[Federal Register Volume 68, Number 127 (Wednesday, July 2, 2003)]
[Notices]
[Pages 39569-39572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16678]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03102]


Expanding Existing Surveillance Systems To Include Pfiesteria, 
Other Harmful Algal Blooms, and Marine Toxins; Notice of Availability 
of Funds

    Application Deadline: August 1, 2003

A. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under section 301 of the Public Health 
Service Act, [42 U.S.C. section 241], as amended. The Catalog of 
Federal Domestic Assistance number is 93.283.

B. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2003 funds for a cooperative agreement 
program for Expanding Existing Surveillance Systems to Include 
Pfiesteria, Other Harmful Algal Blooms, and Marine Toxins. This program 
addresses the ``Healthy People 2010'' focus area Environmental Health.
    The purpose of the program is to assist state and local public 
health departments with expanding surveillance activities for adverse 
human health outcomes and exposure to waters contaminated with not only 
Pfiesteria, but also other harmful algae, their toxins, or other marine 
toxins.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the National Center for Environmental 
Health (NCEH): Increase the capacity of state and local health 
departments to deliver environmental health services in their 
communities.

C. Eligible Applicants

    Applications may be submitted by: state and local governments or 
their bona fide agents (this includes the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of 
the Northern Marianna Islands, American Samoa, Guam, the Federated 
States of Micronesia, the Republic of the

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Marshall Islands, and the Republic of Palau), and political 
subdivisions of states (in consultation with states).
    To be eligible, applicants must:
    1. Provide evidence of an existing surveillance system(s) for 
Pfiesteria or other harmful algae, their toxins, or other marine 
toxins. This may be demonstrated through a letter from your 
organization's leadership and a copy of a recent surveillance report 
print out.
    2. Demonstrate your organization has capacity and experience 
providing surveillance activities for adverse human health outcomes and 
exposure to waters contaminated with Pfiesteria, other harmful algae, 
their toxins, or other marine toxins. This may be demonstrated through 
letters of support.
    This information should be placed directly behind the face page 
(first page) of your application. Applications that fail to submit 
evidence requested above will be considered non-responsive and returned 
without review.

    Note: Title 2 of the United States Code section 1611 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant or loan.

D. Funding

Availability of Funds

    Approximately $3,000,000 is available in FY 2003 to fund 
approximately six to eight awards. It is expected that the average 
award will be $500,000, ranging from $250,000 to $750,000. It is 
expected that the awards will begin on or about September 1, 2003 and 
will be made for a 12-month budget period within a project period of up 
to three years. Funding estimates may change.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.

Recipient Financial Participation

    No matching funds are required for this program.

E. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities listed in 1. 
Recipient Activities, and CDC will be responsible for the activities 
listed in 2. CDC Activities.
1. Recipient Activities
    All proposed activities should be planned and conducted in 
collaboration and coordination with CDC by state/local health 
departments, and where appropriate, in consultation with:
    [sbull] Appropriate state and local professional associations.
    [sbull] Health care providers and institutions serving, diagnosing, 
or providing treatment and care for persons having symptoms related to 
exposure to Pfiesteria, harmful algal blooms, or marine toxins, 
including laboratories conducting testing.
    [sbull] Relevant community groups and organizations.
    [sbull] Universities and health research agencies.
    Surveillance activities should:
    a. Target individuals with high risk of exposure to waters 
containing harmful algae, including Pfiesteria piscicida.
    b. Conduct investigations of all cases of Pfiesteria-related 
illnesses meeting the set of exposure conditions and clinical signs and 
symptoms previously agreed upon by State and Federal partners to 
determine risk factors for illness, and to consider banking clinical 
materials for future laboratory confirmation of exposure.
    c. Conduct investigations of illnesses associated with harmful 
algae to determine risk factors for illness and to consider banking 
clinical materials for future laboratory confirmation of exposure.
    d. Develop and conduct surveillance activities to identify 
potential sources of exposure to harmful algae, including P. piscicida 
and Pfiesteria-like organisms, and bank clinical samples for future 
analysis.
    e. Regularly report information collected using the pre-existing 
PEAS (Possible Estuary Associated Syndrome) surveillance software to 
the aggregate database that is housed at CDC.
    f. Assess clinical data on people with illnesses related to 
exposure to harmful algae.
    g. Develop and implement appropriate preventive strategies and 
develop information materials for use by health professionals and the 
public to aid in prevention and control of illnesses associated with P. 
piscicida and other harmful algae.
    Applicants may include several research activity projects within 
their proposal. If applying for the research funding, suggested 
examples of the specific areas of research activities may include:
    a. Laboratory studies to further define the biological impacts 
associated with the presence of P. piscicida, other harmful algae, and 
the toxins they produce.
    b. Further characterization of the environmental impact on 
estuarine waters associated with the presence of P. piscicida, other 
harmful algae, and the toxins they produce.
    c. Exploring the impact of anthropogenic nutrient sources on the 
composition of phytoplankton communities in drinking water sources and 
recreational waters.
    d. Examining the potential for human health effects from chronic 
low-level exposures to toxins produced by similar organisms.
2. CDC Activities
    a. Provide consultation and scientific and technical assistance and 
training, surveillance, epidemiologic research, laboratory and 
prevention activities.
    b. As needed, assist in refining the format for reporting 
surveillance data including case report forms, database, and 
maintaining the reporting system.
    c. Participate with states to reach mutually agreed upon 
standardized study protocols and, where appropriate, data collection 
instruments for projects or studies.
    d. Assist in preparing standard data collection forms, 
questionnaires, etc., as needed in surveillance activities and special 
epidemiologic investigations.
    e. 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.
    f. 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.
    g. Assist in the development of a research protocol for 
Institutional Review Board (IRB) review by all cooperating institutions 
participating in the research project. The CDC IRB will review and 
approve the protocol initially and on at least an annual basis until 
the research project is completed.

F. Content

Letter of Intent (LOI)

    A LOI is required for this program. The Program Announcement title 
and number must appear in the LOI. The narrative should be no more than 
5 pages, double-spaced, printed on one side, with one-inch margins, and 
unreduced 12-point font. Your letter of intent will be used to enable 
CDC to determine the level of interest in the announcement, and should 
include the following information:
    a. Organization name and address.
    b. Project Director and telephone number.
    c. An abstract briefly summarizing the surveillance program for 
which funds are requested, including the activities to be undertaken 
and an estimated budget.

[[Page 39571]]

    d. If also applying for funding for research activities, a brief 
description of the activities to be undertaken for each research 
project/activity and an estimated budget for each.

Applications

    The Program Announcement title and number must appear in the 
application. Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Your application will be evaluated on the criteria 
listed, so it is important to follow them in laying out your program 
plan. The narrative should be no more than 25 pages, double-spaced, 
printed on one side, with one-inch margins, and unreduced 12-point 
font.
    The narrative should consist of a description of the planned first 
year activities, and clearly lay out future year objectives and 
activities to be conducted over the entire three-year project period. 
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. Budget justification.
    e. Human Subjects review.

G. Submission and Deadline

Letter of Intent (LOI) Submission:

    The LOI must be received by 4 p.m. Eastern Time, July 16, 2003. 
Submit the LOI to the Grants Management Specialist identified in the 
``Where To Obtain Additional Information'' section of this 
announcement. The LOI may not be submitted electronically.

Application Forms

    If applying for surveillance funding, submit the signed original 
and two copies of PHS 5161-1 (OMB Number 0920-0428). If applying for 
research funding, submit the signed original and two copies of PHS 398 
should be utilized. Forms are available at the following Internet 
address: www.cdc.gov/od/pgo/forminfo.htm.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.

Submission Date, Time, and Address

    The application must be received by 4 p.m. Eastern Time, August 1, 
2003. Submit the application to: Technical Information Management-
PA03102, CDC Procurement and Grants Office, 2920 Brandywine 
Road, Atlanta, GA 30341-4146.
    Applications may not be submitted electronically.

CDC Acknowledgement of Application Receipt

    A postcard will be mailed by PGO-TIM, notifying you that CDC has 
received your application.

Deadline

    Letters of intent and applications shall be considered as meeting 
the deadline if they are received before 4 p.m. Eastern Time on the 
deadline date. Any applicant who sends their application by the United 
States Postal Service or commercial delivery services must ensure that 
the carrier will be able to guarantee delivery of the application by 
the closing date and time. If an application is received after closing 
due to (1) carrier error, when the carrier accepted the package with a 
guarantee for delivery by the closing date and time, or (2) significant 
weather delays or natural disasters, CDC will upon receipt of proper 
documentation, consider the application as having been received by the 
deadline.
    Any application that does not meet the above criteria will not be 
eligible for competition, and will be discarded. The applicant will be 
notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Application

    Applicants are required to provide measures of effectiveness that 
will demonstrate the accomplishment of the various identified 
objectives of the cooperative agreement. Measures of effectiveness must 
relate to the performance goals stated in the purpose section of this 
announcement. Measures must be objective and quantitative and must 
measure the intended outcome. These measures of effectiveness must be 
submitted with the application and will be an element of evaluation.
    An independent review group appointed by CDC will evaluate each 
application against the following criteria:
    a. Understanding of the Problem (25 Points):
    The 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 maintain effective surveillance 
systems 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 the 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, methods, and 
evaluations 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 the plans submitted for administering the project.
    f. Budget Justification (Reviewed, but Not Scored):
    Itemized budget for conducting the project, along with 
justification, is provided and is reasonable. The applicant should 
include the costs for one person to travel in Atlanta, GA, to attend 
the 6th National Environmental Health Conference December 3-5, 2003. 
Review the CDC/NCEH web site for

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additional information concerning this conference: http://www.cdc.gov/nceh/default.htm
    g. Human Subjects (Reviewed, but Not Scored)
    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. Not scored, however, an application can 
be disapproved if the research risks are sufficiently serious and 
protection against risks is so inadequate as to make the entire 
application unacceptable.

I. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. An interim progress report, no less than 90 days before the end 
of the budget period. The progress report will serve as your non-
competing continuation application, and must contain the following 
elements:
    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Detailed Line-Item Budget and Justification.
    e. Additional Requested Information.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    3. Final financial and performance reports, no more than 90 days 
after the end of the project period.
    Send all reports to the Grants Management Specialist identified in 
the ``Where to Obtain Additional Information'' section of this 
announcement.
    Projects that involve the collection of information from 10 or more 
individuals and funded by cooperative agreement will be subject to 
review and approval by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act.

Additional Requirements

    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I of the 
program announcement, as posted on the CDC web site.

AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-7 Executive Order 12372 Review
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions

J. Where To Obtain Additional Information

    This and other CDC announcements, the necessary applications, and 
associated forms can be found on the CDC web site, Internet address: 
http://www.cdc.gov. Click on ``Funding'' then ``Grants and Cooperative 
Agreements''.
    For general questions about this announcement, contact: Technical 
Information Management, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2700.
    For business management and budget assistance, contact: Sharron 
Orum, Grants Management Specialist, Procurement and Grants Office, 
Centers for Disease Control and Prevention, 2920 Brandywine Road, 
Atlanta, GA 30341-4146, Telephone: 770-488-2716, E-mail address: 
[email protected].
    For program technical assistance, contact: Dennis Christianson, 
Project Officer, Health Studies Branch, Division of Environmental 
Hazards and Health Effects, National Center for Environmental Health, 
Centers for Disease Control and Prevention, 1600 Clifton Road, NE., 
Mailstop: E23, Atlanta, GA 30333, Telephone: 404-498-1340, E-mail 
address: [email protected].

    Dated: June 26, 2003.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 03-16678 Filed 7-1-03; 8:45 am]
BILLING CODE 4163-18-P