[Federal Register: April 29, 2003 (Volume 68, Number 82)]
[Notices]
[Page 22710-22714]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ap03-91]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 03021]
Fetal Alcohol Syndrome Prevention; Notice of Availability of
Funds
Application Deadline: June 30, 2003.
A. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under section 301 and 317(C) of the
Public Health Service Act, (42 U.S.C. 241 and 247b-4, as amended). The
Catalog of Federal Domestic Assistance number is 93.283.
B. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 2003 funds for a cooperative agreement
program for Fetal Alcohol Syndrome (FAS) Prevention. This program
addresses the ``Healthy People 2010'' focus areas of Substance Abuse
and Maternal, Infant, and Child Health.
The purpose of the program is to develop, implement, and evaluate
population-based and targeted prevention programs for FAS including the
identification of high prevalence geographic areas and/or selected
subpopulations of childbearing-age women at high-risk for an alcohol
exposed pregnancy; establishing or enhancing prenatal and
preconceptional intervention programs to serve these populations; and
establishing or utilizing existing systems for monitoring the impact of
prevention programs. Monitoring programs must include a plan for
ensuring that children identified with FAS have access to appropriate
services within the community.
Measurable outcomes of the program will be in alignment with FAS-
related performance goals for the National Center for Birth Defects and
Developmental Disabilities (NCBDDD) that include establishing new, or
enhancing, prevention programs that reduce the prevalence of FAS,
reduce prenatal exposure to alcohol, and improve and/or link children
currently affected by FAS to health services.
C. Eligible Applicants
Assistance will be provided only to the health departments of
states or their bona fide agents, including the Commonwealth of Puerto
Rico, the Virgin Islands, the Commonwealth of the Northern Mariana
Islands, American Samoa, Guam, the Federated States of Micronesia, the
Republic of the Marshall Islands, the Republic of Palau, and federally
recognized Indian tribal governments.
If the applicant is not the state health agency, the applicant must
provide a letter from the appropriate state health agency designating
the applicant as a bona fide agent. This information should be placed
directly behind the cover letter of the application. Applications that
fail to submit the evidence requested above will be considered non-
responsive and returned without review.
Only one application from each organization may be submitted for
this announcement.
To be eligible, applicants must:
1. Identify a geographic area with high proportions of
childbearing-age women at risk for an alcohol-exposed pregnancy (a
minimum of five percent of the prenatal population reporting frequent
or binge drinking); a minimum of 15 percent of non-pregnant,
childbearing-age women (aged 12-44 years) reporting
[[Page 22711]]
frequent or binge drinking in a population of childbearing-age women of
at least 350,000; or a birth cohort of at least 25,000 births per year
with a minimum FAS prevalence rate of one per 1,000 live births.
2. Demonstrate the capacity to conduct community-based prevention
programs in Maternal and Child Health, and to monitor adverse exposures
and outcomes in these populations.
The applicant must include the above documentation in the first
three pages of the application following the face page. If it is not
included, the application will be determined as non-responsive and
returned without review.
Note: Title 2 of the United States Code section 1611 states that
an organization described in section 501(c)(4) of the Internal
Revenue Code that engages in lobbying activities is not eligible to
receive Federal funds constituting an award, grant or loan.
D. Funding
Availability of Funds
Approximately $1,200,000 may be available in FY 2003 to fund
approximately three to five awards. It is expected that the average
award will range from $300,000 to $500,000. It is expected that the
awards will begin on or about September 1, 2003, and will be made for a
12-month budget period within a project period of up to five years.
Funding estimates may change.
Continuation awards within an approved project period will be made
on the basis of satisfactory progress as evidenced by required reports
and the availability of funds.
Use of Funds
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 defects surveillance
or prevention, health care services, patient care, nor construction.
Award recipients agree to use cooperative agreement funds for
travel by project staff selected by CDC to participate in CDC-sponsored
workshops or other meetings, such as regional or annual meetings.
Recipient Financial Participation
Matching funds are not required for this program.
E. Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities under 1. Recipient
Activities. CDC will be responsible for the activities listed under 2.
CDC Activities.
1. Recipient Activities
a. Use surveillance or other population-based methods or systems
data to identify clusters of FAS cases or populations of high risk
childbearing-age women in specific geographic regions (i.e., state,
county, or tribal community) and/or use innovative analytic techniques
such as Geographic Information Systems (GIS) to identify and monitor
geographic areas of populations at risk.
b. Develop and implement a plan for prevention of FAS in a targeted
geographic region that has increased rates of women at high risk for an
alcohol-exposed pregnancy and/or increased rates of infants and
children with FAS. (See eligibility criteria)
c. Develop linkages with existing, community-based programs that
provide preventive health services to childbearing-age women and their
families. These programs include, but are not limited to, Women,
Infant, and Children (WIC), contraceptive counseling and services
including abstinence, prenatal care clinics, sexually transmitted
diseases clinics, primary care settings, alcohol and drug treatment
centers, and mental health services programs.
d. Design and implement evidence-based interventions, such as, but
not limited to, those recommended by the Institute of Medicine, ``Fetal
Alcohol Syndrome: Diagnosis, Epidemiology, Prevention and Treatment
1996.''
e. Design and implement a provider education component for health
personnel involved in intervention and surveillance and monitoring
activities.
f. Evaluate the outcomes (effectiveness and cost-effectiveness) of
the high priority interventions (universal, selective or group, and/or
indicated or individual) among childbearing-age women exposed to the
intervention at the community and individual level, including the
selection of appropriate outcomes for measuring a reduction in the
number of FAS cases in the targeted community, region, or state, as
well as reductions in alcohol use rates among childbearing-age women,
and reduction in the number of alcohol-exposed pregnancies.
g. Evaluate the interventions using process measures that monitor
key indicators of success, such as levels of alcohol use screening in
childbearing-age women; availability, accessibility and utilization of
proposed interventions; and community services including alcohol and
drug treatment for those who screen positive. Additional measures that
might also be used include, but are not limited to, estimating the
number of alcohol-exposed pregnancies averted and/or number of women
who used alcohol in the previous pregnancy who report intentions to
abstain during their next pregnancy. Depending upon the intervention
being proposed, enhanced use of contraceptive counseling and services
may also be a relevant measure.
h. Evaluate the project components aimed at linking children with
FAS to appropriate services. Examples of process measures include:
Changes in knowledge, attitudes, and practice behaviors of health and
allied professionals, as well as school personnel; increased numbers of
children referred for FAS diagnostic evaluations; increased numbers of
Individual Education Plans (IEPs) that address the specific needs of
children with FAS currently in the school system; and identification of
the barriers children with FAS have in accessing needed services, as
well as gaps in the availability of needed services, including plans to
address these barriers and gaps.
i. Develop procedures that insure that prevention interventions and
surveillance and monitoring systems meet strict confidentiality
standards and incorporate recommended CDC case definitions.
j. Analyze and disseminate prevention and surveillance data
generated by the system(s) in a timely fashion including intervention
outcome results, rates, trends, and risk factors for FAS (e.g., publish
annual peer-review reports on the surveillance data and interventions).
k. Coordinate prevention efforts with state, local, tribal, and
maternal and child health programs to assure appropriate health and
educational services to individuals, as well as to enhance awareness
among public and private providers concerning the prevention, diagnosis
and treatment of FAS.
l. Supply support letters that document concurrence with this plan
by other units or organizations (such as those mentioned in item ``k''
above) that are collaborating with the applicant.
m. Collaborate with other participating sites and CDC in preparing
and publishing study results.
n. Implement quality assurance procedures to ensure that study
protocols are being followed, and that the surveillance and
intervention procedures are being uniformly implemented in all
participating sites.
2. CDC Activities
a. Assist in the design of prevention, surveillance and monitoring
programs.
[[Page 22712]]
b. Assist in developing and evaluating methodologies to assess the
impact of prevention efforts using population-based FAS surveillance
and alcohol use monitoring among childbearing-age women.
c. Assist in analyzing prevention and surveillance data generated
from the prevention interventions and surveillance and monitoring
systems developed.
d. Assist in ensuring that successful prevention interventions,
program models and lessons learned are shared between grantees through
various mediums.
e. Assist in designing strategies to improve the access of children
with FAS to health services and support programs.
f. Assist in the development of standardized evaluation formats and
activities for grantees.
g. Coordinate the dissemination of findings and collaborate with
recipients on specific publications involving data collected.
h. Assist in the development of a research protocol for
Institutional Review Board (IRB) review by all cooperating institutions
participating in the research project. The CDC IRB will review and
approve the protocol initially and on at least an annual basis until
the research project is completed.
F. Content
Letter of Intent (LOI)
A LOI is requested for this program. The Program Announcement title
and number must appear in the LOI. The narrative should be no more than
two pages, double-spaced, printed on one side, with one-inch margins,
and unreduced 12-point font. The LOI will not be used to eliminate
potential applicants, but it will be used to enable CDC to determine
the level of interest and plan the review more efficiently. The LOI
should include the following information: applicant's name and address,
project director's name, phone number, and e-mail address.
Applications
The Program Announcement title and number must appear in the
application. Use the information in the Program Requirements, Other
Requirements, and Evaluation Criteria sections, and in Attachment I,
``Application Guidance,'' which can be found on the CDC Web site, to
develop the application content. Your application will be evaluated on
the criteria listed, so it is important to follow them in laying out
your program plan.
The applicant should provide a detailed description of first-year
activities and briefly describe future-year objectives and activities.
The application must contain the following:
1. Eligibility Response: The response, not to exceed three pages,
should address the eligibility criteria listed in section C. Eligible
Applicants.
2. A one-page, single-spaced, typed abstract in 12-point font 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 organizational structure. The
abstract should precede the program narrative. A table of contents that
provides page numbers for each of the following sections should be
included. All pages must be numbered.
3. The narrative should be no more than 25 pages, double-spaced,
printed on one side, with one-inch margins, and unreduced 12-point
font. The required detailed budget and detailed budget justification
are not considered to be part of the program narrative.
G. Submission and Deadline
Letter of Intent (LOI) Submission
On or before May 29, 2003, submit the LOI to the Public Health
Analyst identified in the ``Where to Obtain Additional Information''
section of this announcement.
Application Forms
Submit the signed original and two copies of PHS 5161-1 (OMB Number
0920-0428). Forms are available at the following Internet address:
http://www.cdc.gov/od/pgo/forminfo.htm.
If you do not have access to the Internet, or if you have
difficulty accessing the forms on-line, you may contact the CDC
Procurement and Grants Office Technical Information Management Section
at: 770-488-2700. Application forms can be mailed to you.
Submission Date, Time, and Address
The application must be received by 4 p.m. Eastern Time on June 30,
2003. Submit the application to: Technical Information Management
Section--PA03021, Procurement and Grants Office, Centers for
Disease Control and Prevention, 2920 Brandywine Rd., Room 3000,
Atlanta, GA 30341-4146.
Applications may not be submitted electronically.
CDC Acknowledgement of Application Receipt
A postcard will be mailed by PGO-TIMS, notifying you that CDC has
received your application.
Deadline
Letters of intent and applications will be considered as meeting
the deadline if they are received before 4 p.m. Eastern Time on the
deadline date. Applicants sending applications by the United States
Postal Service or commercial delivery services must ensure that the
carrier will be able to guarantee delivery of the application by the
closing date and time. If an application is received after closing due
to (1) carrier error, when the carrier accepted the package with a
guarantee for delivery by the closing date and time, or (2) significant
weather delays or natural disasters, CDC will upon receipt of proper
documentation, consider the application as having been received by the
deadline.
Applications which do not meet the above criteria will not be
eligible for competition and will be returned. Applicants will be
notified of their failure to meet the submission requirements.
H. Evaluation Criteria
Application
Applicants are required to provide descriptions of prevention,
surveillance, and monitoring activities, and, to identify outcome
measures of effectiveness and cost-effectiveness that will demonstrate
the accomplishment of the various identified objectives of the
cooperative agreement. Measures of effectiveness must relate to the
performance goals as stated in Section B. Purpose of this announcement.
Measures must be objective and quantitative and must measure the
intended outcome. These measures of effectiveness must be submitted
with the application and will be an element of evaluation.
1. Program Plan (40 points)
a. The extent to which the applicant describes proposed
interventions that are evidence-based, and justifies the
appropriateness of the methods and design to be used in FAS prevention
interventions and monitoring programs.
b. The extent to which the applicant describes their capacity to
identify population(s) or geographic areas with increased rates of
women at risk for having children with FAS, ascertain FAS cases and
exposures, and track and monitor the impact of prevention activities.
[[Page 22713]]
c. The extent to which the applicant includes provisions for
maintaining confidentiality of individual records and/or case reports,
and protecting the status of reported cases.
d. The extent to which the applicant describes the adequacy of the
proposed time-line and personnel for accomplishing the prevention and
surveillance and monitoring activities.
e. The extent to which the application adequately addresses the CDC
Policy requirements regarding the inclusion of women, ethnic, and
racial groups in the proposed research. This includes:
(1) The proposed plan for the inclusion of both sexes and racial
and ethnic minority populations for appropriate representation.
(2) The proposed justification when representation is limited or
absent.
(3) A statement as to whether the design of the study is adequate
to measure differences when warranted.
(4) A statement as to whether the plans for recruitment and
outreach for study participants include the process of establishing
partnerships with community(ies) and recognition of mutual benefits.
2. Quality Assurance and Program Evaluation Plan (30 points)
The extent to which the applicant describes when and how
interventions, and surveillance and monitoring systems, will be
evaluated. The plan should outline the methods, design and process, and
impact and outcome (effectiveness and cost-effectiveness) measures to
be used in determining if the objectives are being achieved.
3. Assessment of Need (10 points)
The extent to which the applicant understands the purpose and
objectives of this project, as reflected in their statement of purpose
and need for the proposed prevention interventions, and FAS
surveillance and prenatal alcohol monitoring systems. A detailed
description should be provided of the proposed area, region or
community targeted for this project based on relevant epidemiological
and demographic information. Emphasis will be placed on demonstrated
access to populations considered at greater risk for high prevalence
rates of FAS and risk factors associated with FAS, and to the
applicant's understanding of the importance of the proposed
surveillance activity in identifying cases of FAS and reducing the risk
of alcohol exposed pregnancies among childbearing-age women. Measures
currently being used to estimate the magnitude of FAS, prenatal alcohol
exposure, and risk factors for FAS should be described in detail and
specifically related to the population(s) being targeted in the
proposal.
4. Goals and Objectives (10 points)
The extent to which the applicant includes specific goals to be
achieved by the proposed FAS prevention interventions and the proposed
FAS surveillance and prenatal monitoring programs by the end of the
five year project period. Each goal should be accompanied by objectives
that are specific, time-phased, measurable and achievable. (See
Attachment I, as posted on the CDC website.)
5. Organizational History and Capacity (10 points)
a. The extent to which the applicant describes past and current
experience in developing and implementing effective and cost-effective
FAS prevention intervention strategies, and in activities that develop
and implement effective and cost-effective surveillance and prenatal
alcohol exposure monitoring activities similar to the one(s) proposed
in this application.
b. The extent to which the applicant describes their previous
experience and accomplishments in the design, implementation, and
evaluation of birth defects surveillance, prenatal alcohol exposure
monitoring systems, and monitoring of population-based risk factors for
FAS or other surveillance and monitoring systems.
c. The extent to which the applicant describes the training,
experience, and competence of the proposed project director and staff
in the design, implementation, and evaluation of surveillance and
prenatal alcohol monitoring activities, and the availability of the
staff to work on the proposed project. This includes staff from
academic institutions that are assisting the applicant in design,
implementation and evaluation of the project.
6. 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.
7. Human Subjects Review (not scored)
Does the application adequately address the requirements of Title
45 CFR part 46 for the protection of human subjects? (Not scored;
however, an application can be disapproved if the research risks are
sufficiently serious and protection against risks are so inadequate as
to make the entire application unacceptable.)
I. Other Requirements
Technical Reporting Requirements
Provide CDC with original plus two copies of:
1. An interim progress report, no less than 90 days before the end
of the budget period. The progress report will serve as your non-
competing continuation application and must include the following
elements:
a. Current Budget Period Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Detailed Line-Item Budget and Justification.
e. For all proposed contracts and consultants: (1) The name of
contractor or consultant; (2) the method of selection; (3) the period
of performance; (4) the scope of work; (5) the method of
accountability; and, (6) an itemized budget with justification for each
contract or consultant.
2. A financial status report, no more than 90 days after the end of
the budget period.
3. Final financial and performance reports, no more than 90 days
after the end of the project period.
Send all reports to the Grants Management Specialist identified in
the ``Where to Obtain Additional Information'' section of this
announcement.
Additional Requirements
The following additional requirements are applicable to this
program. For a complete description of each, see Attachment II of the
program announcement as posted on the CDC Web site.
AR-1 Human Subject Requirements
AR-2 Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
AR-7 Executive Order 12372 Review
AR-8 Public Health System Reporting Requirements
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
J. Where To Obtain Additional Information
This and other CDC announcements, the necessary applications, and
[[Page 22714]]
associated forms can be found on the CDC Web site, Internet address:
http://www.cdc.gov.
Click on ``Funding'' then ``Grants and Cooperative Agreements''.
For general questions about this announcement, contact: Technical
Information Management Section, CDC Procurement and Grants Office, 2920
Brandywine Road, Atlanta, GA 30341-4146, Telephone: (770) 488-2700.
For business management and budget assistance in the states,
contact: Sheryl Heard, Grants Management Specialist, Procurement and
Grants Office, Centers for Disease Control and Prevention, 2920
Brandywine Road, Atlanta, GA 30341-4146, Telephone: (770) 488-2777, E-
mail address: slh3@cdc. For business management and budget assistance in the Territories,
contact: Vincent Falzone, Grants Management Specialist, CDC Procurement
and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146,
Telephone: (770) 488-2763, E-mail address: vcf6@cdc.gov. For program technical assistance, contact: Jorge Rosenthal,
Epidemiologist, Telephone: (770) 488-3525, E-mail address:
jyr4@cdc.gov. or
Louise Floyd, Supervisory Behavioral Scientist, Telephone: (770)
488-7372, E-mail address: rlf3@cdc.gov. or
Connie Granoff, Public Health Analyst, Telephone: (770) 488-7513,
E-mail address: clg4@cdc.gov. Division of Birth Defects and Developmental Disabilities, National
Center on Birth Defects and Developmental Disabilities, Centers for
Disease Control and Prevention, 4770 Buford Highway, (F-49), Atlanta,
GA 30341-3724.
Dated: April 23, 2003.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 03-10502 Filed 4-28-03; 8:45 am]
BILLING CODE 4163-18-P