[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