82_FR_849 82 FR 847 - C.H. Boehringer Sohn AG & Co. KG; Analysis To Aid Public Comment

82 FR 847 - C.H. Boehringer Sohn AG & Co. KG; Analysis To Aid Public Comment

FEDERAL TRADE COMMISSION

Federal Register Volume 82, Issue 2 (January 4, 2017)

Page Range847-850
FR Document2016-31848

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 2 (Wednesday, January 4, 2017)
[Federal Register Volume 82, Number 2 (Wednesday, January 4, 2017)]
[Notices]
[Pages 847-850]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31848]


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FEDERAL TRADE COMMISSION

[File No. 161 0077]


C.H. Boehringer Sohn AG & Co. KG; Analysis To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed Consent Agreement.

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SUMMARY: The consent agreement in this matter settles alleged 
violations of federal law prohibiting unfair 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 27, 2017.

ADDRESSES: Interested parties may file a comment at https://ftcpublic.commentworks.com/FTC/chboehringersohnagcokgconsent online or 
on paper, by following the instructions in the Request for Comment part 
of the SUPPLEMENTARY INFORMATION section below. Write ``C.H. Boehringer 
Sohn AG & Co. KG File No. 1610077--Consent Agreement'' on your comment 
and file your comment online at https://ftcpublic.commentworks.com/FTC/chboehringersohnagcokgconsent by following the instructions on the web-
based form. If you prefer to file your comment on paper, write ``C.H. 
Boehringer Sohn AG & Co. KG File No. 1610077--Consent Agreement'' 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: Michael Barnett (202-326-2362), 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 orders 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 28, 2016), 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 January 27, 
2017. Write ``C.H. Boehringer Sohn AG & Co. KG File No. 1610077--
Consent Agreement'' 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.
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    \1\ In particular, the written request for confidential 
treatment that accompanies the comment must include the factual and 
legal basis for the request, and must identify the specific portions 
of the comment to be withheld from the public record. See FTC Rule 
4.9(c), 16 CFR 4.9(c).
---------------------------------------------------------------------------

    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/chboehringersohnagcokgconsent 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 ``C.H. Boehringer Sohn AG 
& Co. KG File No. 1610077--Consent Agreement'' 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. 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 January 27, 2017. 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 Orders To Aid Public Comment

Introduction

    The Federal Trade Commission (``Commission'') has accepted, subject 
to final approval, an Agreement Containing Consent Orders (``Consent 
Agreement'') from C.H. Boehringer Sohn

[[Page 848]]

AG & Co. KG (``Boehringer Ingelheim''), which is designed to remedy the 
anticompetitive effects of Boehringer Ingelheim's acquisition of the 
Merial Animal Health business (``Merial'') from Sanofi. Under the terms 
of the proposed Decision and Order (``Order'') contained in the Consent 
Agreement, Boehringer Ingelheim is required to divest its relevant U.S. 
companion animal vaccine business to Eli Lily and Company, which 
participates in the animal health industry through its Elanco Animal 
Health (``Elanco'') division. Boehringer Ingelheim is also required to 
divest its U.S. Cydectin parasiticide product to Bayer AG (``Bayer'').
    The proposed Consent Agreement has been placed on the public record 
for thirty days for receipt of comments from interested persons. 
Comments received during this period will become part of the public 
record. After thirty days, the Commission will again evaluate the 
proposed Consent Agreement, along with the comments received, in order 
to make a final decision as to whether it should withdraw from the 
proposed Consent Agreement, modify it, or make it final.

The Transaction

    Pursuant to an Exclusivity Agreement dated December 15, 2015, 
Boehringer Ingelheim proposes to swap its consumer health care business 
for Sanofi's Merial animal health business (the ``Proposed 
Acquisition''). In the proposed swap, Boehringer Ingelheim obtains 
Merial, valued at $13.53 billion, and Sanofi obtains Boehringer 
Ingelheim's Consumer Health Care business unit, valued at $7.98 
billion, as well as cash compensation of $5.54 billion. The Commission 
alleges in its Complaint 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, in the U.S. markets for two types of animal health products: 
(1) Companion animal vaccines--which include various canine, feline, 
and rabies vaccines--and (2) cattle and sheep parasiticides. The 
proposed Consent Agreement will remedy the alleged violations by 
preserving the competition that would otherwise be eliminated by the 
Proposed Acquisition.

The Parties

    Headquartered in Germany, Boehringer Ingelheim is one of the 
world's leading pharmaceutical companies. It manufacturers, researches, 
develops and markets an array of human and animal health products. The 
company's animal health division, Boehringer Ingelheim Vetmedica, Inc., 
is the sixth-largest animal health supplier in the world.
    Sanofi is a multinational pharmaceutical company headquartered in 
Gentilly, France. The company develops and markets a diverse portfolio 
of products, including pharmaceuticals, human vaccines, and, through 
its subsidiary Merial, animal health products. Merial is the fourth-
largest animal health supplier in the world.

The Relevant Products and Structure of the Markets

Companion Animal Vaccines

    There are three classes of companion animal vaccines in which to 
analyze the effects of the Proposed Acquisition: Canine vaccines, 
feline vaccines, and rabies vaccines. A vaccine is a version of an 
antigen that triggers an immune response to the antigen but not the 
disease, causing the animal to develop an immunity that prevents the 
disease. Only vaccines containing an antigen of a specific virus can 
provide the desired immunity response to that virus and the 
corresponding disease. No substitute product immunizes against a 
disease. Nor is treatment following infection a substitute for the 
vaccinations at issue. For these reasons, each vaccine containing an 
antigen to immunize against a particular disease constitutes a relevant 
market in which to analyze the effects of the acquisition.
    Canine vaccines prevent specific illnesses in dogs. The Proposed 
Acquisition raises competitive concerns in the markets for seven canine 
vaccines: Canine distemper virus, canine parvovirus, leptospirosis, 
canine adenovirus, canine parainfluenza virus, canine coronavirus, and 
borreliosis (``Lyme disease''). In addition, the proposed transaction 
raises future competition concerns in the canine vaccine market for 
Bordetella bronchiseptica bacterium, in which Boehringer Ingelheim 
currently competes and Merial is the most likely entrant in the near 
future. The canine vaccine markets are highly concentrated. Boehringer 
Ingelheim, Merial, Zoetis, Inc. (``Zoetis''), and Merck & Co. 
(``Merck'') are the only four suppliers offering or likely to offer 
canine vaccines in the United States. In 2015, Boehringer Ingelheim, 
Merial, Zoetis and Merck had market shares of approximately 30%, 11%, 
35%, and 24%, respectively, of all revenues from canine vaccines sold 
in the United States and comparable shares in each relevant market, 
except Bordetella bronchiseptica bacterium, where Merial is the next 
likely entrant. The Proposed Acquisition would reduce the number of 
current or likely competitors in each market from four to three.
    Feline vaccines prevent diseases common to cats. The transaction 
raises competitive concerns in the feline vaccine markets for five 
diseases: Panleukopenia, calicivirus, viral rhinotracheitis, Chlamydia 
psittaci bacterium, and feline leukemia. The feline vaccine industry in 
the United States is highly concentrated with the same four market 
participants--Boehringer Ingelheim, Merial, Zoetis, and Merck--as the 
canine vaccine industry. In 2015, these four companies had market 
shares of approximately 28%, 33%, 16%, and 23%, respectively, of all 
revenues from feline vaccines sold in the United States and comparable 
shares in each relevant market. The proposed transaction would combine 
the two leading feline vaccine suppliers, reducing the number of 
competitors in each market from four to three.
    The rabies virus, transmitted through bites from infected animals, 
triggers a fatal neurological condition culminating in paralysis, 
respiratory failure, and eventual death. Because this fatal disease is 
transmittable to humans, most U.S. states have mandatory rabies 
vaccination requirements. Regular vaccination for all animals is the 
only means of protection, and there are no substitutes for rabies 
vaccines. All rabies vaccines are approved for use in both dogs and 
cats, although some are approved for use in additional species as well. 
The market for the sale of rabies vaccines in the United States is 
highly concentrated. Boehringer Ingelheim, Merial, Zoetis, and Merck 
are the only four significant suppliers of rabies vaccines in the 
United States, with market shares of 10%, 65%, 13%, and 12% of 
revenues, respectively.

Cattle and Sheep Parasiticides

    Parasiticides prevent and control outbreaks of parasites such as 
worms, flies, lice, and ticks.
Cattle Parasiticides
    Parasiticides are a key part of cattle health care regimens. If 
left unchecked, parasites reduce milk production in dairy cattle and 
prevent weight gain in beef cattle. There are two primary types of 
cattle parasiticides: Macrocyclic lactones, which prevent both internal 
and external parasites, and benzimidazoles, which prevent only internal 
parasites. Because macrocyclic lactones reach a much broader spectrum 
of parasites, other parasiticides, including benzimidazoles, are not 
viable substitutes.

[[Page 849]]

    Boehringer Ingelheim, Merial, and Zoetis are the three primary 
participants in the macrocyclic lactone cattle parasiticide market, and 
the Proposed Acquisition would combine the two most significant 
competitors. Merial, the market leader, offers three brands: Ivomec, 
Eprinex, and LongRange. After Merial, Boehringer Ingelheim is the next 
largest supplier of macrocyclic lactone cattle parasiticides. 
Boehringer Ingelheim's sole product is Cydectin, a parasiticide that is 
functionally identical to Ivomec and Eprinex for beef cattle. Zoetis 
also offers a macrocyclic lactone product, Dectomax, that is similar to 
the products of Merial and Boehringer Ingelheim. Merial, Boehringer 
Ingelheim and Zoetis accounted for 45%, 22%, and 17% of revenues, 
respectively, of U.S. sales in 2015. Beyond these three companies, 
multiple manufacturers produce generic versions of Merial's Ivomec. 
Although these generic products are significantly cheaper than the 
branded products, they have limited competitive significance. Many 
customers prefer the branded products because the branded product 
manufacturers offer valuable technical support, field support, and 
education. In addition, many customers also perceive the generic 
products to be inferior and unreliable, preferring to pay a higher 
price for the guaranteed success of branded products.
    Merial and Boehringer Ingelheim are the only two macrocyclic 
lactone cattle parasiticide suppliers that offer ``zero-day milk 
withhold'' products--Cydectin and Eprinex, respectively. The Proposed 
Acquisition would eliminate the competition between them, effectively 
leaving dairy cattle customers with a sole supplier.
Sheep Parasiticides
    Sheep parasiticides are critical for optimizing wool and meat 
production. Sheep parasiticides utilize the same compounds as cattle 
parasiticides, but use a different route of administration. Because a 
sheep's wool and skin prevent the absorption of topical products and 
the thickness of a sheep's wool makes injections difficult, customers 
view oral administration as the only viable option for sheep 
parasiticides. Both macrocyclic lactones and benzimidazoles can be used 
as sheep parasiticides, but benzimidazoles are not economic substitutes 
for macrocyclic lactones in most cases because they do not treat 
external parasites and are less efficacious.
    Merial and Boehringer Ingelheim are the two primary suppliers of 
macrocyclic lactone sheep parasiticides. Boehringer Ingelheim offers 
Cydectin Oral Drench and Merial offers Ivomec Oral Drench. Following 
the Proposed Acquisition, the merged firm would control more than 78% 
of this market. The other macrocyclic lactone sheep parasiticides are 
generic versions of the Merial product, which are of limited 
competitive significance.

Relevant Geographic Market

    The United States is the relevant geographic market in which to 
assess the competitive effects of the Proposed Acquisition. The USDA 
must approve companion animal vaccines before they are sold in the 
United States. Cattle and sheep parasiticides must be approved by the 
FDA before being sold in the United States. Thus, products sold outside 
the United States, but not approved for sale in the United States, are 
not alternatives for U.S. consumers.

Entry

    Entry into the U.S. markets for companion animal vaccines and 
cattle and sheep parasiticides would not be timely, likely or 
sufficient in magnitude, character and scope to deter or counteract the 
anticompetitive effects of the Proposed Acquisition. Three major 
obstacles stand in the way of a prospective entrant into the relevant 
markets: Lengthy development periods, FDA and USDA approval 
requirements, and difficulty of establishing a brand name and 
reputation and convincing veterinarians to prescribe new products.

Effects of the Acquisition

    The Proposed Acquisition would cause significant competitive harm 
to consumers in the relevant U.S. markets for companion animal vaccines 
and cattle and sheep parasiticides by eliminating actual or future, 
direct, and substantial competition between Boehringer Ingelheim and 
Merial. The transaction would increase the likelihood that Boehringer 
Ingelheim will be able to unilaterally exercise market power, increase 
the likelihood of coordinated interaction between or among suppliers, 
and increase the likelihood that consumers will pay higher prices.

The Consent Agreement

    The proposed Consent Agreement effectively remedies the Proposed 
Acquisition's anticompetitive effects by requiring Boehringer Ingelheim 
to divest its relevant companion animal vaccine business and certain of 
its cattle and sheep parasiticides assets to Elanco and Bayer, 
respectively.
    Under the proposed Order, Boehringer Ingelheim will divest its 
relevant U.S. rights and interests in its companion animal vaccine 
business to Elanco no later than ten days after the consummation of the 
Proposed Acquisition or on the date on which the proposed Order becomes 
final, whichever is earlier. Similarly, the proposed Order requires 
Boehringer Ingelheim to divest all of its respective U.S. rights and 
interests in its parasiticide product, Cydectin, to Bayer. These 
divestitures include all regulatory approvals, brand names, marketing 
materials, confidential business information, customer information, and 
other assets associated with marketing and selling both products. To 
ensure the divestitures are successful, the proposed Order requires 
Boehringer Ingelheim to secure all third-party consents and waivers 
required to permit both buyers to conduct business with the divested 
assets. Additionally, Elanco and Bayer also will have the right to 
interview and offer employment to employees associated with the 
divested businesses.
    Elanco is an experienced supplier in the global animal health 
industry and has the resources and expertise to replicate Boehringer 
Ingelheim's role in the companion animal vaccine markets. In 2015, 
Elanco generated approximately $1 billion in revenue. Elanco currently 
offers a limited portfolio of companion animal pharmaceutical products 
such as parasiticides, pain relievers, and dermatological products. 
Elanco, however, is not a meaningful participant in any of the 
companion animal vaccines subject to divestiture, and its proposed 
acquisition of those assets will complement and expand its existing 
companion animal portfolio. Elanco is well positioned to replicate 
immediately Boehringer Ingelheim's competitive position in all 
companion animal vaccine markets.
    Bayer is similarly well qualified to replicate Boehringer 
Ingelheim's competitive position in the United States with respect to 
the Cydectin product line. Bayer is currently the fifth-largest animal 
health company both worldwide and in the United States. Bayer had 2015 
worldwide sales of $1.6 billion, of which $595 million derived from its 
animal health business. Bayer does not currently offer a parasiticide 
that controls external and internal parasites to cattle and sheep 
farmers. However, Bayer offers a variety of other products to cattle 
and sheep farmers, such as ear tags and external parasite control 
products.
    The Commission has agreed to appoint a Monitor to ensure that 
Boehringer Ingelheim complies with all of its obligations pursuant to 
the Consent Agreement and to keep the

[[Page 850]]

Commission informed about the status of the transfer of the rights and 
assets to Elanco and Bayer.
    The Commission's goal in evaluating possible purchasers of divested 
rights and assets is to maintain the competitive environment that 
existed prior to the Proposed Acquisition. If the Commission determines 
that either buyer is not an acceptable acquirer, or that the manner of 
the divestiture is not acceptable, the proposed Order requires the 
parties to unwind the sale and then divest the products to another 
Commission-approved acquirer within six months of the date that the 
proposed Order becomes final. The proposed Order further allows the 
Commission to appoint a trustee in the event the parties fail to divest 
the products.
    The purpose of this analysis is to facilitate public comment on the 
proposed 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.
April J. Tabor,
Acting Secretary.
[FR Doc. 2016-31848 Filed 1-3-17; 8:45 am]
 BILLING CODE 6750-01-P



                                                                               Federal Register / Vol. 82, No. 2 / Wednesday, January 4, 2017 / Notices                                                           847

                                                  privacy policy located here: http://                    SUPPLEMENTARY INFORMATION:       Pursuant              you have to follow the procedure
                                                  www.ftc.gov/site-information/privacy-                   to Section 6(f) of the Federal Trade                   explained in FTC Rule 4.9(c), 16 CFR
                                                  policy.                                                 Commission Act, 15 U.S.C. 46(f), and                   4.9(c).1 Your comment will be kept
                                                                                                          FTC Rule 2.34, 16 CFR 2.34, notice is                  confidential only if the FTC General
                                                  15. Contact Us
                                                                                                          hereby given that the above-captioned                  Counsel, in his or her sole discretion,
                                                    Please visit the Contest Web site for                 consent agreement containing consent                   grants your request in accordance with
                                                  further Contest information and                         orders to cease and desist, having been                the law and the public interest.
                                                  updates.                                                filed with and accepted, subject to final                 Postal mail addressed to the
                                                  Jessica Rich,                                           approval, by the Commission, has been                  Commission is subject to delay due to
                                                  Director, Bureau of Consumer Protection.
                                                                                                          placed on the public record for a period               heightened security screening. As a
                                                                                                          of thirty (30) days. The following                     result, we encourage you to submit your
                                                  [FR Doc. 2016–31731 Filed 1–3–17; 8:45 am]
                                                                                                          Analysis to Aid Public Comment                         comments online. To make sure that the
                                                  BILLING CODE 6750–01–P
                                                                                                          describes the terms of the consent                     Commission considers your online
                                                                                                          agreement, and the allegations in the                  comment, you must file it at https://
                                                                                                          complaint. An electronic copy of the                   ftcpublic.commentworks.com/FTC/
                                                  FEDERAL TRADE COMMISSION
                                                                                                          full text of the consent agreement                     chboehringersohnagcokgconsent by
                                                  [File No. 161 0077]                                     package can be obtained from the FTC                   following the instructions on the web-
                                                                                                          Home Page (for December 28, 2016), on                  based form. If this Notice appears at
                                                  C.H. Boehringer Sohn AG & Co. KG;                       the World Wide Web, at http://                         http://www.regulations.gov/#!home, you
                                                  Analysis To Aid Public Comment                          www.ftc.gov/os/actions.shtm.                           also may file a comment through that
                                                  AGENCY:    Federal Trade Commission.                       You can file a comment online or on                 Web site.
                                                                                                          paper. For the Commission to consider                     If you file your comment on paper,
                                                  ACTION:   Proposed Consent Agreement.
                                                                                                          your comment, we must receive it on or                 write ‘‘C.H. Boehringer Sohn AG & Co.
                                                  SUMMARY:   The consent agreement in this                before January 27, 2017. Write ‘‘C.H.                  KG File No. 1610077—Consent
                                                  matter settles alleged violations of                    Boehringer Sohn AG & Co. KG File No.                   Agreement’’ on your comment and on
                                                  federal law prohibiting unfair methods                  1610077—Consent Agreement’’ on your                    the envelope, and mail your comment to
                                                  of competition. The attached Analysis to                comment. Your comment—including                        the following address: Federal Trade
                                                  Aid Public Comment describes both the                   your name and your state—will be                       Commission, Office of the Secretary,
                                                  allegations in the complaint and the                    placed on the public record of this                    600 Pennsylvania Avenue NW., Suite
                                                  terms of the consent orders—embodied                    proceeding, including, to the extent                   CC–5610 (Annex D), Washington, DC
                                                  in the consent agreement—that would                     practicable, on the public Commission                  20580, or deliver your comment to the
                                                  settle these allegations.                               Web site, at http://www.ftc.gov/os/                    following address: Federal Trade
                                                  DATES: Comments must be received on                     publiccomments.shtm. As a matter of                    Commission, Office of the Secretary,
                                                  or before January 27, 2017.                             discretion, the Commission tries to                    Constitution Center, 400 7th Street SW.,
                                                                                                          remove individuals’ home contact                       5th Floor, Suite 5610 (Annex D),
                                                  ADDRESSES: Interested parties may file a
                                                                                                          information from comments before                       Washington, DC. If possible, submit
                                                  comment at https://
                                                                                                          placing them on the Commission Web                     your paper comment to the Commission
                                                  ftcpublic.commentworks.com/FTC/
                                                                                                          site.                                                  by courier or overnight service.
                                                  chboehringersohnagcokgconsent online                       Because your comment will be made
                                                  or on paper, by following the                                                                                     Visit the Commission Web site at
                                                                                                          public, you are solely responsible for
                                                  instructions in the Request for Comment                                                                        http://www.ftc.gov to read this Notice
                                                                                                          making sure that your comment does
                                                  part of the SUPPLEMENTARY INFORMATION                                                                          and the news release describing it. The
                                                                                                          not include any sensitive personal
                                                  section below. Write ‘‘C.H. Boehringer                  information, like anyone’s Social                      FTC Act and other laws that the
                                                  Sohn AG & Co. KG File No. 1610077—                      Security number, date of birth, driver’s               Commission administers permit the
                                                  Consent Agreement’’ on your comment                     license number or other state                          collection of public comments to
                                                  and file your comment online at https://                identification number or foreign country               consider and use in this proceeding as
                                                  ftcpublic.commentworks.com/FTC/                         equivalent, passport number, financial                 appropriate. The Commission will
                                                  chboehringersohnagcokgconsent by                        account number, or credit or debit card                consider all timely and responsive
                                                  following the instructions on the web-                  number. You are also solely responsible                public comments that it receives on or
                                                  based form. If you prefer to file your                  for making sure that your comment does                 before January 27, 2017. You can find
                                                  comment on paper, write ‘‘C.H.                          not include any sensitive health                       more information, including routine
                                                  Boehringer Sohn AG & Co. KG File No.                    information, like medical records or                   uses permitted by the Privacy Act, in
                                                  1610077—Consent Agreement’’ on your                     other individually identifiable health                 the Commission’s privacy policy, at
                                                  comment and on the envelope, and mail                   information. In addition, do not include               http://www.ftc.gov/ftc/privacy.htm.
                                                  your comment to the following address:                  any ‘‘[t]rade secret or any commercial or              Analysis of Agreement Containing
                                                  Federal Trade Commission, Office of the                 financial information which . . . is                   Consent Orders To Aid Public Comment
                                                  Secretary, 600 Pennsylvania Avenue                      privileged or confidential,’’ as discussed
                                                  NW., Suite CC–5610 (Annex D),                           in Section 6(f) of the FTC Act, 15 U.S.C.              Introduction
                                                  Washington, DC 20580, or deliver your                   46(f), and FTC Rule 4.10(a)(2), 16 CFR                    The Federal Trade Commission
                                                  comment to the following address:                       4.10(a)(2). In particular, do not include              (‘‘Commission’’) has accepted, subject to
                                                  Federal Trade Commission, Office of the                 competitively sensitive information                    final approval, an Agreement
                                                  Secretary, Constitution Center, 400 7th                 such as costs, sales statistics,
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                                                                                 Containing Consent Orders (‘‘Consent
                                                  Street SW., 5th Floor, Suite 5610                       inventories, formulas, patterns, devices,              Agreement’’) from C.H. Boehringer Sohn
                                                  (Annex D), Washington, DC 20024.                        manufacturing processes, or customer
                                                  FOR FURTHER INFORMATION CONTACT:                        names.                                                    1 In particular, the written request for confidential

                                                  Michael Barnett (202–326–2362),                            If you want the Commission to give                  treatment that accompanies the comment must
                                                                                                                                                                 include the factual and legal basis for the request,
                                                  Bureau of Competition, 600                              your comment confidential treatment,                   and must identify the specific portions of the
                                                  Pennsylvania Avenue NW., Washington,                    you must file it in paper form, with a                 comment to be withheld from the public record. See
                                                  DC 20580.                                               request for confidential treatment, and                FTC Rule 4.9(c), 16 CFR 4.9(c).



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                                                  848                          Federal Register / Vol. 82, No. 2 / Wednesday, January 4, 2017 / Notices

                                                  AG & Co. KG (‘‘Boehringer Ingelheim’’),                 company’s animal health division,                      is the next likely entrant. The Proposed
                                                  which is designed to remedy the                         Boehringer Ingelheim Vetmedica, Inc.,                  Acquisition would reduce the number
                                                  anticompetitive effects of Boehringer                   is the sixth-largest animal health                     of current or likely competitors in each
                                                  Ingelheim’s acquisition of the Merial                   supplier in the world.                                 market from four to three.
                                                  Animal Health business (‘‘Merial’’) from                   Sanofi is a multinational                              Feline vaccines prevent diseases
                                                  Sanofi. Under the terms of the proposed                 pharmaceutical company headquartered                   common to cats. The transaction raises
                                                  Decision and Order (‘‘Order’’) contained                in Gentilly, France. The company                       competitive concerns in the feline
                                                  in the Consent Agreement, Boehringer                    develops and markets a diverse portfolio               vaccine markets for five diseases:
                                                  Ingelheim is required to divest its                     of products, including pharmaceuticals,                Panleukopenia, calicivirus, viral
                                                  relevant U.S. companion animal vaccine                  human vaccines, and, through its                       rhinotracheitis, Chlamydia psittaci
                                                  business to Eli Lily and Company,                       subsidiary Merial, animal health                       bacterium, and feline leukemia. The
                                                  which participates in the animal health                 products. Merial is the fourth-largest                 feline vaccine industry in the United
                                                  industry through its Elanco Animal                      animal health supplier in the world.                   States is highly concentrated with the
                                                  Health (‘‘Elanco’’) division. Boehringer                                                                       same four market participants—
                                                  Ingelheim is also required to divest its                The Relevant Products and Structure of                 Boehringer Ingelheim, Merial, Zoetis,
                                                  U.S. Cydectin parasiticide product to                   the Markets                                            and Merck—as the canine vaccine
                                                  Bayer AG (‘‘Bayer’’).                                   Companion Animal Vaccines                              industry. In 2015, these four companies
                                                     The proposed Consent Agreement has                                                                          had market shares of approximately
                                                                                                             There are three classes of companion
                                                  been placed on the public record for                                                                           28%, 33%, 16%, and 23%, respectively,
                                                                                                          animal vaccines in which to analyze the
                                                  thirty days for receipt of comments from                                                                       of all revenues from feline vaccines sold
                                                                                                          effects of the Proposed Acquisition:
                                                  interested persons. Comments received                                                                          in the United States and comparable
                                                                                                          Canine vaccines, feline vaccines, and
                                                  during this period will become part of                                                                         shares in each relevant market. The
                                                                                                          rabies vaccines. A vaccine is a version                proposed transaction would combine
                                                  the public record. After thirty days, the
                                                  Commission will again evaluate the                      of an antigen that triggers an immune                  the two leading feline vaccine suppliers,
                                                  proposed Consent Agreement, along                       response to the antigen but not the                    reducing the number of competitors in
                                                  with the comments received, in order to                 disease, causing the animal to develop                 each market from four to three.
                                                  make a final decision as to whether it                  an immunity that prevents the disease.                    The rabies virus, transmitted through
                                                  should withdraw from the proposed                       Only vaccines containing an antigen of                 bites from infected animals, triggers a
                                                  Consent Agreement, modify it, or make                   a specific virus can provide the desired               fatal neurological condition culminating
                                                  it final.                                               immunity response to that virus and the                in paralysis, respiratory failure, and
                                                                                                          corresponding disease. No substitute                   eventual death. Because this fatal
                                                  The Transaction                                         product immunizes against a disease.                   disease is transmittable to humans, most
                                                     Pursuant to an Exclusivity Agreement                 Nor is treatment following infection a                 U.S. states have mandatory rabies
                                                  dated December 15, 2015, Boehringer                     substitute for the vaccinations at issue.              vaccination requirements. Regular
                                                  Ingelheim proposes to swap its                          For these reasons, each vaccine                        vaccination for all animals is the only
                                                  consumer health care business for                       containing an antigen to immunize                      means of protection, and there are no
                                                  Sanofi’s Merial animal health business                  against a particular disease constitutes a             substitutes for rabies vaccines. All
                                                  (the ‘‘Proposed Acquisition’’). In the                  relevant market in which to analyze the                rabies vaccines are approved for use in
                                                  proposed swap, Boehringer Ingelheim                     effects of the acquisition.                            both dogs and cats, although some are
                                                  obtains Merial, valued at $13.53 billion,                  Canine vaccines prevent specific                    approved for use in additional species
                                                  and Sanofi obtains Boehringer                           illnesses in dogs. The Proposed                        as well. The market for the sale of rabies
                                                  Ingelheim’s Consumer Health Care                        Acquisition raises competitive concerns                vaccines in the United States is highly
                                                  business unit, valued at $7.98 billion, as              in the markets for seven canine                        concentrated. Boehringer Ingelheim,
                                                  well as cash compensation of $5.54                      vaccines: Canine distemper virus,                      Merial, Zoetis, and Merck are the only
                                                  billion. The Commission alleges in its                  canine parvovirus, leptospirosis, canine               four significant suppliers of rabies
                                                  Complaint that the Proposed                             adenovirus, canine parainfluenza virus,                vaccines in the United States, with
                                                  Acquisition, if consummated, would                      canine coronavirus, and borreliosis                    market shares of 10%, 65%, 13%, and
                                                  violate Section 7 of the Clayton Act, as                (‘‘Lyme disease’’). In addition, the                   12% of revenues, respectively.
                                                  amended, 15 U.S.C. 18, and Section 5 of                 proposed transaction raises future
                                                  the Federal Trade Commission Act, as                    competition concerns in the canine                     Cattle and Sheep Parasiticides
                                                  amended, 15 U.S.C. 45, in the U.S.                      vaccine market for Bordetella                             Parasiticides prevent and control
                                                  markets for two types of animal health                  bronchiseptica bacterium, in which                     outbreaks of parasites such as worms,
                                                  products: (1) Companion animal                          Boehringer Ingelheim currently                         flies, lice, and ticks.
                                                  vaccines—which include various                          competes and Merial is the most likely
                                                                                                          entrant in the near future. The canine                 Cattle Parasiticides
                                                  canine, feline, and rabies vaccines—and
                                                  (2) cattle and sheep parasiticides. The                 vaccine markets are highly                               Parasiticides are a key part of cattle
                                                  proposed Consent Agreement will                         concentrated. Boehringer Ingelheim,                    health care regimens. If left unchecked,
                                                  remedy the alleged violations by                        Merial, Zoetis, Inc. (‘‘Zoetis’’), and                 parasites reduce milk production in
                                                  preserving the competition that would                   Merck & Co. (‘‘Merck’’) are the only four              dairy cattle and prevent weight gain in
                                                  otherwise be eliminated by the                          suppliers offering or likely to offer                  beef cattle. There are two primary types
                                                  Proposed Acquisition.                                   canine vaccines in the United States. In               of cattle parasiticides: Macrocyclic
                                                                                                          2015, Boehringer Ingelheim, Merial,                    lactones, which prevent both internal
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                                                  The Parties                                             Zoetis and Merck had market shares of                  and external parasites, and
                                                    Headquartered in Germany,                             approximately 30%, 11%, 35%, and                       benzimidazoles, which prevent only
                                                  Boehringer Ingelheim is one of the                      24%, respectively, of all revenues from                internal parasites. Because macrocyclic
                                                  world’s leading pharmaceutical                          canine vaccines sold in the United                     lactones reach a much broader spectrum
                                                  companies. It manufacturers, researches,                States and comparable shares in each                   of parasites, other parasiticides,
                                                  develops and markets an array of human                  relevant market, except Bordetella                     including benzimidazoles, are not viable
                                                  and animal health products. The                         bronchiseptica bacterium, where Merial                 substitutes.


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                                                                               Federal Register / Vol. 82, No. 2 / Wednesday, January 4, 2017 / Notices                                                849

                                                    Boehringer Ingelheim, Merial, and                     Oral Drench and Merial offers Ivomec                   companion animal vaccine business to
                                                  Zoetis are the three primary participants               Oral Drench. Following the Proposed                    Elanco no later than ten days after the
                                                  in the macrocyclic lactone cattle                       Acquisition, the merged firm would                     consummation of the Proposed
                                                  parasiticide market, and the Proposed                   control more than 78% of this market.                  Acquisition or on the date on which the
                                                  Acquisition would combine the two                       The other macrocyclic lactone sheep                    proposed Order becomes final,
                                                  most significant competitors. Merial, the               parasiticides are generic versions of the              whichever is earlier. Similarly, the
                                                  market leader, offers three brands:                     Merial product, which are of limited                   proposed Order requires Boehringer
                                                  Ivomec, Eprinex, and LongRange. After                   competitive significance.                              Ingelheim to divest all of its respective
                                                  Merial, Boehringer Ingelheim is the next                                                                       U.S. rights and interests in its
                                                  largest supplier of macrocyclic lactone                 Relevant Geographic Market                             parasiticide product, Cydectin, to Bayer.
                                                  cattle parasiticides. Boehringer                          The United States is the relevant                    These divestitures include all regulatory
                                                  Ingelheim’s sole product is Cydectin, a                 geographic market in which to assess                   approvals, brand names, marketing
                                                  parasiticide that is functionally                       the competitive effects of the Proposed                materials, confidential business
                                                  identical to Ivomec and Eprinex for beef                Acquisition. The USDA must approve                     information, customer information, and
                                                  cattle. Zoetis also offers a macrocyclic                companion animal vaccines before they                  other assets associated with marketing
                                                  lactone product, Dectomax, that is                      are sold in the United States. Cattle and              and selling both products. To ensure the
                                                  similar to the products of Merial and                   sheep parasiticides must be approved by                divestitures are successful, the proposed
                                                  Boehringer Ingelheim. Merial,                           the FDA before being sold in the United                Order requires Boehringer Ingelheim to
                                                  Boehringer Ingelheim and Zoetis                         States. Thus, products sold outside the                secure all third-party consents and
                                                  accounted for 45%, 22%, and 17% of                      United States, but not approved for sale               waivers required to permit both buyers
                                                  revenues, respectively, of U.S. sales in                in the United States, are not alternatives             to conduct business with the divested
                                                  2015. Beyond these three companies,                     for U.S. consumers.                                    assets. Additionally, Elanco and Bayer
                                                  multiple manufacturers produce generic                                                                         also will have the right to interview and
                                                                                                          Entry                                                  offer employment to employees
                                                  versions of Merial’s Ivomec. Although
                                                  these generic products are significantly                  Entry into the U.S. markets for                      associated with the divested businesses.
                                                  cheaper than the branded products, they                 companion animal vaccines and cattle                      Elanco is an experienced supplier in
                                                  have limited competitive significance.                  and sheep parasiticides would not be                   the global animal health industry and
                                                  Many customers prefer the branded                       timely, likely or sufficient in magnitude,             has the resources and expertise to
                                                  products because the branded product                    character and scope to deter or                        replicate Boehringer Ingelheim’s role in
                                                  manufacturers offer valuable technical                  counteract the anticompetitive effects of              the companion animal vaccine markets.
                                                  support, field support, and education. In               the Proposed Acquisition. Three major                  In 2015, Elanco generated
                                                  addition, many customers also perceive                  obstacles stand in the way of a                        approximately $1 billion in revenue.
                                                  the generic products to be inferior and                 prospective entrant into the relevant                  Elanco currently offers a limited
                                                  unreliable, preferring to pay a higher                  markets: Lengthy development periods,                  portfolio of companion animal
                                                  price for the guaranteed success of                     FDA and USDA approval requirements,                    pharmaceutical products such as
                                                  branded products.                                       and difficulty of establishing a brand                 parasiticides, pain relievers, and
                                                    Merial and Boehringer Ingelheim are                   name and reputation and convincing                     dermatological products. Elanco,
                                                  the only two macrocyclic lactone cattle                 veterinarians to prescribe new products.               however, is not a meaningful participant
                                                  parasiticide suppliers that offer ‘‘zero-                                                                      in any of the companion animal
                                                  day milk withhold’’ products—Cydectin                   Effects of the Acquisition                             vaccines subject to divestiture, and its
                                                  and Eprinex, respectively. The Proposed                    The Proposed Acquisition would                      proposed acquisition of those assets will
                                                  Acquisition would eliminate the                         cause significant competitive harm to                  complement and expand its existing
                                                  competition between them, effectively                   consumers in the relevant U.S. markets                 companion animal portfolio. Elanco is
                                                  leaving dairy cattle customers with a                   for companion animal vaccines and                      well positioned to replicate immediately
                                                  sole supplier.                                          cattle and sheep parasiticides by                      Boehringer Ingelheim’s competitive
                                                                                                          eliminating actual or future, direct, and              position in all companion animal
                                                  Sheep Parasiticides
                                                                                                          substantial competition between                        vaccine markets.
                                                    Sheep parasiticides are critical for                  Boehringer Ingelheim and Merial. The                      Bayer is similarly well qualified to
                                                  optimizing wool and meat production.                    transaction would increase the                         replicate Boehringer Ingelheim’s
                                                  Sheep parasiticides utilize the same                    likelihood that Boehringer Ingelheim                   competitive position in the United
                                                  compounds as cattle parasiticides, but                  will be able to unilaterally exercise                  States with respect to the Cydectin
                                                  use a different route of administration.                market power, increase the likelihood of               product line. Bayer is currently the fifth-
                                                  Because a sheep’s wool and skin                         coordinated interaction between or                     largest animal health company both
                                                  prevent the absorption of topical                       among suppliers, and increase the                      worldwide and in the United States.
                                                  products and the thickness of a sheep’s                 likelihood that consumers will pay                     Bayer had 2015 worldwide sales of $1.6
                                                  wool makes injections difficult,                        higher prices.                                         billion, of which $595 million derived
                                                  customers view oral administration as                                                                          from its animal health business. Bayer
                                                  the only viable option for sheep                        The Consent Agreement                                  does not currently offer a parasiticide
                                                  parasiticides. Both macrocyclic lactones                   The proposed Consent Agreement                      that controls external and internal
                                                  and benzimidazoles can be used as                       effectively remedies the Proposed                      parasites to cattle and sheep farmers.
                                                  sheep parasiticides, but benzimidazoles                 Acquisition’s anticompetitive effects by               However, Bayer offers a variety of other
                                                  are not economic substitutes for                        requiring Boehringer Ingelheim to divest               products to cattle and sheep farmers,
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                                                  macrocyclic lactones in most cases                      its relevant companion animal vaccine                  such as ear tags and external parasite
                                                  because they do not treat external                      business and certain of its cattle and                 control products.
                                                  parasites and are less efficacious.                     sheep parasiticides assets to Elanco and                  The Commission has agreed to
                                                    Merial and Boehringer Ingelheim are                   Bayer, respectively.                                   appoint a Monitor to ensure that
                                                  the two primary suppliers of                               Under the proposed Order,                           Boehringer Ingelheim complies with all
                                                  macrocyclic lactone sheep parasiticides.                Boehringer Ingelheim will divest its                   of its obligations pursuant to the
                                                  Boehringer Ingelheim offers Cydectin                    relevant U.S. rights and interests in its              Consent Agreement and to keep the


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                                                  850                          Federal Register / Vol. 82, No. 2 / Wednesday, January 4, 2017 / Notices

                                                  Commission informed about the status                    Floor, Washington, DC 20201.                           facilitating the institution of
                                                  of the transfer of the rights and assets to             Comments received will be available for                proceedings with respect to
                                                  Elanco and Bayer.                                       public inspection at this address from                 applications; establishing paternity and
                                                     The Commission’s goal in evaluating                  9:00 a.m. to 5:00 p.m. EST, Monday                     support orders; recognizing, modifying,
                                                  possible purchasers of divested rights                  through Friday.                                        and enforcing such orders; collecting
                                                  and assets is to maintain the                           DATES: The Convention will enter into                  and distributing payments under such
                                                  competitive environment that existed                    force for the United States on January 1,              orders; and providing administrative
                                                  prior to the Proposed Acquisition. If the               2017.                                                  and legal services without cost to
                                                  Commission determines that either                       FOR FURTHER INFORMATION CONTACT: The                   applicants.
                                                  buyer is not an acceptable acquirer, or                 Division of Policy and Training, Office                  Statutory Authority: Section 459(a) of the
                                                  that the manner of the divestiture is not               of Child Support Enforcement,                          Social Security Act (42 U.S.C. 659(a)
                                                  acceptable, the proposed Order requires                 Administration for Children and                          Dated: December 29, 2016.
                                                  the parties to unwind the sale and then                 Families, 330 C Street SW., 5th Floor,                 Mark H. Greenberg,
                                                  divest the products to another                          Washington, DC 20201.
                                                  Commission-approved acquirer within                                                                            Acting Assistant Secretary for Children and
                                                                                                          SUPPLEMENTARY INFORMATION: The                         Families.
                                                  six months of the date that the proposed                President signed the Instrument of
                                                  Order becomes final. The proposed                                                                              [FR Doc. 2016–31895 Filed 1–3–17; 8:45 am]
                                                                                                          Ratification on August 30, 2016, and the               BILLING CODE 4184–42–P
                                                  Order further allows the Commission to                  United States of America deposited its
                                                  appoint a trustee in the event the parties              Instrument of Ratification of the
                                                  fail to divest the products.                            Convention on September 7, 2016. The
                                                     The purpose of this analysis is to                                                                          DEPARTMENT OF HEALTH AND
                                                                                                          Convention will enter into force for the               HUMAN SERVICES
                                                  facilitate public comment on the                        United States on January 1, 2017.
                                                  proposed Consent Agreement, and it is                   Section 459A of the Social Security Act                Food and Drug Administration
                                                  not intended to constitute an official                  (42 U.S.C. 659a) and Executive Order
                                                  interpretation of the proposed Order or                                                                        [Docket No. FDA–2016–N–0001]
                                                                                                          13752, 81 FR 90181 (Dec. 8, 2016)
                                                  to modify its terms in any way.                         designate the Department of Health and                 Advisory Committee; Technical
                                                   By direction of the Commission.                        Human Services as the Central                          Electronic Product Radiation Safety
                                                  April J. Tabor,                                         Authority of the United States for                     Standards Committee, Renewal
                                                  Acting Secretary.                                       purposes of the Convention, and
                                                                                                          authorize the Secretary of Health and                  AGENCY:   Food and Drug Administration,
                                                  [FR Doc. 2016–31848 Filed 1–3–17; 8:45 am]
                                                                                                          Human Services to perform all lawful                   HHS.
                                                  BILLING CODE 6750–01–P
                                                                                                          acts that may be necessary and proper                  ACTION:Notice; renewal of advisory
                                                                                                          in order to execute the functions of the               committee.
                                                                                                          Central Authority. Article 6(3) of the
                                                  DEPARTMENT OF HEALTH AND                                                                                       SUMMARY:    The Food and Drug
                                                                                                          Convention authorizes the designation
                                                  HUMAN SERVICES                                                                                                 Administration (FDA) is announcing the
                                                                                                          of public bodies to perform specific
                                                                                                          functions under the Convention, subject                renewal of the Technical Electronic
                                                  Administration for Children and                                                                                Product Radiation Safety Standards
                                                  Families                                                to the supervision of the Central
                                                                                                          Authority. The Executive Order                         Committee by the Commissioner of
                                                                                                          specifically authorizes the designation                Food and Drugs (the Commissioner).
                                                  Notice Designating State Title IV–D
                                                                                                          of the state agencies responsible for                  The Commissioner has determined that
                                                  Child Support Agencies as ‘‘Public
                                                                                                          implementing an approved State Plan                    it is in the public interest to renew the
                                                  Bodies’’
                                                                                                          under title IV–D of the Social Security                Technical Electronic Product Radiation
                                                  AGENCY: Office of Child Support                         Act, 42 U.S.C. 651 et seq., as public                  Safety Standards Committee for an
                                                  Enforcement, Administration for                         bodies authorized to perform specific                  additional 2 years beyond the charter
                                                  Children and Families, Department of                    functions in relation to applications                  expiration date. The new charter will be
                                                  Health and Human Services.                              under the Convention. All states have                  in effect until December 24, 2018.
                                                  ACTION: Notice.                                         enacted the Uniform Interstate Family                  DATES: Authority for the Technical
                                                                                                          Support Act of 2008 (UIFSA 2008) to                    Electronic Product Radiation Safety
                                                  SUMMARY:   This notice designates state                                                                        Standards Committee will expire on
                                                                                                          enable uniform implementation of the
                                                  IV–D child support agencies as public                                                                          December 24, 2016, unless the
                                                                                                          Convention in the United States.
                                                  bodies authorized to perform specific                     Under authority delegated by the                     Commissioner formally determines that
                                                  functions of the Central Authority under                Secretary for administration of the title              renewal is in the public interest.
                                                  Article 6(3) of the the Hague Convention                IV–D program, I hereby designate the                   FOR FURTHER INFORMATION CONTACT:
                                                  of 23 November 2007 on the                              state title IV–D child support agencies                Shanika Craig, Center for Devices and
                                                  International Recovery of Child Support                 as public bodies authorized to perform                 Radiological Health, Food and Drug
                                                  and Other Forms of Family Maintenance                   functions related to applications under                Administration, 10903 New Hampshire
                                                  (Convention).and specifies functions to                 the Convention in accordance with                      Ave., Bldg. 66, Rm. 1613, Silver Spring,
                                                  be performed by the state agencies in                   UIFSA 2008, title IV–D and title IV–D                  MD, 20993–0002, 301–796–6639,
                                                  relation to applications under the                      regulations, and guidance and                          Shanika.Craig@fda.hhs.gov
                                                  Convention.                                             instructions, subject to the supervision               SUPPLEMENTARY INFORMATION: Pursuant
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                                                  ADDRESSES:   Interested parties may                     of the federal Office of Child Support                 to 41 CFR 102–3.65 and approval by the
                                                  submit written comments on this notice                  Enforcement. Such functions shall                      Department of Health and Human
                                                  to the United States Central Authority                  include the provision of support                       Services pursuant to 45 CFR part 11 and
                                                  for International Child Support,                        enforcement services to applicants                     by the General Services Administration,
                                                  Department of Health and Human                          under the Convention, including:                       FDA is announcing the renewal of the
                                                  Services, Office of Child Support                       Transmitting and receiving applications                Technical Electronic Product Radiation
                                                  Enforcement, 330 C Street SW., 5th                      under the Convention; initiating or                    Safety Standards Committee. The


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Document Created: 2017-01-04 00:29:37
Document Modified: 2017-01-04 00:29:37
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 27, 2017.
ContactMichael Barnett (202-326-2362), Bureau of Competition, 600 Pennsylvania Avenue NW., Washington, DC 20580.
FR Citation82 FR 847 

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