Cooperative Agreements for State-Based Birth Defect Surveillance Demonstration Projects

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement 531]

Cooperative Agreements for State-Based Birth Defect Surveillance

Demonstration Projects

Introduction

The Centers for Disease Control and Prevention (CDC) announces the

availability of fiscal year (FY) 1995 funds for a cooperative agreement

program for state-based birth defect surveillance demonstration

projects. This cooperative agreement will support the development,

implementation, and evaluation of state-based birth defect surveillance

systems.

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 areas of Alcohol and Other Drugs, Environmental Health,

Maternal and Infant Health, and Surveillance and Data Systems. (For

ordering a copy of ``Healthy People 2000,'' see the section ``Where To

Obtain Additional Information.'')

Authority

This program is authorized under sections 301, 311 and 317C of the

Public Health Service Act (42 U.S.C. 241, 243, and 247b-4) 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

All duly constituted State and local public health agencies that

are officially recognized as such, including State, local, county,

city-county, district, and territorial health departments are eligible

to apply. Also, universities with formal agreements for working with

State or local health departments for carrying out the surveillance and

surveillance-based research are eligible to apply.

Availability of Funds

Approximately $500,000 is available in FY 1995 to fund

approximately 8 to 12 awards. It is expected that awards will be made

to 4 to 6 States with operational birth defect surveillance systems,

and to 4 to 6 States with inactive or no birth defect surveillance

systems. 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 3 years. Funding estimates may vary and are subject to change.

These awards may be used for personnel services, equipment, travel,

and other cost related to project activities. Project funds may not be

used to supplant State funds available for birth defect surveillance or

birth defect prevention.

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 cooperative agreement is to assist States:

a. To develop and implement pilot methodologies and approaches

which will improve or expand the State's capacity to ascertain cases

and generate timely population-based data of major birth defects;

b. To engage, and collaborate with other States and appropriate

organizations in the timely sharing and analysis of surveillance and

epidemiologic data related to birth defects and;

c. To evaluate, in a timely fashion, the effectiveness of

surveillance approaches and progress in the prevention of folic acid-

preventable spina bifida and anencephaly.

Program Requirements

In conducting activities to achieve the purpose of this program,

the recipient will be responsible for the activities under A.

(Recipient Activities for States with inactive or no birth defect

surveillance systems); or B. (Recipient Activities for States with

operational birth defect surveillance systems); and CDC will be

responsible for the activities listed under C. (CDC Activities).

A. Recipient Activities for States with inactive or no birth defect

surveillance systems:

1. Develop plans for, and begin implementation of, a pilot state-

based surveillance system which will ascertain cases and generate

population-based data of major birth defects occurring in the State.

2. Develop a plan for the sharing and analysis of surveillance and

epidemiologic data related to birth [[Page 19942]] defects with other

States and appropriate organizations.

B. Recipient Activities for States with operational birth defect

surveillance systems:

1. Develop and implement pilot methodologies and approaches which

will improve or expand the capacity of an existing state-based

surveillance system to ascertain cases and generate timely population-

based data of major birth defects occurring in the State.

2. Collaborate with other States and appropriate organizations in

the timely sharing and analysis of surveillance and epidemiologic data

related to birth defects.

3. Evaluate, in a timely fashion, the progress in the prevention of

folic acid-preventable spina bifida and anencephaly in the State.

C. CDC Activities:

1. Provide technical assistance.

2. Assist recipients in designing, developing, and evaluating pilot

and demonstration components of state-based birth defect surveillance

systems.

3. Assist recipients in analyzing surveillance and epidemiologic

data related to birth defects.

4. Assist recipients in evaluating the progress in the prevention

of folic acid-preventable spina bifida and anencephaly.

5. Provide a reference point for sharing regional and national data

and information pertinent to the surveillance and prevention of birth

defects.

Evaluation Criteria

Applications will be reviewed and evaluated according to the

following criteria as they relate to the applicant's response to either

A., or B., in the ``Program Requirements.''

1. Applicant's Understanding of the Problem (10%)

The extent to which the applicant has a clear, concise

understanding of the requirements, objectives, and purpose of the

cooperative agreement. The extent to which the application reflects an

understanding of the complexities of birth defect surveillance.

2. Impact on State-Based Birth Defects Surveillance (65%)

The extent to which the applicant describes the anticipated level

of impact this cooperative agreement will have on birth defect

surveillance activities in the State. This description may include

current and proposed:

a. Methods of case ascertainment;

b. Level of coverage of the population;

c. Specific birth defects ascertained;

d. Timeliness of case ascertainment and reporting;

e. Utility of surveillance data for epidemiologic studies and;

f. Utility of surveillance data for evaluating the progress in the

prevention of folic acid-preventable spina bifida and anencephaly.

3. Organizational and Program Personnel Capability (20%)

The extent to which the applicant has the experience, skills, and

ability to implement and evaluate a birth defect surveillance system.

The adequacy of the present staff and capability to assemble competent

staff to implement and evaluate a birth defect surveillance system and

a prevention program. The applicant shall identify, to the extent

possible, all current and potential personnel who will work on this

cooperative agreement, including qualifications and specific experience

as it relates to the requirements set forth in this request.

4. Matching Funds (5%)

The extent to which the applicant proposes matching funds. Matching

funds may be contributions by the recipient of at least five percent of

Federal funds awarded under this program. The applicant should identify

and describe:

a. The amount expended during the preceding year for birth defect

surveillance activities and birth defect prevention activities.

These amounts will be used to establish a baseline for current and

future match amounts and;

b. Sources of matching funds for the project and the estimated

amounts from each.

5. Budget Justification and Adequacy of Facilities (Not Scored)

The budget will be evaluated for the extent to which it is

reasonable, clearly justified, and consistent with the intended use of

the cooperative agreement funds. The applicant shall describe and

indicate the availability of facilities and equipment necessary to

carry out this project. Proposed matching funds must be detailed in the

budget.

6. Human Subject Review (not scored)

The applicant must clearly state whether or not human subjects will

be used in 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 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 for 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., Atlanta, GA 30305. (The receipt date for SPOC comments will

be 60 days after the application deadline date.) The Announcement

Number and Program Title should be referenced on the document. The

granting agency does not guarantee to ``accommodate or explain'' the

State process recommendations it receives after that date.

Public Health System Reporting Requirement

This program is subject to the Public Health System Reporting

Requirements. Under these requirements, all community-based

nongovernmental applicants must prepare and submit the items identified

below to the head of the appropriate State and/or local health

department agency(s) in the program area(s) that may be impacted by the

proposed project no later than the receipt date of the Federal

Application. The appropriate State and/or local health agency is

determined by the applicant. The following information must be

provided:

A. A copy of the face page of the application (SF 424).

B. A summary of the project that should be titled ``Public Health

System Impact Statement'' (PHSIS), not exceed one page, and include the

following:

1. A description of the population to be served;

2. A summary of the services to be provided; and

3. A description of the coordination plans with the appropriate

State and/or local health agencies.

If the State and/or local health official should desire a copy of

the entire application, it may be obtained from the State Single Point

of Contact (SPOC) or directly from the applicant.

Catalog of Federal Domestic Assistance Number

The Catalog of Federal Domestic Assistance number is 93.283.

[[Page 19943]]

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of information from ten 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 an appropriate

institutional review committee. 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 E-13, Atlanta, GA 30305, on

or before June 20, 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 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

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 531. 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 S. 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 E-

13, Atlanta, GA 30305, telephone (404) 842-6630. Programmatic technical

assistance may be obtained from Larry D. Edmonds or David Montanez,

State Services, Birth Defects and Genetic Diseases Branch, Division of

Birth Defects and Developmental Disabilities, National Center for

Environmental Health, Centers for Disease Control and Prevention (CDC),

4770 Buford Highway NE., Mailstop F-45, Atlanta, GA 30341-3724,

telephone (404) 488-7170.

Please refer to Announcement 531 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.

Dated: April 14, 1995.

Joseph R. Carter,

Acting Associate Director for Management and Operations, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 95-9880 Filed 4-20-95; 8:45 am]

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