Statement of Work - Severe IAE in PICUs_DRAFT.docx

STATEMENT OF WORK

Title: Surveillance of severe influenza-associated encephalopathy and related complications in US children Short title: Severe IAE

Option period 1: August 1, 2027 – July 31, 2028 Option period 2: August 1, 2028 – July 31, 2029 Option period 3: August 1, 2029 – July 31, 2030 Option period 4: August 1, 2030 – July 31, 2031

C.1 – Background and Need Influenza-associated encephalopathy (IAE) is a rare and serious neurologic complication of influenza virus infection. One of the most severe forms of IAE is acute necrotizing encephalopathy (ANE), a condition that disproportionately affects children, has a poor prognosis, and can result in lasting neurologic sequelae or death.

In January 2025, CDC received anecdotal reports of critically ill children with IAE, including deaths with ANE in the United States. In response, CDC requested notification of U.S. IAE cases from health departments and clinicians. Among 192 reports of suspected IAE submitted to CDC, 109 were categorized as IAE, roughly one-third of which were subcategorized as ANE. IAE cases were notable for a high frequency of severe disease, including intensive care unit admission (74% of all IAE cases) and death (19% of all IAE cases and 41% of acute necrotizing encephalopathy cases); over half of cases occurred in previously healthy children.

Given the severity of this complication observed in the 2025 investigation and the lack of existing national surveillance, in October of the same year, CDC’s Influenza Division introduced IAE surveillance to two CDC influenza surveillance systems, the Influenza-Associated Pediatric Mortality Surveillance System and the Influenza Hospitalization Surveillance Network (FluSurv-NET). However, these surveillance systems do not comprehensively capture data on critically ill children in the United States especially given the rarity of IAE; pediatric mortality surveillance only captures influenza-related deaths, while FluSurv-NET includes approximately 10% of the US population and does not cover many major pediatric referral hospitals. Significant gaps exist in our understanding of IAE that cannot be completely address by these two surveillance systems. There are no diagnostic criteria or treatment protocols for IAE, and while several forms of IAE have been described, they have not been validated with real-world data. Additional critical gaps in our understanding of IAE include the spectrum of disease, disease course, risk factors for severe disease, and the impact/effectiveness of influenza vaccination and influenza antiviral treatment.

One major gap is the lack of consensus definitions for infection-triggered encephalopathy syndromes associated with influenza; efforts at defining this with neuroimaging patterns have been made, but require real-world validation. No consensus standardized diagnostic criteria exist for IAE and the role of neuroimaging in guiding diagnosis and clinical management is unclear. Obtaining and validating neuroimaging to fit into previously described infection-triggered encephalopathy neuroimaging patterns, or recognizing novel neuroimaging patterns associated with IAE, will significantly contribute to the development of diagnostic definitions for IAE and can potentially guide clinical management.

While IAE has been described during influenza A(H1N1) predominant seasons, data generally support that encephalopathy is a complication of influenza unrelated to virus type or subtype. Evaluation of influenza virus subtype to assess for associations of disease frequency or severity with influenza subtype will contribute to the evidence base. Other viruses, such as SARS-CoV-2 and HHV-6, are also associated with infection-triggered encephalopathy syndromes such as ANE. Research testing for additional viruses allows for better understanding of contributors to disease. Additionally, characterization and description of pre- and post-treatment cytokine and other inflammatory markers for IAE is limited in the data; this information could guide the development of diagnostic and therapeutic parameters.

Children with ANE can have lasting neurologic sequelae. Long-term follow-up studies on outcomes for severe IAE are limited. This follow-up can help understand the implications of severe IAE on neurologic, cognitive, and educational outcomes and overall quality of life.

Other respiratory viral pathogens, like COVID-19, can cause similar neurologic disease (and other non-neurologic complications) as influenza, and some are also implicated in the pathogenesis of ANE. The ability to study other respiratory viruses and their clinical complications, such as respiratory failure and multisystem inflammatory syndrome in children (MIS-C), improves our understanding of how respiratory viruses cause severe disease in children, and is critical for developing preventive strategies.

C.2 – Project Objective The purpose of this contract is to conduct surveillance for severe IAE among critically ill hospitalized children and improve understanding of the spectrum of disease, disease course, risk factors for severe disease, optimal management, and the impact of influenza vaccination and influenza antiviral treatment on disease course. Detailed clinical data will be collected for children with IAE admitted to participating ICUs, estimated to be less than 200 cases during a given non-pandemic influenza season. This active surveillance effort will allow for improved understanding of IAE in U.S. children and the public health impact of this severe complication of influenza.

C.3 – Scope of Work The specific goals of this project are to:

1. Perform surveillance for severe IAE in hospitalized children with laboratory-confirmed influenza using standardized case definitions.

2. Collect clinical information on identified IAE cases to assess risk factors for severe disease, describe the disease course and spectrum of disease, and assess the impact of different clinical interventions including influenza vaccination and antiviral medications.

3. Assess influenza vaccination status of patients and other information about the hospital course.

The project includes the following optional goals (subject to identification of need and funding):

1. Evaluate neuroradiologic reports of children with severe IAE to allow for disease characterization.

2. Test clinical specimens to determine influenza virus subtype, detect additional bacterial/viral pathogens, and assess for pre- or post-treatment inflammatory markers.

3. Evaluate genetic and immunologic risk factors and pathways of severe IAE.

4. Assess neurodevelopmental and neurocognitive sequelae and quality of life outcomes after hospital discharge among severe IAE case patients.

5. Conduct surveillance of other severe complications of influenza and/or other viral respiratory diseases among critically ill hospitalized children.

C.4 – Tasks to be Performed The contractor shall complete the tasks outlined below in accordance with any applicable delivery dates reflected in C.9 – Deliverables/Reporting Schedule:

TASK 1: PROJECT PREPARATION

1. Kickoff Meeting. The Contractor shall schedule a virtual (teleconference) which occurs within ten (10) business days from the beginning of each performance period (“Start Date”). The Contractor shall send a meeting link and a meeting agenda to the Contracting Officer (CO), the Contracting Officer’s Representative (COR) and CDC Technical SMEs. The purpose of the meeting is to review and clarify the scope of work and delivery schedule for tasks, to delineate roles and responsibilities, and to establish communication protocols for the associated performance period. The final presentation will be shared with CDC.

a. The Contractor will provide a list of updated due dates for deliverables based on the date of the start period and kickoff meeting date; CDC will review and confirm these dates.

2. Project Coordination. The Contractor shall communicate (via email, telephone, and/or virtual meetings) as needed to support successful performance of this contract. The primary point of contact for technical discussions related to this contract are the CDC Technical SMEs and primary point of contract for contractual aspects of this contract are the CO and the COR. Meeting cadence and communication preferences will be discussed at the kickoff meeting.

TASK 2: PRE-SURVEILLANCE DOCUMENTATION

1. Identify and present recommendations for healthcare facilities to participate in this project from their already established network. The Contractor shall identify and recommend to CDC a list of a target of forty (40) healthcare facilities within their existing established research network from which patients (“patients” for purposes of this contract are “children from the age of birth to eighteen (18) years”) can be identified and that should support this contract. Healthcare facilities recommended by the Contractor must meet the following criteria:

a. Include a dedicated pediatric intensive care unit(s).

b. Provide care to patients who are representative of the healthcare facility’s location and be able to capture all microbiologically confirmed viruses of interest at that hospital, medical center or facility.

c. Be geographically diverse and representative of the U.S. population and have a diverse population of patients with respect to pediatric age, race, ethnicity, and underlying conditions; and

d. Demonstrate a history of conducting active surveillance of complications of viral respiratory disease, including the ability to identify patients in real-time, complete chart reviews, and obtain laboratory and radiologic data, as part of an established network.

e. Agreement to conduct IAE surveillance per the established protocol for the surveillance period.

The CDC will review the healthcare facilities and provide comments. Contractor shall submit to CDC its final list of participating healthcare facilities for this contract. The final list must include the name, location, healthcare facility type, PICU staffed bed size, and geographic distribution of healthcare facilities.

CDC will review the Contractor’s list of healthcare facilities and advise whether any healthcare facilities may not participate under this contract. Only the CDC approved healthcare facilities will collectively constitute “Healthcare Facilities” and individually are a “Healthcare Facility” under this contract. If an approved Healthcare Facility leaves or is removed from the project, CDC reserves the right to request that the Contractor replace the Healthcare Facility using the criteria stated above to ensure that the number of Healthcare Facilities stays within the identified range.

2. Create and provide a protocol, forms, and data dictionary for active surveillance of severe IAE in critically ill children.

a. The Contractor shall create and revise, as needed, the CDC-approved protocol, data collection form, instruction manual for data entry, Research Electronic Data Capture (REDCap) database (or other database approved by CDC) for data entry, quality assurance/quality control [QA/QC] plan, and data dictionaries to conduct active surveillance in hospitalized children with severe IAE. The following information must be included in these documents:

i. Standardized case definitions for IAE and sub-categories based on clinical, radiologic, and/or laboratory data.

ii. Data elements to be collected; these include but are not limited to baseline demographics, underlying conditions, vaccination status (including statewide vaccine registry review), clinical course (e.g., need for invasive or non-invasive mechanical ventilation), viral/bacterial/fungal coinfections, antiviral treatment and other therapies, imaging results, laboratory data, and clinical outcomes both during hospitalization and up to 30 days post discharge.

iii. Screening criteria for IAE cases admitted to PICUs and study inclusion and exclusion criteria.

b. The draft protocol should be provided to CDC as per the deliverable table. CDC will review and provide feedback within 5 business days. The Contractor shall incorporate CDC’s feedback into a revised version and return to CDC; CDC will determine whether additional revisions are needed or whether the document is final. The CDC-approved draft protocol will be the “Final Surveillance Protocol”.

c. The draft data collection form and instruction manual for data entry should be provided to CDC as per the deliverable table. CDC will review and provide feedback within 5 business days. The Contractor shall incorporate CDC’s feedback into a revised version and return to CDC; CDC will determine whether additional revisions are needed or whether the document is final. The Contractor will include the final REDCap and analytic data dictionary based on the data collection form with this transmission; at a minimum, these data dictionaries should include variable/field names, field labels, and response options.

d. The draft QA/QC plan will be provided to CDC. CDC will review and provide feedback within 5 business days. The Contractor shall incorporate CDC’s feedback into a revised version and send to return to CDC; CDC will determine whether additional revisions are needed or whether the document is final.

3. Institutional Review Board (IRB) approval(s) or non-research determination of the study (including protocols and forms).

a. The Contractor shall prepare IRB documents and share approval with CDC after the Contractor obtains IRB approval or a non-research determination. The IRB decision should be shared with CDC prior to beginning active surveillance.

4. Steering Committee: The Contractor must define a steering committee structure with CDC comprised of all Contractor and CDC principal investigators aligned to this contract. The Contractor shall provide a list of members, including their names, titles, project affiliation, emails, and phone number.

TASK 3: ACTIVE SURVEILLANCE

The Contractor shall conduct surveillance based on the final approved Surveillance Protocol. The target surveillance period would begin on October 1st (“Surveillance Start Date”); if the surveillance start date is delayed, that later date will be coordinated and approved by CDC, to be no later than 30 days after October 1st. The end of the surveillance period will be described in the final approved protocol, subject to change by CDC per seasonal influenza activity and novel influenza virus circulation patterns.

1. IAE surveillance: Cases will include patients hospitalized with laboratory-confirmed influenza in pediatric ICUs. Target case counts for the severe IAE surveillance database in the Base Period are anticipated to be up to 200 infants and children during a severe influenza season, and as few as 10 cases during a low-severity influenza season. The severe IAE surveillance database will be maintained in the Option Periods.

2. Healthcare Facilities will identify patients that meet the surveillance definition as per the protocol, consent to participate in the study if determined to be necessary, and meet other surveillance criteria to be identified by CDC and the Contractor. Patients must be between “0 and 18 years old”.

3. The Contractor will prepare and provide for CDC a bimonthly (i.e. every two months) case count dashboard of all case patients detected, including key variables such as influenza vaccination history.

4. The Contractor will prepare and provide for CDC a bimonthly (i.e. every two months) quality assurance/quality control (QA/QC) report including completeness of data.

5. The Contractor will submit midterm datasets (6 months after the start of the performance period) from the data reporting tool to the CDC Technical SMEs and CDC COR in addition to the final datasets.

a. Raw datasets shall be exports of the data and will include (at a minimum) patient demographics, data from medical chart abstractions, testing results, influenza vaccination history ascertainment (verified through medical records or state vaccine registry), and influenza antiviral receipt ascertainment (by medical records and other potential sources).

b. Analytic datasets will include calculated variables, cleaned and categorized freetext, and additional data as per the final protocol.

TASK 4: POST-SURVEILLANCE DOCUMENTATION

1. Final Electronic Dataset(s). The Contractor will complete the datasets, including both the raw and analytic datasets, on all case patients and deliver to CDC as per the deliverable table. The datasets will include demographic, clinical, and viral testing data.

a. The Contractor shall ensure the data is accurate, complete, and validated for the final datasets.

b. Only the Healthcare Facility surveillance sites will have the link between the patient study ID and the patient identity. CDC will not access, receive, or store any PII.

OPTIONAL TASKS

Tasks #1, #2, #3, #4, #5, and #6 (listed below) are included as Optional Tasks for the Base Period and all Option periods. They will be separately priced as noted in Section B for all performance periods and by each optional task. The Government may elect to exercise one or any of these tasks per the terms of Section B if the Government identifies a bona fide need and identifies available funding.

OPTIONAL TASK #1: Evaluation of neuroradiologic reports of children with severe IAE The Contractor shall conduct the following activities to assess neuroradiologic reports of cases of IAE identified during the Surveillance Period:

1. Develop a neuroradiologic analysis plan and study protocol to evaluate and categorize neuroradiologic imaging patterns in patients with severe IAE;

2. Update all data collection instruments, including forms and databases;

3. Draft any standard operating procedures necessary for Healthcare Facilities to implement this task;

4. Upload de-identified primary neuroradiologic images and reports for patients with severe IAE to a secure central data repository for independent evaluation;

5. Provide neuroimaging expertise to independently review and categorize neuroimaging;

6. Facilitate coordination of this optional task;

7. Provide midterm (6 months after the beginning of the option period) Neuroradiologic Characterization Datasets to CDC; and

8. Provide final Neuroradiologic Characterization Datasets to CDC.

a. The final dataset will include an analytic dataset with clean and categorized freetext as per the protocol.

OPTIONAL TASK #2: Evaluation of influenza virus subtype and inflammatory markers from clinical specimens.

The contractor shall submit residual influenza respiratory specimens for subtyping and additional viral pathogen testing. At a minimum of 5 participating healthcare facilities with IAE cases, collect and submit discarded blood/sera and cerebrospinal fluid (CSF) samples to assess pre-treatment cytokine, antibody, and autoantibody levels in patients. In performing this task, the Contractor shall conduct the following activities:

1. Draft and distribute any required standard operating procedures necessary for Healthcare Facilities to implement this task;

2. Update all data collection instruments from the primary required tasks, including forms and databases, if using the existing instruments, or provide new data collection forms, databases, and data dictionaries to CDC (to be determined by the Contractor);

3. Collect residual upper respiratory specimens and discarded serum/plasma and CSF samples as feasible at participating healthcare facilities on a pre-determined subset of patients with severe IAE (as per the protocol) and test them at a centralized facility or facilities, in quarterly batches (to be determined between Contractor and CDC);

4. Facilitate coordination of this optional task;

5. Provide midterm (6 months after the beginning of the option period) Clinical Specimen Datasets and a progress summary report to CDC; and

6. Provide final Clinical Specimen Datasets to CDC.

OPTIONAL TASK #3: Evaluation of genetic and immunologic risk factors for severe IAE (Immunobiology Task) The contractor shall investigate genetic/immunologic/rheumatologic risk factors and pathways of severe IAE including data/specimen collection, laboratory testing (including immunologic / immunophenotyping analyses), and analysis to evaluate host immunologic parameters for severe IAE patients. In performing this task, the Contractor shall conduct the following activities:

1. Develop an immunologic specimen collection and analysis plan and study protocol to evaluate genetic/immunologic/rheumatologic risk factors for severe IAE;

2. Update all data collection instruments from the primary required tasks, including forms and databases, if using the existing instruments, or provide new data collection forms, databases, and data dictionaries to CDC (to be determined by the Contractor), as per the deliverable table;

3. Draft any standard operating procedures necessary for Healthcare Facilities to implement this task;

4. Identify a biostatistical support at the Contractor’s site to support data cleaning and basic analyses of severe IAE risk factor/immunologic studies and laboratory evaluation (with bioinformatics support);

5. Facilitate coordination of this optional task;

6. Provide midterm (6 months after the beginning of the option period) Immunobiology Clinical Specimen Datasets and Progress Reports to CDC; and

a. Progress report will include a summary of the data, including the number of cases and summary and interpretation of received test results.

7. Provide final Immunobiology Clinical Specimen Datasets to CDC.

OPTIONAL TASK #4: Evaluation of neurodevelopmental and neurocognitive sequelae among children with severe IAE (Neurologic/Cognitive Task).

The Contractor shall investigate neurodevelopmental and neurocognitive sequelae and quality of life outcomes among severe IAE patients using validated tools and assessments to include brain MRIs and patient/parent-reported neurodevelopmental and neurocognitive quality of life scales. In performing this task, the Contractor shall:

1. Establish or maintain a cohort of children aged 0 to18 years with severe IAE, with representation across pediatric age groups, to understand long-term neurologic sequelae and quality of life;

2. Develop a study protocol, data collection instruments, and data dictionary;

3. Facilitate coordination of this optional task;

4. Provide a midterm report (6 months after the beginning of the option period) describing progress in this optional task, to include at a minimum the number of patients followed and neurocognitive progress observed, in addition to the midterm dataset (6 months after the beginning of the option period); and

5. Provide final datasets to CDC.

OPTIONAL TASK #5: Expand surveillance to other complications of influenza and/or other viral respiratory diseases.

The Contractor shall follow similar tasks and deliverables as with the primary tasks of the Contract (1,2, 3, and 4); however, target cases and/or enrollment targets will be determined by CDC at the beginning of the option period dependent on the nature of the task:

1. Schedule a kickoff meeting to discuss the parameters of surveillance, review and clarify the scope of work and delivery schedule for tasks, delineate roles and responsibilities, and establish communication protocols;

2. Provide a list of healthcare facilities participating in this optional task and obtain any necessary IRB approvals;

a. The Contractor shall prepare IRB documents and share approval with CDC after the Contractor obtains IRB approval or a non-research determination. The IRB decision should be shared with CDC prior to beginning active surveillance.

b. If the steering committee for this task differs from the primary steering committee, a revised steering committee list should be provided to CDC.

3. Develop and provide to CDC a study protocol, instruction manual for data abstraction, database for data entry, quality assurance/quality control [QA/QC] plan), and data dictionaries;

4. Facilitate coordination of this optional task with identified participating Healthcare Facilities;

5. Prepare and provide for CDC bimonthly (every 8 weeks) QA/QC reports and a bimonthly surveillance dashboard;

6. Submit one mid-way dataset (6 months after the beginning of the option period) from the data reporting tool to the CDC Technical SMEs and CDC COR in addition to the final datasets in accordance with the deliverable table.

a. Raw datasets shall be exports of the data and will include (among other elements) patient demographics, data from medical chart abstractions, testing results, vaccination history ascertainment (verified through medical records or state vaccine registry), and antiviral receipt ascertainment (by interview, medical records, and other potential sources) if relevant, as to be determined by CDC and the Contractor.

b. Analytic datasets will include calculated variables, cleaned and categorized freetext, and additional data as per the final protocol.

OPTIONAL TASK #6: Expand surveillance to acute respiratory failure as a complication of influenza and/or other viral respiratory diseases.

The Contractor shall investigate clinical characteristics by viral etiology of acute respiratory failure in ICU-admitted patients with clinically-performed comprehensive respiratory viral testing. Other acute or sub-acute consequences of respiratory viruses may be considered and will be discussed between CDC and the Contractor; CDC will provide final approval. For the base period, and each optional period, as funding allows, the Contractor shall create a registry of patients admitted to the ICU with acute respiratory failure attributable to a respiratory viral pathogen.

1. Conduct surveillance based on the final approved Surveillance Protocol, to enroll infants and young patients (e.g., <2 years of age, to be determined by CDC and the Contractor) with acute respiratory failure from a respiratory virus or respiratory viruses (e.g., influenza, RSV, human metapneumovirus, and other specific viruses to be enrolled to be determined by CDC and the Contractor);

2. Develop and provide to CDC a study protocol, data collection forms, instruction manual for data abstraction, database for data entry, quality assurance/quality control (QA/QC) plan, and data dictionaries;

3. For infants <1 year of age, as feasible, verify receipt of maternal vaccination or infant monoclonal antibody through a combination of any of the following: hospital EMR (from the birth hospital if records cannot be verified at treating hospital), state IIS (registry) of patient’s state of residence; pediatrician records; mother’s prenatal medical records; or pharmacy, or other CDC-approved sources of verification determined on a case-by-case basis;

4. Facilitate coordination of this optional task with identified participating Healthcare Facilities that routinely test most children admitted to the ICU using a comprehensive respiratory panel that includes, at a minimum: influenza A and B, RSV, SARS-CoV-2, human metapneumovirus, parainfluenza viruses, adenovirus, non-SARS-CoV-2 human coronaviruses, and rhinovirus/enterovirus. Provide site list to CDC as a deliverable;

5. Ensure target enrollment for the acute respiratory failure registry is approximately 600-800 ICU-admitted patients with acute respiratory failure from a specific respiratory virus or viruses, and enrollment numbers are representative across participating sites;

6. Prepare and provide for CDC a biweekly (i.e. every two weeks) case count dashboard (final structure to be determined by CDC and the contractor) of all enrolled registry patients;

7. Prepare and provide for CDC quarterly QA/QC reports;

8. Submit one mid-way dataset (6 months after the beginning of the option period) from the data reporting tool to the CDC Technical SMEs and CDC COR in addition to the final dataset in accordance with the deliverable table.

a. Datasets shall be exports of the data and will include (among other elements) patient demographics, data from medical chart abstractions, testing results, vaccination/immunization (including receipt of RSV monoclonal antibody) history ascertainment for influenza, RSV, and COVID-19 (vaccination/immunization status by interview only, verified through medical records or state vaccine registry), and antiviral receipt ascertainment (by interview, medical records, and other potential sources) if relevant, as to be determined by CDC and the Contractor.

C.5 – Reference Materials

1. Fazal A, Reinhart K, Huang S, et al. Reports of Encephalopathy Among Children with Influenza-Associated Mortality — United States, 2010–11 Through 2024–25 Influenza Seasons. MMWR Morb Mortal Wkly Rep 2025;74:91–95. DOI: http://dx.doi.org/10.15585/mmwr.mm7406a3

2. Fazal A, Harker EJ, Neelam V, et al. Pediatric Influenza-Associated Encephalopathy and Acute Necrotizing Encephalopathy — United States, 2024–25 Influenza Season. MMWR Morb Mortal Wkly Rep 2025;74:556–564. DOI: http://dx.doi.org/10.15585/mmwr.mm7436a1

3. Silverman A, Walsh R, Santoro JD, et al.; Influenza-Associated Acute Necrotizing Encephalopathy (IA-ANE) Working Group. Influenza-associated acute necrotizing encephalopathy in US children. JAMA 2025;334:692–701. https://doi.org/10.1001/jama.2025.11534

4. Sakuma H, Thomas T, Debinski C, et al. International consensus definitions for infection-triggered encephalopathy syndromes. Dev Med Child Neurol 2025;67:195–207. https://doi.org/10.1111/dmcn.16067 PMID:39143740

5. Mizuguchi M. Influenza encephalopathy and related neuropsychiatric syndromes. Influenza Other Respir Viruses 2013;7(Suppl 3):67–71. https://doi.org/10.1111/irv.12177

6. Mizuguchi M, Abe J, Mikkaichi K, et al. Acute necrotising encephalopathy of childhood: a new syndrome presenting with multifocal, symmetric brain lesions. J Neurol Neurosurg Psychiatry 1995;58:555–61. https://doi.org/10.1136/jnnp.58.5.555

7. Okuno H, Yahata Y, Tanaka-Taya K, Arai S, Satoh H, Morino S, Shimada T, Sunagawa T, Uyeki TM, Oishi K. Characteristics and Outcomes of Influenza-Associated Encephalopathy Cases Among Children and Adults in Japan, 2010-2015. Clin Infect Dis. 2018 Jun 1;66(12):1831-1837. doi: 10.1093/cid/cix1126.

8. Simeone, RM, Newhams, MM, Zambrano, LD, et al. Characteristics of young children hospitalized with acute respiratory failure from infection with RSV, SARS-CoV-2, or both, November 2023–March 2024. OFID 2026 Mar 4; DOI: 10.1093/ofid/ofag088.

9. Feldstein, LR, Tenforde, MW, Friedman, KG, et al. Characteristics and Outcomes of US Children and Adolescents with Multisystem Inflammatory Syndrome in Children (MIS-C) Compared With Severe Acute COVID-19. JAMA. 2021 Mar 16;325(11):1074-1087. https://doi.org/10.1001/jama.2021.2091.

C.6 – Government Furnished Materials

1. Upon contract award and signature of any required nondisclosure agreements, CDC will provide the Contractor with the most current CDC-approved materials to leverage in the performance of the tasks in this contract. The contractor will be provided with CDC laptops.

2. Contractor Request for Government Furnished Materials. If the Contractor needs any additional government-furnished items to perform the work described in this PWS, the Contractor should identify such additional government-furnished items in the Contractor’s proposal.

C.7 – Place of Performance Entirely off site; the work to be performed under this contract will be performed at the Contractor’s facility and associated academic, healthcare, or research facilities as required. No CDC onsite work is required.

C.8 – Period of Performance The performance period for this requirement is:

Base Year: August 1st, 2026 to July 31st, 2027 Option Year I: August 1st, 2027 to July 31st, 2028 Option Year II: August 1st, 2028 to July 31st, 2029 Option Year III: August 1st, 2029 to July 31st, 2030 Option Year IV: August 1st, 2030 to July 31st, 2031 C.9 – Deliverables/Reporting Schedule All deliverables shall be in written form (i) delivered electronically, or such other manner as the contract requires, to the CDC Technical SME (see Section 12 below), the COR and such other parties as included below, or to whom the COR may designate to the Contractor in writing; and (ii) be formatted in Microsoft Word, Excel, or other editable formatting approved by the COR. All deliverables must be prepared in consideration of all applicable security, confidentiality, and architecture compliance requirements.

IMPORTANT NOTES:

· All deliverables are calculated using a 12-month term.

· Unless otherwise noted, the reference to “days” in this contract are to “calendar” days and not “business” days.

· All references to the option period are subject to option year execution.

The Contractor shall deliver the following in accordance with the SOW:

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C.10 – Travel This contract does not include travel.

C.11 – Performance & Quality Assurance

1. CPARS. For acquisitions over the simplified acquisition threshold, the Government will provide and record Past Performance Information of the Contractor’s performance in the Contractor Performance Assessment Reporting System (CPARS). The CPARS process allows contractors to view and comment on the Government's evaluation of the Contractor's performance before it is finalized. Contractors are required to register in the CPARS, so that Contractor’s may review and comment on past performance reports submitted through the CPARS. The CPARS website is https://www.cpars.gov/.

2. Performance-Based Matrix: The Performance-Based Matrix describes a list of the contractual requirements that will be verified as contractually compliant by the Government. Each requirement includes a Government-determined performance standard and the resource that is used to perform the verification. Surveillance of any functional area that does not have critical requirements will be accomplished through surveillance of the Contractor’s Quality Control Program or periodic evaluation.

a) 100% Inspection: One Hundred Percent Inspection is exactly what the title implies – inspecting a requirement every time it occurs.

b) Customer Complaints: Customer complaints will be investigated to ensure compliance with the Performance/Deliverables Matrix prior to being transmitted to the Contractor.

c) Random sampling: Review of a randomly selected subset of cases/specimen collections to assess compliance with contract requirements, as defined in the protocol.

· Timely delivery of the Agenda

· Scheduling call to include key stakeholders

· Directing communications to the appropriate CDC staff

· Timeliness

· Completeness

· Quality

· Timeliness

· Functionality

· Completeness

· Comparison of protocol to contract requirements

· Ensure adherence to ethical requirements for research with human subjects

· Timeliness

· Quality

· Functionality

· Completeness

· Timeliness

· Quality

· Completeness

· Random sampling

· Government inspection and acceptance

· Timeliness

· Quality

· Complete and accurate documentation

· <5% data fields with errors upon CDC review of interim delivery

· Interim dataset <6 months from study launch

· Final dataset per final project delivery schedule

· 95% adherence to data dictionary and data requirements

· No more than 2 revisions before final acceptance by CDC

· Comparison of interim and final dataset to the contract requirement

· Random sampling

· Government inspection and acceptance

· Timeliness

· Quality

· Functionality

· Completeness

· Timeliness

· Quality

· Functionality

· Completeness

· Comparison of updated study protocol, data collection instruments and data dictionary to contract terms

· Timeliness

· Quality

· Complete and accurate documentation

· <5% data fields with errors upon CDC review of interim delivery

· Interim dataset <6 months from study launch

· Final dataset per final project delivery schedule

· Comparison of interim and final dataset to the contract requirement

C.12 – Minimum Vendor Qualifications

Special Skills and Requirements: The contractor must have demonstrated experience in:

1. Serving as the clinical coordinating center (CCC), data coordinating center (DCC), single institutional review board (sIRB), central viral laboratory, and biospecimen repository for an already established observational, multicenter, prospective public health surveillance network comprised of pediatric hospitals, medical centers, and institutes from which to recruit the identified case patients to study influenza-associated encephalopathy in hospitalized children;

2. Identifying and recruiting the type and number of institutions with the “minimum requirements” identified in this requirement;

3. Performing all other tasks as described in C.4 – Tasks to be Performed; and

4. Meeting the critical timelines outlined in this contract, specifically those included in C.9 – Deliverables/Reporting Schedule

C.13 – Special Considerations (Clearance Requirements)

1. Information Security and Privacy

1. Baseline Security Requirements:

a. Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or both of the following:

i. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

ii. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the CDC mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of "information technology" (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

b. Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with HHS/CDC policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must:

i. Protect the:

Confi…