[Federal Register Volume 67, Number 135 (Monday, July 15, 2002)]
[Notices]
[Pages 46520-46522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17628]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02214]


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.

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    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

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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: [email protected].
    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: [email protected].

    Dated: July 9, 2002.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 02-17628 Filed 7-12-02; 8:45 am]
BILLING CODE 4163-18-P