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65902 Federal Register / Vol. 70, No.

210 / Tuesday, November 1, 2005 / Notices

collaborates with NCHSTP investigators HIV antigen and antibody testing plus Plus of Michigan; SureScripts, RxHub
to conduct HIV epidemiologic and related standardized assays in support and MedCo. This is a unique project in
surveillance studies worldwide of the diagnostic/surveillance/ terms of size, sponsoring organizations,
particularly as they pertain to epidemiologic requirements of CDC- patient base, geographic area, and
prevention and intervention strategies; based and CDC-affiliated studies of the approach. This project is consistent
(3) identifies and characterizes new HIV HIV epidemic; (5) serves as a reference with CMS’ goals to improve health care
isolates and develops new screening laboratory for State and local health quality, patient safety, and the use of
tests for these isolates to determine their departments; and (6) provides electronic prescribing. Funding of this
prevalence in various populations; (4) diagnostic services to other Federal unsolicited proposal will result in a
determines geotypic and phenotypic agencies, the World Health desirable public benefit in that its aim
variations of HIVs that may affect Organization, CDC-affiliated academic is to provide needed information on the
pathogenesis, drug resistance, centers, CDC-affiliated studies with costs and critical success factors
persistence, virulence, and other countries, and community associated with the adoption of
transmissibility; (5) conducts and organizations, as appropriate. electronic prescribing, as well as to
supports field epidemiologic Dated: April 1, 2005. provide improvements in quality and
investigations of the prevalence, William H. Gimson, safety of care delivery.
distribution, trends, and risk factors Chief Operating Officer, Centers for Disease FOR FURTHER INFORMATION CONTACT:
associated with non-AIDS retroviral Control and Prevention (CDC). Maria Friedman, Project Officer, Office
infections and associated diseases; (6) [FR Doc. 05–21672 Filed 10–31–05; 8:45 am] of e-health Standards and Services,
serves as a World Health Organization Centers for Medicare and Medicaid
BILLING CODE 4160–18–M
(WHO) Reference Center and as a Services, 7500 Security Blvd., Stop S2–
member of the UNAIDS Virus Network 27–17, Baltimore, MD 21244, (410) 786–
to provide international consultation DEPARTMENT OF HEALTH AND 6333 or Judy Norris, Grants Officer,
and technical assistance on laboratory HUMAN SERVICES Department of Health and Human
procedures for HIV isolation, detection, Services, OOM/AGG/CMS, 7500
and characterization; (7) develops and Centers for Medicare and Medicaid Security Blvd., Stop S2–21–15,
evaluates procedures for the isolation Services Baltimore, MD 21244, (410) 786–5130.
and characterization of HIV and for the
detection of retroviral DNA or RNA Notice of Grant Award to MedCO Authority: Catalog of Federal Domestic
Assistance Program No. 93–779, Center for
from clinical samples; (8) provides Health Solutions, Inc., To Evaluate an
Medicare and Medicaid Services, Research,
training, reference testing, and reference Open-Source Project Entitled, ‘‘A Demonstrations and Evaluations; Section
reagents for virologic and molecular Comparison of Multiple Methods to 1110 of the Social Security Act.
characterization of divergent HIVs for Incent Physicians To Adopt Electronic
Prescribing Devices’’ Dated: August 9, 2005.
public health laboratories in the United
States and WHO; (9) serves as a Mark B. McClellan,
AGENCY: Centers for Medicare and Administrator, Centers for Medicare and
reference laboratory for the isolation of Medicaid Services (CMS), HHS.
zoonotic retroviruses from clinical Medicaid Services.
ACTION: Notice of Grant Award. [FR Doc. 05–21731 Filed 10–31–05; 8:45 am]
samples; (10) develops collaborations
with other CDC and non-CDC scientists SUMMARY: The Centers for Medicare and
BILLING CODE 4120–01–P
to promote scientific progress and Medicaid Services has awarded a grant
accomplishments; and (11) collaborates entitled, ‘‘A Comparison of Multiple
with industry to promote DEPARTMENT OF HEALTH AND
Methods To Incent Physicians To Adopt
commercialization of useful technology, HUMAN SERVICES
Electronic Prescribing Devices’’ to
methodologies, and reagents of public Medco Health Solutions, Inc., 100 Administration for Children and
health importance. Parsons Pond Drive, Franklin Lakes, NJ Families
HIV Immunology and Diagnostic 07417 in response to an unsolicited
Laboratory Branch (HCK58). (1) proposal. The period of performance is Submission for OMB Review;
Conducts basic and applied studies of August 1, 2005 through July 31, 2006. Comment Request
microbial-host interactions that occur in The purpose of this grant is to fund an
infections, particularly infection with initial evaluation of the Southeastern Title: The National Evaluation of the
human immunodeficiency virus (HIV); Michigan e-Prescribing Initiative (SEMI) Court Improvement Program.
(2) conducts basic and applied project. Through the use of e- OMB No.: New Collection.
investigations of the immune cell prescribing, this program is intended to Description: The National Evaluation
interactions that occur in HIV infection reduce the costs associated with the use of the Court Improvement Program will
as well as in related immunologic/ of prescription drugs, and improve describe the many paths followed by
infectious diseases; conducts safety for patients, including Medicare state courts to improve their oversight of
investigations of genetic traits of the beneficiaries, associated with an child welfare cases, and will provide the
host that influence the susceptibility, estimated 6,000 targeted physicians/ field with information on effective
disease course, and immune response to prescribers in Southeastern Michigan. models for juvenile and family court
infectious disease, particularly HIV The project involves the active reform. Funded by the Children’s
diseases; (3) conducts studies related to collaboration of multiple employers, Bureau, U.S. Department of Health and
the development, evaluation, insurance entities and care providers in Human Services (HHS) in 2004, the five-
improvement, and standardization of eight counties in Southeastern year study is being carried out by a
laboratory technologies uses for the Michigan. Partners include the Big partnership of three organizations
diagnosis, surveillance, and monitoring Three automakers, Ford, General Motors consisting of Planning and Learning
of HIV infection both independently and Daimler Chrysler; Blue Cross/Blue Technologies (Pal-Tech, Inc.), the Urban
and in collaboration with the Shield of Michigan; Henry Ford Health Institute and the Center for Policy
biotechnology industry; (4) performs System/Health Alliance Plan; Health Research.

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Federal Register / Vol. 70, No. 210 / Tuesday, November 1, 2005 / Notices 65903

The Federal Court Improvement rigor and findings reported in the the dependency court process coupled
Program (CIP) was established in 1994 substantive areas defined by the EA. with expanded parent representation.
as a source of funding for state courts to These are: • Delaware’s Systemic Reform:
assess and improve their handling of • Alternative dispute resolution. Piloted in 2000, the three primary
foster care and adoption proceedings. • Training and educational materials. components of the state’s
The funding is codified in title IV–B, • Case tracking and management. comprehensive reform effort are:
subpart 2 of the Social Security Act, • Improvements to the consistency • One judge/one case assignment
Section 438, as part of the Promoting and quality of hearings. practice where one judge presides over
Safe and Stable Families Program. • Parent/caregiver outreach, all legal stages of a dependency case
Although anecdotal information education, and support. • Defined sequence of hearings and
documents the program’s success, this is reviews that significantly increases the
• Systemic court reforms.
the first national evaluation of CIP. This number of hearings and oversight role of
3. Conducting in-depth studies of
study builds on the recommendations of the courts
reform models: In-depth evaluation of
a Children’s Bureau funded evaluability
select models of reform will be • Representation for indigent parents
assessment (EA) of the program in child welfare proceedings
completed in 2003 by James Bell undertaken within three, diverse sites
across the country. The study designs • Texas’ Cluster Courts: Piloted in
Associates, Inc. 1997, these courts are located in rural
The National Evaluation of the Court vary among sites, and include quasi-
experimental and descriptive outcome areas of the state. Each court serves a
Improvement Program involves three cluster of contiguous counties, and a
interrelated components: methodologies. Reflecting the Adoption
and Safe Families Act, the primary specially trained judge is appointed to
1. Reviewing and synthesizing state travel to each county within a cluster on
and local court reform activities: This outcome areas of interest will be child
safety, the timely achievement of a given day to hear that county’s child
component will describe the full range welfare cases. The cluster courts were
of CIP-funded court reforms undertaken permanency, and child well-being.
Within each site, outcome evaluation formed to enable rural counties to meet
by states at the beginning and ending of the state’s strict permanency statute
the study’s data collection period. will be complemented by a qualitative
study of the many factors that impacted guidelines that were enacted January 1,
Additionally, it will provide insights 1998.
into states’ reform priorities and how reform including other related reform
efforts, the evolution of the target reform Collectively, findings from the three
these shift over time. Especially study components will capture the
promising models of reform will be over time, barriers encountered, and
methods by which these barriers were ongoing nationwide process of court
highlighted. Finally, this component reform supported by the Court
will provide important contextual overcome.
The outcome evaluation will utilize Improvement Program. A technical
information for the study’s in-depth work group comprised of leading
evaluation component of select models information from existing court and
child welfare agency management researchers, judicial and child welfare
of reform. Information for this activity agency officials and representatives of
will be synthesized from existing information systems. Within select sites,
information from these sources will be public interest groups has been
reports submitted by states to the assembled to provide input at key
Children’s Bureau. supplemented with information
abstracted from existing court and/or points during the study.
2. Reviewing and synthesizing existing
child welfare agency case records. The Respondents: Study respondents
court reform evaluations: This
process evaluation will help inform include individuals in the following
component will identify and synthesize
outcome findings within the study sites categories among the three study sites
findings from research and evaluation
as well as provide important insights for noted above:
conducted on family and juvenile court
the replication of the model within • Court Improvement Program (CIP)
reforms. It will provide important
other sites. It will involve the collection administrators.
context for the study’s in-depth
of new information through structured • Judges.
evaluation component in two ways.
focus groups and interviews with key • Attorneys (representing the parent,
Findings on reform activities beyond
individuals, as well as court child, and agency).
those captured within the study sites
observations of child dependency • Court Appointed Special Advocates
will be provided. It will also help
hearings. This descriptive information (CASAs) and Guardians Ad Litem
inform evaluation within the study sites
will be collected twice during the study. (GALs).
by providing information on previously
The three sites selected for in-depth • Child welfare agency
conducted evaluation of similar reform
analysis are the following: administrators.
models. Information for this activity
• Regional child welfare directors and
will be synthesized from existing • Connecticut’s Case Management
supervisors.
evaluations and studies of court reform. Protocol: Piloted in December 1997, the
• Child welfare agency caseworkers.
Evaluations will be prioritized for protocol involves a pre-hearing
synthesis based on their methodological conference of professionals held early in Annual Burden Estimates

ANNUAL BURDEN ESTIMATES


Number of re- Average bur-
Number of re- Total burden
Instrument sponses per den hours per
spondents hours
respondent response

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

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65904 Federal Register / Vol. 70, No. 210 / Tuesday, November 1, 2005 / Notices

ANNUAL BURDEN ESTIMATES—Continued


Number of re- Average bur-
Number of re- Total burden
Instrument sponses per den hours per
spondents hours
respondent response

Child Welfare Agency Workers ........................................................................ 120 1 2 240

Total .......................................................................................................... ........................ ........................ ........................ 656

Estimated Total Annual Burden information by the agency. Under the With respect to the following
Hours: 656. Paperwork Reduction Act of 1995 (the collection of information, FDA invites
PRA), Federal agencies are required to comments on these topics: (1) Whether
Additional Information
publish notice in the Federal Register the proposed collection of information
Copies of the proposed collection may concerning each proposed collection of is necessary for the proper performance
be obtained by writing to the information, including each proposed of FDA’s functions, including whether
Administration for Children and extension of an existing collection of the information will have practical
Families, Office of Administration, information, and to allow 60 days for utility; (2) the accuracy of FDA’s
Office of Information Services, 370 public comment in response to the estimate of the burden of the proposed
L’Enfant Promenade, SW., Washington, notice. This notice solicits comments on collection of information, including the
DC 20447, Attn: ACF Reports Clearance reporting requirements for filing a validity of the methodology and
Officer. All requests should be notice of participation with FDA. assumptions used; (3) ways to enhance
identified by the title of the information the quality, utility, and clarity of the
collection. e-mail address: DATES:Submit written or electronic
information to be collected; and (4)
infocollection@acf.hhs.gov. comments on the collection of
ways to minimize the burden of the
information by January 3, 2006.
OMB Comment collection of information on
ADDRESSES: Submit electronic respondents, including through the use
OMB is required to make a decision comments on the collection of of automated collection techniques,
concerning the collection of information information to: http://www.fda.gov/ when appropriate, and other forms of
between 30 and 60 days after dockets/ecomments. Submit written information technology.
publication of this document in the comments on the collection of
Federal Register. Therefore, a comment information to the Division of Dockets Notice of Participation—21 CFR 12.45
is best assured of having its full effect Management (HFA-305), Food and Drug (OMB Control Number 0910–0191)—
if OMB receives it within 30 days of Administration, 5630 Fishers Lane, rm. Extension
publication. Written comments and 1061, Rockville, MD 20852. All Section 12.45 (21 CFR 12.45) issued
recommendations for the proposed comments should be identified with the under section 701 of the Federal Food,
information collection should be sent docket number found in brackets in the Drug, and Cosmetic Act (21 U.S.C. 371),
directly to the following: Office of heading of this document. sets forth the format and procedures for
Management and Budget, Paperwork any interested person to file a petition
FOR FURTHER INFORMATION CONTACT:
Reduction Project, Attn: Desk Officer for to participate in a formal evidentiary
ACF, E-mail address: Jonna Capezzuto, Office of Management
hearing, either personally or through a
Katherine_T._Astrich@omb.eop.gov. Programs (HFA-250), Food and Drug
representative. Section 12.45 requires
Administration, 5600 Fishers Lane,
Dated: October 28, 2005. that any person filing a notice of
Rockville, MD 20857, 301–827–4659.
Robert Sargis, participation, state their specific interest
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Under the in the proceedings, including the
PRA (44 U.S.C. 3501–3520), Federal specific issues of fact about which the
[FR Doc. 05–21674 Filed 10–31–05; 8:45 am]
agencies must obtain approval from the person desires to be heard. This section
BILLING CODE 4184–01–M
Office of Management and Budget also requires that the notice include a
(OMB) for each collection of statement that the person will present
information they conduct or sponsor. testimony at the hearing and will
DEPARTMENT OF HEALTH AND
‘‘Collection of information’’ is defined comply with specific requirements in
HUMAN SERVICES
in 44 U.S.C. 3502(3) and 5 CFR § 12.85. Or, in the case of a hearing
Food and Drug Administration 1320.3(c) and includes agency requests before a Public Board of Inquiry (21 CFR
or requirements that members of the 13.25), concerning disclosure of data
[Docket No. 2005N–0426] public submit reports, keep records, or and information by participants. In
provide information to a third party. accordance with § 12.45(e) the presiding
Agency Information Collection
Section 3506(c)(2)(A) of the PRA (44 officer may omit a participant’s
Activities; Proposed Collection;
U.S.C. 3506(c)(2)(A)) requires Federal appearance.
Comment Request; Notice of
agencies to provide a 60-day notice in The presiding officer and other
Participation
the Federal Register concerning each participants will use the collected
AGENCY: Food and Drug Administration, proposed collection of information, information in a hearing to identify
HHS. including each proposed extension of an specific interests to be presented. This
ACTION: Notice. existing collection of information, preliminary information serves to
before submitting the collection to OMB expedite the prehearing conference and
SUMMARY: The Food and Drug for approval. To comply with this commits participation.
Administration (FDA) is announcing an requirement, FDA is publishing notice The respondents are individuals or
opportunity for public comment on the of the proposed collection of households, State or local governments,
proposed collection of certain information set forth in this document. not for profit institutions, and

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