[Federal Register Volume 67, Number 129 (Friday, July 5, 2002)]
[Notices]
[Pages 44847-44850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-16815]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02199]


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) 2002 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 areas for 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 new Center(s) will be part of an 
existing collaborative network (which consist of four Centers 
presently) 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. 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 and developmental disabilities in order to 
develop prevention strategies.

B. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301(a), 311 and 317(C) of 
the Public Health Service Act, (42 U.S.C. Sections 241, 243, and 247b-
4), 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.

C. 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. Only one application from each State or Territory may be 
submitted.
    To be eligible, applicants must document a study population of at 
least 30,000 live births per year (in order to be able to detect 
sufficient numbers of cases) 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, based on United States 
Census Data (based on 2000 census data). This information should be 
placed directly behind the face page of the application. Applications 
that fail to submit the evidence requested above will be considered 
non-responsive and returned without review.

    Note: Title 2 of the United States Code, Section 1611 states 
than 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.

D. Availability of Funds

    Approximately $400,000 to $700,000 will be available in FY 2002 to 
fund approximately one award. The average award will be approximately 
$500,000. It is expected that the award will begin on or about 
September 30, 2002, and will be made for a 12-month budget period 
within a project period of up to four years. Funding estimates may 
change.
    It is anticipated that in FY 2003, additional approved but not 
funded awards may be made from this announcement, if funds become 
available.
    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. Matching funds are not required for this 
program.

E. 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. Surveillance System.

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    (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 are 
not 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 improve community and service provider awareness regarding 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 
previously funded Centers to design, implement, analyze, and evaluate 
joint case-control studies based on a pooled study data base.
    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 Two 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 prenatal, perinatal, 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. Participate fully as a member of the coordinating committee, 
which is comprised of principal investigators of all funded Centers of 
Excellence.
    2. CDC Activities:
    a. Surveillance Activities.
    (1) Assist recipient in the development and implementation of 
surveillance activities including the development of standardized 
surveillance case definitions.
    (2) Provide current information on surveillance methods, including 
the identification of potential sources for surveillance.
    (3) Assist recipient, in the development of quality assurance 
procedures.
    (4) Provide assistance, in the development of an evaluation plan 
for the completeness and validity of data from the surveillance system.
    (5) Facilitate communication/coordination among funded Centers, to 
improve efficiency of activities and quality of surveillance data.
    (6) Provide technical consultation regarding data analyses.
    b. Collaborative Case-Control Studies.
    (1) Assist recipients 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 CDC Institutional Review Board (IRB) clearances and 
Office of Management and Budget (OMB) clearance as necessary.

F. Content of Application

Letter of Intent (LOI)

    An LOI is requested for this program announcement. The LOI will not 
be used to eliminate potential applicants, but it will enable CDC to 
determine the level of interest and plan for the review more 
efficiently. The LOI should be no more than two, double-spaced pages, 
printed on one side, with one-inch margins and 12 point font. The LOI 
should include the following information: this program announcement 
number; applicant's name and address; project director's name, phone 
number, and e-mail address.

Applications

    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 the specific 
information noted in laying out the program plan.

G. Submission and Deadline

Letter of Intent (LOI)

    On or before July 22, 2002, submit the LOI to the official 
designated for programmatic technical assistance identified in the 
``Where to Obtain Additional Information'' section of this 
announcement.

Application

    Submit the original and two copies of PHS 398 (OMB Number 0925-
0001). Forms are available at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
    The application must be received on or before 5 p.m. Eastern Time, 
August 9, 2002. Submit the application to: Technical Information 
Management-PA 02199, Procurement and Grants Office, Centers for Disease 
Control and Prevention, 2920 Brandywine Rd, Room 3000, Atlanta, GA 
30341-4146.
    Deadline: Applications shall be considered as meeting the deadline 
if they are received before 5 p.m. Eastern Time on the deadline date. 
Applicants sending applications 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.
    Applications which do 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

    Applicants are required to provide Measures of Effectiveness that 
will demonstrate the accomplishment of various identified objectives of 
the grant/cooperative agreement. Measures of Effectiveness must relate 
to the performance goals as stated in section ``A. Purpose'' of this 
announcement.

[[Page 44849]]

Measures must be objective/quantitative and must measure the intended 
outcome. These 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. 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 regarding 
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.
    2. 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.
    3. 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:
    (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.
    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, National Institutes of Health, Collaborative Programs of 
Excellence in Autism).
    d. 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 (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.
    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 for the surveillance portion 
of the study.
    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.

I. Other Requirements

Technical Reporting Requirements

    Provide CDC with an original plus two copies of:
    1. Semiannual progress reports, which should include:
    a. Brief project description;
    b. Comparison of the actual accomplishments to the goals and 
objectives established for the period;
    c. Data requirements that demonstrates measures of effectiveness. 
In the case that established goals and objectives are not accomplished, 
or are delayed, please 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. If there is a need to 
change or delete goals or objectives, please discuss and explain the 
reason;
    d. Other pertinent information, including preliminary findings from 
the analysis of any available data; and

[[Page 44850]]

    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.

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

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.''
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Sheryl Heard, Grants Management Specialist, Acquisition and 
Assistance Branch B, Procurement and Grants Office, Centers for Disease 
Control and Prevention, Announcement 02199, 2920 Brandywine Road, Room 
3000, Atlanta, GA 30341-4146, Telephone number: 770-488-2723, email 
address: [email protected].
    For program technical assistance, contact: Frank Destefano, M.D., 
M.P.H., National Center on Birth Defects and Development Disabilities, 
4770 Buford Highway, Mail Stop F-15, Atlanta, Georgia 30341, Telephone 
number: 770-488-7288, email address: [email protected].

    Dated: June 27, 2002.
Sandra R. Manning,
CGFM, Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 02-16815 Filed 7-3-02; 8:45 am]
BILLING CODE 4163-18-P