[Federal Register Volume 63, Number 112 (Thursday, June 11, 1998)]
[Notices]
[Pages 31995-31998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15543]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement Number 98051]


Cooperative Agreements for Enhanced State-Based Birth Defect 
Surveillance and Use of Surveillance Data To Guide Prevention and 
Intervention Programs

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1998 funds for a cooperative agreement 
program for developing and improving birth defect surveillance; and 
using surveillance data to develop birth defect prevention programs and 
activities to improve the access of children born with birth defects to 
health services and early intervention programs. This program addresses 
the ``Healthy People 2000'' priority areas of Substance Abuse, Alcohol 
and Other Drugs, Environmental Health, Maternal and Infant Health, and 
Surveillance and Data Systems.
    The purpose of the program is to support the development, 
implementation, expansion, and evaluation of State-based birth defect 
surveillance systems; the development and implementation of State-based 
programs to prevent birth defects; and the development and 
implementation of activities to improve the access of children with 
birth defects to health services and early intervention programs. More 
specifically, the purpose of this program is to assist States:
    a. To improve the timeliness of neural tube defect (NTD) 
surveillance in order to prevent the recurrence of NTD-affected 
pregnancies among women who have had NTD-affected pregnancies, and to 
improve the completeness of NTD surveillance in selected areas in order 
to evaluate progress made in the prevention of occurrent NTDs in the 
population;
    b. To develop and implement 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; and
    c. To use surveillance data to design, implement and evaluate 
programs to prevent birth defects and improve the access of children 
with birth defects to comprehensive, community-based, family-centered 
care.

B. Eligible Applicants

    Assistance will be provided only to State and local public health 
agencies that are officially recognized as such, including State, 
local, county, city-county, district, and territorial health 
departments. Also, universities with formal agreements for working with 
State or local health departments for carrying out the State's 
surveillance and surveillance-based research are eligible to apply.

C. Availability of Funds

    Approximately $1,500,000 is available in FY 1998 to fund 
approximately 10 to 16 awards. It is expected that awards will be made 
to 3 to 5 States with no birth defect surveillance systems; 3 to 5 
States with newly implemented surveillance systems or systems which are 
only partially operational; and 3 to 5 States with ongoing, operational 
birth defect surveillance systems. It is expected that awards will 
range from $50,000 to $150,000. It is expected that the awards will 
begin on or about September 30, 1998, and will be made for a 12-month 
budget period within a

[[Page 31996]]

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 costs related to project activities. Project funds may not be 
used to supplant State funds available for birth defect surveillance, 
prevention, or health care services.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and other communication with CDC staff, and the availability of funds.

D. Cooperative Activities

    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 no birth defect surveillance systems; B. 
Recipient activities for States with newly implemented surveillance 
systems or systems which are only partially operational; or C. 
Recipient activities for States with ongoing, operational birth defect 
surveillance systems; and CDC will be responsible for the activities 
listed under D. CDC Activities. A list of States and their designated 
category (A, B or C) has been prepared based on information CDC 
currently has on each State program. This list is available with the 
application materials. If States disagree with their designated 
category, they may provide written justification along with the 
application as to which category of recipient activities (A, B, or C) 
the State should be placed in.
    A. Recipient activities for States with no birth defect 
surveillance systems:
    1. Develop and implement an approach to prevent the recurrence of 
NTDs in the State including: (1) timely ascertainment of new NTD cases 
in the population (prenatally diagnosed cases may be ascertained but 
are not required to be ascertained); and (2) referral of affected 
families for sensitive and appropriate education/counseling 
interventions to prevent the recurrence of NTDs;
    2. With the goal of generating data to guide prevention and 
intervention programs, develop and begin implementation of a State-
based surveillance system to ascertain cases and generate timely 
population-based data of major birth defects occurring in the State. 
Analyze the surveillance data generated by the system in a timely 
fashion (including rates and trends of major birth defects) and share 
that data with appropriate organizations within the State and with 
other States;
    3. Working with the appropriate partners in the State, (1) develop 
a plan for a birth defect prevention program (e.g., NTD occurrence 
prevention) and/or, (2) develop a plan for activities to improve the 
access of children with birth defects to comprehensive, community-
based, family-centered care.
    B. Recipient activities for States with newly implemented 
surveillance systems or systems which are only partially operational:
    1. Develop and implement an approach to prevent the recurrence of 
NTDs in the State including: (1) timely ascertainment of new NTD cases 
in the population (prenatally diagnosed cases may be ascertained but 
are not required to be ascertained); and (2) referral of affected 
families for sensitive and appropriate education/counseling 
interventions to prevent the recurrence of NTDs;
    2. With the goal of generating data to guide prevention and 
intervention programs, develop and implement methodologies and 
approaches which will improve, sustain, and expand the capacity of the 
existing State-based surveillance system to ascertain cases and 
generate timely population-based data of major birth defects occurring 
in the State. Analyze the data generated by the surveillance system in 
a timely fashion (including rates and trends of major birth defects) 
and share that data with appropriate organizations within the State and 
with other States; and
    3. Working with the appropriate partners in the State, (1) develop 
and begin implementation of a birth defects prevention program (e.g., 
NTD occurrence prevention) AND/OR, (2) develop and begin implementation 
of activities to improve the access of children with birth defects to 
comprehensive, community-based, family-centered care.
    C. Recipient activities for States with ongoing, operational birth 
defect surveillance systems:
    1. Develop, implement, and evaluate surveillance methodologies and 
approaches to ascertain new cases of NTDs (including those prenatally 
diagnosed, if possible) in a more timely manner, and use the data to: 
(1) develop and implement an approach to prevent the recurrence of NTDs 
in the State including the referral of affected families for sensitive 
and appropriate education/counseling interventions to prevent the 
recurrence of NTDs, and (2) evaluate progress made in the prevention of 
occurrent NTDs in the population;
    2. Evaluate current methodologies used to ascertain cases and 
generate timely population-based data of major birth defects occurring 
in the State, and develop and implement methodologies and approaches 
which will improve or expand the capacity of the existing State-based 
surveillance system. Analyze the data generated by the surveillance 
system in a timely fashion (including rates and trends of major birth 
defects) and share that data with appropriate organizations within the 
State and with other States;
    3. Working with the appropriate partners in the State, (1) develop 
and implement a birth defect prevention program (e.g., NTD occurrence 
prevention) and monitor changes in the prevalence of the birth defects 
being targeted AND/OR, (2) develop and implement activities to improve 
the access of children with birth defects to comprehensive, community-
based, family-centered care; and
    4. Prepare a document describing the surveillance methodologies 
used to generate timely NTD data and how the data was used to monitor 
progress made in the prevention of NTDs; and describe the use of your 
surveillance data for developing and implementing programs to prevent 
birth defects or activities to improve access to health services and 
early intervention programs. This document will be a resource to be 
shared with other States.
    D. CDC activities:
    1. Provide technical assistance.
    2. Assist recipients in designing, developing, and evaluating 
methodologies and approaches used for State-based birth defect 
surveillance.
    3. Assist recipients in analyzing surveillance data related to 
birth defects.
    4. Assist recipients in designing plans for prevention programs and 
plans to improve the access of children with birth defects to health 
services and intervention programs.
    5. Assist recipients in developing methods to: ascertain NTDs in a 
timely manner, prevent recurrence of NTDs in families, and evaluate 
progress made in the prevention of occurrent NTDs.
    6. Provide a reference point for sharing regional and national data 
and information pertinent to the surveillance and prevention of birth 
defects.

E. Application Content

    Use the information in the COOPERATIVE ACTIVITIES, OTHER 
REQUIREMENTS, and EVALUATION CRITERIA sections to develop the 
application content. Applications will be evaluated on the criteria 
listed, so it is important to follow them in describing the program 
plan.

[[Page 31997]]

    Applications must be developed in accordance with PHS Form 5161-1 
(Revised 7/92, OMB Control number 0937-0189), information contained in 
the program announcement and the instructions and format provided 
below:

1. Abstract

    A one-page, single-spaced, typed abstract must be submitted with 
the application. The heading should include the title of the grant 
program, project title, organization, name and address, project 
director and telephone number. The abstract should briefly summarize 
the program for which funds are requested, the activities to be 
undertaken, and the applicant's organization and composition. The 
abstract should follow ``the printed forms'' and precede the Program 
Narrative.

2. Program Narrative

    The Program Narrative should specifically address item A, B, or C 
in the ``COOPERATIVE ACTIVITIES.'' All items of the Program Narrative 
(i.e., Project Description, Results or Benefits Expected, Approach, 
Evaluation, Geographic Location, Additional Information) should begin 
on a new page. If the proposed program is a multiple-year project, the 
applicant should provide detailed description of first year activities, 
and briefly describe future year objectives and activities. The 
``EVALUATION CRITERIA'' will serve as the basis for evaluating the 
application, therefore, the narrative of the application should 
address:
    1. Applicant's understanding of the problem;
    2. Impact on timely ascertainment of new NTD cases and use of the 
data for NTD recurrence prevention;
    3. Impact on State-based birth defects surveillance;
    4. Use of the surveillance data for prevention and intervention;
    5. Organizational and program personnel capability;
    6. Matching funds;
    7. Budget justification and adequacy of facilities; and
    8. Human subjects review.
    The Program Narrative section should not exceed 40 pages, excluding 
attachments (e.g., resumes, appendices, etc.). Do not include a 
detailed budget nor detailed budget justification as part of the 
Program Narrative.
    If the applicant is a university, evidence of an existing formal 
agreement with the State or local health departments for carrying out 
the State's surveillance activities must be included.
    Applicant's are required to submit an original application and 2 
copies. The original and each copy of the application must be submitted 
unstapled and unbound. All material must be typewritten, double-spaced, 
with un-reduced type on 8\1/2\'' by 11'' paper, with at least 1'' 
margins, headers and footers, and printed on one side only.
    All graphics, maps, overlays, etc., should be in black and white 
and meet the above criteria.

F. Application Submission and Deadline

Application

    The original and two copies of the application PHS Form 5161-1 
(Revised 7/92, OMB Control number 0937-0189) must be submitted on or 
before July 27, 1998 to: David Elswick, 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, Georgia 30305-2209.
    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.

G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC as 
they relate to the applicant's response to either A, B, or C in the 
``COOPERATIVE ACTIVITIES.''
    1. Applicant's understanding of the problem (10 percent). 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 defects surveillance.
    2. Impact on timely ascertainment of new NTD cases and use of the 
data for NTD recurrence prevention (20 percent).
    The extent to which the applicant describes the proposed methods 
for the timely ascertainment of new NTD cases occurring in the 
population, and plans for referral of women who have had an NTD-
affected pregnancy for education/counseling about the importance of 
folic acid. Specific criteria include:
    a. Plan for ascertainment of NTD cases;
    b. Timeliness of NTD case ascertainment; and
    c. Plan for referral of families for education/counseling.
    3. Impact on State-based birth defects surveillance (30 percent).
    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. The current and proposed 
activities evaluated in this criteria are specific for the three 
different recipient categories (A, B, or C) as outlined in the 
COOPERATIVE ACTIVITIES:
    A. Evaluation criteria for category A (States with no birth defect 
surveillance systems):
    a. Plans for developing State-based birth defects surveillance;
    b. Methods of case ascertainment;
    c. Timeliness of case ascertainment;
    d. Level of coverage of the population;
    e. Specific birth defects ascertained; and
    f. Plans for analyzing and reporting surveillance data.
    B. Evaluation criteria for category B (States with newly 
implemented birth defect surveillance systems or systems which are only 
partially operational):
    a. Plans for improving/expanding State-based birth defects 
surveillance;
    b. Methods of case ascertainment;
    c. Timeliness of case ascertainment;
    d. Level of coverage of the population;
    e. Specific birth defects ascertained; and
    f. Plans for analyzing and reporting surveillance data.
    C. Evaluation criteria for category C (States with ongoing, 
operational birth defect surveillance systems):
    a. Methods for evaluating current State birth defect surveillance 
system;
    b. Plans for improving/expanding State-based birth defects 
surveillance;
    c. Methods of case ascertainment;
    d. Timeliness of case ascertainment;
    e. Level of coverage of the population;
    f. Specific birth defects ascertained;
    g. Plans for analyzing and reporting surveillance data; and
    h. Plan to evaluate progress made in the prevention of occurrent 
NTDs in the population (including ascertainment of prenatally diagnosed 
NTDs, if possible).
    4. Use of the surveillance data for prevention and intervention (20 
percent)

[[Page 31998]]

    The extent to which the applicant describes the plans for using 
surveillance data to develop and implement programs to prevent birth 
defects and/or activities to improve the access of children with birth 
defects to health services and early interventions. Specific criteria 
include:
     a. Plan for working with appropriate partners in the State; and
    b. Plan for using the surveillance data to develop prevention or 
intervention programs.
    5. Organizational and program personnel capability (15 percent)
    The extent to which the applicant has the experience, skills, and 
ability to develop and improve birth defects surveillance and use 
surveillance data to develop prevention or intervention programs. The 
adequacy of the present staff and capability to assemble competent 
staff to implement a birth defects surveillance system and develop 
programs for prevention or intervention. 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.
    6. Matching funds (5 percent)
    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 defects 
surveillance activities and birth defects prevention and intervention 
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.
    7. 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.
    8. Human subject review (not scored)
    The applicant must clearly state whether or not human subjects will 
be used in research and ensure that adequate human subjects protections 
will be implemented.

H. Other Requirements

    An original and two copies of semi-annual progress reports are 
required of all grantees. Due dates for the semi-annual reports will be 
established at the time of award. Final financial status and 
performance reports are required no later than 90 days after the end of 
the project period.
    Send all reports to: David Elswick, 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, Georgia 30305-2209.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment 1 of the 
application kit.

AR98-1  Human Subjects Requirements
AR98-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR98-7  Executive Order 12372 Review
AR98-9  Paperwork Reduction Act Requirements
AR98-10  Smoke-Free Workplace Requirements
AR98-11  Healthy People 2000
AR98-12  Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301(a), 311 and 317C of 
the Public Health Service Act [42 U.S.C. 241(a), 243, and 247b-4], as 
amended. The Catalog of Federal Domestic Assistance number is 93.238.

J. Where to Obtain Additional Information

    A complete program description and information on application 
procedures are contained in the application package. Business 
management technical assistance may be obtained from David C. Elswick, 
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, Georgia 
30305, telephone (404) 842-6630.
    Programmatic technical assistance may be obtained from Larry D. 
Edmonds or Paula W. Yoon, 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, Georgia 30341-3724, telephone (404) 488-7170.
    Please refer to Announcement Number 98051 when requesting 
information and submitting an application.

    Dated: June 5, 1998.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 98-15543 Filed 6-10-98; 8:45 am]
BILLING CODE 4163-18-P