01-2365. Epidemiology and Laboratory Capacity for Infectious Diseases; Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2001 funds for a cooperative agreement program to promote adequate capacity of local, State, and national efforts for epidemiologic and laboratory surveillance and response for infectious diseases. This program addresses the “Healthy People 2010” focus area of Immunization and Infectious Diseases. For the conference copy of “Healthy People 2010”, visit the internet site: <http://www.health.gov/​healthypeople>

The purpose of the Epidemiology and Laboratory Capacity in Infectious Diseases (ELC) program is to assist State and eligible local public health agencies in strengthening basic epidemiologic and laboratory capacity to address infectious disease threats with a focus on notifiable diseases, food-, water-, and vector-borne diseases, vaccine-preventable diseases, and drug-resistant infections. Awards are intended to support activities that enhance the ability of a program to identify and monitor the occurrence of infectious diseases of public health importance in a community, characterize disease determinants, identify and respond to disease outbreaks, use public health data for priority setting and policy development, and assess the effectiveness of activities. Strengthening collaboration between laboratory and epidemiology practice is seen as a crucial component of this program.

This program is designed to support grantees in a variety of ways. For example, in health departments where gaps in personnel and equipment are identified as major barriers to effective surveillance and response, the ELC program can provide resources to hire staff or purchase necessary equipment. Funds can also be used to enhance ongoing activities.

B. Eligible Applicants

Limited Competition

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 addition, official public health agencies of city governments with jurisdictional populations greater than 1,500,000 or county governments with jurisdictional populations greater than 8,000,000 (based on 1990 census data) are eligible to apply.

The ELC program was initiated in 1995 with Program Announcement 95043 and expanded in 1997 and 1999 with Program Announcements 97020 and 99032, respectively. A total of 39 state and 4 local health departments have been funded to date. This announcement is a further expansion of the ELC program and is intended to add new eligible applicants not already funded in the program. States, counties, and cities currently funded under the ELC program are not eligible to apply under this program announcement.

C. Availability of Funds

Approximately $5,250,000 is available in FY 2001 to fund approximately 15 awards. It is expected that the average award (total direct and indirect costs) will be $350,000. Individual awards may range from $100,000 to $500,000. It is expected that the awards will begin on or about April 1, 2001, and will be made for a 12-month budget period within a project period of up to five years. Funding estimates 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.

Recipient Financial Participation

Although a requirement for matching funds is not a condition for receiving an award under this cooperative agreement program, applicants must document the non-Federal human and fiscal resources that will be available to conduct activities outlined in the proposal. Federal funds cannot be used to replace or supplant existing State and local support. See Evaluation Criteria (paragraph 6: Budget) for additional information.

D. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities listed under 1. (Recipient Activities) and CDC will be responsible for the activities listed under 2. (CDC Activities).

1. Recipient Activities

a. Enhance local capacity for gathering and evaluating infectious disease surveillance data, detecting and investigating outbreaks, and using surveillance data for public health practice and clinical follow-up. Applicants should analyze their current surveillance infrastructure, identify gaps in core epidemiologic and laboratory capacity, and develop applications to this program announcement that address the needs of their respective health jurisdictions. National priority program areas are briefly described below and are examples of activities that would be appropriate to propose under this program announcement. Applicants are encouraged to consider activities in these areas, yet there is no requirement to do so. Details and example activities for each are provided as Attachments in the Application Kit.

(1) Antimicrobial Resistance (Attachment 2)

Develop or improve health department capacity for surveillance, prevention, and control of antimicrobial resistant infections.

(2) Food-borne Disease (Attachment 3)

Enhance capacity for investigation, control, and reporting of foodborne disease outbreaks and improve laboratory-based surveillance for emerging foodborne pathogens.

(3) Hepatitis (Attachment 4)

(a) Develop capacity to prevent and control hepatitis C virus (HCV) infection through activities that are integrated into existing public health prevention services and programs.

(b) Enhance capacity for surveillance of chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infection.

(4) Influenza (Attachment 5)

Develop and enhance capacity for influenza surveillance and response.

(5) National Electronic Disease Surveillance System (NEDSS) Assessment and Planning (Attachment 6)

Assess current information systems personnel and technical infrastructure and develop a plan for the implementation of the NEDSS systems architecture (intended for applicants that did not receive any NEDSS funding from CDC in FY 2000).

(6) West Nile Virus (Attachment 7)

Develop and implement effective surveillance, prevention, and control of West Nile virus and other arboviruses that occur in the U.S.

b. Ensure appropriate representation at planning and priority-setting meetings organized for recipients of this cooperative agreement program, including sending two representatives to the International Conference on Emerging Infections scheduled for March 2002 in Atlanta.

c. If a proposed project involves research on human participants, ensure appropriate Independent Review Board (IRB) review.

2. CDC Activities

a. Provide consultation and assistance in enhancing local epidemiologic and laboratory capacity for surveillance and response for infectious diseases.

b. Assist in monitoring and evaluating scientific and operational accomplishments and progress in achieving the purpose of this program.

c. Provide national coordination of activities where appropriate.

d. If during the project period research involving human subjects should be conducted and if 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 protocol initially and on at least an annual basis until the research project is completed.

E. Application Content

Letter of Intent (LOI)

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 not later than February 9, 2001. Notification should include: (1) name and address of the institution, (2) name, address and telephone number of the contact person, and (3) a list of the activities/areas that will be addressed in the application. This letter of intent will not be used in evaluation of the application. Notification should be provided by facsimile, postal mail, or E-mail, to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement”.

Application

Use the information in this section and in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content.

Your application will be evaluated on the criteria listed in Section G., so it is important that your narrative follow the criteria in the order presented.

The application narrative (excluding budget, budget narrative, appendices, and required forms) must not exceed 20 single-spaced pages, printed on one side, with one inch margins, a font size no smaller than 10, and on white 8.5″ × 11″ paper. All pages must be clearly numbered, a complete index to the application and its appendices must be included, and the required original and two copies must be submitted unstapled and unbound (i.e., so it can be easily fed through an automatic document feed copier).

To the extent possible, application narratives and budgets should clearly delineate separate and distinct program areas or groups of activities.

If any proposed activities involve human subjects research, include plans to assure that appropriate Institutional Review Board (IRB) approval is obtained. Include protocols and IRB review/approval status if available.

If indirect costs are being charged, include a copy of your organization's most current indirect cost rate agreement or cost allocation plan.

Letters of support can be included if applicants anticipate the participation of other organizations or political subdivisions in conducting proposed activities. Specific roles and responsibilities should be delineated. Do NOT include any letters of support from CDC. CDC assistance will be provided to all recipients as described in CDC Activities, above.

F. Submission and Deadline

Letter of Intent (LOI)

The Letter of Intent (LOI) should be submitted on or before February 9, 2001 and can be provided by facsimile, postal mail, or E-mail to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement. Your letter of intent should include: (1) Name and address of the institution, (2) name, address, and telephone number of the contact person, and (3) a list of the activities/areas that will be addressed in the application.

Application

Submit the original and two copies of CDC 0.1246(E). Forms are in the application kit. Submit the application to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement, on or before February 23, 2001.

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 independent 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.)

Late Applications: Applications which do not meet the criteria in (a) or (b) above are considered late applications, will not be considered, and will be returned to the applicant.

G. Evaluation Criteria

Each application will be evaluated individually against the following criteria by an independent review group appointed by CDC.

1. Description of the population under surveillance, either the State or other appropriate jurisdiction (if an applicant is a county, city, or other agency) (5 points). Extent to which the application provides information on the population size, demographic characteristics, geographic distribution, racial/ethnic makeup, and health care delivery systems.

2. Description of existing public health infectious disease epidemiology, laboratory, and information systems capacity (15 points). Extent to which the applicant:

a. Describes existing infectious disease surveillance and response activities, including reporting requirements, spectrum of laboratory specimen testing performed, degree of automation of laboratory and epidemiologic information management, and public health response capacity.

b. Provides information on existing staffing, management, material and equipment investment, training, space, and financial support of laboratory and epidemiologic capacity for public health surveillance and response for infectious diseases.

c. Describes current collaboration between its epidemiology and laboratory programs in surveillance and response including the existence of, or potential for, integrated uses of surveillance data;

d. Describes current or previous collaborative relationships with clinical laboratories, local health agencies, academic medicine groups, and health care practitioners, including HMOs or managed care providers; and demonstrates the potential of these relationships for enhanced surveillance and public health response activities.

3. Identification of areas of need (gaps) in surveillance and response for infectious diseases and understanding of the objectives of this cooperative agreement program (20 points).

The extent to which the applicant outlines State and local needs in epidemiology, laboratory, and/or information systems capacity for public health surveillance and response for infectious diseases.

4. Operational Plan (Note: Provide a detailed description of first year activities only and briefly describe future year activities) (45 points). Extent to which the proposed plan:

a. Outlines activities that clearly address the applicant's identified needs in capacity and that are appropriate for any specific diseases, conditions, and/or national priority program areas addressed by the applicant.

b. Describes steps to be taken to facilitate and strengthen collaboration between epidemiology and laboratory practice.

c. Includes current letters of support from participating agencies, institutions, and organizations indicating their willingness to participate in the activities as proposed in the operational plan.

d. If any research involving human subjects is proposed, has met the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in any 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.

(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. Plan for monitoring and evaluation (15 points). The extent to which the applicant describes a detailed plan for monitoring the implementation of the activities and evaluating the extent to which the proposed activities strengthen local and national epidemiologic and laboratory capacity for infectious diseases.

6. Budget (not scored)

a. A detailed budget with a line-item justification and any other information to demonstrate that the request for assistance is consistent with the purpose and objectives of this cooperative agreement program.

b. Although matching funds are not a condition for receiving an award under this program, include in the budget, a separate line-item accounting of non-Federal contributions (funding, personnel, and other resources) that will be directly allocated to the proposed activities. Identify any non-applicant sources of these contributions.

c. If requesting funds for any contractual activities, provide the following information for each 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, (5) method of contractor selection (e.g., sole-source or competitive solicitation), and (6) method of accountability.

7. Human Subjects: (Not Scored)

If any research involving human subjects is proposed, does the application adequately address the requirements of Title 45 CFR part 46 for the protection of human subjects?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. progress reports (annual), no more than 90 days after the end of the budget period;

2. financial status report, no more than 90 days after the end of the budget period; and

3. Final Financial Status and Performance reports, no more than 90 days after the end of the project period.

Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Public Health Surveillance and Information Systems

To modernize and enhance public health surveillance and information systems, CDC and its public health partners are implementing the NEDSS. CDC's NEDSS implementation strategies include ensuring that relevant activities funded through its various cooperative agreement programs will be consistent with the functional and technical specifications of the NEDSS information architecture (www.cdc.gov/​od/​hissb/​docs.htm). As part of the terms of this program announcement, grantees agree to evaluate current activities with respect to the NEDSS information systems architecture; plan how to modify these activities, if necessary, so that they are consistent with NEDSS specifications; and, if possible, begin to implement NEDSS specifications in relevant activities.

The following additional requirements are applicable to this program. For a complete description of each, see Attachment 1 in the application kit.

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

I. 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)] and 317(k)(2)[42 U.S.C. 247b(k)(2)], as amended. The Catalog of Federal Domestic Assistance number is 93.283.

J. Where to Obtain Additional Information

This and other CDC announcements can be found on the CDC home page Internet address—<http://www.cdc.gov>. Click on “Funding” then “Grants and Cooperative Agreements.”

If you have questions after reviewing the contents of all the documents, business management technical assistance may be obtained from:

Gladys Gissentanna, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta, Georgia 30341-5539, Telephone [phone], Email address : [e-mail]

For program technical assistance, contact: Deborah A. Deppe, M.P.A., National Center for Infectious Diseases, Mailstop C12, Centers for Disease Control and Prevention, Atlanta, GA 30333, Telephone [phone], E-mail address: [e-mail]

Dated: January 22, 2001.

John L. Williams,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC).