03-22715. 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 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:

• Public nonprofit organizations.
• Private nonprofit organizations.
• For profit organizations.
• Small, minority, women-owned businesses.
• Universities.
• Colleges.
• Technical schools.
• Research institutions.
• Hospitals.
• Community-based organizations.
• Faith-based organizations.
• Federally-recognized Indian tribal governments.
• Indian tribes.
• Indian tribal organizations.
• 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 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:

• Maximum number of pages—2.
• Font size—12-point unreduced.
• Paper size—8.5 by 11 inches.
• Page margin size—one-inch margins.
• Printed only on one side of paper.
• 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).

• Applicants must submit a separate typed abstract of their proposal consisting of no more than two single-spaced pages.
• Applicants should also include a table of contents for the project narrative and related attachments.
• 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.
• All material must be typewritten, with 10 characters per inch type (12 point) on 81/2″ 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.
• 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: [e-mail], Telephone: [phone].

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

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 for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: [phone].

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: [phone], E-mail address: [e-mail].

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: [e-mail], Telephone: [phone].

Dated: September 2, 2003.

Sandra R. Manning,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention.