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 

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’’

AGENCY: Centers for Medicare and 

Medicaid Services (CMS), HHS. 

ACTION: Notice of Grant Award. 

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 

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. 

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

Instrument Number of respondents 

Number of responses per 

respondent 

Average burden hours per 

response 

Total burden 

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 

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

ANNUAL BURDEN ESTIMATES—Continued 

Instrument Number of respondents 

Number of responses per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

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 

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 

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. 

DATES: Submit written or electronic 

comments on the collection of 

information by January 3, 2006. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://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. 

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. 

SUPPLEMENTARY INFORMATION: 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. 

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