Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Centers for Disease Control and Prevention 

          - [Program Announcement 00094] 

## A. Purpose 

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2000 funds for a cooperative agreement program for developing and improving birth defects surveillance and using surveillance data to develop birth defects prevention programs and activities to improve the access of children born with birth defects to health services and early intervention programs. CDC is committed to achieving the health promotion and disease prevention objectives of “Healthy People 2010”, a national activity to reduce morbidity and mortality and improve the quality of life. This announcement is related to the focus areas of Substance Abuse, Environmental Health, and Maternal, Infant, and Child Health. For the conference copy of “Healthy People 2010”, visit the internet site: http://www.health.gov/​healthypeople. 

The purpose of the program is to support (1) the development, implementation, expansion, and evaluation of State based birth defects surveillance systems; (2) the development and implementation of State based programs to prevent birth defects; and (3) the development and implementation of activities to improve the access of children with birth defects to health services and early intervention programs. 

## B. Eligible Applicants 

Applicants will be limited to those not currently involved in CDC Program Announcement 051 (Cooperative Agreements for Enhanced State-Based Birth Defects Surveillance and Use of Surveillance Data to Guide Prevention and Intervention Programs) and Program Announcement 643 (Centers of Excellence to Provide Surveillance, Research, Services, and Evaluation Aimed at Prevention of Birth Defects). See Attachment 1 for a list of the States funded under these program announcements. 

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. The eligible States are: Alabama, Alaska, Arizona, Connecticut, Delaware, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Maryland, Minnesota, Mississippi, Nebraska, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Vermont, Virginia, Washington, West Virginia, 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 newly implemented or ongoing surveillance systems. 

In the cover letter to the application, please state the category (1 or 2) for which you are applying. 

# Note:

Public Law 104-65 states that an organization described in section 501(c)(4) of the Internal Revenue Code of 1986 which engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, cooperative agreement, contract, loan, or any other form.

## C. Availability of Funds 

Approximately $800,000 is available in FY 2000 to fund approximately 3-6 awards in Category 1 and 3-6 awards in Category 2. It is expected that the average award will be $100,000, ranging from $50,000 to $150,000. The awards will begin on or about September 30, 2000, and will be made for a 12-month budget period within a project period of up to 3 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                           ( print page 32108)                        to supplant State funds available for birth defects surveillance, prevention, health care services, patient care, construction, nor lease/purchase of facilities or space.                 

## D. Program Requirements 

In conducting activities to achieve the purpose of this program, Category 1 recipients will be responsible for the activities under 1. Recipient activities for States with no birth defects surveillance systems; Category 2 recipients will be responsible for the activities under 2. Recipient activities for States with newly implemented or ongoing surveillance systems; and CDC will be responsible for the activities under 3. CDC activities. 

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

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

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

c. Disseminate data and collaborate with appropriate organizations within the State and with other States. 

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

                    e. Develop a plan and begin implementation of a birth defects prevention program (                    *e.g.*                     Neural Tube Defects (NTD) occurrence prevention), and/or develop a plan and begin implementation of activities to improve the access of children with birth defects to comprehensive, community-based, family-centered care.                 

f. Develop a plan to evaluate the intervention or prevention activities. 

2. Category 2—Recipient Activities for States with newly implemented or ongoing surveillance systems: 

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

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

c. Disseminate data and collaborate with appropriate organizations within the State and with other States. 

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

                    e. Develop a plan and begin implementation of a birth defects prevention program (                    *e.g.*, Neural Tube Defects [NTD] occurrence prevention), and/or develop a plan and begin implementation of activities to improve the access of children with birth defects to comprehensive, community-based, family-centered care.                 

f. Develop a plan to evaluate the intervention or prevention activities. 

3. CDC Activities.

a. Assist, if requested, in designing, developing, and evaluating methodologies and approaches used for State based birth defects surveillance. 

b. Assist, if requested, in analyzing surveillance data related to birth defects. 

c. Assist, if requested, in designing plans for prevention programs and plans to improve the access of children with birth defects to health services and intervention programs. 

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

## E. Application Content 

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. 

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 20 double-spaced pages printed on one side, with one inch margins, and unreduced font (12 pitch). The required detailed budget and detailed budget justification are not considered to be part of the Program Narrative. The narrative must contain the following sections: 

a. Understanding the Problem and Current Status; 

b. Impact on State based Birth Defects Surveillance;

c. Use of Surveillance Data for Prevention and Intervention;

d. Organizational and Program Personnel Capability;

e. 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. 

## F. Submission and Deadline 

Submit the original and two copies of PHS 5161-1 (OMB Number 0937-0189). On or before July 20, 2000, submit the application to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement. Forms are available at the following Internet address: www.cdc.gov/​od/​pgo/​forminfo.htm or in the application kit. 

Deadline: Applications shall be considered as meeting the deadline if they are either:

(a) Received on or before the deadline date; or 

(b) Sent on or before the deadline date and received in time for submission to the independent review group. (Applicants must request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing.)

Late Applications: Applications which do not meet the criteria in (a) or (b) above are considered late applications, will not be considered, and will be returned to the applicant.

## G. Evaluation Criteria

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

1. Applicant's understanding of the problem (10 percent):

                    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 purpose and complexities of birth defects surveillance as it relates to their State.                          ( print page 32109)    

2. Impact on State based birth defects surveillance (35 percent):

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 State 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; and 

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

b. Evaluation criteria for category 2 (States with newly implemented or ongoing birth defects surveillance systems):

(1) Plans for improving/expanding State 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.

Also included in this criteria is 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:

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.

3. Use of the surveillance data for prevention and intervention (35 percent):

The extent to which the applicant describes the plans for using surveillance data to develop and implement programs to prevent birth defects and/or activities to improve the access of children with birth defects to health services and early interventions. 

a. Develop a plan for working with appropriate partners in the State to develop prevention or intervention programs. 

b. Describe methods or a plan for sharing surveillance data with programs or agencies that will use the data for prevention or intervention.

4. Organizational and program personnel capability (20 percent):

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 or intervention programs. The adequacy of the present staff and capability to assemble competent staff to implement a birth defects surveillance system and develop programs for prevention or intervention. 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. Human Subjects Review (not scored):

Does the application adequately address the requirements of Title 45 CFR Part 46 for the protection of human subjects?

6. 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.

## H. Other Requirements

### Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. Semiannual progress reports;

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.

The following additional requirements are applicable to this program. For a complete description of each, see Attachment 2 in the application kit.

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

## I. 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. 241(a), 243, and 247 (b-4)], as amended. The Catalog of Federal Domestic Assistance number is 93.283.

## J. Where To Obtain Additional Information

For this and other CDC funding opportunities, refer to the CDC home page on the Internet: http://www.cdc.gov. To receive additional written information and to request an application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked to leave your name and address and will be instructed to identify the Announcement number of interest.

If you have questions after reviewing the contents of all the documents, business management technical assistance may be obtained from: William A. Paradies, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: (770) 488-2721, E-mail address: WParadies@cdc.gov

Programmatic technical assistance may be obtained from: Larry D. Edmonds, State Services, Birth Defects and Pediatric Genetics Branch, Division of Birth Defects, Child Development, Disability and Health, National Center for Environmental Health, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway NE., Mailstop F-45, Atlanta, GA 30341-3724, Telephone: (770) 488-7170, E-mail address: LEdmonds@cdc.gov

Dated: May 16, 2000.

John L. Williams,

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

[FR Doc. 00-12740 Filed 5-19-00; 8:45 am]

BILLING CODE 4163-18-P