[Federal Register Volume 63, Number 130 (Wednesday, July 8, 1998)]
[Notices]
[Pages 36915-36920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18017]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 99005]
Applied Research Program in Emerging Infections Correlation of
Environmental Monitoring of Microbial Agents With Disease Control;
Notice of Availability of Funds for Fiscal Year 1999
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1999 funds for competitive grants and/
or cooperative agreements to support applied research on emerging
infections. This announcement specifically addresses the correlation of
environmental monitoring of microbial agents with disease control.
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)].
Smoke-Free Workplace
CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the non-use of all tobacco products, and
Public Law 103-227, the Pro-Children's 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
Applications may be submitted by public and private nonprofit
organizations and governments and their agencies. Thus, universities,
colleges, research institutions, hospitals, other public and private
nonprofit organizations, including State and local governments or their
bona fide agents are eligible to apply.
Note: An organization described in Section 501(c)(4) of the
Internal Revenue Code of 1986 which engages in lobbying activities
shall not be eligible to receive Federal funds constituting an
award, grant, contract, loan, or any other form.
Only one application will be accepted from any single applicant,
organization, government, or agency.
Availability of Funds
Approximately $500,000 is available in FY 1999 to fund one to three
awards, ranging from $100,000 to $500,000. It is expected the award(s)
will begin on or about March 1, 1999, and will be made for a 12-month
budget period within a project period of up to three years. (The
funding amounts listed above are for the first 12-month budget period
and include both direct and indirect costs.) Funding estimates may vary
and are subject to change.
Continuation awards within an approved project period will be made
on the basis of satisfactory progress and availability of funds.
[[Page 36916]]
Determination of Which Instrument to Use
Applicants must specify the type of award for which they are
applying, either grant or cooperative agreement. CDC will review the
applications in accordance with the evaluation criteria. Before issuing
awards, CDC will determine whether a grant or cooperative agreement is
the appropriate instrument based upon the need for substantial CDC
involvement in the project.
To assist applicants in making a determination as to which type of
award to apply for, the following information is provided:
1. Grants
A research project grant is one in which substantial programmatic
involvement by CDC is not anticipated by the recipient during the
project period. Applicants for grants must demonstrate an ability to
conduct the proposed research with minimal assistance, other than
financial support, from CDC. This would include possessing sufficient
resources for clinical, laboratory, and data management services and a
level of scientific expertise to achieve the objectives described in
their research proposal without substantial technical assistance from
CDC.
2. Cooperative Agreements
A research project cooperative agreement is one in which CDC will
assist recipients in conducting the proposed research. The application
should be presented in a manner that demonstrates the applicant's
ability to address the research problem in a collaborative manner with
CDC.
Use of Funds
Restrictions on Lobbying
Applicants should be aware of restrictions on the use of 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 1998 ``Department of Labor, Health and Human
Services, and Education, and Related Agencies Appropriations Act''
(Public Law 105-78) states in Section 503 (a) and (b) that no part of
any appropriation contained in this Act shall be used, other than for
normal and recognized executive-legislative relations, 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 or any State legislature, except in presentation to the
Congress or any State legislature itself. 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
Once expected to be eliminated as a public health problem,
infectious diseases remain the leading cause of death worldwide. In the
United States (U.S.) and elsewhere, infectious diseases increasingly
threaten public health and contribute significantly to the escalating
costs of health care.
In 1992, the Institute of Medicine of the National Academy of
Sciences published a report entitled Emerging Infections, Microbial
Threats to Health in the United States highlighting the threat of
emerging infections and making specific recommendations to address the
threat. This report emphasized a critical leadership role for CDC in a
national effort to detect and control infectious disease threats.
In partnership with other Federal agencies, State and local health
departments, academic institutions, and others, CDC has developed a
plan for revitalizing the nation's ability to identify, contain, and
prevent illness from emerging infectious diseases. The plan, Addressing
Emerging Infectious Disease Threats; A Prevention Strategy for the
United States, includes applied research as a major objective,
stressing the importance of integrating laboratory science and
epidemiology to optimize public health practice in the U.S. CDC has
developed an Extramural Applied Research Program in Emerging Infections
(EARP) designed to fill gaps in existing support for research in
emerging infectious disease surveillance, epidemiology, and prevention.
This announcement specifically addresses the correlation of
environmental monitoring of microbial agents with disease control.
The microorganisms present in the environment have played a role in
the transmission of infectious diseases. Legionella, Cryptosporidia,
Cyclospora, Aspergillus, and vancomycin-resistant enterococci are just
a few examples of agents with public health significance. There are
very few situations where the results of environmental monitoring have
been correlated with disease control. A good example of a situation
where correlation has been done is the microbial quality of water and
dialysate in hemodialysis units. Here it has long been established that
once bacteria (and in some instances endotoxin) go above certain
concentrations (2,000 CFU/ml in dialysate, 200 CFU/ml in water, or 5
EU/ml in water used to reprocess hemodialyzers) the risk of patients
developing bacteremia or a ``pyrogenic'' reaction during dialysis
increases substantially. However, the correlation of environmental
monitoring of microbial agents with disease control in other situations
is unclear.
Legionnaires' disease (LD) occurs when an aerosol of water
containing Legionella spp. is inhaled. There are 8,000-18,000 cases of
LD that occur each year in the U.S., and 23 percent of case-patients
reported to the CDC appear to have acquired the infection in a health-
care facility. Recent investigations have demonstrated that nosocomial
transmission from colonized hot water systems can occur for years or
even decades unless the illness is recognized and the organism is
eradicated. Case-fatality rates among patients with nosocomial LD may
reach > 30 percent, particularly in immunocompromised individuals. In
1997, a survey of 253 National Nosocomial Infections Surveillance
System (NNIS) hospitals indicated that 31 percent have identified cases
of nosocomial LD since 1990 and in 41 percent of hospitals legionellae
were recovered from the potable water systems. However, many hospitals
with cases had done little to reduce colonization and prevent further
transmission. Current CDC guidelines only state that an environmental
investigation and intervention should be done after nosocomial cases
are identified.
Vancomycin-resistant enterococci (VRE) were first reported in 1989
and have increased rapidly in incidence and prevalence in the interim.
At 189 hospitals reporting to the NNIS system, the percentage of
enterococcal isolates from all body sites that were resistant to
vancomycin increased from 0.3 percent in 1989 to 10.5 percent in 1995.
[[Page 36917]]
Numerous hospital VRE outbreaks have been reported and contamination of
environmental surfaces (e.g., bed rails, countertops) with VRE has been
documented. Since VRE may survive routine cleaning and disinfection
procedures, contamination of environmental surfaces may contribute to
nosocomial transmission of VRE. There is a need to document the extent
of environmental contamination with this organism, the extent to which
such contamination contributes to nosocomial transmission, and the
cleaning/disinfection procedures necessary to remove VRE.
Invasive aspergillosis is a threat to patients with compromised
macrophage or neutrophil function (i.e., patients with neutropenia,
receiving high-dose corticosteroid therapy) or with underlying chronic
lung disease. Aspergillus spp., are ubiquitous and are routinely
isolated from tap water, soil, decaying vegetation, wet paint, food,
dust, and even sanitizing agents used in hospitals. Several outbreaks
of aspergillosis have occurred during periods of construction in and
around hospitals. Current recommendations are directed at controlling
the production of aerosols during these periods. Additionally, there is
evidence that higher aspergillosis spore counts contribute to higher
rates of invasive disease among immunocompromised patients. However,
there is not consensus about whether there should be a benchmark spore
count or on the best methods to purify air.
Outbreaks of child-care-associated illness may be caused by many
different agents and involve several different modes of transmission.
The environment can play an important role in these outbreaks. Most
environmental studies in child care settings have focused on enteric
diseases. Toys and surfaces become contaminated either directly or
indirectly by feces and body secretions from ill children. The
incidence of diarrhea has been associated with isolation of fecal
coliforms from hands of children and staff and from various
environmental surfaces in child-care centers. Levels of environmental
fecal coliforms have also been linked with diaper type and the use of
over clothing in classes of non-toilet-trained children in child-care
centers. Cytomegalovirus has also been isolated from hands and toys in
a classroom with a high prevalence of infected children. Although
respiratory infections account for the majority of illness episodes
among children in child-care facilities, relatively little work has
been done on the environmental aspects of these infections.
The relationship between results of environmental monitoring of
microbial agents and the risk of infection from these agents in the
environment remains largely undefined. In addressing this issue, it is
necessary to consider the following requirements for environmental
transmission of disease to take place: (1) presence of a microbial
agent in the environment, (2) the organism must have sufficient
virulence, (3) relatively high numbers of organisms, (4) mechanism of
transmission from the environment to the host, (5) a successful portal
of entry, and (6) a susceptible host.
Purpose
The purpose of the EARP is to provide financial and technical
assistance for applied research projects on emerging infections in the
U.S. As a component of EARP, the purpose of this grant/cooperative
agreement announcement is to provide assistance for one or more
projects addressing the correlation of environmental monitoring of
microbial agents with disease control. Environmental monitoring may
play an important role in infectious disease control. However,
additional studies are needed to correlate results of environmental
monitoring with human disease. Examples of areas needing attention
include, but are not limited to, Legionella and Cryptosporidia in
water, Aspergillus spores in air, vancomycin-resistant enterococci and
other agents in hospital and child-care environments. Where
appropriate, projects proposed may include interventions to evaluate
detection methods.
Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities under A.
(Recipient Activities), and CDC will be responsible for conducting
activities under B. (CDC Activities) under cooperative agreements:
A. Recipient Activities
1. Identify a microbial agent of increasing public health
importance that has a known environmental reservoir (air, water, etc).
2. Conduct surveillance for human infections in a particular
setting, e.g., child-care facilities, health-care facilities
(hospitals, clinics, long-term care facilities), etc.
3. Define the relationship between finding the target organism in
the environment and the risk of human disease in the target setting.
4. If feasible, determine the cost effectiveness of different
options for microbial detection and disease control; determine
interventions where appropriate.
5. Publish and/or otherwise disseminate study findings.
B. CDC Activities (Cooperative Agreements)
1. Provide technical assistance in the design and conduct of the
research.
2. Perform selected laboratory tests, as appropriate and necessary.
3. Participate in data management, the analysis of research data,
and the interpretation and presentation of research findings.
4. Provide biological materials (e.g., strains, reagents, etc.) as
necessary for studies.
Technical Reporting Requirements
Narrative progress reports are required semiannually. The first
semiannual report is required with the first noncompeting continuation
application and should cover program activities from date of award. The
second semiannual report is due 90 days after the end of each budget
period and should cover activities from the date of previous report.
Progress reports should summarize tasks completed, problems
encountered, and plans for continued research activities. Reports
should also include copies of any publications resulting from the
project.
An original and two copies of a Financial Status Report (FSR) are
required not later than 90 days after the end of each budget period.
A final performance report and FSR are due not later than 90 days
after the end of the project period. All reports are to be submitted to
the Grants Management Branch, CDC.
Application
1. Pre-application Letter-of-Intent
In order to enable CDC to plan the review of applications submitted
under this Program Announcement, all parties intending to submit
application(s) are requested to inform CDC of their intention to do so
as soon as possible but not later than 30 business days prior to the
application due date. Notification should include: (1) this program
announcement number (99005), (2) name and address of institution, and
(3) name, address, and phone number of contact person. Notification can
be provided by Facsimile, postal mail, or electronic mail (E-mail) to:
Matthew Arduino, Dr. P.H., National Center for Infectious Diseases,
Centers for Disease Control and Prevention (CDC) 1600
[[Page 36918]]
Clifton Road, NE., Mailstop C-1, Atlanta, GA 30333, Facsimile (404)
639-3822, E-mail [email protected].
2. Application Content
Applicants are strongly encouraged to develop applications in
accordance with PHS Form 398 information contained in this grant/
cooperative agreement announcement, and the instructions outlined
below.
The original and five (5) complete copies of the application must
be UNSTAPLED and UNBOUND. ALL pages must be clearly numbered, and a
complete index to the application and its appendices must be included.
All typewritten materials must be single-spaced, using a font no
smaller than size 12. All supplemental pages of the application (i.e.,
in addition to the 398 forms) must be on the 8\1/2\'' by 11'' white
paper. All pages must be printed on ONE side only, with at least 1''
margins, headers, and footers.
The application narrative must not exceed 12 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:
a. Abstract
Provide a brief (two pages maximum) abstract of the project.
Clearly identify the project period proposed (not to exceed maximum of
3 years as indicated in Availability of Funds Section). Clearly
identify the type of award that is being applied for, grant or
cooperative agreement.
b. Background and Need
Discuss the background and need for the proposed project.
Demonstrate a clear understanding of the purpose and objectives of this
program announcement. Discuss and demonstrate how the proposed project
addresses an important gap which is of public health importance.
c. Capacity and Personnel
Describe applicant's past experience in conducting activities
similar to that being proposed. Describe applicant's resources,
facilities, and professional personnel that will be involved in
conducting the project. Clearly identify specific assigned
responsibilities for all key professional personnel. 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. (if any),
which clearly indicate their commitment to participate as described in
the operational plan. (Do not include letters of support from CDC
personnel--they will not be accepted.)
d. Objectives and Technical Approach
Present specific objectives for the proposed project which are
measurable and time-phased and are consistent with the Purpose and
Program Requirements (Recipient Activities) sections of this
announcement. Present a detailed operational plan for initiating and
conducting the project which clearly and appropriately addresses these
objectives (if proposing a multi-year project, provide a detailed
description of first-year activities and a brief overview of
subsequent-year activities). Include a clear description of applicant's
technical approach/methods which are directly relevant to the above
objectives. Describe specific study protocols or plans for the
development of study protocols. Describe the nature and extent of
collaboration with CDC (if proposing a cooperative agreement) and/or
others during various phases of the project. Describe in detail a plan
for evaluating progress toward achieving process and outcome project
objectives. If the project will employ a particular research subject
population, describe characteristics of the patient population and how
research in this subject group will yield generalizable information.
Describe contingency plans which acknowledge how the project will
address likely obstacles and assure that the proposed task(s) can still
be completed. Include sample size calculations where appropriate to
assure that measurable objectives can be evaluated.
e. Budget
Provide a line-item budget and accompanying detailed, line-by-line
justification for the first year of the project that demonstrates the
request is consistent with the purpose and objectives of this program.
If requesting a multi-year project, provide estimated total budget
(direct plus indirect) for subsequent years. If requesting funds for
any 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).
f. Human Subjects
Whether or not exempt from 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 subjects.
Evaluation Criteria
Applications will be reviewed and evaluated according to the
following criteria:
1. Background and Need (15 Points)
Extent to which applicant demonstrates a clear understanding of the
background, purpose, and objectives of the project and the extent to
which the proposed project addresses an area of public health
importance not adequately addressed in ongoing programs.
2. Capacity (30 Points)
Extent to which applicant describes adequate resources and
facilities (both technical and administrative) for conducting the
project. 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. Extent to which
applicant clearly identifies specific assigned responsibilities of all
key professional personnel. If applicable, extent to which applicant
includes letters of support from non-applicant organizations,
individuals, etc., and the extent to which such letters clearly
indicate the author's commitment to participate as described in the
operational plan.
3. Objectives and Technical Approach (55 Points Total)
a. Extent to which applicant describes objectives of the proposed
project which are consistent with the purpose of this announcement and
which are measurable and time-phased. (15 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 the
plan clearly describes applicant's technical approach/methods for
conducting the proposed studies and extent to which the approach/
methods are appropriate and adequate to
[[Page 36919]]
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. Extent to which
applicant describes adequate and appropriate collaboration with CDC (if
proposing a cooperative agreement) and/or others during various phases
of the project. If the proposed project involves human subjects,
whether or not exempt from the HHS regulations, the extent to which
adequate procedures are described for the protection of human subjects,
and the extent that women, racial and ethnic minority populations are
appropriately represented in applications involving human research. (35
points)
c. Extent to which applicant provides a detailed and adequate plan
for evaluating progress toward achieving project process and outcome
objectives. (5 points)
4. Budget (Not Scored)
Extent to which the proposed budget is reasonable, clearly
justifiable, and consistent with the intended use of grant/cooperative
agreement funds.
Executive Order 12372 Review
This program is not subject to Executive Order 12372 Review.
Public Health System Reporting Requirements
This program is not subject to the Public Health System Reporting
Requirements.
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 grant/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.
In addition to other applicable committees, Indian Health Service
(IHS) institutional review committees also must review the project if
any component of IHS will be involved or will support the research. If
the Native American community is involved, its tribal government must
also approve that portion of the project applicable to it.
Women, Racial and Ethnic Minorities
It is the policy of the 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 or Alaska Native, Asian,
Black or African American, Hispanic or Latino, Native Hawaiian or Other
Pacific Islander. 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, and dated Friday, September 15, 1995.
Animal Subjects
If the proposed project involves research on animal subjects, the
applicant must comply with the ``PHS Policy on Humane Care and Use of
Laboratory Animals by Awardee Institutions.'' An applicant organization
proposing to use vertebrate animals in PHS-supported activities must
file an Animal Welfare Assurance with the Office for Protection from
Research Risks at the National Institutes of Health.
Application Submission and Deadline
The original and five complete copies of each application PHS Form
398 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.,
Room 300, Mailstop E-18, Atlanta, GA 30305, on or before October 1,
1998.
1. Deadline: Applications shall be considered as meeting 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 objective review group. (Applicants must request a
legibly dated U.S. Postal Service postmark or obtain a legibly dated
receipt from a commercial carrier or U.S. Postal Service. Private
metered postmarks shall not be acceptable as proof of timely mailing.)
2. Late Applications: Applications which do not meet the criteria
in 1.a. or 1.b. above are 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 and to request an
application kit, call 1-888-GRANTS (1-888 472-6874). You will be asked
to leave your name and address and will be instructed to identify the
announcement number of interest. (Please refer to Announcement Number
99005.) You will receive a complete program description, information on
application procedures and application forms.
If you have questions after reviewing the contents of all the
documents, business management technical assistance may be obtained
from Oppie M. Byrd, Grants Management Specialist, Grants Management
Branch, Procurement and Grants Office, Centers for Disease Control and
Prevention (CDC), 255 East Paces Ferry Road, NE., Room 314, Mailstop E-
18, Atlanta, GA 30305, telephone (404) 842-6546, Facsimile (404) 842-
6513, Internet [email protected].
Programmatic technical assistance may be obtained from Matthew J.
Arduino, M.S., Dr.P.H., National Center for Infectious Diseases,
Hospital Infections Program, Centers for Disease Control and Prevention
(CDC), 1600 Clifton Road, NE., Mailstop C-01, Atlanta, GA 30333,
telephone (404) 639-2318, Internet [email protected].
You may obtain this announcement 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).
[[Page 36920]]
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, D.C. 20402-9325, telephone: (202) 512-1800.
Dated: July 1, 1998.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 98-18017 Filed 7-7-98; 8:45 am]
BILLING CODE 4163-18-P