[Federal Register Volume 62, Number 137 (Thursday, July 17, 1997)]
[Notices]
[Pages 38308-38312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18819]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 787]
Research and Demonstration Programs in Surveillance, Prevention,
and Control of Healthcare-Associated Infections and Antimicrobial
Resistant Infections at Children's Hospitals
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of funds in fiscal year (FY) 1997 for a cooperative
agreement program to develop research and demonstration programs in the
surveillance, prevention, and control of healthcare-associated
infections, antimicrobial resistant infections, and outcomes research
at children's hospitals.
CDC is committed to achieving the health promotion and disease
prevention objectives of Healthy People 2000, a national activity to
reduce morbidity and mortality and improve the quality of life. This
announcement is related to the priority area of Immunization and
Infectious Diseases. (For ordering a copy of Healthy People 2000, see
the section Where To Obtain Additional Information.)
Authority
This program is authorized under Sections 301(a), and 317(k)(2) of
the Public Health Service Act, as amended [42 U.S.C. 241(a) and
247b(k)(2)]. Applicable program regulations are found in 42 CFR Parts
51b and 52, Grants for Preventive Health Service and Grants for
Research Projects.
Smoke-Free Workplace
CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the nonuse of all tobacco products, and
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities that receive Federal funds in which education,
library, day care, health care, and early childhood development
services are provided to children.
Eligible Applicants
Assistance will be provided only to public and private nonprofit
organizations whose members include representatives of children's
hospitals that have an interest in infection control, hospital
epidemiology, antimicrobial use and resistance, and development and
evaluation of benchmark or outcome measurements for patients at
children's hospitals. These organizations must include members involved
with hospitals, health systems, academic medical centers, and other
entities which provide both hospital-based medical care and ambulatory
care to a defined pediatric population.
Applicants should demonstrate that they have a close relationship
with a large number (N>40) of children's hospitals and that infection
control personnel at these member hospitals are interested in
participating in collaborative research studies to improve infection
control programs in children's hospitals. Documentation of eligibility
status including 501(c)(3) certification and listing of 10 or more
relationships with children's hospitals must appear in the Abstract or
Background and Need sections of Application Content.
Note: Effective January 1, 1996, 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 shall not
be eligible for the receipt of Federal funds constituting an award,
grant
[[Page 38309]]
(cooperative agreement), contract, loan, or any other form.
Availability of Funds
Approximately $200,000 will be available in FY 1997 to fund one
award. It is expected that the award will begin on or about September
30, 1997, for a 12-month budget period within a project period of up to
3 years. Funding estimate may vary and is subject to change.
Continuation awards within the project period will be made on the
basis of satisfactory progress and the availability of funds. There are
no matching or cost participation requirements; however, the
applicant's anticipated contribution to the overall program costs, if
any, should be provided on the application.
Use of Funds
Restrictions on Lobbying
Applicants should be aware of restrictions on the use of Department
of Health and Human Services (HHS) funds for lobbying of Federal or
State legislative bodies. Under the provisions of 31 U.S.C. Section
1352 (which has been in effect since December 23, 1989), recipients
(and their subtier contractors) are prohibited from using appropriated
Federal funds (other than profits from a Federal contract) for lobbying
Congress or any Federal agency in connection with the award of a
particular contract, grant, cooperative agreement, or loan. This
includes grants/cooperative agreements that, in whole or in part,
involve conferences for which Federal funds cannot be used directly or
indirectly to encourage participants to lobby or to instruct
participants on how to lobby.
In addition, the FY 1997 Departments of Labor, HHS, and Education,
and Related Agencies Appropriations Act, which became effective October
1, 1996, expressly prohibits the use of 1997 appropriated funds for
indirect or ``grass roots'' lobbying efforts that are designed to
support or defeat legislation pending before State legislatures.
Section 503 of this new law, as enacted by the Omnibus Consolidated
Appropriations Act, 1997, Division A, Title I, Section 101(e), Pub. L.
No. 104-208 (September 30, 1996), provides as follows:
Sec. 503(a). No part of any appropriation contained in this Act
shall be used, other than for normal and recognized executive-
legislative relationships, for publicity or propaganda purposes, for
the preparation, distribution, or use of any kit, pamphlet, booklet,
publication, radio, television, or video presentation designed to
support or defeat legislation pending before the Congress, * * *
except in presentation to the Congress or any State legislative body
itself.
(b) No part of any appropriation contained in this Act shall be
used to pay the salary or expenses of any grant or contract
recipient, or agent acting for such recipient, related to any
activity designed to influence legislation or appropriations pending
before the Congress or any State legislature.
Background
Children's hospitals serve a unique population which have very
special needs. The patient populations served by children's hospitals
range in age from birth to adulthood and have a variety of underlying
diseases which are very different from those seen in adult populations.
Furthermore, the infectious diseases which this population acquire and
the distribution of antimicrobials which they receive differ from that
seen in adult populations. Thus, the infections control, infectious
disease, and quality assurance needs of children's hospitals differ
from those of general acute care facilities, whose patients are
primarily adults.
The epidemiology of nosocomial infections in children differ from
adults in both the distribution of infections by site and by pathogen.
Furthermore, the risk factors for nosocomial infection differ in
children from adults because of the different types of exposures which
children have which adults may not have. For instance, neonates in
intensive care units frequently have umbilical artery or venous
catheters but seldom have urinary catheters whereas adults often have
urinary catheters and never have umbilical catheters. Despite the
unique and special needs of children's hospital personnel, most
infection control guideline recommendations, the national infection
control surveillance system, recommendations for antimicrobial use, and
quality of care benchmarks have either been developed in or written for
general acute care facilities and their patient populations which are
mostly adults.
Because of the differences in the epidemiology of nosocomial
infections, types of care given, infectious disease which occur, and
antimicrobials which these patients receive, there is an urgent need
for the establishment of a pediatric network so that children's
hospital infection control and quality assurance personnel can develop
children-specific infection surveillance and control programs, identify
cost-effective infection control prevention interventions, design
systems to improve antimicrobial use, and develop national benchmarking
programs so that standards can be developed and used to assess the
adequacy of infection control and patient care programs at children's
hospitals.
One of the major challenges to infectious disease and infection
control personnel at children's hospitals is the increase in
antimicrobial resistant pathogens and the increasing widespread use of
antimicrobials. One of the patient populations with the greatest
antimicrobial exposure is the pediatric age group, particularly infants
and young children. In some reports, over 50 percent of the
antimicrobials used in this population are inappropriate. Others have
reported that 50 percent of infants and children with viral
syndromes receive antimicrobials. Concomitant with this widespread use
(and misuse) of antimicrobials have been increasing reports of the
emergence of antimicrobial resistance in bacterial pathogens
colonizing/infecting this population. In hospitalized children,
methicillin-resistant Staphylococcus aureus (MRSA), penicillin-
resistant Streptococcus pneumoniae (PRP), and vancomycin-resistant
enterococcus (VRE) colonizations/infections are increasing and
nosocomial outbreaks have been reported. For all of these pathogens,
antimicrobial use has been a risk factor for colonization/infection.
Furthermore, the emergence of antimicrobial resistant pathogens in the
hospitalized pediatric patient can lead to further transmission (and
vice versa) in the community, particularly day care centers.
Despite the fact that antimicrobial use is a risk factor for
colonization/infection with resistant bacteria, virtually no studies
have been conducted assessing the appropriateness of antimicrobial use
in the pediatric inpatient setting. Such an assessment could lead to
targeted intervention programs to reduce inappropriate antimicrobial
use and reduce the pressure for emergence of antimicrobial pathogens in
this population. Conduct of such projects in a group of children's
hospitals will lesson the pressure to misuse such antimicrobials at any
one institution and provide a program for all other children's
hospitals to follow.
Currently, there is no multicenter pediatric hospital study or
surveillance system to monitor the use of antimicrobials, determine the
prevalence of antimicrobial resistant pathogens, evaluate the risk
factors for colonization/infection with these organisms, or develop,
implement, or assess the efficacy of preventive interventions in
reducing the emergence and transmission of these pathogens in pediatric
settings. Although there has been a great interest in the pediatric
infectious diseases, infection control,
[[Page 38310]]
and quality assurance community for such a network, sufficient
financial support for such a project has been lacking and there has
been the need for strong technical assistance from those with expertise
in pediatric infectious diseases, infection control and quality
assurance. A variety of pediatric infectious diseases groups have urged
the Hospital Infections Program (HIP) of CDC to provide the technical
support for the establishment of such a network. Such a network would
be very beneficial to the children's hospital community, pediatric
infectious diseases and infection control personnel and patients
receiving care in these facilities.
Such a network would have a major influence on pediatric infectious
diseases, infection control, and quality assurance at all hospitals
providing care for large numbers of pediatric patients. For the first
time, through coordination of multiple children's hospitals,
recommendations could be made to personnel at all facilities where
pediatric patients receive care. These recommendations would include:
(1) methods for surveillance, 2) clinical practices which improve
patient care and reduce adverse outcomes, and (3) appropriate
antimicrobial use. These national benchmark rates will permit accurate
and reliable inter-and intra-hospital comparisons; also, those
facilities which are outliers can evaluate differences in practices
which may lead to elevated rates of adverse events. Such a network
would have an enormous impact on improving pediatric patient care in
the United States. Current pediatric organizations which are very
interested in initiating such a network require the technical expertise
of the HIP of CDC in surveillance, benchmark development, analytic
epidemiology and antimicrobial use evaluation. Through partnership
between the HIP and a group of children's hospitals, where the interest
in developing specific standards and prevention interventions for
pediatric patients exists, this cooperative agreement can have a major
impact on reducing morbidity and mortality in children at these
hospitals and in providing this community with pediatric-specific
surveillance methods, antimicrobial use guidelines, benchmarks, and
prevention interventions. This would be the first and only network
established specifically for the benefit of children's hospitals and
their special population.
Purpose
The purpose of this cooperative agreement is to provide assistance
in establishing a center for research and demonstration to improve the
surveillance, prevention, and control of healthcare-associated
infections and antimicrobial resistant infections in children's
hospitals.
Program Requirements
In conducting activities to achieve the purpose of this program,
the recipients will be responsible for conducting activities under Item
A., below, and CDC will be responsible for conducting activities under
Item B., below:
A. Recipient Activities
1. Establish a surveillance system for antimicrobial resistant
pathogens at children's hospitals.
2. Assess the relationship between antimicrobial use and the
emergence of antimicrobial resistance, develop prevention
interventions, and assess the efficacy of these interventions.
3. Develop and administer educational programs to decrease misuse
and improve the appropriateness of antimicrobial use by clinicians.
4. Analyze and publish research findings.
Activities listed below are optional:
5. Assess the relationship between health care worker (i.e.,
nursing, physician, infection control, etc.) staffing levels and
nosocomial infection risk.
6. Conduct cost, cost efficacy and cost-benefit studies to identify
the most useful infection control measures.
7. Develop nosocomial infection outcome benchmark measurement
methods to permit valid interhospital comparison of infection rates.
8. Determine risk factors for nosocomial infection, develop
prevention interventions, introduce the interventions, and assess their
efficacy.
9. Study the effectiveness of traditional hospital-based infection
control methods and practice in integrated health care delivery
systems.
10. Develop and study innovative approaches to infection
surveillance, prevention, and control that will maximize effectiveness.
11. Develop and study improved evaluation methodologies to assess
the effectiveness of prevention and control methods for healthcare-
associated infections and antimicrobial resistant infections.
B. CDC Activities
1. Provide technical assistance in the design and conduct of
research activities, in the design and implementation of innovative
approaches to hospital epidemiologic and infection control practice and
in the design of educational and training strategies and the
dissemination of educational and training materials.
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 and
protocols.
4. Assist in the analysis of research information and dissemination
of research findings.
Technical Reporting Requirements
An original and two copies of an annual performance report and
financial status report are required no later than 90 days after the
end of each budget period. A final performance report and financial
status report are due no later than 90 days after the end of the
project period. Please send all reports and other correspondence to:
Sharron P. Orum, Grants Management Officer, Procurement and Grants
Office, Centers for Disease Control and Prevention (CDC), 255 East
Paces Ferry Road, NE., Mailstop E-18, Room 300, Atlanta, Georgia 30305.
Application Process
Intent Letter
In order to assist CDC in planning for and executing the evaluation
of applications submitted under this Program Announcement, all parties
intending to submit an application are requested to inform CDC of their
intention to do so at their earliest convenience prior to the
application due date. Notification should include: (1) Name and address
of institution and (2) name, address, and telephone number of contact
person. Notification should be provided by facsimile, postal mail, or
Email to Sharron Orum, Grants Management Officer, Procurement and
Grants Office, Centers for Disease Control and Prevention (CDC), 255
East Paces Ferry Road, NE., Mailstop E-18, Room 300, Atlanta, Georgia
30305, facsimile (404) 842-6513.
Application Content
All applicants must develop their applications in accordance with
the PHS Form 5161-1 (OMB Number 0937-0189), information contained in
this announcement, and the instructions outlined below.
General Instructions
1. All pages must be clearly numbered.
2. A complete index to the application and its appendixes must be
included.
3. The original and two copies of the application must be submitted
unstapled and unbound. No bound materials will be accepted.
[[Page 38311]]
4. All materials must be typewritten, single spaced, and in
unreduced type (no smaller than font size 12) on 8\1/2\'' by 11'' white
paper, with at least 1'' margins, headers, and footers.
5. All pages must be printed on one side only.
Specific Instructions
The application narrative must not exceed 10 pages (excluding
budget and appendices). 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 appendices. 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 including documentation of eligibility status. State the length
of the project period (maximum is 3 years) for which assistance is
being requested (see the section Availability of Funds for additional
information).
2. Background and Need: Discuss the background and need for the
proposed project. Demonstrate a clear understanding of the purpose and
objectives of this cooperative agreement program. 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: Describe applicant's past experience in
conducting projects/studies similar to that being proposed. Describe
applicants resources, facilities, and professional personnel that will
be involved in conducting the project. Include in an appendix
curriculum vitae for all professional personnel involved with the
project. Describe plans for administration of the project and identify
administrative resources/personnel that will be assigned to the
project. Provide in an appendix letters of support from all key
participating non-applicant organizations, individuals, etc., which
clearly indicate their commitment to participate as described in the
operational plans. Do not include letters of support from CDC
personnel. Letters of support from CDC will not be accepted in the
application.
4. Objectives and Technical Approach: 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.
Present a detailed operational plan for initiating and conducting the
project which clearly and appropriately addresses Recipient Activities
(1-4) and any optional Activities (if proposing a multi-year project,
provide a detailed description of first-year activities and a brief
overview of activities in subsequent years. Clearly state the proposed
length of the project period.) Clearly identify specific assigned
responsibilities for all key professional personnel. Include a clear
description of applicant's technical approach/methods which are
directly relevant to the study objectives. Describe specific study
protocols or plans for the development of study protocols. Describe the
nature and extent of collaboration with CDC and/or others during
various phases of the project. Describe in detail a plan for evaluating
study results and for evaluating progress toward achieving project
objectives.
5. Budget: Provide in an appendix a budget and accompanying
detailed justification for the first year of the project that is
consistent with the purpose and objectives of this program. Also,
provide estimated total budget for each subsequent year. If requesting
funds for any contracts, provide the following information for each
proposed contract: (a) Name of proposed contractor, (b) breakdown and
justification for estimated costs, (c) description and scope of
activities to be performed by contractor, (d) period of performance,
and (e) method of contractor selection (e.g., sole-source or
competitive solicitation).
6. Human Subjects: Whether or not exempt from Department of Health
and Human Services (DHHS) regulations, if the proposed project involves
human subjects, describe in an appendix adequate procedures for the
protection of human subjects. Also, ensure that women, racial and
ethnic minority populations are appropriately represented in
applications for research involving human beings.
Evaluation Criteria
The applications will be reviewed and evaluated according to the
following criteria: (Total 100 points)
1. Background and Need (20 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 program.
2. Capacity (40 points total): a. Extent to which applicant
describes adequate resources and facilities (both technical and
administrative) for conducting the project. (10 points)
b. Extent to which applicant documents that professional personnel
involved in the project are qualified and have past experience and
achievements in research related to that proposed as evidenced by
curriculum vitae, publications, etc. (20 points)
c. Extent to which applicant includes letters of support from non-
applicant organizations, individuals, etc. Extent to which the letters
clearly indicate the author's commitment to participate as described in
the operational plan. (10 points).
3. Objectives and Technical Approach (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 initiating and conducting the project, which clearly and
appropriately addresses all Recipient Activities. 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. Extent to which applicant describes specific study
protocols or plans for the development of study protocols that are
appropriate for achieving project objectives. The degree to which the
applicant has met the CDC policy requirements regarding the inclusion
of women, ethnic, and racial groups in 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) documentation
of plans for recruitment and outreach for study participants that
includes the process of establishing partnerships with community(ies)
and recognition of mutual benefits. (15 points)
c. Extent to which applicant describes adequate and appropriate
collaboration with CDC and/or others during various phases of the
project. (10 points)
d. Extent to which applicant provides a detailed and adequate plan
for evaluating study results and for evaluating progress toward
achieving project objectives. (5 points)
[[Page 38312]]
4. Budget (not scored): Extent to which the proposed budget is
reasonable, clearly justifiable, and consistent with the intended use
of cooperative agreement funds.
5. Human Subjects Research (not scored): If the proposed project
involves human subjects, whether or not exempt from the DHHS
regulations, the extent to which adequate procedures are described for
the protection of human subjects. Note: Objective Review Group (ORG)
recommendations on the adequacy of protections include: (a) protections
appear adequate and there are no comments to make or concerns to raise,
(b) protections appear adequate, but there are comments regarding the
protocol, (c) protections appear inadequate and the ORG has concerns
related to human subjects, (d) disapproval of the application is
recommended because the research risks are sufficiently serious and
protection against the risks are inadequate as to make the entire
application unacceptable.
Executive Order 12372 Review
This program is not subject to review by Executive Order 12372.
Public Health System Reporting Requirement
This program is not subject to the Public Health System Reporting
Requirement.
Catalog of Federal Domestic Assistance Number
The Catalog of Federal Domestic Assistance Number is 93.283.
Other Requirements
Paperwork Reduction Act
Projects that involve the collection of information from ten or
more individuals and funded by the cooperative agreement will be
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act.
Human Subjects
If the proposed project involves research on human subjects, the
applicant must comply with the Department of Health and Human Services
Regulations (45 CFR Part 46) regarding the protection of human
subjects. Assurance must be provided to demonstrate that the project
will be subject to initial and continuing review by an appropriate
institutional review committee. The applicant will be responsible for
providing evidence of this assurance in accordance with the appropriate
guidelines and form provided in the application kit.
Women, Racial and Ethnic Minorities
It is the policy of the Centers for Disease Control and Prevention
(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR)
to ensure that individuals of both sexes and the various racial and
ethnic groups will be included in CDC/ATSDR-supported research projects
involving human subjects, whenever feasible and appropriate. Racial and
ethnic groups are those defined in OMB Directive No. 15 and include
American Indian, Alaskan Native, Asian, Pacific Islander, Black and
Hispanic. Applicants shall ensure that women, racial and ethnic
minority populations are appropriately represented in applications for
research involving human subjects. Where clear and compelling rationale
exist that inclusion is inappropriate or not feasible, this situation
must be explained as part of the application. This policy does not
apply to research studies when the investigator cannot control the
race, ethnicity and/or sex of subjects. Further guidance to this policy
is contained in the Federal Register, Vol. 60, No. 179, pages 47947-
47951, dated Friday, September 15, 1995.
Application Submission and Deadline
The original and two copies of the application Form PHS-5161-1 (OMB
Number 0937-0189) must be submitted to Sharron P. Orum, Grants
Management Officer, Grants Management Branch, Procurement and Grants
Office, Centers for Disease Control and Prevention (CDC), 255 East
Paces Ferry Road, NE., Mailstop E-18, Atlanta, Georgia 30305, on or
before August 22, 1997.
1. Deadline: Applications will be considered to meet 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 the U.S. Postal Service. Private
metered postmarks will not be acceptable proof of timely mailing.)
2. Late Applications: Applications which do not meet the criteria
in 1.a. or 1.b. above, will be considered late applications. Late
applications will not be considered and will be returned to the
applicant.
Where To Obtain Additional Information
To receive additional written information call (404) 332-4561. You
will be asked to leave your name, address, and telephone number and
will need to refer to Announcement Number 787. You will receive a
complete program description, information on application procedures,
and application forms.
If you have questions after reviewing the contents of all
documents, business management technical assistance may be obtained
from Locke Thompson, Grants Management Specialist, Grants Management
Branch, Procurement and Grants Office, Centers for Disease Control and
Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop E-18, Room
300, Atlanta, Georgia 30305, telephone (404) 842-6595 or through the
Internet or CDC WONDER electronic mail at: [email protected]. Programmatic
technical assistance may be obtained from William R. Jarvis, M.D.,
Hospital Infections Program, National Center for Infectious Diseases,
Centers for Disease Control and Prevention (CDC), 1600 Clifton Road,
Mailstop A-07, Atlanta, Georgia 30333, telephone (404) 639-6413.
You may obtain this and other CDC announcements from one of two
Internet sites on the actual publication date: CDC's homepage at http:/
/www.cdc.gov or at the Government Printing Office homepage (including
free on-line access to the Federal Register at http://
www.access.gpo.gov).
Please refer to Program Announcement Number 787 when requesting
information and submitting an application on the Request for
Assistance.
Potential applicants may obtain a copy of Healthy People 2000 (Full
Report, Stock No. 017-001-00474-0) or Healthy People 2000 (Summary
Report, Stock No. 017-001-00473-1) referenced in the Introduction
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325, telephone (202) 512-1800.
Dated: July 11, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 97-18819 Filed 7-16-97; 8:45 am]
BILLING CODE 4163-18-P