05-7147. Interventions for Individuals With Fetal Alcohol Syndrome: Transitioning Science to Community Projects

Announcement Type: New.

Funding Opportunity Number: RFA DD05-079.

Catalog of Federal Domestic Assistance Number: 93.283.

Key Dates:

Application Deadline: May 26, 2005.

I. Funding Opportunity Description

Authority: This program is authorized under Sections 317(k)(2) and 317C of the Public Health Service Act, (42 U.S.C. 247b(k)(2) and 247b-(4), as amended.

Purpose:

The purpose of this cooperative agreement is to implement the continuation of a directive within the Children's Health Act of 2000 to develop and scientifically evaluate interventions for children and adolescents affected by Fetal Alcohol Syndrome (FAS) or other conditions resulting from prenatal alcohol exposure and their families. Interventions were developed to (1) improve developmental outcomes, (2) prevent secondary conditions, and (3) provide education and support to caregivers and families. The primary objective of this program is to translate successful or promising scientifically evaluated interventions for children with FAS to community settings.

This program addresses the “Healthy People 2010” focus areas of Substance Abuse and Maternal, Infant, and Child Health.

Measurable outcomes of the program will be in alignment with FAS-related performance goals for the National Center on Birth Defects and Developmental Disabilities that include establishing new, or enhancing existing prevention programs designed to reduce the prevalence of FAS, reduce prenatal exposure to alcohol, and improve and/or link children currently affected by FAS to health services.

Research Objectives and Background

Development of interventions and public health programs often occur in large research-oriented medical schools and universities. These settings provide a large number of intellectual and logistical resources that facilitate development of state-of-the-art interventions and programs. Frequently however, developed programs are simply released to community agencies who must determine how best to adapt and implement the programs; otherwise the interventions languish in scientific journals without community implementation. This program seeks to bridge the transition between research-based development of interventions and community implementation of these interventions.

The benefit of intervention, especially early intervention, for individuals with developmental disabilities has long been proven in the scientific and community programs literatures. Until recently, information and strategies for interventions specific to individuals with FAS has been gleaned from other disabilities, and the wisdom gained by parents has been achieved through trial and error and shared through informal networks. Although informative to a limited degree, such treatments have been implemented without being evaluated systematically or scientifically.

To increase scientific understanding of the spectrum of disorders associated with prenatal alcohol exposure, recipients should develop mechanisms to obtain neuro-development assessment data from children participating in the community-based interventions, and estimate and compare economic costs and benefits of prescribed interventions in the community setting.

Hence, the approach of the current cooperative agreement (RFA DD05-079) will be for each funded site to work with a community agency to adapt their program to the community setting. In the later stages of the program, each site will document the intervention process such as through a working manual or guidance, and initiate a train-the-trainer type program to facilitate even broader dissemination of these scientifically evaluated interventions for children with FAS.

In 2001, CDC provided the first federal funding to develop systematic, specific, and scientifically evaluated interventions appropriate for children with FAS and their families.

Under that competitive announcement, awards were made to five recipients to conduct interventions with the aim of improving the developmental outcomes of individuals with FAS, reducing secondary conditions, and improving the lives of families affected by FAS.

For each site, children in both treatment and control groups received comprehensive multi-disciplinary assessments that guided referrals for standard care and services as indicated (e.g., speech therapy, special education). Beyond assessment and standard care, children in the treatment groups also received interventions specifically designed to focus on one of the core vulnerabilities associated with FAS: mathematical skills, social communication, peer relations, foster care stability, compliance, learning readiness, and challenging behaviors. All sites included specific instruction and training for parents and caregivers as part of the treatment process. Final analyses and submission of articles to scientific journals is anticipated in late 2005.

Thus, this announcement seeks to build upon previous activities and foundation building in partnering with community agencies, employing a study design to include outcome assessment data and documenting performance toward process and time-bounded objectives, and implementing a dissemination program to publicize approaches, collaborations, and results.

In effect, these five recipients should have completed or be nearing completion of intervention research that has: Concluded data collection; completed or is advanced in data analysis; measured behavioral and/or health outcomes related to intervention(s) for individuals with prenatal alcohol exposure; collected pre- and post-test data, used treatment and control/comparison groups with random assignment; and evaluated the effectiveness of intervention(s) using quantitative statistics.

Activities

Project activities should focus on tailoring and adapting a proven intervention to community settings and facilitating start-up activities. Awardee activities for this program are as follows:

1. Translate scientifically evaluated interventions for children with a Fetal Alcohol Syndrome Disorder (FASD) for use in community settings through partnership with a community agency (e.g., school, health department, state service organization) and to adapt each intervention to the resources; infrastructure, and personnel of their partner;

2. Demonstrate the utility and scientific credibility of developed materials and training of community agencies for implementing these interventions toward enhancing cognitive, developmental, or behavioral outcomes for children with FASD;

3. Work with partner agency to develop outreach and recruitment procedures for identification of affected children and their families from multiple sources to maximize the possibility of ascertaining participants;

4. Develop mechanisms to identify core elements of intervention necessary to ensure fidelity of implementation;

5. Disseminate these scientifically evaluated and proven credible interventions for children with FAS by development of a train-the-trainer or other similar programs to be offered to appropriate professionals (e.g., medical and allied health, education, case managers, etc);

6. Facilitate definition of the full spectrum of neuro-developmental disabilities associated with prenatal exposure to alcohol and its consequences by development of a cross-site collaborative database including: (a) Neuro-developmental testing results for children with FAS or other prenatal alcohol exposure related conditions in the community setting; and (b) outcomes;

7. Subsequent to definition of variables to be included in development of the database and the convening of investigators from other funded projects, discuss and develop a common protocol that could be implemented for obtaining assessment data from children, and in determining outcomes, costs and benefits of each intervention;

8. Prepare scientific reports for publication that document the translated research study findings. The dissemination effort should seek to convert interventions into packages of “how to” materials for use in community settings for implementing the target intervention.

CDC Responsibilities

In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring. In this cooperative agreement, CDC Scientists (Scientific Collaborator) within the National Center on Birth Defects and Developmental Disabilities (NCBDDD) are an equal partner with scientific and programmatic involvement during the conduct of the project through technical assistance, advice, and coordination. Scientific Collaborators will:

1. Use their experience in studies of this nature to advise the project on specific questions regarding the project-developed protocol;

2. As requested, assist the project in responding to inquiries regarding such areas as data management, data analysis, intervention design, family dynamics, formats for presenting research findings, and in comparing project-developed evaluation formats with other research projects and activities known to CDC;

3. Provide scientific consultation and technical assistance as requested on questions related to epidemiology, statistical and power calculations, and data storage and tracking formats used in other CDC sponsored research that could be advantageous to the project; and

4. Suggest to the project upon request; processes for analysis, interpretation, and reporting of findings in the literature that can serve a broad range of scientific interests.

CDC Scientific Program Administrator (SPA)

The CDC NCBDDD will appoint an SPA, apart from the NCBDDD Scientific Collaborator who will:

1. Serve as the Program Official for the funded research institutions.

2. Carry out continuous review of all activities to ensure objectives are being met.

3. Attend Coordinating Committee meetings for purposes of assessing overall progress and for program evaluation purposes.

4. Provide scientific consultation and technical assistance in the conduct of the project as requested.

5. Conduct site visits to recipient institutions to determine the adequacy of the research and to monitor performance against approved project objectives.

Collaborative Responsibilities

The planning and implementation of the cooperative aspects of the study will be effected by a coordinating committee consisting of the Principal Investigator from the organizations receiving awards under this program and the CDC Scientific Collaborator. Organizations serving as sub-contractors under awarded projects are not considered members of the coordinating committee. This coordinating committee will formulate a plan for cooperative research and address issues of common concern throughout the life of the project.

At periodic coordination committee meetings, the group will: (1) Make recommendations on the study protocol and data collection approaches; (2) discuss common protocols as they relate to neuro-development assessment data from children participating in community-based interventions, development of a cross-site collaborative database of testing results, and collecting cost estimates for each intervention; (3) discuss the target populations that have been or will be recruited; (4) identify and recommend solutions to unexpected study problems; and (5) discuss ways to efficiently coordinate study activities and best practices.

II. Award Information

Type of Award: Cooperative agreement.

CDC involvement in this program is listed in the Activities Section above.

Mechanism of Support: U84 (The Administrative Code for FAS cooperative agreements).

Fiscal Year Funds: 2005.

Approximate Total Funding: $1,500,000. The estimated funding amount is pending availability of FY 2005 funds, and is subject to change.

Approximate Number of Awards: Five.

Approximate Average Award: $300,000. This amount is for the first 12-month budget period for each of the five awarded projects, and includes both direct and indirect costs.

Floor of Award Range: $300,000.

Ceiling of Award Range: $300,000.

Anticipated Award Date: August 1, 2005.

Budget Period Length: 12 months.

Project Period Length: Four Years. Throughout the project period, CDC's commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal government.

III. Eligibility Information

III.I. Eligible Applicants

Eligibility is limited to those projects previously funded under CDC Program Announcement Number 01074; FAS Neuro-development Disorders in Children and/or Adolescents. They include the University of California, Los Angeles; Children's Research Triangle, Chicago, IL; Kennedy Krieger Institute, Baltimore, MD (with the project located at the Marcus Institute in Atlanta, GA); University of Oklahoma Health Sciences Center; and the University of Washington. This limited eligibility is based on sustaining support to well-established projects, and to take advantage of the foundation and multiple systems developed over time and now in place to identify and impact on the lives of individuals with FAS and their families.

III.2. Cost Sharing or Matching

Matching funds are not required for this program.

III.3. Other

If you request a funding level greater than the upper threshold, your application will not be eligible for review. You will be notified that you did not meet submission requirements.

Special Requirements

If your application is incomplete or non-responsive to the requirements listed below, it will not be entered into the review process. You will be notified that your application did not meet submission requirements.

Applicants must document their present infrastructure, capacity, expertise, and experience (within organization or within organizations of collaborators) in conducting research directly related to the awardee activities cited in this announcement.

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.

Individuals Eligible to Become Principal Investigators: Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from under-represented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC programs.

IV. Application and Submission Information

IV.1 Address To Request Application Package

To apply for this funding opportunity, use application form PHS 398 (OMB number 0925-0001 rev. 11/2004). Forms and instructions are available in an interactive format on the CDC Web site, at the following Internet address: http://www.cdc.gov/​od/​pgo/​forminfo.htm.

Forms and instructions are also available in an interactive format on the National Institutes of Health (NIH) Web site at the following Internet address: http://grants.nih.gov/​grants/​funding/​phs398/​phs398.html.

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 (PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to you.

IV.2. Content and Form of Application Submission

Application: Follow the PHS 398 application instructions for content and formatting of your application. If the instructions in this announcement differ in any way from the PHS 398 instructions, follow the instructions in this announcement. For further assistance with the PHS 398 application form, contact PGO-TIM staff at [phone], or contact Grants Info, Telephone [phone], E-mail: [e-mail].

You are required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. Your DUNS number must be entered on line 11 of the face page of the PHS 398 application form. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access www.dunandbradstreet.com or call 1-866-705-5711. For more information, see the CDC Web site at: http://www.cdc.gov/​od/​pgo/​funding/​pubcommt.htm.

This announcement uses the non-modular budgeting format. See: http://grants.nih.gov/​grants/​funding/​modular/​modular.htm.

The PHS 398 grant application form requires the applicant to enter the project title on page 1 (Form AA, “Face Page”) and the project description (abstract on page 2).

The main body of the application narrative should not exceed 25 single-spaced pages. This narrative research plan should address activities to be conducted over the entire project period.

Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information may include curriculum vitae and résumés for key project staff, organizational charts, letters of commitment and support, graphic work plan with time intervals related to goals and objectives, etc.; and should be limited to those items relevant to the requirements of this announcement. Applicants must provide a graphic work plan that outlines major goals and objectives with timelines established for each calendar quarter covering the entire project period.

All material must be typewritten, with 10 characters per inch type (12 point) on 8 -1/2 by 11 inch white paper with one inch margins, no headers or footers (except for applicant-produced forms such as organizational charts, c. vitae, graphs and tables, etc). Applications must be held together only by rubber bands or metal clips, and not bound together in anyway (including attachments/appendices).

Additional requirements that may require you to submit additional documentation with your application are listed in section “VI.2. Administrative and National Policy Requirements.”

IV.3. Submission Dates and Time

Application Deadline Date: May 26, 2005.

Explanation of Deadlines: Applications must be received in the CDC Procurement and Grants Office by 4 p.m. Eastern Time on the deadline date. If you send your application by the appropriate postal service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If CDC receives your application 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, you will be given the opportunity to submit documentation of the carrier's guarantee. If the documentation verifies a carrier problem, CDC will consider the application as having been received by the deadline.

This announcement is the definitive guide on the application submission address and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline above, it will not be eligible for review, and will be discarded. You will be notified that your application did not meet the submission requirements.

CDC will not notify you upon receipt of your submission. If you have a question about the receipt of your application, first contact your courier. If you still have a question, contact the PGO-TIM staff at: 770-488-2700. Before calling, please wait two to three days after the submission deadline. This will allow time for submissions to be processed and logged.

IV.4. Intergovernmental Review of Applications

Executive Order 12372 does not apply to this program.

IV.5. Funding Restrictions

Restrictions, which must be taken into account while writing your budget are:

• Project funds cannot be used to supplant other available applicant or collaborating agency funds for construction or for lease or purchase of facilities or space.
• Funds may be spent for reasonable program purposes, including personnel, travel, supplies, and services. Equipment may be purchased if deemed necessary to accomplish program objectives, however, prior approval by CDC officials must be requested in writing.
• The applicant may contract with other organizations under this program; however the applicant must perform a substantial portion of the activities (including program management and operations, and delivery of prevention services for which funds are required).
• If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement must be less than 12 months from the application due date.

IV.6. Other Submission Requirements

Application Submission Address: Submit the original and one hard copy of your application by mail or express delivery service to: Technical Information Management—RFA DD05-079, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, Georgia 30341.

At the time of submission, four additional copies of the application, and all appendices must be sent via overnight commercial carrier to: Dr. Kathleen Madden, Office of Public Health Research (OPHR), 1 West Court Square, Suite 7000, Room 7008, Mailstop D-72, Decatur, Georgia 30030, E-mail address: [e-mail].

V. Application Review Information:

V.1. Criteria

You are required to provide measures of outcome and effectiveness that will demonstrate the accomplishment of the various identified objectives for each stage of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section 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.

In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address the applications' overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score.

Under the evaluation criteria noted below, applicants must describe how they will address the program components as they relate to the Purpose and Research Objectives, and Recipient Activities as cited in this Announcement.

Your application will be evaluated against the following criteria. Please ensure that your narrative describes not only what will be done, but how and through what tasks and activities the work will be undertaken:

1. Resources and Organizational Capacity, including but not limited to applicant experience, within its organization and with collaborating partners to meet all the requirements of this announcement; and a demonstrated ability to assemble a team with the experience and time commitments to dedicate full attention to all planning, implementation, and outcome assessment components of the project.

2. Methods and Activities, including but not limited to ensuring that proposed methods and activities convincingly and comprehensively meet the intention and goals of the announcement; that the methods and activities are feasible within scientific, programmatic and fiscal constraints and will produce accurate, valid and reliable data; that the calculated statistical power and the potential capacity of the research design is adequate to generate meaningful results during the study period; and that the design can be easily replicated for future use by sponsoring organizations including the dissemination of findings and recommendations for the benefit of other agencies.

3. Management, Staffing, and Objectives, including evidence that the applicant has sufficient scientific and management resources for project planning and data management/analysis; that the proposed staffing, staff qualifications, experience, and project organization are sufficient to accomplish the objectives of the program; and that the project goals and objectives can be accomplished through the proposed methods and within the proposed timeline.

4. Evaluation Plan, including that the evaluation components described in the announcement have been addressed in the proposal; that the measurable objectives included in the methods proposed are appropriate for the measurable objectives; and that the evaluation plan includes a process for overall evaluation of sub-components and the entire project, including the assignment of responsibility for ongoing review of all specified components.

5. Budget Description and Justification, including the comprehensiveness and adequacy of the proposed budget in relation to program operations, collaborations, and services; and the extent to which the budget is reasonable, clearly justified, accurate, and consistent with the purposes of this research.

6. Protections: Does the application adequately address the requirements of 45 CFR Part 46 for the protection of human subjects? This criteria will not be scored; however, an application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable.

7. Inclusion: Does the application adequately address the CDC policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research? This includes:

a. The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation.

b. The proposed justification when representation is limited or absent.

c. A statement as to whether the design of the study is adequate to measure differences when warranted.

d. 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.

V.2. Review and Selection Process

Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) and for responsiveness by OPHR. Incomplete applications and applications that are non-responsive as to the eligibility criteria and other eligibility requirements will not advance through the review process. Applicants will be notified that their application did not meet submission requirements and will not receive further consideration.

Applications, which are complete and responsive, will be subjected to a preliminary evaluation (triage) by the scientific review group (Special Emphasis Panel—SEP) composed of external (non-CDC) peer reviewers to determine if the application is of sufficient technical and scientific merit to warrant further review by the SEP. Applications that are determined to be non-competitive will not be considered. Subsequent to the review meeting CDC will notify the investigator/program director and the official signing for the applicant organization of that determination.

Applications determined to be competitive will then be reviewed and scored under the formal SEP peer review process. The review of these fully competitive applications will result in the determination of the score and ranking for those applications.

Subsequent to the formal peer review by the SEP, a second level of review will be conducted by senior CDC program staff. This review is not intended to revisit the scientific merit of the applications. It is designed to review and discuss issues related to the adequacy and justification of the proposed budgets and funding ceilings, and to review the overall rating and ranking of all recommended applications. This will be done in order to prepare recommendations for funding based on the scientific merit as determined by the SEP; and to ensure that the recommendations are consistent and compatible with the Review and Selection section of the original program announcement.

V.3. Anticipated Award Date:

August 1, 2005.

VI. Award Administration Information

VI.1. Award Notices: If your application is to be funded, you will receive a Notice of Award (NoA) from the CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and CDC. The NoA will be signed by an authorized Grants Management Officer and mailed to the recipient fiscal officer identified in the application.

Unsuccessful applicants will receive notification of the results of the application review by mail.

VI.2. Administrative and National Policy Requirements

45 CFR Parts 74 and 92.

For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/​nara/​cfr/​cfr-table-search.html. The following additional requirements apply to this project:

• AR-1: Human Subjects Requirements
• AR-2: Requirement for Inclusion of Women and Racial and Ethnic Minorities in Research
• AR-10: Smoke-Free Workplace Requirements
• AR-11: Healthy People 2010
• AR-12: Lobbying Restrictions
• AR-22: Research Integrity
• AR-25: Release and Sharing of Data

Projects that involve the collection of information from 10 or more individuals and funded by cooperative agreement will be subject to review by the Office of Management and Budget under the Paperwork Reduction Act.

Additional information on these requirements can be found on the CDC web site at the following Internet address: http://www.cdc.gov/​od/​pgo/​funding/​ARs.htm.

VI.3. Reporting

You must provide CDC with an original, plus two copies of the following reports:

1. Interim progress report, (PHS 2590, OMB Number 0925-0001, rev. 11/2004), on a date to be determined for your project for each subsequent budget year. The progress report will serve as your non-competing continuation application, and must contain the following elements:

a. Current Budget Period Activities and Objectives.

b. Current Budget Period Financial Progress.

c. New Budget Period Program Proposed Activities and Objectives.

d. Budget.

e. Additional Requested Information.

f. Measures of Effectiveness.

2. Financial status report and annual 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.

These reports must be sent to the Grants Management Specialist listed in the “Agency Contacts” section of this announcement.

VII. Agency Contacts

We encourage inquiries concerning this announcement. For general questions contact: Technical Information Management Section (PGO-TIM), CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, Georgia 30341, Telephone: [phone].

For program technical assistance, contact: Don Lollar, Ed.D., National Center on Birth Defects and Developmental Disabilities, CDC, 1600 Clifton Road, Mailstop E-87, Atlanta, Georgia 30333, E-Mail Address: [e-mail]. Telephone: [phone].

For budget assistance, contact: Nealean Austin, Grants Management Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, Georgia 30341, Telephone: [phone], E-mail: [e-mail].

VIII. Other Information

This and other CDC funding opportunity announcements can be found on the CDC web site, Internet address: http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.”

Dated: April 5, 2005.

William P. Nichols,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention.