[Federal Register Volume 66, Number 93 (Monday, May 14, 2001)]
[Notices]
[Pages 24373-24376]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11997]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01086]


Centers of Excellence for Autism and Other Developmental 
Disabilities Epidemiology; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2001 funds for a cooperative agreement 
program for Centers of Excellence for Autism and Other Developmental 
Disabilities Epidemiology. This program addresses the ``Healthy People 
2010'' focus area Maternal, Infant, and Child Health.
    The purpose of the program is to collect and analyze epidemiologic 
data on the prevalence, correlates, and causes of autism and other 
developmental disabilities. The Centers will be part of a collaborative 
network investigating autism spectrum disorder (ASD) and other 
developmental disabilities. The Centers will conduct active population-
based surveillance; multi-Center analytic case-control studies; and 
Center-initiated special studies (see Attachment II for Background).

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.
    Only one application from each State or Territory may be submitted.
    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 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 US Census Bureau (based on 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 non-responsive and returned 
without review.

C. Availability of Funds

    Approximately $2,000,000 will be available in FY 2001 to fund 
approximately four awards. It is expected that the average award will 
be $500,000, ranging from $400,000 to $700,000. It is expected that the 
awards will begin on or about September 30, 2001, and will be made for 
a 12-month budget period within a project period of up to five 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.

Funding Preferences

    Priority consideration may be given to the establishment of Centers 
of Excellence in different geographic areas of the United States, its 
Territories, and Indian tribal governments to assure a broad geographic 
representation insofar as possible. This is based on legislative intent 
as provided in the Children's Health Act of 2000. Additional priority 
consideration may be given to the selection of Centers of Excellence 
which, as a group, provide for a diverse racial and ethnic population.

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), CDC will be responsible for the activities 
listed under 2. (CDC Activities). A Coordinating Committee will be 
established to coordinate cross-Center activities as listed under 3. 
(Collaborative Responsibilities).

1. Recipient Activities

A. Surveillance System
    1. Develop or enhance a population-based epidemiologic surveillance 
system for ASD 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.
    2. Establish or enhance a multiple-source methodology for case 
ascertainment by developing collaborative relationships with 
appropriate professionals and organizations.
    3. Develop or enhance a plan for training community service 
providers to improve case ascertainment.
    4. Implement or enhance quality assurance procedures to ensure that 
study protocols are followed.
    5. Develop or enhance an evaluation plan for estimating the 
validity and completeness of the surveillance system.
    6. Develop, implement, and evaluate a plan to use surveillance data 
to

[[Page 24374]]

improve community and service provider awareness of ASD and other 
developmental disabilities and/or access of children with ASD and other 
developmental disabilities to comprehensive, community-based, family-
centered care.
B. Collaborative Case-Control Study
    Collaborate with other Centers funded by this announcement to 
design, implement, analyze, and evaluate joint case-control studies 
based on a pooled study data base (see 3., Collaborative 
Responsibilities, below). The pooled data will be used by Centers 
funded under this announcement to address a variety of epidemiologic 
research issues related to ASD and other developmental disabilities. It 
is anticipated that the collaborative protocol would be developed and 
initiated in the first year of the grant award. Each Center will be 
responsible independently for on-site activities, such as selection and 
enrollment of study subjects, implementation of the joint study 
protocol, quality assurance procedures, data management, and timely 
submission of computerized data to a central repository for inclusion 
in a pooled data set (see 3., Collaborative Responsibilities, below).
C. Center-Initiated Special Studies
    Develop, implement, and evaluate a Center-initiated special study 
drawing on special strengths and expertise of Center staff. It is 
anticipated that development of the special study would be initiated in 
Year 2 of the grant award and utilize the Center's surveillance and 
case-control study infrastructure. The study could include, but may not 
be limited to, the following issues related to ASD or other 
developmental disabilities:
    1. Evaluation of pre-, peri-, and/or postnatal risk factors, 
including genetic factors and environmental exposures.
    2. Evaluation of natural history, including associated 
developmental disabilities and secondary conditions.
    3. Identification of biomarkers.
    4. Evaluation of economic costs.
    5. Development, implementation, and evaluation of intervention 
programs for children with ASD and their families.
D. Disseminate Findings of the Surveillance, Collaborative Case 
Control, and Center-Initiated Special Studies Activities for the 
Professional Community and the Public to Increase Public Health 
Awareness
E. Coordinating Committee (CC)--Participate Fully in the Establishment 
and Operation of the CC, Comprised of Principle Investigators of the 
Centers of Excellence (see 3., Collaborative Responsibilities, below)

2. CDC Activities

A. Surveillance Activities
    1. Assist recipient, as requested, in the development and 
implementation of surveillance activities including the development of 
standardized surveillance case definitions.
    2. Provide current information on surveillance methods, as 
requested, including the identification of potential sources for 
surveillance.
    3. Assist recipient, as requested, in the development of quality 
assurance procedures.
    4. Provide assistance, as requested, in the development of an 
evaluation plan for the completeness and validity of data from the 
surveillance system.
    5. Facilitate communication/coordination among Centers, as 
requested, to improve efficiency of activities and quality of 
surveillance data.
    6. Provide technical consultation regarding data analyses as 
requested.
B. Collaborative Case-Control Studies
    1. Assist recipients as requested in developing a plan for on-site 
activities, such as selection and enrollment of study subjects, 
implementation of the joint study protocol, quality assurance 
procedures, data management, and timely submission of computerized data 
to a central repository for inclusion in a pooled data set.
    2. Obtain Center for Disease Control Institutional Review Board 
clearances and OMB clearance as necessary.
C. Coordinating Committee
    Provide assistance as requested to the Centers in the establishment 
and conduct of activities carried out by the CC.
3. Collaborative Responsibilities (Coordinating Committee)
    The CC will provide leadership and collaborative work to: (1) 
Enhance surveillance efforts across all Centers, including 
establishment of a multi-Center pooled data set, (2) develop a plan for 
the multi-Center case-control study, and (3) enhance communication and 
collaboration among Centers. The CC will combine the expertise and 
resources of the Centers to achieve a more integrated and effective 
program in surveillance and epidemiologic studies of ASD and other 
developmental disabilities. It is anticipated that critical issues for 
understanding the epidemiology of ASD and other developmental 
disabilities will be better defined through the deliberations of the 
CC. Periodic scientific meetings and proceedings of these meetings will 
be used to advance the state of knowledge in the field of ASD and 
developmental disabilities epidemiology. The CC may designate working 
groups for specific purposes, made up of staff members from the 
Centers. The working groups could include, but may not be limited to:
    1. Surveillance work groups to establish common case definitions 
and surveillance data elements for a multi-Center pooled surveillance 
data set;
    2. For the collaborative case-control study, working groups to 
establish (a) suitable study hypotheses, (b) case and control 
definitions, (c) study protocol and methodology, such as collection of 
biosamples, and/or (d) data collection instruments.
    A plan will be developed by the CC for a Center-funded repository 
for the pooled surveillance and case-control study data for common use 
by all Centers. The CC, or a designated work group, will establish 
procedures for management, access and use of the repository and it's 
pooled data.

E. Application Content

    Applicants 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 for applicants to follow them in laying out 
the program plan. Forms are in the application kit.

F. Submission and Deadline

Letter of Intent

    A letter of intent (LOI) is requested to enable CDC to determine 
the level of interest in the announcement. Include name, address, and 
telephone number.
    The LOI is requested on or before June 11, 2001. Submit the letter 
of intent to the Grants Management Specialist identified in the ``Where 
to Obtain Additional Information'' section of this announcement.

Application

    Submit the original and five copies of PHS 398 (OMB Number 0925-
0001) on

[[Page 24375]]

or before July 09, 2001, to the Grants Management Specialist identified 
in the ``Where to Obtain Additional Information'' section of this 
announcement. Deadline: Applications shall 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 shall 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

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

1. Understanding the Problem (15 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 and epidemiologic studies 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 disability surveillance and 
epidemiologic studies in their State.

2. Goals and Objectives (15 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:
    i. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    ii. The proposed justification when representation is limited or 
absent.
    iii. A statement as to whether the design of the study is adequate 
to measure differences when warranted.
    iv. 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. Description of Program and Methodology (30 Points)

    a. 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.
    b. Extent to which applicant describes the plan for implementing 
the collaborative case-control study, including selection and 
enrollment of cases and controls from the applicant's study population.
    c. Extent to which the applicant describes the objectives, based on 
special strengths and expertise of the applicant, for a Center-
initiated special study.

4. Collaborative Efforts (15 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 Centers to develop joint project efforts and 
carry out the joint project efforts in a manner that allows for pooling 
of standardized data.
    c. Extent to which recipient identifies possible collaborative 
relationships with existing surveillance and research programs that may 
enhance recipients' future research activities (e.g., birth defects 
surveillance, NIH CPEAs, PROS).
    d. Extent to which collaborative efforts with other relevant 
programs are documented (such as Part C, State developmental 
disabilities programs, genetics programs etc.)

5. 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 for the surveillance portion 
of the study.

6. Staffing and Management System (15 Points)

    a. 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 and 
analytic studies in ASD and other developmental disabilities.
    b. Extent to which applicant has the ability to manage and 
coordinate surveillance, research, and integration components of the 
project.
    c. Extent to which applicant demonstrates expertise in abstracting 
and reviewing records.
    d. Extent to which there is appropriate dedicated staff time to 
develop and implement the project.
    e. Extent to which applicant provides an appropriate time line and 
includes activities and personnel responsibilities.
    f. 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.

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.

[[Page 24376]]

H. Other Requirements

Technical Reporting Requirements
    Provide CDC with original plus two copies of:
    1. Progress reports (semiannual);
    2. Financial status report, no more than 90 days after the end of 
the budget period; and
    3. Final financial 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.
    For descriptions of the following Other Requirements, see 
Attachment I.

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
AR-22  Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301 and 317 of the Public 
Health Service Act [42 U.S.C. sections 241 and 247b] as amended, and 
Section 102 of the Children's Health Act of 2000 (Pub. L. 106-310). 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 home page 
Internet address--http://www.cdc.gov Click on ``Funding'' then ``Grants 
and Cooperative Agreements.''
    To receive additional written information and to request an 
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked 
to leave your name and address and will be instructed to identify the 
Announcement number of interest.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Nancy Pillar, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146, 
Telephone number: 770-488-2721, Email: <a href="/cdn-cgi/l/email-protection#b6d8d0c680f6d5d2d598d1d9c0"><span class="__cf_email__" data-cfemail="fb959d8bcdbb989f98d59c948d">[email protected]</span></a>.
    For program technical assistance, contact: Diana Schendel, Ph.D., 
National Center on Birth Defects and Developmental Disabilities, 4770 
Buford Highway, Mail Stop F-15, Atlanta, Georgia 30341, Telephone 
number: 770-488-7359, Email: <a href="/cdn-cgi/l/email-protection#66020515502605020548010910"><span class="__cf_email__" data-cfemail="46222535700625222568212930">[email protected]</span></a>.

    Dated: May 8, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-11997 Filed 5-11-01; 8:45 am]
BILLING CODE 4163-18-P


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