[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
