A22 Sample Task Order Clinical_Contributing_Revised.pdf

ATTACHMENT 1

CISA SAMPLE TASK ORDER # 1

CLINICAL IMMUNIZATION SAFETY ASSESSMENT (CISA) PROJECT

VACCINE SAFETY EVALUATION – CONTRIBUTING CONTRACTOR

Subject to FAR 52.232-18 Availability of Funds

Department of Health and Human Services Public Health Service Centers for Disease Control and Prevention National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) Division of Healthcare Quality Promotion (DHQP) Immunization Safety Office Atlanta, GA 30333

Date Issued: April 3, 2023 Date Response Due: May 19, 2023

Request for Task Order Proposal (RFTP) Number: 2023 CISA 01

Title: CISA Clinical Vaccine Safety Evaluation - Contributing Contractor Task Order Contract Reference: This RFTP is consistent with the purposes for which the indefinite delivery, indefinite quantity (IDIQ) contract for the CDC’s Clinical Immunization Safety Assessment (CISA) project was awarded. The terms and conditions of the IDIQ are applicable to this task order.

1. Applicability This effort is within the scope of the basic contract discussed in Requirement 1 section C.5.1 of the Work Statement for the CISA IDIQ.

2. Order Type

The Task Order shall be Cost Reimbursement. The Offeror must submit a technical and business proposal for the Contributing Contractor Task Order. These items will be scored in the technical evaluation requirements section for this Task Order award. This Task Order for a Contributing Contractor consists of:

• Task 1: Clinical Consultations and Issue Evaluations (BASE) o A response is required for all offerors

• Task 2: Clinical On-Call services (SUPPLEMENTAL) o A response is only required if the Offeror is competing for Task 2

The Offerors are required to apply for Task 1. All Offerors must submit a technical and business proposal for Task 1. The Offerors are encouraged, but not required, to apply for Task 2. The Offerors must submit a technical and business proposal for Task 2 if they apply for these Tasks. Therefore, if an Offeror applies for Task1 and Task 2, the Offeror must submit a technical and business proposal for both Tasks.

3. Period of Performance The period of performance is from the date of the contract award for twelve months.

The expected period of performance is

• Year 1: 9/22/2023 – 9/21/2024

• Year 2: 9/22/2024 – 9/21/2025

• Year 3: 9/22/2025 – 9/21/2026

• Year 4: 9/22/2026 – 9/21/2027

• Year 5: 9/22/2027 – 9/21/2028

4. Place of Performance Services will be performed at Contractor specified site in the United States.

5. Background and Need CDC seeks to continue the CISA Project Clinical Vaccine Safety Evaluation activity at its current functional level. This public health activity serves as a vaccine safety resource to provide clinical case consultations and assist CDC in developing strategies to optimize vaccine safety. This activity consists of: 1) a Lead Clinical Vaccine Safety Contractor (referred to as the ‘Lead Contractor’); and 2) one or more Contributing Clinical Vaccine Safety Contractors (referred to as the ‘Contributing Contractor’). CDC intends to award multiple separate Contributing Contractor Task Orders. This RFTP describes the Tasks that the Contributing Contractor shall conduct for the Clinical Vaccine Safety Evaluation activity. The Contributing Contractor(s) will work under the technical direction of CDC, and CDC will make assignments.

CDC’s Immunization Safety Office (ISO) monitors the safety of vaccines across the lifespan.

The CISA Project Clinical Vaccine Safety Evaluation activity provides a service to U.S.

healthcare providers that have a vaccine safety question about a specific patient residing in the U.S., and the question is not readily answered by CDC, Advisory Committee on Immunization Practices (ACIP), or other professional society guidelines (e.g., American Academy of Pediatrics, Infectious Diseases Society of America, or American College of Obstetrics and Gynecology). In seeking expert opinion, the healthcare provider can contact CDC to request a CISA clinical case evaluation through the CDC website link:

(https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/evaluation.html). The CISA Project tracks clinical case evaluations and associated patient outcomes in a secure database.

The CISA Project also provides consultation about vaccine safety issues that are important for public health. For example, CISA has assessed vaccine safety evidence to assist the ACIP regarding influenza vaccine recommendations (https://www.cdc.gov/vaccines/acip/index.html).

The CISA Project also has assisted with several vaccine safety emergencies, such as evaluating the safety of an unlicensed meningococcal B vaccine (i.e., investigational new drug), used as part of outbreak response on college campuses1, and has assisted state health departments in evaluating vaccine safety issues. The CISA Project has also contributed to vaccine safety monitoring efforts during several public health emergency responses, including the ongoing response to the COVID-19 pandemic2. Since December 2020, CISA has operated a 24/7 on-call service for U.S. healthcare providers and state health departments with complex questions about COVID-19 vaccine safety3,4, and during 2022 engaged with the U.S. public health emergency (PHE) response for Mpox5.

6. Objective

6.1. Task 1: Clinical Consultations and Issue Evaluations (BASE):

The purpose of this Task is for the Contributing Contractor to provide one primary Principal Investigator (PI) and one secondary Principal Investigator to participate in the CISA Clinical Vaccine Safety Evaluation activities and assist CDC and the Lead Contractor in meeting clinical vaccine safety and public health needs. These activities https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/evaluation.html https://www.cdc.gov/vaccines/acip/index.html will extend to safety monitoring of the use of licensed and authorized vaccines in the U.S. CDC seeks to maintain the CISA Clinical Vaccine Safety Evaluation activity at its current functional level. This activity covers two CISA goals: 1) To serve as a vaccine safety resource for U.S. healthcare providers with complex vaccine safety questions about a specific patient to assist with immunization decision-making; 2) To assist the CDC and its partners in evaluating emerging vaccine safety issues.

6.2. Task 2: Clinical On-Call Services (SUPPLEMENTAL):

The purpose of this Task is for Contributing Contractor to provide one primary Principal Investigator (PI) and secondary Principal Investigators to participate in CISA Clinical On- Call Service for Vaccine Safety Evaluation. The PI and secondary PI(s) can be the same as in Task 1. Core CISA Clinical On-Call activities include participating in Day Call and Night Call duties, serving as a vaccine safety resource for the clinical evaluation of vaccine safety issues including individual case reviews. In addition, Contributing Contractor shall provide medical subject matter experts in some or all of the medical specialties for children and adults.

7. Scope of Work Under this Task Order, the Contributing Contractor shall provide consultation to the Clinical Vaccine Safety Evaluation activity to meet the objectives described above.

The primary PI shall have a current U.S. medical license from at least 1 of the 50 states or Washington DC, board certification in a medical specialty, and substantive expertise in infectious diseases or vaccine safety. The secondary Principal Investigator shall have a current U.S. medical license from least 1 of the 50 states or Washington DC and board certification in a medical specialty. Medical subject matter experts (SMEs) shall have clinical expertise in their field.

7.1. Task 1: Clinical Consultations and Issue Evaluations (BASE)

Under Task 1, the primary PI is anticipated to provide approximately 116 hours per contract year and the secondary PI is anticipated to provide approximately 36 hours per contract year (Table 1). In addition the secondary PI may cover for the primary PI when he/she is not available.

Working Groups and general responsibilities of the Lead Contractor are described below:

7.1.1. Clinical Case Consultation and Inquiry Response (Clinical Case Working Group 1 (WG-1) The Clinical Case Consultation and Inquiry Response (Clinical Case WG-1) will assist CDC by conducting review of cases of adverse events following immunization (AEFI), or cases in which an AEFI has not occurred, but the patient has a personal or family history of a medical condition that might increase their risk for an AEFI. The Contributing Contractor shall participate and contribute to the Clinical Case WG activities. The aim of this review by the Clinical Case WG is to assist U.S. healthcare providers with specific vaccine safety questions about a specific patient residing in the U.S. Advice from the Clinical Case WG evaluation is meant to assist in decision-making, rather than provide direct patient management.

Patient management decisions are the responsibility of the treating healthcare provider.

These Clinical Case WG calls will be scheduled to take place about twice per month (approximately 24 per contract year); most calls will be scheduled on

Wednesday 12:00-2:00 pm Eastern Time zone. The calls may be used to evaluate cases, to provide information about follow-up on cases reviewed on an earlier call, or to discuss procedures needed to support and update or enhance the clinical case review processes.

Two methods will generally be used to address vaccine safety requests for inquiry about a specific patient or vaccine safety clinical inquiries:

1. CISA Structured Clinical Case Consultation (led by a CISA Contractor)

2. CISA Enhanced Inquiry Response (led by CDC)

Draft Standard Operating Procedures (SOP) for these will be provided by CDC after the contract has been awarded.

The Clinical Case WG-1 will generally be composed of at least one U.S.-licensed physician from the CDC’s Immunization Safety Office (ISO), at least one from the Lead or Contributing Contractors, and the patient’s healthcare provider(s). In addition, other subject matter experts, CDC staff, other federal partners, and state health departments may participate.

7.1.2. Vaccine Safety Issues Working Group 2 (WG-2)

Vaccine Safety Issues WG-2 will evaluate and synthesize vaccine safety issues. The WG-2 will be composed of at least one scientific/medical staff from the CDC’s ISO and scientific/medical staff from the Lead Contractor, generally the primary Principal Investigator, secondary Principal Investigator, or a medical subject matter expert at the site. The Contributing Contractor shall participate and contribute to the Working Group activities. Approximately nine Working Group calls will be scheduled throughout the 12-month contract cycle; most calls will be scheduled on Wednesday, 12:00- 2:00 pm Eastern Time zone. Contributing Contractors, CDC staff, and subject matter experts will attend most of these calls; federal or state partners involved in vaccine safety might be invited to some of these calls.

Vaccine safety issues may be brought to CISA by ACIP Working Group(s) (e.g., issue regarding assessment of safety data on influenza vaccine in older persons), by Federal partners, by a state health department, by a CISA Contractor, or could involve assisting CDC with responding to a vaccine safety and/or public health urgent/emergency need.

Vaccine safety issues may include assisting with the review of reports of concerning AEFIs for a specific vaccine; helping to develop a potential adverse event (AE) profile for an unlicensed vaccine that is being implemented in response to a public health outbreak or pandemic; or assessing the biological plausibility and/or causality of a unique/novel or serious AEFI with respect to a recently licensed/authorized vaccine. In addition, this WG may conduct case reviews to assist the government with surveillance for adverse events following immunization (AEFIs), or may review a case of a novel or unusual AEFI reported to the Vaccine Adverse Event Reporting System (VAERS).6

7.1.3. Medical Subject Matter Experts (SMEs) Support

The Contributing Contractor shall identify and have available medical Subject Matter Experts (SMEs) to support specific assignments in the Clinical Case Evaluation activity and meet the objective above. The secondary PI may provide SME support if their expertise matches the public health need (approximately 20 additional hours per contract year).

7.1.4. Adjunct Scientific Functions

The Contributing Contractor shall conduct adjunct activities to support CISA scientific functions, under the direction of CDC.

7.1.4a Research Portfolio (RP): The Contributing Contractor shall participate and provide technical input during the Research Portfolio (RP) calls which will be led by CDC (approximately 9 calls per contract year); most calls will be scheduled on Wednesday 12:00-2:00 pm Eastern Time zone.

7.1.4b The Contributing Contractor shall assist CDC and health care providers to collect, transport, and analyze biological specimens obtained from a limited number of individuals, reviewed by the Contractor, to a centralized specimen repository or other laboratory.

7.1.4c Provide external data safety monitoring expertise (e.g., evaluate patient safety data from a research study that is being conducted by a different contractor in which the Contributing Clinical Case Evaluation Contractor is not an investigator).

7.1.4d Carry out technical writing or give presentation(s) about scientific work, with approval of CDC.

7.1.4e Identify and contact a limited number of patients with AEFIs (cases) that were reviewed to facilitate their enrollment in government-supported vaccine safety studies (the Contractor may or may not be a co-investigator in these studies).

7.1.4f Perform technical consultation as assigned by CDC ISO that would be in support of U.S. Government Federal vaccine safety research, or public health surveillance, or development of clinical guidance. No human subjects shall be enrolled in a CISA research study under this Task Order.

7.1.4g Contribute to developing, maintaining, and updating the CISA Emergency Response Plan for enhancing the vaccine safety Clinical Case Evaluation activities in the event of an emergency or urgent public health incident.

7.1.4h Attendance and participation at CDC scientific meeting and conferences, including the CISA Annual Conference.

7.1.5. Coordination/Administrative Functions (one designated coordinator) The Contributing Contractor shall provide coordination/administrative support to the CISA Clinical Case Evaluation activity. This will include securely obtaining patient’s medical records and entering the data about case evaluations into a CISA secure database managed by the Lead Contractor. Also, the Contributing Contractor may participate in collecting follow-up information on the cases they review.

7.2. Task 2: Clinical On-Call Services: (SUPPLEMENTAL)

The purpose of this Task is for Contributing Contractor to provide one primary Principal Investigator and one or two secondary Principal Investigators to participate in CISA Clinical On-Call Service for vaccine safety evaluation. Core CISA Clinical On-Call activities includes participating in Day On-Call and Night On-Call duties and serving as a vaccine safety resource for the clinical evaluation of vaccine safety issues including individual case reviews. The Contributing Contractor shall designate a primary PI and 1 or 2 secondary PIs to be available to contribute expertise and provide consultation to the CISA Clinical On-Call Service to meet the objective described in Section 6.2 above.

The CISA Project’s core CISA Clinical On-Call activities for the Contributing Contractor are listed below. All functions specified in Task 1 may apply to Task 2.

7.2.1. Day On-call Services

CISA Day On-call service will include CISA investigators from the Lead and Contributing Contractors. One PI (Lead or Contributing Contractor) shall serve as primary CISA physician on-call. The Contributing Contractor primary or secondary PIs will serve one day per week as the primary Contractor Day On-call.

7.2.2. Night On-call service

The Night On-call pool covers nights during the weekdays, and days and nights on weekends and Federal holidays. The primary function of the night call pool will be to address vaccine safety emergencies that require clinical consultation that come in after hours and cannot wait until the next business day. The Contributing Contractor shall participate in Night On-call rotation. Night on-call responsibilities will occur about at a frequency of 1 week every 5 to 6 weeks.

7.2.3. CISA Medical Subject Matter Experts (SMEs)

The Contributing Contractor shall provide and maintain a list of medical experts to provide consultation to CISA On-call services and be responsible for communicating and assigning work to the experts at their site (exceptions may need to be made for emergency situations). The SMEs will assist the Principal Investigators in providing clinical consultations of vaccine safety for on-call services.

8. Technical Requirements The Contributing Contractor, with technical direction from CDC, shall accomplish the following tasks listed below. These tasks will extend to safety monitoring of licensed and authorized vaccines in the U.S. They shall also extend to assist CDC assess the safety of an unlicensed vaccine if needed for public health purposes.

Close communication between CDC and each of the Contributing Contractors will ensure optimal use of consultation and technical expertise.

• Repurposing of consultation hours for Task 1: For all technical items that involve CISA investigator consultation hours, CDC may repurpose work for the Clinical CaseWG-1, the Vaccine Safety Issue WG-2, and the scientific adjunct functions to best meet CDC public health needs. When re-purposing is done, consideration will be given to maintaining the overall same time and effort needs. For example, if an extra Vaccine Safety Issue WG-2 call is scheduled, then one case review (Clinical Case WG-1) call could be dropped. If the CDC assigns a Principal Investigator to assist with data safety monitoring that takes 8 hours, then responsibility for attending about 4 calls could be removed.

Table 1. Task 1: CISA Contributing Clinical Consultations and Issue Evaluations (BASE) Summary Table (REQUIRED FOR ALL OFFERORS)

Description Staffing Estimated Working Group Meetings or Main Activities

Contribute to WG-1, WG-2, and scientific adjunct functions (RP and other adjunct activities) and annual conference participation

Primary PI • Clinical Case Consultation WG-1 o 24 WG-1 calls per contract year (estimated duration: 1 hour for each call and

1 hour for preparation/wrap up)

• Vaccine Safety Issues WG-2 o 9 WG-2 calls per contract year (estimated duration: 1 hour for each call and 1 hour for preparation/wrap up)

• Adjunct Scientific function o 9 RP call per contract year (estimated duration: 1 hour for each call and 1 hour for preparation/wrap up) o 16 hours per contract year additional Adjunct Functions

• 16 hours per contract year Scientific input and participation at CISA Annual Conference

Note: If not all hours are used by primary PI, the hours may be repurposed for use by the secondary PI These hours may be repurposed Repurposing of consultation hours for Task 1: For all technical items that involve CISA investigator consultation hours, CDC may repurpose work for the Clinical Case WG-1, the Vaccine Safety Issue WG-2, and the scientific adjunct functions to best meet CDC public health needs. When re-purposing is done, consideration will be given to maintaining the overall same time and effort needs. For example, if an extra Vaccine Safety Issue WG-2 call is scheduled, then one case review (Clinical Case WG1) call could be dropped. If the CDC assigns a Principal Investigator to assist with data safety monitoring that takes 8 hours, then responsibility for attending about 4 calls could be removed.

Contribute to WG-1, WG-2, and scientific adjunct functions (RP and other adjunct activities) and Annual Conference

Secondary

PI

The secondary PI would be a different staff from the primary

PI

• Contributes to activities listed above (mix of WG-1, WG-2, adjunct scientific functions):

o 20 hours per contract year Scientific input o 16 hours per contract year participation at CISA Annual Conference

Note: If not all hours are used by secondary PI, the hours may be repurposed for use by the primary PI

Assist with specific functions in Task

SMEs • Assist with specific clinical case consultation, vaccine safety issues, or adjunct scientific functions o 20 hours per contract year

Contributing Contractor administrative activities

Coordinator

• Coordinator effort:

o About 20 hours per contract year; may participate in Annual Conference

Table 2. Task 2: CISA Contributing Clinical On-Call Services (SUPPLEMENTAL) Summary Table (See section 8.2 of RFTP for details)

Description Staffing Estimated Working Group Meetings or Main Activities Clinical On-Call services

Primary and secondary PIs to provide coverage.

In addition to Task 1 the following services apply:

• Clinical On-Call services o Day on-call service - Operates during business hours Monday – Friday (9am-5pm ET) o The Contributing site will serve one day per week as the primary site on-call l (approximately 4 hours per on-call day) o Night on-call service o Sites are on call approximately 1 week every 5-6 weeks; 5pm ET Friday – 9am ET Friday and 9am-9am weekend and Federal holidays (approximately 4 hours per week of night call) o Check-in meeting o One hour; 2-3 times per week (for example: M-W-F)

The CISA clinical on-call services may change during a Public Health Emergency (PHE) or urgent response

Clinical On-Call services

SMEs Provide and maintain a list of medical subject matter experts to provide consultation to CISA on-call services

Clinical On-Call services

Coordination/Ad ministrative Functions (1 Coordinator) (same person as Task 1)

Coordinator effort (same person as Task 1)

8.1. Task 1: Clinical Consultations and Issue Evaluations (BASE) Working with guidance from CDC, the Contributing Contractor shall accomplish the technical functions below for the Task 1 Clinical Consultations and Issue Evaluations. One or two investigators may act as the back-up primary Principal Investigator to provide coverage for the primary PI (e.g., when he/she is unavailable) or to assist on selected Clinical Vaccine Safety Evaluation activity.

The distribution of the time is as follows for each contract year for the Primary PI; see Table 1 for the secondary PI and coordinator estimated hours:

Primary PI:

• 24 WG-1 calls per year (estimated duration: 1 hour for each call and 1 hour for preparation/wrap)

• 9 WG-2 calls per year (estimated duration: 1 hour for each call and 1 hour for preparation/wrap)

• Adjunct Scientific functions o 9 RP calls per year (estimated duration: 1 hour for each call and

1 hour for preparation/wrap) o 16 hours per contract year additional adjunct functions

• 16 hours per contract year participation at Annual Conference

8.1.1. Clinical Case Consultation and Inquiry Response Working Group 1 (WG-1)

The Offeror shall use Appendix A, which contains summary information about ‘CISA Clinical Consultation Process’ to accomplish the objectives of WG-1. In addition, CDC will provide a draft SOP after the contract is awarded.

The Lead Contractor will have primary responsibility for this WG. The Contributing

Contractor may be requested to assist with some functions of the WG.

There are five steps to a CISA structured clinical case consultation review:

1. Preparation

2. Presentation and discussion during Working Group

3. Assessment and Communication (including minutes and letter to the healthcare provider)

4. Follow-up survey of healthcare provider satisfaction

5. Follow-up survey of patient outcomes

Case and follow-up data are entered into a secure database which is maintained by the Lead Contractor.

A shorter process is used for the CISA enhanced inquiry response. CDC leads these responses and the Lead or Contributing Contractor(s) provide expertise.

8.1.1.1. The Lead Contractor will have primary responsibility for presenting most cases to the Clinical Case Consultation and Inquiry Response WG calls; however, a Contributing Contractor may be asked to assist with the presentation of a case and facilitate the case discussion.

8.1.1.2. CDC will determine if assigned cases necessitate an urgent or routine evaluation.

8.1.1.3. The Contributing Contractor shall participate in approximately 2 WG calls per month (approximately 24 calls per contract year). Estimated duration of Working Group call:

1 hour for each call participation 1 hour for preparation and/or wrap-up activities

8.1.1.4. The Contributing Contractor shall review case materials shared in advance of the Working Group call, attend the WG call, provide their expertise during the case discussion and assessment of causality of the adverse event(s) following immunization (AEFI) during the call.

Information from the presentation and discussion of a Working Group case will be used to provide a final assessment of the case. The Lead Contractor will usually communicate the final assessment of each case reviewed. Under most circumstances, pertinent clinical aspect of the case, discussion, final assessment, and guidance information will be summarized in a letter that, after review and approval by CDC, will be sent to the healthcare provider(s) that requested the CISA consultation.

For an AEFI case, the letter will contain subject matter experts’ opinions regarding the assessment of causality, as well as guidance regarding any additional testing and administration of future vaccines. Any differences in expert opinion and guidance shall be documented in the letter that will be provided to the healthcare provider. A Contributing Contractor may be asked to review meeting minutes or the final draft letter before it is sent to the provider. If the Contributing Contractor had substantial and/or unique contributions to the case, they may be asked to send the final letter to the provider. CDC may assign a CISA Contributing Contractor to assist with clinical case review, literature review, and/or to lead the technical discussion, including presenting on a case or clinical topic. If a CISA Contributing Contractor assists with the Clinical Case Consultation and Inquiry Response Working Group (WG-1) call, the technical functions below will apply:

8.1.1.5a. The Contributing Contractor assigned to be the primary reviewer/presenter or clinical case will be primarily responsible for obtaining and reviewing the medical records. If the assigned Contributing Contractor does not have access to the medical records, the Lead Contractor will solicit the medical records for the case. On occasion, the CDC may be called upon to assist the Lead or Contributing Contractors with obtaining medical records (e.g., if CDC has access to the desired medical records through the VAERS database) for Working Group calls.

8.1.1.5b. The Lead Contractor will be responsible for providing coordination and administrative support, such as call hosting and taking meeting minutes. The Contributing Contractor may assist with these functions.

8.1.1.5c. The Lead Contractor shall have the responsibility for providing clinical subject matter experts (e.g., Allergy/Immunology; Hematology; Neurology) for Working Group calls even if a Contributing Contractor is serving as the primary reviewer/presenter the call. The Contributing Contractor may assist with these functions.

8.1.1.5. The Lead Contractor shall have primary responsibility for taking minutes and drafting the summary letter to the healthcare provider for all Working Groups calls.

The Contributing Contractor assigned to assist or contribute expertise to a portion of the call, shall be invited to review and contribute to the draft minutes and the draft letter that will be sent to the healthcare provider(s) before these documents are finalized. The Lead Contractor will usually send the final version of the letters to the requesting healthcare provider. With approval from CDC, the Contributing Contractor may send a letter to the healthcare provider.

8.1.1.6. The Contributing Contractor may assist with the development of manuscripts from the Clinical Case Evaluation Working Group reviews, under the technical direction of CDC. CDC Human Subjects protection and clearance policies shall apply (see section C.10.2 and C.10.3 of the CISA IDIQ Work Statement).

8.1.1.7. The Contributing Contractor may enter information about clinical cases reviewed into a secure tracking database, maintained by the Lead Contractor.

8.1.2. Vaccine Safety Issues Working Group 2 (WG-2)

The Lead Contractor shall have responsibility for leading the scientific aspects of about two to three issues per year. In addition, CDC may also lead an issue and may assign a Contributing Contractor to lead a component or assist with an issues review.

8.1.2.1. The Contributing Contractor shall attend up to 9 vaccine safety issues WG-2 calls per contract year. Estimated duration of Working Group call:

1 hour for each call participation 1 hour for preparation and/or wrap-up activities

8.1.2.2. The Contributing Contractor shall review the materials shared in advance of the WG-2 call and provide their expertise during the discussion of the vaccine safety issue.

8.1.2.3. The Lead Contractor will be responsible for providing coordination and administrative support, such as call hosting and meeting minutes. The Contributing Contactor may assist with these functions. Review of minutes by Contributing Contractors and SMEs that were on the call may be requested before CDC approves the minutes to be Final. An issue report shall be the responsibility of the Lead or Contributing Contractor leading the issue assessment. Contributors to an issue assessment may be invited to review and contribute to the summary report before it is finalized. The format of the summary report (e.g., WORD document or PowerPoint presentation) would be determined in advance with CDC.

8.1.2.4. The Contributing Contractor may assist with development of manuscripts from the Vaccine Safety Issues WG reviews, under the technical guidance of CDC. CDC Human Subjects protection and clearance policies shall apply (see section C.10.2 and C.10.3 of the Work Statement).

8.1.2.5. The CDC may assign any of the CISA Contributing Contractors or other parties to lead the evaluation of a vaccine safety issue. If the Contributing Contractor receives the assignment to lead the scientific aspects of a vaccine safety issue WG, the technical functions below will apply:

8.1.2.5a The Contributing Contractor shall obtain additional information and background on the issue. Assessment may involve reviewing the literature and having discussions with experts. The Contributing Contractor shall help identify the expertise needed to help assess the assigned issue. When indicated, CDC will conduct VAERS report reviews to search for similar cases and will prepare slides for the case presentation and provide that information to the assigned Contributing Contractor.

8.1.2.5b If requested, the Contributing Contractor shall present the vaccine safety issue on the WG-2 call. The Working Group call may be used to help further assess the vaccine safety issue. The Contributing Contractor shall state the results of the assessment and conclusions for the topic assigned.

8.1.2.5c The Lead Contractor shall have the primary responsibility for organizing and providing the logistics for the Working Group call, such as arranging the conference call, obtaining subject matter experts, and taking meeting minutes. The Contributing Contractor may assist with these functions.

8.1.2.5d The Contributing Contractor leading the review of the vaccine safety issue may have one or more planning calls with CDC and other parties in advance of the WG-2 call where the vaccine safety issue will be discussed.

8.1.2.5e The Contributing Contractor may be requested by CDC to assess a vaccine safety issue on its own. This issue assessment might not be presented on a CISA WG call. For example, this type of issue assessment might be requested of CDC by an ACIP Working Group. If there is no CISA call, then a summary report of findings of the issue assessment would be required. The format of the summary report (e.g., WORD document or PowerPoint presentation) will be determined in advance with

CDC.

8.1.2.5f The Contributing Contractor shall be responsible for the leading the writing of the summary report on the vaccine safety issue that they are assigned to lead the review. The format of the summary report (e.g., WORD document or PowerPoint presentation) would be determined in advance with CDC. Medical Subject Matter Experts (SMEs) Support

The Contributing Contractor, with technical direction from CDC, shall accomplish the following tasks listed below to provide SMEs to assist with a specific clinical case consultation, vaccine safety issue(s), or adjunct scientific functions. These SMEs shall include pediatric and adult infectious diseases physicians. In addition, examples of the areas of expertise that may be requested include pediatric and adult subspecialties of allergy, neurology, hematology, and cardiology, and also obstetrics and gynecology;

additional SME areas may also be identified to meet public health needs.

The framework described above (in section 7.1) shall be used.

8.1.2.6. The Contributing Contractor shall provide about 20 hours of expert clinical/vaccine safety consultation time for specific vaccine safety evaluation needs per 12-month contract year. The hours may be used to support a single PI alone, or a PI and one or more SMEs.

8.1.2.7. CDC’s ISO has responsibility for responding to urgent vaccine safety issues. Therefore, a Contributing Contractor must be able to demonstrate capacity to complete a request for initial consultation and assessment with a turn-around time of 5 business days.

8.1.3. Adjunct Scientific Functions

With technical guidance from CDC, the Contributing Contractor may lead or assist with the following adjunct clinical and research scientific activities, if requested by CDC.

8.1.3.1. Research Portfolio (RP) call

CDC has primary responsibility for organizing and scheduling the RP call, inviting SMEs, taking the minutes, etc.

The Contributing Contractor shall attend approximately 9 RP calls per contract year. It is estimated that for each hour of a RP call, an average of one additional hour is needed for preparation and/or wrap-up activities.

8.1.3.2. The Contributing Contractor shall assist CDC and health care providers to collect, transport, and analyze biological specimens obtained from a limited number of individuals, reviewed by the Contractor, to a centralized specimen repository or other laboratory.

8.1.3.3. Vaccine safety data monitoring expertise

The Contributing Contractor may be requested to provide a few hours of expertise for one or more data safety monitoring tasks for CISA research studies. This may include participation of a subspecialist clinician or other SME from the Contributing Contractor on a technical panel to evaluate interim patient safety data from an ongoing study.

8.1.3.4. Technical writing and presentation(s)

When requested by CDC, the Contributing Contractor shall conduct technical writing or shall create and give presentation(s) associated with CISA clinical or issues evaluation work. Example activities could include working with CDC and other CISA Contractor(s) to develop educational materials and/or presentations about CISA clinical vaccine safety evaluation functions and activities that could be shared externally. The Contributing Contractor may also be requested to use consultation hours to work on a vaccine safety clinical evaluation or research writing activity of public health importance and of relevance to CISA.

8.1.3.5. PI(s) or SMEs from Contractor Contractor(s) may be assigned by the CDC to securely conduct reviews of individual reports of Vaccine Adverse Event Reporting System (VAERS) or similar type of vaccine safety surveillance reports.

8.1.3.6. The Contributing Contractor may be requested to perform technical consultation tasks/activities as assigned by CDC Immunization Safety Office that would be in support of U.S. Government Federal vaccine safety research or surveillance priority efforts, such as during a public health emergency.

8.1.3.7. Emergency Response preparedness Plan

The Contributing Contractor shall provide site-specific updates to the list of clinical experts that are willing to participate in the CISA Emergency Preparedness Plan. This plan outlines activities, at the direction of the Government, to rapidly support in-depth vaccine safety clinical case reviews and synthesis in the case of an urgent public health incident or emergency situation. CDC will review and approve plan updates/enhancements. In the event of an emergency, Task Orders may be issued by the Government for the execution of this plan. This plan will include maintaining and periodically updating a spreadsheet with names and basic contact information of clinical and vaccine safety subject matter experts located/affiliated with the Lead and Contributing CISA Contractors who could be called upon in a public health emergency to help assess vaccine safety clinical cases and/or issues. For emergency preparedness, the Lead Contractor might be requested to provide select investigators at one or more CISA Contributing Contractors a secure identification method, such as RSA SecureID token/fob, which would allow the investigators access to review, update, edit, and analyze data for a public health emergency response effort.

8.1.3.8. Attendance and participation at CDC scientific meeting and conferences, including the CISA Annual Conference.

8.1.4. Coordination/ Administrative Functions

The Contributing Contractor administrative activities

8.1.4.1. Provide a coordinator to support Clinical Vaccine Safety Case Evaluation activities.

8.1.4.2. The Contributing Contractor(s) shall have teleconference meeting with CDC, if requested, to discuss contractor-specific issues.

8.1.4.3. The Contributing Contractor shall provide a staffing plan for this Task Order.

8.1.4.4. The Contributing Contractor shall provide the appropriate facilities, data management, and other equipment for conducting this Task Order. This includes the appropriate office facilities, record keeping, disaster recovery plans, computer hardware and software, communication, and conferencing equipment.

8.1.4.5. The Contributing Contractor shall ensure timely monitoring of expenditures while implementing the project and submit invoices

8.1.4.6. The Contributing Contractor shall have responsibility for attending [or arranging for the back-up PI(s) to attend assigned CISA clinical vaccine safety evaluation calls in a 12- month contract period unless:

1. they have been asked to repurpose the time and effort by CDC; or

2. they have requested and been granted permission by CDC to repurpose the time and effort; or

3. the call is scheduled at a non-standard time or designated as “optional” by CDC.

8.1.4.7. The Contributing Contractor may be asked to add their coordinator to participate in the CISA Annual Conference.

8.2. Task 2: Clinical On-Call services: (SUPPLEMENTAL)

The Contributing Contractor shall designate a primary PI and secondary PIs to contribute expertise and provide consultation to the CISA Clinical On-Call Service for Vaccine Safety Evaluation activities to meet the objectives described in Section 6.1 and

6.2 above. All functions specified in Task 1 may apply to Task 2.

Table 3: Sample Day and Night On-Call Schedule for CISA Note: This sample schedule may be adjusted to meet program needs, with consideration of number of Contractors awarded this Task.

Role Monday Tuesday Wednesday Thursday Friday

Primary CISA site Site 1 Site 2 Site 3 Site 4 Site 5 *The night call pool covers nights during the weekdays, and days and nights on weekends and Federal holidays The CISA Project’s core CISA Clinical On-Call activities for the Contributing Contractor are:

8.2.1. Day On-call service

The Contributing Contractor shall participate in the CISA Day On-call service. This service will provide clinical consultation to healthcare providers and health departments with complex vaccine safety questions. CISA Day On-call service will include CISA investigators from the Lead and Contributing Contractors. One PI (Lead or Contributing Contractor) shall serve as primary CISA physician on-call. The Contributing Contractor primary or secondary PIs will serve one day per week as the primary Contractor Day On-call; the day of the week assigned to each site will be determined after award, with consideration of Contractors’ schedules and public health needs. When a site (Contractor) is on call for the day, they have responsibility for ensuring back-up (e.g.

coverage if the primary PI is unavailable). In addition, a second CISA site (Contractor) may be assigned to be a back-up; this may be useful for weather emergencies that might affect a site in a specific region. The hours for the day call coverage shall be 9:00 am through 5:00 pm Eastern Time (ET). The vaccine safety inquiries might be complicated, and when feasible the day on-call person shall follow the inquiry through to closure. Non-emergency or complex inquiries might take approximately 1-2 weeks to complete. The clinical on-call physician is encouraged to follow their case review inquiry through to completion. This may also include collecting follow-up information. When this is not possible and an inquiry response requires additional information promptly, the Day On-call physician may sign the inquiry out to the night on-call physician. The Day On-call physician shall participate in sign in/ sign out meetings on the primary on-call day. While the Day On-call physician needs to be available during their shift, it is anticipated that most days on call service will require 4 or fewer hours of work.

8.2.2. Night On-call service

Contributing Contractor shall participate in the CISA Night On-call service. The Night On-call pool covers nights during the weekdays, and days and nights on weekends and Federal holidays. When a site is on night call for the week, they have responsibility for ensuring back-up (e.g. coverage if the primary PI is unavailable). The primary function of the night call pool will be to address vaccine safety emergencies that come in after hours and require clinical consultation which cannot wait until the next business day. Night On-call responsibilities will occur about at a frequency of 1 week every approximately 5 to 6 weeks. The rotations last 1 week, usually from Friday to Friday. The Night On-call physician may sign over any vaccine safety inquiries to the Day On-call physician the next morning on business days. The hours of night call coverage are 5:00 pm-9:00 am ET on weeknights and 9:00 am-9:00 am (24 hours) on weekend and Federal holiday days.

There are fewer calls on most weekdays, nights, weekends, and Federal holidays.

Therefore, the Night On-call investigator is expected to work 4 or fewer hours per week on most weeks; additional hours may be required during an emergency public health response.

8.2.3. CISA Medical Subject Matter Experts (SMEs)

The Contributing Contractor shall provide and maintain a list of medical subject matter experts to provide consultation to CISA On-call services and be responsible for communicating and assigning work to the experts at their site for the on-call service (exceptions may need to be made for emergency situations). The on-call site shall have pediatric/adult infectious diseases physicians available for on-call services. In addition, the site shall have access to an infectious disease expert in the alternative area e.g., if the PI is pediatric infectious disease, then the site shall have access to an adult medicine infectious disease expert on the next business day.

The hosting Contractor shall NOT have responsibility for supporting travel for CDC staff or other CISA Contractor(s). All conference travel will be authorized and funded in advance by the Government via task order modification.

9. Reporting

9.1. Quarterly Status Report

The Contributing Contractor shall provide a Quarterly Status Report, in accordance with this Task Order. The Contractor shall electronically submit a copy of the quarterly report to the Contracting Officer’s Representative (COR) and the Contracting Officer. The report shall be due the 15th day of each quarter following the initiation of the contract.

CDC shall provide a template for this report which will include

a. Time spent on WG-1, WG-2 and scientific adjunct functions and calls attended

b. Work accomplished in prior quarter; and work scheduled on tasks for the next quarter

9.2. Final Annual Report

The Contributing Contractor shall provide a written report to the Government documenting significant work activities for the preceding 12-month period. The report should detail work accomplishments, ongoing activities, and time spent on Clinical Vaccine Safety Evaluation activities. The final annual report shall be delivered no later than the end of the contract-specified reporting period.

9.3. Vaccine safety Issue Report

The Contributing Contractor shall provide a technical report for each vaccine safety issue that they were the primary reviewer of the WG-2 issue. This report shall include a summary of the issue and a response to the particular issue evaluation questions or assignment, requested by CDC. The report shall be prepared with technical guidance from CDC. At its option, CDC may request this report to be included within the quarterly and/or Annual reports. If this issue involves a matter that might affect vaccine policy.

CDC may request the Contractor to present the findings of this report to a vaccine advisory body, such as the ACIP.

9.4. Form Format

Specific form, format and additional content requirements of the delivery schedule items shall be coordinated between the Contractor and the Government. The COR will provide the Contractor with disposition instructions for all technical documents (including, all databases, software documentation, questionnaires, case summaries, electronic files, etc.).

10. Deliverables During the performance of this Task Order, the Contractor shall deliver to the CDC COR in electronic format (pdf or MS Word), the Deliverables below.

Table 4: Deliverables for Task 1: Clinical Consultations and Issue Evaluations (BASE) and Task

2: Clinical On-Call services (SUPPLEMENTAL) Item Description of Deliverable Quantity Due Date Reference 1 Provide staffing plan for study 1 1 month after award of

Task Order 8.1.5.3

Item Description of Deliverable Quantity Due Date Reference 2 Report for each vaccine safety issue evaluated in Working Group or individually evaluated by the Contractor. This is applicable if CDC assigns the Contributing Contractor to lead the review of a specific vaccine safety issue. At its discretion, CDC may request this report be included within the Quarterly and/or Annual Reports

1 Within 6 weeks following assignment completion

8.1.2.5e;

8.1.2.5f;

9.3

3 Quarterly Status Report 1 15th day of the following month

9.1

4 Annual Report 1 At 12 months after award 9.2

11. Travel Attendance and participation at CDC scientific meeting and conferences.

The contractor shall notify CDC in advance of any travel plans and will adhere to all federal travel policies. The number of staff permitted to attend the Annual Conference will be determined and approved by CDC.

All conference travel will be authorized and funded in advance by the Government via task order modification.

The Contractor may send up to 1 - 3 staff to the CISA Annual Conference or a CDC approved academic meeting. Special Considerations

12. Vaccine Adverse Event Reporting System (VAERS)

The Special Consideration’s VAERS section C.10.1 of the CISA IDIQ Work Statement applies to this Task Order.

12.1. CDC Scientific Review and Clearance

The Special Consideration’s CDC Scientific Review and Clearance section C.10.3 of the CISA IDIQ

Work Statement applies to this Task Order.

12.2. Assurance of Confidentiality 308(d)

The Special Consideration’s Assurance of Confidentiality 308(d) C.10.4 of the CISA IDIQ Work

Statement applies to this Task Order.

12.3. Rehabilitation Act

The Special Consideration’s Rehabilitation section Act in the CISA IDIQ Work Statement applies to this Task Order.

12.4. Information Security and Confidentiality

The CDC Security compliance requirements for E-Government Act of 2002 (FISMA 2002) and

Federal Information Security Modernization Act of 2014 (FISMA 2014) are not applicable to this Task Order.

12.5. Paperwork Reduction Act of 1995 (PRA)

The Paperwork Reduction Act of 1995 (PRA): Offerors are advised that any activities involving information collections (i.e., surveys, questionnaires, applications, audits, data requests, reporting, recordkeeping, and disclosure requirements, etc.) from 10 or more non- Federal entities, including State and local governmental agencies, are subject to the conditions of the PRA. Under the PRA, a Federal agency sponsoring a standardized data collection or directly obtaining standardized or substantially similar information from ten or more persons or entities (other than Federal employees within the scope of their employment) in any 12-month period must obtain advance written approval from the Office of Management and Budget (OMB).” Regardless of form or format (oral, written, or electronically transmitted), responses of opinion or fact requested or required by or for CDC, except those specifically exempted or excluded, are subject to the provisions of the PRA and its implementing regulation, 5 CFR 1320 (Controlling Paperwork Burdens on the Public)

12.6. Rights in Data

Unless modified or otherwise specified authorized, and notwithstanding section I.3 FAR 52.216-18 Ordering (Oct 1995) in the basic contract and any modifications to the contract, the FAR…