[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

[[Page 3139]]

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: 
[email protected].
    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: [email protected].
    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