[Federal Register Volume 64, Number 44 (Monday, March 8, 1999)]
[Notices]
[Pages 11025-11027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5559]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 99018]
Water Intervention Studies To Determine the Fraction of
Gastrointestinal Illness Attributable to Drinking Water; Notice of
Availability of Funds
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 water intervention studies to determine the amount of
gastrointestinal illness attributable to drinking water. This program
addresses the ``Healthy People 2000'' priority area(s) of Immunization
and Infectious Diseases. The purpose of the program is to provide
assistance for conducting two studies: one in a municipality receiving
drinking water from a conventionally treated, surface water source and
a second in a municipality with a ground water source. Since the amount
of waterborne disease in a population can most directly be estimated by
determining the rate of gastrointestinal illness in the community and
multiplying this by an estimate of the percentage of illness that is
attributable to water, these studies will involve measuring both of
these parameters in a population.
B. Eligible Applicants
Applications may be submitted by public and private nonprofit
organizations and by governments and their agencies; that is,
universities, colleges, research institutions, hospitals, other public
and private nonprofit organizations, State and local governments or
their bona fide agents, and federally recognized Indian tribal
governments, Indian tribes, or Indian tribal organizations.
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 $1,800,000 is available in FY 1999 to fund
approximately two awards. It is expected that the average award will be
$900,000 ranging from $900,000 to $1,800,000. It is expected that the
awards will begin on or about April 15, 1999, and will be made for a
12-month budget period within a project period of up to two years. The
funding estimate may change.
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.
D. Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient shall be responsible for the activities under ``Recipient
Activities'' below and CDC shall be responsible for the activities
under ``CDC Activities'' below:
Recipient Activities
1. Develop a study design and protocol.
2. Identify a community where residences are served by a single
water utility.
3. Conduct a household intervention trial that allows determination
of what proportion of illness is attributable to drinking water. For
example, studies have been conducted using intervention devices
installed in household plumbing to eliminate viable pathogens.
Investigators may want to consider conducting a randomized, blinded
trial in which control households receive a sham device.
4. Measure disease outcomes among study participants. Examples of
such outcomes could include: (a) clinically defined diarrhea, (b)
vomiting, (c) laboratory studies of stool from cooperative, ill
participants that would be tested broadly for bacterial, parasitic, and
viral pathogens, and (d) antibody response to specific pathogens such
as Cryptosporidium and caliciviruses in study participants willing to
give serum.
5. Collaborate with the water utility, the American Water Works
Research Foundation (AAWRF) and its collaborators, and others as
appropriate to evaluate the relationship between health outcomes and
physical and microbial water quality data.
6. The recipient(s) will develop a Quality Assurance Project Plan
(QAPP) and will coordinate the plan with EPA to ensure that the results
are of high quality.
7. Determine rates of relevant outcomes in the community in which
the intervention study is being conducted. For example, this could be
done through ongoing, cross-sectional, random telephone surveys of the
population served by the water utility during the study period.
Examples of outcomes that could be measured include signs and symptoms
of gastrointestinal illness, water consumption patterns, days of work
or school missed, etc.
8. Publish the results of the study.
CDC Activities
1. CDC and EPA are available to provide technical assistance in the
design and conduct of the research. If needed, this may include:
a. providing technical consultation in the design and conduct of
the project, including data collection, evaluation, and analytic
approach;
b. facilitating exchange of information among collaborators;
c. performing selected laboratory tests;
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d. participating in analysis of research data and the
interpretation and dissemination of research findings; and
e. providing educational materials, including working with grantees
to develop new materials that might be needed.
2. Assist in the development of a research protocol for IRB review
by all institutions participating in the research project. 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 25 double-spaced pages,
printed on one side, with one inch margins, and unreduced font.
F. Submission and Deadline
Letter of Intent (LOI)
In order to assist CDC in planning and executing the evaluation 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)
name and address of institution, (2) name, address, and phone number of
contact person, and (3) the name and address of the water utility the
applicant intends to collaborate with if awarded this cooperative
agreement, and (4) information regarding whether the source water for
the households the applicant intends to study is from a ground water
source or a surface water source. Notification can be provided by
facsimile, postal mail, or electronic mail (E-mail) to Deborah Levy,
Ph.D., National Center for Infectious Diseases, 4770 Buford Highway,
N.E., Mailstop F-22, Atlanta, Georgia 30341. Facsimile: (770) 488-7761.
E-mail address: DEL7@cdc.gov.
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 May 14, 1999,
submit the application to: Andrea Wooddall, Grants Management
Specialist, Grants Management Branch, Procurement and Grants Office,
Announcement 99018, Centers for Disease Control and Prevention, 2920
Brandywine Road, Room 3000, Atlanta, Georgia 30341
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).
The application should identify a water utility that:
1. For surface water sites: (a) serves a population of
50,000 persons, (b) has a surface water source known to be challenged
with highly variable water quality which at times has evidence of
substantial fecal contamination, (c) is served by only one water
treatment plant and that plant employs standard, conventional treatment
(i.e. coagulation, sedimentation, filtration, and chlorine
disinfection), (d) has source water that is difficult to treat (e.g.
average finished water turbidity 0.1 NTU and/or occasional
spikes of finished water turbidity or particle counts), and (e)
generally does not place treated water in a reservoir for more than 24
hours prior to entering the distribution system; or
2. For ground water sites: (a) serves a population of
25,000 persons, (b) is served solely by ground water, (c) is
not under the direct influence of surface water, and (d) has
information available that will allow inference on likelihood of
microbial source water contamination, e.g. multiyear records of
microbial source water quality and/or well characterized hydrogeology
(such as knowledge of recharge area 1 and sources of fecal
contamination), (e) is disinfected, and (f) is not subject to membrane
filtration or softening; and
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\1\ The recharge area of a well is the land surface from which
water that is drawn into the well originated. Typical sources of
human fecal contamination include septic systems, sewers (which
invariably leak), and rivers subject to sewage treatment plant
discharges.
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3. Contain written assurance from the water utility that it will
collaborate with the grantee, CDC, EPA, AWWARF and its cooperators in
the collection and analysis of physical and microbial water quality
data. The reason for this requirement is that it will be useful to
examine the relationship between water quality indicators and health
outcomes. AWWARF will be simultaneously issuing requests for proposals
(RFPs) for the collection and analysis of physical and microbiological
water quality data from the utilities participating in the studies
funded through this CDC cooperative agreement. One of these RFPs will
be for the surface water site (RFP 2850) and the other for the ground
water site (RFP 2851). These AWWARF RFPs can be found on the World Wide
Web at: http://www.awwarf.com/newprojects/rfps/98rfps.htm. The types of
water quality data collected will be determined by AWWARF, EPA, and the
grantee in collaboration with the utility. It would be advantageous if
the water utility continuously monitors turbidity or particle counts of
water coming from each individual filter bed. Such monitoring would
need to be accompanied by frequent equipment calibration for quality
assurance and quality control; and
4. Provide information regarding the number of households the
applicant anticipates recruiting into the study and the anticipated
drop out rate. The study should have power to detect an attributable
fraction of gastrointestinal illness due to drinking water that is less
than 15 percent. It would be advantageous to be able to detect an
attributable fraction of gastrointestinal illness due to drinking water
that is less than or equal to 10 percent.
G. Evaluation Criteria
Each application will be evaluated individually against the
following criteria by an independent review group appointed by CDC.
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.
2. Capacity and Personnel (35 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. (10 points)
c. Extent to which applicant includes letters of support from the
proposed water utility, non-applicant organizations, individuals, etc.
Extent to which the letters clearly indicate commitment to participate
as described in the operational plan, which must include the water
utility's intent to provide specific water quality data and collaborate
with others involved in the study. If appropriate, the extent to which
letters from non-participating local and State health departments
express their support of the operational
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plan (15 points). Do not include letters of support from CDC or EPA
personnel.
3. Objectives and Technical Approach (55 points total)
a. Extent to which applicant adequately 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 the described cohort and water supply will
be appropriate for achieving the goals of this request for assistance.
Extent to which applicant describes specific study protocols or plans
for the development of study protocols that are appropriate for
achieving project objectives. If there is a laboratory component to the
proposal, the extent to which plans for ensuring quality of
measurements are included. 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. This specifically includes working with CDC and EPA to obtain
human subjects clearances and approval for data collection activities.
Note: Objective Review Group (ORG) recommendations on the
adequacy of protections include: (1) protections appear adequate and
there are no comments to make or concerns to raise, or (2)
protections appear adequate, but there are comments regarding the
protocol, or (3) protections appear inadequate and the ORG has
concerns related to human subjects, or (4) 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. 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 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. (25 points)
c. Extent to which the applicant describes adequate and appropriate
collaboration with CDC, EPA and/or others (e.g. water utilities and
health departments) during various phases of the project. (10 points)
d. Extent to which the applicant provides a detailed and adequate
plan for evaluating study results and for evaluating study results for
evaluating progress toward achieving project objectives. (10 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.
H. Other Requirements
Technical Reporting Requirements
Provide CDC with original plus two copies of
1. Progress reports (annual);
2. Financial status report, no more than 90 days after the end of
the budget period; and
3. Final financial status and performance reports, no more than 90
days after the end of the project period.
Send all reports to: Andrea Wooddall, Grants Management Specialist,
Grants Management Branch, Procurement and Grants Office, Centers for
Disease Control and Prevention, 2920 Brandywine Road, Room 3000,
Atlanta, GA 30341.
The following additional requirements are applicable to this
program. For a complete description of each, see Attachment 1, in 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-9......................... Paperwork Reduction Act Requirements.
AR-10........................ Smoke-Free Workplace Requirements.
AR-11........................ Healthy People 2000.
AR-12........................ Lobbying Restrictions.
AR-14........................ Accounting System Requirements.
AR-15........................ Proof of Non-Profit Status.
I. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under the Public Health Service Act
Sections 301(a)[42 U.S.C. 241(a)], 317(k)(1)(2), [42 U.S.C. 247b
(k)(1)] and [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 99018 when you request
information. For a complete program description, information on
application procedures, an application package, and business management
technical assistance, contact: Andrea Wooddall, Grants Management
Specialist, Grants Management Branch, Procurement and Grants Office,
Announcement 99018, Centers for Disease Control and Prevention, 2920
Brandywine Road, Room 3000, Atlanta, GA 30341, telephone (770) 488-
2751, E-mail address ayw3@cdc.gov.
See also the CDC home page on the Internet: http://www.cdc.gov.
For program technical assistance, contact Deborah Levy, Ph.D.,
Division of Parasitic Diseases, National Center for Infectious
Diseases, Center for Disease Control and Prevention, 4770 Buford
Highway, Mail Stop F22, Atlanta, GA 30341, telephone (770) 488-7760, E-
mail address DEL7@cdc.gov.
To receive additional written information and to request an
application kit, call 1-888-GRANTS4 (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.
Dated: March 2, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention (CDC).
[FR Doc. 99-5559 Filed 3-5-99; 8:45 am]
BILLING CODE 4163-18-P
