[Federal Register Volume 63, Number 175 (Thursday, September 10, 1998)]
[Notices]
[Pages 48510-48513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24257]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 99013]
Notice of Availability of Funds; Economic and Outcome Analysis of
Antimicrobial Resistance in Hospital-Acquired Infections Among
Intensive Care Unit Patients
A. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1999 funds for a cooperative agreement
program for economic and outcome analysis of antimicrobial resistance
in hospital-acquired infections among intensive care unit (ICU)
patients. This program addresses the ``Healthy People 2000'' priority
area(s) of Immunization and Infectious Diseases.
The purpose of the program is to provide assistance to the National
Nosocomial Infections Surveillance
[[Page 48511]]
(NNIS) system hospitals to quantify the impact of antimicrobial
resistance on their institution and their patients. Understanding the
economic costs and patient outcomes associated with such resistant
infections will aid the infection control community in their efforts to
justify the allocation of resources to improve efforts at preventing
the emergence and spread of antimicrobial resistant pathogens. This
data will originate from several institutions and allow generalizable
estimates of the economic impact and patient outcomes associated with
antimicrobial resistance at U.S. hospitals.
The specific objectives of this cooperative agreement are:
1. Assess the impact of antimicrobial resistance, specifically
methicillin resistant S. aureus and vancomycin-resistant enterococci,
causing nosocomial infections, specifically primary bloodstream
infections, both in terms of poor patient outcomes (e.g., morbidity and
mortality) and economic cost, at participating hospitals.
2. Disseminate information regarding economic costs incurred from
antimicrobial resistant organisms.
B. Eligible Applicants
Limited Competition
Assistance will be provided only to U.S. hospitals actively
participating in the Intensive Care Unit (ICU) component of CDC's NNIS
System, and have used NNIS definitions and methodology for surveillance
of nosocomial infections to identify 60 ICU patients with
nosocomial primary bloodstream infection, 20 of which were
associated with methicillin resistant Staphylococcus aureus, and 15 of
which were associated with vancomycin resistant enterococci over the
past 5 years.
Competition is limited to hospitals actively participating in the
NNIS System, currently the only source of national data on risk-
adjusted, nosocomial infection rates in the United States using
standardized methodology.
Note: Public Law 104-65 states that an organization described in
section 501(c)(4) of the Internal Revenue Code of 1986 that 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 $130,000 is available in FY 1999 to fund
approximately 5 awards. It is expected that the average award will be
$25,000, ranging from $15,000 to $30,000 depending on the number of
case- and control-patients included in the applicant's proposal. It is
expected that the awards will begin on or about December 15, 1998 and
will be made for a 12-month budget period within a 12-month project
period. Funding estimates may change.
D. Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient shall be responsible for conducting activities under A.,
below, and CDC shall be responsible for conducting activities under B.
below.
A. Recipient Activities
1. Design a matched case-control study, where case-patients (i.e.,
those infected with the antimicrobial resistant pathogen) will be
compared to matched control-patients (i.e., those infected with the
respective antimicrobial susceptible pathogen). Factors that may
influence patient outcome, costs of hospitalization, and adaptability
of criteria to other recipients should be considered. Examples of
matching criteria may include location of patient, month or year of
infection, APACHE II score (+/-5 points), comorbid conditions, or a
combination of these characteristics. A published example includes that
performed by D. Pittet, et al. when determining extra costs of
nosocomial bloodstream infection in critically ill patients (JAMA.
1994;271:1598-1601).
2. Collect limited existing data from medical records of all
potential case- and control-patients eligible for matching algorithm.
3. Collect detailed data on case- and control-patients of two
types: financial and clinical (i.e., descriptive and patient outcome).
Determining excess costs may require recording total costs of
hospitalization per study patient and costs by each day of
hospitalization. In addition, it would be desirable to record costs by
category (i.e., laboratory or diagnostic tests, pharmaceuticals, bed
occupancy, physician, extra nursing, materials). Patient outcome data
must include, but not limited to, mortality, length of stay, response
to therapy, and relapse or recurrent infection.
4. Publish results through collaboration with other recipients of
this cooperative agreement and CDC.
B. CDC Activities
1. Provide technical assistance in the design and conduct of a pair
wise-matched case-control study which may include data collection forms
and designing innovative approaches to matching controls to cases.
2. Provide assistance to recipients regarding development of study
protocols, data collection methods, and analyses, as necessary.
3. Assist in the development of data management processes,
materials, and protocols.
4. Coordinate pooling data from each site and participate in the
analysis of study information and dissemination of study findings.
5. The CDC IRB will review and approve the protocol initially and
on at least an annual basis until the research project is completed.
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 laying out your program
plan. The narrative should be no more than 10 double-spaced pages
(excluding budget and appendixes), printed on one side, with one inch
margins, and unreduced font. Unless indicated otherwise, all
information requested below must appear in the narrative. Materials or
information that should be part of the narrative will not be accepted
if placed in the appendixes. The application narrative must contain the
following sections in the order presented below:
1. Abstract: Provide a brief (two pages maximum) abstract of the
project. State the length of the project period (maximum is 1 year) for
which assistance is being requested (see ``Availability of Funds'' for
additional information).
2. Background and Need: Discuss the background and need for the
proposed project. Illustrate and justify the need for the proposed
project that is consistent with the purpose and objectives of this
cooperative agreement program.
3. Capacity and Personnel:
a. Describe past experience in conducting projects/studies similar
to that being proposed.
b. Describe resources, facilities, and professional personnel that
will be involved in conducting the project. Include in an appendix,
curriculum vitae for all professional personnel directly involved with
the project.
c. Because award size should reflect the number of patients on
which data will be collected, provide in an appendix a list of all
patients, void of personal identifiers, identified by infection control
staff using standard NNIS definitions as having a nosocomial primary
bloodstream infection while in an intensive care unit for at least the
past 5 years. This list
[[Page 48512]]
must include, but not be limited to, infections associated with S.
aureus (both methicillin-susceptible and methicillin-resistant), and
enterocococcus spp. (both vancomycin-susceptible and vancomycin-
resistant). Other organisms of interest, and highly desirable to study
if present in sufficient quantity, include Klebsiella pneumoniae not-
susceptible to ceftazidime or aztreonam, Candida albicans, and C.
krusei. For each patient, the list must document the organism(s)
associated with the nosocomial bloodstream infection, susceptibility
status to the antimicrobial of interest (e.g., pathogens stated above),
date of admission to hospital, date of infection, and location of
patient at time of infection.
d. Provide in an appendix letters of support from all key
participating non-applicant Departments (i.e., medical informatics,
medical records), individuals, etc., which clearly indicate their
commitment to participate as described in the operational plan. Do not
include letters of support from CDC personnel.
4. Objectives and Technical Approach: a. Describe specific
objectives for the proposed project which are measurable and time-
phased and are consistent with the purpose and goals of this
cooperative agreement.
b. Present a detailed operational plan for initiating and
conducting the project which clearly and appropriately addresses all
Recipient Activities, including the approach to collecting financial
data.
c. Clearly identify specific assigned responsibilities for all key
professional personnel.
d. Describe the nature and extent of collaboration with CDC and/or
others during various phases of the study.
e. Describe in detail a plan for evaluating progress toward
achieving project objectives.
5. Budget: Provide in an appendix, a budget and accompanying
detailed justification for the project that is consistent with the
purpose and objectives of this program. If requesting funds for
contracts, provide the following information for each proposed
contract: (1) Name of proposed contractor, (2) breakdown and
justification for estimated costs, (3) description and scope of
activities to be performed by contractor, (4) period of performance,
and (5) method of contractor selection (e.g., sole-source or
competitive solicitation).
6. Human Subjects: Whether or not exempt from DHHS regulations, if
the proposed project involves human subjects, document in an appendix
that the principal investigator has obtained human subjects clearance.
F. Submission and Deadline
Application
Submit the original and five copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for
PHS 398). Forms are in the application kit. On or before November 1,
1998 submit the application to: Van Malone, Grants Management
Specialist, Grants Management Branch, Procurement and Grants Office,
Announcement #99013, Centers for Disease Control and Prevention, Room
300, 255 East Paces Ferry Road, NE, MS E-18, Atlanta, Georgia 30305-
2209.
If your application does not arrive in time for submission to the
independent review group, it will not be considered in the current
competition unless you can provide proof that you mailed it on or
before the deadline (i.e., receipt from U.S. Postal Service or a
commercial carrier; private metered postmarks are not acceptable).
G. Evaluation Criteria
Applications will be reviewed and evaluated based on the following
weighted criteria.
1. Background and Need (10 Points)
Extent to which applicant's discussion of the background for the
proposed project demonstrates a clear understanding of the purpose and
objectives of this cooperative agreement program. Extent to which
applicant illustrates and justifies the need for the proposed project
that is consistent with the purpose and objectives of this cooperative
agreement.
2. Capacity (50 Points Total)
A. The extent to which applicant has the appropriate organizational
structure, administrative support, and ability to access the defined
target population, and that this access will ensure an adequate sample
size and representation so that epidemiologic analysis of patient
outcomes and excess costs will be appropriate and statistically valid.
Considerable attention will be given to the quantity of patients having
had nosocomial bloodstream infections caused by the targeted
antimicrobial resistant pathogens (i.e., potential cases) and those
caused by the corresponding susceptible pathogen (i.e., potential
controls) documented by the recipient. Considerable attention will be
given to the recipient's capacity to access cost data for potential
cases and matched controls, and the ability to link cost data to
specific categories of costs and/or date of costs during patient's
hospitalization. (40 points)
b. Extent to which applicant documents that professional personnel
involved in the project are qualified, by training and experience
(i.e., NNIS hospital personnel must have the essential understanding of
definitions of nosocomial infections used in the NNIS system); and have
an appropriate projected level of effort directed toward accomplishment
of the proposed objectives. (10 points)
3. Objectives and Technical Approach (i.e., Plan) (40 Points Total)
a. Extent to which applicant describes specific objectives of the
proposed project which are consistent with the purpose and goals of
this cooperative agreement program and which are measurable and time-
phased. (10 points)
b. Extent to which applicant presents a detailed operational plan
for performing the matching process to pick controls for the case-
control study. (10 points)
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.
c. Extent to which applicant clearly identifies specific assigned
responsibilities for all key professional personnel. Extent to which
the plan clearly describes applicant's technical approach/methods for
conducting the proposed studies and extent to which the plan is
adequate to accomplish the objectives. (20 points)
4. Budget (Not Scored)
The extent to which the budget is reasonable (i.e., in proportion
to the number of patients for which data will be collected), clearly
justified, and consistent with the intended use of cooperative
agreement funds.
5. Does the application adequately address the requirements of 45
CFR Part 46 for the protection of human subjects?
________ YES ______No
[[Page 48513]]
Comments: ______
H. Other Requirements
Technical Reporting Requirements
Provide CDC with original plus two copies of:
1. Progress reports. Narrative progress reports are required every
6 months. An original and two copies of reports are due within 30 days
after first 6 months and 90 days following end of project period.
Progress reports should address progress toward overall objectives as
represented in the Purpose and Recipient Activities sections of this
announcement including status report of case and control selection,
enrollment, and progress of data abstraction.
2. Financial status report, no more than 90 days after the end of
the budget period. Send all reports to: Van Malone, Grants Management
Specialist, Grants Management Branch, Procurement and Grants Office,
Centers for Disease Control and Prevention, Room 300, 255 East Paces
Ferry Road, NE, M/S E-18, Atlanta, GA 30305-2209.
The following additional requirements are applicable to this
program. For a complete description of each, see Attachment 1 (included
in the application kit).
AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
AR-10 Smoke-Free Workplace Requirements
AR-7 Executive Order 12372 Review
AR-11 Healthy People 2000
AR-12 Lobbying Restrictions
I. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under the Public Health Service Act
Section(s) 301(a)[42 U.S.C. 241(a)], 317(k)(2)[42 U.S.C. 247b(k)(2)],
as amended. The Catalog of Federal Domestic Assistance number is
93.283.
J. Where to Obtain Additional Information
Please refer to Program Announcement 99013 when you request
information. For a complete program description, information on
application procedures, an application package, and business management
technical assistance, contact: Van Malone, Grants Management
Specialist, Grants Management Branch, Procurement and Grants Office,
Announcement [99013], Centers for Disease Control and Prevention (CDC),
Room 300, 255 East Paces Ferry Road, N.E., [E-18], Atlanta, GA 30305-
2209, telephone (404) 842-6872, Email address vxm7@cdc.gov.
See also the CDC homepage on the Internet: http://www.cdc.gov
For program technical assistance, contact Scott K. Fridkin,
Hospital Infections Program, National Center for Infectious Diseases,
Centers for Disease Control and Prevention, 1600 Clifton Road, N.E.,
Mailstop E-55, Atlanta, Georgia 30333. Facsimile: (404) 639-6436. E-
mail address: [email protected]
John L. Williams,
Director, Procurement and Grants, Centers for Disease Control and
Prevention (CDC).
[FR Doc. 98-24257 Filed 9-9-98; 8:45 am]
BILLING CODE 4163-18-P
