[Federal Register Volume 68, Number 173 (Monday, September 8, 2003)]
[Notices]
[Pages 52944-52948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22715]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Data Coordinating Center for Autism and Other Developmental 
Disabilities Surveillance and Epidemiologic Research

    Announcement Type: New.
    Funding Opportunity Number: PA 04014.
    Catalog of Federal Domestic Assistance Number: 93.283.
    Key Dates:

Letter of Intent Deadline: October 8, 2003
Application Deadline: November 14, 2003

I. Funding Opportunity Description

    Authority: This program is authorized under sections 301, 311, 
and 317(C) of the

[[Page 52945]]

Public Health Service Act, [42 U.S.C. Sections 241, 243, and 247b-4, 
as amended].

    Purpose: The Centers for Disease Control and Prevention (CDC) 
announces the availability of fiscal year (FY) 2004 funds for a 
cooperative agreement program for a new Data Coordinating Center (DCC) 
to support surveillance data and research data management related to 
developmental disabilities, such as Autism Spectrum Disorders (ASD) and 
other Developmental Disabilities (DD). This program addresses the 
``Healthy People 2010'' focus area of Maternal, Infant, and Child 
Health.
    The purpose of the program is to support a DCC to coordinate and 
facilitate data management activities across both the Autism and 
Developmental Disabilities Monitoring Network (ADDM) surveillance 
grantees, and the Centers of Excellence for Autism and Developmental 
Disabilities Research and Epidemiology (CADDRE) surveillance and 
epidemiologic research grantees. The Children's Health Act of 2000 
established a national mandate for autism surveillance activities and 
for research to address etiologic questions and identify effective 
interventions. The DCC is the third component necessary to provide a 
coordinated and standardized collection and output of information 
between and from these two grantee programs. The DCC is necessary to 
ensure accurate and timely processing and reporting of both 
surveillance data and research data related to ASD and DD. The data 
collected from these grantee sites will be stored at the DCC. Data 
activities related to other birth conditions and developmental 
disabilities may be added in the future, based on needs.
    The ADDM, CADDRE, and DCC cooperative agreements have been 
developed to assist us with our goal of preventing ASDs and DDs. The 
first step in preventing these conditions is to understand their scope. 
Specifically, we need to know how many children are affected, the 
health outcomes for these children, the costs to the family and to the 
community, and the risk factors or protective factors for each 
condition. This information is needed to set priorities, design studies 
of causes and develop effective interventions in the public setting.
    Measurable outcomes of the program will be in alignment with the 
following performance goals for the National Center on 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.
    Activities:
    Awardee activities for this program are as follows:
    a. Support the cooperative activities of the research sites through 
meetings, telephone conferences, and web support.
    b. Develop, after the initial meeting/discussions with research 
sites, a work plan for all activities proposed for the DCC (See 
Attachment 1 posted with this announcement on the CDC Web site).
    c. Develop the needed documentation, testing requirements, and a 
relational database application after CDC's approval of the work plan. 
This application should contain all of the necessary computerized data 
collection forms for autism and other DD surveillance.
    d. Develop a secure Web site for surveillance and research sites to 
access the individual and pooled data sets for analysis. Note that all 
data collected and accessible through the secure Web site is 
confidential and should be maintained in accordance with all federal, 
state, and local rules, regulations, and laws governing privacy of 
personal health and health-related data (no personal identifiers will 
be forwarded to the DCC).
    e. Assist the research sites in administering questionnaires to 
individuals they identify.
    f. Develop manuals and plans for training of research site 
personnel, and conduct on-site training on the use of the relational 
database application and transmission of study data to DCC.
    g. Prepare written system documentation for the relational database 
application and secure Web site.
    h. Develop a plan to transfer the data and source code to CDC at 
the end of the funding period.
    In a cooperative agreement, CDC staff is substantially involved in 
the program activities, above and beyond routine grant monitoring. CDC 
activities for this program are as follows:
    a. Assist with protocol development, including reviewing and 
commenting on each stage of the program before subsequent stages are 
started.
    b. Assist in the analysis and interpretation of findings.
    c. Assist in the reporting of findings in scientific literature, 
other media, and among the public.
    d. Assist in the development of a research protocol for 
Institutional Review Board (IRB) review by all cooperating institutions 
participating in the research project. The CDC IRB will review and 
approve the protocol initially, and on at least an annual basis until 
the research project is completed.
    e. Provide technical guidance as to the development of the 
relational database application and secure Web site.

II. Award Information

    Type of Award: Cooperative Agreement. CDC involvement in this 
program is listed in the Activities Section above.
    Fiscal Year (FY) of Funds: 2004.
    Approximate Total Funding: $700,000 per budget period.
    Approximate Number of Awards: 1.
    Anticipated Award Date: April 1, 2004.
    Budget Period Length: 12 months.
    Project Period Length: Five years. Throughout the project period, 
continuation awards will be based on the availability of funds, and 
evidence of progress as documented in required reports.

III. Eligibility Information

    Eligible Applicants: Applications may be submitted by:
    [sbull] Public nonprofit organizations.
    [sbull] Private nonprofit organizations.
    [sbull] For profit organizations.
    [sbull] Small, minority, women-owned businesses.
    [sbull] Universities.
    [sbull] Colleges.
    [sbull] Technical schools.
    [sbull] Research institutions.
    [sbull] Hospitals.
    [sbull] Community-based organizations.
    [sbull] Faith-based organizations.
    [sbull] Federally-recognized Indian tribal governments.
    [sbull] Indian tribes.
    [sbull] Indian tribal organizations.
    [sbull] State and local governments or their bona fide agents (this 
includes the District of Columbia, the Commonwealth of Puerto Rico, the 
Virgin Islands, the Commonwealth of the Northern Marianna Islands, 
American Samoa, Guam, the Federated States of Micronesia, the Republic 
of the Marshall Islands, and the Republic of Palau).
    If you are applying as a bona fide agent of a state or local 
government, you must provide a letter from the State as documentation 
of your status. Place this letter behind the face page of your 
application form.
    Other Eligibility Requirements:
    To be eligible applicants must:
    1. Propose a Principal Investigator who shall expend at least 20 
percent annual effort on the award in each year of support. This 20 
percent effort may not be in-kind support.
    2. Proposed Principal Investigator cannot be the current Autism and

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Developmental Disabilities Monitoring (ADDM) or Centers for Autism and 
Developmental Disabilities Research and Epidemiology (CADDRE) Principal 
Investigator on an existing funded project. Other individuals from 
their institutions are eligible applicants.
    Applications will be reviewed upon receipt at CDC for the above 
eligibility requirements. Applications that do not meet each 
requirement will be found ineligible and will be returned to the 
applicant without review.
    Cost sharing or matching: Matching funds are not required for this 
program.
    Title 2 of the United States Code Section 1611 states that an 
organization described in section 501(c)(4) of the Internal Revenue 
Code that engages in lobbying activities is not eligible to receive 
Federal funds constituting an award, grant or loan.

IV. Application and Submission Information

    How to Obtain Application Forms: To apply for this funding 
opportunity, use application Form PHS-398 (OMB Number 0925-0001) and 
adhere to the instructions on the Errata Instruction Sheet (For PHS-398 
the errata sheet is posted with the application forms on the CDC Web 
site). 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 
(PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.
    Beginning October 1, 2003, applicants will be required to have a 
Dun and Bradstreet (DUNS) number to apply for a grant or cooperative 
agreement from the Federal government. The DUNS number is a nine-digit 
identification number, which uniquely identifies business entities. 
Obtaining a DUNS number is easy and there is no charge.
    You are encourage to obtain a DUNS number now if you believe you 
will be submitting an application to any Federal agency on or after 
October 1, 2003. Proactively obtaining a DUNS number at the same time 
will facilitate the receipt and acceptance of applications after 
September 2003.
    To obtain a DUNS number, access the following Web site: http://www.dunandbradstreet.com or call 1-866-705-5711.
    Content and Form of Submission:
    Letter of Intent (LOI):
    CDC requests that you send a LOI if you intend to apply for this 
program. Your LOI will be used to gauge the level of interest in this 
program, and to allow CDC to plan the application review. Your LOI must 
be submitted in the following format:
    [sbull] Maximum number of pages--2.
    [sbull] Font size--12-point unreduced.
    [sbull] Paper size--8.5 by 11 inches.
    [sbull] Page margin size--one-inch margins.
    [sbull] Printed only on one side of paper.
    [sbull] Single-spaced.
    Your LOI must contain the following information: Name, address, and 
telephone number of the Principal Investigator; names of other key 
personnel; participating institutions; number and title of this program 
announcement.

Applications

    You must submit a signed original and two copies of your 
application forms. The PHS-398 grant application form requires the 
applicant to enter the project title on page 1 (Form AA, ``face page'') 
and the project description (abstract) on page 2 (Form BB).
    [sbull] Applicants must submit a separate typed abstract of their 
proposal consisting of no more than two single-spaced pages.
    [sbull] Applicants should also include a table of contents for the 
project narrative and related attachments.
    [sbull] The main body of the application narrative should not 
exceed 30 single-spaced pages. The narrative must address activities to 
be conducted over the entire length of the project period. Please note 
that this maximum number of pages allowed exceeds the maximum number of 
pages (25 pages) indicated in the PHS-398 grant application form (Form 
CC, ``Research Grant Table of Contents''). The budget justification and 
biographical sketch sections do not count toward the maximum page 
limit. Pages must be numbered and printed on only one side of the page.
    [sbull] All material must be typewritten, with 10 characters per 
inch type (12 point) on 8\1/2\'' by 11'' white paper with one inch 
margins, no headers and footers (except for applicant-produced forms 
such as organizational charts, graphs and tables, etc.). Applications 
must be held together only by rubber bands or metal clips, and not 
bound together in any other way. Attachments to the application should 
be held to a minimum in keeping to those items required or referenced 
by this announcement.
    [sbull] If you are requesting indirect costs in your budget, you 
must include a copy of your indirect cost rate agreement.
    LOI Deadline Date: October 8, 2003
    LOI Submission Address: Submit your LOI by mail, delivery service, 
or e-mail to: Ms. Joanne Wojcik, Public Health Analyst, Centers for 
Disease Control and Prevention, National Center on Birth Defects and 
Developmental Disabilities, 1600 Clifton Road, Mailstop E-86, Atlanta, 
Georgia 30333, Email address: [email protected], Telephone: 404-498-3848.
    Application Deadline Date: November 14, 2003
    Application Submission Address: Submit your application by mail or 
delivery service to: Technical Information Management-PA 
04014, Procurement and Grants Office, Centers for Disease 
Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146.
    Applications may not be submitted by fax or other electronic means.
    Submission, Date, Time and Address:
    Explanation of Deadlines: Applications must be received in the 
Procurement and Grants Office (PGO) at CDC by 4 p.m. Eastern Time on 
the deadline date. If you send your application by the United States 
Postal Service or commercial delivery services, you must ensure that 
the carrier will be able to guarantee delivery of the application by 
the closing date and time. If CDC receives your application after the 
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, you will be given the 
opportunity to submit documentation of the carrier's problem. If the 
documentation verifies a carrier problem, CDC will consider the 
application as having been received by the deadline.
    If your application does not meet the criteria above, it will not 
be eligible for competition, and will be discarded. You will be 
notified of the failure to meet the submission requirements.
    CDC Acknowledgement of Application Receipt: A postcard will be 
mailed by PGO-TIM, notifying you that CDC has received your 
application.
    Intergovernmental Review of Applications: Your application is 
subject to Intergovernmental Review of Federal Programs, as governed by 
Executive Order (EO) 12372. This order sets up a system for state and 
local governmental review of proposed federal assistance applications. 
You should contact your state single point of contact (SPOC) as early 
as possible to alert the SPOC to prospective applications, and to 
receive instructions on your state's process. Click on the following 
link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html

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V. Application Review Information

    Review Criteria: Applicants are required to provide measures of 
effectiveness that will demonstrate the accomplishment of the various 
identified objectives of the cooperative agreement. Measures must be 
objective and quantitative and must measure the intended outcome. These 
measures of effectiveness must be submitted with the application and 
will be an element of evaluation.
    Each application will be evaluated individually against the 
following criteria relevant to the successful establishment and 
performance of a DCC. It is suggested that applications be organized to 
be compatible with the evaluation criteria, as that is the process by 
which the review committee will assess the quality of the applications.
    1. Organizational experience and capabilities, including, but not 
limited to: Adequacy of site support; governance support; staff 
training plans; including onsite training; adequacy of plans to 
guarantee the quality and integrity of collected data; adequacy of 
plans to maintain accurate and timely information on the progress of 
research and site performance; adequacy of plans to facilitate and 
maintain close communication with CDC and among the other surveillance 
and research sites; evidence of high-quality past performance in 
relevant data coordination activities; flexibility of plans to respond 
to the changing analytic needs of the surveillance and research sites; 
adequacy of plans and procedures for monitoring DCC expenditures; and 
demonstrated willingness and ability to adhere to the terms and 
conditions of the cooperative agreement award.
    2. Staff experience and capabilities, including, but not limited 
to: Adequacy of the proposed resources; including staffing; for 
supporting the surveillance and research sites; demonstration of 
innovative analytic approaches to organizing and evaluating research 
data; and adequacy of the qualifications and research experience of the 
management and analytic team.
    3. Specialized capabilities and experience in large scale network 
coordination, including, but not limited to: Adequacy of experience in, 
and plans for, conducting periodic onsite monitoring of multi-site 
research; adequacy of previous experience with design; administration; 
management; and coordination of multi-site research; surveillance 
sites; and demonstrated willingness and ability to expand resources, 
personnel, and facilities to serve as the DCC for other CDC initiatives 
if deemed appropriate to meet future needs.
    4. Protections: Does the application adequately address the 
requirements of Title 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 risks is 
so inadequate as to make the entire application unacceptable.
    5. Inclusion: Does the application adequately address the CDC 
policy requirements regarding the inclusion of women, ethnic, and 
racial groups in the proposed research? This includes:
    a. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    b. The proposed justification when representation is limited or 
absent.
    c. A statement as to whether the design of the study is adequate to 
measure differences when warranted.
    d. 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.
    6. Budget: The reasonableness of the proposed budget and the 
requested period of support in relation to the proposed research.
    Application Review Process: Applications will be reviewed by CDC 
staff for completeness and responsiveness as outlined in the ``Other 
Eligibility Requirements''. Incomplete applications and applications 
that are non-responsive will be returned to the applicant without 
further consideration.
    Applications, which are complete and responsive, will be subjected 
to a preliminary evaluation (triage) by a Special Emphasis Panel (SEP) 
to determine if the application is of sufficient technical and 
scientific merit to warrant further review by the SEP. Applications 
that are determined to be non-competitive will not be considered, and 
the SEP will promptly notify the investigator/program director and the 
official signing for the applicant organization. A dual review process 
will evaluate applications then determined to be competitive.

VI. Award Administration Information

    Award Notices: If your application is to be funded, you will 
receive a Notice of Grant Award (NGA) from the CDC Procurement and 
Grants Office. The NGA shall be the only binding, authorizing document 
between the recipient and CDC. The NGA will be signed by an authorized 
Grants Management Officer, and mailed to the recipient fiscal officer 
identified in the application.
    Administrative and National Policy Requirements: 45 CFR part 74 or 
92.
    The following additional requirements apply to this project:

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-8 Public Health System Reporting Requirements
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-14 Accounting System Requirements
AR-15 Proof of Non-Profit Status
AR-21 Small, Minority, and Women-Owned Businesses
AR-22 Research Integrity
AR-24 HIPAA Requirements

    Additional information on these requirements can be found on the 
CDC Web site at the following Internet address: http://www.cdc.gov.
    Reporting Requirements:
    You must provide CDC with original, plus two copies of the 
following reports:
    1. Interim Progress Report for a PHS Grant (PHS-2590), no less than 
90 days before the end of the budget period (date to be determined at 
time of award).
    (a) The progress report should represent the accomplishments of the 
project during the reporting period. You do not need to limit the 
progress report to two pages as specified in the instructions (page 2, 
item A).
    (b) The report should describe the work, which has been 
accomplished to date. Please describe accomplishments in terms of the 
specific aims/timetable.
    (c) List each specific aim separately and elaborate on the progress 
that has been made and where you are in terms of the time schedule.
    (d) A detailed budget with justification.
    (e) Include a copy of your most current IRB approval.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    3. Final financial and performance reports, no more than 90 days 
after the end of the project period.

VII. Agency Contacts

    For general questions about this announcement, contact: Technical 
Information Management Section, Procurement and Grants Office, Centers

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for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 
30341-4146, Telephone: 770-488-2700.
    For business management and budget assistance, contact: Rick 
Jaeger, Grants Management Specialist, Procurement and Grants Office, 
Centers for Disease Control and Prevention, 2920 Brandywine Road, 
Atlanta, GA 30341-4146, Telephone: 770-488-2727, E-mail address: 
[email protected].
    For program technical assistance, contact: Joanne Wojcik, Public 
Health Analyst, Centers for Disease Control and Prevention, National 
Center on Birth Defects and Developmental Disabilities, Division of 
Birth Defects and Developmental, Disabilities, 1600 Clifton Road, Mail 
Stop-E86, Atlanta, Georgia 30333, Email address: [email protected], 
Telephone: 404-498-3848.

    Dated: September 2, 2003.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 03-22715 Filed 9-5-03; 8:45 am]
BILLING CODE 4163-18-P