a.  Funding Opportunity Description. 16

A. General Award Information

Fiscal Year Funds: Awards from this cooperative agreement are funds that will be applied to a Budget Period beginning May 1, 2008 and ending April 30, 2009. 

Measuring Effectiveness: 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 each project.  Measures must be objective and quantitative and must measure the intended outcome.  The measures of effectiveness must be submitted with the application. How an awardee intends to measure the effectiveness of its plan should be included in the plan narrative. (See “Selection Criteria” for each of the projects.) The awardee’s approach to measuring effectiveness will contribute to the overall score for the plan section.

B. Project Descriptions

1. Public Engagement Demonstration Projects on Pandemic Influenza

a. Funding Opportunity Description

Purpose: The public engagement demonstration project on pandemic influenza has five purposes:

1. To inform and assist state and local level decision-makers involved in pending, values-oriented policy decisions related to pandemic influenza planning
2. To evaluate the effectiveness of engaging both citizens-at-large and other stakeholders in public health policy decisions
3. To increase state and local capacity to effectively engage the public on policy choices
4. To empower citizens to participate effectively in public decision-making work
5. To achieve results that enhance public trust in public health decisions regarding policy choices

Awardees should consider developing a public engagement model similar to the model used recently by CDC to obtain public input on priorities for pandemic influenza vaccine and on tradeoffs associated with community control measures for pandemic influenza, or they can develop their own innovative approach that engages both citizens-at-large and stakeholders on real-life policy decisions facing public health and other officials.

Examples of values-oriented policy decisions facing state, local, territorial, or tribal officials may include:

a)      Who should receive vaccine in the early days of a pandemic when supplies are limited?

b)      A pandemic can cause numerous deaths, school closings, and high absenteeism.  Should schools be closed and important social activities cancelled before there is evidence of disease in the local area in an effort to slow down the spread of the disease?

c)      Who should receive access to limited supplies of respirators, ICU beds, and other life-sustaining equipment or medical treatments during a pandemic?

d)      To what extent should jurisdictions in a different city, county, states, or region act as one unit to implement uniform pandemic influenza policies? Is consistency across areas more important than tailored policies meeting the specific needs of particular areas? 

By collaborating with and learning from public engagement experts and CDC, the awardees that participate in the project will enhance their capacity for conducting similar public engagement activities in the future and develop approaches to public engagement that could benefit other awardees. 

Background: Pandemic influenza planning calls for state, local, territorial, and tribal public health agencies and many other stakeholders to consider federal recommendations in several pandemic influenza preparedness areas, such as vaccination and social distancing policies, and to adopt or modify the federal guidance on these topics to address their residents’ needs. Public health agencies and other decision-makers may exercise different degrees of autonomy in making decisions about these individual issues. 

Pandemic influenza planning requires making difficult choices: Who should be the first to receive limited supplies or equipment? How aggressively should disease-control strategies be implemented early on when disease is not yet prevalent?  These decisions are not purely technical in nature, for they require consideration of societal values. An approach to public engagement should:

• Address decision-oriented work where both values and facts are relevant, where tradeoffs between positive benefits and challenging consequences are required, and where there is no one “scientifically right” answer or solution that can be anticipated

• Involve representatives of stakeholder organizations, such as protection and advocacy groups, with recognized interests and citizens-at-large without agendas for the issue at hand
• Involve stakeholders from at-risk and special-needs populations, including new immigrants and non-English speakers, as well as cross-border international partners
• Require the participation of decision-makers or their representatives to be responsible for the issue being worked on
• Utilize neutral facilitation and respectful listening to all voices
• Provide information that is balanced to all participants, ensuring that enough detail is included to aid in comprehension of the issues
• Provide a structured forum for genuine dialogue, mutual learning, and deliberation including, when necessary, sign language and other language services
• Require integration of the viewpoints of representatives from stakeholder organizations and citizens-at-large into one report describing the “societal perspective”
• Provide feedback to the participants about the final decisions made and the reasons for them
• Be diverse and inclusive of all populations including at-risk individuals and special-needs populations represented within a state’s citizenry

At present, many states, localities, territories, and tribes do not have the capability or mechanisms in place to routinely engage citizens in a highly interactive dialogue about the difficult decisions and tradeoffs that go hand-in-hand with pandemic influenza response planning.

A U.S.–Canada summit meeting entitled “Disease, Disaster, and Democracy — The Public’s Stake in Health Emergency Planning” was held in May 2006. It highlighted the need for greater government interaction with citizens and stakeholders. The purpose of the summit, sponsored by the Center for Biosecurity of the University of Pittsburgh Medical Center, was to advise leaders in government, public health, and disaster management on the feasibility and societal benefits of actively engaging citizens in health emergency planning. [Schoch-Spana M, Franco C, Nuzzo J, & Usenza C on behalf of the Working Group on Community Engagement in Health Emergency Planning. “Community Engagement: Leadership Tool for Catastrophic Health Events,” Biosecurity & Bioterrorism 2007; 5(1) – in press] [http://www.upmcbiosecurity.org/website/focus/

community_engage/2007_working_group/full_report.html]

In 2005, a national-level public engagement project partly supported by 14 organizations pilot-tested a federal-level model for public engagement.  It considered the question of which population should be first to receive vaccination in the event of a pandemic. The project showed that citizens and stakeholders could be successfully recruited, engaged in meaningful give-and-take discussions, weigh difficult tradeoffs, and reach a conclusion that could be useful in informing decision-makers. [Citizen Voices on Pandemic Flu Choices — A Report of the Public Engagement Pilot Project on Pandemic Influenza, December 2005 at http://www.keystone.org/spp/health-pandemic.html]

The federal-level model also was used successfully, in 2006, in obtaining public input on which control measures should be implemented in the early days of a pandemic of influenza. [The Public Engagement Project On Community Control Measures for Pandemic Influenza, Findings and Recommendations from Citizen and Stakeholder Deliberation Days in Atlanta, GA, Lincoln, NE, Seattle WA, Syracuse NY, and Washington DC, December 2006 at http://www.keystone.org/Public_Policy/pandemic_control.html]

Using this model or implementing a similar model emphasizing the benefits of public engagement for pandemic influenza planning might generate novel ideas that would otherwise be unavailable to decision-makers. It also might increase buy-in and public support for eventual policy decisions. Public support is critical for successful implementation of disaster management or disease management strategies during an emergency. If a public engagement model is successful, its key elements might be replicated for other pending decisions and/or be adopted by other awardees to assist in their health emergency planning.

1. Establish an overall steering committee for the project
2. Provide infrastructure to fulfill public engagement and logistical support
3. Implement an existing public engagement model or develop a new approach, both of which must be representative of the diversity of the local community in collaboration with public health partners

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

CDC Activities:

1. Assist in establishing an overall steering committee for the project
2. Provide technical assistance in finalizing the design for the project
3. Assist in recruiting appropriate stakeholders
4. Assist in convening stakeholders
5. Assist in recruiting citizens-at-large
6. Assist in convening citizens-at-large
7. Assist in providing information to stakeholders and citizens-at-large, including alternate formats
8. Provide neutral facilitation
9. Assist in integrating the contributions of stakeholders and citizens-at-large into a single report
10. Evaluate the effectiveness and safety of the overall project
11. Organize a workgroup, which includes representatives from jurisdictions, to monitor the project, exchange information, and obtain lessons learned for future work
12. Both citizens-at-large and stakeholders should include at-risk populations 

b. Award Information

Approximate Current Fiscal Year Funding: Between $1 million and $2 million

Approximate Total Project Period Funding: Between $1 million and $2 million (Includes direct and indirect costs.)

Approximate Number of Awards: 5 to 10

Approximate Average Award: $100,000 to $200,000 (Includes direct and indirect costs.)

Floor of Individual Award Range: None

Ceiling of Individual Award Range: None

Anticipated Award Date: April 18, 2008

Budget Period Length: The budget period for the Pandemic Influenza Competitive Projects is one year, beginning May 1, 2008 and ending April 30, 2009.

Project Period Length: The project period for the Pandemic Influenza Competitive Projects is one year, beginning May 1, 2008 and ending April 30, 2009.

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.

1. The pending decision at the state level on which the awardee wishes to receive meaningful public input. Ideally, this pending decision will involve an important pending policy choice or a decision related to pandemic influenza planning that requires having some technical knowledge or information about influenza and requires weighing of competing societal values to arrive at a decision. Choices that are broad in scope (“upstream” or early decisions) are preferred to choices that are narrow (“downstream” or late decisions) because broad choices 1) can benefit the most from the knowledge and experience of the stakeholders and citizens, 2) will be most satisfying and empowering for the participants to contribute to, and 3) will be the most likely to earn participant buy-in and support for implementation. Very often, but not always, these broad choices are values-driven (“should-type”) decisions about ends, rather than more narrow technical (“how to”) decisions about means. The narrative should make clear the specific product that is desired as the outcome from the consultation.
2. How both citizens-at-large and stakeholders representing different organizations with a recognizable interest in the decision will be recruited to participate in the consultation. The narrative should explain how the applicant will encourage diverse participation (including by age, race, sex, disability status, and principal region), so that overall participation will be large and diverse enough to produce results seen as legitimate.
3. The types of linkage that decision-makers will have with the project. At a minimum, the narrative should describe the level of support for and commitment to the project, the type of participation that decision-makers or their representatives will contribute or engage in with the public participants, and the type of feedback to participants that decision-makers will give after the decision is taken.
4. How the awardee will convene citizens and stakeholders to participate in group processes designed to address the pending decision of interest.  Since collaboration with local health departments is anticipated as a means of successfully recruiting citizens and hosting the meetings, the narrative should describe which local health departments have been selected to participate and the reasons for selection. Letters of support from public health officials of those health departments should be included, if available, and the letters should describe how meetings will be hosted.
5. How the awardee will provide or assure that balanced information on all sides of the issue is presented to the participants and that the information is adequate for them to reach informed opinions on the decision at hand.  This may include information in alternate formats and languages or the use of a sign or other language interpreter. 
6. How the group process used will encourage dialogue among the participants.
7. How decision-makers will provide feedback to participants in the process, including the reasons behind the decision. The project will be based on the assumption that the decision-makers will, at a minimum, give serious consideration to the results of the citizen and stakeholder deliberations. 
8. How the awardee will establish an overall steering committee for the project, to be composed of the key contributors to the project.
9. When the awardee refers to citizens and stakeholders, it will include the concerns of at-risk individuals and special needs populations.

c. Selection Criteria

The following criteria will be used to rank awardees for this project:

1. Plan.  Does the plan adequately address each of the objectives described in the Purpose section? More specifically, how well does the narrative describe how the applicant will address each of the elements of good public engagement? How complete and comprehensive is the plan for carrying out the project?  Does the plan clearly describe the population characteristics of the state, city, or community in which the project will take place?  Does the plan include quantitative and/or qualitative performance measures? What measures of effectiveness are in place to show progress and performance? (60 points)
2. Methods.  Are the proposed methods feasible?  To what extent will they accomplish the program goals? (30 Points)
3. Personnel.  Do the staff members have appropriate experience?  Are the staff roles clearly defined?  As described, will the staff be sufficient to accomplish the program goals? (10 Points)
4. Budget and Justification.  (Reviewed, but not scored)

2. Electronic Laboratory Data Exchange to Support Pandemic

    Influenza Surveillance and Laboratory Testing Surge

    Capacity

a. Funding Opportunity Description

Purpose: To facilitate electronic exchange of laboratory orders and test results among public health laboratories, their surveillance partners, and CDC. This project is intended to support demonstrations of laboratory and state information systems capable of performing the following functions incorporating PHIN-compliant approaches:

1. Sharing of influenza surveillance laboratory test results from state laboratories with state and local and cross-border international public health partners, as well as with CDC
2. Ordering influenza reference tests and sharing electronic reference test results between partners and CDC
3. Interstate and intrastate and bi-national laboratory test result and test order exchange supporting surge capacity among laboratories

Background: Laboratory test results will play a critical role in detecting and defining the presence of disease attributable to a pandemic strain in an area, and defining strain variability during a pandemic. State public health laboratories will be key participants in performing such testing and/or forwarding specimens for testing by other reference laboratories, or for triaging specimens to surge capacity laboratories when local capacity is overwhelmed.  In addition to conducting the testing, laboratories must be able to order tests and electronically transmit patient- or specimen-level test results to relevant partners, such as CDC, state and local health departments, and cross-border international partners as well as receive results from other laboratory partners, including commercial laboratories and other facilities that do testing on behalf of a public health lab to meet surge capacity needs.  Equally important is the need to link laboratory results to related epidemiologic data, including local or state health departments, quarantine stations, and bi-national partners. Nearly two-thirds of state public health laboratories transmit influenza laboratory results to CDC as aggregate data, a form that would not meet information needs during the early phases of a pandemic.

Recipient Activities:

1. Development, implementation, and licensing of a laboratory information system that will support pandemic influenza surveillance and surge capacity testing

a.       Tools and services for message mapping and appropriate terminology implementation

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

CDC Activities:

1. Provide “Pandemic Influenza Aggregate Vaccine Doses Data Exchange Requirements” to project participants
2. Provide advice regarding CRA issues
3. Develop and provide multiple formats needed to transmit data
4. Assist in the facilitation and adaptation of aggregated data to meet PHIN requirements
5. Certify that systems, submitting personnel, and data are PHIN-compliant
6. Test each system for reliability and inter-connectivity
7. Develop an analytical package to assist awardees in interpreting and presenting gathered data
8. Develop and assist in the methods and systems needed to enable the assessment of pandemic influenza vaccine effectiveness in the event of  a pandemic in areas with existing active surveillance systems, such as CDC's Emerging Infections Program

b. Award Information

c. Selection Criteria

1. Plan.  Does the plan adequately address each of the objectives described in the Purpose section (to integrate existing state-based immunization information systems (IISs) and CRA systems for tracking doses of pandemic influenza vaccine)? For example, the plan should demonstrate the ability to be population-based — denominator is populated with vital records data in a timely manor — and be inclusive of all ages (lifespan); it should demonstrate how it will achieve 100% participation of providers administering pandemic vaccine; it should develop an approach that will yield reporting of 100% of pandemic vaccine doses administered within one week from the date of vaccination; and it should show collaboration between state immunization and bioterrorism programs, and with other state preparedness stakeholders. Does the plan clearly describe the population characteristics of the state, city, or community in which the project will take place?  Does the plan include quantitative and/or qualitative performance measures? What measures of effectiveness are in place to show progress and performance?  (45 Points)  Is the awardee currently linking its active surveillance systems with IIS, or does the awardee have a plan to do so?

2. Methods.  Are the proposed methods feasible?  To what extent will they accomplish the program goals? (30 Points)
3. Personnel.  Do the staff members have appropriate experience?  Are the staff roles clearly defined?  As described, will the staff be sufficient to accomplish the program goals? (20 Points)
4. Budget and Justification.  (Reviewed, but not scored)

4. Electronic Death Reporting

a. Funding Opportunity Description

Purpose:  Implement a statewide PHIN-compliant electronic mortality reporting system that is capable of transmission of fact of death and demographic information within five days and also the cause of death information within 10 days in 80% of all deaths in the awardee’s jurisdiction. The developed system should be created in accordance with National Center for Health Statistics (NCHS) standards and use the PHIN-compliant systems. Awardees should engage the National Association of Public Health Statistics and Information Systems (NAPHSIS) for expertise in electronic death reporting systems implementation, stakeholder education, and systems evaluation.  The electronic death reporting system should allow for immediate reporting of fact of death and demographic information on the deceased with the addition of cause of death information as it becomes available. The reporting system should promote funeral directors’ electronic submission of at least 80% of death certificate data to the appropriate public health authority in the state.

Background: Rapid tracking of influenza-related mortality currently is obtained through the 122 Cities Mortality Reporting System.  The current system collects weekly summary information from 122 U.S. cities covering between one-quarter to one-third of U.S. deaths. The average lag time from death to reporting is 15 days.  Data collected include the weekly number of death certificates filed and the number with pneumonia or influenza listed anywhere on the death certificate by age group.  The percentage of deaths with pneumonia or influenza listed is calculated and compared to an expected percentage for that week, as derived through mathematical modeling.  While this allows for rapid tracking of influenza-related deaths, it does not allow for estimation of the total number of influenza-related deaths, rates of influenza-associated deaths, or state-level analysis, and the system is not designed to collect daily data.  Data from the NCHS national vital statistics system are used for these more detailed analyses, but these data typically are not available for a given influenza season until 2 to 3 years later.

2. Work with bi-national public health partners to rapidly share cross-border mortality information
3. Monitor system for meeting time frames
4. The developed death reporting system should demonstrate inter-jurisdictional transmission of mortality data and allow for fact of death data reporting to federal partners within 5 days of death for at least 80% of deaths occurring in the state
5. Demonstrate the ability to transmit death certificate data including cause of death data for at least 80% of deaths occurring in the state to appropriate federal agencies within 10 days of the occurrence
6. Any engagement with cross-border international partners should be consistent

1. Assist awardees in managing and reviewing data sent to federal partners
2. Provide subject matter advice in the development of mortality reporting standards

b. Award Information

1. Plan.  Does the plan adequately address each of the objectives described in the Purpose section (implement a statewide PHIN-compliant electronic mortality reporting system that is capable of transmission of fact of death and demographic information within five days and the cause of death information within ten days in 80% of all deaths in the awardee’s jurisdiction)? For example, does the plan demonstrate how it will develop a system in accordance with NCHS standards; how the system will allow for immediate reporting of fact of death and demographic information; how it will achieve 80% compliance with electronic submission of death certificate data to the appropriate public health authority in the state by funeral directors; how it will transmit death certificate data from at least 80% of deaths that occur in the awardee’s jurisdiction to a central data repository within 10 days of the occurrence of death? Does the plan clearly describe the population characteristics of the state, city, or community in which the project will take place?  Does the plan include quantitative and/or qualitative performance measures?  What measures of effectiveness are in place to show progress and performance?  (50 Points)
2. Methods.  Are the proposed methods feasible?  To what extent will they accomplish the program goals? (30 Points)
3. Personnel.  Do the staff members have appropriate experience?  Are the staff roles clearly defined?  As described, will the staff be sufficient to accomplish the program goals? (20 Points)
4. Budget and Justification.  (Reviewed, but not scored)

5. Collaborative Planning for Delivery of Essential Healthcare  

    Services

a. Funding Opportunity Description

Purpose: The purpose of the program is to demonstrate and evaluate methods for coordination of healthcare delivery that will function despite disruptions during a pandemic.  The intended outcome is for a jurisdiction to be able to coordinate various unrelated healthcare delivery resources and maintain delivery of essential services while providing care for large numbers of influenza patients during a pandemic.

Background: Healthcare surge capacity is currently inadequate.  During an influenza pandemic, large numbers of patients will require care during a short period of time.  Concurrently, healthcare personnel will be affected by community-acquired infections leading to as much as 40% absenteeism, based on several models and projections.  In addition, supply and support systems on which healthcare systems rely will be affected by similar absenteeism, further reducing the ability of this critical infrastructure (i.e., the healthcare and public health systems) to function normally.  Additionally, there will be a surge in home healthcare delivery and need of services.  Home health agencies likely will be called upon to provide care for patients who do not require hospitalization for pandemic influenza, or for whom hospitalization is not an option because hospitals have reached their capacity to admit patients.  These agencies may become overburdened very quickly and shortages of personnel and supplies for providing home healthcare may occur. 

Recipient Activities:

1.      Define which “essential services” will be priorities for your community (e.g. labor and delivery, trauma care, acute cardiac and neurological care, etc.) and which services will be curtailed

C. Eligibility Information for All Projects

Eligible Applicants

Cost Sharing or Matching

Other

• Late applications will be considered non-responsive.  See section “D. 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 a grant, loan, or an award.

• Descriptive title of proposed project.
• Name, address, and telephone number of the Principal Investigator/Project Director.
• Names of other key personnel.
• Participating institutions.

• Microsoft Word format
• Length: 1 page

• Font size: 12 point unreduced, Times New Roman
• Single-spaced
• All projects that a awardee intends to apply should be included in

Submission through www.grants.gov is required, but awardees have the option of submitting the original and two hard copies of the application as a backup by mail or express delivery service to:

Content and Form of Submission

• Maximum of 2-3 paragraphs.

• Font size: 12 point unreduced, Times New Roman
• Single spaced
• Paper size: 8.5 by 11 inches
• Page margin size: One inch

• Maximum number of pages: 20.  If your narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed.

• Font size: 12 point unreduced, Times New Roman
• Single spaced
• Paper size: 8.5 by 11 inches
• Page margin size: One inch
• Printed only on one side of page.
• Number all narrative pages; not to exceed the maximum number of pages.

1. Plan
2. Objectives
3. Methods
4. 12-month Project Timeline
5. Staff
6. Performance Measures
7. Budget and Budget Justification (The Budget Justification will not be counted in the narrative page limit)

Submission Dates and Times

Funding Restrictions

• Recipients may not use funds for research
• Recipients may not use funds for clinical care
• Recipients may expend funds only for reasonable program purposes, including personnel, travel, supplies, and contractual services
• Awardees may not generally use HHS/CDC/ATSDR funding for the purchase of furniture or equipment.  Any such proposed spending must be identified in the budget
• The direct and primary recipient in a cooperative agreement program must perform a substantial role in carrying out project objectives and not merely serve as a conduit for an award to another party or provider who is ineligible

• Reimbursement of pre-award costs is not allowed

LOI Submission Address: Submit the to the following email address: panflucomp@cdc.gov.

F. Application Review Information

Review and Selection Process

Anticipated Announcement Award Dates

G. Award Administration Information

Award Notices

Reporting Requirements

1.   1.   A progress report will be due no later than 45 days after the midway point of the project (6 months). The progress report must contain the following elements: