[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.
[[Page 35595]]
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: gcg4@cdc.gov.
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,
[[Page 35598]]
NE., Atlanta, GA 30333, Telephone: (770) 488-7784. E-mail address:
wrm0@cdc.gov
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
