# Notice of Availability of Funds; Emerging Infections Program

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A98-15924

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** June 16, 1998
- **Citation:** 63 FR 32882

## Text

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

[[Page 32883]]

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

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A98-15924. Public record. Not legal advice.