Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Notices 10803 

4E.g., Microsoft, 253 F.3d at 59. 

5 Id. 

6 ‘‘Interbrand free-riding’’ occurs when a 

manufacturer provides services, training, or other 

incentives in the promotion of its products for 

which it cannot easily charge its dealer, and that 

dealer ‘‘free-rides’’ on these demand-generating 

services by substituting a cheaper, more profitable 

product made by another manufacturer that does 

not invest in comparable services. See generally 

Howard P. Marvel, Exclusive Dealing, 25 J.L. & 

Econ. 1, 8 (1982). 

7See United States v. Dentsply Int’l, Inc., 277 F. 

Supp. 2d 387, 445 (D. Del. 2003), aff’d in rel. part, 

399 F.3d at 196-97; Marvel, Exclusive Dealing, 25 

J.L. & Econ. at 8 (explaining that an interbrand freeriding justification ‘‘does not apply if the 

promotional investment is purely brand specific. In 

such cases, the dealer will not be in a position to 

switch customers from brand to brand.’’). 

8See In re Polygram, 136 F.T.C. 310, 361-62 

(2003), aff’d, 416 F.3d 29, 37-38 (D.C. Cir. 2005). 

9We use the term ‘‘de facto exclusive dealing’’ to 

refer to practices that significantly deter a customer 

from purchasing or selling a competing 

photochromic lens. 

further foreclose rivals, in whole or in 

part, from as much as 40 percent or 

more of these downstream distribution 

channels. Transitions’ exclusionary 

conduct has thus likely caused higher 

prices, lower output, and reduced 

innovation and consumer choice. 

A monopolist may rebut a such a 

showing of competitive harm by 

demonstrating that the challenged 

conduct is reasonably necessary to 

achieve a procompetitive benefit.4 Any 

proffered justification, if proven, must 

be balanced against the harm caused by 

the challenged conduct.5

No procompetitive efficiencies justify 

Transitions’ exclusionary and 

anticompetitive conduct. Transitions 

cannot show that the exclusive 

arrangements were reasonably necessary 

to achieve a procompetitive benefit, 

such as protecting Transitions’ 

intellectual property or technical knowhow, or preventing interbrand freeriding.6 Transitions does not transfer 

substantial intellectual property or 

technical know-how to its customers, 

and even if it did, any such transfer 

would likely be protected by existing 

confidentiality agreements. 

A concern about interbrand freeriding also does not justify the 

substantial anticompetitive effects 

found here. The vast majority of 

Transitions’ promotional efforts are 

brand specific, reducing the significance 

of any free-riding concern.7 While 

Transitions’ marketing efforts may 

generate some consumer interest in the 

product category as a whole – and not 

just in Transitions’ own products – this 

is a part of the natural competitive 

process. This type of consumer response 

does not raise a free-riding concern 

sufficient to justify the substantial 

anticompetitive effects found here.8

III. The Order 

The proposed Order remedies 

Transitions’ anticompetitive and 

exclusionary conduct and imposes 

certain fencing-in requirements that are 

designed to prevent de facto exclusive 

dealing.9 Paragraph II of the Order 

addresses the core of Transitions’ 

exclusionary conduct and seeks to lower 

entry barriers and to restore 

competition. Paragraph III requires 

Transitions to implement an antitrust 

compliance program, which includes 

providing notice of this Order to 

Transitions’ customers. Paragraphs IVVI impose reporting and other 

compliance requirements. The Order 

expires in 20 years unless otherwise 

indicated. 

Paragraph II.A prohibits Transitions 

from adopting or implementing any 

agreement or policy that results in 

‘‘exclusivity’’ with lens casters, or its 

‘‘Direct Customers.’’ ‘‘Exclusivity’’ is 

defined in the Order to include any 

requirement that a customer limit or 

refrain from dealing with a competing 

photochromic lens, as well as any 

requirement that a customer give 

Transitions’ products more favorable 

treatment as compared to a competitor’s 

products. 

Paragraph II.B allows Transitions to 

enter into exclusive agreements with 

retailers and wholesale labs (‘‘Indirect 

Customers’’), provided certain 

safeguards are met. Specifically, any 

exclusive agreements with Indirect 

Customers must: i) be terminable 

without cause, and without penalty, on 

30 days written notice; ii) be available 

on a partially exclusive basis, if 

requested by the customer; and iii) not 

offer flat payments of monies in 

exchange for exclusivity. These 

provisions, along with Paragraph II.E, 

which prohibits Transitions from 

bundling discounts, are designed to 

enable a competitor or entrant to 

compete for a customer’s business, even 

if it does not offer a photochromic 

treatment that applies to a full line of 

ophthalmic lenses. Creating conditions 

conducive to effective entry on an 

incremental basis is likely to hasten new 

entry and to restore competition. 

Under Paragraph II.C, Transitions may 

not limit its customers from 

communicating or discussing a 

competing photochromic lens with 

consumers and others. This Paragraph 

also requires Transitions to allow a lens 

caster or another customer that sells 

Transitions’ photochromic treatment on 

a particular brand of lens to sell a 

competitors’ photochromic treatment on 

the same brand. 

Paragraph II.D has two provisions 

designed to prevent de facto exclusive 

dealing through pricing policies. First, 

Transitions cannot offer market share 

discounts, i.e., discounts based on the 

percentage of a customer’s sales of 

Transitions’ lenses as a percentage of all 

photochromic lens sales. Second, 

Transitions cannot offer discounts that 

are applied retroactively once a 

customer reaches a specified threshold. 

For example, Transitions may provide a 

discount on sales beyond 1000 units but 

it may not lower the price of the first 

999 units if and when the customer 

buys the 1000th unit. The provisions in 

Paragraph II.D, along with Paragraph 

II.E, will be in effect for 10 years. 

Notwithstanding any provision of the 

Order, Paragraph II.G explicitly allows 

Transitions to provide volume discounts 

that reflect certain cost differences, and 

to offer discounts to meet competition. 

It also allows Transitions to require that 

any monies it provides to customers be 

used solely for the manufacture, 

promotion or sale of Transitions lenses. 

Finally, Paragraph II.F prohibits 

Transitions from retaliating against a 

customer that purchases or sells 

Transitions lenses on a non-exclusive 

basis. 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. 2010–4979 Filed 3–8–10; 7:23 am] 

BILLING CODE 6750–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–10–09AM] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Prevalence Survey of Healthcare 

Associated Infections (HAIs) and 


sroberts on DSKD5P82C1PROD with NOTICES
10804 Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Notices 

Antimicrobial Use in U.S. Acute Care 

Hospitals—New—National Center for 

Emerging and Zoonotic Infectious 

Diseases (NCEZID) (proposed), Centers 

for Disease Control and Prevention 

(CDC). 

Background and Brief Description 

CDC is requesting OMB approval to 

conduct two surveys to obtain national 

estimates of HAI prevalence and 

antimicrobial use in the United States. 

Preventing HAIs is a CDC priority, and 

an essential step in reducing the 

occurrence of HAIs is to accurately 

estimate the burden of these infections 

in U.S. hospitals and to describe the 

types of HAIs and their causative 

organisms, including antimicrobialresistant pathogens. 

The scope and magnitude of HAIs in 

the U.S. were last directly estimated in 

the 1970s and 1980s by CDC’s Study on 

the Efficacy of Nosocomial Infection 

Control (SENIC), in which 

comprehensive data were collected from 

a sample of 338 hospitals; 5% of 

hospitalized patients acquired an 

infection not present at the time of 

admission. CDC’s current HAI 

surveillance system, the National 

Healthcare Safety Network (NHSN) 

(OMB Control No. 0920–0666, 

expiration date 9/30/2012), focuses 

instead on device-associated and 

procedure-associated infections in a 

variety of patient locations, and does 

not receive data on all types of HAIs to 

make hospital-wide burden estimates. 

The purpose of this information 

collection request is to assess the 

magnitude and types of HAIs and 

antimicrobial use occurring in all 

patient populations within acute care 

hospitals. This information will be used 

to inform decisions made by local and 

national policy makers and hospital 

infection control personnel regarding 

appropriate targets and strategies for 

preventing HAIs and the emergence of 

antimicrobial-resistant pathogens and 

encouraging appropriate antimicrobial 

use. Such assessments can be obtained 

in periodic national prevalence studies, 

such as those that have been conducted 

in several European countries. 

CDC proposes to conduct two surveys 

to collect this data. The first survey will 

be a limited roll-out survey and will be 

conducted in 30 facilities across 10 

states in collaboration with state public 

health authorities and CDC’s Emerging 

Infections Program (EIP). The survey 

will be conducted on a single day in 

participating facilities. Infection Control 

Practitioners in participating facilities, 

such as infection control personnel, will 

collect limited demographic and clinical 

information on a sample of eligible 

inpatients and, on the same day, EIP site 

personnel will collect information on 

HAIs and antimicrobial use for surveyed 

patients who are on antimicrobial 

therapy at the time of the survey. The 

second survey will involve 500 facilities 

across the same 10 states and use the 

same methodology. As with the first 

survey, CDC will collaborate with state 

public health authorities and EIP sites. 

CDC has made the following 

assumptions in calculating the response 

burden. Infection Control Practitioners 

will be asked to collect a minimal 

amount of data, limited to basic 

demographic and risk factor/ 

antimicrobial use information. We 

anticipate that this data collection will 

take 5 minutes per patient. EIP 

personnel will complete data collection 

on antimicrobial use and HAIs. CDC 

estimates that this data collection will 

take approximately 15 minutes per 

patient. 

CDC has assumed an average daily 

patient census of 250 patients for each 

of the 30 participating facilities in 

Survey #1. An Infection Control 

Practitioner (ICP) in his/her own facility 

will be asked to review 1⁄3 or 33% of this 

number (250); thus, the ICP would 

review 82.5 records (rounded up to 83). 

This number is estimated to be the same 

in each phase of the prevalence survey 

effort. 

EIP Personnel will be reviewing 

medical records of approximately 40% 

of all patients surveyed in their EIP site 

in both surveys #1 and #2. In Survey #1, 

the total number of patient records 

surveyed in each EIP site (assuming 3 

facilities in each EIP site and 83 patient 

records per site) is 247.5 patient records. 

Forty percent of that number (247.5) is 

99 patient records or 99 responses per 

EIP site. In Survey #2, there will be 

more facilities participating per EIP site 

(50 facilities per EIP site for a total of 

500 facilities). Again, CDC assumes 82.5 

records surveyed per site (50 × 82.5) or 

a total of 4,125 patient records. As 

above, EIP personnel in each of the 10 

sites will review approximately 40% of 

the 4,125 patient records per site or 

1,650 patient records. 

CDC will use the data provided to 

estimate the prevalence of HAIs and 

antimicrobial use across this sample of 

U.S. hospitals as well as to estimate the 

distribution of infection types, causative 

organisms, and nature of and rationale 

for antimicrobial use. 

This proposed project supports CDC’s 

Strategic Goal of ‘‘Healthy Healthcare 

Settings,’’ specifically the objectives to 

‘‘Promote compliance with evidencebased guidelines for preventing, 

identifying, and managing disease in 

healthcare settings’’ and ‘‘Prevent 

adverse events in patients and 

healthcare workers in healthcare 

settings.’’ 

There are no costs to respondents, 

other than their time to complete the 

survey. The total annualized burden for 

this data collection is 8,039 hours. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Infection Control Practitioners—Survey #1 ................................................................................. 30 83 5/60 

EIP Personnel—Survey #1 .......................................................................................................... 10 99 15/60 

Infection Control Practitioners—Survey #2 ................................................................................. 500 83 5/60 

EIP Personnel—Survey #2 .......................................................................................................... 10 1,650 15/60 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Notices 10805 

Dated: February 26, 2010. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–4885 Filed 3–8–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects: 

Title: Child Support Enforcement 

Program Expenditure Report (Form 

OCSE–396A) and the Child Support 

Enforcement Program Collection Report 

(Form OCSE–34A). 

OMB No.: 0970–0181. 

Description: State and Tribal agencies 

administering the Child Support 

Enforcement Program under Title IV–D 

of the Social Security Act are required 

to provide information each fiscal 

quarter to the Office of Child Support 

Enforcement (OCSE) concerning 

administrative expenditures and the 

receipt and disposition of child support 

payments from non-custodial parents. 

State title IV–D agencies report quarterly 

expenditures and collections using 

Forms OCSE–396A and OCSE–34A, 

respectively. Tribal title IV–D agencies 

report quarterly expenditures using 

Form SF–269, as prescribed in program 

regulations, and formerly reported 

quarterly collections using only a 

modified version of Form OCSE–34A. 

The information collected on these 

reporting forms is used to compute 

quarterly grant awards to States and 

Tribes, the annual incentive payments 

to States and provides valuable 

information on program finances. This 

information is also included in a 

published annual statistical and 

financial report, available to the general 

public. 

Under Public Law 111–5, the 

‘‘American Recovery and Reinvestment 

Act of 2009’’ (ARRA), enacted in 

February 2009, the availability of 

Federal funding to State administered 

child support enforcement programs 

was substantially increased with a 

change in methodology of calculating 

these funds. We propose to formally 

incorporate this necessary revision into 

the quarterly expenditure report and to 

update the existing quarterly collection 

report to enable the same version of that 

form to be used by both State and Tribal 

IV–D agencies. We also propose to 

review other data entry elements and 

the accompanying instructions in both 

data collection forms to assure that the 

financial information requested from 

States and Tribes remains relevant and 

will assure that OCSE collects the 

information needed in the most efficient 

format feasible. 

Respondents: State agencies 

(including the District of Columbia, 

Puerto Rico, Guam and the Virgin 

Islands) administering the Child 

Support Enforcement Program. Tribal 

agencies with approved plans to 

administer the Child Support 

Enforcement Program. 

ANNUAL BURDEN ESTIMATES

Instrument Number of respondents 

Number of responses per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

OCSE–396A .................................................................................................... 54 4 8 1,728 

OCSE–34A ...................................................................................................... 100 4 8 3,200 

Estimated Total Annual Burden 

Hours: 4,928. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: March 3, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–4895 Filed 3–8–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2008–P–0435 and FDA– 

2008–P–0554] 

Determination That DOVONEX 

(Calcipotriene) Ointment, 0.005%, Was 

Not Withdrawn From Sale for Reasons 

of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing its 

determination that DOVONEX 

(calcipotriene) Ointment, 0.005%, was 

not withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for calcipotriene 

Ointment, 0.005%, if all other legal and 

regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

David Joy, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 


sroberts on DSKD5P82C1PROD with NOTICES