[Federal Register Volume 68, Number 82 (Tuesday, April 29, 2003)]
[Notices]
[Pages 22710-22714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10502]


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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: [email protected].
    For program technical assistance, contact: Jorge Rosenthal, 
Epidemiologist, Telephone: (770) 488-3525, E-mail address: 
[email protected].
 or
    Louise Floyd, Supervisory Behavioral Scientist, Telephone: (770) 
488-7372, E-mail address: [email protected].
 or
    Connie Granoff, Public Health Analyst, Telephone: (770) 488-7513, 
E-mail address: [email protected].
    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