Optional Influenza Surveillance Enhancements Funding Opportunity Announcement Revised on 6/19/2018 (Application deadline extended see enclosed)

Transcription

1 Optional Influenza Surveillance Enhancements Funding Opportunity Announcement Revised on 6/19/2018 (Application deadline extended see enclosed) Issuing Organization Council of State and Territorial Epidemiologists (CSTE) at Participating Organizations Centers for Disease Control and Prevention (CDC), at Components of Participating Organizations Influenza Division, National Center for Immunization and Respiratory Diseases (NCIRD/CDC), at 1

2 Table of Contents Part I Overview Information 1. Overview Part II Full Text of Announcement Section I. Application Description 1. Background 2. Objectives 3. Methods Section II. Award Information 1. Mechanism(s) of Support 2. Funds Available Section III. Eligibility Information 1. Eligible Applicants 2. Cost Sharing or Matching Section IV. Application and Submission Information 1. Content and Form of Application Submission 2. Submission Dates and Times Section V. Application Review Information 1. Criteria and Prioritization 2. Review and Selection Process Section VI. Award Administration Information 1. Award Notices 2. Recipient Rights and Responsibilities 3. CSTE Responsibilities 4. CDC/Influenza Division Rights and Responsibilities 5. Collaborative Responsibilities 2

3 Part I Overview Information 1. Overview CSTE seeks proposals to expand influenza surveillance activities for the purposes of informing identified gaps in our current knowledge base, maximizing the utilization of existing data reporting platforms, improving influenza disease burden estimates, and developing a greater understanding of the clinical impact of genetically distinct influenza viruses. State and local health departments with established epidemiologic and laboratory surveillance systems and reporting informatics will be supported to collaborate with CDC Influenza Division partners to accomplish these goals. While some methodology has been established, applicants may propose alternative methods for consideration. Part II Full Text of Announcement Section I. Application Description 1. Problem statement The Epidemiology and Prevention Branch in the Influenza Division at CDC monitors influenza through multiple surveillance components that inform situational awareness, influenza virus characteristics, and burden of disease estimates. However, CDC continuously works to make improvements in these components and expand surveillance capacity to fill gaps. In collaboration with CSTE, CDC supports the enhancement of influenza surveillance at state and local health departments to leverage available resources and maximize the utilization of existing influenza surveillance systems. This funding announcement has been designed to aid in the resolution of any one or more of the following gaps in routine surveillance: Influenza-attributable proportion of influenza-like illness (ILI): Through the U.S. Outpatient Influenza-like Illness Surveillance Network (ILINet), providers report the number of patients meeting the case definition for ILI; no laboratory confirmation of influenza is required. While the ILI case definition is used for surveillance due to the high positive predictive value during periods of influenza virus circulation, influenza illness is often clinically indistinguishable from other respiratory pathogens. The influenza attributable proportion of ILI, not biased by clinician-directed testing, is needed to better inform influenza disease burden estimates and improve interpretation of data from ILINet and other influenza surveillance components. Level of care associated with influenza positive specimens: Public health laboratories (PHL) throughout the United States conduct testing for influenza, and report specimen level results electronically to CDC through the Public Health Laboratory Interoperability Project (PHLIP). A subset of specimens are sent to CDC for antigenic and genetic characterization, and antiviral resistance testing. The clinical level of care (inpatient, 3

4 outpatient) or an indicator of specimens tested for specific CDC study/surveillance programs that reflect setting (e.g. ILINet) are not uniformly reported to CDC along with the specimen-level virologic surveillance data, but could be used as an indicator of illness severity. Identification of care level associated with specimens tested at the PHL would allow for evaluation of differences by virus characteristics. Outpatient ILI rates: Population-based rates of influenza allow for disease burden comparisons across seasons, geographic regions, and varying influenza viruses. Population based rates can be calculated from the current national influenza hospitalization (FluSurvNet) and mortality (NCHS and pediatric death) surveillance components but not from the outpatient ILI component (ILINet). An estimate of the population served by ILINet providers would allow outpatient ILI rates to be calculated and used to inform disease burden estimates. For the influenza surveillance season, CSTE seeks proposals that address any one or more of the identified surveillance gaps. Funding is open to any state or local health department which meets the eligibility requirements. Funding awards will be commensurate with which activity or activities are included and the methods proposed, as outlined in the guidance of the current FOA. 2. Objectives The overarching objective of this pilot project is to fund public health departments to accomplish one or more of the specific objectives below that address gaps in national influenza surveillance. The compilation of data from each objective across awardees will contribute to improved influenza disease burden estimation and a greater understanding of influenza viruses across illness severity levels. Specific objectives include expansion of existing influenza surveillance activities to: A. Determine weekly the proportion of ILI outpatients positive for influenza using a systematic patient sampling algorithm among patients meeting the ILI case definition. B. Identify and report to CDC the level of care (inpatient/outpatient) at the time of specimen collection and/or identifying the CDC-funded surveillance program associated with specimens tested for influenza viruses at the PHL. C. Estimate population-based rates of ILI by enumerating the patient population size for a subset of new or existing ILINet providers. 3. Methods Applicants should propose methods that accomplish any one or more of the outlined objectives above. If methods to address more than one objective are proposed, the methods for each may build on one another, or be completely independent. 4

5 Methods based on past successes are provided in activities A C, below; however, new methods or innovations are welcomed. Project period. The funding period is from September 1, 2018 July 31, 2019 for deliverables associated with activities A C. The surveillance period for Activity A is from October 1, 2018 July 31, Case definition. Influenza-like illness (ILI) is defined as acute onset fever (temperature of 100 F [37.8 C]) with cough and/or a sore throat. Optional activities. Activity A. Surveillance sampling of ILI patients 1. Activity. The goal of Activity A is to have a subset of new or existing ILINet providers collect specimens for influenza surveillance from patients meeting the ILI case definition according to a sampling algorithm, regardless of rapid test results, suspicion of influenza, patient severity, or other criteria. Applications should outline methods to directly identify patients with ILI and approach them about specimen collection. The results will be used to calculate the influenza-attributable proportion of ILI. 2. Outpatient locations. Typical outpatient locations engaged in the care of acutely ill patients within a week of onset are pediatric clinics, family practice clinics, community clinics, urgent care clinics, retail care clinics, and emergency departments. a. Suggested provider characteristics and considerations: i. Recruiting from within your existing ILINet providers is recommended (but not required) to allow for reporting history and compliance evaluation. ii. The combination of all clinics/providers participating should represent all age groups. iii. Particular care should be taken to identify clinics serving patients aged 50 years, as this is a very difficult population to capture. iv. Provider incentives, even if minimal, are likely to improve participation. Provider agreements or contracts for participation (e.g., memorandum of understanding between health department and provider) are recommended. 3. Sample size considerations. Applications should include the number of clinics/ilinet providers that are planned for participation and number of specimens collected per week to support sufficient sample size to calculate a reliable proportion of specimens positive for influenza by age group. a. Approximately specimens per age group per season (for a total of specimens per state per season) are needed from each state to calculate a reliable influenza proportion in each site (based on 95% confidence, 7% error, and 15-25% positivity in sample size calculations). 5

6 4. Data collection and reporting. a. Required variables to accompany specimens are date of birth (age is acceptable), specimen collection date, and a means to identify that specimen was collected as part of this project. b. Proposals can include a mechanism for reporting additional variables of interest to the site (e.g., vaccination status, rapid test result, etc.). 5. Specimen collection. The type of specimen collected is at the discretion of the provider, but must be a respiratory specimen. a. Nasopharyngeal (NP) swab: optimal upper respiratory tract specimen for influenza testing, but cannot be collected from infants. b. Combined nasal and throat swabs or nasal aspirate: can provide good influenza virus yield. c. Single throat (oropharyngeal) or nasal swab: can have lower influenza virus yield. d. Guidance for influenza specimen collection is available at e. Proposals should include accommodations for shipping of specimens from clinics to the PHL, including frequency during the week. 6. Specimen testing a. The state or local PHL should process and test specimens using the CDC IVD kit including influenza A (subtypes 2009 H1N1, H3) and influenza B (genotypes Yamagata and Victoria). b. Reagents and qualifying ancillary reagents for influenza testing are provided by CDC at no cost to validated PHL through the International Reagent Resource (IRR). c. Results would ideally be identifiable to CDC in PHLIP through an identified study flag and ILINet provider ID, but an alternative mechanism may be proposed: i. A proposal for Activity B (below) can be used to aid in developing a process for the PHL to identify specific project specimens in their LIMS so it can be included in the PHLIP message (i.e., should linkage to ILINet identifiers or other not be available in LIMS). ii. Until reporting via PHLIP is enabled and validated, excel files may be used to report results and required data elements to CDC via secure file transfer protocol (FTP) or . d. Specimens positive for influenza and linked to this project may be prioritized for routine submission to the National Influenza Reference Centers (NIRC) according to specimen submission guidance and to meet Right Size goals. Efforts should be made to maintain a mix of illness severity among the specimens submitted to the NIRC but giving priority within each severity level to those specimens for which more data (i.e., linked to this project) are available. Activity B. Report level of care (inpatient or outpatient) for patients tested for influenza 1. Activity. The goal of Activity B is to allow CDC to identify specimens tested for influenza at the PHL according to the level of care (i.e., inpatient or outpatient) at the time of specimen collection and to have the PHL preferentially select these specimens for routine submission to the NIRC according to 6

7 specimen submission guidance and to meet Right Size goals. Applications should include how the level of care could be reported to CDC and/or if PHLIP is the chosen method, the steps required to develop this capacity. Level of care information will enable comparisons of virologic data associated with severe and mild cases. 2. Mechanism. Identify a new or existing mechanism to share level of care data with CDC. The information could be incorporated into the PHLIP HL7 message or an alternative mechanism may be proposed. a. One existing mechanism to do this is populating the optional data element in PHLIP HL7 reporting for Patient Location, which allows responses to indicate inpatient or outpatient. b. As described in Activity A, another mechanism is to identify CDC-funded program(s) for which a specimen was collected if the program is specific to a level of care (e.g., ILINet, FluSurvNet, US Flu VE network, HAIVEN). c. Other mechanisms, including use of other fields in PHLIP, an Excel spreadsheet, etc. may be proposed. 3. Barriers and resolution plan. These funds can be used to support the development of processes to integrate the level of care data into a data stream such as, but not limited to, PHLIP. The proposal should identify any barriers that exist and delineate a plan to overcome these barriers so that these data can be included in a routine report to CDC. 4. Prioritization. Efforts should be made to maintain a mix of illness severity among the specimens submitted to the NIRC while giving priority within each severity level to those specimens for which more data are available. Activity C. Estimate population served by ILINet providers 1. Activity. The goal of Activity C is to enumerate the population served by a subset of new or existing ILINet providers so that population-based rates of outpatient ILI can be calculated. Population served should be enumerated by ILINet age groups. Two methods used previously are described below. Applicants may propose additional methods. a. Total number of patients registered with the provider. b. Average number of unique persons who have been seen by the provider in a given year (3 years of data desired for making this estimation). This is NOT the same as the number of patient visits each year, since patients may come more than once per year or they may not have a visit. 2. Reporting considerations. Population estimation is conducted once a season and may apply to multiple seasons if no substantial change in size or age distribution of the population served has occurred. a. Providers for whom population is estimated must report weekly ILI and patient visit counts to ILINet ( 7

8 b. ILINet reporters participating in this activity should report age-specific denominators (patient visits for any reason) to ILINet. i. CDC uses these data to evaluate the estimated population served by comparing the patient visit count to the estimated population size for each age group. States/awardees are not expected to conduct these analyses. 4. Program evaluation Successful applicants should also demonstrate capacity to participate in a CSTE/CDC-led evaluation at the conclusion of the project period to assess feasibility of implementation of relevant pilot project methods, including successes, challenges, and lessons learned. Section II. Award Information 1. Mechanism(s) of Support CSTE will manage all matters related to financial support for this project. CSTE will provide fixed-funding contracts to each of the sites. Funds will be distributed upon contract initiation (25%) and on December 30 (25%), March 31 (25%), and July 31 (25%). In all cases, funds will only be reimbursed upon receipt of invoice from the applicant as well as sufficient progress as determined by CSTE made toward the activities outlined in this FOA and contract agreement with CSTE. Recipients are responsible for allocating appropriate amounts to support activities including compensation for providers and to supplement the PHL for the duration of the project. Contracts will not be automatically renewed yearly. 2. Funds Available CSTE will award successful applicants with a maximum of $50,000 per site. Award amounts will be determined commensurate with activities outlined in the proposal and may vary based on the optional activities included and the complexity of the methods for each activity. Although the financial plans provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the number of applications received. CSTE receives funding for this project through a cooperative agreement with the Centers for Disease Control and Prevention (CDC). The development of supplemental surveillance methods is a joint project of CSTE and CDC based on previous CSTE Position Statements. All position statements, including 06-ID-04, are available at Funds awarded under this announcement are subject to the laws, regulations and policies governing the U.S. Public Health Service grant awards. 8

9 Section III. Eligibility Information 1. Eligible Applicants Applicants should clearly describe their ability to meet the objectives and methods for each activity proposed as listed in Sections 1.2 and 1.3. State, territorial, large city/county* public health agencies. *A large local public health agency is defined as a city or county health department serving a population of one million residents or greater. 2. Cost Sharing or Matching Cost sharing, matching, or cost participation is required only for activities that overlap with other CDC funded programs to avoid duplicate funding. For example, if a personnel is fully funded by the Epidemiology and Laboratory Capacity Grant, the same individual cannot receive extra salary through this funding mechanism. Section IV. Application and Submission Information 1. Content and Form of Application Submission Applications should include the following headings in the order listed and should address the issues included under each heading. Page limits noted are strongly encouraged, but will not affect the review if it is necessary to exceed. o Contact information: Applicants should identify a primary public health project coordinator who will serve as the primary contact for this project, and if applicable, a primary laboratory contact. Additional contacts may be listed as relevant to the proposal. Information should include , mailing address (no PO boxes) and phone number. 1 page limit o Surveillance Experience: Applicants should briefly outline their influenza surveillance components to aid in understanding where the activities included in this application align and demonstrating the ability to successfully participate in this project and achieve the goals outlined. Details may include participation in IISP, ARIES, or any additional CDC or CSTE surveillance programs or studies that may compliment this platform, such as surveillance in the hospital or community setting. Applications should also include a description of an experienced staff member who will oversee the project s progress. 1 page limit. o Methods: Applicants should indicate which activities are included in the proposal and describe their proposed methods to accomplish the objectives. Applications should include at least the following: o Activity A: Number of ILINet providers/clinics planned for participation. Sampling strategy and number of specimens to be collected weekly and/or season. Patient data reporting and specimens shipping methods 9

10 o Activity B: Influenza testing algorithm, and if planning to test for other respiratory viruses do not include assay package inserts Description of methods for reporting level of care or CDC project identifier with specimens tested for influenza to CDC. o Activity C: Describe the methods for determining the patient population. o 4 page limit o IRB: Human subject review process for the applicant if necessary. ½ page limit o Letters of Support: A letter of support from the participating public health laboratory (Activities A & B), and at least three providers or representative organization (Activities A & C) is required and must address commitment to participate and ability to integrate protocol. 1 page limit per letter o Budget: Vague budgets may not be considered. Proposed budget should be reasonable for each activity included in the proposal and include the amount of funding needed and how it will be appropriated to coordination personnel time, supplies, laboratory testing, and services such as informatics, information technology support, specimen shipping, and provider/clinic incentives for participation. Do not include the cost of reagents or supplies that are provided by the IRR. No limit For further assistance, technical questions, or inquiries about the application, contact Monica Schroeder at CSTE ( or mschroeder@cste.org). CSTE and CDC will be available to speak to potential applicants to discuss administrative and technical questions. Upon request, all questions and answers will be made available to all potential applicants during the application process. 2. Submission Dates and Times A completed letter of intent should be sent by to CSTE: Monica Schroeder Program Analyst II Council of State and Territorial Epidemiologists 2872 Woodcock Blvd., Suite 250 Atlanta, GA (phone) (fax) mschroeder@cste.org Submission, Review and Anticipated Start Dates Letter of Intent Receipt Date: June 22, 2018 (required) Application Submission Receipt Date: July 27, 2018 (extended deadline) 10

11 Award notification date: August 8, 2018 *subject to change based on the availability of funding Contract Initiation Date: After September 1, 2018 Budget Period: September 1, 2018 July 31, 2019 Submitting an Application An electronic copy of the completed application should be submitted electronically to by July 27, All application materials must be submitted in one electronic file attachment. Applications must be received by CSTE no later than 11:59pm Eastern on July 27, Applications received after this deadline may not be reviewed. The receipt deadline for all application components is 11:59pm Eastern on July 27, Submitted appendices should be kept at a minimum and may not be reviewed as part of the application process. Inquires about successful receipt of application by CSTE will be sent only upon request by to mschroeder@cste.org. Application Processing All applications received will be reviewed by August 8, Applications will be reviewed based on criteria described in Section V. Section V. Application Review Information 1. Review and Selection Process Eligible applications that are complete will be evaluated for scientific and technical merit by CSTE and CDC/Influenza Division in accordance with the review criteria stated within this announcement. Funding awards will be made based upon the quality of the submitted proposal and the ability of the applicant to meet the objectives stated above. 2. Criteria and Prioritization To what extent will the proposal meet the objectives of the project? 40 How much will the proposal improve participant contribution to filling the gaps in surveillance? Does the proposal accomplish more than one objective? What is the potential impact of the proposal (e.g., estimated number of providers that proposed activities will engage, test a sufficient number of specimens to meet the surveillance goals, or extent of reporting level of care for specimens)? How well does the submission describe the implementation of the proposal? 20 Does the proposal include a thorough description of project deliverables? Is there a clear and appropriate timeline for implementation? Are the staff roles clearly defined? Is there a commitment of support from the 11

12 laboratory for Activities A and/or B? Are there letters of support from providers engaged in Activities A and/or C? To what extent are the project plan and personnel adequate to carry out the proposed objectives? How well does the proposed budget reflect the resources needed to accomplish the objectives? 20 Does the proposal include a project budget with line-item description of how funding would be allocated? Is the budget is reasonable and consistent with the purpose of the announcement, the proposed objectives, and project timeline? Does the applicant have a record of demonstrated success in surveillance activities (IISP/ARIES/other surveillance)? 20 As relevant to the activities included in the proposal, does the applicant demonstrate the capacity to accomplish the objectives? Has the applicant participated in other CSTE or CDC-led influenza or respiratory disease surveillance programs that could align with this pilot for greater understanding of influenza disease burden in hospital, other outpatient, or community settings? Section VI. Award Administration Information 1. Award Notices Applicants will be notified via or phone by August 8, Award date is subject to change based on the availability of funding and any delays in award notification will be shared with all applicants. 2. Recipient Responsibilities Each recipient public health department and PHL will have primary responsibility for the following: Providing scientific and management oversight for the overall project at participating provider sites, including surveillance design and conduct, data collection and reporting, quality control, and collaborations with other awardees, CDC, and CSTE. Obtaining the appropriate human subjects clearances at local sites if required. Working with CDC scientists to refine protocols and data collection instruments. Performing laboratory tests and reporting data as specified in the protocols. Ensuring that any changes in PHLIP messaging will not interrupt or delay routine reporting for surveillance through PHLIP. Participate in data quality assurance activities, such as correcting errors identified in data cleaning. Participate in scheduled project group conference calls. Providing written progress reports that describe performance milestones and invoices to CSTE as required in the contract agreement. 12

13 3. CSTE Responsibilities During the established grant period, CSTE is responsible for: Monitoring the terms of the contract agreement between the recipient and CSTE. Collecting invoices from the recipient and paying invoices according to the terms of the contract agreement between the recipient and CSTE. Providing information about the progress of the program to the CSTE Executive Board and to CDC. Reviewing and distributing progress reports and the final report with CDC. Providing technical expertise. Convene an expert review panel to provide an objective review of the submitted applications. Providing CSTE staff to support the day to day activities of this project at both CSTE and CDC. 4. CDC/Influenza Division Responsibilities CDC/Influenza Division will have substantial programmatic involvement as described below: If IRB review is deemed necessary at the state/local level, CDC will assist the recipient in the development of a research protocol that will be acceptable for local site IRB review and approval. CDC will provide technical advice concerning laboratory methods for the diagnosis of influenza if needed and may perform or suggest quality control testing of the laboratory methods used to diagnosis influenza at each funded site. CDC will provide the reporting mechanism and maintain a database for all project related data including ILI and patient visit tallies and the specimen related case report form. CDC will work with participants to determine appropriate methods to define the patient population. CDC will provide technical expertise and ensure appropriate training to awarded applicants. CDC will develop analytic tools to help sites maintain data quality. 5. Collaborative Responsibilities CSTE and CDC in conjunction with the State Health Department Contacts will: Promote collaboration, share best practices, and coordinate surveillance activities where needed. Provide guidance to investigators regarding project implementation and sustainability for the duration of the influenza season. Evaluate monthly progress of all funded project activities Meet by phone at least once per month and up two twice per year for an in person meeting. CSTE will provide non-federal travel support if required. CSTE and CDC will conduct site visits as required to provide guidance, assure methods are consistent among participants, discuss analyses, and document recommendations. 13

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