Notice of Availability of Funds; Emerging Infections Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 99011]

Notice of Availability of Funds; Emerging Infections Program

A. Purpose

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

availability of fiscal year (FY) 1999 funds for a cooperative agreement

program to establish an Emerging Infections Program (EIP) to join a

national network of EIPs. This program will assist in local, State, and

national efforts to conduct surveillance and applied epidemiologic and

laboratory research in emerging infectious diseases and to pilot and

evaluate prevention measures. This program addresses the ``Healthy

People 2000'' priority area of Immunization and Infectious Diseases.

The purpose of the program is to assist State health departments to

establish new EIPs as part of the national network. EIPs will be

population-based centers designed to assess the public health impact of

emerging infections and to evaluate methods for their prevention and

control.

Activities of the EIPs will fall into the general categories of:

(1) active surveillance; (2) applied epidemiologic and applied

laboratory research; and (3) implementation and evaluation of pilot

prevention/intervention projects.

The EIPs will maintain sufficient flexibility to accommodate

changes in projects as required by the emergence of public health

infectious disease problems. EIPs will be strategically located to

serve a variety of geographical areas, diverse groups and difficult-to-

reach populations--e.g., under-served women and children, the homeless,

immigrants and refugees, and persons infected with HIV. They will

enlist the participation of local health departments, academic

institutions, and other public and private organizations with an

interest in addressing public health issues relating to emerging

infectious diseases, and will seek support from sources, in addition to

CDC, to operate the EIP.

B. Eligible Applicants

Assistance will be provided only to the health departments of

States or their bona fide agents, including the District of Columbia,

the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth

of the Northern Mariana Islands, American Samoa, Guam, federally-

recognized Indian tribal governments, the Federated States of

Micronesia, the Republic of the Marshall Islands, and the Republic of

Palau. In consultation with States, assistance may be provided to

political subdivisions of States.

The following States already participating in the EIP cooperative

agreement program should not apply to this announcement: California,

Connecticut, Georgia, Maryland, Minnesota, New York, and Oregon.

C. Availability of Funds

Up to $1,000,000 is available in FY 1999 to fund two awards. The

average award will be about $500,000. This amount is for both direct

and indirect costs. It is expected that the awards will begin on or

about October 1, 1998, and will be made for a 12-month budget period

within a project period of up to five years. The funding estimate 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.

Note: Per instructions in Evaluation Criteria section below, the

application should include proposals for four projects. CDC will

select from one to four of those projects to fund based on the

capacity of the applicant, priorities of the EIP network, and

availability of resources.

Funding Preferences

EIPs are currently established in the seven following states:

California, Connecticut, Georgia, Maryland, Minnesota, New York, and

Oregon. To achieve appropriate geographical representation in the EIP

network, for one of the two potential awards made under this

announcement, funding preference may be given to approved applications

from States in Standard Federal Regions VI, VII, and VIII.

Region VI: Arkansas, Louisiana, New Mexico, Oklahoma, Texas

Region VII: Iowa, Kansas, Missouri, Nebraska

Region VIII: Colorado, Montana, North Dakota, South Dakota, Utah,

Wyoming

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D. Program Requirements

Recipient Activities

1. Establish and operate an EIP to further local, State, and

national efforts to address emerging infectious diseases:

a. Organize the EIP so that it will have the capacity to conduct

approximately three concurrent projects.

b. Organize the EIP so that it will maintain the ability to

accommodate changes in specific projects and priorities as the public

health system's need for information changes or new health problems

emerge.

c. Operate the EIP so that it can function effectively as part of a

national network of EIPs. Collaborate with CDC and other EIP sites,

through the EIP steering committee and otherwise, to coordinate project

priorities and to assure that important emerging infections issues are

addressed appropriately.

d. Establish the EIP in a defined population, which could include

either an entire State or a geographically defined area (or areas)

within a State. To accomplish the objectives of certain EIP activities,

a minimum population base of approximately 1,000,000 may be necessary.

2. Obtain technical and financial assistance to supplement the core

assistance from CDC.

3. Collaborate with other public and private organizations that

have an interest in addressing public health issues relating to

emerging infectious diseases (e.g., local public health agencies,

schools of public health, university medical schools, medical

examiners, health care providers, clinical laboratories, community-

based organizations, other Federal and State government agencies,

research organizations, medical institutions, foundations, etc.).

4. Propose and conduct emerging infections activities in

collaboration with appropriate partner organizations. Collaborate with

other EIPs, as appropriate, to finalize protocols for and conduct EIP

activities.

a. Categories of EIP activities. Activities of the EIP will fall

into three categories:

(1) Active population-based surveillance projects. These may

include collection and submission of disease-causing infectious agents

to State, CDC, or other laboratories. For example, the surveillance

case definition for the condition might involve detection of a positive

culture or a drug resistant isolate in a microbiology laboratory, a

serologic test result, a histopathologic finding, or a clinical

syndrome, depending upon the disease or condition under surveillance;

the specific approach to surveillance could also vary depending on the

disease or condition under surveillance. Surveillance should be

comprehensive (e.g., inclusion of audits to assure complete reporting),

with active rather than passive case-finding.

(2) Applied epidemiologic and applied laboratory projects. Examples

of potential projects include: evaluation of illnesses often not

specifically diagnosed for which information about trends and etiology

are important (e.g., diarrhea, community-acquired pneumonia);

evaluation of clinical outcomes or risk factors for drug resistant

infections; and evaluation of the clinical spectrum of influenza and

the efficacy of influenza vaccines in target populations.

(3) Implementation and evaluation of pilot prevention/intervention

projects for emerging infectious diseases. Examples might include

assessment of efforts to promote safe food preparation in the home,

evaluation of impact of hand-washing promotion on infectious diseases

in child-care facilities, or evaluation of antibiotic prescribing

practices in out-patient settings.

b. Specific EIP activities. In the application, propose a total of

4 projects from the following list (see Applicant Content section for

details):

Required (propose both):

(1) Active population-based laboratory surveillance for foodborne

diseases and related activities (FoodNet).

(2) Active Bacterial Core Surveillance (ABCs) activities.

Optional (select and propose 2 of the following):

(3) Active surveillance for syndromes of possibly infectious

etiology (e.g., encephalitis, fulminant hepatitis).

(4) A collaboration with one or more managed-care organizations on

a surveillance, risk factor, or pilot prevention project.

(5) A project to quantify or otherwise explore linkages between

chronic and infectious diseases.

5. As a part of certain EIP projects, provide specimens such as

disease-causing isolates or serum specimens to appropriate

organizations (which may include CDC) for laboratory evaluation (e.g.,

molecular epidemiologic studies, evaluation of diagnostic tools).

6. Manage, analyze, and interpret data from EIP projects, and

publish and disseminate important public health information stemming

from EIP projects in collaboration with CDC.

7. Monitor and evaluate scientific and operational accomplishments

and progress in achieving the purpose of this program.

8. Provide training opportunities at the EIP site (e.g., infectious

disease fellows, laboratory fellows, public health students) that are

consistent with the purpose of this announcement.

CDC Activities

1. Provide consultation, scientific, and technical assistance in

general operation of the EIP and in designing and conducting individual

EIP projects.

2. Participate in analysis and interpretation of data from EIP

projects. Participate in the dissemination of findings and information

stemming from EIP projects.

3. Assist in monitoring and evaluating scientific and operational

accomplishments of the EIP and progress in achieving the purpose and

overall goals of this program.

4. As needed, perform laboratory evaluation of specimens or

isolates (e.g., molecular epidemiologic studies, evaluation of

diagnostic tools) obtained in EIP projects and integrate results with

other data from EIP projects.

E. Application Content

Use the information in the Program Requirements, Other

Requirements, and Evaluation Criteria sections to develop the

application. Your application will be evaluated on the criteria listed,

so it is important to follow them in preparing your program plan.

Applications should address the following topics in the order

presented:

1. Understanding the objectives of the EIP;

2. Description of the population base for the EIP;

3. Description of existing capacity to assess, control, and prevent

emerging infectious diseases;

4. Operational plan (including 4 project proposals as described

below);

5. Personnel qualifications and management plan;

6. Evaluation plan; and

7. Budget.

Applicants should propose a total of 4 projects from the following

list of activities.

Note: Two of the four projects proposed must be the FoodNet and

ABC's projects (numbers 1 and 2 below). The other two should be

selected from numbers 3-5 below. Each specific project proposal

should be clearly identified in a distinct portion of the

Operational Plan and should not exceed 3 pages. Though the

activities described below address distinct issues and needs, they

may be implemented in an integrated manner such that staff members

work on more than one activity (supplies and equipment are shared,

etc.):

[[Page 32884]]

1. Population-based laboratory surveillance for foodborne diseases

and related activities (FoodNet): Conduct population-based laboratory

surveillance including completion of case reports (which include

demographic information as well as information about the diagnosis and

outcome) and collection of disease-causing isolates--for seven

bacterial and two parasitic foodborne pathogens (Salmonella, E. coli

O157, Campylobacter, Shigella, Listeria, Yersinia, Vibrio,

Cryptosporidium and Cyclospora). Completeness of surveillance should be

verified by periodic (at least yearly) audits of area laboratories. In

these audits, records in each laboratory should be reviewed and case

report form information should be completed on cases not identified

through the routine surveillance. Since this core activity will be done

in collaboration with other EIP sites and CDC, the project should be

designed so that data can be integrated with data from the other EIPs.

Additional core activities for foodborne disease surveillance: (a)

systematic survey of physician and laboratory practices regarding

diagnostic practices for diarrheal pathogens (similar to those done in

other sites), (b) active hemolytic uremic syndrome (HUS) surveillance

through pediatric nephrologists, (c) pulsed-field gel electrophoresis

(PFGE) of all E. coli O157 from catchment area, as part of expanding

national network, and when the method is ready to be applied, PFGE of

Salmonella typhimurium isolates, (d) participation in national

antimicrobial resistance surveillance, and (e) surveillance for

outbreaks of calicivirus gastroenteritis and/or endemic calicivirus

gastroenteritis.

2. Active Bacterial Core Surveillance (ABCs) activities:

Population-based laboratory surveillance for invasive disease caused by

emerging, vaccine preventable, and drug resistant bacterial diseases.

Conduct active population-based laboratory surveillance including

completion of case reports (which include demographic information as

well as information about the diagnosis and outcome) and collection of

disease-causing isolates for invasive bacterial disease caused by

Streptococcus pneumoniae, Haemophilus influenzae, Neisseria

meningitidis, groups A and B streptococci, Vancomycin-resistant

enterococcus and Listeria monocytogenes. Collect additional

demographic, medical, and vaccination history information on all

invasive Haemophilus influenzae cases in persons less than 15 years of

age (very small numbers). Collect additional information in cases of

early-onset group B streptococcus disease. Completeness of surveillance

should be verified by periodic (semiannual) audits of area

laboratories. In these audits, records in each laboratory should be

reviewed and case report form information should be completed on cases

not identified through the routine surveillance. Since this core

activity will be done in collaboration with the other EIP sites and

CDC, the project should be designed so that data can be integrated with

data from the other EIPs.

3. Active surveillance for syndromes of possibly infectious

etiology: (For example: encephalitis, fulminant hepatitis, or

myocarditis.) Protocols for this project should be developed together

with CDC and the EIP sites involved in the current EIP project on

Unexplained Deaths and Critical Illnesses Possibly Due to Infections.

4. Collaboration with managed-care organizations. (For example,

collaborations with one or more managed-care organizations might

include surveillance of infectious syndromes or piloting and evaluation

of prevention projects.) Emphasis should be on infectious diseases of

public health importance.

5. Linkages between chronic and infectious diseases. (For example,

projects might seek to quantify or otherwise explore links between

chronic diseases and infectious diseases (e.g., hepatitis C and chronic

liver disease; infections due to Chlamydia pneumoniae and

atherosclerosis; mycoplasma infections and asthma, human papilloma

virus and cervical cancer, genital infections and premature birth, or

others.)

Funding in future years may permit implementation of projects which

are developed and implemented by individual EIP sites. Briefly describe

activities which the applicant would propose to implement in the EIP in

the future if given the opportunity.

Page Limitations

The application narrative (excluding budget, appendices, and

required forms) must not exceed 25 single-spaced pages, printed on one

side, with one inch margins, and unreduced font. Only the following

information should be presented in appendices: Letters of support,

documentation of bona fide agent status, curricula vitaes, and budget.

All other materials or information that should be included in the

narrative will not be accepted if placed in the appendices.

Budget Instructions

For each line-item (as identified on the Form 424a of the

application), show both Federal and non-Federal (e.g., State funding)

shares of total cost for the EIP. For each staff member listed under

the Personnel line item, indicate their specific responsibilities

relative to each of the proposed projects. Include provisions for

travel of the principal investigator and one EIP participant to two

meetings at CDC in Atlanta during the first year of the program.

Bona Fide Agent Status

If applicant is an agent of a State public health agency and not a

State public health agency itself, documentation that applicant is

acting as a bona fide agent of a State public health agency should be

provided in an appendix. Applicants acting as bona fide agents of a

State public health agency are strongly encouraged to consult with

CDC's Grants Management Specialist (identified in Section J below)

prior to submitting the application for guidance regarding what

constitutes acceptable documentation.

F. Submission and Deadline

Notice of Intent To Apply

In order to assist CDC in planning and executing the evaluation of

applications submitted under this announcement, all parties intending

to submit an application are requested to inform CDC of their intention

to do so at least ten (10) days prior to the application due date.

Notification should include: (1) name and address of institution, and

(2) name, address, and telephone number of contact person. Notification

should be provided by facsimile, postal mail, or E-mail, to Laura Conn,

National Center for Infectious Diseases (NCID), Centers for Disease

Control and Prevention (CDC), 1600 Clifton Road, NE., Mailstop C-12,

Atlanta, GA 30333, E-mail address [email protected], Facsimile (404) 639-

4197.

Application

Submit the original and two copies of PHS 5161-1 (OMB Number 0937-

0189). Forms are provided in the application kit. On or before July 31,

1998, submit the application to: Oppie Byrd, Grants Management

Specialist, Grants Management Branch, Procurement and Grants Office,

Announcement 99011, Centers for Disease Control and Prevention (CDC),

255 East Paces Ferry Road, NE., Room 300, Mailstop E-18, Atlanta, GA

30305-2209

If your application does not arrive in time for submission to the

independent review group, it will not be considered

[[Page 32885]]

in the current competition unless you can provide proof that you mailed

it on or before the deadline (i.e., receipt from U.S. Postal Service or

a commercial carrier; private metered postmarks are not acceptable).

G. Evaluation Criteria

Each application will be evaluated individually against the

following criteria by an independent review group appointed by CDC.

Your application should address each section in the order presented

below:

1. Understanding the objectives of the EIP (10 points)

a. Demonstration of a clear understanding of the background and

objectives of this cooperative agreement program.

b. Demonstration of a clear understanding of the requirements,

responsibilities, problems, constraints, and complexities that may be

encountered in establishing and operating the EIP.

c. Demonstration of a clear understanding of the roles and

responsibilities of participation in the EIP network.

2. Description of the population base of the EIP area (10 points).

a. Clear definition of the geographic area and population base in

which the EIP will operate. Detailed description of the demographics of

the proposed population base.

b. Clear description of various special populations within the

defined population base as they relate to the proposed activities of

the EIP, such as the rural or inner city poor, under served women and

children, the homeless, immigrants and refugees, and persons infected

with HIV.

c. Extent to which the population base is diverse in terms of

demographics and special populations.

3. Description of existing capacity to assess, control and prevent

emerging infectious diseases: (35 points)

a. Description of applicant's past experience in conducting active

surveillance, applied epidemiologic research, applied laboratory

research, and prevention research, in general, and on emerging

infectious diseases, including antimicrobial drug resistant, foodborne

and waterborne, currently or potentially vaccine preventable, and

opportunistic diseases.

b. Demonstration of applicant's ability to develop and maintain

strong cooperative relationships with both public and private, local

and regional, medical, public health, laboratory, academic, and

community organizations. Evidence of applicant's ability to solicit and

secure programmatic collaboration, and financial and technical support

from such organizations.

c. Demonstration of support from non-applicant participating

agencies, institutions, organizations, laboratories, individuals,

consultants, etc., indicated in applicant's operational plan. Applicant

should provide (in an appendix) letters of support which clearly

indicate collaborators' willingness to be participants in the EIP. Do

not include letters of support from CDC personnel.

4. Operational plan (40 points).

a. The extent to which the applicant's plan for establishing and

operating the population-based EIP clearly describes the proposed

organizational and operating structure/procedures and clearly

identifies the roles and responsibilities of all participating

agencies, organizations, institutions, and individuals. The extent to

which the applicant describes plans for collaboration with CDC and

other EIP sites in the establishment and operation of the EIP and

individual EIP projects, including project design/development (e.g.,

protocols), management and analysis of data, and synthesis and

dissemination of findings.

b. Description of applicant's partnerships with necessary and

appropriate organizations for establishing and operating the proposed

EIP and for conducting individual EIP projects.

c. Description of plans to provide training opportunities for

providers-in-training (e.g., infectious disease fellows, laboratory

fellows, public health students).

d. Description of a plan to solicit and secure financial and

technical assistance from other public and private organizations (e.g.,

schools of public health, university medical schools, public health

laboratories, community-based organizations, other Federal and State

government agencies, research organizations, foundations, etc.) to

supplement the core funding from CDC.

e. Quality of the proposed projects (as requested in the

Application Content section above) regarding consistency with public

health needs, intent of this program, feasibility, methodology/

approach, and collaboration/participation of partner organizations. The

degree to which the applicant has met 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 community(ies) and recognition of mutual benefits.

5. Personnel qualifications and management plan.

a. Identification of applicant's key professional personnel to be

assigned to the EIP and EIP projects (provide curriculum vitae for each

in an appendix). Clear identification of their respective roles in the

management and operation of the EIP. Descriptions of their experience

in conducting work similar to that proposed in this announcement.

b. Identification of key professional personnel from other

participating or collaborating institutions, agencies, organizations

outside of the applicant's agency that will be assigned to EIP

activities (provide curriculum vitae for each in an appendix). Clear

identification of their respective roles.

c. Description of all support staff and services to be assigned to

the EIP.

d. Description of approach to maintaining sufficiently flexible EIP

staffing to accommodate the likelihood that the requirements of EIP

projects will change from time to time due to changes in the public

health system's need for information or the emergence of new diseases.

6. Evaluation (5 points).

a. Quality of plan for monitoring and evaluating scientific and

operational accomplishments of the EIP and of individual EIP projects.

b. Quality of plan for monitoring and evaluating progress in

achieving the purpose and overall goals of this cooperative agreement

program.

7. Budget (not scored).

Extent to which the line-item budget is detailed, clearly

justified, and consistent with the purpose and objectives of this

program. Extent to which applicant shows both Federal and non-Federal

(e.g., State funding) shares of total cost for the EIP.

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).

8. Human Subjects (not scored).

[[Page 32886]]

Does the application adequately address the requirements of Title

45 CFR Part 46 for the protection of human subjects?

____ Yes ____ No Comments:__________

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. Semiannual progress reports. The first semiannual report is

required with each year's continuation application and should cover

program activities from beginning of the current budget period to date

of report/application preparation. The second semiannual report is due

90 days after the end of each budget period and should cover activities

for the entire budget period recently completed. This second report may

simply be a ``cut/paste'' update of the first semiannual (partial

budget period) report to add information from date of first report to

the end of the budget period.

2. Financial Status Report (FSR), no more than 90 days after the

end of the budget period; and

3. Final FSR and performance reports, no more than 90 days after

the end of the project period. Send all reports to: Oppie Byrd, Grants

Management Specialist, Grants Management Branch, Procurement and Grants

Office, Centers for Disease Control and Prevention (CDC), 255 East

Paces Ferry Rd., NE., Rm. 300, Mailstop E-18, Atlanta, GA 30305-2209.

The following additional requirements are applicable to this

program. For a complete description of each, see Attachment I in the

application kit.

AR98-1 Human Subjects Requirements

AR98-2 Requirements for Inclusion of Women and Racial and Ethnic

Minorities in Research

AR98-7 Executive Order 12372 Review

AR98-9 Paperwork Reduction Act Requirements

AR98-10 Smoke-Free Workplace Requirements

AR98-11 Healthy People 2000

AR98-12 Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under Sections 301(a) and 317(k)(1)(2)

of the Public Health Service Act [42 U.S.C. sections 241(a) and

247b(k)(1)(2)], as amended. The Catalog of Federal Domestic Assistance

number is 93.283.

J. Where To Obtain Additional Information

To receive additional written information and to request an

application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked

to leave your name and address and will be instructed to identify the

Announcement number of interest.

If you have questions after reviewing the contents of all the

documents, business management technical assistance may be obtained

from Oppie Byrd, Grants Management Specialist Grants Management Branch,

Procurement and Grants Office, Announcement 99011, Centers for Disease

Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300,

Mailstop E-18, Atlanta, GA 30305-2209, Telephone (404) 842-6546, E-mail

address: [email protected].

For program technical assistance, contact Robert W. Pinner, M.D.,

or Pat McConnon, M.P.H., Office of the Director, National Center for

Infectious Diseases, Centers for Disease Control and Prevention (CDC),

Mailstop C-12, 1600 Clifton Road, NE., Atlanta, GA 30333, Telephone

(404) 639-2603, E-mail address for Dr. Pinner: [email protected]/E-mail

address for Mr. McConnon: [email protected].

See also the CDC homepage on the Internet: http://www.cdc.gov

Potential applicants may obtain a copy of ``Addressing Emerging

Infectious Disease Threats: A Prevention Strategy for the United

States'' through the Centers for Disease Control and Prevention (CDC),

National Center for Infectious Diseases, Office of Planning and Health

Communication--EP, Mailstop C-14, 1600 Clifton Road, NE., Atlanta, GA

30333. Requests may also be sent by facsimile to (404) 639-3039.

Dated: June 10, 1998.

John L. Williams,

Director, Procurement and Grants Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98-15924 Filed 6-15-98; 8:45 am]

BILLING CODE 4163-18-P