03-5584. Population-Based Birth Defects Surveillance Programs and the Utilization of Surveillance Data by Public Health Programs; Notice of Availability of Funds

Application Deadline: April 30, 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 developing, implementing, and improving state's birth defects surveillance data and utilizing the surveillance data by other public health programs. This program addresses the “Healthy People 2010” focus area of Maternal, Infant, and Child Health.

The purpose of the program is to support: (1) The development, implementation, expansion, and evaluation of state's population-based birth defects surveillance systems; (2) the development and implementation of population-based programs to prevent birth defects; (3) the development and implementation or expansion of activities to improve the access of children with birth defects to health services and early intervention programs; and (4) the evaluation of the effectiveness of the referral activities and the impact on the affected children and families.

Measurable outcomes of the program will be in alignment with one or more of the following performance goals for the National Center on Birth Defects and Developmental Disabilities:

• Improve the data on the prevalence of birth defects and developmental disabilities.
• Find causes and risk factors for birth defects and developmental disabilities in order to develop prevention strategies.

C. Eligible Applicants

Assistance will be provided only to the 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.

Recipients funded under CDC Program Announcement 02011 (Cooperative Agreements for the Development and Improvement of Population-Based Birth Defect Surveillance Programs and the Integration of Surveillance Data with Public Health Programs) and Program Announcement 02081 (Centers for Birth Defects Research and Prevention) are not eligible. See Attachment I, as posted on the CDC website, for a list of the States currently funded under these program announcements. Additionally, 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. This information should be placed directly behind the cover letter of the application. Applications that fail to submit the evidence requested above will be considered non-responsive and returned without review.

The eligible States are: Arizona, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Kansas, Louisiana, Maryland, Mississippi, Nebraska, Nevada, New Jersey, New York, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Vermont, Washington, Wisconsin, and Wyoming.

Applicants may apply under one of two categories:

Category 1—States/territories/tribes with no birth defects surveillance systems; or

Category 2—States/territories/tribes with ongoing surveillance systems.

Note:

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.

D. Availability of Funds

Approximately $1,900,000 is available in FY 2003 to fund approximately 2-4 awards in Category 1, and 6-10 awards in Category 2. It is expected that the awards will range from $50,000 to $250,000. The average award will be $100,000 for Category 1 States and $200,000 for Category 2 States. The awards will begin on or about September 1, 2003, 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.

Use of Funds: These awards may be used for personnel services, equipment, travel, and other costs related to project activities. Project funds may not be used to supplant State funds available for birth defects surveillance or prevention, health care services, patient care, nor construction.

Award recipients agree to use cooperative agreement funds for travel by project staff selected by CDC to participate in CDC-sponsored workshops, or other called meetings such as regional or annual meetings.

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 for States with no birth defects surveillance systems; or 2. Recipient activities for States with ongoing surveillance systems; and CDC will be responsible for the activities under 3. CDC activities.

1. Recipient Activities for States with no birth defects surveillance systems:

a. Develop and begin implementation of a population-based surveillance system to ascertain cases and generate timely population-based data of major birth defects occurring in the State.

b. Analyze and disseminate the surveillance data generated by the system in a timely fashion including rates and trends of major birth defects.

c. Develop and implement a plan to evaluate the surveillance methodology used.

d. Involve the appropriate partners within the State, including the State's organization receiving title V Federal funds, to develop a plan and begin implementation of a birth defects prevention program (i.e., Neural Tube Defects (NTD) occurrence prevention). Share results with appropriate organizations within the State and with other States.

e. Develop a plan to evaluate your prevention activities.

f. Involve the appropriate partners within the State to develop a plan and begin implementation of activities to improve the access of children with birth defects to comprehensive, community-based, family-centered care (e.g., establish linkages with other programs like Children with Special Health Care Needs).

g. Develop a plan to evaluate the identification of and/or timeliness of referral to services among eligible children or families.

2. Recipient Activities for States with ongoing surveillance systems:

a. Broaden methodologies and approaches which will improve and expand the capacity of the existing population-based surveillance system to ascertain cases and generate timely population-based data of major birth defects occurring in the State.

b. Analyze and disseminate the surveillance data generated by the system in a timely fashion including rates and trends of major birth defects (e.g., publish a report on the surveillance data).

c. Evaluate the surveillance methodology used.

d. Involve the appropriate additional partners within the State, including the State's organization receiving title V Federal funds, to expand birth defects prevention programs (i.e., Neural Tube Defects (NTD) occurrence prevention). Share results with appropriate organizations within the State and with other States.

e. Evaluate the prevention progress.

f. Involve the appropriate partners within the State to expand activities to improve the access of children with birth defects to comprehensive, community-based, family-centered care (e.g., establish linkages with other programs like Children with Special Health Care Needs).

g. Evaluate the progress on improving access to services (e.g., identification of children and families eligible for services; evaluate the timeliness of referral to services).

h. Evaluate the effectiveness of the referral activities and the benefit/impact on the affected children and families.

3. CDC Activities:

a. Provide technical assistance such as presenting the need, benefits, and description of a birth defects surveillance, prevention, and intervention program, reviewing draft legislation, etc. to state agencies and interested parties.

b. Assist in designing, developing, and evaluating methodologies and approaches used for population-based birth defects surveillance. Discuss the advantages and disadvantages of different case ascertainment methods.

c. Assist in analyzing surveillance data related to birth defects.

d. Assist in designing, developing, and evaluating plans for prevention programs.

e. Assist in designing, developing, and evaluating plans to improve the access of children with birth defects to health services and intervention programs.

f. Provide a reference point for sharing regional and national data and information pertinent to the surveillance and prevention of birth defects.

F. Content

Letter of Intent (LOI): A LOI is requested for this program. The Program Announcement title and number must appear in the LOI. The narrative should be no more than two, double-spaced pages, printed on one side, with one-inch margins and 12-point font. The LOI will not be used to eliminate potential applicants, but it will enable CDC to determine the level of interest and plan the review more efficiently. The LOI should include the following information: This program announcement number; applicant's name and address; project director's name, phone number, and email; identification of the category for which the applicant is applying (Category 1 or Category 2); a brief description of the number of state-wide births and current birth defect surveillance system; and a brief description of the planned statement of work.

Applications: The Program Announcement title and number must appear in the application. Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed, so it is important to follow them in describing the program plan.

The applicant should provide a detailed description of first-year activities and briefly describe future-year objectives and activities. The application must contain the following:

1. Cover Letter: A one page cover letter should indicate whether the applicant is applying for Category 1 or Category 2. Additionally, 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. This information should be placed directly behind the cover letter of the application.

2. A one-page, single-spaced, typed abstract in 12-point font must be submitted with the application. The heading should include the title of the grant program, project title, organization, name and address, project director and telephone number. The abstract should clearly state which option the applicant is applying for: Category 1 or Category 2. The abstract should briefly summarize the program for which funds are requested, the activities to be undertaken, and the applicant's organization structure. The abstract should precede the program narrative. A table of contents that provides page numbers for each of the following sections should be included. All pages must be numbered.

3. Narrative: The narrative should be no more than 25 double-spaced pages, printed on one side, with one-inch margins, and unreduced font (12-point). The required detailed budget and detailed budget justification are not considered to be part of the program narrative. The narrative should specifically address item 1. or 2. in the “Program Requirements” and should contain the following sections:

a. Use of Surveillance Data for Prevention Activities.

b. Use of Surveillance Data for Improving Access to Health Services and Early Intervention Programs.

c. Impact on Population-Based Birth Defects Surveillance.

d. Organizational and Program Personnel Capability.

e. Understanding of the Public Health Impact of Birth Defects.

f. Human Subjects Review.

4. Budget and Budget Justification—Provide a detailed budget which indicates the anticipated costs for personnel, fringe benefits, travel, supplies, contractual, consultants, equipment, indirect, and other items. Please provide a copy of the appropriate indirect rate agreement letter or cost allocation plan.

G. Submission and Deadline

Letter of Intent (LOI) Submission: On or before March 7, 2003, submit the LOI to Larry Edmonds, 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 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 [phone]. Application forms can be mailed to you.

Submission Date, Time, and Address: The application must be received by 4 p.m. eastern time on April 30, 2003. Submit the application to: Technical Information Management—PA #03019, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Rd., Room 3000, Atlanta, GA 30341-4146.

Applications may not be submitted electronically.

CDC Acknowledgment 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. 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 the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals as stated in section “B. Purpose” of this announcement. 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.

An independent review group appointed by CDC will evaluate each application against the applicant's response to either item 1. or 2. in the “Program Requirements” section.

1. Use of the surveillance data for prevention activities (30 points):

The extent to which the applicant describes the plans for using surveillance data to develop and implement or expand existing programs to prevent birth defects. The current and proposed activities evaluated in this element are specific for Category 1 and Category 2.

a. Evaluation criteria for Category 1 (States with no birth defects surveillance systems):

(1) Ability to work with appropriate partners in the State (e.g., provide letters of support, Memorandums of Agreement/Understanding).

(2) Plan for using the surveillance data to develop prevention programs.

(3) Plan for sharing surveillance data (e.g., personal identifiers and contact information) with programs or agencies so that children or families can be enrolled in prevention programs.

(4) Letter from the State's organization receiving title V Federal funds that describe the data linkages and other collaborative activities with the applicant.

b. Evaluation criteria for Category 2 (States with ongoing birth defects surveillance systems):

(1) Ability to work with appropriate partners in the State (e.g., provide letters of support, Memorandums of Agreement/Understanding).

(2) Use of surveillance data to expand prevention programs.

(3) Sharing the surveillance data (e.g., personal identifiers and contact information) with programs or agencies so that children or families are enrolled in prevention programs.

(4) Evaluation of progress made in the prevention of birth defects.

(5) Letter from the State's organization receiving title V Federal funds that describe the data linkages and other collaborative activities with the applicant.

2. Use of surveillance data for improving access to health services and early intervention programs (30 points):

The extent to which the applicant describes the plans to develop and implement or expand existing activities to improve the access of children with birth defects to health services and early interventions. The current and proposed activities evaluated in this element are specific for Category 1 and Category 2.

a. Evaluation criteria for Category 1 (States with no birth defects surveillance systems):

(1) Identification of appropriate programs within the State for referral to health services (e.g., provide letters of support, Memorandums of Agreement/Understanding).

(2) Plan for linking programs or developing other approaches to increase identification of children or families eligible for health services.

(3) Plan to evaluate the implementation process.

b. Evaluation criteria for Category 2 (States with ongoing birth defects surveillance systems):

(1) Ability to integrate programs within the State (e.g., provide letters of support, Memorandums of Agreement/Understanding, documentation of numbers of eligible children or families referred for and percent receiving services).

(2) Improve and expand approaches to increase identification of children or families eligible for health services.

(3) Plan for evaluating the effectiveness of the referral services and the outcomes of children and families who receive services.

3. Impact on population-based birth defects surveillance (20 points):

The extent to which the applicant describes the anticipated level of impact this cooperative agreement will have on birth defects surveillance activities in the State. The current and proposed activities evaluated in this element are specific for Category 1 and Category 2.

a. Evaluation criteria for Category 1 (States with no birth defects surveillance systems):

(1) Plans for developing population-based birth defects surveillance.

(2) Methods of case ascertainment.

(3) Timeliness of case ascertainment.

(4) Level of coverage of the population.

(5) Specific birth defects ascertained.

(6) Plans for analyzing and reporting surveillance data to appropriate State, local, and Federal health officials.

(7) Plans for evaluating the surveillance methodology and the quality of the surveillance data.

(8) The degree to which the applicant has met 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.

b. Evaluation criteria for Category 2 (States with ongoing birth defects surveillance systems):

(1) Ability to improve/expand population-based birth defects surveillance.

(2) Methods of case ascertainment.

(3) Timeliness of case ascertainment.

(4) Level of coverage of the population.

(5) Specific birth defects ascertained.

(6) Analyzing and reporting surveillance data to appropriate State, local, and Federal health officials.

(7) Evaluating the surveillance methodology and quality of the surveillance data.

(8) The degree to which the applicant has met 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.

4. Organizational and program personnel capability (15 points):

a. The extent to which the applicant has the experience, skills, and ability to develop and improve birth defects surveillance and use surveillance data to develop prevention programs and improve access to health services or early intervention programs.

b. The adequacy of the present staff and/or the capability to assemble competent staff to either implement or improve upon a birth defects surveillance system and develop programs for prevention or improving access to health services and early intervention programs. If it is necessary to hire staff to conduct program activities, provide plans for identifying and hiring qualified applicants on a timely basis. Also, provide plans for how work on program activities will be conducted prior to hiring necessary staff.

c. To the extent possible, the applicant shall identify all current and potential personnel who will work on this cooperative agreement including qualifications and specific experience as it relates to the requirements set forth in this announcement.

5. Applicant's understanding of the public health impact of birth defects (5 points):

The extent to which the applicant has a clear, concise understanding of the requirements, objectives, and purpose of the cooperative agreement. The extent to which the application reflects an understanding of the public health impact of birth defects in their State and the purpose and complexities of birth defects surveillance as it relates to their State.

6. Human Subjects Review (not scored):

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 are so inadequate as to make the entire application unacceptable.)

7. Budget justification and adequacy of facilities (not scored):

The budget will be evaluated for the extent to which it is reasonable, clearly justified, and consistent with the intended use of the cooperative agreement funds. The applicant shall describe and indicate the availability of facilities and equipment necessary to carry out this project.

I. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. Interim progress report, no less than 90 days before the end of the budget period. The interim progress report will serve as your non-competing continuation application and must include the following elements:

a. Current Budget Period Activities Objectives.

b. Current Budget Period Financial Progress.

c. New Budget Period Proposed Activity Objectives.

d. Detailed Line-Item Budget and Justification.

e. Additional Requested Information.

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.

Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

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 website.

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

J. Where To Obtain Additional Information

This and other CDC announcements, the necessary applications, and associated forms can be found on the CDC website, 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., Room 3000, Atlanta, GA 30341-4146. Telephone: [phone].

For business management and budget assistance, contact: Sheryl L. Heard, Grants Management Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, Announcement 03019, 2920 Brandywine Road, Atlanta, GA 30341-4146. Telephone: [phone]. E-mail address: [e-mail].

For business management and budget assistance in the territories, contact: Charlotte Flitcraft, Grants Management Officer, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146. Telephone: [phone]. E-mail address: [e-mail].

For program technical assistance, contact: Larry D. Edmonds, Project Officer, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, 4770 Buford Highway, NE., Atlanta, GA 30341-3724. Telephone: [phone]. E-mail address: [e-mail].

Dated: March 3, 2003.

Sandra R. Manning,

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