Federal Register / Vol. 60, No. 101 / Thursday, May 25, 1995 / Notices 27731

pursuant to § 225.25(b)(1) of the Board’s

Regulation Y, and leasing real and

personal property or acting as agent,

broker, or adviser in leasing such

property, pursuant to §§ 225.25(b)(5)(i)

and 225.25(b)(5)(ii) of the Board’s

Regulation Y.

Comments on this application must

be received by May 31, 1995.

Board of Governors of the Federal Reserve

System, May 19, 1995.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 95–12845 Filed 5–24–95; 8:45 am]

BILLING CODE 6210–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Announcement 568]

Community-Based Asthma

Intervention Demonstration Programs

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1995

funds for cooperative agreements for the

development, implementation, and

evaluation of community-based asthma

intervention demonstration programs.

The Public Health Service (PHS) is

committed to achieving the health

promotion and disease prevention

objectives of ‘‘Healthy People 2000,’’ a

PHS-led national activity to reduce

morbidity and mortality and improve

the quality of life. This announcement

is related to the priority area of

Environmental Health. (For ordering a

copy of ‘‘Healthy People 2000,’’ see the

section ‘‘Where to Obtain Additional

Information.’’)

Authority

This cooperative agreement is

authorized under the Public Health

Service Act, section 301 (42 U.S.C. 241).

Smoke-Free Workplace

PHS strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the nonuse of

all tobacco products, and Public Law

103–227, the Pro-Children Act of 1994,

prohibits smoking in certain facilities

that receive Federal funds in which

education, library, day care, health care,

and early childhood development

services are provided to children.

Eligible Applicants

Eligible applicants are the official

public health agencies of States or their

bona fide agents or instrumentalities.

This includes the District of Columbia,

American Samoa, the Commonwealth of

Puerto Rico, the Virgin Islands, the

Federated States of Micronesia, Guam,

the Northern Mariana Islands, the

Republic of Palau, and federally

recognized Indian tribal governments.

Only one application from an official

agency (State or local) may enter the

review process and be considered for

award under this program. Eligible

applicants may enter into contracts and

consortia agreements and

understandings as necessary to meet the

requirements of the program and

strengthen the overall application. The

intent to use the above mechanisms

must be stated in the application and

the nature and scope of work of these

mechanisms requires the approval of

CDC.

Availability of Funds

Approximately $200,000 will be

available in FY 1995 to fund two

awards. It is expected that the average

award will be $100,000. It is expected

that the awards will begin on or about

September 30, 1995, and will be made

for a 12-month budget period within a

project period of up to 2 years.

Continuation awards within the

project period will be made on the basis

of satisfactory progress and the

availability of funds.

Purpose

The purpose of this project is to

develop and test cost-effective,

community-based asthma interventions

which address one or more of the

environmental risk factors among poor

children. The specific objectives are:

A. Develop a community-based

intervention program which is

demonstrated to be cost-effective, can be

sustained over time, and can serve as a

model for other communities;

B. Evaluate the effectiveness of

interventions which are targeted at

specific risk factors;

C. Establish a network of public and

private organizations and individuals

within the community who share a

common goal of preventing morbidity

due to asthma among poor and other

high-risk children to work on improved

public education about asthma and its

prevention and;

D. Improve the understanding

concerning the prevalence of specific

environmental risk factors among poor

and other high-risk children with

asthma.

Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under A. (Recipient Activities), and

CDC will be responsible for the

activities under B. (CDC Activities).

A. Recipient Activities:

1. Establish a mechanism for the

surveillance of urgent care visits for

asthma among a target population;

2. Develop a network of community

organizations and individuals who

share an interest in the health of poor

children for the purpose of enhanced

coordination of efforts aimed at patient

and public education about asthma;

3. Measure the prevalence of one or

more environmental risk factors within

a target population and;

4. Develop, pilot test, and evaluate a

community-based asthma intervention

program focused primarily on one

environmental risk factor.

B. CDC Activities:

1. Sponsor a planning workshop for

all recipients and selected outside

experts;

2. Collaborate with the recipient in all

stages of the project, including the

design of the protocol and data

collection instruments, data analysis,

interpretation of results, and

preparation of written reports;

3. Provide on-site programmatic

technical assistance in planning,

implementing, and evaluating ongoing

and innovative program activities;

4. Participate in improving program

performance through consultation based

on information and activities of other

projects and;

5. Coordinate the activities of all

recipients and facilitate the exchange of

information and experiences among

recipients.

Evaluation Criteria

Applications will be reviewed and

evaluated according to the following

criteria:

1. Understanding the Problem (10

points)

Evidence of the applicant’s

understanding of the problem and the

purpose of the cooperative agreement.

2. Measurable Objectives (25 points)

The consistency of the measurable

objectives with the stated purpose of the

cooperative agreement and the ability to

meet the objectives and timetable within

the specified period.

3. Proposed Plan (25 points)

The adequacy of the applicant’s plan

to carry out the activities proposed. Of

particular interest is the potential longterm sustainability of the intervention

and the involvement of community

organizations.
27732 Federal Register / Vol. 60, No. 101 / Thursday, May 25, 1995 / Notices

4. Management and Staffing Plan (25

points)

The extent to which the proposal has

described (a) the qualifications and

commitment of the applicant, (b)

detailed allocations of time and effort of

staff devoted to the project, (c)

information on how the applicant will

implement and administer the project

and (d) the qualifications of the key

project staff.

5. Proposed Evaluation Plan (15 points)

The adequacy of the applicant’s plan

to monitor progress toward meeting the

objectives of the project.

6. Budget (not scored)

The extent to which the budget is

reasonable, adequately justified, and

consistent with the intended use of the

cooperative agreement funds.

7. Human Subjects (not scored)

The applicant must clearly state

whether or not human subjects will be

used in research.

Executive Order 12372 Review

Applications are subject to

Intergovernmental Review of Federal

Programs as governed by Executive

Order (E.O.) 12372. E.O. 12372 sets up

a system for State and local government

review of proposed Federal assistance

applications. Applicants (other than

federally recognized Indian tribal

governments) should contact their State

Single Point of Contact (SPOC) as early

as possible to alert them to the

prospective applications and receive

any necessary instructions on the State

process. For proposed projects serving

more than one State, the applicant is

advised to contact the SPOC of each

affected State. A current list of SPOCs

is included in the application kit. If

SPOCs have any State process

recommendations on applications

submitted to CDC, they should send

them to Henry S. Cassell, III, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E13, Atlanta, Georgia 30305,

no later than 60 days after the

application deadline. The

Announcement Number and Program

Title should be referenced on the

documents. The granting agency does

not guarantee to ‘‘accommodate or

explain’’ for State process

recommendations it receives after that

date.

Indian tribes are strongly encouraged

to request tribal government review of

the proposed application. If tribal

governments have any tribal process

recommendations on applications

submitted to CDC, they should send

them to Henry S. Cassell, III, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E13, Atlanta, Georgia 30305,

no later than 60 days after the

application deadline. The

Announcement Number and Program

Title should be referenced on the

documents. The granting agency does

not guarantee to ‘‘accommodate or

explain’’ for tribal process

recommendations it receives after that

date.

Public Health System Reporting

Requirements

This program is not subject to the

Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance Number is 93.283.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of

information from 10 or more individuals

and funded by cooperative agreement

will be subject to approval by the Office

of Management and Budget (OMB)

under the Paperwork Reduction Act.

Human Subjects

If the proposed project involves

research on human subjects, the

applicant must comply with the

Department of Health and Human

Services Regulations, 45 CFR Part 46,

regarding the protection of human

subjects. Assurance must be provided to

demonstrate that the project will be

subject to initial and continuing review

by appropriate institutional review

committees. In addition to other

applicable committees, Indian Health

Service (IHS) institutional review

committees also must review the project

if any component of IHS will be

involved or will support the research. If

any American Indian community is

involved, its tribal government must

also approve that portion of the project

applicable to it. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and form provided in the

application kit.

Application Submission and Deadline

The original and two copies of the

application PHS Form 5161–1 (OMB

Number 0937-0189) must be submitted

to Henry S. Cassell, III, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E13, Atlanta, Georgia 30305,

on or before July 19, 1995.

1. Deadline: Applications shall be

considered as meeting the deadline if

they are either:

a. Received on or before the deadline

date; or

b. Sent on or before the deadline date

and received in time for submission to

the objective review group. (Applicants

must request a legibly dated U.S. Postal

Service postmark or obtain a legibly

dated receipt from a commercial carrier

or the U.S. Postal Service. Private

metered postmarks shall not be

acceptable as proof of timely mailing.)

2. Late Applications: Applications

that do not meet the criteria in 1.a. or

1.b. above are considered late

applications. Late applications will not

be considered in the current

competition and will be returned to the

applicant.

Where To Obtain Additional

Information

A complete program description,

information on application procedures,

an application package, and business

management technical assistance may

be obtained from Adrienne Brown,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E13, Atlanta, Georgia 30305,

telephone (404) 842–6634.

Programmatic technical assistance may

be obtained from James Rifenburg, Air

Pollution and Respiratory Health

Branch, Division of Environmental

Hazards and Health Effects, National

Center for Environmental Health,

Centers for Disease Control and

Prevention (CDC), Mailstop F39, 4770

Buford Highway, NE., Atlanta, Georgia

30341–3724, telephone (404) 488–7320.

Please refer to Announcement 568

when requesting information or

submitting an application.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report, Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report, Stock No. 017- 001–00473–1)

referenced in the ‘‘INTRODUCTION’’

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.
Federal Register / Vol. 60, No. 101 / Thursday, May 25, 1995 / Notices 27733

Dated: May 19, 1995.

Joseph R. Carter,

Acting Associate Director for Management,

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 95–12834 Filed 5–24–95; 8:45 am]

BILLING CODE 4163–18–P

[Announcement 519]

Prevention of the Complications of

Hemophilia

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1995

funds for a cooperative agreement

program to conduct a trial of primary

prophylaxis therapy for the prevention

of joint disease and/or inhibitor

formation in children with hemophilia.

The Public Health Service (PHS) is

committed to achieving the health

promotion and disease prevention

objectives of Healthy People 2000, a

PHS-led national activity to reduce

morbidity and mortality and improve

the quality of life. This announcement

is related to the priority area of Diabetes

and Chronic Disabling Conditions. (For

ordering a copy of Healthy People 2000,

see the section Where to Obtain

Additional Information.)

Authority

This program is authorized under

Sections 301(a) and 317(k)(2) of the

Public Health Service Act, as amended

[42 U.S.C. 241(a) and 247b(k)(2)].

Applicable program regulations are

found in 42 CFR Part 51b—Project

Grants for Preventive Health Services.

Smoke-Free Workplace

PHS strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote nonuse of all

tobacco products, and Public Law 103–

227, the Pro-Children Act of 1994,

prohibits smoking in certain facilities

that receive Federal funds in which

education, library, day care, health care,

and early childhood development

services are provided to children.

Eligible Applicants

Because of the low prevalence of

hemophilia, competition is limited to

hemophilia treatment centers (HTCs)

that routinely access and administer

comprehensive health care to sufficient

numbers of previously untreated

patients with severe hemophilia each

year. Since HTCs are the only health

care facilities administering to the

numbers of hemophiliacs required for

this study, assistance will be provided

only to hemophilia treatment centers.

Availability of Funds

Approximately $500,000 is available

in FY 1995 to fund up to two awards.

It is expected that the award will begin

on or about September 30, 1995, and

will be made for a 12-month budget

period within a project period of up to

5 years. Funding estimates may vary

and are subject to change. Continuation

awards within the project period will be

made on the basis of satisfactory

programmatic progress and the

availability of funds.

Purpose

The purpose of this hemophilia

cooperative agreement program is to

assist recipients in the implementation

of and analysis of data from a

randomized, controlled trial of primary

prophylaxis in previously untreated

patients with severe hemophilia A and

no demonstrable factor VIII inhibitors.

Cost and efficacy of early intervention

should be determined in the treatment

group and should be compared to

similar data from appropriately treated,

control subjects. In addition to objective

measures of joint function and mobility,

the cumulative risk of factor VIII

inhibitor development should be

determined for each treatment group

and total costs and complication rates

ascertained. Molecular characterization

of factor VIII defects and detailed

molecular HLA typing should be

determined for all subjects in an effort

to predict which subjects will develop

inhibitors.

Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

shall be responsible for the activities

under A. below, and CDC shall be

responsible for conducting activities

under B. below:

A. Recipient Activities

1. Develop standardized study

protocols, data collection instruments,

interview questionnaires, progress

report forms, and amend previous

protocols with new activities or

procedures incorporating all changes

agreed to at assistance meetings.

2. Train study coordinators and

medical personnel in methods of data

collection and patient assessment in the

use of standard data abstraction

instruments, in techniques of reviewing

medical records, in interviewing

patients, and in other methods of data

collection as appropriate and provided

for in the study protocols. It is the

responsibility of the recipient to ensure

uniform training of study personnel at

all data collection sites and to ensure

that the data is collected in a uniform

manner at all locations.

3. Develop appropriate management

and evaluation systems to ensure that

study personnel use data collection and

interview instruments according to

standard study protocols.

4. Collect and edit all data from all

sites, including cost effectiveness data.

5. Obtain and transmit to CDC

sufficient clinical specimens for

specialized laboratory analysis and

genetic testing, including whole blood,

plasma, cell pellets or joint tissue/fluid,

to meet the requirements of the study.

6. Publish the results of the study

using a writing committee to determine

the inclusion and order of authors on all

publications.

B. CDC Activities

1. Provide consultation, and scientific

and technical assistance in planning

and implementing the study protocol.

This assistance will include the

development of standard study

protocols, data abstraction instruments,

interview questionnaires, consent and

progress report forms.

2. Participate in the planning,

coordination, and facilitation of initial

and periodic meetings with recipients to

exchange operational experiences, and

to provide consultation and assistance

in the modification of standard study

protocols as needed.

3. Provide the required software and

technical assistance in statistical and

epidemiologic methods to conduct data

analysis.

4. The coagulation research laboratory

at CDC will be responsible for

confirmation of factor VIII inhibitor

levels and will serve as the central

reference laboratory for molecular

analysis of all study participants. CDC

will be responsible for epitope typing of

all inhibitors and other specialized

immunological/genetic testing.

Evaluation Criteria

Applications will be reviewed and

evaluated according to the following

criteria: (Total 100 points)

A. Capacity

1. The capacity of the applicant to

accrue a minimum total of 40 boys with

severe factor VIII (<1%) who are 30

months old or less without a history of

joint hemorrhage from multiple HTCs to

each treatment arm of the protocol. Each

participating HTC must be able to enroll

a minimum of 5 previously untreated

patients who meet the above criteria. (20

points)

2. The capacity to accrue and

maintain patients on trials will be

measured by (a) the number of patients