80 FR 60902 - Wright Medical Group, Inc. and Tornier N.V.; Analysis To Aid Public Comment
FEDERAL TRADE COMMISSION Federal Register Volume 80, Issue 195 (October 8, 2015)
Federal Register Volume 80, Issue 195 (October 8, 2015)
| Page Range | 60902-60905 | |
| FR Document | 2015-25604 |
[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)] [Notices] [Pages 60902-60905] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25604] ======================================================================= ----------------------------------------------------------------------- FEDERAL TRADE COMMISSION [File No. 151 0018] Wright Medical Group, Inc. and Tornier N.V.; 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 methods of competition. 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 October 30, 2015. ADDRESSES: Interested parties may file a comment at https://ftcpublic.commentworks.com/ftc/wrighttornierconsent online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write ``Wright Medical Group, Inc. and Tornier N.V.--Consent Agreement; File No. 151 0018'' on your comment and file your comment online at https://ftcpublic.commentworks.com/ftc/wrighttornierconsent by following the instructions on the web-based form. If you prefer to file your comment on paper, write ``Wright Medical Group, Inc. and Tornier N.V.--Consent Agreement; File No. 151 0018'' 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: Aylin M. Skroejer (202-326-2459), Bureau of Competition, 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 [[Page 60903]] 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 30, 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 30, 2015. Write ``Wright Medical Group, Inc. and Tornier N.V.--Consent Agreement; File No. 151 0018'' 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/wrighttornierconsent 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 ``Wright Medical Group, Inc. and Tornier N.V.--Consent Agreement; File No. 151 0018'' 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 30, 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 Agreement Containing Consent Order To Aid Public Comment Introduction The Federal Trade Commission (``Commission'') has accepted, subject to final approval, an Agreement Containing Consent Order (``Consent Agreement'') from Wright Medical Group, Inc. (``Wright'') and Tornier N.V. (``Tornier'') designed to remedy the anticompetitive effects resulting from the proposed merger of Wright and Tornier. Under the terms of the proposed Decision and Order (``Order'') contained in the Consent Agreement, the parties are required to divest to Integra Lifesciences Corporation (``Integra'') all of Tornier's rights and assets related to the following reconstructive joint markets: (1) Total ankle replacements; (2) total silastic big toe joint replacements; and (3) total silastic toe joint replacements for the second through fifth ``lesser'' toes. The proposed Consent Agreement has been placed on the public record for thirty 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 Consent Agreement and the comments received, and decide whether it should withdraw from the Consent Agreement, modify it, or make it final. Pursuant to an Agreement and Plan of Merger dated October 27, 2014, Wright and Tornier propose to merge in an all-stock transaction valued at approximately $3.3 billion (the ``Proposed Merger''). The Commission's Complaint alleges that the Proposed Merger, if consummated, would violate Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. 45, by substantially lessening competition in the U.S. markets for total ankle replacements and total silastic toe joint replacements. The proposed Consent Agreement will remedy the alleged violations by preserving the competition that otherwise would be lost in these markets as a result of the Proposed Merger. The Parties Headquartered in Memphis, Tennessee, Wright is a global orthopedic company that divides its business into three categories: foot and ankle hardware; upper extremity reconstructive devices; and biologics products. Tornier is a global medical device company based in Amsterdam, the Netherlands, with U.S. operations headquartered in Bloomington, Minnesota. Tornier's U.S. products include those for the upper extremity joints; lower extremity joints; sports medicine; and biologics. The Relevant Products and Structure of the Markets I. Total Ankle Replacements Total ankle replacements are used to treat end-stage ankle arthritis, which develops when cartilage on the bones of the ankle joint wears away and causes bone-on-bone grinding down of the joint [[Page 60904]] surface. Patients with end-stage ankle arthritis experience pain and swelling at the ankle along with difficulty walking. Total ankle replacements reduce the pain while maintaining the motion at the ankle joint. They replace damaged bone and cartilage with a metal tibial tray, a metal talar dome, and a polyethylene bearing. In a fixed bearing total ankle replacement, the polyethylene bearing is locked to the tibial component, while in a mobile bearing system it moves independently. Physicians and their patients would not switch to an alternative product or therapy in response to a small but significant increase in the price of total ankle replacements. Wright, Tornier, and Stryker Corporation (``Stryker'') are the only significant suppliers in the U.S. market for total ankle replacements, accounting for 44%, 19%, and 31% of 2014 sales, respectively. Wright and Tornier are each other's closest competitor. These companies both offer fixed bearing technologies and the only options for revision surgeries, i.e., surgeries to redo a prior total ankle replacement procedure. The other leading supplier, Stryker, supplies the only mobile bearing system in the United States, making it a more distant competitor to Wright and Tornier. The only other U.S. supplier of total ankle replacements, Zimmer Holdings, Inc. (``Zimmer'') offers a technology that typically is used only in specialized cases. Zimmer maintains a fringe position in the market. II. Total Silastic Toe Joint Replacements Total big toe joint replacements treat severe cases of hallux rigidus, an arthritic condition in the first metatarsophalangeal (``MTP'') joint of the big toe. Pain and inflammation at the first MTP joint restricts movement of the big toe and leads to difficulty walking. Total big toe joint replacements relieve pain and preserve motion in the big toe. There are two types of total big toe joint replacements: Metal and silastic. Total silastic big toe joint replacements are a distinct antitrust market. Surgeons that favor total silastic big toe joint replacements over metal implants do so for the silastic implants' flexibility and longevity. The silastic implants are also significantly less expensive than total metal big toe joint replacements. Physicians and patients do not view total silastic and total metal big toe joint replacements as reasonably interchangeable. A small but significant increase in the price of total silastic big toe joint replacements would not cause physicians or patients to switch to other products or therapies. The U.S. market for total silastic big toe joint replacements is highly concentrated. Wright and Tornier are the only significant suppliers of the product, accounting for approximately 60% and 38% of the market, respectively. The next closest competitor to Wright and Tornier--Sgarlato Med LLC--accounts for a nominal share of the market. Although more rare than in the big toes, severe arthritis also occurs in the MTP joints of the lesser toes. Physicians and patients who use total silastic lesser toe joint replacements would not switch to any other product or procedure in response to a small but significant increase in the price of the total silastic toe joint implants. Wright, Tornier, and OsteoMed supply total silastic lesser toe joint replacements in the United States, and Wright and Tornier are each other's closest competitor. The Proposed Merger would result in a combined market share of approximately 76%. The relevant geographic market for total ankle replacements and total silastic toe joint replacements 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. 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 Merger. To enter or effectively expand in any of the relevant markets successfully, a supplier would need to design and manufacture an effective product, obtain FDA approval, and develop clinical history supporting the long- term efficacy of its product. The new entrant or expanding firm would also need to develop and foster product loyalty and establish a nationwide sales network capable of marketing the product and providing on-site service at hospitals nationwide. Establishing a track record for quality, service, and consistency is difficult, expensive, and typically spans several years. Competitive Effects of the Merger The Proposed Merger would likely result in significant competitive harm to consumers in the markets for total ankle replacements and total silastic toe joint replacements. As particularly close substitutes in each relevant market, Wright and Tornier respond directly to competition from each other with improved products, better service, and lower prices. By eliminating this direct and substantial head-to-head competition, the Proposed Merger likely would allow the combined firm to exercise market power unilaterally, resulting in less innovation and higher prices for consumers. The Consent Agreement The Consent Agreement eliminates the competitive concerns raised by the Proposed Merger by requiring the parties to divest to Integra all of the rights and assets needed for it to become an independent, viable, and effective competitor in the U.S. markets for total ankle replacements and total silastic toe joint replacements. The divestitures will maintain the competition that currently exists in each of the relevant markets. Integra is well positioned to restore the competition that otherwise would be lost through the Proposed Merger. Headquartered in Plainsboro, New Jersey, Integra is a global medical device company that has experience manufacturing, marketing, and distributing orthopedic devices in the United States, and a track record for quality, service, and consistency. Integra's lower extremity product portfolio is also highly complementary to Tornier's total ankle replacements and total silastic toe joint replacements. The Order requires Tornier to divest all U.S. assets and rights related to the relevant products, including intellectual property, manufacturing technology, and existing inventory. In order to ensure continuity of supply, the Order requires that the parties supply Integra with total ankle replacements for up to three years and total silastic toe joint replacements for up to one year while Integra transitions to independent manufacturing and works to obtain FDA approval. To ensure that the divestitures are successful, the Order requires the parties to enter into a transitional services agreement with Integra to assist the company in establishing its manufacturing capabilities and securing all necessary FDA approvals. Further, the Order requires that the parties transfer all confidential business information to Integra, as well as provide access to employees who possess or are able to identify such information. Integra also will have the right to interview and offer employment to employees associated with the relevant products. The parties must accomplish these divestitures and relinquish their rights to Integra no later than ten days after the [[Page 60905]] Proposed Merger is consummated. If the Commission determines that Integra 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 Integra and then divest the products to a Commission-approved acquirer within six months of the date the Order becomes final. The proposed Order further allows the Commission to appoint a trustee in the event the parties fail to divest the products as required. The Order also requires the parties to appoint Quantic Regulatory Services, LLC as interim monitor to ensure the parties comply with the obligations pursuant to the Consent Agreement and to keep the Commission informed about the status of the transfer of the assets and rights to Integra. 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. 2015-25604 Filed 10-7-15; 8:45 am] BILLING CODE 6750-01-P
![60902 Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices
be filed pursuant to section procedures to assess the diversity Board of Governors of the Federal Reserve
241.3(b)(3)(i) is covered in specific policies and practices in all business System, October 5, 2015.
memoranda relating to those forms. and activities of the agency at all levels, Robert deV. Frierson,
With respect to the ‘‘Registration of a including procurement, insurance, and Secretary of the Board.
Securities Holding Company’’ form all types of contracts. (12 U.S.C. [FR Doc. 2015–25664 Filed 10–7–15; 8:45 am]
required pursuant to section 241.3(a)(1), 5452(c)(1)). ‘‘Such procedure shall BILLING CODE 6210–01–P
the information submitted on and with include a written statement, in a form
the form is normally public. However, a and with such content as the Director
company may seek confidential [of OMWI] shall prescribe . . . that a FEDERAL TRADE COMMISSION
treatment for any such information that contractor shall ensure . . . the fair
it believes is exempt from disclosure inclusion of women and minorities in [File No. 151 0018]
under FOIA (5 U.S.C. 552(b)(1)–(9)). A the workforce of the contractor and, as
Wright Medical Group, Inc. and Tornier
determination of confidentiality would applicable, subcontractors.’’ (12 U.S.C.
N.V.; Analysis To Aid Public Comment
be made on a case-by-case basis. 5452(c)(2)).
Abstract: On June 4, 2012, the Federal Proposals from vendors that are not AGENCY: Federal Trade Commission.
Reserve published a final rulemaking for accepted and incorporated into ACTION: Proposed consent agreement.
Securities Holding Companies contracts with the Federal Reserve
(Regulation OO) in the Federal Register would be protected from Freedom of SUMMARY: The consent agreement in this
(77 FR 32881). Regulation OO Information (FOIA) disclosure by 41 matter settles alleged violations of
implements section 618 of the Dodd- U.S.C. 4702, which expressly prohibits federal law prohibiting unfair methods
Frank Act, which permits nonbank FOIA disclosure of these proposals. of competition. The attached Analysis to
companies that own at least one Moreover, during the solicitation Aid Public Comment describes both the
registered securities broker or dealer, process vendors are permitted to mark allegations in the draft complaint and
and that are required by a foreign information contained in their proposals the terms of the consent order—
regulator or provision of foreign law to that is proprietary or confidential with embodied in the consent agreement—
be subject to comprehensive the label RESTRICTED DATA. For that would settle these allegations.
consolidated supervision, to register information so marked, the Federal DATES: Comments must be received on
with the Board and subject themselves Reserve also may determine on a case- or before October 30, 2015.
to supervision by the Board. by-case basis whether FOIA exemption ADDRESSES: Interested parties may file a
Current Actions: On July 23, 2015, the 4, which applies to ‘‘trade secrets and comment at https://ftcpublic.comment
Federal Reserve published a notice in commercial or financial information,’’ works.com/ftc/wrighttornierconsent
the Federal Register (80 FR 43777) would protect information from online or on paper, by following the
requesting public comment on the disclosure pursuant to a FOIA request (5 instructions in the Request for Comment
proposed extension, without revision, of U.S.C. 552(b)(4)). part of the SUPPLEMENTARY INFORMATION
the FR 2082. The comment period for Abstract: The Federal Reserve uses section below. Write ‘‘Wright Medical
the notice expired on September 21, the RFP and the RFPQ as appropriate to Group, Inc. and Tornier N.V.—Consent
2015. The Federal Reserve did not obtain competitive proposals and Agreement; File No. 151 0018’’ on your
receive any comments on the proposal, contracts from approved vendors of comment and file your comment online
and the FR 2082 will be extended goods and services. This information at https://ftcpublic.commentworks.com/
without revision as proposed. collection is required to collect data on ftc/wrighttornierconsent by following
Final approval under OMB delegated prices, specifications of goods and the instructions on the web-based form.
authority of the extension, with services, and qualifications of If you prefer to file your comment on
revision, of the following report: prospective vendors. paper, write ‘‘Wright Medical Group,
Report title: Request for Proposal and Inc. and Tornier N.V.—Consent
Current Actions: On July 23, 2015, the
Request for Price Quotations. Agreement; File No. 151 0018’’ on your
Federal Reserve published a notice in
Agency form number: RFP and RFPQ. comment and on the envelope, and mail
OMB control number: 7100–0180. the Federal Register (80 FR 43777)
requesting public comment on the your comment to the following address:
Frequency: On occasion.
proposed extension, with revision, of Federal Trade Commission, Office of the
Reporters: Vendors of goods and
the RFP and RFPQ. In connection with Secretary, 600 Pennsylvania Avenue
services.
Estimated annual reporting hours: the RFP and RFPQ process, the Federal NW., Suite CC–5610 (Annex D),
RFP: 17,500 hours; RFPQ: 4,400 hours; Reserve proposed to require prime Washington, DC 20580, or deliver your
Subcontractor report: 50 hours. contractors to submit a Subcontracting comment to the following address:
Estimated average hours per response: Report that would collect information Federal Trade Commission, Office of the
RFP: 50 hours; RFPQ: 2 hours; about their subcontractors’ Secretary, Constitution Center, 400 7th
Subcontractor report: 20 minutes. commitments toward diversity and Street SW., 5th Floor, Suite 5610
Number of respondents: RFP: 350; inclusion of minority-owned and (Annex D), Washington, DC 20024.
RFPQ: 2,200; Subcontractor report: 150. women-owned vendors in the FOR FURTHER INFORMATION CONTACT:
General description of report: The subcontractor’s activities. The comment Aylin M. Skroejer (202–326–2459),
RFP and RFPQ are required to obtain a period for the notice expired on Bureau of Competition, 600
benefit and are authorized by Sections September 21, 2015. The Federal Pennsylvania Avenue NW., Washington,
DC 20580.
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10(3), 10(4), and 11(1) of the Federal Reserve received one comment, which
Reserve Act (12 U.S.C. 243, 244, and stated that contracting programs should SUPPLEMENTARY INFORMATION: Pursuant
248(l)). With regard to the be open to all and that no one should to Section 6(f) of the Federal Trade
Subcontracting Report, Section 342(c) of be discriminated against nor granted Commission Act, 15 U.S.C. 46(f), and
the Dodd-Frank Wall Street Reform and preferential treatment because of skin FTC Rule 2.34, 16 CFR 2.34, notice is
Consumer Protection Act (Dodd-Frank color, national origin, or sex. The RFP hereby given that the above-captioned
Act) requires the Federal Reserve to and RFPQ will be extended with consent agreement containing consent
develop and implement standards and revision as proposed. order to cease and desist, having been
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filed with and accepted, subject to final confidential only if the FTC General contained in the Consent Agreement,
approval, by the Commission, has been Counsel, in his or her sole discretion, the parties are required to divest to
placed on the public record for a period grants your request in accordance with Integra Lifesciences Corporation
of thirty (30) days. The following the law and the public interest. (‘‘Integra’’) all of Tornier’s rights and
Analysis to Aid Public Comment Postal mail addressed to the assets related to the following
describes the terms of the consent Commission is subject to delay due to reconstructive joint markets: (1) Total
agreement, and the allegations in the heightened security screening. As a ankle replacements; (2) total silastic big
complaint. An electronic copy of the result, we encourage you to submit your toe joint replacements; and (3) total
full text of the consent agreement comments online. To make sure that the silastic toe joint replacements for the
package can be obtained from the FTC Commission considers your online second through fifth ‘‘lesser’’ toes.
Home Page (for September 30, 2015), on comment, you must file it at https:// The proposed Consent Agreement has
the World Wide Web, at http:// ftcpublic.commentworks.com/ftc/wright been placed on the public record for
www.ftc.gov/os/actions.shtm. tornierconsent by following the thirty days for receipt of comments by
You can file a comment online or on instructions on the web-based form. If interested persons. Comments received
paper. For the Commission to consider this Notice appears at http://www. during this period will become part of
your comment, we must receive it on or regulations.gov/#!home, you also may the public record. After thirty days, the
before October 30, 2015. Write ‘‘Wright file a comment through that Web site. Commission will again review the
Medical Group, Inc. and Tornier N.V.— If you file your comment on paper, Consent Agreement and the comments
Consent Agreement; File No. 151 0018’’ write ‘‘Wright Medical Group, Inc. and received, and decide whether it should
on your comment. Your comment— Tornier N.V.—Consent Agreement; File withdraw from the Consent Agreement,
including your name and your state— No. 151 0018’’ on your comment and on modify it, or make it final.
will be placed on the public record of the envelope, and mail your comment to Pursuant to an Agreement and Plan of
this proceeding, including, to the extent the following address: Federal Trade Merger dated October 27, 2014, Wright
practicable, on the public Commission Commission, Office of the Secretary, and Tornier propose to merge in an all-
Web site, at http://www.ftc.gov/os/ 600 Pennsylvania Avenue NW., Suite stock transaction valued at
publiccomments.shtm. As a matter of CC–5610 (Annex D), Washington, DC approximately $3.3 billion (the
discretion, the Commission tries to 20580, or deliver your comment to the ‘‘Proposed Merger’’). The Commission’s
remove individuals’ home contact following address: Federal Trade Complaint alleges that the Proposed
information from comments before Commission, Office of the Secretary, Merger, if consummated, would violate
placing them on the Commission Web Constitution Center, 400 7th Street SW., Section 7 of the Clayton Act, as
site. 5th Floor, Suite 5610 (Annex D), amended, 15 U.S.C. 18, and Section 5 of
Because your comment will be made Washington, DC 20024. If possible, the Federal Trade Commission Act, as
public, you are solely responsible for submit your paper comment to the amended, 15 U.S.C. 45, by substantially
making sure that your comment does Commission by courier or overnight lessening competition in the U.S.
not include any sensitive personal service. markets for total ankle replacements and
information, like anyone’s Social Visit the Commission Web site at
total silastic toe joint replacements. The
Security number, date of birth, driver’s http://www.ftc.gov to read this Notice
proposed Consent Agreement will
license number or other state and the news release describing it. The
remedy the alleged violations by
identification number or foreign country FTC Act and other laws that the
preserving the competition that
equivalent, passport number, financial Commission administers permit the
otherwise would be lost in these
account number, or credit or debit card collection of public comments to
markets as a result of the Proposed
number. You are also solely responsible consider and use in this proceeding as
Merger.
for making sure that your comment does appropriate. The Commission will
not include any sensitive health consider all timely and responsive The Parties
information, like medical records or public comments that it receives on or Headquartered in Memphis,
other individually identifiable health before October 30, 2015. You can find Tennessee, Wright is a global orthopedic
information. In addition, do not include more information, including routine company that divides its business into
any ‘‘[t]rade secret or any commercial or uses permitted by the Privacy Act, in three categories: foot and ankle
financial information which . . . is the Commission’s privacy policy, at hardware; upper extremity
privileged or confidential,’’ as discussed http://www.ftc.gov/ftc/privacy.htm. reconstructive devices; and biologics
in Section 6(f) of the FTC Act, 15 U.S.C. Analysis of Agreement Containing products.
46(f), and FTC Rule 4.10(a)(2), 16 CFR Consent Order To Aid Public Comment Tornier is a global medical device
4.10(a)(2). In particular, do not include company based in Amsterdam, the
competitively sensitive information Introduction
Netherlands, with U.S. operations
such as costs, sales statistics, The Federal Trade Commission headquartered in Bloomington,
inventories, formulas, patterns, devices, (‘‘Commission’’) has accepted, subject to Minnesota. Tornier’s U.S. products
manufacturing processes, or customer final approval, an Agreement include those for the upper extremity
names. Containing Consent Order (‘‘Consent joints; lower extremity joints; sports
If you want the Commission to give Agreement’’) from Wright Medical medicine; and biologics.
your comment confidential treatment, Group, Inc. (‘‘Wright’’) and Tornier N.V.
you must file it in paper form, with a (‘‘Tornier’’) designed to remedy the The Relevant Products and Structure of
mstockstill on DSK4VPTVN1PROD with NOTICES
request for confidential treatment, and anticompetitive effects resulting from the Markets
you have to follow the procedure the proposed merger of Wright and I. Total Ankle Replacements
explained in FTC Rule 4.9(c), 16 CFR Tornier. Under the terms of the
Total ankle replacements are used to
4.9(c).1 Your comment will be kept proposed Decision and Order (‘‘Order’’)
treat end-stage ankle arthritis, which
1 In particular, the written request for confidential and must identify the specific portions of the
develops when cartilage on the bones of
treatment that accompanies the comment must comment to be withheld from the public record. See the ankle joint wears away and causes
include the factual and legal basis for the request, FTC Rule 4.9(c), 16 CFR 4.9(c). bone-on-bone grinding down of the joint
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Proposed Merger is consummated. If the the population and to develop services use of automated collection techniques
Commission determines that Integra is and allocate resources to improve long- or other forms of information
not an acceptable acquirer, or that the term health and wellbeing. technology; and (e) estimates of capital
manner of the divestitures is not DATES: Written comments must be or start-up costs and costs of operation,
acceptable, the proposed Order requires received on or before December 7, 2015. maintenance, and purchase of services
the parties to unwind the sale of rights ADDRESSES: You may submit comments, to provide information. Burden means
to Integra and then divest the products identified by Docket No. CDC–2016– the total time, effort, or financial
to a Commission-approved acquirer 0088 by any of the following methods: resources expended by persons to
within six months of the date the Order • Federal eRulemaking Portal: generate, maintain, retain, disclose or
becomes final. The proposed Order Regulation.gov. Follow the instructions provide information to or for a Federal
further allows the Commission to for submitting comments. agency. This includes the time needed
appoint a trustee in the event the parties • Mail: Leroy A. Richardson, to review instructions; to develop,
fail to divest the products as required. Information Collection Review Office, acquire, install and utilize technology
The Order also requires the parties to Centers for Disease Control and and systems for the purpose of
appoint Quantic Regulatory Services, Prevention, 1600 Clifton Road, NE., collecting, validating and verifying
LLC as interim monitor to ensure the MS–D74, Atlanta, Georgia 30329. information, processing and
parties comply with the obligations Instructions: All submissions received maintaining information, and disclosing
pursuant to the Consent Agreement and must include the agency name and and providing information; to train
to keep the Commission informed about Docket Number. All relevant comments personnel and to be able to respond to
the status of the transfer of the assets received will be posted without change a collection of information, to search
and rights to Integra. to Regulations.gov, including any data sources, to complete and review
The purpose of this analysis is to personal information provided. For the collection of information; and to
facilitate public comment on the access to the docket to read background transmit or otherwise disclose the
Consent Agreement, and it is not documents or comments received, go to information.
intended to constitute an official Regulations.gov. Proposed Project
interpretation of the proposed Order or FOR FURTHER INFORMATION CONTACT: To
to modify its terms in any way. Congenital Heart Surveillance To
request more information on the Recognize Outcomes, Needs, and Well-
By direction of the Commission. proposed project or to obtain a copy of being (CHSTRONG)—New—National
Donald S. Clark, the information collection plan and Center on Birth Defects and
Secretary. instruments, contact the Information Developmental Disabilities (NCBDDD),
[FR Doc. 2015–25604 Filed 10–7–15; 8:45 am]
Collection Review Office, Centers for Centers for Disease Control and
Disease Control and Prevention, 1600 Prevention (CDC).
BILLING CODE 6750–01–P
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570; Background and Brief Description
Email: omb@cdc.gov. Congenital heart defects (CHDs) are
DEPARTMENT OF HEALTH AND
SUPPLEMENTARY INFORMATION: Under the the most common type of structural
HUMAN SERVICES
Paperwork Reduction Act of 1995 (PRA) birth defects, affecting approximately 1
Centers for Disease Control and (44 U.S.C. 3501–3520), Federal agencies in 110 live-born children. In prior
Prevention must obtain approval from the Office of decades, many CHDs were considered
Management and Budget (OMB) for each fatal during infancy or childhood, but
[60Day–16–15BHD; Docket No. CDC–2016– collection of information they conduct with tremendous advances in pediatric
0088] or sponsor. In addition, the PRA also cardiology and cardiac surgery, at least
Proposed Data Collection Submitted requires Federal agencies to provide a 85% of patients now survive to
for Public Comment and 60-day notice in the Federal Register adulthood and there are approximately
Recommendations concerning each proposed collection of 1.5 million adults with CHD living in
information, including each new the United States. With vast declines in
AGENCY: Centers for Disease Control and proposed collection, each proposed mortality from pediatric heart disease
Prevention (CDC), Department of Health extension of existing collection of over the past 30 years, it is vital to
and Human Services (HHS). information, and each reinstatement of evaluate long term outcomes and quality
ACTION: Notice with comment period. previously approved information of life issues for adults with CHD.
collection before submitting the However, U.S. data on long term
SUMMARY: The Centers for Disease collection to OMB for approval. To outcomes, quality of life issues, and
Control and Prevention (CDC), as part of comply with this requirement, we are comorbidities of adults born with CHD
its continuing efforts to reduce public publishing this notice of a proposed are lacking. U.S. data is needed to
burden and maximize the utility of data collection as described below. provide insight into the public health
government information, invites the Comments are invited on: (a) Whether questions that remain for this
general public and other Federal the proposed collection of information population and to develop services and
agencies to take this opportunity to is necessary for the proper performance allocate resources to improve long-term
comment on proposed and/or of the functions of the agency, including health and wellbeing.
continuing information collections, as whether the information shall have For this one-year project, we will use
mstockstill on DSK4VPTVN1PROD with NOTICES
required by the Paperwork Reduction practical utility; (b) the accuracy of the data from U.S. state birth defect
Act of 1995. This notice invites agency’s estimate of the burden of the surveillance systems to identify a
comment on Congenital Heart proposed collection of information; (c) population-based sample of individuals
Surveillance to Recognize Outcomes, ways to enhance the quality, utility, and 18 to 45 years of age born with CHD. We
Needs and well-being (CHSTRONG). clarity of the information to be will then use state databases and online
CDC seeks to collect data for the collected; (d) ways to minimize the search engines to find current addresses
purpose of providing insight into the burden of the collection of information for those individuals and mail surveys
public health questions that remain for on respondents, including through the to them inquiring about their barriers to
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Document Created: 2015-12-15 08:42:21
Document Modified: 2015-12-15 08:42:21
| 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, 2015. | |
| Contact | Aylin M. Skroejer (202-326-2459), Bureau of Competition, 600 Pennsylvania Avenue NW., Washington, DC 20580. | |
| FR Citation | 80 FR 60902 |
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