82_FR_62008 82 FR 61759 - Becton, Dickinson and Company and C. R. Bard; Analysis To Aid Public Comment

82 FR 61759 - Becton, Dickinson and Company and C. R. Bard; Analysis To Aid Public Comment

FEDERAL TRADE COMMISSION

Federal Register Volume 82, Issue 249 (December 29, 2017)

Page Range61759-61762
FR Document2017-28213

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 complaint and the terms of the consent orders-- embodied in the consent agreement--that would settle these allegations.

Federal Register, Volume 82 Issue 249 (Friday, December 29, 2017)
[Federal Register Volume 82, Number 249 (Friday, December 29, 2017)]
[Notices]
[Pages 61759-61762]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-28213]


=======================================================================
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FEDERAL TRADE COMMISSION

[File No. 171 0140]


Becton, Dickinson and Company and C. R. Bard; 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 complaint and the terms of the consent orders--
embodied in the consent agreement--that would settle these allegations.

DATES: Comments must be received on or before January 23, 2018.

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 
Becton Dickinson and Co./Bard, Inc., File No. 171 0140'' on your 
comment, and file your comment online at https://
ftcpublic.commentworks.com/ftc/

[[Page 61760]]

bectondickinsonconsent by following the instructions on the web-based 
form. If you prefer to file your comment on paper, write ``In the 
Matter of Becton Dickinson and Co./Bard, Inc., File No. 171 0140'' 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: Jared Nagley, Attorney, (212-607-2813) 
and Geralyn Trujillo, Attorney, (212-607-2806), Northeast Region, One 
Bowling Green, Suite 318, New York, New York 10004.

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 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 December 22, 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 January 23, 
2018. Write ``In the Matter of Becton Dickinson and Co./Bard, Inc., 
File No. 171 0140'' 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 website, 
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/bectondickinsonconsent 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 website.
    If you prefer to file your comment on paper, write ``In the Matter 
of Becton Dickinson and Co./Bard, Inc., File No. 171 0140'' 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 
website 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 website--as legally required by FTC Rule 
4.9(b)--we cannot redact or remove your comment from the FTC website, 
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 website 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 January 23, 2018. 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 Agreement Containing Consent Orders To Aid Public Comment

I. Introduction

    The Federal Trade Commission (``Commission'') has accepted, subject 
to final approval, an Agreement Containing Consent Orders (``Consent 
Agreement'') from Becton, Dickinson and Company (``BD'') and C. R. 
Bard, Inc. (``Bard'') (collectively, the ``Respondents'') that is 
designed to remedy the anticompetitive effects that would likely result 
from BD's proposed acquisition of Bard. The proposed Decision and Order 
(``Order'') requires the Respondents to divest all rights and assets 
related to Bard's tunneled home drainage catheter business and BD's 
soft tissue core needle biopsy device business to Merit Medical 
Systems, Inc. (``Merit''). The Order To Maintain Assets requires 
Respondents to maintain the viability and competitiveness of the 
businesses pending divestiture.
    Pursuant to an Agreement and Plan of Merger, dated as of April 23, 
2017, BD and Lambda Corp., a wholly-owned subsidiary of BD, will 
acquire the issued and outstanding shares of Bard by means of a merger 
in exchange for cash and stock valued at approximately $24 billion (the 
``Acquisition''). The Commission's Complaint alleges that the proposed 
Acquisition, 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 tunneled home drainage catheter 
systems and soft tissue core needle biopsy devices. The Consent 
Agreement

[[Page 61761]]

is designed to remedy the alleged violations by preserving the 
competition that otherwise would be lost in these markets as a result 
of the proposed Acquisition.
    The Commission has placed the Consent Agreement on the public 
record for 30 days to solicit comments from interested persons. 
Comments received during this period will become part of the public 
record. After 30 days, the Commission will again review the Consent 
Agreement, along with any comments received, and decide whether it 
should withdraw from the Consent Agreement, modify the Consent 
Agreement or Order, or make the Order final.

II. The Respondents

    BD, headquartered in Franklin Lakes, New Jersey, is a medical 
technology company that manufactures and sells a broad range of medical 
supplies, devices, laboratory equipment, and diagnostic products 
throughout the world. Its operations consist of two business segments: 
BD Medical and BD Life Sciences. BD Medical provides a broad array of 
medical technologies and devices to hospitals, clinics, physicians' 
office practices, pharmacies, pharmaceutical companies, and healthcare 
workers.
    Bard, headquartered in Murray Hill, New Jersey, is a medical 
technology company that manufactures medical, surgical, diagnostic, and 
patient care devices sold to hospitals, healthcare professionals, 
extended care facilities, and other medical facilities throughout the 
world. Its operations consist of four principal divisions: Bard Access 
Systems, Inc., Bard Medical Division, Bard Peripheral Vascular, Inc., 
and Bard Biopsy Systems.

III. The Relevant Markets and Structure of the Markets

A. Tunneled Home Drainage Catheter Systems

    Tunneled home drainage catheter systems are medical devices used to 
treat recurrent fluid buildup in the lungs and abdomen, conditions 
known as pleural effusions and malignant ascites, respectively. 
Patients suffering from these conditions, often due to cancer or other 
serious illnesses, commonly require frequent fluid drainage. Tunneled 
home drainage catheter systems drain fluid from the lungs (pleural 
drainage) or abdomen (peritoneal drainage) through a tunneled, 
indwelling catheter connected to a disposable receptacle. After a 
medical doctor places the indwelling catheter, the device allows fluid 
drainage to take place conveniently in a patient's home or in a hospice 
setting where the patient or a caregiver can attach, remove, replace, 
and dispose of the drainage receptacle as frequently as needed. 
Although patients requiring pleural or peritoneal drainage can undergo 
an outpatient medical procedure when fluid build-up becomes severe, 
such procedures are not suitable alternatives to tunneled home drainage 
catheter systems, because they require a patient to make repeated trips 
to a healthcare facility to see a doctor. Customers likely would not 
substitute outpatient medical procedures in response to a small but 
significant increase in the price of tunneled home drainage catheter 
systems.
    BD and Bard are the two largest manufacturers of tunneled home 
drainage catheter systems in the United States, with a combined market 
share of approximately 98%. The remaining market share is divided 
between Rocket Medical plc (``Rocket Medical'') and B. Braun Medical 
Inc. (``B. Braun''). Rocket Medical is a new entrant to the U.S. 
market, and both Rocket Medical and B. Braun, in addition to having a 
much smaller share of the market than BD and Bard, have far less 
recognition among U.S. customers.

B. Soft Tissue Core Needle Biopsy Devices

    Soft tissue core needle biopsy devices are used by medical 
clinicians, typically interventional radiologists or oncologists, to 
remove small samples of tissue from soft tissue organs for examination 
and diagnosis. There are no practical alternatives to soft tissue core 
needle biopsy devices for clinicians seeking to perform a soft tissue 
biopsy. Other biopsy devices, such as bone or bone marrow biopsy 
devices, are not approved or intended to be used for soft tissue 
biopsies. Soft tissue core needle biopsy devices do not include, and 
are distinguished from, vacuum-assisted biopsy (``VAB'') devices which 
employ a vacuum to remove larger tissue samples. VAB devices are used 
for breast biopsies involving lesions that are difficult to locate and 
are not used to perform biopsies of other soft tissues and organs. VAB 
devices are more complex devices that are sold at a significantly 
higher price than soft tissue core needle biopsy devices. Accordingly, 
customers likely would not switch to VAB devices in response to a small 
but significant increase in the price of soft tissue core needle biopsy 
devices.
    Bard and BD are the two largest manufacturers of soft tissue core 
needle biopsy devices in the United States, with a combined market 
share of 60% or greater. Other participants in the market include Cook 
Medical, Argon Medical Devices, Inc., and Hologic, Inc., but each of 
these manufacturers has a smaller market share than either Bard or BD. 
In addition, there is a fringe of other manufacturers with very small 
market shares.

C. The Relevant Geographic Market

    The relevant geographic market for both tunneled home drainage 
catheter systems and soft tissue core needle biopsy devices is the 
United States. These relevant 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, are not viable competitive alternatives for U.S. consumers.

IV. Competitive Effects of the Transaction

    The proposed Acquisition would likely substantially lessen 
competition in the U.S. markets for tunneled home drainage catheter 
systems and soft tissue core needle biopsy devices. The Acquisition 
would combine the largest and second-largest suppliers of both products 
in the United States and would substantially increase concentration in 
already highly concentrated markets. Under the Horizontal Merger 
Guidelines, the Acquisition would presumptively create or enhance 
market power. By eliminating direct and substantial competition between 
Respondents, the proposed Acquisition likely would allow the combined 
firm to exercise market power unilaterally, resulting in higher prices 
and/or reduced innovation.

V. Entry

    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 into 
the markets for each of these devices is difficult, time-consuming, and 
expensive, requiring a significant investment of time and money for 
product research and development, regulatory approval by the FDA, and 
the establishment of a sales and marketing infrastructure sufficient to 
develop customer awareness and acceptance of the products.

VI. The Proposed Consent Agreement

    The Consent Agreement remedies the competitive concerns raised by 
the proposed Acquisition by requiring the Respondents to divest all of 
the assets, facilities, and resources relating to

[[Page 61762]]

Bard's tunneled home drainage catheter systems business and BD's soft 
tissue core needle biopsy devices business to Merit. The provisions of 
the Consent Agreement will enable Merit to become an independent, 
viable, and effective competitor in the respective relevant markets and 
maintain the competition that currently exists.
    Merit, headquartered in South Jordan, Utah, is a global company 
with 30 years of experience in the development, manufacture, and 
distribution of medical devices used in interventional, diagnostic, and 
therapeutic procedures. Merit offers a portfolio of products that is 
highly complementary to the tunneled home drainage catheter systems 
being acquired. Merit also recently introduced its first soft tissue 
core needle biopsy device product. Merit possesses substantial industry 
expertise in these product areas and sells its products to similar 
customers as BD and Bard. For these reasons, Merit is well positioned 
to restore the benefits of competition that would be lost due to the 
Acquisition.
    Pursuant to the Order, Merit will receive all rights and assets 
related to Bard's tunneled home drainage catheter system business and 
BD's soft tissue core needle biopsy device business, including all of 
the confidential business information used in those businesses. Merit 
will own or receive a license to all intellectual property necessary to 
run the businesses. It will also acquire the equipment used in the 
manufacturing of the products and all documentation and other 
information related to the products. Respondents will also contract 
manufacture products for Merit until it is able to manufacture them 
itself, and Respondents will provide transitional services to Merit to 
assist the company in establishing manufacturing capabilities for the 
divested products.
    The Respondents must accomplish the divestitures no later than 10 
days after the consummation of the proposed Acquisition. If the 
Commission determines that Merit is not an acceptable acquirer, or that 
the manner of the divestitures is not acceptable, the proposed Order 
requires the Respondents to unwind the sale of assets to Merit and then 
divest the assets to a Commission-approved acquirer(s) within 180 days 
of the date the Order becomes final. Pursuant to the Order To Maintain 
Assets, Respondents must maintain the businesses pending divestiture.
    The Commission has agreed to appoint a Monitor to ensure that the 
Respondents comply with all of their obligations pursuant to the 
Consent Agreement and to keep the Commission informed about the status 
of the transfer of assets to Merit. The Commission has appointed Mazars 
LLP as the Monitor in this matter. The proposed Order further allows 
the Commission to appoint a trustee in the event the parties fail to 
divest the products as required.

VII. Opportunity for Public Comment

    The purpose of this analysis is to facilitate public comment on the 
Consent Agreement to aid the Commission in determining whether it 
should make the Order final. This analysis is not intended to 
constitute an official interpretation of the proposed Consent Agreement 
and does not modify its terms in any way.

    By direction of the Commission.
April J. Tabor,
Acting Secretary.
[FR Doc. 2017-28213 Filed 12-28-17; 8:45 am]
BILLING CODE 6750-01-P



                                                                                Federal Register / Vol. 82, No. 249 / Friday, December 29, 2017 / Notices                                                                                                                           61759

                                               assets equal to $250 billion or more; (ii)                               institution holding company or                                                           more; or (C) a company that has been
                                               have total consolidated on-balance sheet                                 depository institution that has total                                                    designated by the Financial Stability
                                               foreign exposure equal to $10 billion or                                 assets equal to $250 billion or more; (B)                                                Oversight Council for supervision by the
                                               more; or (iii) have total consolidated                                   a covered depository institution holding                                                 Federal Reserve Board.
                                               assets equal to $10 billion or more and                                  company or depository institution that                                                     Burden Estimate:
                                               are a consolidated subsidiary of one of                                  has total consolidated on-balance sheet
                                               the following: (A) a covered depository                                  foreign exposure equal to $10 billion or
                                                                                                                                SUMMARY OF ANNUAL BURDEN
                                                                                                                                                             Estimated                   Estimated                                                                           Total annual
                                                                                                                               Obligation to                                                                      Estimated time                Frequency of
                                                                                              Type of burden                                                 number of                 frequency of                                                                           estimated
                                                                                                                                respond                                                                            per response                   response
                                                                                                                                                            respondents                  responses                                                                             burden

                                               Liquidity Coverage Ratio (LCR)—12             Reporting ...........          Mandatory ..........           ........................   ........................    ........................   ............................   ........................
                                                  CFR 329.40(a), (b).
                                               § 329.40(a) Notification that liquidity       Reporting ...........          Mandatory ..........                                 2                        12                      0.25       On Occasion ......                              6.00
                                                  coverage ratio is less than min-
                                                  imum in § 329.10.
                                               § 329.40(b) Notification that liquidity       Reporting ...........          Mandatory ..........                                 2                          1                      0.25      On Occasion ......                              0.50
                                                  coverage ratio is less than min-
                                                  imum in § 329.10 for 3 consecu-
                                                  tive days or otherwise noncompli-
                                                  ant.
                                               § 329.40(b) Plan for achieving com-           Recordkeeping ...              Mandatory ..........                                 2                          1                  100.00        On Occasion ......                         200.00
                                                  pliance.
                                               § 329.40(b)(4) Weekly report of               Reporting ...........          Mandatory ..........                                 2                          4                     0.25       On Occasion ......                              2.00
                                                  progress toward achieving compli-
                                                  ance.
                                               Liquidity Coverage Ratio (LCR)—12             Recordkeeping ...              Mandatory ..........           ........................   ........................    ........................   ............................   ........................
                                                  CFR 329.22(a)(2), (5).
                                               § 329.22(a)(2) Policies that require          Recordkeeping ...              Mandatory ..........                                 2                          1                    10.00       On Occasion ......                            20.00
                                                  eligible HQLA to be under control
                                                  of liquidity risk management func-
                                                  tion.
                                               § 329.22(a)(5) Documented method-             Recordkeeping ...              Mandatory ..........                                 2                          1                    10.00       On Occasion ......                            20.00
                                                  ology providing consistent treat-
                                                  ment for determining whether eli-
                                                  gible HQLA meets operational re-
                                                  quirements.

                                                   Total Hourly Burden ..................    ............................   ............................   ........................   ........................    ........................   ............................                248.50



                                                  General Description of Collection: The                                increase in burden hours is the result of                                                FEDERAL TRADE COMMISSION
                                               LCR rule implements a quantitative                                       these changes.
                                                                                                                                                                                                                 [File No. 171 0140]
                                               liquidity requirement and contains
                                               requirements subject to the PRA. The                                     Request for Comment
                                                                                                                                                                                                                 Becton, Dickinson and Company and
                                               reporting and recordkeeping                                                Comments are invited on: (a) Whether                                                   C. R. Bard; Analysis To Aid Public
                                               requirements are found in Sections                                       the collections of information are                                                       Comment
                                               329.22 and 329.40. The requirement is                                    necessary for the proper performance of
                                               designed to promote the short-term                                                                                                                                AGENCY:         Federal Trade Commission.
                                                                                                                        the FDIC’s functions, including whether
                                               resilience of the liquidity risk profile of                                                                                                                       ACTION:        Proposed Consent Agreement.
                                                                                                                        the information has practical utility; (b)
                                               large and internationally active banking
                                                                                                                        the accuracy of the estimates of the                                                     SUMMARY:   The consent agreement in this
                                               organizations, thereby improving the
                                               banking sector’s ability to absorb shocks                                burden of the information collections,                                                   matter settles alleged violations of
                                               arising from financial and economic                                      including the validity of the                                                            federal law prohibiting unfair methods
                                               stress, and to further improve the                                       methodology and assumptions used; (c)                                                    of competition. The attached Analysis to
                                               measurement and management of                                            ways to enhance the quality, utility, and                                                Aid Public Comment describes both the
                                               liquidity risk. The LCR rule establishes                                 clarity of the information to be                                                         allegations in the complaint and the
                                               a quantitative minimum liquidity                                         collected; and (d) ways to minimize the                                                  terms of the consent orders—embodied
                                               coverage ratio that requires a company                                   burden of the collections of information                                                 in the consent agreement—that would
                                               subject to the rule to maintain an                                       on respondents, including through the                                                    settle these allegations.
                                               amount of high-quality liquid assets (the                                use of automated collection techniques                                                   DATES: Comments must be received on
                                               numerator of the ratio) that is no less                                  or other forms of information                                                            or before January 23, 2018.
                                               than 100 percent of its total net cash                                   technology. All comments will become                                                     ADDRESSES: Interested parties may file a
                                               outflows over a prospective 30 calendar-                                 a matter of public record.                                                               comment online or on paper, by
                                               day period (the denominator of the                                         Dated at Washington, DC, on December 22,                                               following the instructions in the
ethrower on DSK3G9T082PROD with NOTICES




                                               ratio).                                                                  2017.                                                                                    Request for Comment part of the
                                                  The FDIC has reviewed its previous                                    Federal Deposit Insurance Corporation.                                                   SUPPLEMENTARY INFORMATION section
                                               PRA submission and has updated its                                                                                                                                below. Write: ‘‘In the Matter of Becton
                                                                                                                        Valerie J. Best,
                                               methodology for calculating the burden                                                                                                                            Dickinson and Co./Bard, Inc., File No.
                                               in order to be consistent with the Office                                Assistant Executive Secretary.                                                           171 0140’’ on your comment, and file
                                               of the Controller of the Currency and the                                [FR Doc. 2017–28138 Filed 12–28–17; 8:45 am]                                             your comment online at https://
                                               Federal Reserve Board. The overall                                       BILLING CODE 6714–01–P                                                                   ftcpublic.commentworks.com/ftc/


                                          VerDate Sep<11>2014     20:09 Dec 28, 2017        Jkt 244001        PO 00000         Frm 00032           Fmt 4703         Sfmt 4703         E:\FR\FM\29DEN1.SGM                     29DEN1


                                               61760                       Federal Register / Vol. 82, No. 249 / Friday, December 29, 2017 / Notices

                                               bectondickinsonconsent by following                     www.regulations.gov/#!home, you also                  has been posted on the public FTC
                                               the instructions on the web-based form.                 may file a comment through that                       website—as legally required by FTC
                                               If you prefer to file your comment on                   website.                                              Rule 4.9(b)—we cannot redact or
                                               paper, write ‘‘In the Matter of Becton                     If you prefer to file your comment on              remove your comment from the FTC
                                               Dickinson and Co./Bard, Inc., File No.                  paper, write ‘‘In the Matter of Becton                website, unless you submit a
                                               171 0140’’ on your comment and on the                   Dickinson and Co./Bard, Inc., File No.                confidentiality request that meets the
                                               envelope, and mail your comment to the                  171 0140’’ on your comment and on the                 requirements for such treatment under
                                               following address: Federal Trade                        envelope, and mail your comment to the                FTC Rule 4.9(c), and the General
                                               Commission, Office of the Secretary,                    following address: Federal Trade                      Counsel grants that request.
                                               600 Pennsylvania Avenue NW, Suite                       Commission, Office of the Secretary,                    Visit the FTC website at http://
                                               CC–5610 (Annex D), Washington, DC                       600 Pennsylvania Avenue NW, Suite                     www.ftc.gov to read this Notice and the
                                               20580, or deliver your comment to the                   CC–5610 (Annex D), Washington, DC                     news release describing it. The FTC Act
                                               following address: Federal Trade                        20580, or deliver your comment to the                 and other laws that the Commission
                                               Commission, Office of the Secretary,                    following address: Federal Trade                      administers permit the collection of
                                               Constitution Center, 400 7th Street SW,                 Commission, Office of the Secretary,                  public comments to consider and use in
                                               5th Floor, Suite 5610 (Annex D),                        Constitution Center, 400 7th Street SW,               this proceeding, as appropriate. The
                                               Washington, DC 20024.                                   5th Floor, Suite 5610 (Annex D),                      Commission will consider all timely
                                               FOR FURTHER INFORMATION CONTACT:
                                                                                                       Washington, DC 20024. If possible,                    and responsive public comments that it
                                               Jared Nagley, Attorney, (212–607–2813)                  submit your paper comment to the                      receives on or before January 23, 2018.
                                               and Geralyn Trujillo, Attorney, (212–                   Commission by courier or overnight                    For information on the Commission’s
                                               607–2806), Northeast Region, One                        service.                                              privacy policy, including routine uses
                                                                                                          Because your comment will be placed                permitted by the Privacy Act, see
                                               Bowling Green, Suite 318, New York,
                                                                                                       on the publicly accessible FTC website                https://www.ftc.gov/site-information/
                                               New York 10004.
                                                                                                       at https://www.ftc.gov, you are solely                privacy-policy.
                                               SUPPLEMENTARY INFORMATION: Pursuant                     responsible for making sure that your
                                               to Section 6(f) of the Federal Trade                    comment does not include any sensitive                Analysis of Agreement Containing
                                               Commission Act, 15 U.S.C. 46(f), and                    or confidential information. In                       Consent Orders To Aid Public Comment
                                               FTC Rule 2.34, 16 CFR 2.34, notice is                   particular, your comment should not
                                               hereby given that the above-captioned                                                                         I. Introduction
                                                                                                       include any sensitive personal
                                               consent agreement containing a consent                  information, such as your or anyone                      The Federal Trade Commission
                                               order to cease and desist, having been                  else’s Social Security number; date of                (‘‘Commission’’) has accepted, subject to
                                               filed with and accepted, subject to final               birth; driver’s license number or other               final approval, an Agreement
                                               approval, by the Commission, has been                   state identification number, or foreign               Containing Consent Orders (‘‘Consent
                                               placed on the public record for a period                country equivalent; passport number;                  Agreement’’) from Becton, Dickinson
                                               of thirty (30) days. The following                      financial account number; or credit or                and Company (‘‘BD’’) and C. R. Bard,
                                               Analysis to Aid Public Comment                          debit card number. You are also solely                Inc. (‘‘Bard’’) (collectively, the
                                               describes the terms of the consent                      responsible for making sure that your                 ‘‘Respondents’’) that is designed to
                                               agreement, and the allegations in the                   comment does not include any sensitive                remedy the anticompetitive effects that
                                               complaint. An electronic copy of the                    health information, such as medical                   would likely result from BD’s proposed
                                               full text of the consent agreement                      records or other individually                         acquisition of Bard. The proposed
                                               package can be obtained from the FTC                    identifiable health information. In                   Decision and Order (‘‘Order’’) requires
                                               Home Page (for December 22, 2017), on                   addition, your comment should not                     the Respondents to divest all rights and
                                               the World Wide Web, at https://                         include any ‘‘trade secret or any                     assets related to Bard’s tunneled home
                                               www.ftc.gov/news-events/commission-                     commercial or financial information                   drainage catheter business and BD’s soft
                                               actions.                                                which . . . is privileged or                          tissue core needle biopsy device
                                                  You can file a comment online or on                  confidential’’—as provided by Section                 business to Merit Medical Systems, Inc.
                                               paper. For the Commission to consider                   6(f) of the FTC Act, 15 U.S.C. 46(f), and             (‘‘Merit’’). The Order To Maintain
                                               your comment, we must receive it on or                  FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—               Assets requires Respondents to maintain
                                               before January 23, 2018. Write ‘‘In the                 including in particular competitively                 the viability and competitiveness of the
                                               Matter of Becton Dickinson and Co./                     sensitive information such as costs,                  businesses pending divestiture.
                                               Bard, Inc., File No. 171 0140’’ on your                 sales statistics, inventories, formulas,                 Pursuant to an Agreement and Plan of
                                               comment. Your comment—including                         patterns, devices, manufacturing                      Merger, dated as of April 23, 2017, BD
                                               your name and your state—will be                        processes, or customer names.                         and Lambda Corp., a wholly-owned
                                               placed on the public record of this                        Comments containing material for                   subsidiary of BD, will acquire the issued
                                               proceeding, including, to the extent                    which confidential treatment is                       and outstanding shares of Bard by
                                               practicable, on the public Commission                   requested must be filed in paper form,                means of a merger in exchange for cash
                                               website, at https://www.ftc.gov/policy/                 must be clearly labeled ‘‘Confidential,’’             and stock valued at approximately $24
                                               public-comments.                                        and must comply with FTC Rule 4.9(c).                 billion (the ‘‘Acquisition’’). The
                                                  Postal mail addressed to the                         In particular, the written request for                Commission’s Complaint alleges that
                                               Commission is subject to delay due to                   confidential treatment that accompanies               the proposed Acquisition, if
                                               heightened security screening. As a                     the comment must include the factual                  consummated, would violate Section 7
                                               result, we encourage you to submit your                 and legal basis for the request, and must             of the Clayton Act, as amended, 15
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                                               comments online. To make sure that the                  identify the specific portions of the                 U.S.C. 18, and Section 5 of the Federal
                                               Commission considers your online                        comment to be withheld from the public                Trade Commission Act, as amended, 15
                                               comment, you must file it at https://                   record. See FTC Rule 4.9(c). Your                     U.S.C. 45, by substantially lessening
                                               ftcpublic.commentworks.com/ftc/                         comment will be kept confidential only                competition in the U.S. markets for
                                               bectondickinsonconsent by following                     if the General Counsel grants your                    tunneled home drainage catheter
                                               the instructions on the web-based form.                 request in accordance with the law and                systems and soft tissue core needle
                                               If this Notice appears at http://                       the public interest. Once your comment                biopsy devices. The Consent Agreement


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                                                                           Federal Register / Vol. 82, No. 249 / Friday, December 29, 2017 / Notices                                            61761

                                               is designed to remedy the alleged                       drainage to take place conveniently in a              with a combined market share of 60%
                                               violations by preserving the competition                patient’s home or in a hospice setting                or greater. Other participants in the
                                               that otherwise would be lost in these                   where the patient or a caregiver can                  market include Cook Medical, Argon
                                               markets as a result of the proposed                     attach, remove, replace, and dispose of               Medical Devices, Inc., and Hologic, Inc.,
                                               Acquisition.                                            the drainage receptacle as frequently as              but each of these manufacturers has a
                                                  The Commission has placed the                        needed. Although patients requiring                   smaller market share than either Bard or
                                               Consent Agreement on the public record                  pleural or peritoneal drainage can                    BD. In addition, there is a fringe of other
                                               for 30 days to solicit comments from                    undergo an outpatient medical                         manufacturers with very small market
                                               interested persons. Comments received                   procedure when fluid build-up becomes                 shares.
                                               during this period will become part of                  severe, such procedures are not suitable
                                                                                                       alternatives to tunneled home drainage                C. The Relevant Geographic Market
                                               the public record. After 30 days, the
                                               Commission will again review the                        catheter systems, because they require a                 The relevant geographic market for
                                               Consent Agreement, along with any                       patient to make repeated trips to a                   both tunneled home drainage catheter
                                               comments received, and decide whether                   healthcare facility to see a doctor.                  systems and soft tissue core needle
                                               it should withdraw from the Consent                     Customers likely would not substitute                 biopsy devices is the United States.
                                               Agreement, modify the Consent                           outpatient medical procedures in                      These relevant products are medical
                                               Agreement or Order, or make the Order                   response to a small but significant                   devices regulated by the U.S. Food and
                                               final.                                                  increase in the price of tunneled home                Drug Administration (‘‘FDA’’). Medical
                                                                                                       drainage catheter systems.                            devices sold outside of the United
                                               II. The Respondents                                        BD and Bard are the two largest                    States, but not approved for sale in the
                                                 BD, headquartered in Franklin Lakes,                  manufacturers of tunneled home                        United States, are not viable competitive
                                               New Jersey, is a medical technology                     drainage catheter systems in the United               alternatives for U.S. consumers.
                                               company that manufactures and sells a                   States, with a combined market share of
                                                                                                       approximately 98%. The remaining                      IV. Competitive Effects of the
                                               broad range of medical supplies,                                                                              Transaction
                                               devices, laboratory equipment, and                      market share is divided between Rocket
                                               diagnostic products throughout the                      Medical plc (‘‘Rocket Medical’’) and B.                  The proposed Acquisition would
                                               world. Its operations consist of two                    Braun Medical Inc. (‘‘B. Braun’’). Rocket             likely substantially lessen competition
                                               business segments: BD Medical and BD                    Medical is a new entrant to the U.S.                  in the U.S. markets for tunneled home
                                               Life Sciences. BD Medical provides a                    market, and both Rocket Medical and B.                drainage catheter systems and soft tissue
                                               broad array of medical technologies and                 Braun, in addition to having a much                   core needle biopsy devices. The
                                               devices to hospitals, clinics, physicians’              smaller share of the market than BD and               Acquisition would combine the largest
                                               office practices, pharmacies,                           Bard, have far less recognition among                 and second-largest suppliers of both
                                               pharmaceutical companies, and                           U.S. customers.                                       products in the United States and would
                                               healthcare workers.                                                                                           substantially increase concentration in
                                                                                                       B. Soft Tissue Core Needle Biopsy
                                                 Bard, headquartered in Murray Hill,                                                                         already highly concentrated markets.
                                                                                                       Devices
                                               New Jersey, is a medical technology                                                                           Under the Horizontal Merger
                                               company that manufactures medical,                         Soft tissue core needle biopsy devices             Guidelines, the Acquisition would
                                               surgical, diagnostic, and patient care                  are used by medical clinicians, typically             presumptively create or enhance market
                                               devices sold to hospitals, healthcare                   interventional radiologists or                        power. By eliminating direct and
                                                                                                       oncologists, to remove small samples of               substantial competition between
                                               professionals, extended care facilities,
                                                                                                       tissue from soft tissue organs for                    Respondents, the proposed Acquisition
                                               and other medical facilities throughout
                                                                                                       examination and diagnosis. There are no               likely would allow the combined firm to
                                               the world. Its operations consist of four
                                                                                                       practical alternatives to soft tissue core            exercise market power unilaterally,
                                               principal divisions: Bard Access
                                                                                                       needle biopsy devices for clinicians                  resulting in higher prices and/or
                                               Systems, Inc., Bard Medical Division,
                                                                                                       seeking to perform a soft tissue biopsy.              reduced innovation.
                                               Bard Peripheral Vascular, Inc., and Bard
                                                                                                       Other biopsy devices, such as bone or
                                               Biopsy Systems.                                                                                               V. Entry
                                                                                                       bone marrow biopsy devices, are not
                                               III. The Relevant Markets and                           approved or intended to be used for soft                Entry in the relevant markets would
                                               Structure of the Markets                                tissue biopsies. Soft tissue core needle              not be timely, likely, or sufficient in
                                                                                                       biopsy devices do not include, and are                magnitude, character, and scope to deter
                                               A. Tunneled Home Drainage Catheter
                                                                                                       distinguished from, vacuum-assisted                   or counteract the anticompetitive effects
                                               Systems
                                                                                                       biopsy (‘‘VAB’’) devices which employ                 of the proposed Acquisition. New entry
                                                  Tunneled home drainage catheter                      a vacuum to remove larger tissue                      into the markets for each of these
                                               systems are medical devices used to                     samples. VAB devices are used for                     devices is difficult, time-consuming,
                                               treat recurrent fluid buildup in the                    breast biopsies involving lesions that are            and expensive, requiring a significant
                                               lungs and abdomen, conditions known                     difficult to locate and are not used to               investment of time and money for
                                               as pleural effusions and malignant                      perform biopsies of other soft tissues                product research and development,
                                               ascites, respectively. Patients suffering               and organs. VAB devices are more                      regulatory approval by the FDA, and the
                                               from these conditions, often due to                     complex devices that are sold at a                    establishment of a sales and marketing
                                               cancer or other serious illnesses,                      significantly higher price than soft                  infrastructure sufficient to develop
                                               commonly require frequent fluid                         tissue core needle biopsy devices.                    customer awareness and acceptance of
                                               drainage. Tunneled home drainage                        Accordingly, customers likely would                   the products.
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                                               catheter systems drain fluid from the                   not switch to VAB devices in response
                                               lungs (pleural drainage) or abdomen                     to a small but significant increase in the            VI. The Proposed Consent Agreement
                                               (peritoneal drainage) through a                         price of soft tissue core needle biopsy                 The Consent Agreement remedies the
                                               tunneled, indwelling catheter connected                 devices.                                              competitive concerns raised by the
                                               to a disposable receptacle. After a                        Bard and BD are the two largest                    proposed Acquisition by requiring the
                                               medical doctor places the indwelling                    manufacturers of soft tissue core needle              Respondents to divest all of the assets,
                                               catheter, the device allows fluid                       biopsy devices in the United States,                  facilities, and resources relating to


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                                               61762                       Federal Register / Vol. 82, No. 249 / Friday, December 29, 2017 / Notices

                                               Bard’s tunneled home drainage catheter                  Agreement and to keep the Commission                  minimize the information collection
                                               systems business and BD’s soft tissue                   informed about the status of the transfer             burden.
                                               core needle biopsy devices business to                  of assets to Merit. The Commission has                DATES: Comments on the collection(s) of
                                               Merit. The provisions of the Consent                    appointed Mazars LLP as the Monitor in                information must be received by the
                                               Agreement will enable Merit to become                   this matter. The proposed Order further               OMB desk officer by January 29, 2018.
                                               an independent, viable, and effective                   allows the Commission to appoint a                    ADDRESSES: When commenting on the
                                               competitor in the respective relevant                   trustee in the event the parties fail to              proposed information collections,
                                               markets and maintain the competition                    divest the products as required.                      please reference the document identifier
                                               that currently exists.
                                                                                                       VII. Opportunity for Public Comment                   or OMB control number. To be assured
                                                  Merit, headquartered in South Jordan,
                                                                                                                                                             consideration, comments and
                                               Utah, is a global company with 30 years                   The purpose of this analysis is to
                                                                                                                                                             recommendations must be received by
                                               of experience in the development,                       facilitate public comment on the
                                               manufacture, and distribution of                                                                              the OMB desk officer via one of the
                                                                                                       Consent Agreement to aid the
                                               medical devices used in interventional,                                                                       following transmissions: OMB, Office of
                                                                                                       Commission in determining whether it
                                               diagnostic, and therapeutic procedures.                                                                       Information and Regulatory Affairs,
                                                                                                       should make the Order final. This
                                               Merit offers a portfolio of products that                                                                     Attention: CMS Desk Officer, Fax
                                                                                                       analysis is not intended to constitute an
                                               is highly complementary to the                                                                                Number: (202) 395–5806 OR, Email:
                                                                                                       official interpretation of the proposed
                                               tunneled home drainage catheter                                                                               OIRA_submission@omb.eop.gov.
                                                                                                       Consent Agreement and does not                          To obtain copies of a supporting
                                               systems being acquired. Merit also                      modify its terms in any way.                          statement and any related forms for the
                                               recently introduced its first soft tissue
                                                                                                        By direction of the Commission.                      proposed collection(s) summarized in
                                               core needle biopsy device product.
                                               Merit possesses substantial industry                    April J. Tabor,                                       this notice, you may make your request
                                               expertise in these product areas and                    Acting Secretary.                                     using one of following:
                                                                                                       [FR Doc. 2017–28213 Filed 12–28–17; 8:45 am]            1. Access CMS’ website address at
                                               sells its products to similar customers as
                                                                                                                                                             https://www.cms.gov/Regulations-and-
                                               BD and Bard. For these reasons, Merit                   BILLING CODE 6750–01–P
                                                                                                                                                             Guidance/Legislation/
                                               is well positioned to restore the benefits
                                                                                                                                                             PaperworkReductionActof1995/PRA-
                                               of competition that would be lost due to
                                                                                                                                                             Listing.html.
                                               the Acquisition.
                                                                                                       DEPARTMENT OF HEALTH AND                                2. Email your request, including your
                                                  Pursuant to the Order, Merit will
                                                                                                       HUMAN SERVICES                                        address, phone number, OMB number,
                                               receive all rights and assets related to
                                               Bard’s tunneled home drainage catheter                                                                        and CMS document identifier, to
                                                                                                       Centers for Medicare & Medicaid                       Paperwork@cms.hhs.gov.
                                               system business and BD’s soft tissue                    Services                                                3. Call the Reports Clearance Office at
                                               core needle biopsy device business,
                                                                                                                                                             (410) 786–1326.
                                               including all of the confidential                       [Document Identifier: CMS–R–262]
                                               business information used in those                                                                            FOR FURTHER INFORMATION CONTACT:
                                               businesses. Merit will own or receive a                                                                       William Parham at (410) 786–4669.
                                                                                                       Agency Information Collection
                                               license to all intellectual property                                                                          SUPPLEMENTARY INFORMATION: Under the
                                                                                                       Activities: Submission for OMB
                                               necessary to run the businesses. It will                Review; Comment Request                               Paperwork Reduction Act of 1995 (PRA)
                                               also acquire the equipment used in the                                                                        (44 U.S.C. 3501–3520), federal agencies
                                               manufacturing of the products and all                   AGENCY: Centers for Medicare &                        must obtain approval from the Office of
                                               documentation and other information                     Medicaid Services, HHS.                               Management and Budget (OMB) for each
                                               related to the products. Respondents                    ACTION: Notice.                                       collection of information they conduct
                                               will also contract manufacture products                                                                       or sponsor. The term ‘‘collection of
                                               for Merit until it is able to manufacture               SUMMARY:    The Centers for Medicare &                information’’ is defined in 44 U.S.C.
                                               them itself, and Respondents will                       Medicaid Services (CMS) is announcing                 3502(3) and 5 CFR 1320.3(c) and
                                               provide transitional services to Merit to               an opportunity for the public to                      includes agency requests or
                                               assist the company in establishing                      comment on CMS’ intention to collect                  requirements that members of the public
                                               manufacturing capabilities for the                      information from the public. Under the                submit reports, keep records, or provide
                                               divested products.                                      Paperwork Reduction Act of 1995                       information to a third party. Section
                                                  The Respondents must accomplish                      (PRA), federal agencies are required to               3506(c)(2)(A) of the PRA (44 U.S.C.
                                               the divestitures no later than 10 days                  publish notice in the Federal Register                3506(c)(2)(A)) requires federal agencies
                                               after the consummation of the proposed                  concerning each proposed collection of                to publish a 30-day notice in the
                                               Acquisition. If the Commission                          information, including each proposed                  Federal Register concerning each
                                               determines that Merit is not an                         extension or reinstatement of an existing             proposed collection of information,
                                               acceptable acquirer, or that the manner                 collection of information, and to allow               including each proposed extension or
                                               of the divestitures is not acceptable, the              a second opportunity for public                       reinstatement of an existing collection
                                               proposed Order requires the                             comment on the notice. Interested                     of information, before submitting the
                                               Respondents to unwind the sale of                       persons are invited to send comments                  collection to OMB for approval. To
                                               assets to Merit and then divest the assets              regarding the burden estimate or any                  comply with this requirement, CMS is
                                               to a Commission-approved acquirer(s)                    other aspect of this collection of                    publishing this notice that summarizes
                                               within 180 days of the date the Order                   information, including the necessity and              the following proposed collection(s) of
                                               becomes final. Pursuant to the Order To                 utility of the proposed information                   information for public comment:
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                                               Maintain Assets, Respondents must                       collection for the proper performance of                1. Type of Information Collection
                                               maintain the businesses pending                         the agency’s functions, the accuracy of               Request: Revision of a currently
                                               divestiture.                                            the estimated burden, ways to enhance                 approved collection; Title of
                                                  The Commission has agreed to                         the quality, utility, and clarity of the              Information Collection: Contract Year
                                               appoint a Monitor to ensure that the                    information to be collected; and the use              2019 Plan Benefit Package (PBP)
                                               Respondents comply with all of their                    of automated collection techniques or                 Software and Formulary Submission;
                                               obligations pursuant to the Consent                     other forms of information technology to              Use: We require that Medicare


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Document Created: 2018-01-03 13:16:44
Document Modified: 2018-01-03 13:16:44
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionProposed Consent Agreement.
DatesComments must be received on or before January 23, 2018.
ContactJared Nagley, Attorney, (212-607-2813) and Geralyn Trujillo, Attorney, (212-607-2806), Northeast Region, One Bowling Green, Suite 318, New York, New York 10004.
FR Citation82 FR 61759 

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