Federal Register / Vol. 60, No. 92 / Friday, May 12, 1995 / Notices 25727

submitted to CDC, they should forward

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, GA 30305, no

later than 60 days after the application

deadline. The granting agency does not

guarantee to ‘‘accommodate or explain’’

for State 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 94.136.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of

information from 10 or more individuals

and funded by the cooperative

agreement will be subject to review 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 the 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, GA 30305, on or

before July 14, 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 independent review committee. For

proof of timely mailing, applicant 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 will 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. Late

applications will not be considered in

the current competition and will be

returned to the applicant.

Where To Obtain Additional

Information

To receive additional written

information call (404) 332–4561. You

will be asked to leave your name,

address, and phone number and will

need to refer to Announcement 549.

You will receive a complete program

description, information on application

procedures, and application forms.

If you have questions after reviewing

the contents of all the documents,

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.,

Mailstop E13, Atlanta, GA 30305,

telephone (404) 842–6634.

Programmatic assistance may be

obtained from Tim W. Groza, M.P.A.,

National Center for Injury Prevention

and Control, Centers for Disease Control

and Prevention (CDC), 4770 Buford

Highway, NE., Mailstop K63, Atlanta,

GA 30341–3724, telephone (404) 488–

4652.

Please refer to Announcement 549

when requesting information and

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.

A copy of American Society for

Testing and Materials (ASTM) Number

1292 may be obtained from ASTM,

Customer Services, 1916 Race Street,

Philadelphia, PA 19103–1187,

telephone (215) 299–5585.

Dated: May 8, 1995.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 95–11764 Filed 5–11–95; 8:45 am]

BILLING CODE 4163–18–P

[Announcement 536]

State-Based Evaluation of Trends and

Risk Factors in Morbidity and Mortality

From Sickle Cell Disease After

Newborn Screening; Availability of

Funds for Fiscal Year 1995

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1995

funds for a cooperative agreement

program for the State- based evaluation

of trends and risk factors in morbidity

and mortality from sickle cell disease

(SCD) after newborn screening.

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 Maternal

and Infant Health. (For ordering a copy

of ‘‘Healthy People 2000,’’ see the

section entitled Where To Obtain

Additional Information.)

Authority

This program is authorized under

sections 301 and 317 of the Public

Health Service Act (42 U.S.C. 241 and

247b), as amended.

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
25728 Federal Register / Vol. 60, No. 92 / Friday, May 12, 1995 / Notices

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.

Each applicant must have a minimum of

50 newborns identified each year, for at

least the past five years, with presumed

Hemoglobin SS, SC, or S/β-thalassemia.

Each applicant must also have an

existing mechanism for ascertaining

health outcomes for these children.

Note: Eligible applicants may enter into

contracts, including consortia agreements, as

necessary to meet the essential requirements

of this program and to strengthen the overall

application, provided that the lead

organization is a State.

Availability of Funds

Approximately $100,000 is available

in FY 1995 to fund one to three awards.

It is expected that the average award

will be $50,000. 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 three years.

Funding estimates may vary and are

subject to change.

Continuation awards within the

project period will be made on the basis

of satisfactory progress, the need to

continue the program, and the

availability of funds.

Purpose

These awards will support State

programs that are already involved with

the follow-up of children with SCD

ascertained through their newborn

screening programs. Data from this

program will be used to determine the

proportion of affected newborns who

receive appropriate health care, which

will measure progress toward the

applicable ‘‘Healthy People 2000’’

objectives.

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. Refine existing efforts to ascertain

follow-up information about cohorts of

children with SCD, including vital

status and other relevant data, such as

major illnesses and hospitalizations.

The database of outcomes will contain

a core common to all collaborating

States. Individual States may, at their

option, develop a non-core section to

account for local conditions.

2. Determine risk factors for mortality

and morbidity from SCD including (but

not limited to) extent of medical care

follow-up, location of treatment, use of

penicillin prophylaxis, immunization

patterns, and other relevant factors. The

risk factor database will contain a core

common to all collaborating States.

Individual States may, at their option,

develop a non-core section to account

for local conditions.

3. Conduct a collaborative casecontrol study of risk factors for mortality

and morbidity.

4. Design and implement a

mechanism for reducing all data to

computer readable form.

5. Engage, and collaborate with, other

States and CDC in the timely sharing,

joint analysis and publication of pooled

data.

B. CDC Activities

1. Assist recipients in standardizing

and implementing collection of outcome

data for the SCD cohorts.

2. Assist recipients in developing a

common data-collection instrument and

database of risk factors for mortality and

morbidity.

3. Assist recipients in designing and

implementing a case-control study of

risk factors for mortality and morbidity.

4. Assist recipients in designing and

implementing a mechanism for reducing

data to computer readable form.

5. Assist with statistical analyses,

interpretation, and dissemination of

applicable results.

6. Provide technical assistance.

Evaluation Criteria

Applications will be reviewed and

evaluated according to the following

criteria:

1. Need and Purpose (10%)

Responsiveness to the objectives of

the cooperative agreement program,

including the applicant’s recognition of

the public health significance of the

problem and the relevance of the

proposed project to the purpose of the

agreement.

2. Project Description and Methods

(45%)

a. Strength of the project design in

describing the objectives of the

proposed project.

b. Strength of the project design in

describing the attributes of the State

SCD newborn screening database as

related to the purposes of the project.

c. Quality, extent, and history of the

State newborn screening program,

including the population base and

percent of State residents screened, the

cumulative number of infants identified

with SCD since the inception of

screening, the existence of an

established database of identified

infants, and efforts to ascertain mortality

and morbidity over time.

d. Quality of the project design in

describing the technical approach,

including identification of available

State resources for follow-up;

description of proposed and existing

follow-up methods; and description of

methods for ascertaining risk factors for

mortality and morbidity.

e. Ability to protect the

confidentiality of data.

f. Strength of the project design in

describing the steps to be taken in

planning and implementing the project.

3. Capability and Experience (25%)

a. Demonstration of capability to

conduct a project of this nature,

including reputation in the field, ability

to access all necessary data, and ability

to demonstrate a pre-eminent position

as an appropriate agency to carry out the

project.

b. Demonstration of ability to identify,

organize, and determine appropriate

responsibilities among the applicant,

CDC, and other participants.

c. Demonstration of applicant’s

successful experience and performance

in conducting and evaluating similar

projects, including the strength and

value to the project of any collaborating

organizations.

4. Staffing and Management Resources

(20%)

a. Demonstration that proposed

Project Director is knowledgeable

regarding newborn screening and

prevention of SCD complications, and

has management capabilities, scientific

skills, and experience with prevention

activities, as evidenced by publications,

program summaries, or other materials

that document prior work.

Demonstration of a minimum of five

percent time commitment to the project

by the proposed Project Director.

b. Demonstration that proposed

professional staff are the appropriate

mix of professional disciplines based on

their training, experience, and expertise

in their disciplines, as evidenced by

publications, program summaries, or

other materials that document prior

work. Demonstration of a mimimum of

twenty percent time commitment by the

proposed professional staff that is

sufficient to accomplish the project.

c. Demonstration of ability to provide

facilities and other necessary

management or administrative

resources.
Federal Register / Vol. 60, No. 92 / Friday, May 12, 1995 / Notices 25729

5. Budget (Not Scored)

Extent to which the project budget is

reasonable, clearly justified, and

consistent with the intended use of

funds.

6. Human Subjects (Not Scored)

The applicant must clearly state

whether or not human subjects will be

used in their research.

Executive Order 12372

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 Program

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 Program

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.

Public Health System Reporting

Requirement

This program is not subject to the

Public Health Reporting Requirements.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance number is 93.283.

Other Requirements

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 the 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.

Paperwork Reduction Act

Projects that involve the collection of

information from 10 or more individuals

and are funded by the cooperative

agreement will be subject to review by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act.

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 14, 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 for

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 U.S. Postal Service. Private metered

postmarks will not be acceptable as

proof of timely mailing.)

2. Late Applications: Applications

which 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 Richard S. Olney,

M.D., M.P.H., Division of Birth Defects

and Developmental Disabilities,

National Center for Environmental

Health, Centers for Disease Control and

Prevention (CDC), 4770 Buford

Highway, NE., Mailstop F45, Atlanta,

Georgia 30341, telephone (404) 488–

7176, electronic mail

rso0@cehbddd.em.cdc.gov.

Please refer to Announcement 536

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.

Dated: May 8, 1995.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 95–11765 Filed 5–11–95; 8:45 am]

BILLING CODE 4163–18–P