[Federal Register Volume 63, Number 125 (Tuesday, June 30, 1998)]
[Notices]
[Pages 35594-35598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17306]


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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

[[Page 35596]]

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

[[Page 35597]]

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