Submission for OMB Review; Comment Request, 65902-65904 [05-21674]
Download as PDF
65902
Federal Register / Vol. 70, No. 210 / Tuesday, November 1, 2005 / Notices
collaborates with NCHSTP investigators
to conduct HIV epidemiologic and
surveillance studies worldwide
particularly as they pertain to
prevention and intervention strategies;
(3) identifies and characterizes new HIV
isolates and develops new screening
tests for these isolates to determine their
prevalence in various populations; (4)
determines geotypic and phenotypic
variations of HIVs that may affect
pathogenesis, drug resistance,
persistence, virulence, and
transmissibility; (5) conducts and
supports field epidemiologic
investigations of the prevalence,
distribution, trends, and risk factors
associated with non-AIDS retroviral
infections and associated diseases; (6)
serves as a World Health Organization
(WHO) Reference Center and as a
member of the UNAIDS Virus Network
to provide international consultation
and technical assistance on laboratory
procedures for HIV isolation, detection,
and characterization; (7) develops and
evaluates procedures for the isolation
and characterization of HIV and for the
detection of retroviral DNA or RNA
from clinical samples; (8) provides
training, reference testing, and reference
reagents for virologic and molecular
characterization of divergent HIVs for
public health laboratories in the United
States and WHO; (9) serves as a
reference laboratory for the isolation of
zoonotic retroviruses from clinical
samples; (10) develops collaborations
with other CDC and non-CDC scientists
to promote scientific progress and
accomplishments; and (11) collaborates
with industry to promote
commercialization of useful technology,
methodologies, and reagents of public
health importance.
HIV Immunology and Diagnostic
Laboratory Branch (HCK58). (1)
Conducts basic and applied studies of
microbial-host interactions that occur in
infections, particularly infection with
human immunodeficiency virus (HIV);
(2) conducts basic and applied
investigations of the immune cell
interactions that occur in HIV infection
as well as in related immunologic/
infectious diseases; conducts
investigations of genetic traits of the
host that influence the susceptibility,
disease course, and immune response to
infectious disease, particularly HIV
diseases; (3) conducts studies related to
the development, evaluation,
improvement, and standardization of
laboratory technologies uses for the
diagnosis, surveillance, and monitoring
of HIV infection both independently
and in collaboration with the
biotechnology industry; (4) performs
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HIV antigen and antibody testing plus
related standardized assays in support
of the diagnostic/surveillance/
epidemiologic requirements of CDCbased and CDC-affiliated studies of the
HIV epidemic; (5) serves as a reference
laboratory for State and local health
departments; and (6) provides
diagnostic services to other Federal
agencies, the World Health
Organization, CDC-affiliated academic
centers, CDC-affiliated studies with
other countries, and community
organizations, as appropriate.
Dated: April 1, 2005.
William H. Gimson,
Chief Operating Officer, Centers for Disease
Control and Prevention (CDC).
[FR Doc. 05–21672 Filed 10–31–05; 8:45 am]
BILLING CODE 4160–18–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
Notice of Grant Award to MedCO
Health Solutions, Inc., To Evaluate an
Open-Source Project Entitled, ‘‘A
Comparison of Multiple Methods to
Incent Physicians To Adopt Electronic
Prescribing Devices’’
Centers for Medicare and
Medicaid Services (CMS), HHS.
ACTION: Notice of Grant Award.
AGENCY:
SUMMARY: The Centers for Medicare and
Medicaid Services has awarded a grant
entitled, ‘‘A Comparison of Multiple
Methods To Incent Physicians To Adopt
Electronic Prescribing Devices’’ to
Medco Health Solutions, Inc., 100
Parsons Pond Drive, Franklin Lakes, NJ
07417 in response to an unsolicited
proposal. The period of performance is
August 1, 2005 through July 31, 2006.
The purpose of this grant is to fund an
initial evaluation of the Southeastern
Michigan e-Prescribing Initiative (SEMI)
project. Through the use of eprescribing, this program is intended to
reduce the costs associated with the use
of prescription drugs, and improve
safety for patients, including Medicare
beneficiaries, associated with an
estimated 6,000 targeted physicians/
prescribers in Southeastern Michigan.
The project involves the active
collaboration of multiple employers,
insurance entities and care providers in
eight counties in Southeastern
Michigan. Partners include the Big
Three automakers, Ford, General Motors
and Daimler Chrysler; Blue Cross/Blue
Shield of Michigan; Henry Ford Health
System/Health Alliance Plan; Health
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
Plus of Michigan; SureScripts, RxHub
and MedCo. This is a unique project in
terms of size, sponsoring organizations,
patient base, geographic area, and
approach. This project is consistent
with CMS’ goals to improve health care
quality, patient safety, and the use of
electronic prescribing. Funding of this
unsolicited proposal will result in a
desirable public benefit in that its aim
is to provide needed information on the
costs and critical success factors
associated with the adoption of
electronic prescribing, as well as to
provide improvements in quality and
safety of care delivery.
FOR FURTHER INFORMATION CONTACT:
Maria Friedman, Project Officer, Office
of e-health Standards and Services,
Centers for Medicare and Medicaid
Services, 7500 Security Blvd., Stop S2–
27–17, Baltimore, MD 21244, (410) 786–
6333 or Judy Norris, Grants Officer,
Department of Health and Human
Services, OOM/AGG/CMS, 7500
Security Blvd., Stop S2–21–15,
Baltimore, MD 21244, (410) 786–5130.
Authority: Catalog of Federal Domestic
Assistance Program No. 93–779, Center for
Medicare and Medicaid Services, Research,
Demonstrations and Evaluations; Section
1110 of the Social Security Act.
Dated: August 9, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare and
Medicaid Services.
[FR Doc. 05–21731 Filed 10–31–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: The National Evaluation of the
Court Improvement Program.
OMB No.: New Collection.
Description: The National Evaluation
of the Court Improvement Program will
describe the many paths followed by
state courts to improve their oversight of
child welfare cases, and will provide the
field with information on effective
models for juvenile and family court
reform. Funded by the Children’s
Bureau, U.S. Department of Health and
Human Services (HHS) in 2004, the fiveyear study is being carried out by a
partnership of three organizations
consisting of Planning and Learning
Technologies (Pal-Tech, Inc.), the Urban
Institute and the Center for Policy
Research.
E:\FR\FM\01NON1.SGM
01NON1
65903
Federal Register / Vol. 70, No. 210 / Tuesday, November 1, 2005 / Notices
The Federal Court Improvement
Program (CIP) was established in 1994
as a source of funding for state courts to
assess and improve their handling of
foster care and adoption proceedings.
The funding is codified in title IV–B,
subpart 2 of the Social Security Act,
Section 438, as part of the Promoting
Safe and Stable Families Program.
Although anecdotal information
documents the program’s success, this is
the first national evaluation of CIP. This
study builds on the recommendations of
a Children’s Bureau funded evaluability
assessment (EA) of the program
completed in 2003 by James Bell
Associates, Inc.
The National Evaluation of the Court
Improvement Program involves three
interrelated components:
1. Reviewing and synthesizing state
and local court reform activities: This
component will describe the full range
of CIP-funded court reforms undertaken
by states at the beginning and ending of
the study’s data collection period.
Additionally, it will provide insights
into states’ reform priorities and how
these shift over time. Especially
promising models of reform will be
highlighted. Finally, this component
will provide important contextual
information for the study’s in-depth
evaluation component of select models
of reform. Information for this activity
will be synthesized from existing
reports submitted by states to the
Children’s Bureau.
2. Reviewing and synthesizing existing
court reform evaluations: This
component will identify and synthesize
findings from research and evaluation
conducted on family and juvenile court
reforms. It will provide important
context for the study’s in-depth
evaluation component in two ways.
Findings on reform activities beyond
those captured within the study sites
will be provided. It will also help
inform evaluation within the study sites
by providing information on previously
conducted evaluation of similar reform
models. Information for this activity
will be synthesized from existing
evaluations and studies of court reform.
Evaluations will be prioritized for
synthesis based on their methodological
rigor and findings reported in the
substantive areas defined by the EA.
These are:
• Alternative dispute resolution.
• Training and educational materials.
• Case tracking and management.
• Improvements to the consistency
and quality of hearings.
• Parent/caregiver outreach,
education, and support.
• Systemic court reforms.
3. Conducting in-depth studies of
reform models: In-depth evaluation of
select models of reform will be
undertaken within three, diverse sites
across the country. The study designs
vary among sites, and include quasiexperimental and descriptive outcome
methodologies. Reflecting the Adoption
and Safe Families Act, the primary
outcome areas of interest will be child
safety, the timely achievement of
permanency, and child well-being.
Within each site, outcome evaluation
will be complemented by a qualitative
study of the many factors that impacted
reform including other related reform
efforts, the evolution of the target reform
over time, barriers encountered, and
methods by which these barriers were
overcome.
The outcome evaluation will utilize
information from existing court and
child welfare agency management
information systems. Within select sites,
information from these sources will be
supplemented with information
abstracted from existing court and/or
child welfare agency case records. The
process evaluation will help inform
outcome findings within the study sites
as well as provide important insights for
the replication of the model within
other sites. It will involve the collection
of new information through structured
focus groups and interviews with key
individuals, as well as court
observations of child dependency
hearings. This descriptive information
will be collected twice during the study.
The three sites selected for in-depth
analysis are the following:
• Connecticut’s Case Management
Protocol: Piloted in December 1997, the
protocol involves a pre-hearing
conference of professionals held early in
the dependency court process coupled
with expanded parent representation.
• Delaware’s Systemic Reform:
Piloted in 2000, the three primary
components of the state’s
comprehensive reform effort are:
• One judge/one case assignment
practice where one judge presides over
all legal stages of a dependency case
• Defined sequence of hearings and
reviews that significantly increases the
number of hearings and oversight role of
the courts
• Representation for indigent parents
in child welfare proceedings
• Texas’ Cluster Courts: Piloted in
1997, these courts are located in rural
areas of the state. Each court serves a
cluster of contiguous counties, and a
specially trained judge is appointed to
travel to each county within a cluster on
a given day to hear that county’s child
welfare cases. The cluster courts were
formed to enable rural counties to meet
the state’s strict permanency statute
guidelines that were enacted January 1,
1998.
Collectively, findings from the three
study components will capture the
ongoing nationwide process of court
reform supported by the Court
Improvement Program. A technical
work group comprised of leading
researchers, judicial and child welfare
agency officials and representatives of
public interest groups has been
assembled to provide input at key
points during the study.
Respondents: Study respondents
include individuals in the following
categories among the three study sites
noted above:
• Court Improvement Program (CIP)
administrators.
• Judges.
• Attorneys (representing the parent,
child, and agency).
• Court Appointed Special Advocates
(CASAs) and Guardians Ad Litem
(GALs).
• Child welfare agency
administrators.
• Regional child welfare directors and
supervisors.
• Child welfare agency caseworkers.
Annual Burden Estimates
ANNUAL BURDEN ESTIMATES
Number of respondents
Instrument
Number of responses per
respondent
Average burden hours per
response
8
30
95
55
10
30
1
1
1
1
1
1
2
1
2
2
1
2
CIP Administrators ...........................................................................................
Judges .............................................................................................................
Attorneys (parent and agency) ........................................................................
CASAs and GALs ............................................................................................
Child Welfare Agency Administrators ..............................................................
Child Welfare Agency Directors & Supervisors ...............................................
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Frm 00027
Fmt 4703
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E:\FR\FM\01NON1.SGM
01NON1
Total burden
hours
16
30
190
110
10
60
65904
Federal Register / Vol. 70, No. 210 / Tuesday, November 1, 2005 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Number of respondents
Number of responses per
respondent
Average burden hours per
response
Child Welfare Agency Workers ........................................................................
120
1
2
240
Total ..........................................................................................................
........................
........................
........................
656
Instrument
Estimated Total Annual Burden
Hours: 656.
Additional Information
Copies of the proposed collection may
be obtained 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. All requests should be
identified by the title of the information
collection. e-mail address:
infocollection@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, Attn: Desk Officer for
ACF, E-mail address:
Katherine_T._Astrich@omb.eop.gov.
Dated: October 28, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05–21674 Filed 10–31–05; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0426]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Notice of
Participation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
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15:39 Oct 31, 2005
Jkt 208001
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
reporting requirements for filing a
notice of participation with FDA.
Submit written or electronic
comments on the collection of
information by January 3, 2006.
DATES:
Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
Total burden
hours
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Notice of Participation—21 CFR 12.45
(OMB Control Number 0910–0191)—
Extension
Section 12.45 (21 CFR 12.45) issued
under section 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 371),
sets forth the format and procedures for
any interested person to file a petition
to participate in a formal evidentiary
hearing, either personally or through a
representative. Section 12.45 requires
that any person filing a notice of
participation, state their specific interest
in the proceedings, including the
specific issues of fact about which the
person desires to be heard. This section
also requires that the notice include a
statement that the person will present
testimony at the hearing and will
comply with specific requirements in
§ 12.85. Or, in the case of a hearing
before a Public Board of Inquiry (21 CFR
13.25), concerning disclosure of data
and information by participants. In
accordance with § 12.45(e) the presiding
officer may omit a participant’s
appearance.
The presiding officer and other
participants will use the collected
information in a hearing to identify
specific interests to be presented. This
preliminary information serves to
expedite the prehearing conference and
commits participation.
The respondents are individuals or
households, State or local governments,
not for profit institutions, and
E:\FR\FM\01NON1.SGM
01NON1
Agencies
[Federal Register Volume 70, Number 210 (Tuesday, November 1, 2005)]
[Notices]
[Pages 65902-65904]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-21674]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: The National Evaluation of the Court Improvement Program.
OMB No.: New Collection.
Description: The National Evaluation of the Court Improvement
Program will describe the many paths followed by state courts to
improve their oversight of child welfare cases, and will provide the
field with information on effective models for juvenile and family
court reform. Funded by the Children's Bureau, U.S. Department of
Health and Human Services (HHS) in 2004, the five-year study is being
carried out by a partnership of three organizations consisting of
Planning and Learning Technologies (Pal-Tech, Inc.), the Urban
Institute and the Center for Policy Research.
[[Page 65903]]
The Federal Court Improvement Program (CIP) was established in 1994
as a source of funding for state courts to assess and improve their
handling of foster care and adoption proceedings. The funding is
codified in title IV-B, subpart 2 of the Social Security Act, Section
438, as part of the Promoting Safe and Stable Families Program.
Although anecdotal information documents the program's success, this is
the first national evaluation of CIP. This study builds on the
recommendations of a Children's Bureau funded evaluability assessment
(EA) of the program completed in 2003 by James Bell Associates, Inc.
The National Evaluation of the Court Improvement Program involves
three interrelated components:
1. Reviewing and synthesizing state and local court reform
activities: This component will describe the full range of CIP-funded
court reforms undertaken by states at the beginning and ending of the
study's data collection period. Additionally, it will provide insights
into states' reform priorities and how these shift over time.
Especially promising models of reform will be highlighted. Finally,
this component will provide important contextual information for the
study's in-depth evaluation component of select models of reform.
Information for this activity will be synthesized from existing reports
submitted by states to the Children's Bureau.
2. Reviewing and synthesizing existing court reform evaluations:
This component will identify and synthesize findings from research and
evaluation conducted on family and juvenile court reforms. It will
provide important context for the study's in-depth evaluation component
in two ways. Findings on reform activities beyond those captured within
the study sites will be provided. It will also help inform evaluation
within the study sites by providing information on previously conducted
evaluation of similar reform models. Information for this activity will
be synthesized from existing evaluations and studies of court reform.
Evaluations will be prioritized for synthesis based on their
methodological rigor and findings reported in the substantive areas
defined by the EA. These are:
Alternative dispute resolution.
Training and educational materials.
Case tracking and management.
Improvements to the consistency and quality of hearings.
Parent/caregiver outreach, education, and support.
Systemic court reforms.
3. Conducting in-depth studies of reform models: In-depth
evaluation of select models of reform will be undertaken within three,
diverse sites across the country. The study designs vary among sites,
and include quasi-experimental and descriptive outcome methodologies.
Reflecting the Adoption and Safe Families Act, the primary outcome
areas of interest will be child safety, the timely achievement of
permanency, and child well-being. Within each site, outcome evaluation
will be complemented by a qualitative study of the many factors that
impacted reform including other related reform efforts, the evolution
of the target reform over time, barriers encountered, and methods by
which these barriers were overcome.
The outcome evaluation will utilize information from existing court
and child welfare agency management information systems. Within select
sites, information from these sources will be supplemented with
information abstracted from existing court and/or child welfare agency
case records. The process evaluation will help inform outcome findings
within the study sites as well as provide important insights for the
replication of the model within other sites. It will involve the
collection of new information through structured focus groups and
interviews with key individuals, as well as court observations of child
dependency hearings. This descriptive information will be collected
twice during the study.
The three sites selected for in-depth analysis are the following:
Connecticut's Case Management Protocol: Piloted in
December 1997, the protocol involves a pre-hearing conference of
professionals held early in the dependency court process coupled with
expanded parent representation.
Delaware's Systemic Reform: Piloted in 2000, the three
primary components of the state's comprehensive reform effort are:
One judge/one case assignment practice where one judge
presides over all legal stages of a dependency case
Defined sequence of hearings and reviews that
significantly increases the number of hearings and oversight role of
the courts
Representation for indigent parents in child welfare
proceedings
Texas' Cluster Courts: Piloted in 1997, these courts are
located in rural areas of the state. Each court serves a cluster of
contiguous counties, and a specially trained judge is appointed to
travel to each county within a cluster on a given day to hear that
county's child welfare cases. The cluster courts were formed to enable
rural counties to meet the state's strict permanency statute guidelines
that were enacted January 1, 1998.
Collectively, findings from the three study components will capture
the ongoing nationwide process of court reform supported by the Court
Improvement Program. A technical work group comprised of leading
researchers, judicial and child welfare agency officials and
representatives of public interest groups has been assembled to provide
input at key points during the study.
Respondents: Study respondents include individuals in the following
categories among the three study sites noted above:
Court Improvement Program (CIP) administrators.
Judges.
Attorneys (representing the parent, child, and agency).
Court Appointed Special Advocates (CASAs) and Guardians Ad
Litem (GALs).
Child welfare agency administrators.
Regional child welfare directors and supervisors.
Child welfare agency caseworkers.
Annual Burden Estimates
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
CIP Administrators.............................. 8 1 2 16
Judges.......................................... 30 1 1 30
Attorneys (parent and agency)................... 95 1 2 190
CASAs and GALs.................................. 55 1 2 110
Child Welfare Agency Administrators............. 10 1 1 10
Child Welfare Agency Directors & Supervisors.... 30 1 2 60
[[Page 65904]]
Child Welfare Agency Workers.................... 120 1 2 240
-----------------
Total....................................... .............. .............. .............. 656
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 656.
Additional Information
Copies of the proposed collection may be obtained 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. All requests
should be identified by the title of the information collection. e-mail
address: infocollection@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, Attn: Desk Officer
for ACF, E-mail address: Katherine--T.--Astrich@omb.eop.gov.
Dated: October 28, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05-21674 Filed 10-31-05; 8:45 am]
BILLING CODE 4184-01-M