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
49210 Federal Register / Vol. 73, No. 162 / Wednesday, August 20, 2008 / Notices 

tracking form every week for each child 

in the sample for all years to determine 

what services are being delivered to 

families. 

Respondents: Parents of EHS 

Children, EHS Children, EHS Teachers, 

Home Visitors, and Program Directors/ 

Managers. 

ANNUAL BURDEN ESTIMATES

Instrument 

Annual 

number of 

respondents 

Number of 

responses 

per 

respondent 

Average burden 

hour per 

response 

Estimated 

annual 

burden hours 

Parent Interview ............................................................................................. 1,715 1 1 1,715 

Program Director/Manager Interview ............................................................. 90 1 1 90 

Child Care Provider Interview ........................................................................ 180 1 1 180 

Home Visitor Interview ................................................................................... 270 1 1 270 

Teacher/Home Visitor Child Rating ............................................................... 450 2.6 0 .25 293 

Family Service Tracking ................................................................................ 450 136 0 .1666 10,200 

Child Direct Assessment ............................................................................... 907 1 1 907 

Parent-Child Interaction ................................................................................. 907 1 0 .25 227 

Total Burden Hours: ............................................................................... ........................ ........................ .......................... 12,975 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: OPRE Reports 

Clearance Officer. All requests should 

be identified by the title of the 

information collection. E-mail address: 

OPREinfocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–6974, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: August 12, 2008. 

Brendan C. Kelly, 

OPRE Reports Clearance Officer. 

[FR Doc. E8–19110 Filed 8–19–08; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request NIH-American 

Association for Retired Persons 

(AARP) Comprehensive Lifestyle 

Interview by Computer (CLIC) Study 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Cancer Institute (NCI), the National 

Institutes of Health (NIH), has submitted 

to the Office of Management and Budget 

(OMB) a request to review and approve 

the information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on June 10, 2008 (Vol. 73, No. 

112, p. 32717) and allowed 60-days for 

public comment. There were no public 

comments received during this time. 

The purpose of this notice is to allow an 

additional 30 days for public comment. 

The National Institutes of Health may 

not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised, or implemented 

on or after October 1, 1995, unless it 

displays a currently valid OMB control 

number. 

Proposed Collection: Title: NIHAmerican Association for Retired 

Persons (AARP) Comprehensive 

Lifestyle Interview by Computer (CLIC) 

Study. Type of Information Collection 

Request: New. Need and Use of 

Information Collection: The Nutritional 

Epidemiology Branch of the Division of 

Cancer Epidemiology and Genetics of 

the National Cancer Institute has 

planned this study to evaluate the 

feasibility of using these three new 

computerized questionnaires as well as 

the Diet and Health Questionnaire 

(DHQ), a well-established food 

frequency questionnaire in a population 

of early-to-late-middle-aged men and 

women. Participants will be asked to 

complete one of four different series 

(pathways) of computerized 

questionnaires over a 90 day period, 

with some questionnaires in a series 

being completed twice. This evaluation 

study comprises the necessary 

performance and feasibility tests for the 

new computerized questionnaires, 

which will provide an opportunity to 

assess the possibility of administering 

computerized questionnaires in future 

large prospective cohort studies. The 

computerized questionnaires will 

support the ongoing examination 

between cancer and other health 

outcomes with nutritional, physical 

activity, and lifestyle exposures. The 

computerized questionnaires adhere to 

The Public Health Service Act, Section 

412 (42 U.S.C. 285a–1) and Section 413 

(42 U.S.C. 285a–2), which authorizes 

the Division of Cancer Epidemiology 

and Genetics of the National Cancer 

Institute (NCI) to establish and support 

programs for the detection, diagnosis, 

prevention and treatment of cancer; and 

to collect, identify, analyze and 

disseminate information on cancer 

research, diagnosis, prevention and 

treatment. Frequency of Response: 

Either 2 or 4 times, depending on the 

pathway. Affected Public: Individuals. 

Type of Respondents: U.S. adults (aged 

50 and over). The annual reporting 

burden is displayed in the table below. 

The estimated total annual burden 

hours being requested is 2616. The 

annualized cost to respondents is 

estimated at: $46,242. There are no 


dwashington3 on PRODPC61 with NOTICES