Water Intervention Studies To Determine the Fraction of Gastrointestinal Illness Attributable to Drinking Water; Notice of Availability of Funds

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: DEL[email protected].

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 [email protected].

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 DEL[email protected].

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