80 FR 52475 - Pfizer Inc. and Hospira, Inc.; Analysis of Proposed Consent Orders To Aid Public Comment
FEDERAL TRADE COMMISSION Federal Register Volume 80, Issue 168 (August 31, 2015)
Federal Register Volume 80, Issue 168 (August 31, 2015)
| Page Range | 52475-52478 | |
| FR Document | 2015-21513 |
[Federal Register Volume 80, Number 168 (Monday, August 31, 2015)] [Notices] [Pages 52475-52478] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-21513] ======================================================================= ----------------------------------------------------------------------- FEDERAL TRADE COMMISSION [File No. 151 0074] Pfizer Inc. and Hospira, Inc.; Analysis of Proposed Consent Orders To Aid Public Comment AGENCY: Federal Trade Commission. ACTION: Proposed Consent Agreement. ----------------------------------------------------------------------- SUMMARY: The consent agreement in this matter settles alleged violations of federal law prohibiting unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent orders-- embodied in the consent agreement--that would settle these allegations. DATES: Comments must be received on or before September 23, 2015. ADDRESSES: Interested parties may file a comment at https://ftcpublic.commentworks.com/ftc/pfizerhospiraconsent online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write ``Pfizer Hospira Consent, File No. 151 0074'' on your comment and file your comment online at https://ftcpublic.commentworks.com/ftc/pfizerhospiraconsent by following the instructions on the web-based form. If you prefer to file your comment on paper, write ``Pfizer Hospira Consent, File No. 151 0074'' 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: Kari A. Wallace, Bureau of Competition, (202-326-3085), 600 Pennsylvania Avenue NW., Washington, DC 20580. [[Page 52476]] 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, have 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 August 24, 2015), on the World Wide Web, at http://www.ftc.gov/os/actions.shtm. You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before September 23, 2015. Write ``Pfizer Hospira Consent, File No. 151 0074'' on your comment. Your comment--including your name and your state--will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission Web site. Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any ``[t]rade secret or any commercial or financial information which . . . is privileged or confidential,'' as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names. If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).\1\ Your comment will be kept confidential only if the FTC General Counsel, in his or her sole discretion, grants your request in accordance with the law and the public interest. --------------------------------------------------------------------------- \1\ In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c), 16 CFR 4.9(c). --------------------------------------------------------------------------- Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/pfizerhospiraconsent 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 ``Pfizer Hospira Consent, File No. 151 0074'' on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service. Visit the Commission Web site at http://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before September 23, 2015. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see http://www.ftc.gov/ftc/privacy.htm. Analysis of Agreement Containing Consent Orders To Aid Public Comment The Federal Trade Commission (``Commission'') has accepted, subject to final approval, an Agreement Containing Consent Orders (``Consent Agreement'') from Pfizer Inc. (``Pfizer'') and Hospira, Inc. (``Hospira'') that is designed to remedy the anticompetitive effects resulting from Pfizer's acquisition of Hospira. Under the terms of the proposed Consent Agreement, the parties are required to divest all of Pfizer's rights and assets related to generic acetylcysteine inhalation solution and all Hospira's rights and assets related to clindamycin phosphate injection, voriconazole injection, and melphalan hydrochloride injection to Alvogen Group, Inc. (``Alvogen''). 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, to make a final decision as to whether it should withdraw from the proposed Consent Agreement or make final the Decision and Order (``Order''). Pursuant to an Agreement and Plan of Merger executed on February 5, 2015, Pfizer proposes to acquire Hospira for approximately $16 billion (the ``Proposed Acquisition''). 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, by lessening current competition in the markets for generic acetylcysteine inhalation solution and clindamycin phosphate injection and future competition in the markets for voriconazole injection and melphalan hydrochloride injection in the United States. The proposed Consent Agreement will remedy the alleged violations by preserving the competition that otherwise would be eliminated by the Proposed Acquisition. I. The Products and Structure of the Markets The Proposed Acquisition would reduce the number of current suppliers in the markets for generic acetylcysteine inhalation solution and clindamycin phosphate injection, and reduce the number of future suppliers in the markets for voriconazole injection and melphalan hydrochloride injection. Generic acetylcysteine inhalation solution is a mucolytic therapy used to treat certain respiratory disorders. Acetylcysteine liquefies mucus in the lungs, which then can be coughed or suctioned out. Patients inhale the solution through a nebulizer mask, facemask, mouthpiece, tent, or intermittent positive pressure-breathing machine. Only three companies--Fresenius Kabi, partnered with Gland Pharma Ltd. and Pfizer; Hospira; and [[Page 52477]] American Regent, Inc.--supply generic acetylcysteine inhalation solution in the United States. The branded version of this product, Mucomyst, is no longer available. Fresenius/Gland/Pfizer is the market leader with an approximately 69% share and Hospira has an approximately 22% share. Clindamycin phosphate injection is an antibiotic used to treat lung, skin, blood, bone, joint, and gynecological infections in hospitals. Currently, only four companies supply the product in the United States: Pfizer, Hospira, Sagent Pharmaceuticals, and Fresenius Kabi. While Pfizer's clindamycin phosphate product is a branded version, the price of Pfizer's product is competitive with the generic products. Customers, therefore, play the branded and the generic products against each other to negotiate prices. Pfizer and Hospira have a combined approximate market share of more than 80%. Voriconazole injection is an antifungal medication used to treat significant fungal infections in hospitals. Pfizer currently sells its Vfend brand voriconazole injection product priced competitively with the only generic version in the United States, which is offered by Sandoz. Hospira is one of a limited number of suppliers capable of entering the voriconazole injection market in the near future. Melphalan hydrochloride injection is a chemotherapy agent used to treat multiple myeloma and ovarian cancer. There are currently two melphalan hydrochloride injection products available in the United States: The branded version, which was originally developed and marketed by Glaxo Smith Kline and is now supplied by ApoPharma USA, Inc. (``ApoPharma''), and the generic version, sold by Mylan N.V. (``Mylan''). ApoPharma prices its branded version of the product competitively with the generic version offered by Mylan. Pfizer and Hospira are developing melphalan hydrochloride injection products, and are two of a limited number of suppliers capable of entering the market in the near future. II. Entry Entry into the four markets described earlier would not be timely, likely, or sufficient in magnitude, character, and scope to deter or counteract the anticompetitive effects of the Proposed Acquisition. The combination of drug development times and regulatory requirements, including approval by the United States Food and Drug Administration (``FDA''), is costly and lengthy. III. Effects In markets for pharmaceutical products used primarily in hospitals, like the products here, branded drug manufacturers are typically unable to command a premium price for their products because of the reimbursement structure for drugs administered in hospitals. Hospitals typically would not be reimbursed for using a premium-priced branded injectable product, when lower-priced therapeutically equivalent products are available. As a result, brand manufacturers of sterile injectable or inhalation products may lower their prices and compete directly with generic manufacturers' products. Customers tend to gravitate to the lowest-priced product, regardless of whether the drug was approved by the FDA as a brand or a generic product. Like true generic pharmaceutical markets, these multi-source pharmaceutical products generally are commodities, and prices often are inversely correlated with the number of competitors in each market. As the number of suppliers offering a therapeutically equivalent drug increases, the price for that drug decreases due to the direct competition between the existing suppliers and each additional supplier. The Proposed Acquisition would eliminate the current competition between two of the three competitors in the market for generic acetylcysteine inhalation solution, resulting in a duopoly and likely price increases. Similarly, in the market for clindamycin phosphate solution, the Proposed Acquisition would eliminate competition between two of only four current competitors, leading to higher prices. In addition, the Proposed Acquisition likely would cause significant anticompetitive harm to consumers by eliminating future competition that would otherwise have occurred if Pfizer and Hospira remained independent. The evidence shows that anticompetitive effects are likely to result from the Proposed Acquisition due to the elimination of an additional independent entrant in the currently concentrated markets for voriconazole injection and melphalan hydrochloride injection, which would have enabled customers to negotiate lower prices. Customers and competitors have observed--and pricing data confirms--that the price of these pharmaceutical products decreases with new entry even after several other suppliers have entered the market. Thus, absent a remedy, the Proposed Acquisition will likely cause U.S. consumers to pay significantly higher prices for voriconazole injection and melphalan hydrochloride injection. IV. The Consent Agreement The proposed Consent Agreement effectively remedies the competitive concerns raised by the acquisition in all four markets at issue by requiring Pfizer to divest all its rights to generic acetylcysteine inhalation solution and Hospira to divest all of its rights and assets related to clindamycin phosphate injection, voriconazole injection, and melphalan hydrochloride injection to Alvogen. Alvogen is a private, global pharmaceutical corporation that develops, manufacturers, sells, and distributes generic pharmaceuticals in the United States and in 33 other countries around the world. The parties must accomplish these divestitures and relinquish their rights no later than ten days after the Proposed Acquisition is consummated. The Commission's goal in evaluating possible purchasers of divested assets is to maintain the competitive environment that existed prior to the Proposed Acquisition. If the Commission determines that Alvogen is not an acceptable acquirer, or that the manner of the divestitures is not acceptable, the proposed Order requires the parties to unwind the sale of rights to Alvogen and then divest the products to a Commission- approved acquirer within six months of the date the Order becomes final. The proposed Order further allows the Commission to appoint a trustee in the event the parties fail to divest the products as required. The proposed Consent Agreement and Order contain several provisions to help ensure that the divestitures are successful. Alvogen will acquire Pfizer's acetylcysteine inhalation ANDA and stream of revenue associated with the product and will assume Pfizer's role in the contractual relationships with the third parties. Pfizer/Hospira will supply Alvogen with the clindamycin phosphate injection products for three years while the company transfers the manufacturing technology to Alvogen or its designee. Similarly, Pfizer/Hospira will transfer the third-party development and contract manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to Alvogen. The proposed Order also requires Pfizer and Hospira to provide transitional services to Alvogen to assist it in establishing its manufacturing capabilities and securing all of the necessary FDA approvals. These transitional services include technical assistance to manufacture clindamycin in substantially the same manner and quality employed or [[Page 52478]] achieved by Hospira, and advice and training from knowledgeable employees of the parties. 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. Donald S. Clark, Secretary. [FR Doc. 2015-21513 Filed 8-28-15; 8:45 am] BILLING CODE 6750-01-P
![Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Notices 52475
there are impacts under the Privacy Act. requirements as part of this information Market Street, San Francisco, California
The FCC’s system of records notice collection, because they are no longer 94105–1579:
(SORN), FCC/WCB–1, ‘‘Lifeline applicable; revise the FCC Form 555 and 1. KEDAP S.A. de C.V., Mexico City,
Program.’’ The Commission will use the the accompanying instructions to Mexico; to become a bank holding
information contained in FCC/WCB–1 require ETCs to provide a Service company by acquiring at least 34
to cover the personally identifiable Provider Identification Number (SPIN); percent of the voting shares of
information (PII) that is required as part and make non-substantive changes to Commerce Bank of Temecula Valley,
of the Lifeline Program (‘‘Lifeline’’). As this information collection, pursuant to Murrieta, California.
required by the Privacy Act of 1974, as 44 U.S.C. 3507, to update the FCC Form Board of Governors of the Federal Reserve
amended, 5 U.S.C. 552a, the 497 Instructions and require the System, August 26, 2015.
Commission also published a SORN, electronic filing of the FCC Forms 497 Michael J. Lewandowski,
FCC/WCB–1 ‘‘Lifeline Program’’ in the and 555. These updates do not modify Associate Secretary of the Board.
Federal Register on December 6, 2013 the burdens or costs contained in this [FR Doc. 2015–21461 Filed 8–28–15; 8:45 am]
(78 FR 73535). information collection. BILLING CODE 6210–01–P
Also, respondents may request
Federal Communications Commission.
materials or information submitted to
the Commission or to the Universal Gloria J. Miles,
Service Administrative Company Federal Register Liaison Officer. FEDERAL TRADE COMMISSION
(USAC or Administrator) be withheld [FR Doc. 2015–21407 Filed 8–28–15; 8:45 am] [File No. 151 0074]
from public inspection under 47 CFR BILLING CODE 6712–01–P
0.459 of the FCC’s rules. We note that Pfizer Inc. and Hospira, Inc.; Analysis
USAC must preserve the confidentiality of Proposed Consent Orders To Aid
of all data obtained from respondents; Public Comment
must not use the data except for FEDERAL RESERVE SYSTEM
AGENCY: Federal Trade Commission.
purposes of administering the universal
service programs; and must not disclose Formations of, Acquisitions by, and ACTION: Proposed Consent Agreement.
data in company-specific form unless Mergers of Bank Holding Companies
SUMMARY: The consent agreement in this
directed to do so by the Commission. The companies listed in this notice matter settles alleged violations of
Needs and Uses: The Commission federal law prohibiting unfair methods
have applied to the Board for approval,
will submit this information collection of competition. The attached Analysis to
pursuant to the Bank Holding Company
after this comment period to obtain the Aid Public Comment describes both the
Act of 1956 (12 U.S.C. 1841 et seq.)
full, three year clearance from the Office allegations in the draft complaint and
(BHC Act), Regulation Y (12 CFR part
of Management and Budget (OMB). The the terms of the consent orders—
225), and all other applicable statutes
Commission also proposes several embodied in the consent agreement—
and regulations to become a bank
revisions to this information collection. that would settle these allegations.
holding company and/or to acquire the
In June 2015, the Commission adopted
assets or the ownership of, control of, or DATES: Comments must be received on
an order reforming its low-income
the power to vote shares of a bank or or before September 23, 2015.
universal service support mechanisms.
Lifeline and Link Up Reform and bank holding company and all of the ADDRESSES: Interested parties may file a
Modernization; Telecommunications banks and nonbanking companies comment at https://
Carriers Eligible for Universal Service owned by the bank holding company, ftcpublic.commentworks.com/ftc/
Support; Connect America Fund, WC including the companies listed below. pfizerhospiraconsent online or on
Docket Nos. 11–42, 09–197, 10–90, The applications listed below, as well paper, by following the instructions in
Second Further Notice of Proposed as other related filings required by the the Request for Comment part of the
Rulemaking, Order on Reconsideration, Board, are available for immediate SUPPLEMENTARY INFORMATION section
Second Report and Order, and inspection at the Federal Reserve Bank below. Write ‘‘Pfizer Hospira Consent,
Memorandum Opinion and Order, indicated. The applications will also be File No. 151 0074’’ on your comment
(Lifeline Second Reform Order). This available for inspection at the offices of and file your comment online at https://
revised information collection addresses the Board of Governors. Interested ftcpublic.commentworks.com/ftc/
requirements to carry out the programs persons may express their views in pfizerhospiraconsent by following the
to which the Commission committed writing on the standards enumerated in instructions on the web-based form. If
itself in the Lifeline Second Reform the BHC Act (12 U.S.C. 1842(c)). If the you prefer to file your comment on
Order. Under this information proposal also involves the acquisition of paper, write ‘‘Pfizer Hospira Consent,
collection, the Commission seeks to a nonbanking company, the review also File No. 151 0074’’ on your comment
revise the information collection to includes whether the acquisition of the and on the envelope, and mail your
comply with the Commission’s new nonbanking company complies with the comment to the following address:
rules, adopted in the 2015 Lifeline standards in section 4 of the BHC Act Federal Trade Commission, Office of the
Second Reform Order, regarding the (12 U.S.C. 1843). Unless otherwise Secretary, 600 Pennsylvania Avenue
retention of subscriber eligibility noted, nonbanking activities will be NW., Suite CC–5610 (Annex D),
documentation, eligible conducted throughout the United States. Washington, DC 20580, or deliver your
telecommunications carrier (ETC) Unless otherwise noted, comments comment to the following address:
designation, and ETC reimbursement regarding each of these applications Federal Trade Commission, Office of the
tkelley on DSK3SPTVN1PROD with NOTICES
under the Lifeline program; update the must be received at the Reserve Bank Secretary, Constitution Center, 400 7th
number of respondents for all the indicated or the offices of the Board of Street SW., 5th Floor, Suite 5610
existing information collection Governors not later than September 25, (Annex D), Washington, DC 20024.
requirements, thus increasing the total 2015. FOR FURTHER INFORMATION CONTACT: Kari
burden hours for some requirements A. Federal Reserve Bank of San A. Wallace, Bureau of Competition,
and decreasing the total burden hours Francisco (Gerald C. Tsai, Director, (202–326–3085), 600 Pennsylvania
for other requirements; eliminate some Applications and Enforcement) 101 Avenue NW., Washington, DC 20580.
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![52476 Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Notices
SUPPLEMENTARY INFORMATION: Pursuant explained in FTC Rule 4.9(c), 16 CFR acquisition of Hospira. Under the terms
to Section 6(f) of the Federal Trade 4.9(c).1 Your comment will be kept of the proposed Consent Agreement, the
Commission Act, 15 U.S.C. 46(f), and confidential only if the FTC General parties are required to divest all of
FTC Rule 2.34, 16 CFR 2.34, notice is Counsel, in his or her sole discretion, Pfizer’s rights and assets related to
hereby given that the above-captioned grants your request in accordance with generic acetylcysteine inhalation
consent agreement containing consent the law and the public interest. solution and all Hospira’s rights and
orders to cease and desist, having been Postal mail addressed to the assets related to clindamycin phosphate
filed with and accepted, subject to final Commission is subject to delay due to injection, voriconazole injection, and
approval, by the Commission, have been heightened security screening. As a melphalan hydrochloride injection to
placed on the public record for a period result, we encourage you to submit your Alvogen Group, Inc. (‘‘Alvogen’’).
of thirty (30) days. The following comments online. To make sure that the The proposed Consent Agreement has
Analysis to Aid Public Comment Commission considers your online been placed on the public record for
describes the terms of the consent comment, you must file it at https:// thirty days for receipt of comments from
agreement, and the allegations in the ftcpublic.commentworks.com/ftc/ interested persons. Comments received
complaint. An electronic copy of the pfizerhospiraconsent by following the during this period will become part of
full text of the consent agreement instructions on the web-based form. If the public record. After thirty days, the
package can be obtained from the FTC this Notice appears at http:// Commission will again evaluate the
Home Page (for August 24, 2015), on the www.regulations.gov/#!home, you also proposed Consent Agreement, along
World Wide Web, at http://www.ftc.gov/ may file a comment through that Web with the comments received, to make a
os/actions.shtm. site. final decision as to whether it should
You can file a comment online or on If you file your comment on paper, withdraw from the proposed Consent
paper. For the Commission to consider write ‘‘Pfizer Hospira Consent, File No. Agreement or make final the Decision
your comment, we must receive it on or 151 0074’’ on your comment and on the and Order (‘‘Order’’).
before September 23, 2015. Write envelope, and mail your comment to the Pursuant to an Agreement and Plan of
‘‘Pfizer Hospira Consent, File No. 151 following address: Federal Trade Merger executed on February 5, 2015,
0074’’ on your comment. Your Commission, Office of the Secretary, Pfizer proposes to acquire Hospira for
comment—including your name and 600 Pennsylvania Avenue NW., Suite approximately $16 billion (the
your state—will be placed on the public CC–5610 (Annex D), Washington, DC ‘‘Proposed Acquisition’’). The
record of this proceeding, including, to 20580, or deliver your comment to the Commission alleges in its Complaint
the extent practicable, on the public following address: Federal Trade that the Proposed Acquisition, if
Commission Web site, at http:// Commission, Office of the Secretary, consummated, would violate Section 7
www.ftc.gov/os/publiccomments.shtm. Constitution Center, 400 7th Street SW., of the Clayton Act, as amended, 15
As a matter of discretion, the 5th Floor, Suite 5610 (Annex D), U.S.C. 18, and Section 5 of the Federal
Commission tries to remove individuals’ Washington, DC 20024. If possible, Trade Commission Act, as amended, 15
home contact information from submit your paper comment to the U.S.C. 45, by lessening current
comments before placing them on the Commission by courier or overnight competition in the markets for generic
Commission Web site. service. acetylcysteine inhalation solution and
Because your comment will be made Visit the Commission Web site at clindamycin phosphate injection and
public, you are solely responsible for http://www.ftc.gov to read this Notice future competition in the markets for
making sure that your comment does and the news release describing it. The voriconazole injection and melphalan
not include any sensitive personal FTC Act and other laws that the hydrochloride injection in the United
information, like anyone’s Social Commission administers permit the States. The proposed Consent
Security number, date of birth, driver’s collection of public comments to Agreement will remedy the alleged
license number or other state consider and use in this proceeding as violations by preserving the competition
identification number or foreign country appropriate. The Commission will that otherwise would be eliminated by
equivalent, passport number, financial consider all timely and responsive the Proposed Acquisition.
account number, or credit or debit card public comments that it receives on or
number. You are also solely responsible I. The Products and Structure of the
before September 23, 2015. For
for making sure that your comment does Markets
information on the Commission’s
not include any sensitive health privacy policy, including routine uses The Proposed Acquisition would
information, like medical records or permitted by the Privacy Act, see http:// reduce the number of current suppliers
other individually identifiable health www.ftc.gov/ftc/privacy.htm. in the markets for generic acetylcysteine
information. In addition, do not include inhalation solution and clindamycin
any ‘‘[t]rade secret or any commercial or Analysis of Agreement Containing phosphate injection, and reduce the
financial information which . . . is Consent Orders To Aid Public Comment number of future suppliers in the
privileged or confidential,’’ as discussed The Federal Trade Commission markets for voriconazole injection and
in Section 6(f) of the FTC Act, 15 U.S.C. (‘‘Commission’’) has accepted, subject to melphalan hydrochloride injection.
46(f), and FTC Rule 4.10(a)(2), 16 CFR final approval, an Agreement Generic acetylcysteine inhalation
4.10(a)(2). In particular, do not include Containing Consent Orders (‘‘Consent solution is a mucolytic therapy used to
competitively sensitive information Agreement’’) from Pfizer Inc. (‘‘Pfizer’’) treat certain respiratory disorders.
such as costs, sales statistics, and Hospira, Inc. (‘‘Hospira’’) that is Acetylcysteine liquefies mucus in the
inventories, formulas, patterns, devices, designed to remedy the anticompetitive lungs, which then can be coughed or
tkelley on DSK3SPTVN1PROD with NOTICES
manufacturing processes, or customer effects resulting from Pfizer’s suctioned out. Patients inhale the
names. solution through a nebulizer mask,
If you want the Commission to give 1 In particular, the written request for confidential facemask, mouthpiece, tent, or
your comment confidential treatment, treatment that accompanies the comment must intermittent positive pressure-breathing
include the factual and legal basis for the request,
you must file it in paper form, with a and must identify the specific portions of the
machine. Only three companies—
request for confidential treatment, and comment to be withheld from the public record. See Fresenius Kabi, partnered with Gland
you have to follow the procedure FTC Rule 4.9(c), 16 CFR 4.9(c). Pharma Ltd. and Pfizer; Hospira; and
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![52478 Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Notices
achieved by Hospira, and advice and DEPARTMENT OF HEALTH AND more detail than CMS has previously
training from knowledgeable employees HUMAN SERVICES anticipated. While conducting program
of the parties. integrity reviews of submitted data,
Centers for Medicare & Medicaid CMS has identified a number of
The purpose of this analysis is to
Services significant discrepancies in the 2014
facilitate public comment on the
[Document Identifiers: CMS–10401] benefit year submissions that issuers
proposed Consent Agreement, and it is
made for MLR and risk corridors on July
not intended to constitute an official
Emergency Clearance: Public 31, 2015. CMS also identified a number
interpretation of the proposed Order or of common errors that may lead to
Information Collection Requirements
to modify its terms in any way. submissions that do not comply with
Submitted to the Office of Management
By direction of the Commission. and Budget (OMB) CMS regulations and guidance. In order
Donald S. Clark, to resolve these potential discrepancies,
AGENCY: Centers for Medicare & ensure all submissions comply with
Secretary. Medicaid Services.
[FR Doc. 2015–21513 Filed 8–28–15; 8:45 am]
applicable guidance, and operate the
ACTION: Notice. MLR and risk corridors program
BILLING CODE 6750–01–P
SUMMARY: The Centers for Medicare & accurately and effectively, CMS needs
Medicaid Services (CMS) is announcing additional information to explain the
an opportunity for the public to data found in issuers’ underlying MLR
comment on CMS’ intention to collect and risk corridors submissions. Without
GULF COAST ECOSYSTEM this additional information, CMS will be
RESTORATION COUNCIL information from the public. Under the
Paperwork Reduction Act of 1995 (the unable to verify the accuracy of the
PRA), federal agencies are required to submission and validate the data
[Docket No.: 108002015–1111–07] needed to operate the MLR or risk
publish notice in the Federal Register
concerning each proposed collection of corridors programs.
Notice of Standard Terms and
information. Interested persons are DATES: Comments must be received by
Conditions for Council Grants September 3, 2015.
invited to send comments regarding our
AGENCY: Gulf Coast Ecosystem burden estimates or any other aspect of ADDRESSES: When commenting, please
this collection of information, including reference the document identifier or
Restoration Council.
any of the following subjects: (1) The OMB control number. To be assured
ACTION: Notice. necessity and utility of the proposed consideration, comments and
information collection for the proper recommendations must be submitted in
SUMMARY: The Gulf Coast Ecosystem performance of the agency’s functions; any one of the following ways:
Restoration Council (Council) has (2) the accuracy of the estimated 1. Electronically. You may send your
established Financial Assistance burden; (3) ways to enhance the quality, comments electronically to http://
Standard Terms and Conditions (STCs) utility, and clarity of the information to www.regulations.gov. Follow the
that will apply to all grants awarded by be collected; and (4) the use of instructions for ‘‘Comment or
the Council. automated collection techniques or Submission’’ or ‘‘More Search Options’’
other forms of information technology to to find the information collection
DATES: The STCs are effective on August minimize the information collection document(s) that are accepting
31, 2015. burden. comments.
We are, however, requesting an 2. By regular mail. You may mail
FOR FURTHER INFORMATION CONTACT:
emergency review of the information written comments to the following
Kristin Smith, Council staff, telephone
collection referenced below. In address: CMS, Office of Strategic
number: 504–444–3558. compliance with the requirement of Operations and Regulatory Affairs,
SUPPLEMENTARY INFORMATION: The section 3506(c)(2)(A) of the Paperwork Division of Regulations Development,
Council is authorized to award grants Reduction Act of 1995, we have Attention: CMS–10401/OMB Control
pursuant to the Council-Selected submitted to the Office of Management Number 0938–1155, Room C4–26–05,
Restoration and Spill Impact and Budget (OMB) the following 7500 Security Boulevard, Baltimore,
Components of the Resources and requirements for emergency review. Maryland 21244–1850.
Ecosystems Sustainability, Tourist This is necessary to ensure compliance To obtain copies of a supporting
Opportunities, and Revived Economies with an initiative of the Administration. statement and any related forms for the
of the Gulf Coast States Act of 2012 We are requesting an emergency review proposed collection(s) summarized in
(RESTORE Act), 33 U.S.C. 1321(t)(2) under 5 CFR 1320.13(a)(2)(i) because this notice, you may make your request
and 1321(t)(3). The Council has public harm is reasonably likely to using one of following:
result if the normal clearance 1. Access CMS’ Web site address at
established STCs that will apply to and
procedures are followed. We are seeking http://www.cms.hhs.gov/
be incorporated into all grants awarded
emergency approval for modifications to PaperworkReductionActof1995.
by the Council under the RESTORE Act. the information collection request (ICR)
The electronic version of the STCs can 2. Email your request, including your
currently approved under Office of address, phone number, OMB number,
be viewed and downloaded at Management and Budget (OMB) control
www.restorethegulf.gov/resources/foia- and CMS document identifier, to
number 0938–1155. CMS seeks an Paperwork@cms.hhs.gov.
library-council-documents.
tkelley on DSK3SPTVN1PROD with NOTICES
emergency revision to the ICR approved 3. Call the Reports Clearance Office at
Will D. Spoon, under 0938–1155 to collect additional (410) 786–1326.
information from health insurance
Program Analyst, Gulf Coast Ecosystem FOR FURTHER INFORMATION CONTACT:
Restoration Council.
companies as part of the MLR and risk
corridors programs. This ICR is Reports Clearance Office at (410) 786–
[FR Doc. 2015–21417 Filed 8–28–15; 8:45 am]
necessary to validate data that issuers 1326.
BILLING CODE P have previously submitted to CMS in SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014 16:19 Aug 28, 2015 Jkt 235001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\31AUN1.SGM 31AUN1](https://thefederalregister.org/doc/80_FR_52643/page/4.svg)
Document Created: 2018-02-23 11:04:10
Document Modified: 2018-02-23 11:04:10
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Proposed Consent Agreement. | |
| Dates | Comments must be received on or before September 23, 2015. | |
| Contact | Kari A. Wallace, Bureau of Competition, (202-326-3085), 600 Pennsylvania Avenue NW., Washington, DC 20580. | |
| FR Citation | 80 FR 52475 |
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