Submission for OMB Review; Comment Request, 49209-49210 [E8-19110]

Download as PDF dwashington3 on PRODPC61 with NOTICES 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 VerDate Aug<31>2005 17:24 Aug 19, 2008 Jkt 214001 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 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 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 E:\FR\FM\20AUN1.SGM 20AUN1 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 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 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 E:\FR\FM\20AUN1.SGM 20AUN1

Agencies

[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