[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: 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