Demonstration Project To Reduce the Incidence and Severity of Infection in Patients With End Stage Renal Disease (ESRD) in Hawaii; Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2002 funds for a grant program to reduce the incidence and severity of infection in patients with End Stage Renal Disease (ESRD) in Hawaii. This program addresses the “Healthy People 2010” focus area(s) Immunization and Infectious Diseases.

The purpose of the program is to establish a plan to conduct a home-based and community-based demonstration project to reduce the incidence and severity of infections in patients with ESRD in Hawaii and to monitor the impact that this project has in the defined patient population.

Measurable outcomes of the program will be in alignment with the following performance goal for the National Center for Infectious Diseases: To apply scientific findings to prevent and control infectious diseases.

B. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under section 301(a) and 317(k)(2) of the Public Health Service Act, (42 U.S.C. sections 241(a) and 247b(k)(2)), as amended. The Catalog of Federal Domestic Assistance number is 93.283.

C. Eligible Applicants

Assistance will be provided only to public and private nonprofit organizations located in the State of Hawaii having at least five dialysis centers on at least three of the Hawaiian Islands, and which treat at least 800 patients.

Based on data from CDC's Dialysis Surveillance Network, the estimated rate of serious infection with bacteremia is 2.3 per 100 patient-months. To detect a 25% decrease in this rate (with 80% power), the study would need 9,706 patient-months of followup. If the study lasts 12 months, then approximately 800 patients need to be studied each month. In order to recruit a sufficient number of high-risk patients and complete the project in a timely fashion, it will be necessary to have a large population base of ESRD patients.

The effect of the intervention is likely to vary among dialysis centers; therefore to determine the effectiveness of the intervention it is necessary that the applicant have at least five facilities. To ensure the capture of a representative patient sample, dialysis units on at least three of the Islands should be included. These requirements are necessary for the success of this project.

The House of Representatives Conference Report accompanying the Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriation Bill ending September 30, 2002, and For Other Purposes (H.R. 3061, 107th Congress), recognized that many Native Hawaiians in rural Hawaii afflicted with ESRD and on dialysis have a history of repeated infections that put them at greater risk for frequent hospitalization. The Committee encouraged CDC to consider a demonstration project in Hawaii to reduce the incidence of infection in this patient population.

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 $300,000 is available in FY 2002 to fund approximately one award. It is expected that the award will begin on or about September 15, 2002, and will be made for a 12-month budget period within a project period of up to five years. Funding estimates may change. Matching funds are not required for this program.

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.

E. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the following activities:

1. Collect baseline data on infection incidence using a standardized protocol in a large group of ESRD patients.

2. Assess risk factors for infection in this group. Potential risk factors include patient factors, infection control practices at the dialysis centers, and home practices.

3. Through risk factor analyses, identify a group of patients at high risk for infection.

4. Design and develop a home-based and community-based intervention program to make home visits, provide education, and implement infection prevention measures. A multidisciplinary team should use a case management approach, assess each patient's needs, and develop a plan of individualized interventions.

5. Implement case management services and home visits on the group of high-risk ESRD patients.

6. Monitor and evaluate the impact of the interventions. Collect followup data on the problems of implementing the program, the lessons learned, acceptability to patients, and infection incidence in the group of ESRD patients.

F. Content

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. The narrative should be no more than 25 pages, double-spaced, printed on one side, with one inch margins, and unreduced font.

The narrative should consist of, at a minimum, a Plan, Objectives, Methods, Evaluation and Budget.

G. Submission and Deadline

Submit the original and two copies of PHS 5161-1 (OMB Number 0920-0428). Forms are available in the application kit and at the following Internet address: www.cdc.gov/od/pgo/forminfo.htm.

Application forms must be submitted in the following order:

Cover Letter

Table of Contents

Application

Budget Information Form

Budget Justification

Checklist

Assurances

Certifications

Disclosure Form

HIV Assurance Form (if applicable)

Human Subjects Certification (if applicable)

Indirect Cost Rate Agreement (if applicable)

Narrative

The application must be received by 5 p.m. Eastern Time August 14, 2002. Submit the application to:

Technical Information Management-PA02214, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Rd, Room 3000, Atlanta, GA 30341-4146.

Deadline: Applications shall be considered as meeting the deadline if they are received before 5 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 grant. Measures of effectiveness must relate to the performance goal stated in section “A. Purpose” of this announcement. Measures must be objective and quantitative and must measure the intended outcome. These measures of effectiveness shall be submitted with the application and shall be an element of evaluation.

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

1. Background and Need (30 points)

The extent to which the applicant demonstrates a strong understanding of the problem of infections in ESRD patients. The extent to which the applicant illustrates the need for this grant program. The extent to which the applicant presents a clear goal for this grant that is consistent with the described need.

2. Capacity (30 points)

The extent to which the applicant demonstrates that they have the expertise, facilities, and other resources necessary to accomplish the program requirements, including curricula vitae of key personnel and letters of support from any participating organizations/institutions.

3. Operational Plan (30 points)

a. The extent to which the applicant presents clear, time-phased objectives that are consistent with the stated program goal and a detailed operational plan outlining specific activities that are likely to achieve the objective. The extent to which the plan clearly outlines the responsibilities of each of the key personnel.

b. The extent 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; and (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.

4. Evaluation Plan (5 points)

The extent to which the applicant presents a plan for monitoring progress toward the stated goals and objectives.

5. Measures of Effectiveness (5 points)

Does the applicant provide Measures of Effectiveness that will demonstrate the accomplishment of the various identified objectives of the grant? Are the measures objective/quantitative and do they adequately measure the intended outcome?

6. Budget (Not Scored)

The extent to which the applicant presents a detailed budget with a line-item justification and any other information to demonstrate that the request for assistance is consistent with the purpose and objectives of this grant program.

7. Human Subjects (Not Scored)

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

I. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of—

1. Semi-annual progress reports. The progress report will include a data requirement that demonstrates measures of effectiveness.

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 I of 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-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

AR-12 Lobbying Restrictions

AR-15 Proof of Non-Profit Status

J. Where To Obtain Additional Information

This and other CDC announcements, the necessary applications, and associated forms can be found on the CDC home page Internet address— http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.”

For business management assistance, contact:

Sharon Robertson, Grants Management Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146, Telephone number: 770-488-2748, E-mail address: sqr2@cdc.gov.

For program technical assistance, contact:

Jerome Tokars, M.D., Division of Healthcare Quality Promotion, National Center for Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road, NE. Mailstop E-55, Atlanta, GA 30333, Telephone number: 404-498-1125, E-mail address: Jtokars@cdc.gov.