

order to maintain the competition that 

currently exists. 

Siemens is a global conglomerate with 

a healthcare division that is one of the 

world’s largest suppliers of technology 

to the healthcare industry and a leader 

in medical imaging and laboratory 

diagnostics. Siemens currently supplies 

a benchtop blood gas testing system, 

and Alere’s handheld system will be 

highly complementary to Siemens’ 

portfolio in the United States. Siemens 

has the expertise, U.S. sales 

infrastructure, and resources to restore 

the competition that otherwise would 

have been lost pursuant to the proposed 

Acquisition. 

Based in San Diego, California, Quidel 

develops, manufactures, and markets 

point-of-care diagnostic testing 

solutions globally. The company has 

expertise with immunoassay testing and 

currently focuses on infectious diseases, 

women’s and general health, and 

gastrointestinal diseases. The 

acquisition of Alere’s point-of-care 

cardiac marker testing business will 

complement Quidel’s portfolio of rapid 

diagnostic testing solutions. Moreover, 

Quidel’s chairman was co-inventor of 

Alere’s point-of-care cardiac marker 

testing system, providing Quidel with 

additional understanding and 

background of the divestiture business. 

The parties must accomplish the 

divestitures no later than thirty days 

after the consummation of the Proposed 

Acquisition. If the Commission 

determines that either Siemens or 

Quidel is not an acceptable acquirer, or 

that the manner of the divestitures is not 

acceptable, the proposed Order requires 

the parties to unwind the sale of rights 

to Siemens and/or Quidel and then 

divest the products to a Commissionapproved acquirer(s) within six months 

of the date the Order becomes final. 

The Commission has agreed to 

appoint a Monitor to ensure that Abbott 

and Alere comply with all of their 

obligations pursuant to the Consent 

Agreement and to keep the Commission 

informed about the status of the transfer 

of the rights and assets to Siemens and 

Quidel. The proposed Order further 

allows the Commission to appoint a 

trustee in the event the parties fail to 

divest the products as required. 

The purpose of this analysis is to 

facilitate public comment on the 

Consent Agreement, and 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. 2017–21290 Filed 10–3–17; 8:45 am] 

BILLING CODE 6750–01–P 

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 


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46244 Federal Register / Vol. 82, No. 191 / Wednesday, October 4, 2017 / Notices 

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/commissionactions. 

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 plantbased 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 


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Federal Register / Vol. 82, No. 191 / Wednesday, October 4, 2017 / Notices 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10110] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: 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 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by November 3, 2017. 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–5806 OR Email: 

OIRA_submission@omb.eop.gov. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

Web site address at https://

www.cms.gov/Regulations-andGuidance/Legislation/

PaperworkReductionActof1995/PRAListing.html. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Manufacturer 

Submission of Average Sales Prices 

(ASP) Data for Medicare Part B Drugs; 

Use: In accordance with Section 1847A 

of the Social Security Act (the Act), 

Medicare Part B covered drugs and 

biologicals not paid on a cost or 

prospective payment basis are paid 

based on the average sales price (ASP) 

of the drug or biological, beginning in 

Calendar Year (CY) 2005. The ASP data 

reporting requirements are specified in 

Section 1927 of the Act. The reported 

ASP data are used to establish the 

Medicare payment amounts. Form 

Number: CMS–10110 (OMB control 

number: 0938–0921); Frequency: 

Quarterly; Affected Public: Business or 

other For-profits; Number of 

Respondents: 180; Total Annual 

Responses: 720; Total Annual Hours: 

9360. (For policy questions regarding 

this collection contact Felicia Eggleston 

at 410–786–9287.) 

Dated: September 28, 2017. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2017–21249 Filed 10–3–17; 8:45 am] 

BILLING CODE 4120–01–P 


sradovich on DSK3GMQ082PROD with NOTICES