03-12396. Building Capacity for Population-Based Surveillance of Autism Spectrum Disorders and Other Developmental Disabilities; Notice of Availability of Funds

Application Deadline: July 18, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under sections 301, 311 and 317(C) of the Public Health Service Act, (42 U.S.C. 241, 243 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 Building Capacity for Population-Based Surveillance of Autism Spectrum Disorders (ASDs) and other Developmental Disabilities (DDs).

CDC is committed to achieving the health promotion and disease prevention objectives of “Healthy People 2010.” This announcement is related to the focus area of Maternal, Infant and Child Health.

The purpose of this program is to enhance the capacity to design and implement population-based, multiple-source surveillance for ASDs and other DDs to include children who are eight years of age.

This program will support funding for applicants to develop a new surveillance system for ASDs and other DDs, beginning with the ASDs and Mental Retardation (MR) in eight year-old children, in collaboration with a network of CDC-funded ASD/DD surveillance projects known as the Autism and Developmental Disabilities Monitoring (ADDM) Network.

Measurable outcomes of the program will be in alignment with the following performance goals for the National Center for Birth Defects and Developmental Disabilities (NCBDDD): To improve the data on the prevalence of birth defects and developmental disabilities and find causes and risk factors of birth defects and developmental disabilities in order to develop prevention strategies.

For additional information applicable to this announcement, see Attachment I. All attachments referenced in this announcement are posted with the announcement on the CDC Web site.

C. Eligible Applicants

Applications may be submitted by 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.

Competition is limited to State Health Departments, or their bona fide agents, because they maintain public health responsibility for these health conditions, and their record systems and expertise are essential to continued program operation. 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 to conduct ASD and DD surveillance. If an applicant is acting as an agent for their Health Department, the Health Department will be expected to assign a liaison with no less than ten percent time dedicated to participate in major activities of the program. Applicants are expected to provide some in-kind support for these activities.

Only one application per state will be accepted. If multiple states, territories or regions are represented, a lead applicant must be specified. Information indicating the lead applicant and the letter granting authority from the Health Department for this application should be placed directly behind the cover letter of the application. Applicants that fail to submit the evidence requested above will be considered non-responsive and returned without review.

Applicants from States that currently have ASD and other DD surveillance programs funded by CDC are ineligible. These States include: Arizona, Arkansas, California, Colorado, Georgia, Florida, Maryland, Delaware, New Jersey, North Carolina, Pennsylvania, South Carolina, Utah, and West Virginia.

To be eligible, applicants must document a study population of at least 30,000 live births per year within a State, a contiguous area (geographically linked) of a State, or a contiguous area comprised of a combination of States. Applicants who are unable to document the minimum study population size based on live birth data from their State Health Department or proxy data from the United States Census Bureau (based on 2000 census data or other appropriate data source) will be determined ineligible.

Note:

Title 2 of the United States Code, section 1611 states that an organization described in section 501c(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 $800,000 may be available in FY 2003 to fund approximately four awards. It is expected that the average award will be $200,000, ranging from $150,000 to $250,000. The award is expected to begin on September 1, 2003, and will be made for a 12-month budget period within a project period of up to three years. Funding estimates may change.

Continuation awards within an approved project period will be dependent upon demonstration of reasonable progress towards establishing ongoing, population-based surveillance for ASDs and other DDs as evidenced by required reports and the availability of funds.

Use of Funds

Funds awarded should be used solely for the implementation of the approved project for ASD and DD surveillance.

Recipient Financial Participation

Although matching funds are not a requirement under this announcement, applicants are encouraged to seek additional funds to support project activities. Applicants should document the source and amount of financial support, including in-kind contributions. Such letters of financial commitment as well as additional correspondence citing specific areas of project collaborations should be included in the application Appendix.

Funding Preferences

During the selection process CDC will make every effort to ensure a balanced geographic distribution with currently funded grantees.

E. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities listed in 1. Recipient Activities, and CDC will be responsible for the activities listed in 2. CDC Activities. Please see Attachment I for additional guidance information.

1. Recipient Activities:

a. Develop a collaborative, population-based epidemiologic surveillance system for ASDs including Autistic Disorder, Pervasive Developmental Disorder—Not Otherwise Specified (PDD-NOS) and Asperger's Disorder and other developmental disabilities (e.g., MR, cerebral palsy, hearing loss, vision impairment, and/or epilepsy) with a minimum inclusion of MR, in eight year old children.

b. Develop collaborative relationships with appropriate professionals and organizations and existing funded surveillance partners to establish a multiple-source methodology for case ascertainment that is compatible with current collaborative CDC methodology.

c. Determine data linkages that may be needed to supplement the ASD/DD surveillance system.

d. Develop a plan to identify and access potential sources for ASD/DD surveillance.

e. Identify a surveillance project team capable of conducting ASD and DD surveillance. If acting as a bona fide agent of a health department, a department employee with no less than 10 percent of his/her time dedicated to participate in major activities of the program must be assigned to the project.

f. Develop a plan for quality assurance procedures for abstraction and case review and to ensure that study protocols are followed.

g. Develop an evaluation plan for estimating the validity and completeness of the surveillance system.

h. Develop a plan to increase community and public health awareness of ASDs/DDs to facilitate early and accurate identification of children and to improve the consistent identification of children with an ASD/DD in order to improve case ascertainment.

i. Outline a plan to disseminate findings of the surveillance activities for the professional community and the public to increase public health awareness.

j. Collaborate with funded CDC ASD surveillance partners and participate in surveillance development workshop(s) and meetings with CDC staff and ADDM Network members concerning population-based surveillance of ASDs/DDs.

2. CDC Activities:

a. Assist recipient in the development and implementation of surveillance activities including the development of a standardized surveillance case definition.

b. Provide current scientific information on surveillance methods, including the identification of potential sources for surveillance.

c. Assist recipient in the development of quality assurance procedures.

d. Provide assistance in the development of an evaluation plan for the completeness of the surveillance system.

a. Facilitate communication/coordination among the ADDM and other CDC-funded surveillance programs, to improve efficiency of activities and quality of surveillance data.

f. Provide technical consultation regarding data analyses.

F. Content

Letter of Intent (LOI)

A LOI is requested for this program. The LOI will be used to determine level of interest in the announcement and should include the following information: The program announcement title and number; name of applicant; project director's name and contact information.

Application

The Program Announcement title and number must appear in the application. The applicant should use the information in the Purpose, Program Requirements, Evaluation Criteria, and Other Program Requirements sections of this announcement, as well as the additional information in Attachment I to develop the application content. The application will be evaluated on the criteria listed, so it is important to follow them in laying out the program plan.

The applicant should provide a detailed description of first-year goals, objectives, and activities and provide general goals, objectives, and activities for year two. Plans to sustain the program in the event of limited CDC future funding should also be addressed. The application must contain the following:

1. Cover Letter: A one-page cover letter indicating the program announcement name and number.

2. Health Department Letter: A one-page letter indicating that the applicant is either the State Health Department or the bona fide agent assigned to conduct ASD and DD surveillance.

3. Abstract: A one-paged, single-spaced typed abstract in 12-point font. The heading should include the title of the program announcement, the project title, organization, name and address, project director, and contact information. The abstract should clearly state the health department represented, the study area, and the number of live births in the area (based on 2000 Census data). The abstract should briefly summarize the program scope, activities, objectives, methods, and anticipated results.

4. Table of Contents: A table of contents that provides page numbers for the sections listed below. Pages must be numbered.

5. Narrative: The narrative should be no more than 25 double-spaced pages, printed on one side, with one inch margins, unreduced font, unbound, and unstapled. The narrative should specifically address the below items, the “Program Requirements” and should contain the following sections:

a. Understanding of the Public Health Impact of the ASDs and other DDs.

b. Understanding of the need for population-based, multiple source prevalence data on the ASDs and DDs and the particular needs in the applicant's area.

c. Plans for collaboration with CDC and other partners and sources in the development of the surveillance system.

d. Description of the surveillance system planned including disabilities covered, age of children, study area, case definitions, multiple source case ascertainment methods, data collection instruments, data linkages and analyses, and reporting of results.

e. A plan to identify and access potential sources with written assurances from major sources. The plan should address issues pertaining to Federal privacy laws, and applicable state laws dealing with confidentiality issues, as well as any other assurances considered necessary to ensure the privacy and confidentiality of individuals. Sources should include a range of facilities that provide evaluation and treatment services for children with developmental disabilities, particularly ASDs and MR. Sources should include: Schools (public and private, including evaluations to determine eligibility for special education services), Clinical (including diagnostic and developmental assessment information), and other programs (for example, state DD programs).

f. Plan to address quality assurance procedures for abstraction and case review to ensure that study protocols are followed.

g. An evaluation plan for estimating the validity and completeness of the surveillance system.

h. A plan for data storage and maintaining confidentiality.

i. A plan for data analysis.

j. A plan to increase community and public health awareness of ASDs/DDs to facilitate early and accurate identification of children and to develop linkages between identification and assessment and intervention resources.

k. A plan for training local community service providers to improve the consistent identification of children with an ASD/DD in order to improve case ascertainment.

l. Intent to collaborate with the ADDM Network and participate in surveillance development workshop(s) and weekly conference call meetings with CDC staff and ADDM Network members concerning population-based surveillance of ASDs/DDs.

6. Organizational and Program Personnel Structure, Duties, and Capabilities: Provide an organizational chart of project personnel, as well as a description of percent effort and specific duties as they relate to the project. In addition, submit appropriate documentation of related professional experience of primary project personnel. Project personnel should include, at a minimum depending on the time line, a Principal Investigator, full-time Project Coordinator, at least two part-time records abstractors, at least 30 percent effort from an epidemiologist, at least two consultant or part-time clinician reviewers, and provision of data management/programmer support.

7. Project Timeline: Include a timeline with goals, objectives, and personnel responsible for the two-year project. Provide a summary of plans for future continuation of the project in the event that CDC funding is not available after the project period ends.

8. Human Subjects Review: Include requirements and considerations related to Human Subjects Review. Include time and activities related to submissions to Institutional and Human Subjects Review Boards at the home institution and other potential sources in the project timeline.

9. Letters of Support: In addition to letter of representation from the Health Department placed before the abstract, include appropriate letters of support from partners, consultants, references, potential sources, etc., as appropriate.

10. Budget and Budget Justification: Provide a detailed budget which indicates the anticipated costs for personnel, fringe benefits, travel, supplies, contracts, consultants, equipment, indirect, and other items. The amount and source of in-kind support provided by the applicant should be included.

G. Submission and Deadline

LOI Submission

On or before June 18, 2003, submit the LOI to the Project Officer, at the address designated for programmatic technical assistance 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 0937-0189). 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 telephone number [phone]. Application forms can be mailed to you.

Submission Date, Time, and Address

The application must be received by 4 p.m. Eastern Time on July 18, 2003. Submit the application to: Technical Information Management—PA #03065, CDC Procurement and Grants Office, 2920 Brandywine Rd., Atlanta, GA 30341-4146.

Applications may not be submitted electronically.

CDC Acknowledgement of Application Receipt

A postcard will be mailed by PGO-TIM, 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. Any applicant who sends their application 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.

Any application that does not meet the above criteria will not be eligible for competition and will be discarded. Applicants will be notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Application

Applicants are required to provide measures of 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 the “B. Purpose” section of this announcement. Measures must be objective and quantitative and must measure the intended outcome. The measures of effectiveness must be submitted with the application and shall be an element of evaluation.

An independent review group appointed by CDC will evaluate each application against the following criteria:

1. Technical Approach (25 points)

a. The extent to which the applicant describes the specific planning objectives, strategies for achieving these objectives, and describes an approach to surveillance of ASDs and other DDs.

b. Extent to which applicant describes the methods they will use to:

(1) Identify all relevant sources for surveillance case ascertainment for ASD and other DDs within the study area.

(2) Obtain permission to access records from relevant sources.

(3) Address relevant records access issues as related to federal privacy laws, and applicable state laws dealing with confidentiality issues, as well as any other assurances considered necessary to ensure the privacy and confidentiality of individuals.

(4) Collaborate with ADDM Network to develop standard case definitions for ASD and other DDs and implement a strategy to conduct multiple-source case ascertainment.

(5) Train community service providers to improve case ascertainment.

(6) Develop and implement quality assurance procedures and an evaluation plan for the surveillance system.

(7) Develop and implement a plan to use surveillance data to improve public awareness of ASD and other developmental disabilities and/or access to care of affected children.

(8) Develop an analytic and dissemination plan, and prepare manuscripts.

c. The extent to which the applicant demonstrates its collaboration with health and education services that would be appropriate sources of cases for the surveillance system (by letters of support which address the level of support, activities, and involvement).

2. Understanding the Problem (20 points)

a. Extent to which applicant has a clear, concise understanding of the requirements and purpose of the cooperative agreement.

b. Extent to which applicant understands the issues, challenges, and barriers associated with developing and implementing population-based surveillance for the range of ASDs and other DDs, particularly MR, and

c. Extent to which applicant describes the need for funds to develop/enhance ASD and other DD surveillance in their State or territory.

3. Goals and Objectives (20 points)

a. Extent to which applicant clearly describes the short-term and long-term goals and measurable objectives of the project.

b. A statement as to whether the design of the activities is adequate to enable the applicant to implement an ongoing population-based surveillance system for ASDs/DDs.

c. Extent to which applicant's goals and objectives are realistic and are consistent with the stated goals and purpose of this announcement.

d. The degree to which applicant has met 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 why and in what ways the design of the surveillance system is adequate to establish the rates and descriptive data to evaluate 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.

4. Staffing and Management System (15 points)

a. Extent to which the applicant demonstrates that the proposed Project Director or Principal Investigator is knowledgeable regarding ASDs, DDs, and surveillance issues, as evidenced by publications, presentations, or other materials that document prior work.

b. Extent to which key personnel have qualifications, skills and experience in epidemiologic methods, public health surveillance, data management and analysis to develop and implement surveillance in ASD and other DDs, as evidenced by publications, presentations, or other materials that document prior work.

c. Extent to which applicant has the ability and experience to manage and coordinate surveillance related activities for this project.

d. Extent to which applicant involves adequate personnel with expertise the abstraction of records. In addition, adequate personnel with clinical expertise to review records to determine case status are also needed.

e. Extent to which there is appropriate dedicated staff and staff time to develop and implement the project.

f. Extent to which applicant provides an appropriate time line, which includes activities, percent of time staff will work on this project, and responsibilities/duties for assigned personnel.

g. Extent to which applicant demonstrates an organizational structure (include an organizational chart) and facilities/space/equipment that are adequate to carry out the activities of the program. The level of in-kind support and commitment to sustaining an ongoing surveillance system will also be considered.

5. Collaborative Efforts (10 points)

a. Extent to which applicant identifies an appropriate team with expertise in both epidemiology and disabilities and disorders of childhood, particularly the ASDs.

b. Extent to which applicant demonstrates the ability to collaborate with multiple sources such as school systems, diagnostic centers, health/mental health service providers and other intervention service providers for the purpose of case ascertainment (include written assurances).

c. Extent to which applicant demonstrates their willingness to collaborate with the ADDM Network and other CDC-funded ASD/DD surveillance programs to develop and implement joint project efforts.

d. Extent to which collaborative efforts with other relevant programs are documented (such as education sources, Part C, state developmental disabilities programs, specialty clinics, etc.).

6. Evaluation Plan (10 points)

a. Extent to which applicant describes an evaluation plan that will monitor reliability, progress, timeliness, and completeness of the objectives and activities of the project.

b. Extent to which applicant describes a study to evaluate the completeness of ascertainment of children throughout this on-going surveillance program.

7. Budget (not scored)

The extent to which the budget is reasonable, clearly justified, and consistent with the intended use of funds. Applicants should include in their first year budget two trips to CDC (Atlanta), for up to four persons at two days per trip.

8. Human Subjects Review (not scored)

Does the applicant adequately address the requirements of 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 such risks is so inadequate as to make the entire application unacceptable.

I. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. Interim progress reports, which are due annually on April 22nd and annual progress reports, which are due annually no more than 30 days after the end of the budget period (September 29th). The interim progress report will serve as your non-competing continuation application. Progress reports 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 (for interim progress reports only).

e. Additional Requested Information.

2. Financial Status Report (FSR), no more than 90 days after the end of the budget period; and

3. Final financial Status Report (FSR) and performance reports, no more than 90 days after the end of the project period.

Send all reports to the Grants Management Specialist and a copy to the Project Officer 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 page.

AR-1 Human Subjects Requirements

AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

AR-7 Executive Order 12372 Review

AR-9 Paperwork Reduction Act Requirements

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

R-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, CDC Procurement and Grants Office, 2920 Brandywine Rd, Atlanta, GA 30341-4146, Telephone: [phone].

For business/grant management and budget assistance, please contact: Sheryl L. Heard, Grants Management Specialist, Assistance and Acquisition Branch B, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone number: [phone], Email address: [e-mail].

For business/grant 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 number: [phone], Email address: [e-mail].

For program technical assistance, contact: Joanne Wojcik, Public Health Analyst, Developmental Disabilities Team, CDC National Center on Birth Defects and Developmental Disabilities, 4770 Buford Hwy, NE (F-15), Atlanta, GA 30341, Telephone: [phone], Email address: [e-mail].

Dated: May 13, 2003.

Sandra R. Manning,

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