03-10502. 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 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.

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—PA#03021, 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.

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 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: [phone].

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: [phone], 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: [phone], E-mail address: [e-mail].

For program technical assistance, contact: Jorge Rosenthal, Epidemiologist, Telephone: [phone], E-mail address: [e-mail].

  or

Louise Floyd, Supervisory Behavioral Scientist, Telephone: [phone], E-mail address: [e-mail].

  or

Connie Granoff, Public Health Analyst, Telephone: [phone], E-mail address: [e-mail].

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.