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Billing Code: 4163-18-P

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Emerging Infections Programs

Announcement Type: Competing Continuation

Funding Opportunity Number: CI05-026

Catalog of Federal Domestic Assistance Number: 93.283

Key Dates:

Letter of Intent Deadline: October 11, 2004

Application Deadline: November 1, 2004

Executive Summary: The purpose of this program announcement is to provide continued support to existing Emerging Infections Programs (EIPs), or to develop new EIPs, as part of the national network. EIPs are population-based centers which assess the public health impact of and respond to emerging infections. Activities of the EIPs fall into these general categories: (1) active surveillance; (2) applied public health epidemiologic and laboratory activities; and (3) implementation and evaluation of pilot prevention/intervention projects. The EIPs function as a collaborative network of public and private organizations that have an interest in addressing infectious diseases health issues; EIPs maintain sufficient flexibility to address infectious disease health issues as they emerge. EIPs are strategically located to serve a variety of geographical areas and diverse groups of people.

The following guiding principles motivate the work of the EIPs: (1) EIPs aim to be a national resource for surveillance, prevention, and control of emerging infectious diseases - EIP functions go beyond the routine functions of health departments in ways that allow important public health questions to be answered; (2) EIP activities address important issues in infectious diseases, selected with regard to what is appropriate for this population-based infrastructure; (3) EIPs maintain sufficient flexibility for emergency response and to address new problems as they arise; (4) training is a key function of the EIPs; (5) EIPs develop and evaluate public health practices and transfer what is learned to the public health community; and (6) EIPs give high priority to activities that lead directly to prevention of disease.

I. Funding Opportunity Description

Authority: This program is authorized under the Public Health Service Act Sections 301(a)[42 U.S.C. 241(a)], 317(k)(1)[42 U.S.C. 247b(k)(1)], and 317(k)(2)[42 U.S.C. 247b(k)(2)], as amended.

Purpose: The purpose of the program is to assist in local, state, and national efforts to conduct surveillance and public health epidemiologic and laboratory activities in emerging infectious diseases, and to pilot and evaluate methods for the prevention and control of emerging infectious diseases. This program addresses the "Healthy People 2010" focus area(s) of Immunization and Infectious Diseases.

Measurable outcomes of the program will be in alignment with the following performance goal for the National Center for Infectious Diseases (NCID): Protect Americans from infectious diseases.

Research Objectives:

The overall objective of the EIP cooperative agreement is to assess the public health impact of and respond to emerging infections. Activities of the EIPs fall into these general categories: (1) active surveillance; (2) applied public health epidemiologic and laboratory activities; and (3) implementation and evaluation of pilot prevention/intervention projects. Specific objectives for research and other activities supported by this cooperative agreement are outlined in the individual Activities, below.

Activities:

Awardee activities for this program are as follows:

(a) Functions and structure for EIP - Establish and operate an EIP to further local, State, and national efforts to address emerging infectious diseases.

(1) Establish each EIP activity in a defined population, which could include either an entire State or a geographically defined area (or areas) within a State. The population base may vary for various activities. For certain activities, the population base may be defined by a healthcare delivery system such as a health maintenance organization (HMO). To accomplish the objectives of certain EIP activities, a minimum population base of approximately 1,500,000 may be necessary.

(2) Provide effective scientific leadership, coordination, and execution of EIP activities.

(3) Provide effective management to support operation of the EIP.

(4) Organize the EIP so that it maintains the flexibility to respond to new health problems as they emerge.

(5) Operate the EIP so that it can function effectively as part of a national network of EIPs. Collaborate with CDC and other EIPs, through the EIP steering group and other EIP working groups, to establish priorities, to coordinate and monitor projects, and to assure that important emerging infections issues are appropriately addressed.

(6) Ensure that site representatives attend and participate in EIP Steering Group Meetings and other required EIP meetings.

(7) As a part of certain EIP projects, provide specimens such as disease-causing isolates or serum specimens to appropriate organizations (which may include, but is not limited to CDC) for laboratory evaluation (e.g., molecular epidemiologic studies, evaluation of diagnostic tools).

(8) Manage, analyze, and interpret data from EIP projects; publish and disseminate important public health information stemming from EIP projects in collaboration with CDC and other EIP sites.

(9) Monitor and evaluate scientific and operational accomplishments and progress in achieving the purpose of this program.

(10) If a proposed project involves research on human participants, ensure appropriate IRB review.

(11)Information systems used or developed through this cooperative agreement should conform to the Public Health Information Network (PHIN) standards, the goal of which is the creation of standards-based, interoperable public health information systems. For more information on PHIN, the PHIN architecture, PHIN messaging, and PHIN standards, functions, and specifications, see the CDC web site: http://www.cdc.gov/phin. CDC will work with EIP sites to evolve EIP information systems to conform to PHIN standards.

(b) Partnerships - Develop the EIP as a partnership between the health department and 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, academic institutions, health care providers, infection control professionals, clinical laboratories, other Federal and state government agencies, and research organizations. Build and draw upon these relationships for the conduct of specific EIP activities.

(c) Tools and Capacities - Develop and utilize a set of tools or capacities to conduct EIP activities, e.g., active laboratory-based surveillance; medical records review for surveillance or studies; case-control studies; selected laboratory testing of isolates or specimens; surveys (e.g., of laboratories, providers, public); collection of isolates of disease-causing agents in the context of surveillance; network of infection control professionals; and analyses of hospital admission or discharge data.

(d) General EIP Activities - Activities of the EIPs generally 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., may include audits to assure complete reporting) with active 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., pneumonia); evaluation of clinical outcomes or risk factors for drug resistant infections; evaluation of the role of human genomics in disease causation and individual susceptibility; and evaluation of the efficacy of pneumococcal and meningococcal conjugate vaccines.

(3) Implementation and evaluation of pilot prevention/intervention projects for emerging infectious diseases. Examples might include, e.g., evaluation of the impact of Group B Streptococcus prevention guidelines, or evaluation of the role of human genomics in public health investigations.

(e) Specific EIP activities – All applicants should propose activities # 1 – 5; additional activities may be proposed (# 6-12) at the discretion of the applicant. Each application will be evaluated as a whole (see Criteria for evaluation in Section V.1 below). Therefore, any additional activity proposals should be commensurate with the applicant's capacity and should be designed to enhance the applications as whole. Applicants are invited to consult with CDC programs in planning their proposed activities. [For details about these activities, see Appendices posted on the CDC web site: "http://www.cdc.gov/od/pgo/funding/grantmain.htm".]

(1) Active Bacterial Core surveillance (ABCs) and related activities – ALL applicants should propose this activity. CDC expects to provide support for ABCs activities in all EIPs, although some ABCs activities are expected to be conducted only in certain sites. For more details, see Appendix 1 posted on the CDC web site: http://www.cdc.gov/od/pgo/funding/grantmain.htm.

(2) Active population-based laboratory surveillance for food-borne diseases (FoodNet) and related activities – ALL applicants should propose this activity. CDC expects to provide support for FoodNet activities in all EIPs, although some FoodNet activities are expected to be conducted only in certain sites. For more details, see Appendix 2 posted on the CDC web site: http://www.cdc.gov/od/pgo/funding/grantmain.htm.

(3) Surveillance for respiratory diseases and syndromes - ALL applicants should propose this activity. CDC expects to provide support for five to nine EIPs for one or more aspects of this activity. For more detailed guidance, see Appendix 3 posted on the CDC web site: http://www.cdc.gov/od/pgo/funding/grantmain.htm.

(4) Flexible Response to Emerging Problems – ALL applicants should propose this activity. Each EIP will be expected to participate in a workgroup to review newly emerging infectious disease issues on short notice and contribute to rapid study design, initiation, and completion. Fore more details, see Appendix 4 posted on the CDC web site: http://www.cdc.gov/od/pgo/funding/grantmain.htm.

 (5) EIP rapid population-based survey capacity – ALL applicants should propose this activity. CDC expects to provide support for population-based survey capacity in all EIP sites. For detailed guidance on applying for this activity, see Appendix 5 posted on the CDC web site: http://www.cdc.gov/od/pgo/funding/grantmain.htm.

(6) Integrated hepatitis surveillance – Applicants may choose to propose some or all components of this activity, and CDC may provide some support for each of the components. See For detailed guidance and specific eligibility criteria for this activity, see Appendix 6 posted on the CDC web site: http://www.cdc.gov/od/pgo/funding/grantmain.htm.

(7) Surveillance for encephalitis syndrome – Applicants may choose to propose this activity. CDC expects to provide support for up to three EIPs for this activity. For more details, see Appendix 7 posted on the CDC web site: http://www.cdc.gov/od/pgo/funding/grantmain.htm.

(8) Surveillance for Unexplained Deaths (UNEX) – EIPs that are currently conducting UNEX may choose to propose to continue this activity. Any proposal for syndrome surveillance, e.g., respiratory syndromes, should be proposed and managed as part of the corresponding EIP syndrome activity, not separately as part of this activity. For more details, see Appendix 7 posted on the CDC web site: http://www.cdc.gov/od/pgo/funding/grantmain.htm.

(9) Border Infectious Disease Surveillance (BIDS) – Applicants along the U.S./Mexico Border may propose this activity. For more details, see Appendix 7 posted on the CDC web site: http://www.cdc.gov/od/pgo/funding/grantmain.htm.

(10) Incorporate a training activity into the operation of the EIP – Any applicant may propose this activity. See Appendix 7 for details.

(11) Prepare for and engage in activities to assess human genomics risk factors into acute public health investigations - Any applicant may propose this activity. CDC may provide support for one to three sites for this activity. For more details, see Appendix 7 posted on the CDC web site: "http://www.cdc.gov/od/pgo/funding/grantmain.htm"

(12) Site-specific EIP activity – Applicants may propose other activities of local interest or concern that are consistent with EIP objectives and guiding principles.

In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring.

CDC Activities for this program are as follows:

Provide general coordination for the EIPs as a network.

Assist in developing collaborative relationships and facilitate multi-site collaboration as needed to support the successful completion of the project.

Provide consultation, scientific and technical assistance in the operation of the EIP and in designing and conducting individual EIP projects. (Examples include, participating in protocol development, helping with study design, assisting in the development of information systems, data analysis and dissemination of results, coordinating and facilitating communications among EIPs).

Participate in analysis and interpretation of data from EIP projects. Participate in the dissemination of findings and information stemming from EIP projects.

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

If 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.

If a proposed project involves research with human subjects and CDC scientists will be co-investigators in that research, assist in the development of a research protocol for IRB review by all institutions participating in the research project. The CDC IRB will review and approve the project initially and on, at least, an annual basis until the research project is completed.

Consult with sites to assist evolution of EIP-related information systems to conform to Public Health Information Network (PHIN) standards.

II. Award Information

Type of Award: Cooperative Agreement. CDC involvement in this program is listed in the Activities Section above.

Mechanism of Support: U01

Fiscal Year Funds: 2005

Approximate Total Funding: $19,600,000

Approximate Number of Awards: 9

Approximate Average Award: $2,400,000 (This amount is for the first 12-month budget period, and includes both direct and indirect costs)

Floor of Award Range: $1,400,000

Ceiling of Award Range: $3,500,000

Anticipated Award Date: December 29, 2004

Budget Period Length: 12 months

Project Period Length: 5 years

Throughout the project period, CDC’s commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government.

III. Eligibility Information

III.1. Eligible applicants

Applications may be submitted by state governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau).

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status. Place this documentation behind the first page of your application form.

III.2. Cost Sharing or Matching

Matching funds are not required for this program.

III.3. Other

CDC will accept and review applications with budgets greater than the ceiling of the award range.

Special Requirements:

If your application is incomplete or non-responsive to the requirements listed in this section, it will not be entered into the review process. You will be notified that your application did not meet submission requirements.

Late applications will be considered non-responsive. See "Section IV.3. Submission Dates and Times" for more information on deadlines.

Note: Title 2 of the United States Code section 1611 states that an organization described in section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

Individuals Eligible to Become Principal Investigators or Co-Principal Investigators:

Any individual with the skills, knowledge, and resources necessary to carry out the proposed EIP activities is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC programs.

IV. Application and Submission Information

IV.1. Address to Request Application Package

To apply for this funding opportunity use application form PHS 398 (OMB number 0925-0001 rev. 5/2001). Forms and instructions are available in an interactive format on the CDC web site, at the following Internet address: "www.cdc.gov/od/pgo/forminfo.htm"

Forms and instructions are also available in an interactive format on the National Institutes of Health (NIH) web site, at the following Internet address: "http://grants.nih.gov/grants/funding/phs398/phs398.html"

If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to you.

IV.2. Content and Form of Submission

Letter of Intent (LOI): A letter of intent is requested to help plan the application review; but it is not mandatory. Your LOI must be written in the following format:

Maximum number of pages: 2

Font size: 12-point unreduced

Single spaced

Paper size: 8.5 by 11 inches

Page margin size: One inch

Printed only on one side of page

Written in plain language, avoid jargon


Your LOI must include the following information:

Number and title of this Program Announcement (PA)

Name of Applicant (i.e. State Health Department or bona fide agent)
If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state as documentation of your status at the time of application.

Name, address, E-mail address, and telephone number of the Principal Investigator and Co-Investigator.

Brief description of your eligibility and intent to apply.

Application:

Follow the PHS 398 application instructions for content and formatting of your application. If the instructions in this announcement differ in any way from the PHS 398 instructions, follow the instructions in this announcement. For further assistance with the PHS 398 application form, contact PGO-TIM staff at 770-488-2700, or contact GrantsInfo, Telephone (301)435-0714, E-mail: GrantsInfo@nih.gov.

Your research plan should address activities to be conducted over the entire project period, focusing in detail on the first year and summarizing plans for subsequent years.

You are required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. Your DUNS number must be entered on line 11 of the face page of the PHS 398 application form. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access www.dunandbradstreet.com or call 1-866-705-5711.

For more information, see the CDC web site at:

http://www.cdc.gov/od/pgo/funding/pubcommt.htm

This announcement uses just-in-time concepts.

This announcement uses the non-modular budgeting format.

In place of the format specified for the Research Plan in PHS Form 398, use the following format:

Maximum number of pages: 35 single-spaced (excluding budget, budget narrative, appendices, and required forms)
If your narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed. Materials or information that should be included in the narrative will not be reviewed if placed in the appendices.

Font size: 12 point unreduced

Paper size: 8.5 by 11 inches

Page margin size: One inch

Printed only on one side of page

Held together only by rubber bands or metal clips; not bound in any other way.

Your narrative should address activities to be conducted over the entire project period, and must include the following items in the order listed:

Capacity to carry out the functions and responsibilities of an EIP.

Operational plan for the EIP in general and for specific EIP activities. (Include descriptions of populations for each proposed activity.)

Measures of Effectiveness (Include Measures for each of the specific EIP activities proposed.)

Human Subjects

Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes:

Documentation of bona fide agent status

Letters of support (Do not solicit or include letters of support from CDC personnel.)

Curricula vitas

Detailed budget justification (i.e., supporting budget information outlined in "Budget and Budget Narrative" below.)

Documentation of relevant accomplishments, such as abstracts, manuscripts, or bibliographies, may be included in appendices.

Budget and Budget Narrative

This part of the application does not count toward the narrative page limit. For each line-item (as identified on the PHS Form 398, Page 4), 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. All other line-items should also be clearly justified. In addition to the budget justification, provide an estimate of the budget for each separate activity or project (e.g., FoodNet, ABCs, etc. as outlined above in Section I, Activities, section e.) . 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).

Additional requirements that may require you to submit additional documentation with your application are listed in section "VI.2. Administrative and National Policy Requirements."

IV.3. Submission Dates and Times

LOI Deadline Date: October 11, 2004

CDC requests that you send a LOI if you intend to apply for this program. Although the LOI is not required, not binding, and does not enter into the review of your subsequent application, the LOI will be used to gauge the level of interest in this program, and to allow CDC to plan the application review.

Application Deadline Date: November 1, 2004

Explanation of Deadlines: Applications must be received in the CDC Procurement and Grants Office by 4:00 p.m. Eastern Time on the deadline date. If you send your application by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If CDC receives your application after closing due to: (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you will be given the opportunity to submit documentation of the carriers guarantee. If the documentation verifies a carrier problem, CDC will consider the application as having been received by the deadline.

This announcement is the definitive guide on application submission address and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline above, it will not be eligible for review, and will be discarded. You will be notified that your application did not meet the submission requirements.

CDC will not notify you upon receipt of your application. If you have a question about the receipt of your application, first contact your courier. If you still have a question, contact the PGO-TIM staff at: 770-488-2700. Before calling, please wait two to three days after the application deadline. This will allow time for applications to be processed and logged.

IV.4. Intergovernmental Review of Applications

Your application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372. This order sets up a system for state and local governmental review of proposed federal assistance applications. You should contact your state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications, and to receive instructions on your state’s process. Click on the following link to get the current SPOC list:

http://www.whitehouse.gov/omb/grants/spoc.html

IV.5. Funding Restrictions

Restrictions, which must be taken into account while writing your budget, are as follows:

Funds relating to the conduct of research will not be released until the appropriate assurances and Institutional Review Board approvals are in place.

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.

If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age.

IV.6. Other Submission Requirements

LOI Submission Address: Submit your LOI by express mail, delivery service, fax, or E-mail to:

Angela Slaughter

National Center for Infectious Diseases (NCID)

Centers for Disease Control and Prevention (CDC)

1600 Clifton Rd, NE, Mailstop D-59

Atlanta, GA 30333

Telephone: 404-371-5357

E-mail address: aslaughter@cdc.gov

Application Submission Address: Submit the original and -four hard copies of your application by mail or express delivery service to:

Technical Information Management- CI05-026

CDC Procurement and Grants Office

2920 Brandywine Road

Atlanta, GA 30341

Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria

Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the "Purpose" section of this announcement. Measures must be objective and quantitative, and must measure the intended outcome. These measures of effectiveness must be submitted with the application and will be an element of evaluation.

The goals of CDC-supported research are to advance the understanding of biological systems, improve the control and prevention of disease and injury, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.

Your application will be evaluated against the following criteria:

Capacity to carry out the functions and responsibilities of an EIP. (50 points)

a. Does the applicant demonstrate a clear understanding of the objectives of the EIP in the following aspects?

1) Background and objectives of this cooperative agreement program.

2) The roles and responsibilities of participation in the EIP network.

3) The requirements, responsibilities, problems, constraints, and complexities that may be encountered in establishing and operating the EIP.

b. EIP functions and structure.

1) To what extent does the applicant’s plan for establishing and operating the EIP clearly describe the proposed organizational and operating structure/procedures; and clearly identify the roles and responsibilities of all participating agencies, organizations, institutions, and individuals?

2) To what extent does the applicant describe how the EIP as a whole will be established in a defined population with a minimum population base of approximately 1,500,000 persons?

3) To what extent does the applicant clearly describe how the EIP, or its design for the EIP, is flexible and able to swiftly address new public health challenges in infectious diseases?

4) Does the applicant plan to provide effective scientific leadership and coordination, and adequate administrative infrastructure, to manage an EIP?

5) Does the applicant demonstrate ability to operate the EIP so it can function effectively as part of a national network of EIPs?

6) To what extent does the applicant describe 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?

c. Partnerships.

1) To what extent does the applicant demonstrate ability to develop and maintain strong cooperative relationships with public and private, local and regional, medical, public health, laboratory, academic, and community organizations? Does the applicant provide sufficient evidence of its ability to solicit and secure programmatic collaboration and support from such organizations?

2) Are the applicant's partnerships with necessary and appropriate organizations adequate for establishing and operating the proposed EIP and for conducting individual EIP projects?

d. EIP tools and capacities.

To what extent does the applicant demonstrate past experience and documentation of accomplishments in conducting active surveillance, applied epidemiologic research, applied laboratory research, and prevention research, in general, and on emerging infectious diseases, including antimicrobial resistant, food-borne and waterborne, and currently or potentially vaccine preventable diseases? Is a list of relevant papers and abstracts included in an appendix?

Operational Plan for the EIP in general and for specific EIP activities. (40 points)

a. General EIP Activities:

1) To what extent is the quality of the proposed projects (as requested in the Application Content section above), taken as a whole, consistent with EIP guiding principles, public health needs, intent of this program, feasibility, methodology/approach, and collaboration/participation of partner organizations? Does the proposal include clear descriptions of the population bases for each project, and include descriptions of race and ethnic distributions and descriptions of various special populations as they relate to the proposed activities, such as the rural or inner-city poor, under-served women and children, the homeless, immigrants and refugees, and persons infected with HIV?

2) Does the applicant demonstrate support from non-applicant participating agencies, institutions, organizations, laboratories, individuals, and consultants included in the operational plan? Does the applicant provide (in an appendix) letters of support which clearly indicate collaborators’ commitment to participate in the EIP and define their roles?

3) Does the applicant clearly identify key professional personnel to be assigned to the EIP and EIP projects as well as key professional personnel from other participating or collaborating institutions, agencies, and organizations outside of the applicant's agency that will be assigned to EIP activities? (Is curriculum vitae for each person included in an appendix?) Is there a clear identification of participants’ respective roles in the management and operation of the EIP? Do participants have adequate experience in conducting work comparable to that described in this announcement?

4) For projects involving human subjects research, does the application adequately address the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research? This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits.

b. Specific EIP Activities:

1) What is the quality of each proposed project with respect to planned approach and methodology, as well as consistency with EIP guiding principles, public health needs, intent of this program, and collaborations?

2) For each proposed activity, is there a clear definition of the geographic area and population base in which the activity will operate (different activities may use different populations)?

3) For each proposed activity, is there evidence of support from non-applicant participating agencies, institutions, organizations, laboratories, individuals, consultants, etc., included in the operational plan? Does the applicant provide (in an appendix) letters of support which clearly indicate collaborators’ commitment to participate in the EIP and define their roles?

4) For each proposed activity, does the applicant clearly identify key professional personnel to be assigned to the EIP and EIP projects as well as key professional personnel from other participating or collaborating institutions, agencies, and organizations outside of the applicant's agency that will be assigned to EIP activities (provide a curriculum vitae for each in an appendix). Clear identification of participants’ respective roles in the management and operation of the EIP? Do participants have adequate experience in conducting work comparable to that proposed in this announcement?

Measures of Effectiveness (10 points)

a. Does the applicant provide measures of effectiveness for each proposed activity that will demonstrate the accomplishment of the cooperative agreement objectives identified in Section B "Purpose" of this program announcement?

b. Are the measures objective and quantitative, and do they adequately measure the intended outcome of each activity?

Budget (not scored)

Is the line-item budget detail broken out for each activity (or project) and contract, clearly justified, and consistent with the purpose and objectives of this program? Does the applicant show both Federal and non-Federal (e.g., State funding) shares of total cost for the EIP?

Human Subjects (not scored)

Does the application adequately address the requirements of Title 45 CFR Part 46 for the protection of human subjects? (Not scored; however, an application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable.)

V.2. Review and Selection Process

Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) staff, and for responsiveness by National Centers for Infectious Diseases (NCID) Office of Surveillance. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified that their application did not meet submission requirements.

An objective review panel will evaluate complete and responsive applications against the evaluation criteria. In addition, the following factors may affect the funding decision:

Funding preference may be given to approved applications that would enhance the geographic diversity of the network to achieve appropriate geographic representation in the EIPs.

Funding preference may also be given to competing continuation applications over applications for programs not already receiving support under this cooperative agreement.

VI. Award Administration Information

VI.1. Award Notices

Successful applicants will receive a Notice of Grant Award (NGA) from the CDC Procurement and Grants Office. The NGA shall be the only binding, authorizing document between the recipient and CDC. The NGA will be signed by an authorized Grants Management Officer, and mailed to the recipient fiscal officer identified in the application.

Unsuccessful applicants will receive notification of the results of the application review by mail.

VI.2. Administrative and National Policy Requirements

45 CFR Part 74 and Part 92

For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html

 

The following additional requirements apply to this project:

AR-1 Human Subjects Requirements

AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

AR-7 Executive Order 12372

AR-9 Paperwork Reduction Act Requirements

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

AR-12 Lobbying Restrictions

AR-22 Research Integrity

Additional information on these requirements can be found on the CDC web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

VI.3. Reporting Requirements

You must provide CDC with an original, plus two hard copies of the following reports:

Interim progress report, (use form PHS 2590, OMB Number 0925-0001, rev. 5/2001 as posted on the CDC website) no less than 90 days before the end of the budget period. The progress report will serve as your non-competing continuation application, and must contain the following elements:

a. Current Budget Period Activities Objectives including report specifically on progress towards stated Measures of Effectiveness from the current budget period (i.e., previous application).

b. Current Budget Period Financial Progress.

c. New Budget Period Program Proposed Activity and Objectives.

d. Budget.

e. Measures of Effectiveness.

f. Additional Requested Information

Financial status report and annual progress report, no more than 90 days after the end of the budget period.

Final financial and performance reports, no more than 90 days after the end of the project period.

These reports must be mailed to the Grants Management or Contract Specialist listed in the "Agency Contacts" section of this announcement.

VII. Agency Contacts

For general questions about this announcement, contact:

Technical Information Management Section

CDC Procurement and Grants Office

2920 Brandywine Road

Atlanta, GA 30341

Telephone: 770-488-2700

For program technical assistance, contact:

Catherine Rebmann

National Center for Infectious Diseases (NCID)

Centers for Disease Control and Prevention (CDC)

1600 Clifton Rd, NE, Mailstop D-59

Atlanta, GA 30333

Telephone 404-371-5363

E-mail address: csr9@cdc.gov

For financial, grants management, or budget assistance, contact:

Lynn Walling, Grants Management Specialist

CDC Procurement and Grants Office

2920 Brandywine Road

Atlanta, GA 30341

Telephone: 770-488-2612

E-mail: lqw5@cdc.gov

VIII. Other Information

This and other CDC funding opportunity announcement can be found on the CDC website, Internet address: www.cdc.gov Click on "Funding" then "Grants and Cooperative Agreements."

Visit these websites for additional information about the EIPs:

 

http://www.cdc.gov/ncidod/EID/vol9no7/03-0083.htm

http://www.cdc.gov/ncidod/osr/site/eip/index.htm

http://www.cdc.gov/ncidod/osr/site/eip/publications.htm

 

Dated: ___________________________

William P. Nichols, M.P.A.

Acting Director

Procurement and Grants Office

Centers for Disease Control and Prevention

 

 

APPENDIX 1 - Active Bacterial Core Surveillance (ABCs)

Specific Activity Details

ALL applicants should propose this activity. CDC expects to provide support for ABCs activities in all EIPs, although some ABCs activities are expected to be conducted only in certain sites.

a. ABCs activities that should be proposed by all applicants:

Conduct active population-based laboratory surveillance for invasive disease caused by emerging, vaccine preventable, and drug resistant bacterial diseases. Active surveillance includes 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, and groups A and B streptococci. 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. The infrastructure for ABCs and related activities is intended to be available for additional special activities. The project should also ensure that ABCs isolates are sent to CDC on a monthly or bimonthly basis, with a goal of no later than January 2005 for bar-code labeling of all ABCs isolates sent to CDC using an agreed upon standard label and system.

Additional core activities for ABCs are:

Annually collect live births denominators from vital statistics;

Annually collect missing race and ethnicity data on ABCs cases less then 2 years of age using birth certificates;

Annually compare ABCs cases to the vital statistics deaths registry within the surveillance area. Using a CDC algorithm, match records in order to capture any deaths due to an ABCs pathogen that were not captured during routine surveillance;

Collect additional demographic, medical, and vaccination history information on all invasive Haemophilus influenzae cases (type b or unknown) in children less than 15 years of age;

Collect additional demographic, medical, and vaccination history information on all invasive pneumococcal infections in children less than 2 years of age;

Collect additional information on cases of early- and late-onset GBS disease and conduct a population-based review of randomly selected labor and delivery records to characterize implementation of interventions to prevent perinatal infection transmission and risk factors for neonatal sepsis;

Conduct a case-control study of new meningococcal disease vaccine. The ABCs surveillance will serve as a platform for enrollment of subjects into a multi-state case-control study of the effectiveness of a new vaccine for meningococcal disease prevention among adolescents. This will involve collection of data regarding vaccine history from physicians and interviews with parents of both cases and control children.

b. ABCs activities that may be proposed by interested applicants:

The infrastructure for ABCs and related activities is intended to be available for additional special activities.

Conduct population-based surveillance for invasive community-onset MRSA infections, including ascertainment of community- vs. healthcare- associated status based on hospital medical record review, ascertainment of isolates from select/sentinel and collection of appropriate denominator data (i.e., total invasive S. aureus tested). Population served by laboratories in surveillance program should span the spectrum of healthcare delivery (ambulatory, long-term care, acute care).

Conduct surveillance for neonatal sepsis in children less than seven days old, including enhanced surveillance for E. coli.

Collect additional demographic, medical and vaccination history information on all invasive pneumococcal infections among children age between 24 and 59 months of age.

Conduct prospective surveillance for gram positive rods.

Participate in a study to determine risk factors for meningococcal infections among high school students.

Perform enhanced molecular subtyping of meningococcal isolates pre- and post-vaccine introduction

Evaluate non-invasive isolates of Neisseria meningitidis pre- and post-vaccine introduction through nasopharyngeal carriage studies.

Conduct surveillance for and collection of beta-hemolytic (non-group A, non-group B) streptococcus isolates for further laboratory characterization at CDC.

 

APPENDIX 2 - Foodborne Diseases Active Surveillance Network (FoodNet)

Specific Activity Details

ALL applicants should propose this activity. CDC expects to provide support for FoodNet activities in all EIPs, although some FoodNet activities are expected to be conducted only in certain sites.

FoodNet activities that should be proposed by all applicants:

Conduct active, population-based surveillance for laboratory-confirmed Salmonella, Shiga toxin-producing E. coli (STEC), Campylobacter, Shigella, Listeria, Yersinia, Vibrio, Cryptosporidium, and Cyclospora infections. Complete case report forms for each case, including collection of demographic and outcome information. Collect information on foreign travel and outbreak-association on all or a statistically representative portion of E. coli O157 and Salmonella cases. Completeness of case ascertainment should be verified by audits of every clinical laboratory within the FoodNet surveillance area at least twice a year. In these clinical laboratory audits, records in each laboratory should be reviewed and case report forms should be completed on cases not identified through the routine surveillance, as described in the FoodNet performance standards.

Submit data to CDC in a consistent and comprehensive way to allow monitoring of changes in disease incidence and tracking of progress to Healthy People 2010 national health objectives.

Additional FoodNet core activities are:

Active surveillance for cases of hemolytic uremic syndrome (HUS) ascertained through pediatric nephrologists; selected sites may also validate surveillance for pediatric HUS cases and identify adult HUS cases by review of annual hospital discharge data;

Conduct cohort study of persons infected with STEC;

Active participation in PulseNet including: pulsed-field gel electrophoresis (PFGE) of all E. coli O157 and Listeria isolates from the catchment area;

Submission of isolates to the National Antimicrobial Resistance Monitoring System (NARMS): send from State Public Health Laboratory to CDC all Salmonella Typhi, non-cholerae Vibrio, and Listeria; every twentieth Shigella, Non-Typhi Salmonella, and E. coli O157; and one Campylobacter isolate per week from designated laboratories;

Participation in the Retail Food Study;

Use expanded case report form developed by Outbreak Working Group and approved by CSTE to interview all persons with listeriosis;

Enhanced outbreak investigation; report all foodborne disease outbreaks to CDC monthly using the Electronic Foodborne Outbreak Report System (EFORS); complete and submit to CDC the supplemental form to the Outbreak reporting form;

Active participation in Steering Committee calls, Working Group calls, and Coordinator calls;

Required attendance at FoodNet’s annual Vision Meeting.

FoodNet activities that may be proposed by interested applicants:

The infrastructure for FoodNet and related activities is intended to be available for additional special activities including:

Completion and analysis of case-control studies of infant Salmonella and Campylobacter infections (at sites where this is ongoing);

Continued participation in the Enterococcus antimicrobial resistance study of outpatient stool samples. Each month participating sites send enterococci isolates to CDC for antimicrobial testing (at sites where this is ongoing);

Completion and analysis of the Reactive Arthritis Study (at sites where this is ongoing);

Completion and analysis of the Giardia case-control study (at sites where this is ongoing);

Participation in toxoplasmosis surveillance (at sites where this is ongoing or interested sites);

Development and implementation of a study on the human health consequences of antimicrobial-resistant foodborne diseases (interested sites);

Participation in laboratory survey and retail food study to understand regional differences in the incidence of laboratory-confirmed Campylobacter infections (interested sites);

Conduct surveillance for cases of Guillain Barré Syndrome using hospital discharge data (interested sites);

Development and implementation of a case-control study for Salmonella Javiana (interested sites);

Interview patients with laboratory-confirmed Shigella infections to determine the proportion likely to be foodborne (interested sites);

Development and participation in a study designed to validate the proportion of persons with gastroenteritis that seek medical attention and submit a diagnostic specimen (interested sites);

Development and implementation of a study to better understand why incidence rates of some foodborne diseases are higher in young children (interested sites);

Implementation of molecular subtyping of norovirus strains using RT-PCR amplification and nucleotide sequence analysis.

 

APPENDIX 3 - Surveillance for Respiratory Diseases and Syndromes

Specific Activity Details

All applications should include a proposal for activities 1 and 2 below. Applicants may include proposals for other activities in this section; those already currently involved in activities 3 or 4 are encouraged to include proposals for continuation of these activities. CDC expects to fund five to nine EIPs for a combination of these activities involving surveillance for respiratory diseases and syndromes.

Establish a flexible, long-term, population-based surveillance for hospitalized, community-acquired lower respiratory tract infection (LRTI) within the EIPs to characterize the rate and epidemiology of LRTI and to evaluate trends in the context of EIP influenza and invasive bacterial surveillance and interventions to prevent illness (e.g., influenza vaccine, pneumococcal conjugate vaccine). Because LRTI is such a common syndrome, case finding will be conducted initially through hospital discharge data for the EIP catchment areas using a standard list of ICD-9 codes across EIPs. In the first year of establishing surveillance, EIPs will identify mechanisms of timely acquisition of electronic hospital discharge data (e.g., monthly or quarterly data transfers with a 3 month delay in time period covered) and methods of limiting data to catchment population (e.g., limiting by zip code of residence); in addition to establishing a system for routine collection of prospective data, retrospective data from 1998-2004 will be requested. Discharge data will be used in future years as a sampling frame for more detailed chart review to evaluate accuracy of surveillance and address priority questions. It will also serve as a foundation for exploration of innovative methods of prospective LRTI surveillance. Since this activity provides a platform and context for other EIP projects, it will be designed to ensure integration of discharge data across EIP sites and with other related EIP projects

Conduct active, population-based surveillance for laboratory-confirmed influenza-related hospitalizations in children. The overall aims of this surveillance are to characterize the burden of laboratory-confirmed pediatric influenza in the United States and to influence future ACIP influenza vaccine recommendations. Case finding should occur through retrospective and prospective searches of hospital laboratory and admissions databases. Case finding methods may vary slightly among surveillance areas or among hospitals within an area depending on the availability of laboratory and admissions databases. Influenza admissions may be tracked by infection control professionals or other hospital staff serving pediatric wards where influenza cases might be admitted for a particular community. Chart reviews should be conducted on all or a sample of cases to collect more detailed clinical and epidemiologic information. Influenza vaccination information for cases should be collected through chart review or contact with health care providers or parents.

Conduct surveillance for hospitalized pneumonia among health care workers and/or returned international travelers. Areas participating in this surveillance will work on defining denominators for these populations and on improving timeliness of data collection/analysis to allow for identification of clusters or unusual events.

Implement a common protocol (e.g. based upon the unexplained deaths and critical illnesses (UNEX) project protocol) to characterize the etiologies of severe respiratory syndrome. Applicants should identify one or more institutions within their site to perform this activity. At these selected institutions, patients admitted to the intensive care unit with community-acquired pneumonia or acute respiratory distress syndrome (ARDS) will be identified and enrolled. Specimens will be obtained from enrolled participants for diagnostic evaluation using real-time polymerase chain reaction and antibody-based assays. Applicants should propose to acquire the technical capacity to conduct their own diagnostic testing using standardized and validated methods consistent across surveillance areas and collaborate on developing a pneumonia diagnostics test panel with highly sensitive and specific assays that can be exported for general use in other public health laboratories. As new diagnostics become available or new respiratory pathogens emerge as threats, incorporate appropriate tests into the etiology component of the study. 

As part of the toolkit for flexible response to emerging problems, develop EIP capacity to facilitate investigation of outbreaks of respiratory illness of unknown etiology or emerging problems of concern. This activity will begin with a focus on improved detection and investigation of clusters of severe or lower respiratory infections in facilities and institutions.  This could include developing an algorithm to facilitate the public health response and investigation of a cluster of respiratory illness or piloting a CDC algorithm for the evaluation of a respiratory disease outbreak.  The algorithm might include case finding strategies, implementing infection control, obtaining appropriate specimens, specimen storage, and diagnostic testing and reporting. EIPs involved in this activity will work together as a network to hone algorithms and share lessons learned. 

 

APPENDIX 4 – Flexible Response to Emerging Problems

Specific Activity Details

ALL applicants should propose this activity. As a manifestation of EIP capacity for flexible response, each EIP will be expected to participate in a workgroup convened on short notice to review newly emerging infectious disease issues. Should that group determine that EIPs could help guide the response to that issue in the short-term, each EIP is expected to contribute to rapid study design and initiate and complete the relevant study within one month of its proposal (it is expected that this will occur at least once per year).

In its operational plan, each applicant should elaborate on the surge capacity that would be used to participate in workgroups convened on short notice to review newly emerging infectious disease issues. Applicants should also elaborate on the surge capacity that would be used, if the workgroup determines that EIPs could help guide the response to that issue in the short-term, to contribute to rapid study design and initiate and complete relevant studies in a timely manner.

 

APPENDIX 5 – Rapid Population Surveys

Specific Activity Details

ALL applicants should propose this activity. CDC recommends that resources for this activity be requested as Direct Assistance in the approximate amount of $20,000, which will be applied toward contractual arrangements for EIP-wide population survey services.

In 2004 the EIP Steering Group decided to develop the capacity to do population surveys on a broad scale, in order to rapidly obtain acute population-level information about emerging infections. Surveys are planned for 3 to 10 minutes in length and consist of several readily-changeable questions that can be administered to 200 respondents in each EIP site over a short period of time. Surveys can be rapidly modified to meet acute population-level information needs related to newly emerging infections such as SARS, influenza, acceptability of spraying to reduce mosquito numbers in response to West Nile Virus, etc.

The first EIP population survey was conducted as part of the public health response to the 2003-2004 influenza epidemic and collected telephone interviews with adults from randomly sampled, telephone-equipped households in California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon, Tennessee, and Texas.

The Flu Survey questionnaire was designed by principal investigators at the EIP sites, the Influenza "Team B" (a group of external experts convened by CDC), and the Influenza Special Investigations team. Questionnaire topics included incidence of influenza-like illness, healthcare use, prevention behaviors, vaccination history and plans, and knowledge and perceptions about influenza.

 

APENDIX 6 - Integrated Hepatitis Surveillance

Specific Activity Details

Participate in a program to develop centers of hepatitis surveillance excellence to conduct enhanced surveillance for viral hepatitis and chronic liver disease. There are two components of this activity: (1) Acute viral hepatitis surveillance and (2) surveillance for chronic viral hepatitis and liver disease. Applicants applying for Integrated Hepatitis Surveillance are required to address at least one of the activities included in recipient activities (1) Acute Viral Hepatitis Surveillance (exception is made for current Chronic Liver Disease Study grantees who are required only to apply for Chronic Viral Hepatitis and Liver Disease Surveillance).

All hepatitis surveillance activities described should be population-based. Funding will be awarded separately for each section.

Eligibility Criteria

Acute Viral Hepatitis Surveillance:

Eligible applicants must have laws or regulations within the proposed catchment area for surveillance requiring laboratory reporting of IgM anti-HAV, IgM anti-HBc, and HBsAg. Laws or regulations requiring laboratory reporting of anti-HCV or HCV RNA, or provider reporting of acute hepatitis C are also required.

This section includes two activities, each with additional specific eligibility criteria. Applicants meeting the eligibility criteria should apply for one or both activities.

a. Acute viral hepatitis surveillance in State and Local Health Departments. Eligible applicants must have an average of at least 40 reported cases of acute hepatitis A and 40 reported cases of acute hepatitis B in 2000-2002 in the area under surveillance.

b. Acute viral hepatitis surveillance in the Sentinel Counties. Eligible applicants must have an existing Sentinel County project in place.

Chronic Viral Hepatitis and Chronic Liver Disease Surveillance:

This section includes two activities, each with specific eligibility criteria. Applicants meeting the eligibility criteria may apply for one or both activities. These activities are optional for all but current Chronic Liver Disease Study grantees.

a. Chronic Viral Hepatitis Surveillance. Eligible applicants must have, within the proposed catchment area under surveillance 1) laws or regulations requiring laboratory reporting of hepatitis B surface antigen (HbsAg) and antibody to hepatitis C virus (anti-HCV EIA or RIBA) and/or hepatitis C virus RNA (PCR). Applicants that do not yet have such laws or regulations but can provide evidence of a plan to establish them will be considered; 2) existing de-duplicated computerized longitudinal databases or registries of persons with laboratory markers of chronic infection (HBsAg, anti-HCV [EIA, RIBA] and HCV-RNA) which are representative of the population under surveillance.

b. Chronic Liver Disease Surveillance. Eligible applicants must have an existing Chronic Liver Disease Surveillance (CLDS) site and have assembled a cohort of patients meeting the CLDS case definition for newly-diagnosed chronic liver disease during 1999-2001.

Recipient Activities

1. Acute Viral Hepatitis Surveillance (Required for all except Chronic Liver Disease

Study grantees)

Acute Hepatitis A and B

Establish laboratory based surveillance for acute hepatitis A and B.

Follow-up reports of laboratory markers of acute hepatitis A and B virus infection (anti-HAV IgM, anti-HBc IgM and/or HBsAg) to determine case status. Cases should be defined using the CSTE/CDC Case Definitions for Infectious Conditions Under Public Health Surveillance.

Investigate cases of acute hepatitis A and B, and collect data on clinical manifestations, laboratory findings, and risk factors. Investigations may involve provider and patient interview, and medical record review.

Explore the feasibility of collecting serologic specimens on acute hepatitis A and B cases.

Complete the Viral Hepatitis Case Report (attached) and submit surveillance data to CDC

Acute Hepatitis C

Increase the sensitivity and specificity of case reporting (activities depend on local mechanism for reporting). Cases should be defined using the CSTE/CDC Case Definitions for Infectious Conditions under Public Health Surveillance.

Complete the Viral Hepatitis Case Report (attached) and submit surveillance data to CDC.

  • Acute Viral Hepatitis Surveillance in the Sentinel Counties
  • Identify acute cases of hepatitis A, hepatitis B, hepatitis C and other NANB hepatitis in a defined geographic area. Such cases will be identified through clinical sources and by reviewing laboratory reports of viral hepatitis testing conducted on residents of the catchment area.

    Collect demographic and clinical information on all cases identified with acute hepatitis A, hepatitis B, hepatitis C, and other NANB hepatitis. Cases identified with a discrete date of onset will be interviewed for known and potential risk factors associated with disease acquisition and a serologic sample will be collected on these cases and provided to CDC.

    Determine the role of health or dental care providers or other nosocomial exposures as potential sources of transmission for persons with acute symptomatic hepatitis B, hepatitis C, or other NANB hepatitis in whom no source is identified.

    Determine the role of transfusion as a potential source of transmission for persons with acute symptomatic hepatitis B, hepatitis C, or NANB hepatitis.

    Identify household and sexual contacts of persons with acute symptomatic hepatitis B and obtain serum samples on these persons.

    Identify household and sexual contacts of persons with acute hepatitis C and other NANB hepatitis and obtain serum samples on these persons.

     2. Chronic Viral Hepatitis and Chronic Liver Disease Surveillance (Optional for all

    except Chronic Liver Disease Study grantees)

    Chronic Viral Hepatitis Surveillance

    Within the existing registry of persons with laboratory markers of chronic HBV and HCV infection, explore the feasibility of linking laboratory reports of liver enzymes test results with markers for HCV infection (anti-HCV, HCV RNA) to facilitate determination of case status.

    Determine case status on as many reports as possible using the CSTE/CDC Case Definitions for Infectious Conditions Under Public Health Surveillance.

    Complete Viral Hepatitis Case Report (attached) and submit surveillance data to CDC.

    Follow-up chronically infected persons in the data base. Follow-up can be limited to a sample of persons identified in the data base who meet demographic or risk criteria. Follow-up of persons with chronic infection might include but is not limited to education, counseling, medical referral, and, in the case of persons with chronic HBV infection, vaccination of eligible contacts.

    (Optional) Contact and interview a sample of chronically-infected persons followed-up from the data base. Data collected from interviews might include demographic, risk factor, and health outcome data, such as, access to medical care, treatment for chronic infection, and health status. Contact these persons’ physicians as appropriate to assess disease stage. Common protocols and data collection tools should be developed by funded participants and federal collaborators. Submit follow-up data to CDC on a quarterly basis (format to be discussed).

    Chronic Liver Disease Surveillance

    Five year follow-up.

    Contact patients with chronic viral hepatitis, alcoholic liver disease, nonalcoholic fatty liver disease, or chronic liver disease of unknown etiology who were enrolled in the CLDS during 1999-2000. Attempts should be made to locate patients using multiple methods.

    Obtain informed consent

    Interview patients to collect information on current disease stage and health status, access to medical care, treatments, and alcohol consumption, and other relevant exposures during the time since initial diagnosis and previous interview. All funded sites should use a common data collection instrument.

    Collect available clinical information, including but not limited to diagnostic tests and liver biopsies performed since initial diagnosis and previous data collection.

    Submit data to CDC (format to be determined).

    Share protocols, planning documents, progress reports, and monitoring/ evaluation data with other funded participants and federal collaborators.

    Obtain necessary human subjects approvals and ensure the confidentiality of individual identifying information collected according to applicable laws and regulations

    (Optional) Chronic liver disease in primary care practices.

    Complete population based surveillance for physician diagnosed chronic liver disease in primary care practices for a one year period.

    Using a standardized case definition, conduct active surveillance and routine reporting of chronic liver disease from all primary care and gastroenterologist/hepatologist providers in the catchment area who agree to participate.

    Complete reviews of in and outpatient medical records on all patients reported to the surveillance system, and obtain samples of liver biopsies if appropriate.

    Conduct interviews for demographic, clinical, and risk factor information and obtain blood specimens on all patients reported to the surveillance system with a confirmed chronic liver disease diagnosis after obtaining physician and patient permission.

     

    Viral Hepatitis Case Report

     

    APPENDIX 7 – OTHER EIP ACTIVITIES that may be proposed

    Specific Activity Details

    Applicants may propose projects from the list below or propose projects of local interest, concern, or expertise that are in keeping with the guiding principles of the EIP.

    Surveillance for Encephalitis Syndrome:

    Active surveillance for encephalitis of possibly infectious etiology. Methods for these activities should be developed together with CDC and other EIP sites currently engaged in such activities. Protocols should be written to complement other syndrome-based surveillance activities

    Unexplained Deaths and/or implementation of Med-X:

    Conduct population-based surveillance to evaluate the frequency of unexplained deaths and critical illnesses due to infectious diseases in previously healthy persons aged 6 months - 49 years. Unexplained deaths surveillance may serve as a sentinel system to identify new infectious agents, recognize unique presentations of known pathogens or detect bioterrorism.

    As part of this activity, applicants may propose to adapt the Med-X approach for medical examiner-based surveillance for deaths due to possible infectious etiologies. Med-X is a model pathology-based syndromic surveillance system designed by the New Mexico Office of the Medical Investigator to recognize bioterrorism mortality and fatal infectious of public health importance. It uses a set of antemortem symptoms (e.g., fever, cough) to identify cases that warrant an autopsy for infectious or toxic related etiologies. Based on autopsy findings, the case in then classified into a set of pathologic syndromes and each syndrome is used to define a differential diagnosis. These uniform criteria for performing medical examiner autopsies and reporting cases to public health authorities provide timely surveillance for infections of public health importance.

    Border Infectious Disease Surveillance (BIDS):

    Perform active surveillance for infectious diseases along the U.S. - Mexico border in order to better understand and detect infectious disease problems along this international border. Conduct active sentinel or population-based surveillance for infectious disease syndromes such as febrile exanthems, (such as measles, rubella, dengue, rickettsial diseases, ehrlichiosis, leptospirosis, brucellosis), acute viral hepatitis, non-respiratory /non-diarrheal febrile syndromes, meningoencephalitis and bioterrorism-agent related syndromes using established U.S. - Mexico border infectious diseases surveillance (BIDS) protocols and questionnaires in border counties and/or in cities/facilities serving a high proportion of Latin American immigrants. Integrate border diagnostic, demographic and questionnaire data with state case reports for notifiable infectious diseases and regularly review quality of data. Since this activity will be done in collaboration with other Border States and CDC, the project should be designed so that data can be integrated with data from other sites. Completeness of syndromic and laboratory reporting should be verified by periodic (semiannual) audits of clinic and emergency room charts and laboratory records. Case report form information should be completed on cases not identified through "routine" active surveillance. Inform Mexico of binational cases and urgently notifiable cases through BIDS binational protocols. Collaborate with CDC in putting together borderwide binational surveillance reports. Participate in BIDS steering committee and annual BIDS binational meetings. The infrastructure for border infectious disease surveillance and related activities is intended to be available for additional special activities, such as Intensified Hepatitis Surveillance Protocol.

    Training Activity:

    Training activities may be proposed as a separate activity or they may be integrated into other proposed activities. The approach for training activities is up to the applicant. For example, training activities may take one or more of these forms:

    a. Provide training opportunities for persons in professional training, such as infectious disease fellows, laboratory fellows, or public health students.

    b. Provide training for partner organizations within the EIP area, such as infection control practitioners, laboratorians, or local health department personnel.

    c. Act as a resource for states that are not participating in the EIP network, for example, by providing information, training, or recommendations about emerging public health issues and evolving public health practices.

    Participate in an exchange program with the International Emerging Infections Program. Ensure that a domestic EIP epidemiologist, surveillance officer, or laboratorian is able to spend 3 months to a year at an International EIP site or propose to host an epidemiologist, surveillance officer, or laboratorian visiting from an International EIP site.

    Human Genomics:

    Develop and conduct activities related to exploring the role of human genomics in public health and infectious diseases in one or both of the following ways:

    1. Conduct an evaluation of the value of assessing human genomic risk factors in acute public health investigations. This might be conducted by applying human genomic technologies to infectious disease outbreaks, or by designing a study to examine response to a specific pathogen or the affect of a specific gene. Health investigations where human genomics may be important include, e.g., infectious disease outbreaks, bioterrorism events, environmental exposures, disease clusters, and adverse events to therapeutic such as vaccines. In addition, emerging technologies, such as use of proteomics and toxicogenomics will increasingly allow us to assess signature profiles for unknown environmental exposures and identify subgroups of disease outcomes with different etiologies or pathogens.

    2. As an enhancement of routine active surveillance or as a component of other EIP activities (e.g., in ABCs, FoodNet, or Surveillance for Respiratory Diseases and Syndromes), incorporate human genomics-related activities, e.g., by collecting appropriate specimens for the determination of the role of human genomics in the susceptibility and resistance to disease, or by collecting appropriate additional information. Work closely with CDC scientists to identify options for specimen collection and storage and human genomic testing.

     

     


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