[Federal Register Volume 60, Number 77 (Friday, April 21, 1995)]
[Notices]
[Pages 19941-19943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9880]



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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]
BILLING CODE 4163-18-P