[Federal Register Volume 68, Number 135 (Tuesday, July 15, 2003)]
[Notices]
[Pages 41812-41815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17805]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03188]


Emerging Infections Program--FY03 Competitive Supplement; Notice 
of Availability of Funds

    Application Deadline: August 14, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under the Public Health Service Act 
sections 301(a) [42 U.S.C. 241(a)], 317(k)(1) [42 U.S.C. 247b(k)(1)], 
and 317(k)(2) [42 U.S.C. 247b(k)(2)], as amended. The Catalog of 
Federal Domestic Assistance number is 93.283.

B. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the

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availability of fiscal year (FY) 2003 funds for competitive 
supplemental awards to current grantees of the Emerging Infections 
Programs (EIPs) cooperative agreements. This program addresses the 
``Healthy People 2010'' priority areas of Immunization and Infectious 
Diseases.
    These supplemental funds are available to assist grantees in 
developing and conducting projects in the following two areas:

Project A--Surveillance for Severe Acute Respiratory Syndrome (SARS) 
and Severe Pneumonia Syndrome
Project B--Enhanced surveillance for Viral Hepatitis

    The purpose of these supplemental awards is to complement 
activities associated with the established EIP. EIPs are population-
based centers designed to assess the public health impact of emerging 
infections and to evaluate methods for their prevention and control. 
This program will assist local, state, and national efforts to conduct 
surveillance and applied epidemiologic and laboratory research in 
emerging infectious diseases, and it will enhance bioterrorism 
preparedness.
    Project A--Surveillance for SARS and Severe Pneumonia Syndrome 
Activities (See Appendix 1 as posted with this announcement on the CDC 
Web site):
    The purposes of Project A are to:
    1. Establish flexible, multi-state, long-term population-based 
surveillance for severe pneumonia syndrome.
    2. Facilitate diagnostics for respiratory syndromes posing 
immediate threats/concerns (e.g., SARS, pandemic influenza, a 
bioterrorism agent), developing more effective approaches to 
respiratory disease outbreak investigation.
    3. Characterize pneumonia etiologies at selected institutions.
    Project B--Viral Hepatitis Activities (See Appendix 2):
    The purpose of Project B is to develop model demonstration projects 
for enhanced surveillance for viral hepatitis. The specific objectives 
are to:
    1. Provide stable estimates of the incidence of and risk factors 
for viral hepatitis.
    2. Improve the completeness of case report data and ascertainment 
of cases.
    3. Standardize the application of the case definition for viral 
hepatitis.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the National Center for Infectious 
Diseases: Protect Americans from infectious diseases.

C. Eligible Applicants

    Eligibility for these competitive supplemental awards is limited to 
the ten current Emerging Infections Program grantees: California, 
Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New 
York, Oregon, and Tennessee.
    Eligibility is limited to existing EIP grantees because EIPs are 
population-based centers designed to work as a network to assess the 
public health impact of emerging infections and to evaluate methods for 
their prevention and control. The EIPs are well established with an 
infrastructure in place to provide the necessary foundation for the 
development of novel or innovative surveillance activities such as 
those proposed in this program announcement. EIPs are based in state 
health departments, each having a variety of established 
collaborators--local health departments, laboratorians, infection 
control professionals, healthcare providers, academic institutions, and 
other EIPs in the network.
    Grantees interested in the enhanced surveillance for viral 
hepatitis must have laws or regulations requiring laboratory reporting 
of anti-HAV IgM, anti-HBc IgM, HBsAg, and antibody to HCV or HCV RNA 
(PCR) (HCV reporting preferable, but not required). Eligible health 
departments should have at least 50 reported cases of acute hepatitis A 
and 50 reported cases of acute hepatitis B in 2002. (``HAV''--Hepatitis 
A virus; ``HB''--Hepatitis B; ``HCV''--Hepatitis C virus; ``RNA''--
ribonucleic acid; ``PCR''--polymerase chain reaction).

    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

Project A--Surveillance for SARS and Severe Pneumonia Syndrome
    Approximately $500,000-600,000 is available in FY 2003 for four to 
five awards. Funding will begin on or about September 1, 2003 and be 
made for the remainder of the current EIP budget period that expires 
December 29, 2003. It is expected that individual awards will range 
from $100,000-200,000. Information about subsequent funding, for the 
12-month period beginning with the next EIP cycle on December 30, 2003, 
will be provided with EIP continuation funding guidance and will depend 
on availability of funds.
Project B--Enhanced Surveillance for Viral Hepatitis
    Approximately $300,000-400,000 is available in FY 2003 to fund two 
to three awards. Funding will begin on or about September 1, 2003 and 
be made for the remainder of the current EIP budget period that expires 
December 29, 2003. It is expected that individual awards will range 
from $100,000-200,000. Information about subsequent funding, for the 
12-month period beginning with the next EIP cycle on December 30, 2003, 
will be provided with EIP continuation funding guidance and will depend 
on availability of funds.

Recipient Financial Participation

    Matching funds are not 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
Project A: Surveillance for SARS and Severe Pneumonia Syndrome
    This multi-state surveillance activity will consist of three tiered 
activities, which should be integrated closely with related projects 
currently being conducted by the EIPs:
    a. Establish a flexible, multi-state, long-term population-based 
surveillance for severe pneumonia syndrome. As a first phase of this 
activity, surveillance for health care workers with hospitalized 
pneumonia should be established before the 2003 influenza season.
    (1) Characterize the rate of severe pneumonia and seasonal trends.
    (2) Describe demographic and epidemiologic characteristics of 
patients with severe pneumonia.
    (3) Characterize clinical features of severe pneumonia 
hospitalizations.
    b. Facilitate diagnostics for respiratory syndromes posing 
immediate threats/concerns (e.g., SARS, pandemic influenza, a 
bioterrorism agent).
    (1) When SARS-associated coronavirus (SARS-CoV) diagnostics become 
available to state laboratories: Detect SARS-CoV positive patients 
(including those who don't have a known epidemiologic link).
    (2) Characterize the rate of SARS-CoV positivity among severe 
pneumonia cases.
    (3) Expand facilitated diagnostic testing to other agents of 
concern as they arise and diagnostics become available.

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    c. Characterize pneumonia etiologies at selected institutions
    (1) Identify causes of unexplained pneumonia.
    (2) Refine and simplify pneumonia diagnostics to develop a 
``toolkit'' appropriate for state health departments.
    (3) Store a well-characterized set of specimens from people with 
severe respiratory illness for diagnostic testing/retrospective 
discovery of new pathogens.
Project B: Viral Hepatitis
    a. Acute Hepatitis A and B.
    (1) Establish laboratory-based surveillance for acute hepatitis A 
and B.
    (2) Follow-up reports of laboratory markers of acute hepatitis A 
and B infection (anti-HAV IgM, anti-HBc IgM and/or HBsAg) to determine 
case status.
    (3) Investigate cases of acute hepatitis A and B, and collect data 
on clinical manifestations, laboratory findings, and risk factors. 
Investigations may include provider and patient interview, and medical 
record review.
    (4) Explore the feasibility of collecting serologic specimens on 
acute hepatitis A and B cases.
    b. Acute Hepatitis C.
    (1) Increase the sensitivity and specificity of case reporting 
(activities depend on local mechanism for reporting).
    (2) Explore the feasibility of laboratory-based reporting for acute 
hepatitis C, including linking liver enzyme test results with 
laboratory markers for hepatitis C infection (antibody to HCV, and HCV 
RNA (PCR)).
    c. Chronic Hepatitis B and C (optional activity in first year).
    (1) Develop an unduplicated database of laboratory reports of 
markers of chronic hepatitis B and C infection (antibody to HCV, 
HBsAg).
    (2) Develop a prioritized algorithm for follow-up of laboratory 
reports of markers of chronic hepatitis B and C infection. Contact 
prioritized cases of chronic hepatitis B and C for counseling and 
preventive services.
    2. CDC Activities (for both projects).
    a. Provide consultation and scientific and technical assistance as 
needed in general operations of the studies and in designing and 
conducting individual projects.
    b. Assist in developing collaborative relationships and facilitate 
multi-site collaboration as needed to support the successful completion 
of the project.
    c. Participate in analysis and interpretation of data from the 
project.
    d. As needed, assist in monitoring and evaluating scientific and 
operational accomplishments of the project and progress in achieving 
the purpose and overall goals of the program.
    e. If a proposed project involves research with human subjects and 
CDC scientists will be co-investigators in that research, assist in the 
development of a research protocol for IRB review by all institutions 
participating in the research project. The CDC IRB will review and 
approve the project initially and on, at least, an annual basis until 
the research project is completed.

F. Application Content

    Grantees may apply for supplemental funds for one or both of the 
two described projects. If applying for both projects (A-SARS and B-
Hepatitis), a separate narrative, budget, and budget justification must 
be submitted for each. On Form 424 and in the budget justification, 
applicants should provide a 12-month budget that clearly distinguishes 
the resources requested for ``Project A'' activities and/or ``Project 
B'' activities. The line item budgets for Project A--Surveillance for 
SARS and Severe Pneumonia and for Project B--Hepatitis, should separate 
costs by the separate activities as broken out in the Recipient 
Activities section, above.
    For all activities proposed, the requested budget should be for a 
12-month period; however funding will be awarded only for items that 
can be obligated by the end of the current EIP budget period (December 
29, 2003).
    If requesting funds for any contracts, provide the following 
information for each proposed contract: (1) Name of proposed 
contractor; (2) breakdown and justification for estimated costs; (3) 
description and scope of activities to be performed by contractor; (4) 
period of performance; and (5) method of contractor selection (e.g. 
sole-source or competitive solicitation).
    Use the information in the Program Requirements section to develop 
the application content. Narratives for each Project (A-SARS or B-
Hepatitis), should be no more than five single-spaced pages (not 
including budget and appendices for items such as curricula vitae, 
letters of support, and other similar supporting information). Material 
or information that should be part of the narrative will not be 
accepted if placed in the appendices. Do NOT solicit or submit letters 
of support from CDC personnel.

G. Submission and Deadline

Application Forms

    Submit the signed original and two copies of PHS 5161-1 (OMB Number 
0920-0428). Forms are available at the following Internet address: 
http://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 14, 
2003. Submit the application to: Technical Information Management--
PA03188, 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

    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 goal 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.

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    An independent review group appointed by CDC will evaluate each 
application (separately reviewing Project A--SARS and Project B--
Hepatitis) against the following criteria:
1. Operational Plan (60 points)
    a. Extent to which applicant presents an operational plan for 
initiating and conducting the project, which clearly and appropriately 
addresses all Recipient Activities in the application.
    b. Extent to which applicant clearly identifies specific assigned 
responsibilities of all key professional personnel.
    c. Extent to which the plan clearly describes the applicant's 
technical approach and method for conducting the proposed project and 
the extent to which the plan is adequate to accomplish the objectives.
    d. Extent to which the applicant proposes specific draft study 
protocols or plans for the development of study protocols that are 
appropriate for achieving project objectives.
    e. Extent to which the applicant describes plans for collaboration 
with CDC in initiating the project, developing final protocols, and 
ongoing operation of the project.
    f. Extent to which the applicant describes how they will integrate 
the project(s) with related projects currently being conducted by the 
EIPs (such as with Unexplained Deaths and Critical Illnesses projects).
    g. Does the application adequately address the CDC Policy 
requirements regarding the inclusion of women, ethnic, and racial 
groups in the proposed research. This includes: (1) The proposed plan 
for 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 communities and recognition of mutual 
benefits.
2. Description of Capacity (15 points)
    a. Extent to which applicant demonstrates past experience in 
conducting activities similar to those proposed and that the new 
activities will complement current ones. Applicants that are already 
engaged in the Unexplained Deaths and Critical Illnesses project should 
demonstrate that Surveillance for SARS and Severe Pneumonia Syndrome 
activities will be integrated with ongoing activities.
    b. Extent to which applicant provides evidence that this activity 
can be accomplished while satisfactorily maintaining their ongoing EIP 
activities.
    Extent to which applicant documents accomplishments in conducting 
active surveillance, applied epidemiologic research, laboratory 
research, and prevention research.
    c. Extent to which applicant identifies key personnel with 
appropriate experience for the project.
    Extent to which applicant includes letters of support from proposed 
collaborators indicating essential collaborating organizations or 
individuals and their willingness to participate as proposed. Do not 
include letters of support from CDC personnel.
3. Background (10 points)
    a. Extent to which applicant demonstrates a clear understanding of 
the subject area, particularly as it relates to the local situation.
    b. Extent to which applicant illustrates and justifies the need for 
the proposed project and demonstrates how the project is consistent 
with the purpose and objectives of the EIP and of this cooperative 
agreement supplement.
4. Evaluation (10 points)
    Extent to which applicant provides a detailed and adequate plan for 
evaluating progress toward achieving project process and outcome 
objectives.
5. Measures of Effectiveness (5 points)
    Does the applicant provide Measures of Effectiveness that will 
demonstrate the accomplishment of the various identified objectives of 
the grant? Are the measures objective/quantitative and do they 
adequately measure the intended outcome?
6. Budget (not scored)
    Extent to which the proposed budget is reasonable, clearly 
justified, and consistent with the intended use of the cooperative 
agreement funds.
7. Human Subjects (not scored)
    Does the application adequately address the requirements of Title 
45 CFR part 46 for the protection of human subjects?

I. Other Requirements

Technical Reporting Requirements

    Technical reporting requirements are the same as those under 
grantee's existing EIP cooperative agreement award.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Appendix 3 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-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:

Lynn Walling, Grants Management Specialist, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, e-mail address: 
[email protected].

    For program technical assistance, contact:

Cathy Rebmann, National Center for Infectious Diseases (NCID), Centers 
for Disease Control and Prevention (CDC), 1600 Clifton Rd., NE, 
Mailstop D-59, Atlanta, GA 30333, Telephone (404) 371-5363, e-mail 
address: [email protected].

 or

Angela Slaughter, National Center for Infectious Diseases (NCID), 
Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd., NE, 
Mailstop D-59, Atlanta, GA 30333, Telephone (404) 371-5357, e-mail 
address: [email protected].

    Dated: July 9, 2003.
Sandra R. Manning,
Director, Procurement and Grants Office, Center for Disease Control and 
Prevention.
[FR Doc. 03-17805 Filed 7-14-03; 8:45 am]
BILLING CODE 4163-18-P