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Governors not later than February 3, Each notice is available for inspection in electronic form should be directed to: 2003. at the Federal Reserve Bank indicated. [email protected], as A. Federal Reserve Bank of Atlanta The notice also will be available for prescribed below. (Sue Costello, Vice President) 1000 inspection at the offices of the Board of FOR FURTHER INFORMATION CONTACT: Peachtree Street, N.E., Atlanta, Georgia Governors. Interested persons may Joanne Lewers, FTC, Bureau of 30303: express their views in writing on the Competition, 600 Pennsylvania Avenue, 1. CBS Banc Corp, Russellville, question whether the proposal complies NW., Washington, DC 20580, (202) 326– Alabama; to merge with Community with the standards of section 4 of the 2667. Financial Services, Inc., Bolivar, BHC Act. Additional information on all SUPPLEMENTARY INFORMATION: Pursuant Tennessee, and thereby indirectly bank holding companies may be to section 6(f) of the Federal Trade acquire The Bank of Bolivar, Bolivar, obtained from the National Information Commission Act, 38 Stat. 721, 15 U.S.C. Tennessee. Center website at www.ffiec.gov/nic/. 46(f), and section 2.34 of the 2. Coast Financial Holdings, Inc., Unless otherwise noted, comments Commission’s rules of practice, 16 CFR Bradenton, Florida; to become a bank regarding the applications must be 2.34, notice is hereby given that the holding company by acquiring 100 received at the Reserve Bank indicated above-captioned consent agreement percent of the voting shares of Coast or the offices of the Board of Governors containing a consent order to cease and Bank of Florida, Bradenton, Florida. not later than January 22, 2003. desist, having been filed with and B. Federal Reserve Bank of St. Louis A. Federal Reserve Bank of Atlanta accepted, subject to final approval, by (Randall C. Sumner, Vice President) 411 (Sue Costello, Vice President) 1000 the Commission, has been placed on the Locust Street, St. Louis, Missouri 63166- Peachtree Street, N.E., Atlanta, Georgia public record for a period of 30 days. 2034: 30303: The following analysis to aid public 1. Frontenac Bancshares, Inc., Earth 1. Bancshares of Florida, Inc. comment describes the terms of the City, Missouri; to become a bank (formerly Citizens Bancshares of consent agreement, and the allegations holding company by acquiring 100 Southwest Florida), Naples, Florida; to in the complaint. An electronic copy of percent of the voting shares of acquire Florida Trust Company, Inc., Ft. the full text of the consent agreement Frontenac Bank, Earth City, Missouri. Lauderdale, Florida, and thereby engage package can be obtained from the FTC C. Federal Reserve Bank of San in trust company activites, pursuant to home page (for December 20, 2002), on Francisco (Maria Villanueva, Consumer section 225.28(b)((15) of Regulation Y. the World Wide Web, at ‘‘http:// Regulation Group) 101 Market Street, These activities will be conducted in www.ftc.gov/os/2002/12/index.htm.’’ A San Francisco, California 94105-1579: Florida. paper copy can be obtained from the 1. Utah Community Bancorp, Sandy, Board of Governors of the Federal Reserve FTC Public Reference Room, Room 130– Utah; to become a bank holding System, January 2, 2003. H, 600 Pennsylvania Avenue, NW., company by acquiring 100 percent of Robert deV. Frierson, Washington, DC 20580, either in person the voting shares of Utah Community Deputy Secretary of the Board. or by calling (202) 326–2222. Bank, Sandy, Utah. [FR Doc. 03–301 Filed 1–7–03; 8:45 am] Public comments are invited, and may Board of Governors of the Federal Reserve BILLING CODE 6210–01–S be filed with the Commission in either System, January 2, 2003. paper or electronic form. Comments Robert deV. Frierson, filed in paper form should be directed Deputy Secretary of the Board. FEDERAL TRADE COMMISSION to: FTC/Office of the Secretary, Room 159–H, 600 Pennsylvania Avenue, NW., [FR Doc. 03–302 Filed 1–7–03; 8:45 am] [File No. 021 0171] Washington, DC 20580. If a comment BILLING CODE 6210–01–S contains nonpublic information, it must Baxter International, Inc., and Wyeth be filed in paper form, and the first page Corporation; Analysis To Aid Public FEDERAL RESERVE SYSTEM of the document must be clearly labeled Comment ‘‘confidential.’’ Comments that do not Notice of Proposals to Engage in AGENCY: Federal Trade Commission. contain any nonpublic information may instead be filed in electronic form (in Permissible Nonbanking Activities or ACTION: Proposed consent agreement. to Acquire Companies that are ASCII format, WordPerfect, or Microsoft Engaged in Permissible Nonbanking SUMMARY: The consent agreement in this Word) as part of or as an attachment to Activities matter settles alleged violations of email messages directed to the following federal law prohibiting unfair or email box: [email protected]. The companies listed in this notice deceptive acts or practices or unfair Such comments will be considered by have given notice under section 4 of the methods of competition. The attached the Commission and will be available Bank Holding Company Act (12 U.S.C. Analysis to Aid Public Comment for inspection and copying at its 1843) (BHC Act) and Regulation Y (12 describes both the allegations in the principal office in accordance with CFR Part 225) to engage de novo, or to draft complaint that accompanies the section 4.9(b)(6)(ii) of the Commission’s acquire or control voting securities or consent agreement and the terms of the rules of practice, 16 CFR 4.9(b)(6)(ii)). assets of a company, including the consent order—embodied in the consent companies listed below, that engages Analysis of Agreement Containing agreement—that would settle these Consent Orders To Aid Public Comment either directly or through a subsidiary or allegations. other company, in a nonbanking activity The Federal Trade Commission has that is listed in § 225.28 of Regulation Y DATES: Comments must be received on accepted, subject to final approval, an (12 CFR 225.28) or that the Board has or before January 18, 2003. agreement containing consent orders determined by Order to be closely ADDRESSES: Comments filed in paper (‘‘Consent Agreement’’) from Baxter related to banking and permissible for form should be directed to: FTC/Office International Inc. and Wyeth. The bank holding companies. Unless of the Secretary, Room 159–H, 600 Consent Agreement contains an order to otherwise noted, these activities will be Pennsylvania Avenue, NW., maintain assets to preserve, among other conducted throughout the United States. Washington, DC 20580. Comments filed things, the viability, marketability, and

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competitiveness of the assets to be including the ability to quickly adjust concerns as the acquirer of the propofol divested pending their divestiture. The the amount of sedation and its superior assets. If the Commission determines Consent Agreement also contains a safety profile. Because propofol has a that Faulding is not an acceptable decision and order that is designed to short duration profile, it is the preferred purchaser, or that the manner of remedy the anticompetitive effects of anesthetic agent for out-patient surgery. divestiture is not acceptable, Baxter and Baxter’s proposed acquisition of the Annual U.S. sales of propofol total Wyeth must divest the propofol assets to generic injectable pharmaceutical between $375 and $400 million. a Commission-approved buyer no later business of Wyeth. Under the terms of The market for propofol is highly than 90 business days from the date the the Consent Agreement, the companies concentrated. AstraZeneca sells Order becomes final. Should they fail to will be required to: (1) Divest all of Diprivan, the branded propofol do so, the Commission may appoint a Wyeth’s assets relating to propofol to a product. Baxter markets the only generic trustee to divest the propofol assets. The Commission-approved acquirer; (2) propofol product, which is Consent Agreement also requires the terminate all of Baxter’s rights and manufactured by GensiaSicor. Wyeth is parties to license certain additional interests in GensiaSicor’s pancuronium, seeking approval from the Food and know-how that relates, but does not vecuronium, and metoclopramide Drug Administration (‘‘FDA’’) for its exclusively relate, to propofol to the products, and divest all of its own propofol product, and it is one of propofol acquirer. pancuronium, vecuronium, and the two best-positioned firms to enter The Consent Agreement contains metoclopramide assets to GensiaSicor; the market. several provisions designed to ensure and (3) terminate Baxter’s co-marketing Entry into the propofol market that the divestiture is successful. Baxter agreement with Watson requires lengthy development efforts and Wyeth are required to provide Pharmaceuticals, Inc. by March 14, because of the product’s unique transitional services to the propofol 2004. characteristics. Propofol is considered to acquirer relating to regulatory approvals The proposed Consent Agreement has be one of the most difficult injectable and manufacturing, and in responding been placed on the public record for 30 products to develop. Indeed, only one to, and defending against, any lawsuit, days for receipt of comments by company has been able to introduce a investigation or proceeding relating to interested persons. Comments received generic propofol product. Propofol is propofol. The Consent Agreement also during this period will become part of manufactured using a complex process, requires Baxter and Wyeth to provide the public record. After 30 days, the and it requires the use of a preservative. incentives to certain employees to Commission will again review the The preserved formulation used for continue in their positions until the agreement and any comments received Diprivan and the preserved divestiture is accomplished. For a and will decide whether it should formulation used for the generic period of six months from the date the withdraw from the agreement or make propofol marketed by Baxter are both assets are divested, Baxter and Wyeth final the agreement’s proposed Consent protected by patents. For this reason, will provide the propofol acquirer an Order. any new entrant would have to develop opportunity to enter into employment Pursuant to an asset purchase a propofol product using a different contracts with individuals who have agreement dated June 8, 2002, between preservative that does not infringe experience relating to Wyeth’s propofol Baxter and Wyeth, Baxter proposes to existing patents. Once a company has product. Baxter and Wyeth are also acquire from Wyeth substantially all of developed a viable product, it is also required to provide incentives to these the assets related to Wyeth’s generic required to conduct studies and obtain individuals to accept employment with injectable pharmaceutical business approval from the FDA to market the propofol acquirer. For a period of operated by Wyeth’s ESI Lederle propofol. Clinical development and one year following the divestiture date, division for a total of $316 million in FDA approval for this particular generic Baxter and Wyeth are prohibited from cash and assumed liabilities. The drug takes several years. hiring any employees of the acquirer of Commission’s complaint alleges that the The proposed acquisition would the propofol assets who have proposed acquisition, if consummated, cause significant anticompetitive harm responsibility related to propofol. would constitute a violation of section in the U.S. market for the manufacture Finally, Baxter and Wyeth must take 7 of the Clayton Act, as amended, 15 and sale of propofol by eliminating steps to maintain the confidentiality of U.S.C. 18, and section 5 of the Federal potential competition between Baxter confidential information related to Trade Commission Act, as amended, 15 and Wyeth. With only two firms propofol. U.S.C. 45, in the markets for the currently supplying propofol to manufacture and sale of: (1) Propofol; customers in this market (Baxter and Pancuronium (2) pancuronium; (3) vecuronium; (4) AstraZeneca), entry by Wyeth and the Pancuronium is a rapid-onset, long- metoclopramide; and (5) new injectable one other firm well-positioned to enter acting neuromuscular blocking agent iron replacement therapies (‘‘NIIRTs’’). would likely increase competition and used to temporarily freeze muscles The proposed Consent Agreement reduce propofol prices. Accordingly, during surgery or mechanical would remedy the alleged violations by allowing Baxter to acquire Wyeth’s ventilation and to assist in the replacing in each of these markets the generic injectable business likely would intubation process. Although lost competition that would result from reduce the number of rivals in the future pancuronium is an older drug, doctors the merger. from four to three and force customers continue to use it because it is an to pay higher prices for propofol. effective and inexpensive product with Propofol The proposed Consent Agreement a known side-effect profile. The market Propofol is a general anesthetic preserves future competition in the for pancuronium in the United States is commonly used for the induction and market for propofol by requiring the approximately $2 million. maintenance of anesthesia during parties to divest Wyeth’s propofol assets Pancuronium is a small and highly surgical procedures and as a sedative for to Faulding Pharmaceutical Company concentrated market. Baxter, Wyeth and patients who are mechanically no later than 10 business days after the Abbott are the only suppliers of generic ventilated. Although there are other acquisition. Faulding is well-positioned injectable pancuronium in the United anesthetic agents, there are many to continue Wyeth’s development efforts States. Currently, Baxter, which markets benefits associated with propofol and poses no separate competitive pancuronium pursuant to an exclusive

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agreement with GensiaSicor, accounts Wyeth were the two leading suppliers of the branded metoclopramide product, for almost half of U.S. sales of the drug. vecuronium in the United States, with Reglan. Baxter is the exclusive Post-acquisition, Baxter would account a combined market share of 53%, until supplier of GensiaSicor’s for 74% of the sales of pancuronium in Wyeth temporarily suspended its metoclopramide product. Wyeth and the United States, and the post- vecuronium production in 2001. Prior to Baxter together represent over half of acquisition Herfindahl-Hirschman Index the announcement of the acquisition, the sales of metoclopramide in the (‘‘HHI’’) would be 6,152 points, Wyeth planned to re-enter the United States. Post-acquisition, the HHI representing a 2,496 point increase in vecuronium market in the near future. would be 3,852 points, an increase of the HHI. Post-acquisition, Abbott would Post-acquisition, the HHI would be 936 points above the pre-Acquisition be the only other supplier of 3,598 points, representing a 1,364 point HHI. Only two other companies supply pancuronium in the United States. increase in the HHI. There are only metoclopramide in the United States: The market for the manufacture and three other suppliers of vecuronium in Abbott and Faulding. sale of pancuronium is unlikely to the United States. Organon continues to New entry into the market for the attract new entrants because market its branded vecuronium, and manufacture and sale of pancuronium is an older drug whose Abbott and Bedford supply generic metoclopramide is difficult, expensive usage and price have declined over vecuronium products. and unlikely to occur. Metoclopramide time. Although pancuronium is still an Entry into the market for the is an older drug with small sales relative important drug, companies are unlikely manufacture and sale of vecuronium is to newer injectable anti-emetics. to devote resources to developing an unlikely because it is an older drug with Therefore, firms do not consider the older drug with limited sales. Even if a established suppliers, and it is a market for the manufacture and sale of supplier of other injectable drugs difficult drug to manufacture. Although metoclopramide to be an attractive entry decided to develop pancuronium, it vecuronium continues to be an opportunity. Several manufacturers would be costly and time consuming to important drug, companies are unlikely have already exited the market and none complete the necessary research and to devote resources to entering this are interested in re-entering. Even if development, and to obtain the requisite market because existing suppliers have firms that have exited were interested in approval from the FDA. Consequently, become entrenched, making it difficult re-launching their drugs, re-entry would entry into the pancuronium market is for new entrants to capture meaningful likely take such firms an estimated two not likely to occur in a timely manner, market share. In addition, vecuronium years or more. if at all. is a complicated drug to manufacture. The proposed acquisition would The proposed acquisition would Because of the unique manufacturing cause significant anticompetitive harm create a duopoly in the market for the process involved in making in the U.S. market for the manufacture manufacture and sale of pancuronium vecuronium, entry would take longer and sale of metoclopramide by reducing in the United States. Post-acquisition, than two years and cost hundreds of the number of suppliers from four to Baxter and Abbott would be the only thousands of dollars. three. The combined entity would remaining suppliers of pancuronium. The proposed acquisition is likely to account for over half of all sales of This is likely to lead to higher prices of result in anticompetitive harm in the metoclopramide in the United States. pancuronium. U.S. market for the manufacture and The proposed acquisition is likely to The proposed Consent Agreement sale of vecuronium. Absent the lead to higher prices. preserves competition in the proposed acquisition, Wyeth would The proposed Consent Agreement pancuronium market by requiring have re-entered this market. By preserves competition in the Baxter to terminate all of its rights and acquiring Wyeth’s vecuronium, Baxter metoclopramide market by requiring interests in GensiaSicor’s pancuronium would likely delay or forego the re- Baxter to terminate all of its interests in product and divest all of its launch of Wyeth’s vecuronium and GensiaSicor’s metoclopramide and pancuronium assets to GensiaSicor no eliminate any associated price divest all of its metoclopramide assets to later than five days after the acquisition. competition. GensiaSicor no later than five days after GensiaSicor is capable of marketing and The proposed Consent Agreement the acquisition. selling its own pancuronium. It is a well preserves future competition in the recognized and respected company in market for vecuronium by requiring New Injectable Iron Replacement the injectable pharmaceutical industry, Baxter to terminate all of its rights and Therapies and will be an able competitor in the interests in GensiaSicor’s vecuronium NIIRTs are used to treat iron market for the manufacture and sale of product and divest all of its vecuronium deficiency in patients undergoing pancuronium. assets to GensiaSicor no later than five hemodialysis. NIIRTs include both days after the acquisition. injectable iron gluconate and iron Vecuronium sucrose. Annual U.S. sales of NIIRTs Vecuronium is an intermediate-acting Metoclopramide total approximately $225 million. neuromuscular blocking agent that Metoclopramide is an antiemetic used The market for the manufacture and temporarily freezes muscles during for the prevention and treatment of sale of NIIRTs is highly concentrated. surgery, mechanical ventilation, or nausea and vomiting for patients Watson markets Ferrlecit, the only intubation. Vecuronium is a popular undergoing certain types of injectable iron gluconate product neuromuscular blocking agent with a chemotherapy and for post-operative available in the United States. American superior side effect profile. The market treatment. Metoclopramide is an older Regent markets Venofer, the only for the manufacture and sale of antiemetic that continues to be used injectable iron sucrose product in the vecuronium in the United States is because it is effective, has a known United States. Watson recently entered approximately $21 million. safety profile, and is considerably into a co-promotional agreement with The market for the manufacture and cheaper than newer antiemetics. Annual Baxter, pursuant to which Baxter sale of vecuronium is highly U.S. sales of metoclopramide total promotes Ferrlecit. concentrated. Baxter markets approximately $13 million. Entry into the market for the vecuronium under an exclusive supply The market for metoclopramide is manufacture and sale of NIIRTs is very agreement with GensiaSicor. Baxter and highly concentrated. Wyeth developed difficult and time consuming. Because

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of FDA-imposed New Chemical Entity DEPARTMENT OF HEALTH AND priorities and monitor their exclusivity periods, the earliest that any HUMAN SERVICES performance. The use of outcome data company could file for regulatory (e.g., fatal injuries) for measuring approval of a generic iron gluconate Centers for Disease Control and program effectiveness is problematic product is February 2004. Similar Prevention because cause-specific events are provisions protect iron sucrose, though [60Day–03–33] relatively rare and because data on its exclusivity period expires in critical risk factors (e.g., was a helmet November 2003. Entry into the market Proposed Data Collections Submitted worn in a bike crash?; was a smoke for the manufacture and sale of NIIRTs for Public Comment and detector present at a fatal fire?) are often is further complicated by a lack of raw Recommendations missing. Because these risk factors are material suppliers. Even if a new entrant early in the causal chain of injury, they In compliance with the requirement were to locate a raw material supplier, are what injury control programs target both iron gluconate and iron sucrose are of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for to prevent injuries. Accordingly, difficult products that would take more monitoring the level of injury risk than two years to develop. Wyeth is the opportunity for public comment on proposed data collection projects, the factors in a population can help best-positioned firm to successfully Centers for Disease Control and programs set priorities and evaluate develop a NIIRT product. Prevention (CDC) will publish periodic interventions. The proposed acquisition is likely to summaries of proposed projects. To The first Injury Control and Risk have anticompetitive effects in the request more information on the Factor Survey (ICARIS), conducted in market for the manufacture and sale of proposed projects or to obtain a copy of 1994, was a random digit dial telephone NIIRTs in the United States because it the data collection plans and survey that collected injury risk factor would eliminate potential competition instruments, call the CDC Reports and demographic data on 5,238 English- between Baxter and Wyeth. The Clearance Officer on (404) 498–1210. and Spanish-speaking adults (greater proposed acquisition would remove Comments are invited on: (a) Whether than or equal to 18 years old) in the Wyeth as the best-positioned the proposed collection of information United States. Proxy data were collected independent entrant into this market is necessary for the proper performance on 3,541 children <15 years old. More and prevent all associated price of the functions of the agency, including than a dozen peer-reviewed scientific competition. whether the information shall have reports have been published from the The proposed Consent Agreement practical utility; (b) the accuracy of the ICARIS data on subjects including dog preserves future competition in the agency’s estimate of the burden of the bites, bicycle helmet use, residential market for the manufacture and sale of proposed collection of information; (c) smoke detector usage and fire escape NIIRTs by requiring Baxter to terminate ways to enhance the quality, utility, and practices, attitudes toward violence, its co-marketing agreement with Watson clarity of the information to be suicidal ideation and behavior, and within weeks of the expiration of collected; and (d) ways to minimize the  compliance with pediatric injury Ferrlicit ’s New Chemical Entity burden of the collection of information prevention counseling. exclusivity. This termination provides on respondents, including through the an incentive for Baxter to continue use of automated collection techniques ICARIS–2, a national telephone developing and ultimately launch the or other forms of information survey about injury, which began in the iron gluconate product that it will technology. Send comments to Seleda summer of 2000, has collected data on acquire from Wyeth. Perryman , CDC Assistant Reports more than 8,700 of the targeted 10,200 Pursuant to the terms of the Order, the Clearance Officer, 1600 Clifton Road, respondents to date. The first phase of Commission has appointed William E. MS–D24, Atlanta, GA 30333. Written the survey was initiated as a means for Hall as a Monitor Trustee to ensure comments should be received within 60 monitoring the injury risk factor status Baxter’s and Wyeth’s compliance with days of this notice. of the nation at the start of the all of the requirements of the Order. Mr. Proposed Project: The Second Injury millennium. The second phase of the Hall has over 30 years of experience in Control and Risk Survey (ICARIS 2) survey is needed to expand knowledge the pharmaceutical industry and is well- Phase 2—New—The National Center for in areas investigators could not fully respected in the industry. In order to Injury Prevention and Control (NCIPC), explore, previously. By using data ensure that the Commission remains Centers for Disease Control and collected in ICARIS as a baseline, data informed about the status of the Prevention (CDC)—This project will use collected in ICARIS–2 Phase-2 will be proposed divestitures and the transfers data from a telephone survey to measure used along with data currently being of assets, the Consent Agreement injury-related risk factors and guide collected (ICARIS–2 Phase-1) to requires Baxter and Wyeth to file reports injury prevention and control priorities measure changes and gauge the impact with the Commission periodically until including those identified as priorities of injury prevention policies. The the divestitures are accomplished. in Healthy People 2010 objectives for ICARIS–2 surveys may also serve as the The purpose of this analysis is to the nation. Injuries are a major cause of only readily available source of data to facilitate public comment on the premature death and disability with measure several of the Healthy People proposed Consent Agreement, and it is associated economic costs of over $150 2010 injury prevention objectives. In not intended to constitute an official billion dollars in lifetime costs for order to more fully monitor injury risk interpretation of the proposed Consent persons injured each year. Healthy factors and selected year Healthy People Agreement or to modify its terms in any People 2010 objectives and the recent 2010 injury objectives, as well as way. report from the Institute of Medicine, evaluate the effectiveness of injury Reducing the Burden of Injury, call for prevention programs, the second phase By direction of the Commission. reducing this toll. In addition to (ICARIS–2 Phase-2) of the current C. Landis Plummer, national efforts, NCIPC funds injury national telephone survey on injury risk Acting Secretary. control prevention programs at the state is being implemented. The only cost to [FR Doc. 03–309 Filed 1–7–03; 8:45 am] and local levels. These programs need the respondents is the time involved to BILLING CODE 6750–01–P data both to establish their prevention complete the survey.

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