[Federal Register Volume 61, Number 125 (Thursday, June 27, 1996)]
[Notices]
[Pages 33524-33528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16389]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement Number 655]


Emerging Infections Program

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1996 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. Although only one award will

[[Page 33525]]

be made in FY 1996, CDC may make additional awards in FY 1997 to 
approved applications received and evaluated under this announcement.
    The CDC is committed to achieving the health promotion and disease 
prevention objectives of ``Healthy People 2000,'' a national activity 
to reduce morbidity and mortality and improve the quality of life. This 
announcement is related to the priority area of Immunization and 
Infectious Diseases. (For ordering a copy of ``Healthy People 2000,'' 
see the section ``Where To Obtain Additional Information.'')

Authority

    This program is authorized under sections 301(a) [42 U.S.C. 241(a)] 
and 317(k) [42 U.S.C. 247b(k)] of the Public Health Service Act, as 
amended.

Smoke-Free Workplace

    CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the nonuse of all tobacco products, and 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities that receive Federal funds in which education, 
library, day care, health care, and early childhood development 
services are provided to children.

Eligible Applicants

    Eligible applicants are the official public health agencies of 
States or their bona fide agents. This includes the District of 
Columbia, American Samoa, the Commonwealth of Puerto Rico, the Virgin 
Islands, the Federated States of Micronesia, Guam, the Northern Mariana 
Islands, the Republic of the Marshall Islands, the Republic of Palau, 
and federally recognized Indian tribal governments. Non-State public 
health agency applicants must provide certification by the State 
designating the institution as the State's official applicant.

Availability of Funds

    Approximately $500,000 is available in FY 1996 to fund one award. 
It is expected that the award will begin on or about September 30, 
1996, and will be made for a 12-month budget period within a project 
period of up to 3 years. Funding estimates may vary and are subject to 
change. Continuation awards within the project period will be made on 
the basis of satisfactory progress and the availability of funds.

Purpose

    The purpose of this cooperative agreement is to assist State health 
departments to establish Emerging Infections Programs (EIP) as part of 
a 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.
    Activities of the EIPs will be focused in the areas of drug-
resistant infections, foodborne and waterborne diseases, and vaccine 
preventable or potentially vaccine preventable diseases. 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., 
underserved 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.

Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under A. 
(Recipient Activities), and CDC will be responsible for the activities 
listed under B. (CDC Activities).

A. 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 four 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. EIPs will need to coordinate project 
priorities with CDC and among themselves 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. Work to obtain technical and financial assistance to supplement 
the core assistance from CDC, as well as programmatic collaboration 
from other ``partner organizations.'' Partner organizations may be 
academic institutions and other public and private organizations with 
an interest in addressing public health issues relating to emerging 
infectious diseases (e.g., local public health agencies, public health 
laboratories, medical examiners, university medical schools, schools of 
public health, health care providers, clinical laboratories, community-
based organizations, other Federal and State government agencies, 
research organizations, medical institutions, foundations, etc.).
    3. Propose and conduct emerging infections activities in 
collaboration with appropriate partner organizations. Collaborate with 
other EIPs, as appropriate, to finalize protocols for 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.
    (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 drug resistant infections; evaluation of the clinical 
spectrum of influenza and the efficacy of influenza vaccines in target 
populations; investigation of the relationships between infections and 
chronic diseases (e.g., respiratory infections and asthma attacks); 
behavioral surveillance projects designed to assess trends in behaviors 
(e.g., food handling practices, antibiotic use) that affect the risk 
for infectious diseases; assessment of the use and impact of newer 
diagnostic tools on the

[[Page 33526]]

diagnosis and management of specific diseases (e.g., neonatal group B 
streptococcal disease, Lyme disease); evaluation of emerging infectious 
diseases in difficult-to-reach populations, such as persons who do not 
have access to routine medical care or the homeless; examination of 
infectious diseases in particular populations (e.g., studying the 
relationship between cervical papillomavirus infection and cervical 
carcinoma in women); evaluation of the economic impact of infectious 
diseases or cost-benefit studies of intervention strategies.
    (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 outpatient settings.
    b. Specific EIP activities.
    (1) Propose and conduct the following core activities:
    Active population-based laboratory surveillance for invasive 
disease caused by emerging, vaccine preventable, and drug resistant 
bacterial diseases, and for foodborne diseases (for additional 
information see Application Content, Operational Plan, paragraph d. of 
the Program Announcement included in the application kit).
    (2) Propose up to 2 additional projects that could be conducted in 
the EIP. The optional projects may be chosen from the following list 
(see more complete description in Application Content, Operational 
Plan, paragraph e. of the Program Announcement included in the 
application kit).
    (a) Population-based surveillance for hepatitis,
    (b) Surveillance for emerging etiologies of pneumonia in the U.S.,
    (c) Laboratory-based surveillance for Vancomycin-resistant Gram-
positive pathogens,
    (d) Laboratory-based Surveillance for Clostridium difficile,
    (e) Infectious complications associated with blood transfusion,
    (f) Surveillance for emerging etiologies of protozoal diarrhea,
    (g) Surveillance for metronidazole-resistant Trichomonas infection,
    (h) Evaluation of prevention of neonatal group B streptococcal 
disease,
    (i) Active surveillance for Hemolytic Uremic Syndrome.
    4. 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).
    5. Manage, analyze, and interpret data from EIP projects, and 
publish and disseminate important public health information stemming 
from EIP projects in collaboration with CDC.
    6. Provide training opportunities (e.g., infectious disease 
fellows).
    7. Monitor and evaluate scientific and operational accomplishments 
of the EIP and progress in achieving the purpose and overall goals of 
this program.

B. CDC Activities

    1. Provide consultation and 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.

Notice of Intent To Apply

    In order to assist CDC in planning for 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 their earliest convenience 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 Greg Jones, M.P.A., Funding Resources Specialist, National 
Center for Infectious Diseases (NCID), Centers for Disease Control and 
Prevention (CDC), 1600 Clifton Road, NE., Mailstop C-19, Atlanta, GA 
30333, E-mail address [email protected], facsimile (404) 639-4195.

Evaluation Criteria

    The applications will be reviewed and evaluated according to the 
following criteria (total 100 points):

1. Understanding the objectives of the EIP (total 5 points):

    The extent to which the applicant demonstrates a clear 
understanding of the objectives of this cooperative agreement program. 
The extent to which the applicant demonstrates a clear understanding of 
the requirements, responsibilities, problems, constraints, and 
complexities that may be encountered in establishing and operating the 
EIP.

2. Population Base (total 5 points):

    The extent to which the applicant defines clearly the geographic 
area and population base in which the EIP will operate. The extent to 
which the applicant defines a population base for the EIP that is 
sufficiently large and diverse to accomplish proposed EIP activities. 
The extent to which the applicant clearly describes various special 
populations in the EIP area, such as the rural or inner city poor, 
underserved women and children, the homeless, immigrants/refugees, and 
persons infected with HIV, that could be the focus of one or more EIP 
projects.

3. Capacity (total 35 points):

    a. The extent to which the applicant demonstrates its capacity and 
ability to conduct active surveillance, applied epidemiologic and 
applied laboratory research, and prevention research in emerging 
infectious diseases (25 points).
    b. The extent to which the applicant demonstrates its ability to 
develop and maintain strong cooperative relationships with various 
public and private local and regional medical, public health, academic, 
and community organizations. The extent to which applicant demonstrates 
its ability to solicit and secure financial and technical support and 
programmatic collaboration from other public and private organizations 
for conducting public health research projects. The extent to which 
applicant provides letters of support from non-applicant participating 
agencies, institutions, organizations, individuals, consultants, etc., 
indicating their willingness to participate, as represented in 
applicant's operational plan, in establishing and operating the center 
(total 10 points).

4. Operational Plan (total 40 points):

    a. The extent to which the applicant's proposed plan for 
establishing and operating the EIP is detailed and 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 in the 
establishment and ongoing operation of the EIP and individual EIP 
projects. The

[[Page 33527]]

extent to which the applicant's plan addresses all Recipient Activities 
listed in the announcement and appears feasible and capable of 
accomplishing the purpose of the program (15 points).
    b. The extent to which the applicant proposes to conduct the core 
activities, as outlined in the Application Content section of the 
Program Announcement included in the application kit. The extent to 
which the applicant proposes potential additional appropriate projects 
that could be conducted at the EIP. The extent to which the proposed 
core and additional projects demonstrate that the applicant understands 
and is capable of conducting population-based surveillance, applied 
epidemiologic and applied laboratory studies, and pilot prevention 
programs. The quality of the proposed projects 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 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) documentation of plans for recruitment and outreach for study 
participants that includes the process of establishing partnerships 
with community(ies) and recognition of mutual benefits (total 15 
points).
    c. The extent to which the applicant's plan clearly describes 
partnerships with appropriate organizations for establishing and 
operating the proposed EIP and for conducting individual EIP projects. 
Partner organizations may be academic institutions and other public and 
private organizations with an interest in addressing public health 
issues relating to emerging infectious diseases (e.g., local public 
health agencies, public health laboratories, medical examiners, 
university medical schools, schools of public health, health care 
providers, clinical laboratories, community-based organizations, other 
Federal and State government agencies, research organizations, medical 
institutions, foundations, etc.). The extent to which the applicant's 
plan describes possible training opportunities (e.g., infectious 
disease fellows). The extent to which the applicant proposes a clearly 
detailed and viable plan for soliciting and securing financial and 
technical assistance from other public and private organizations to 
supplement the core funding from CDC (total 10 points).

5. Project Management and Staffing (total 10 points):

    The extent to which the applicant identifies its own professional 
and support staff, and professional and support staff from other 
agencies, institutions, and organizations, that have the experience, 
authority, and willingness to carry out recipient activities as 
evidenced by job descriptions, curriculum vitae, organizational charts, 
etc. The extent to which the applicant describes an approach to 
maintaining sufficiently flexible EIP staffing to accommodate the 
likelihood that the requirements of EIP projects will change from time 
to time.

6. Evaluation (total 5 points):

    The extent to which applicant provides a detailed evaluation plan. 
The quality of the proposed plan for monitoring scientific and 
operational accomplishments of the EIP and of individual EIP projects. 
The quality of the proposed evaluation plan for monitoring progress in 
achieving the purpose and overall goals of this program.

7. Budget (not scored):

    The extent to which the proposed budget is reasonable, clearly 
justifiable, and consistent with the intended use of cooperative 
agreement funds. The extent to which both Federal and non-Federal 
(e.g., State funding) contributions are presented.

8. Human Subjects (not scored):

    If any proposed project involves human subjects, whether or not 
exempt from the DHHS regulations, the extent to which adequate 
procedures are described for the protection of human subjects. Note: 
Objective Review Group (ORG) recommendations on the adequacy of 
protections include: (1) protections appear adequate and there are no 
comments to make or concerns to raise, or (2) protections appear 
adequate, but there are comments regarding the protocol, or (3) 
protections appear inadequate and the ORG has concerns related to human 
subjects, or (4) disapproval of the application is recommended because 
the research risks are sufficiently serious and protection against the 
risks are inadequate as to make the entire application unacceptable.

Executive Order 12372 Review

    Applications are subject to Intergovernmental Review of Federal 
Programs as governed by Executive Order 12372. E.O. 12372 sets up a 
system for State and local government review of proposed Federal 
assistance applications. Applicants (other than federally recognized 
Indian tribal governments) should contact their State Single Point of 
Contact (SPOC) as early as possible to alert them to the prospective 
applications and receive any necessary instructions on the State 
process. For proposed projects serving more than one State, the 
applicant is advised to contact the SPOC for each affected State. A 
current list of SPOCs is included in the application kit. Indian tribes 
are strongly encouraged to request tribal government review of the 
proposed application. If SPOCs or tribal governments have any process 
recommendations on applications submitted to CDC, they should forward 
them to Sharron P. Orum, Grants Management Officer, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop E-18, Room 
314, Atlanta, GA 30305. The due date for State process recommendations 
is 30 days after the application deadline date for new and competing 
continuation awards. The appropriation for this financial assistance 
program was received late in the fiscal year and would not allow for an 
application receipt date which would accommodate the 60-day State 
recommendation process period. CDC does not guarantee to ``accommodate 
or explain'' for State process recommendations it receives after that 
date.

Public Health System Reporting Requirements

    This program is not subject to the Public Health System Reporting 
Requirements.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance number is 93.283.

Other Requirements

Paperwork Reduction Act

    Projects that involve the collection of information from ten or 
more individuals and funded by the cooperative agreement will be 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act.

[[Page 33528]]

Human Subjects

    If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human Services 
Regulations 45 CFR Part 46, regarding the protection of human subjects. 
Assurance must be provided to demonstrate that the project will be 
subject to initial and continuing review by the appropriate 
institutional review committee. In addition to other applicable 
committees, Indian Health Service (IHS) institutional review committees 
also must review the project if any component of IHS will be involved 
or will support the research. If any American Indian community is 
involved, its tribal government must also approve that portion of the 
project applicable to it. The applicant will be responsible for 
providing assurance in accordance with the appropriate guidelines and 
form provided in the application kit.

Women, Racial and Ethnic Minorities

    It is the policy of the Centers for Disease Control and Prevention 
(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) 
to ensure that individuals of both sexes and the various racial and 
ethnic groups will be included in CDC/ATSDR-supported research projects 
involving human subjects, whenever feasible and appropriate. Racial and 
ethnic groups are those defined in OMB Directive No. 15 and include 
American Indian, Alaskan Native, Asian, Pacific Islander, Black and 
Hispanic. Applicants shall ensure that women, racial and ethnic 
minority populations are appropriately represented in applications for 
research involving human subjects. Where clear and compelling rationale 
exist that inclusion is inappropriate or not feasible, this situation 
must be explained as part of the application. This policy does not 
apply to research studies when the investigator cannot control the 
race, ethnicity and/or sex of subjects. Further guidance to this policy 
is contained in the Federal Register, Vol. 60, No. 179, pages 47947-
47951, dated Friday, September 15, 1995.

Animal Subjects

    If the proposed project involves research on animal subjects, the 
applicant must comply with the ``PHS Policy on Humane Care and Use of 
Laboratory Animals by Awardee Institutions.'' An applicant organization 
proposing to use vertebrate animals in PHS-supported activities must 
file an Animal Welfare Assurance with the Office for Protection from 
Research Risks at the National Institutes of Health.

Application Submission and Deadline

    The original and two copies of the application PHS Form 5161-1 
(Revised 7/92, OMB Control Number 0937-0189) must be submitted to 
Sharron P. Orum, Grants Management Officer, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE., Room 314, Mailstop E-
18, Atlanta, GA 30305, Attention: Marsha Driggans, on or before August 
23, 1996.
    1. Deadline: Applications shall be considered as meeting the 
deadline if they are either:
    (a) Received on or before the deadline date; or
    (b) Sent on or before the deadline date and received in time for 
submission to the objective review group. (Applicants must request a 
legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or U.S. Postal Service. Private 
metered postmarks shall not be acceptable as proof of timely mailing.)
    2. Late Applications: Applications which do not meet the criteria 
in 1.(a) or 1.(b) above are considered late applications. Late 
applications will not be considered in the current competition and will 
be returned to the applicant.

Where To Obtain Additional Information

    A complete program description and information on application 
procedures are contained in the application package. Business 
management technical assistance may be obtained from Marsha Driggans, 
Grants Management Specialist, Grants Management Branch, Procurement and 
Grants Office, Centers for Disease Control and Prevention (CDC), 255 
East Paces Ferry Road, NE., Room 314, Mailstop E-18, Atlanta, GA 30305, 
telephone (404) 842-6523, facsimile (404) 842-6513, E-mail 
[email protected] or CDC WONDER.
    Programmatic technical assistance may be obtained from Robert 
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] or CDC WONDER. E-mail address for Mr. McConnon: 
[email protected] or CDC WONDER.
    Please refer to Announcement Number 655 when requesting information 
and submitting and application.

    Important Notice: Atlanta, GA, will be the host of the 1996 
Summer Olympics Games, July 19 through August 4, 1996. As a result 
of this event, it is likely that the Procurement and Grants Office 
(PGO), CDC, may experience delays in the receipt of both regular and 
overnight mail deliveries. Contacting PGO employees during this time 
frame may also be hindered due to the possible telephone 
disruptions. To the extent authorized, please consider the use of 
voice mail, E-mail, and facsimile transmission to the maximum extent 
practicable. However, do not fax lengthy documents or grant 
applications.

    You may obtain this announcement from one of two Internet sites on 
the actual publication date: CDC's homepage at http://www.cdc.gov or at 
the Government Printing Office homepage (including free on-line access 
to the Federal Register at http://www.access.gpo.gov).
    Potential applicants may obtain a copy of ``Healthy People 2000'' 
(Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000'' 
(Summary Report, Stock No. 017-001-00473-1) referenced in the 
``Introduction'' through the Superintendent of Documents, Government 
Printing Office, Washington, DC 20402-9325, telephone (202) 512-1800.
    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, Atlanta, GA 30333. 
Requests may also be sent by facsimile to (404) 639-3039.

    Dated: June 21, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 96-16389 Filed 6-26-96; 8:45 am]
BILLING CODE 4163-18-P