Program Announcement Number 98042; Cooperative Agreement for Waterborne Disease Occurrence Studies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Program Announcement Number 98042; Cooperative Agreement for

Waterborne Disease Occurrence Studies

Introduction

The Centers for Disease Control and Prevention (CDC) announces the

availability of fiscal year (FY) 1998 funds to provide assistance for

conducting waterborne disease occurrence studies that will aid in

producing a national estimate of waterborne disease.

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 Section(s) 301(a), 317(k)(1), and

317 (k)(2) of the Public Health Service Act [42 U.S.C. 241(a),

247b(k)(1) and 247b(k)(2)], as amended.

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

Applications may be submitted by public and private non-profit

entities, including universities; university-affiliated systems

including not-for-profit medical centers; research institutions and

rehabilitation hospitals; State and local health departments and other

related State government agencies; federally recognized Indian tribal

governments, Indian tribes or Indian tribal organizations, and small,

minority- and/or women-owned non-profit businesses are eligible to

apply.

Note: 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 to receive Federal

funds constituting an award, grant, contract, loan, or any other

form.

Availability of Funds

Approximately $450,000 is available in FY 1998 to fund

approximately three awards. It is expected that the average award will

be $150,000. It is expected that the awards will begin on or about

September 30, 1998, and will be made for a 12-month budget period

within a project period of up to two years. 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.

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 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 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 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.

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Background

The last few years have seen increased attention to microbiological

contaminants in drinking water. This concern has led to a number of new

provisions for research and regulation of such contaminants in the

August 1996 Amendments to the Safe Drinking Water Act (SDWA) P.L. 104-

182. Section 137(d) of the 1996 amendments, 42 U.S.C. Section 300j-18d

calls for waterborne disease occurrence studies to estimate the

incidence of waterborne disease in the United States. Only a limited

number of studies have been done to develop such an estimate, in part

because some of the methodologies needed require further refinement and

experience in conducting studies of this problem is limited.

Unfortunately, no single study or study design will allow such an

estimate to be made with confidence. The Environmental Protection

Agency (EPA) and CDC are collaborating to aid other organizations to

conduct studies regarding the incidence of waterborne disease and

etiologic agents causing waterborne disease. Such studies will

concentrate on gastrointestinal illness due to microbial contaminants

in drinking water, including both well known and emerging bacteria,

viruses, and protozoa. This announcement is not intended to support

studies addressing illness due to chemical contamination.

Purpose

The purpose of this cooperative agreement is to provide assistance

for conducting studies to: (1) estimate the incidence of waterborne

disease due to microbial contamination of drinking water and/or (2)

identify and describe the relationship between measures of water

quality and health outcomes or the evidence of infection due to

gastrointestinal pathogens.

Program Requirements

In conducting activities to achieve the purpose of this program,

the recipient shall be responsible for the activities under A., below,

and CDC shall be responsible for conducting activities under B., below:

A. Recipient Activities

1. identify and describe the population to be studied,

2. identify and describe the water system(s) serving the population

studied,

3. form a collaborative relationship with the water utility(s) and

local health department(s) serving the population to be studied,

4. if appropriate, assess the methods used by the water utility(s)

to measure water quality and obtain water quality data. Describe

surrogate measures of water contamination that would be evaluated,

5. collect data on outcomes of interest and/or identify and

evaluate existing data on these outcomes. If appropriate, collect

specimens from human participants to determine the etiologic agents

causing gastrointestinal illness. Evaluate the likelihood that the

etiologic agents are waterborne,

6. maintain data, including databases, and confidentiality

protections,

7. document your Quality Assurance Project Plan (QAPP), as required

by EPA, for assuring that the data collected are of the expected

quality for their intended use and are properly assessed,

8. analyze data to describe the relationship(s) of the health

outcome(s) with water-related exposure variables,

9. evaluate and describe the generalizability of the study

findings, and

10. analyze collected data and disseminate research results by

appropriate methods such as publication in journals, presentation at

meetings, conferences, etc.

B. CDC Activities

CDC and EPA will provide technical assistance in the design and

conduct of the research. This may include:

(1) providing technical consultation in the design and conduct of

the project, including data collection and analytic approach, and

evaluation;

(2) providing technical assistance regarding special clearances and

approval for human subjects and data collection;

(3) providing format and guidance for QAPP

(4) providing educational materials, including working with

grantees to develop new materials that might be needed; and

(5) facilitating exchange of information among recipients.

Technical Reporting Requirements

An original and two copies of an annual progress report are

required and must be submitted no later than 90 days after the end of

each budget period. These progress reports must include: (1) a

comparison of actual accomplishments to the goals and objectives

established for the period; and (2) the reasons for failure, if

established goals were not met; (3) other pertinent information

including, when appropriate, analysis and explanation of performance

costs significantly higher than expected. All manuscripts published as

a result of the work supported in part or whole by the cooperative

agreement will be submitted with the progress report.

An annual Financial Status Report (FSR) must be submitted no later

than 90 days after the end of each budget period.

The final financial status and progress reports are required no

later than 90 days after the end of the project period. All reports are

submitted to Grants Management Branch, CDC. Please send all reports or

other correspondence 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, N.E.,

Mailstop E-18, Room 314, Atlanta, GA 30305-2209.

Application Content

Application

An original and five copies of the application should be submitted

to the Grants Management Officer, Grants Management Branch, CDC at the

address above. All applicants must develop their application in

accordance with the PHS Form 398 (revised 5/95), information contained

in this cooperative agreement announcement, and the instructions

outlined below. In order to ensure an objective, impartial, and prompt

review.

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 material will be accepted.

4. All material 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 appendixes). 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.

2. Background and Need: Discuss the background and need for the

proposed project. Demonstrate a clear

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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

applicant's 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 plan. Specifically, letters of support from water utilities

that outline the types of data they intend to share should be provided.

Do not include letters of support from CDC or EPA personnel. Letters of

support from CDC or EPA will not be accepted in the application. Award

of a cooperative agreement implies CDC and EPA participation as

outlined in the Program Requirements section of this announcement.

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 all Recipient

Activities. If proposing a two (2) year project, provide a detailed

description of first-year activities and a brief overview of activities

in the second year. 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, EPA, 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. If

proposing a multi-year project, also provide estimated total budget for

each subsequent year.

6. Human Subjects: Whether or not exempt from HHS regulations, if

the proposed project involves human subjects, describe adequate

procedures for the protection of human subjects.

7. Women, Racial, and Ethnic minorities: 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.

Noncompeting Continuation Applications

For noncompeting continuation applications submitted within the

approved project period, include only:

1. brief progress report describing the accomplishments of the

preceding budget period;

2. New or significantly revised items or information (objectives,

scope of activities, operational methods, evaluation), that is not in

the initial application; and

3. Annual budget and justification (budget items that are unchanged

from the preceding budget period do not need re-justification, simply

list the items in the budget and note that they are continuation

items).

Evaluation Criteria

The applications will be reviewed and evaluated according to the

following criteria:

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 non-

applicant organizations, individuals, etc. Extent to which the letters

clearly indicate the author's commitment to participate as described in

the operational plan, such as a water utility's intent to provide

specific water quality data. If appropriate, the extent to which

letters from non-participating local and state health departments

express their support of the operational 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 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. If there is a laboratory

component to the proposal, the extent to which plans for ensuring

quality of measurements are included. The extent the proposed plan

includes the inclusion of women, ethnic, and racial groups in the

proposed research to include (1) 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) a statement as to whether the plans

for recruitment and outreach for study participants include the process

of establishing partnerships with the community and recognition of

mutual benefits will be documented.

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. 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

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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. (25 points)

c. Extent to which 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 applicant provides a detailed and adequate plan

for evaluating study results and 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 cooperative

agreement funds.

Executive Order 12372 Review

Applications are subject to Intergovernmental Review of Federal

Programs as governed by Executive Order 12372 (E.O.), which sets up a

system for State and local government review of proposed Federal

assistance applications. Applicants (other than federally recognized

Indian tribal governments) should contact their State Single Point of

Contact (SPOC) as early as possible to alert them to the prospective

applications and receive any necessary instructions on the State

process. For proposed projects serving more than one State, the

applicant is advised to contact the SPOC for each affected State. A

current list of SPOCs is included in the application kit. Indian tribes

are strongly encouraged to request tribal government review of the

proposed application. If SPOCs or tribal governments have any process

recommendations on applications submitted to CDC, they should forward

them to Sharron Orum, Grants Management Officer, Grants Management

Branch, Procurement and Grants Office, Centers for Disease Control and

Prevention (CDC), 255 East Paces Ferry Road, N.E., Mailstop E-18, Room

314, Atlanta, GA 30305-2209. The due date for State process

recommendations is 30 days after the application deadline date for new

and competing continuation awards (the appropriation for this financial

assistance program was received late in the fiscal year and would not

allow for an application receipt date that would accommodate the 60-day

State recommendation process period). The granting agency does not

guarantee to ``accommodate or explain'' for State process

recommendations it receives after that date.

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 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.

Requirements for Inclusion of Women and Racial and Ethnic Minorities in

Research

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 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.

Application Submission and Deadline

The original and five copies of the completed application PHS Form

398 (revised 5/95), OMB Control Number 0925-0001) 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 314, Mailstop E-

18, Atlanta, GA 30305-2209, on or before August 5, 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 in the current competition 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-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. If you have any questions after

reviewing the contents of all the documents, business management

technical assistance may be obtained from Gladys T. Gissentanna, 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 30305-2209,

(404) 842-6801. E-mail address: [email protected].

Programmatic technical assistance may be obtained from Bill

MacKenzie, MD, Division of Parasitic Diseases, National Center for

Infectious Diseases, Centers for Disease Control and Prevention (CDC),

1600 Clifton Road,

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NE., Atlanta, GA 30333, Telephone: (770) 488-7784. E-mail address:

[email protected]

Please refer to Announcement Number 98042 when requesting

information regarding this program.

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: June 24, 1998.

John L. Williams,

Director Procurement and Grants Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 98-17306 Filed 6-29-98; 8:45 am]

BILLING CODE 4163-18-P