[Federal Register Volume 63, Number 13 (Wednesday, January 21, 1998)]
[Notices]
[Pages 3138-3141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1327]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 98019]
Fiscal Year 1998 Pfiesteria-Related Illness Surveillance and
Prevention
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1998 funds for cooperative agreements
for Pfiesteria-Related Illness Surveillance and Prevention. These
cooperative agreements are intended to strengthen and provide
interstate uniformity for surveillance programs, epidemiologic and
laboratory investigations, prevention and control activities, and
identification of exposed cohorts at the State and local levels.
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 Environmental Health.
(For ordering a copy of Healthy People 2000, see the section Where to
Obtain Additional Information.)
Authority
This program is authorized under section 301(a) and 317 of the
Public Health Service Act, (42 U.S.C. 241(a) and 247b), as amended.
Smoke-Free Workplace
CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the non-use of all tobacco products, and
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities that receive Federal funds and in which education,
library, day care, health care, and early childhood development
services are provided to children.
Restrictions on Lobbying
Applicants should be aware of restrictions on the use of 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
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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 current HHS Appropriations Act expressly prohibits
the use of appropriated funds for indirect or grass roots lobbying
efforts that are designed to support or defeat legislation pending
before State legislatures.
Section 503 of the law provides as follows:
(a) 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.
(b) 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.
Eligible Applicant
Applicants will be limited to the official State public health
departments of States having confirmed (i.e., cases meeting the CDC set
of exposure criteria and clinical signs and symptoms for Pfiesteria) or
suspected cases of Pfiesteria-related illness that are being
investigated by State health departments, or those States with coastal
waters that have been infected by Pfiesteria or Pfiesteria-like
organisms.
The CDC set of exposure criteria and clinical signs and symptoms
for Pfiesteria are defined as: Exposure to estuarine water
characterized by one of the following: (1) Fish with lesions consistent
with Pfiesteria piscicida or morphologically related organisms (MRO)
toxicity (20 percent of at least 50 fish of one species having
lesions); (2) a fish kill with fish having lesions consistent with
Pfiesteria or MRO toxicity; or (3) a fish kill involving fish without
lesions, in the presence of Pfiesteria or MRO, without an alternative
reason for the fish kill. The clinical features include the following
signs and symptoms: (1) Memory loss, (2) confusion, (3) acute skin
burning (upon direct contact with water), or (4) three or more of the
following: a. headaches; b. skin rash; c. eye irritation; d. upper
respiratory irritation; e. muscle cramps; f. nausea/vomiting/diarrhea/
abdominal cramps.
Availability of Funds
Up to $3.5 million will be available in FY 1998 to fund up to 8
awards. Awards for the initial budget period will be based upon the
extent of the problem and are expected to range from approximately
$150,000 to $450,000. The awards will be made on or about March 15,
1998, for a 12-month budget period and a project period of up to 5
years. Funding estimates may vary and are subject to change.
Continuation awards within the project period will be made on the
basis of satisfactory progress and the availability of funds.
Purpose
The purpose of the Pfiesteria-related Surveillance and Prevention
Program is to assist State/local public health departments with: (1)
Surveillance activities for adverse human health outcomes and exposure
to infected waters; (2) epidemiologic studies including objective
review of human health outcomes; (3) laboratory investigations; and (4)
prevention and control activities.
Program Requirements
Cooperative Activities
In conducting activities to achieve the purpose of this program,
the recipient shall be responsible for conducting activities under A.
(Recipient Activities), and CDC will be responsible for conducting
activities under B. (CDC Activities).
A. Recipient Activities
The following activities should be planned and conducted in
collaboration and coordination with CDC by State/local health
departments, and, where appropriate, in consultation with:
--Appropriate State and local professional associations;
--Health care providers and institutions serving, diagnosing, or
providing treatment and care for persons having Pfiesteria-related
symptoms, including laboratories conducting testing;
--Community groups and organizations.
--Universities and health research agencies.
Specific surveillance and prevention activities should:
1. Identify individuals with high risk of exposure to Pfiesteria-
infected waters.
2. Conduct investigation of all cases of Pfiesteria-related
illnesses meeting the CDC set of exposure conditions and clinical signs
and symptoms to determine risk factors for illness and to provide
clinical materials for laboratory confirmation.
3. Develop and conduct surveillance activities to identify
potential sources of exposure to Pfiesteria or Pfiesteria-like
organisms, and provide samples to CDC for additional laboratory
analysis.
4. Assess clinical data on persons with Pfiesteria-related
illnesses to assist in guiding the development of treatment strategies.
5. Develop and implement appropriate prevention strategies and
develop information materials for use by health professionals and the
public to aid in prevention and control of Pfiesteria-related illness.
B. CDC Activities
1. Provide consultation and scientific and technical assistance and
training, in planning, implementing, and evaluating Pfiesteria exposure
cohort studies, surveillance, epidemiologic research, laboratory and
prevention activities.
2. Assist in developing a format for reporting surveillance data
including case report forms, database, and assistance in establishing
and maintaining the reporting system.
3. Bank and conduct laboratory analysis of biological specimens.
4. Participate with States to finalize mutually agreed upon
standardized study protocols and, where appropriate, data collection
instruments for the projects/studies.
5. Coordinate clinical evaluations and studies to assure
comparability of data and therapeutic protocols.
6. Provide or assist in preparing standard data collection forms,
questionnaires, etc., as needed in surveillance activities and special
epidemiologic investigations.
7. Assist in the evaluation of the overall effectiveness of program
operations, including the impact of surveillance data on the
development of public policy, and on targeting and evaluating
prevention activities.
8. Participate in the analysis of information and data gathered
from program activities and facilitate the transfer of information and
technology among all States and communities.
Technical Reporting Requirements
An original and two copies of a semiannual progress report must be
submitted 30 days after the end of each semiannual period. Final
financial and performance reports are due no later than 90 days after
the end of the project period. All reports will be submitted to the
Grants Management Branch, Procurement and Grants Office, CDC.
[[Page 3140]]
Application Content
Applications must be developed in accordance with PHS Form 5161-1
(OMB Number 0937-0189), information contained in the program
announcement and the instructions and format provided below.
1. Abstract
A one-page, single spaced, typed abstract must be submitted with
the application. The heading should include the title of the grant
program, project title, organization name and address, project director
and telephone number. The abstract should briefly summarize the program
for which funds are requested, the activities to be undertaken, and the
applicants's organization and composition. The abstract should follow
application forms and precede the Program Narrative.
2. Program Narrative
The Program Narrative should specifically address all items in the
Program Requirements section of this announcement. The applicant should
provide a description of the planned first year activities, and briefly
describe future year objectives and activities. The criteria listed in
the Evaluation Criteria section will serve as the basis for evaluating
the application; therefore, the narrative of the application should
address the following.
a. Applicant's understanding of the problem.
b. Applicant's ability to carry out the project.
c. Technical and program personnel capability.
d. Women, Racial and Ethnic Minorities. A description of the
proposed plan for the inclusion of both sexes and racial and ethnic
minority populations for appropriate representation.
e. Budget justification.
f. Human Subjects review: The project involves research on human
subjects, and therefore, the applicant must describe and demonstrate
that the project has been subject to initial review by an appropriate
institutional review committee, and that continuing review will occur.
The applicant will be responsible for providing assurance in accordance
with the appropriate guidelines and Human Subjects Assurance form
provided in the application kit.
The Program Narrative section should not exceed 40 double-spaced
pages excluding attachments (e.g., resumes, appendices, etc.). Do not
include a detailed budget or detailed budget justification as part of
the Program Narrative.
An original application and two copies should be submitted. The
original and each copy of the application must be submitted unstapled
and unbound. All material must be typewritten, double-spaced, with un-
reduced type on 8\1/2\'' by 11'' paper, with at least 1'' margins,
headers and footers, and printed on one side only.
All graphics, maps, overlays, etc., should be in black and white
and meet the above criteria.
Omissions or incomplete information may affect the rating of the
application.
Evaluation Criteria
Each application will be reviewed and evaluated individually
according to the following criteria:
A. Understanding of the Problem--25 Points
Extent to which the applicant understands the purpose and
requirements of the program. This includes the extent of the
applicant's identification and description of the problem, the
realistic presentation of objectives to establish effective
surveillance system and prevention programs, and evaluation criteria
established to assess surveillance, epidemiologic research, and
prevention activities.
B. Ability to Carry Out the Project--25 Points
Degree to which the applicant provides evidence of ability to carry
out the proposed project and the extent to which the applicant
documents demonstrated capability to achieve the objectives of the
proposed program. This may include plans, approaches, and methods to be
used in conducting and evaluating surveillance, epidemiologic research,
and prevention programs, and may include collaborating with
universities or other health research agencies.
C. Technical Approach--20 Points
Degree to which proposed objectives are clearly stated, realistic,
measurable, time-phased, and related to the stated purpose of this
project. Also, the adequacy of the proposed surveillance, epidemiologic
research, and prevention plans to achieve the objectives. The degree to
which the applicant has met the CDC Policy requirements regarding the
inclusion of women, ethnic, and racial groups in the proposed project.
This includes: (a) The proposed plan for the inclusion of both sexes
and racial and ethnic minority populations for appropriate
representation; (b) The proposed justification when representation is
limited or absent; (c) A statement as to whether the design of the
study is adequate to measure differences when warranted; and (d) A
statement as to whether the plans for recruitment and outreach for
study participants include the process of establishing partnerships
with communities and recognition of mutual benefits will be documented.
D. Personnel--20 Points
Extent to which professional personnel involved in this project are
qualified, including evidence of experience similar to this project.
E. Plans for Administration--10 Points
Adequacy of plans for administering the project.
F. Funding Requirements--(Not Weighted)
Itemized budget for conducting the project, along with
justification, is provided and is reasonable.
G. Human Subjects--(Not Weighted)
The extent to which the applicant complies with the Department of
Health and Human Services Regulations (45 CFR part 46) regarding the
protection of human subjects.
Executive Order 12372
Applications are subject to the Intergovernmental Review of Federal
Programs as governed by Executive Order (E.O.) 12372.
E.O. 12372 sets up a system for State and local government review
of proposed Federal assistance applications. Applicants should contact
their State Single Point of Contact (SPOC) as early as possible to
alert them to the application and receive any necessary instructions on
the State process. Since the proposed project will serve more than one
State, the applicant is advised to contact the SPOC of each affected
State. A current list of SPOCs is included in the application kit. If
SPOCs have any State process recommendations on the application
submitted to CDC, they should forward them to Ron Van Duyne, Grants
Management Officer, Grants Management Branch, Procurement and Grants
Office, Centers for Disease Control and Prevention (CDC), 255 East
Paces Ferry Road, NE., Room 321, Mailstop E-13, Atlanta, Georgia 30305,
no later than 60 days after the receipt date of the application.
The granting agency does not guarantee to ``accommodate or
explain'' State process recommendations it receives after that date.
[[Page 3141]]
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 for this program
is 93.283.
Other Requirements
Paperwork Reduction Act
Projects that involve the collection of information from 10 or more
individuals and funded by the cooperative agreement will be subject to
review and approval by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act.
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. Assurances 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 assurance in accordance with the appropriate guidelines and
forms provided in the application kit.
Women, Racial and Ethnic Minorities
It is the policy of the CDC to ensure that individuals of both
sexes and the various racial and ethnic groups will be included in CDC-
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, and 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 exists that inclusion is inappropriate or not
reasonable, 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, Friday, September 15, 1995, pages 47947-47951 (a copy
is included in the application kit).
Application Submission and Deadline
The original and two copies of the application, PHS Form 5161-1
(OMB Number 0937-0189), must be submitted to Ron Van Duyne, Grants
Management Officer, Attention: Patrick A. Smith, Grants Management
Specialist, Grants Management Branch, Procurement and Grants Office,
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry
Road, NE., Mailstop E-13, Room 321, Atlanta, Georgia 30305, on or
before February 23, 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 should 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 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 shall not be considered in the current competition for
funding and will be returned to the applicant.
Where To Obtain Additional Information
To receive additional written information call 1-888-GRANTS4. You
will be asked to leave your name, address, and telephone number and
will need to refer to NCEH Announcement 98019. You will receive a
complete program description, information on application procedures,
and application forms. CDC will not send application kits by facsimile
or express mail.
Please refer to announcement number 98019 when requesting
information and submitting an application.
If you have questions after reviewing the contents of all the
documents, business management technical assistance may be obtained
from Patrick Smith, Grants Management Specialist, Grants Management
Branch, Procurement and Grants Office, Centers for Disease Control and
Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop E-13,
Atlanta, Georgia 30305, telephone (404) 842-6803, Internet:
phs3@cdc.gov.
Programmatic technical assistance may be obtained from Lawrence E.
Posey, Health Studies Branch, Division of Environmental Health,
National Center for Environmental Health, Centers for Disease Control
and Prevention (CDC), 1600 Clifton Road, NE., Mailstop F-46, Atlanta,
Georgia 30333, telephone (770) 488-7350, Internet: lep1@cdc.gov.
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 may be obtained through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325, telephone (202)
512-1800.
This and other CDC announcements are available through the CDC
homepage on the Internet. The address for the CDC homepage is: http://
www.cdc.gov.
Dated: January 14, 1998.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 98-1327 Filed 1-20-98; 8:45 am]
BILLING CODE 4163-18-P
