Federal Register / Vol. 73, No. 162 / Wednesday, August 20, 2008 / Notices 49207 

1 The comment must be accompanied by an 

explicit request for confidential treatment, 

including the factual and legal basis for the request, 

and must identify the specific portions of the 

comment to be withheld from the public record. 

The request will be granted or denied by the 

Commission’s General Counsel, consistent with 

applicable law and the public interest. See 

Commission Rule 4.9(c), 16 CFR 4.9(c). 

credit needs of their communities, 

including low- and moderate-income 

neighborhoods, consistent with safe and 

sound banking practices. The Federal 

Reserve System uses the information in 

the examination process and in 

evaluating applications for mergers, 

branches, and certain other corporate 

activities. Financial institutions 

maintain and provide the information to 

the Federal Reserve System. 

Board of Governors of the Federal Reserve 

System, August 14, 2008. 

Robert deV. Frieson, 

Deputy Secretary of the Board. 

[FR Doc. E8–19189 Filed 8–19–08; 8:45 am] 

BILLING CODE 6210–01–P 

FEDERAL TRADE COMMISSION 

[File No. 071 0193] 

Sun Pharmaceutical Industries Ltd.; 

Analysis of Agreement Containing 

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 or 

deceptive acts or practices or unfair 

methods of competition. The attached 

Analysis to Aid Public Comment 

describes both the allegations in the 

draft complaint and the terms of the 

consent order—embodied in the consent 

agreement—that would settle these 

allegations. 

DATES: Comments must be received on 

or before September 11, 2008. 

ADDRESSES: Interested parties are 

invited to submit written comments. 

Comments should refer to ‘‘Sun 

Pharmaceutical, File No. 071 0193,’’ to 

facilitate the organization of comments. 

A comment filed in paper form should 

include this reference both in the text 

and on the envelope, and should be 

mailed or delivered to the following 

address: Federal Trade Commission/ 

Office of the Secretary, Room 135-H, 

600 Pennsylvania Avenue, N.W., 

Washington, D.C. 20580. Comments 

containing confidential material must be 

filed in paper form, must be clearly 

labeled ‘‘Confidential,’’ and must 

comply with Commission Rule 4.9(c). 

16 CFR 4.9(c) (2005).1 Comments should 

not include any sensitive personal 

information, such as an individual’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. Comments also should not 

include any sensitive health 

information, such as medical records 

and other individually identifiable 

health information. The FTC is 

requesting that any comment filed in 

paper form be sent by courier or 

overnight service, if possible, because 

U.S. postal mail in the Washington area 

and at the Commission is subject to 

delay due to heightened security 

precautions. Comments that do not 

contain any nonpublic information may 

instead be filed in electronic form by 

following the instructions on the webbased form at (http:// 

secure.commentworks.com/ftcSunPharmaceutical). To ensure that the 

Commission considers an electronic 

comment, you must file it on that webbased form. 

The FTC Act and other laws the 

Commission administers permit the 

collection of public comments to 

consider and use in this proceeding as 

appropriate. All timely and responsive 

public comments, whether filed in 

paper or electronic form, will be 

considered by the Commission, and will 

be available to the public on the FTC 

website, to the extent practicable, at 

www.ftc.gov. As a matter of discretion, 

the FTC makes every effort to remove 

home contact information for 

individuals from the public comments it 

receives before placing those comments 

on the FTC website. More information, 

including routine uses permitted by the 

Privacy Act, may be found in the FTC’s 

privacy policy, at (http://www.ftc.gov/ 

ftc/privacy.htm). 

FOR FURTHER INFORMATION CONTACT: 

David L. Inglefield, Bureau of 

Competition, 600 Pennsylvania Avenue, 

NW, Washington, D.C. 20580, (202) 326- 

2637. 

SUPPLEMENTARY INFORMATION: Pursuant 

to section 6(f) of the Federal Trade 

Commission Act, 38 Stat. 721, 15 U.S.C. 

46(f), and § 2.34 of the Commission 

Rules of Practice, 16 CFR 2.34, notice is 

hereby given that the above-captioned 

consent agreement containing a consent 

order to cease and desist, having been 

filed with and accepted, subject to final 

approval, by the Commission, has been 

placed on the public record for a period 

of thirty (30) days. The following 

Analysis to Aid Public Comment 

describes the terms of the consent 

agreement, and the allegations in the 

complaint. An electronic copy of the 

full text of the consent agreement 

package can be obtained from the FTC 

Home Page (for August 13, 2008), on the 

World Wide Web, at (http:// 

www.ftc.gov/os/2008/08/index.htm). A 

paper copy can be obtained from the 

FTC Public Reference Room, Room 130- 

H, 600 Pennsylvania Avenue, NW, 

Washington, D.C. 20580, either in 

person or by calling (202) 326-2222. 

Public comments are invited, and may 

be filed with the Commission in either 

paper or electronic form. All comments 

should be filed as prescribed in the 

ADDRESSES section above, and must be 

received on or before the date specified 

in the DATES section. 

Analysis of Agreement Containing 

Consent Order to Aid Public Comment 

The Federal Trade Commission 

(‘‘Commission’’) has accepted, subject to 

final approval, an Agreement 

Containing Consent Orders (‘‘Consent 

Agreement’’) from Sun Pharmaceutical 

Industries Ltd. (‘‘Sun’’) which is 

designed to remedy the anticompetitive 

effects of the acquisition of Taro 

Pharmaceutical Industries Ltd. (‘‘Taro’’) 

by Sun. Under the terms of the proposed 

Consent Agreement, Sun is required to 

divest all of Sun’s rights and assets 

necessary to manufacture and market: 

(1) generic immediate-release 

carbamazepine tablets; (2) generic 

chewable carbamazepine tablets; and (3) 

generic extended-release carbamazepine 

tablets to Torrent Pharmaceuticals Ltd. 

(‘‘Torrent’’). 

The proposed Consent Agreement has 

been placed on the public record for 

thirty (30) days for receipt of comments 

by interested persons. Comments 

received during this period will become 

part of the public record. After thirty 

(30) days, the Commission will again 

review the proposed Consent Agreement 

and the comments received, and will 

decide whether it should withdraw from 

the proposed Consent Agreement, 

modify it, or make final the Decision 

and Order (‘‘Order’’). 

Pursuant to an Agreement of Merger 

executed on May 18, 2007, Sun 

proposed to acquire all of the issued and 

outstanding shares of Taro in a 

transaction then valued at 

approximately $454 million. In the 

event that agreement has been properly 

terminated, as Taro claims, Sun intends 

to acquire controlling interest in Taro 

via an Option Agreement executed at 

the time of the merger agreement and/ 

or via a tender offer. The Commission’s 

Complaint alleges that the proposed 


dwashington3 on PRODPC61 with NOTICES
49208 Federal Register / Vol. 73, No. 162 / Wednesday, August 20, 2008 / Notices 

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 

competition in the U.S. markets for the 

manufacture and sale of generic 

immediate-release carbamazepine 

tablets and chewable carbamazepine 

tablets, and in the research, 

development, manufacture and sale of 

extended-release carbamazepine tablets 

(collectively, the ‘‘Products’’). The 

proposed Consent Agreement will 

remedy the alleged violations by 

replacing the lost competition that 

would result from the acquisition in 

each of these markets. 

Sun, headquartered in Mumbai, India, 

is a leading developer, manufacturer, 

marketer, and distributor of niche 

pharmaceuticals in its home country 

and active pharmaceutical ingredients 

(APIs’’) and generic drugs worldwide. 

Sun is intent on growing its U.S. generic 

drugs business and sells generic 

pharmaceuticals in the United States 

through wholly-owned Caraco 

Pharmaceutical Laboratories Ltd. Taro, 

headquartered in Israel, also develops 

and manufactures generic 

pharmaceutical products, primarily for 

sale in the United States. 

The Products and Structure of the 

Markets 

The proposed acquisition of Taro by 

Sun would increase Sun’s worldwide 

position in generic pharmaceuticals and 

augment Sun’s pipeline of future 

generic products. Sun and Taro overlap 

in a number of generic pharmaceutical 

markets, and if consummated, the 

transaction likely would lead to 

anticompetitive effects in the markets 

for three different forms of 

carbamazepine. Carbamazepine is an 

anticonvulsant that is used primarily as 

an anti-epileptic drug. It is taken daily, 

either alone or in combination with 

other drugs, to prevent and control 

seizures. 

The transaction would reduce the 

number of competing generic suppliers 

in the overlap markets. The number of 

generic suppliers has a direct and 

substantial effect on generic pricing as 

each additional generic supplier can 

have a competitive impact on the 

market. Because there are at least two 

generic equivalents for each of the 

products at issue, the branded versions 

no longer significantly constrain the 

price of the generic drugs. 

Generic immediate-release 

carbamazepine tablets are AB-rated 

generic versions of Novartis’s Tegratol. 

In this market, Taro is the leading 

supplier with half the market. Teva 

Pharmaceutical Industries Ltd. (‘‘Teva’’) 

follows with more than a quarter of the 

market, and Sun’s Caraco is the thirdleading supplier with a share of about 

18 percent. The only other supplier 

currently in the market is Apotex. 

Generic chewable carbamazepine 

tablets are a chewable form of the 

anticonvulsant that carry the same label 

and indications as the immediaterelease tablets. They are prescribed in 

the same way as the immediate-release 

products, but come in a more 

convenient dosing form, which makes 

them better-suited for pediatric, 

geriatric, and other patients who may 

have difficulty swallowing pills. With a 

market share of 65 percent, Teva is the 

leading seller of the generic chewable 

carbamazepine tablets in 2007, followed 

by Taro with a share of about 31 percent 

and Sun, with a share of only 4 percent 

in 2007. Cadista, the only other 

approved supplier of generic chewable 

carbamazepine tablets, is not supplying 

the product currently. 

Sun and Taro are the only companies 

that have applied for Food and Drug 

Administration (‘‘FDA’’) approval of 

generic versions of Novartis’s Tegretol- 

XR extended-release carbamazapine 

tablets. This extended-release 

formulation of the drug is indicated for 

the same uses as the immediate release 

products but offers the added 

convenience of a less frequent dosing 

regimen. 

Entry 

Entry into the markets for the 

manufacture and sale of any of these 

three carbamazepine products would 

not be timely, likely or sufficient in its 

magnitude, character, and scope to deter 

or counteract the anticompetitive effects 

of the acquisition. Entry would not take 

place in a timely manner because the 

combination of generic drug 

development times and FDA drug 

approval requirements takes at least two 

years. Entry would not be likely because 

the relevant markets are relatively small 

and in decline, so the limited sales 

opportunities available to a new entrant 

are likely insufficient to warrant the 

time and investment necessary to enter. 

Competitive Effects 

The proposed acquisition would 

cause significant anticompetitive harm 

to consumers in the U.S. markets for the 

manufacture and sale of generic 

immediate-release carbamazepine 

tablets, generic chewable carbamazepine 

tablets, and generic extended-release 

carbamazepine tablets. In generic 

pharmaceutical markets, pricing is 

heavily influenced by the number of 

competitors that participate in a given 

market. Both empirical research and the 

Commission’s many investigations into 

generic drug competition confirm that 

finding. Here, the evidence shows that, 

given the small number of suppliers or 

prospective suppliers in the relevant 

markets, the prices of the generic 

pharmaceutical products at issue 

decrease with the entry of each 

additional competitor. 

Among currently-marketed products, 

the acquisition would reduce the 

number of firms producing generic 

chewable carbamazepine tablets from 

three to two, with Teva being the only 

remaining competitor (at least until 

Cadista is able to re-enter the market). 

Similarly, the proposed transaction 

would reduce from four to three the 

number of firms remaining in the 

immediate-release carbamazepine tablet 

market, leaving Teva as the only other 

significant player. In the market for 

generic versions of extended-release 

carbamazepine tablets, the merging 

parties are the only two firms in the 

process of entering, so the proposed 

transaction likely would eliminate the 

generic competition that would 

otherwise exist in that market when the 

products are introduced. 

As the market share information 

suggests, the proposed transaction 

would eliminate one of a small number 

of suppliers in the markets for two 

currently-marketed generic 

carbamazepine products, with the likely 

result that prices would increase above 

current levels. For extended-release 

generic carbamazepine, the 

consolidation would result in a merger 

to monopoly, with the likely result that 

prices would be higher than they would 

be without the transaction and both 

companies had entered independently. 

The competitive concerns can be 

characterized as both unilateral and 

coordinated in nature. The homogenous 

nature of the products involved, the 

minimal incentives to deviate, and the 

relatively predictable prospects of 

gaining new business all indicate that 

the firms in the market will find it 

profitable to coordinate their pricing. 

The impact that a reduction in the 

number of firms would have on pricing 

can also be explained in terms of 

unilateral effects, as the likelihood that 

the merging parties would be the first 

and second choices in a significant 

number of bidding situations is 

enhanced where the number of firms 

participating in the market decreases 

substantially. 

The Consent Agreement 

The proposed Consent Agreement 

effectively remedies the proposed 

acquisition’s anticompetitive effects in 


dwashington3 on PRODPC61 with NOTICES
Federal Register / Vol. 73, No. 162 / Wednesday, August 20, 2008 / Notices 49209 

the relevant product markets. Pursuant 

to the Consent Agreement, Sun is 

required to divest all of its rights and 

assets related to the Products to a 

Commission-approved acquirer no later 

than the earlier of ten (10) days after the 

acquisition occurs or ten (10) days after 

the Commission’s Order becomes final. 

Specifically, the proposed Consent 

Agreement requires that Sun divest its 

assets in the Products to Torrent 

Pharmaceutical Limited (‘‘Torrent’’). 

The acquirer of the divested assets 

must receive the prior approval of the 

Commission. The Commission’s goal in 

evaluating a possible purchaser of 

divested assets is to maintain the 

competitive environment that existed 

prior to the acquisition. A proposed 

acquirer of divested assets must not 

itself present competitive problems. 

Torrent, a growing generic 

manufacturer, headquartered in India, is 

particularly well-positioned to 

manufacture and market its acquired 

products and compete effectively in 

those markets. Currently, Torrent sells 

generic pharmaceuticals in the United 

States but none of the relevant products, 

and therefore its acquisition of the 

relevant products would not raise 

independent competitive concerns. 

Torrent has numerous Abbreviated New 

Drug Applications (ANDAs’’) pending 

approval at the FDA, and has the 

resources, capabilities, reputation, and 

experience in marketing generic 

products, as well as a central focus on 

rapidly growing its U.S. generic drugs 

business, necessary to expeditiously 

replicate the competition that would be 

lost with the proposed acquisition. 

If the Commission determines that 

Torrent is not an acceptable acquirer of 

the assets to be divested, or that the 

manner of the divestitures to Torrent is 

not acceptable, Sun must unwind the 

sale and divest the assets within six (6) 

months of the date the Order becomes 

final to another Commission-approved 

acquirer. If the parties fail to divest 

within six (6) months, the Commission 

may appoint a trustee to divest the 

Products. 

The proposed remedy contains 

several provisions to ensure that the 

divestitures are successful. The Order 

requires Sun to provide transitional 

services to enable the Commissionapproved acquirer to obtain all of the 

necessary approvals from the FDA. 

These transitional services include 

technology transfer assistance to 

manufacture the Products in 

substantially the same manner and 

quality employed or achieved by Sun. 

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. E8–19213 Filed 8–19–08; 8:45 am] 

BILLING CODE 6750–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Mine Safety and Health Research 

Advisory Committee, National Institute 

for Occupational Safety and Health 

(NIOSH) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following meeting for the 

aforementioned committee: 

Time and Date: 8 a.m.—5:30 p.m., 

September 25, 2008. 

Place: Hilton Garden Inn, 7830 S. Las 

Vegas Boulevard, Las Vegas, Nevada 

89123, telephone (702) 453–7830, fax 

(702) 453–7850. 

Status: Open to public, limited only 

by the space available. The meeting 

room accommodates approximately 50 

people. 

Purpose: This committee is charged 

with providing advice to the Secretary, 

Department of Health and Human 

Services; the Director, CDC; and the 

Director, NIOSH, on priorities in mine 

safety and health research, including 

grants and contracts for such research, 

30 U.S.C. 812(b)(2), Section 102(b)(2). 

Matters To Be Discussed: The meeting 

will focus on diesel monitoring and 

control research, communications and 

tracking developments, training 

research, chemical hazards in mining, 

and dust monitoring and control 

research. The agenda will also include 

an update from the Associate Director 

for Mining, NIOSH. 

Agenda items are subject to change as 

priorities dictate. 

CONTACT PERSON FOR MORE INFORMATION: 

Jeffery L. Kohler, PhD, Executive 

Secretary, Mine Safety and Health 

Research Advisory Committee, NIOSH, 

CDC, 626 Cochrans Mill Road, 

Pittsburgh, Pennsylvania 15236, 

telephone: (412) 386–5301, Fax (412) 

386–5300. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: August 13, 2008. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E8–19240 Filed 8–19–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Proposed Project: 

Title: Early Head Start Family and 

Child Experiences Survey (Baby 

FACES). 

OMB No. New Collection 

Description: The Administration for 

Children and Families (ACF), U.S. 

Department of Health and Human 

Services, is conducting a descriptive 

study of Early Head Start Programs 

(Early Head Start Family and Child 

Experiences Survey, or Baby FACES). 

Baby FACES is a longitudinal study of 

a nationally representative sample of 

programs and children in two cohorts 

(perinatal and age 1) that will collect 

information about programs, services, 

families, and children. Data for Baby 

FACES will be annually collected 

through interviews with parents, 

teachers, home visitors, and program 

directors/managers, as well as direct 

child assessments, videotaped parent 

child interactions, and observations of 

the home environment when children 

are two and three years old. Data 

collection will also include quality 

observations of child care center 

classrooms and home visits conducted 

by program staff. 

Data will be collected on a sample of 

approximately 2,000 children and 

families selected at random from 90 

Early Head Start programs. Over the life 

of the project, Baby FACES will involve 

four waves of data collection, ending 

when the second cohort of children 

(perinatal cohort) reaches 36 months of 

age. This information collection request 

covers the first three years of data 

collection. All waves of data collection 

will acquire program level information 

through an hour-long program director 

interview. Additionally, staff from all 

programs will complete a simple service 


dwashington3 on PRODPC61 with NOTICES