Submission for OMB Review; Comment Request, 49209-49210 [E8-19110]
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Federal Register / Vol. 73, No. 162 / Wednesday, August 20, 2008 / Notices
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
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17:24 Aug 19, 2008
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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]
49209
meetings and other committee
management activities for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
BILLING CODE 6750–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
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
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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
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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
Number of
responses
per
respondent
Annual
number of
respondents
Instrument
Average burden
hour per
response
Estimated
annual
burden hours
Parent Interview .............................................................................................
Program Director/Manager Interview .............................................................
Child Care Provider Interview ........................................................................
Home Visitor Interview ...................................................................................
Teacher/Home Visitor Child Rating ...............................................................
Family Service Tracking ................................................................................
Child Direct Assessment ...............................................................................
Parent-Child Interaction .................................................................................
1,715
90
180
270
450
450
907
907
1
1
1
1
2.6
136
1
1
1
1
1
1
0.25
0.1666
1
0.25
1,715
90
180
270
293
10,200
907
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]
dwashington3 on PRODPC61 with NOTICES
BILLING CODE 4184–01–M
VerDate Aug<31>2005
15:36 Aug 19, 2008
Jkt 214001
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
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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
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[Federal Register Volume 73, Number 162 (Wednesday, August 20, 2008)]
[Notices]
[Pages 49209-49210]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19110]
-----------------------------------------------------------------------
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
[[Page 49210]]
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
----------------------------------------------------------------------------------------------------------------
Annual number Number of Average burden Estimated
Instrument of responses per hour per annual burden
respondents respondent response 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
