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Population-Based Surveillance of Autism Spectrum Disorders and Other Developmental Disabilities; Notice of Availability of Funds

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A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2002 funds for a cooperative agreement program for Population-Based Surveillance of Autism Spectrum Disorders and Other Developmental Disabilities. 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 the program is to enhance an existing system or develop and implement a new system to undertake a multiple source surveillance methodology, from existing data records, for determining the prevalence of autism and other developmental disabilities, such as mental retardation, cerebral palsy, and vision and hearing impairments, in three through ten-year-old children within a geographically-defined area (combination of States, Statewide, or regions within a State). This program augments CDC's ongoing extramural surveillance program for autism and other developmental disabilities.

Quantifiable and measurable outcomes of the cooperative agreement will be measured against the “Government Performance Results Act” performance goal to find causes and risk factors for birth defects in order to develop prevention strategies.

B. Eligible Applicants

Assistance will be provided only to the Health Departments of States or their bona fide agents, including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Mariana Islands, American Samoa, Guam, federally recognized Indian Tribal Governments, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.

Competition is limited to State Health Departments because they maintain public health responsibility for these health conditions, and their record systems and expertise are essential to program success. State agencies, or their bona fide agents, applying under this announcement, that are other than the official State Health Department must provide written concurrence on the application from the official State Health Department. If an applicant is acting as an agent for their State Health Department, the Health Department will be expected to assign a liaison to participate in major activities of the program.

To be eligible, applicants must document a study population of at least 30,000 live births per year within a State, a contiguous area of a State (such as the catchment of a local health agency), or a contiguous area comprising 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 US Census Bureau (based on 2000 census data, or 1999 Postcensal estimates) will be determined ineligible.

The applicant should include this information as part of the abstract. If it is not included, then the application will be determined as nonresponsive and returned without review.

Note:

Only one application will be accepted from each State or combination of States, and the latter must specify which State is the lead applicant.

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.

C. Availability of Funds

Approximately $700,000 is available in FY 2002 to fund two to three awards. It is expected that the award will begin on September 30, 2002, 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 made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

D. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities under 1. (Recipient Activities), and CDC will be responsible for the activities listed under 2. (CDC Activities).

1. Recipient Activities

a. Develop or enhance a population-based epidemiologic surveillance system for autism spectrum disorders and other developmental disabilities to generate timely population-based data. Activities may include, but not be limited to, development or enhancement of surveillance case definitions, multiple source case ascertainment methods (e.g., from educational and medical sources), and data collection instruments.

b. Establish or enhance a multiple-source methodology for case ascertainment by developing collaborative relationships with appropriate professionals and organizations.

c. Develop or enhance a plan for training community service providers to improve case ascertainment.

d. Implement or enhance quality assurance procedures to ensure that study protocols are followed.

e. Develop or enhance an evaluation plan for estimating the validity and completeness of the surveillance system.

f. Develop, implement, and evaluate a plan to use surveillance data to improve community and service provider awareness of Autism Spectrum Disorders (ASD) and other developmental disabilities and/or access of children with ASD and other developmental disabilities to comprehensive, community-based, family-centered care.

g. Collaborate with other State surveillance programs for autism and other developmental disabilities. Participate in scheduled meetings and existing activities.

h. Disseminate findings of the surveillance activities for the professional community and the public to increase public health awareness.

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, as requested, including the identification of potential sources for surveillance.

c. Assist recipient in the development of quality assurance procedures. Start Printed Page 16399

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

e. Facilitate communication/coordination among the surveillance programs, to improve efficiency of activities and quality of surveillance data.

f. Provide technical consultation regarding data analyses.

E. Application Content

The applicant should use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections 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 narrative should be no more than 25 double-spaced pages, printed on one side, with one inch margins, unreduced font, unbound, and unstapled.

F. Submission and Deadline

Application

Submit the original and two copies of PHS 5161-1 (OMB Number 0937-0189). Forms are available at the following internet address: www.cdc.gov/​od/​pgo/​forminfo.htm.

On or before May 22, 2002, submit the application to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Deadline: Applications will be considered as meeting the deadline if they are either:

(a) Received on or before the deadline date; or

(b) Sent on or before the deadline date and received in time for submission to the Objective Review Panel. (Applicants must request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or U.S. Postal Service. Private metered postmarks will not be acceptable as proof of timely mailing.)

Late Applications: Applications which do not meet the criteria in (a) or (b) above are considered late applications, will not be considered, and will be returned to the applicant.

G. Evaluation Criteria

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 goal as stated in section “A. Purpose” of this announcement. Measures must be objective/quantitative and must measure the intended outcome. The Measures of Effectiveness shall be submitted with the application and shall be an element of evaluation.

Each application will be evaluated individually against the following criteria by an independent review group appointed by CDC.

1. 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 ASD and other developmental disabilities;

c. Extent to which applicant understands the issues, challenges, and barriers associated with case ascertainment for ASD; and

d. Extent to which applicant describes the need for funds to develop/enhance ASD and other developmental disabilities surveillance in their State.

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

c. 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 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.

3. Technical Approach (30 points)

a. The extent to which the applicant describes the planning process, including specific planning objectives, strategies for achieving these objectives, and describes an approach to surveillance of autism and other developmental disabilities.

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 developmental disabilities within the study area; (2) obtain permission to access records from relevant sources; (3) develop standard case definitions for ASD and other developmental disabilities and implement a strategy to conduct multiple-source case ascertainment; (4) train community service providers to improve case ascertainment; (5) develop and implement quality assurance procedures and an evaluation plan for the surveillance system; (6) 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; and (7) 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).

4. Collaborative Efforts (10 points)

a. 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).

b. Extent to which applicant demonstrates their willingness to collaborate with other State surveillance programs for autism and other developmental disabilities to develop and implement joint project efforts.

c. Extent to which collaborative efforts with other relevant programs are documented (such as Part C, State developmental disabilities programs, genetics programs etc.).

5. Staffing and Management System (10 points)

a. Extent to which the applicant demonstrates that the proposed Project Director or Principal Investigator is knowledgeable regarding autism, developmental disabilities, 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 developmental disabilities, 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 Start Printed Page 16400coordinate surveillance related activities for this project.

d. Extent to which applicant demonstrates expertise in abstracting and reviewing records.

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.

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 ongoing surveillance program.

7. Human Subjects Review (not scored)

Does the applicant adequately address the requirements of 45 CFR part 46 for the protection of human subjects?

8. 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 two persons and two days each trip.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of 1. Semiannual progress reports, no more than 30 days after the end of the report period. The progress reports should include:

a. A brief project description;

b. A comparison of the actual accomplishments to the goals and objectives established for the period;

c. The progress report will include a data requirement that demonstrates measures of effectiveness. In the case that established goals and objectives are not accomplished, discuss the reason for the goals and objectives not being accomplished, as well as the anticipated corrective action needed to achieve the goals and objectives; and

d. Other pertinent information, including preliminary findings from the analysis of any available data; or the need to change an activity.

e. Financial recap of obligated dollars to date as a percentage of total available funds.

2. Financial status report, no more than 90 days after the end of the budget period; and

3. Final financial status 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.

The following additional requirements are applicable to this program. For a complete description of each, see the application kit.

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

AR-12 Lobbying Restrictions

I. 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. Sections 241, 243 and 247b-4 as amended]. The Catalog of Federal Domestic Assistance number is 93.283.

J. Where to Obtain Additional Information

This and other CDC announcements can be found on the CDC homepage Internet address—http://www.cdc.gov Click on “Funding” then “Grants and Cooperative Agreements”.

For business management technical assistance, please contact:

Sheryl L. Heard, Grants Management Specialist, Assistance and Acquisition Branch B, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146, Telephone number: 770-488-2723, Email address: SHeard@cdc.gov.

For program technical assistance, contact: Catherine Rice, Project Officer Developmental Disabilities Team, National Center on Birth Defects and Developmental Disabilities Centers for Disease Control and Prevention 4770 Buford Hwy, NE (F-15) Atlanta, GA 30341 Telephone: 770-488-7202 Email address: CRice@cdc.gov.

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Dated: April 1, 2002.

Sandra R. Manning, CGFM,

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

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[FR Doc. 02-8225 Filed 4-4-02; 8:45 am]

BILLING CODE 4163-18-P