[Federal Register Volume 68, Number 96 (Monday, May 19, 2003)]
[Notices]
[Pages 27073-27078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12396]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03065]


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.

[[Page 27074]]

    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

[[Page 27075]]

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

[[Page 27076]]

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 (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 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.

[[Page 27077]]

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: (770) 488-2700.

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: (770) 488-
2723, Email address: [email protected].

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: (770) 488-2763, Email address: [email protected].

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: (770) 488-7288, Email address: 
[email protected].


[[Page 27078]]


    Dated: May 13, 2003.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 03-12396 Filed 5-16-03; 8:45 am]
BILLING CODE 4163-18-P