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Notice

Cooperative Agreement for Early Hearing Detection and Intervention (EHDI) Tracking, Surveillance, and Integration; Notice of Availability of Funds

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Information about this document as published in the Federal Register.

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Application Deadline: June 9, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under sections 301(a) and 317(C) of the Public Health Service Act, (42 U.S.C. sections 241(a) 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 Early Hearing Detection and Intervention (EHDI). This program addresses the “Healthy People 2010” focus area of Vision and Hearing.

The purpose of the program is to (1) develop or enhance a sustainable, centralized EHDI tracking and surveillance system, and (2) integrate the EHDI system with other newborn screening programs. EHDI is a national initiative to improve the communicative, cognitive, and social outcomes of children with hearing loss through a program of services and research.

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 Disabilities: Prevent birth defects and developmental disabilities and improve the health and quality of life of Americans with disabilities. Start Printed Page 20007

C. Eligible Applicants

Applications may be submitted by State and local governments or their bona fide agents, including 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, the Republic of Palau and Federally recognized Indian Tribal Governments. Only one application from each State or Territory may be submitted.

To be eligible, applicants must document that they:

1. Do not have an established State centralized EHDI surveillance and tracking program;

2. Are in the beginning stages of establishing a centralized EHDI surveillance and tracking program; or

3. Already have a program but would like to refine their existing surveillance and tracking program to integrate it with other newborn screening and tracking programs.

The applicant must include this documentation in the cover letter of the application. If it is not included, then the application will be determined as “non-responsive” and returned without review.

Note:

Title 2 of the United States Code section 1611 states that an organization described in section 501c(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. Funding

Availability of Funds

Approximately $300,000 is available in FY 2003, to fund two awards. It is expected that the average award will be $150,000, ranging from $110,000 to $150,000. It is expected that 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 two 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

Project funds may not be used to supplant other available applicant or collaborating agency funds or to supplant State funds available for screening, diagnosis, intervention or tracking for hearing loss or other disorders detected by newborn screening. Project funds may not be used for construction, for lease or purchase of facilities or space, or for patient care.

Recipient Financial Participation

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 listed in 1. Recipient Activities, and CDC will be responsible for the activities listed in 2. CDC Activities.

1. Recipient Activities

a. Establish and implement a State surveillance and data tracking system to assure minimal loss to follow-up by monitoring the status and progress of infants through the three components of the EHDI program (screening, detection, and intervention).

b. Establish methods for populating the EHDI data base (e.g., linking with the electronic birth certificate) to develop strategies for collecting standardized EHDI data (including the type of hearing loss and type of intervention services) from multiple sources, (e.g. birthing hospitals, diagnostic centers, audiologists, physicians, intervention programs.) Develop and enumerate reporting systems that will ensure that tracking and surveillance data collected from multiple sources will be used so that there is minimal loss to follow-up.

c. Develop mechanisms to identify and collect standardized data on infants/children with late onset or progressive hearing loss.

d. Outline an analytic plan to use EHDI data in order to obtain outcome data such as: Number/percent of infants screened, referred, evaluated, and enrolled in intervention programs; unexpected clusters of infants with hearing loss in particular regions at particular times; unexpected differences in EHDI screening performance between participating birthing hospitals; false positive rates; loss to follow-up rates.

e. Document concerns from parents and professionals about the EHDI process.

f. Establish or use existing EHDI advisory committee with appropriate representation of parents and professionals to provide guidance and assistance in the development of the EHDI program.

g. Design the program so that it can be integrated with other screening and tracking programs that identify children with special health care needs such as newborn blood spot screening, birth defects registries, fetal alcohol syndrome surveillance, and Part C of the Individuals with Disabilities Education Act (IDEA) (http://www.nectac.org).

h. Collaborate with State programs such as Maternal and Child Health (MCH) (http://www.mchb.hrsa.gov), part C of IDEA, private service programs, and advocacy groups to build a coordinated EHDI infrastructure.

i. Develop an evaluation plan to monitor progress on activities and to assess the timeliness, completeness, and success of the project.

j. Prepare and publish manuscript(s) that describe(s) the tracking system, definitions, methodology, collaborative relationships, data collection, findings, and recommendations across sites. Collaboration with other participating sites is encouraged.

k. Share information and collaborate with other recipients, and with CDC and other Federal and national agencies.

2. CDC Activities

a. Provide technical assistance such as presenting the need, benefits, and description of a comprehensive, state-based EHDI tracking and surveillance program, reviewing draft legislation, etc. to state agencies and interested parties.

b. Assist in designing, developing, and evaluating methodologies and approaches used in state-based data collection and analysis of data across sites.

c. Facilitate collaborative efforts to compile and disseminate program results through presentations and publications.

d. Assist in analyzing surveillance data related to EHDI.

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

f. Provide a reference point for sharing state-based data and information pertinent to the surveillance and tracking of hearing loss.

F. Content

Letter of Intent (LOI)

A LOI is requested for this program. The LOI should identify the program announcement number, program title and the proposed project director. The LOI should be no more than 2 pages, single-spaced, printed on one side, with one-inch margins, and unreduced 12-point font. The LOI will be used to determine the level of interest in the announcement, and assist CDC in planning for the application review process. Start Printed Page 20008

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 laying out your program plan. Applications should include the following items, in the following order:

Cover Letter: A one-page cover letter stating that the applicant is applying and how the applicant fulfills eligibility requirements.

Table of Contents: A table of contents that provides page numbers for each of the following sections (all pages must be numbered).

Abstract: A one-page, single-spaced, typed abstract 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 briefly summarize the project for which funds are requested, the activities to be undertaken, and the applicant's organization structure. The abstract should precede the program narrative.

Budget and Budget Justification: The budget should be reasonable, clearly justified, and consistent with the intended use of the agreement funds. The applicant must include a detailed first-year budget justification with future annual projections. Budgets should include costs for travel for two project staff to attend annual meetings. The applicant should provide a budget justification for each budget item. Proposed sub-contracts should identify the name of the contractor, if known; describe the services to be performed; provide an itemized budget and justification for the estimated costs of the contract; specify the period of performance; and describe the method of selection.

Narrative: The narrative should be no more than 30, double-spaced pages. The narrative is to be printed on one side, with one-inch margins, and unreduced 12-point font. The narrative must contain the following sections:

a. Understanding the Problem and Current Status

b. Goals and Objectives

c. Description of Program and Methodology (Include a timeline for the entire two-year project period.)

d. Collaborative Efforts

e. Evaluation Plan

f. Staffing and Management System (A one-page CV or resume for each key personnel must be included in an attachment). Plan must also provide details of the role of each key personnel.

g. Organizational Structure and Facilities (Must include an organizational chart)

h. Human Subjects Review

G. Submission and Deadline

Letter of Intent (LOI) Submission

On or before May 13, 2003, submit the LOI to the Public Health Analyst identified in the “Where to Obtain Additional Information” section of this announcement.

Application Forms

Submit the signed original and two copies of PHS 5161-1 (OMB Number 0937-0189). Forms can be found at the following Internet address: 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.

Submission Date, Time, and Address

The application must be received by 4 p.m. eastern time June 9, 2003. Submit the application to: Technical Information Management—PA#03055, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146.

Applications may not be submitted electronically.

CDC Acknowledgement 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 shall be considered as meeting the deadline if they are received before 4 p.m. eastern time on the deadline date. Any applicant who sends their application 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.

Any application that does not meet the above criteria will not be eligible for competition, and will be discarded. The applicant will be notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Application

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 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 following criteria:

1. Description of Program and Methodology (35 percent).

a. Extent to which applicant describes the methods they will use to address all recipient activities, such as: (1) Establishing and implementing an EHDI tracking and surveillance system; (2) describing methods of populating the data base; (3) standardizing data from multiple sources; (4) developing strategies for reporting system; (5) documenting methods for collecting data on infants/children with late onset or progressive hearing loss; (6) designing analytic plan; (7) documenting concerns; (8) describing advisory committee; (9) describing plans for integrating data sets; (10) collaborating with other state programs; (11) developing an evaluation plan; (12) preparing manuscripts; and (13) collaborating and sharing information.

b. Extent to which applicant provides a time line which includes activities to be accomplished, and personnel responsible to complete the project. The timeline should address activities to be conducted over the entire two-year project period.

2. Understanding the Problem and Current Status (20 percent).

a. Extent to which the applicant has a clear, concise understanding of the requirements and purpose of the cooperative agreement.

b. Extent to which the applicant understands the challenges, barriers, and problems associated with developing and implementing an EHDI tracking and surveillance program.

c. Extent to which the applicant describes the need for funds to develop/enhance an EHDI tracking and surveillance program in their State. Start Printed Page 20009

d. Extent to which the applicant describes the target population and the current status of their existing EHDI program, e.g., number of birthing hospitals with and without universal hearing screening program; number of infants born, number of infants screened, identified and referred to intervention; protocol for screening and referral, including informed consent information.

e. Extent to which applicant describes (1) their current EHDI tracking and surveillance system (if any exists); (2) other relevant tracking, surveillance systems, or registries in the State; and (3) linkages with other relevant systems.

f. Extent to which applicant describes diagnostic facilities and intervention services available in the State for infants/children with hearing loss.

g. Extent to which applicant shows willingness and interest to integrate EHDI surveillance and tracking system with other newborn screening program activities.

3. Goals and Objectives (10 percent).

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 the applicant has met the CDC policy requirements regarding the inclusion of women, ethnic and racial groups in the proposed research. This includes the proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation and justification when representation is limited or absent.

4. Collaborative Efforts (10 percent).

a. Extent to which applicant describes their methods for collaboration with multiple data sources (include written assurances) such as hospitals, diagnostic centers, and intervention service providers.

b. Extent to which collaborative relationships are documented which will facilitate linkage with other screening programs. (Letters of agreement and cooperation from collaborating programs should be included.)

c. Extent to which collaborative efforts with other relevant programs are documented (such as MCH, IDEA part C, etc.)

d. Extent to which applicant states their willingness to work collaboratively with other funded States and to modify their projects if necessary in order to allow anonymized pooled data sets of standardized data.

5. Evaluation Plan (10 percent).

Extent to which applicant describes an evaluation plan that will monitor progress toward their goals, and assess timeliness, completeness, and success of the objectives and activities of the project.

6. Staffing and Management System (10 percent).

a. Extent to which key personnel have skills and experience to develop and implement an EHDI tracking and surveillance system.

b. Extent of the managerial ability to coordinate the tracking, surveillance, and research, and integration components of the project.

c. Extent to which expertise in abstracting screening, identification, and intervention records are demonstrated.

d. Extent to which expertise in epidemiologic methods, public health surveillance, data management and computer programming is demonstrated.

e. Extent to which there is sufficient dedicated staff time to develop and implement an EHDI tracking and surveillance system and to integrate the EHDI system with other newborn screening systems (include percentage of time each staff member will contribute to the project).

7. Organizational Structure and Facilities (5 percent).

Extent to which the organization structure and facilities/space/equipment are adequate to carry out the activities of the program.

8. 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 is so inadequate as to make the entire application unacceptable.

9. Budget (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.

I. Other Requirements

Technical Reporting Requirements

Provide CDC with the original plus two copies of:

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

a. Current Budget Period Activities Objectives.

b. Current Budget Period Financial Progress.

c. New Budget Period Program 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.

Additional Requirements

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I of the program announcement, as posted on the CDC Web site.

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

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 Web site, 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 Road, Atlanta, GA 30341-4146. Telephone: 770-488-2700.

For business management and budget assistance, contact: Sheryl Heard, Grants Management Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146. Telephone: 770-488-2723. E-mail address: SHeard@cdc.gov.

For program technical assistance, contact: Lee Ann B. Ramsey, BBA, GCPH, Public Health Analyst, Centers for Disease Control and Prevention, National Center on Birth Defects and Developmental Disabilities, 1600 Clifton Road, NE, Mailstop F-35, Atlanta, GA 30333. Telephone: 404-498-3034. E-mail Address: LRamsey@cdc.gov.

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Dated: April 17, 2003.

Sandra R. Manning,

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

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[FR Doc. 03-9977 Filed 4-22-03; 8:45 am]

BILLING CODE 4163-18-P