[Federal Register: July 15, 2003 (Volume 68, Number 135)]
[Notices]
[Page 41812-41815]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jy03-54]
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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
[[Page 41813]]
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.
[[Page 41814]]
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:
Lwalling@cdc.gov.
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: csr9@cdc.gov.
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: aslaughter@cdc.gov.
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