CISAAttachment J.1 5_24_2012.docx

ATTACHMENT J.1

PERFORMANCE WORK STATEMENT

CISA SAMPLE TASK ORDER # 1

Subject to FAR 52.232-18 Availability of Funds

Title of Project: CISA Clinical Vaccine Safety Evaluation - Lead Contractor Functions

1. Applicability This effort is within the scope of the basic contract discussed in Requirement 1 section C.4.1 of the basic Performance Work Statement (PWS)

2. Order Type The Task Order shall be Cost-Plus-Fixed-Fee.

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

Base contract year: 9/20/2012-9/19/2013 Option year 1: 09/20/2013-9/19/2014 Option year 2: 09/20/2014-09/19/2015 Option year 3: 09/20/2015-09/19/2016 Option year 4: 09/20/2016-09/19/2017

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

5. Background and Need CDC seeks to develop the CISA Clinical Vaccine Safety Evaluation activity. This public health activity will serve as a vaccine safety resource for consultations and assist CDC in developing vaccine safety strategies. This activity will consist of: 1) a Lead Clinical Vaccine Safety Contractor (referred to as the ‘Lead Contractor’); 2) one or more Contributing Clinical Vaccine Safety Evaluation Contractor(s) (referred to as the ‘Contributing Contractor’). Task Order 1 describes the functions that the Lead Contractor shall conduct for the Clinical Vaccine Safety Evaluation activity. A separate Task Order 2 describes the functions for the Contributing Contractor. The Lead Contractor will work under the technical direction of CDC and CDC will make assignments. The Lead Contractor will coordinate and provide administrative support for the CISA Clinical Vaccine Safety Evaluation activity. The Lead Contractor will lead the scientific and public health activities for the clinical case reviews regarding vaccine safety. The Contributing Contractor may participate in, but may not lead, the clinical case reviews. The Lead Contractor will also provide assessments to CDC about specific vaccine safety issues.

The Clinical Vaccine Safety Evaluation functions will usually be conducted through two Working Groups (WGs). We describe below the scope of work of Task 1 for the Lead Contractor’s Coordination functions. We also specify the activities conducted through the Clinical Case Evaluation Working Group (WG-1) and Vaccine Safety Issues Evaluation Working Group (WG-2). (For the remainder of this Task Order the term ‘Contractor’ refers to the Lead Contractor).

6. Objective

CDC seeks to implement the CISA Clinical Vaccine Safety Evaluation activity. This activity covers two CISA goals: 1) To serve as a vaccine safety resource for consultation on clinical vaccine safety issues, including individual case reviews, and assist with immunization decision -making and, 2) To assist CDC in developing strategies to assess individuals who may be at increased risk for adverse events following immunization.

7. Scope

Based on technical guidance from CDC, the Contractor shall conduct the Clinical Vaccine Safety Evaluation activity work. CDC may request that the Contractor conduct this work on its own. CDC, at its option, may also request that this work be conducted through two Working Groups (described below). CDC will determine which cases or topics should be addressed in each Working Group; some topics could be applicable to both Working Groups. The Contractor shall coordinate and provide administrative support to the Clinical Vaccine Safety Evaluation activity.

The two Working Groups are:

· Clinical Case Evaluation Working Group (WG-1): WG-1 will conduct in-depth case reviews for AEFI to assist CDC. WG-1 will be compromised of at least one staff from the CDC’s Immunization Safety Office and the Lead Contractor’s Principal Investigator. These WG calls may also be attended by the other CISA Contractors, CDC staff, the patient’s healthcare provider, and other subject matter experts. Cases will come in from a variety of sources, including the CDC vaccine safety inquiry lines and health departments.1 The following are examples of inquiries from clinicians that the Contractor would be expected to address: Did this vaccine cause an adverse reaction in my patient?; Can I safely revaccinate my patient if I believe an earlier vaccine in the series caused an adverse reaction?; or Can my patient with an immunocompromising disorder, safely receive a vaccine? Cases will require expertise from a variety of medical disciplines, including, pediatrics, adult medicine, allergy, neurology, infectious diseases and obstetrics and gynecology. Advice from CDC and CISA is meant to assist in decision-making, rather than provide direct patient management. Patient management decisions are the responsibility of the treating healthcare provider. In addition, WG-1 should be readily available to provide expert opinion for ongoing vaccine safety clinical case reviews, within CDC. For example, WG-1 may conduct case reviews to assist the government with surveillance for AEFIs, by reviewing a striking case report of a novel AEFI reported to the Vaccine Adverse Event Reporting System (VAERS)2. The Contractor will utilize input from WG-1 to help produce a summary of each case reviewed. The Contractor will also consider input from WG-1 to produce an annual report summarizing all the cases and any lessons learned. In addition, under the direction of CDC manuscripts or scientific reports of cases may be developed.

· Vaccine Safety Issues Evaluation Working Group (WG-2): WG-2 will evaluate and synthesize vaccine safety issues. WG-2 will be compromised of at least one staff from the CDC’s Immunization Safety Office and the Lead Contractor’s Principal Investigator. These calls may also be attended by the other CISA Contractors, CDC staff, and other subject matter experts. While WG-1 focuses on vaccine safety clinical case reviews, WG-2 will focus on vaccine safety issues. The following are examples of emerging or important vaccine safety issues, which WG-2 may evaluate: 1. ACIP deliberations regarding administering influenza vaccines to individuals with egg allergy3; 2. an assessment of risk intervals to assess febrile seizure following immunization with influenza and pneumococcal conjugate vaccines4. In addition, WG-2 can be used as a forum to gather input on hypotheses for studies and review current studies or other scientific projects. It may be used to develop a broader understanding of vaccine safety, and to help translate findings into public health practice or policy. The Contractor will use input from WG-2 to help develop reports on issues that are assessed.

Clinical Vaccine Safety Evaluation Coordination Functions

The Contractor shall provide coordination, logistical, and administrative support for the Clinical Evaluation activities. The Contractor shall coordinate logistics for both Clinical Vaccine Safety Evaluation Working Groups. Activities include the development of a Working Plan, organizing phone conferences, summarizing minutes, and cost activity reporting.

The Contractor shall provide clinical experts in various disciplines who can participate in the review and synthesis of vaccine safety cases and issues in the clinical working groups. In addition to knowledge of vaccine safety, the areas of expertise may include pediatrics, internal medicine, allergy, neurology, infectious diseases, and obstetrics and gynecology.

The Contractor shall also conduct clinical evaluation adjunct activities to support the Clinical Vaccine Safety Evaluation function, namely: 1. Develop an Emergency Response Plan for enhancing the Clinical Vaccine Safety Evaluation activities in the event of an emergency or urgent public health incident. 2. Assist CDC and health care providers to collect and transport biological specimens obtained from a limited number of individuals, reviewed by the Contractor, to a centralized specimen repository or other laboratory. 3. 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.

Clinical Case Evaluation (WG-1) The Contractor will lead the scientific and public health activities for the clinical case reviews, in addition to coordinating the logistics for these activities. At its option, CDC may request that this function be carried out through the Clinical Case Evaluation Working Group (WG-1). In addition to their logistical functions described above, the Contractor shall prepare and present cases on the working group call, facilitate discussion, and provide their assessment. This working group call will be scheduled to take place once per week.

Vaccine Safety Issues Evaluation (WG- 2)

For any issue assigned, the Contractor shall conduct work to assess the issue and provide results of this assessment to CDC. At its option, CDC may request that this function be carried out through the Vaccine Safety Issues Evaluation Working Group (WG-2). When the Contractor is assigned to lead an issue discussion for WG-2, the Contractor shall conduct work to investigate the issue and present it on the working group call. The WG-2 call will be scheduled approximately once per month. CDC may also assign other parties to lead an issues assessment. In these situations, the Contractor will still organize logistics of WG-2, such as arranging the phone conference and drafting minutes; the Contractor shall also participate in the scientific discussions and provide expert input.

8. Technical Requirements The Contractor, with technical direction from CDC, shall accomplish the following tasks:

8.1. Clinical Case Evaluation Working Group (WG-1)

a. CDC will assign vaccines safety clinical cases. The Contractor shall evaluate vaccine safety cases from general adult and pediatric medicine, as well as a wide range of specialty areas, such as allergy, neurology, infectious diseases, immunology, and obstetrics and gynecology.

b. The Contractor shall follow the CDC’s Clinical Case Evaluation Draft Working Plan (see appendix 1). This working plan may be subject to change.

c. When requested by CDC, the Contractor shall organize a Clinical Case Evaluation working group conference call and will lead and coordinate case presentations in the working group call or similar venue. WG-1 will be compromised of at least one staff from the CDC Immunization Safety office and the Lead Contractor’s Principal Investigator. These WG calls may also be attended by the other CISA Contractors, CDC staff, the patient’s healthcare provider, and other subject matter experts. CDC may also request the Contractor to review a clinical case on its own.

d. The Contractor is expected to lead and coordinate up to 144 clinical case reviews per year. This may be up to about 12 cases per month, or may be less. Because a larger volume of inquiries usually are received during the influenza season, the case volume may be higher in the fall and winter months.

e. CDC will determine if assigned cases necessitate an urgent or routine evaluation. The Contractor shall evaluate the urgent cases rapidly within 3 working days and evaluate the routine cases within approximately one month

f. Following receipt of an assignment, there are three stages to a clinical case review: 1.Preparation, 2. Presentation and discussion during working group (WG-1), 3. Assessment and Communication. The Contractor will be responsible for leading this process. When CDC requests the Contractor to review the case on its own, stage 2 is not needed.

g. Preparation: The Contractor shall prepare the case for assessment and possible discussion. The Lead Contractor shall obtain additional information and background prior to the case assessment and presentation, and gain subject matter expertise, as needed.

h. Presentation: The Contractor will, when requested by CDC, present the case on the Clinical Case Evaluation Working Group Call. The Contractor will gather input through this call to help formulate the final assessment.

i. Assessment and Communication: The Contractor will provide an assessment of the case, and shall communicate the results of the case reviews. The specific communication strategy may vary. When requested by CDC, the Contractor will produce a summary of the key findings in a letter. CDC may request use of a standard letter template. CDC may also, at its option, review the case assessment letter and may determine if this letter is sent to the requesting healthcare provider or other party.

j. When applicable, communication with healthcare providers or public health professionals should indicate whether the advice is based on official CDC Policy (e.g., recommendations from the Advisory Committee on Immunization Practices (ACIP)) or expert opinion from the Contractor. The communication should also state the limitations of the case review, such as all medical records might not have been available. The communication should also reiterate that advice from CDC and CISA is meant to assist in decision-making, rather than provide direct patient management. Patient management decisions are the responsibility of the treating healthcare provider.

k. The Contractor shall seek follow-up information on the outcomes of patients who were the subject of case reviews. In particular, the Contactor shall track outcomes after revaccination in persons who had safety concerns.

l. The Contractor shall provide the working group meeting minutes for the cases, which they clinically reviewed or coordinated.

m. The Contractor will assist CDC in obtaining follow-up information on relevant cases and facilitate reporting to VAERS.

n. The Contractor may develop manuscripts from the Clinical Case Evaluation Working Group reviews, under the technical direction of CDC.

8.2. Vaccine Safety Issues Evaluation Working Group (WG-2)

a. The Contractor shall coordinate the Vaccine Safety Issues Evaluation Working Group (WG-2). These calls may be attended by the other CISA Contractors, CDC staff, and other subject matter experts.

b. CDC will make the issue assignments for this working group to any of the CISA Contractors or other parties. In addition, CDC may lead an issues assignment. If another party receives the issue assignment or CDC leads an issues assessment, the Contractor shall still organize and provide the logistics for the working group, such as arranging the conference call, obtaining any subject matter experts, producing meeting minutes, and the interim and annual reports. The Contractor shall also attend the working group discussion and provide their expert opinion.

c. If the Contractor receives the assignment to lead a vaccine safety issue assessment, they shall do following:

i. The Contractor shall obtain additional information and background on the issue, and subject matter expertise, as needed. Assessment may involve reviewing the literature and reports to VAERS, and having discussions with experts.

ii. If requested, the Contractor shall present the issue on the working group call. The WG call will be used to help further assess the vaccine safety issue in some but not all situations and the Contractor shall state the results of the assessment and conclusions for the topic assigned. The Contractor shall also produce meeting minutes for the call, and provide a Project Report on the vaccine safety issue to CDC, for each issue reviewed.

iii. The Contractor may also be requested by CDC to assess a vaccine safety issue on its own, in which case the working group call and meeting minutes would not be needed.

iv. The Contractor shall provide the necessary subject matter experts for reviewing assigned vaccine safety issues.

v. The Contractor may develop manuscripts from the Vaccine Safety Issues Working Group reviews, under the technical guidance of CDC.

8.3. Clinical Vaccine Safety Evaluation – Coordination Functions Based on technical input from CDC, the Contractor shall coordinate the following activities to support the Clinical Vaccine Safety Evaluation function.

a. Clinical Vaccine Safety Evaluation – Working Group Support Activities

i. CDC has developed a Clinical Case Evaluation Working Plan (see appendix 1). The Contractor will implement this Working Plan. The Contractor shall maintain this plan on file. The Contractor will submit to CDC any modifications to this Working Plan, based on approval with CDC. CDC may also make changes to the Working Plan.

ii. The Contractor shall organize the Working Groups logistics, including the phone conference, meeting minutes, and subject matter expert invitations. The Contractor, under technical input from CDC, will also determine the Clinical Case Evaluation WG-1 frequency and if certain working groups calls should be focused on specific clinical issues (such as neurology or allergy).

iii. The Contractor shall obtain additional medical records for the WG reviews. If a case is from VAERS, CDC and Contractor may coordinate on an approach for obtaining records from CDC’s VAERS database, using the VAERS VPN or other methods (refer to basic PWS VAERS section C.9.1). In addition, the contractor may coordinate with CDC to avoid duplication with records collection effort.

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

b. Clinical Case Evaluation Tracking Activity

i. The Contractor shall develop and maintain database to track the Clinical Case Evaluations. This database should be searchable and include key information on demographics, nature of the case, outcomes, and follow up information. This database help evaluate other similar cases and to compile the annual report of case reviews. This system would be subject to federal and institutional policies and Federal Information Security Management Act (FISMA) requirements to protect data and privacy (refer to HHS Acquisition Regulation (HHSAR) clauses 352.239-70, 352.239-71, 352.239-72 (section H) and the addendums to 352.239-72 in the Information Security and Confidentiality section C.9.6 of the Basic Performance Work Statement). If the Contractor assisted CDC to collect bio- specimens, this information should be entered in the database.

c. Clinical Vaccine Safety Evaluation - Website Development

i. The Contractor shall establish and maintain a secure password protected CISA website to host a variety of CISA activities. These include non-patient personal identifiers materials such as, conference call materials, research protocols and manuscripts and other relevant documents.

ii. The Contractor shall, as needed, submit non-patient identified information to this internal website site.

d. Clinical Vaccine Safety Evaluation - Adjunct Activities With technical guidance from CDC, the Contractor will lead or coordinate the following clinical adjunct activities

i. The Contractor shall develop a CISA Emergency Preparedness plan, which will outline activities, at the direction of the Government, to rapidly support enhanced vaccine safety clinical case reviews and synthesis in the case of an urgent public health incident or emergency situation. CDC will review and approve this plan. (In the event of an emergency, Task Orders may be issued by the Government for the execution of this plan).

ii. When indicated through technical guidance from CDC the Contractor shall assist CDC or providers to collect and send a limited number of biological specimens from individuals with AEFIs evaluated during the case reviews discussed in the WG, to a centralized specimen repository or other laboratory. For example, the Contractor may facilitate sending a cerebrospinal fluid (CSF) specimen for varicella vaccine virus for further testing and track this information in a database. The contractor shall also advise CDC on appropriate specimens that would be useful in evaluating AEFIs, based on their clinical expertise.

iii. The Contractor shall, under technical guidance from CDC, identify and contact a limited number of individuals with AEFIs who were identified through VAERS or other sources, to obtain consent and enroll them for participation in CDC supported studies. The Contractor may or may not be a co-investigator in these studies.

9. Reporting Schedule

Monthly Status Report The Contractor shall provide a Monthly Status Report, in accordance with this Task Order. The report shall include a summary of the Clinical Vaccine Safety Evaluation activities, program management, and financial activities. The Contractor shall electronically submit a copy of the monthly report to the Contracting Officer’s Representative (COR) and the Contracting Officer. The report shall be due the 15th day of each month following the month reported. In addition, the report shall describe and include:

1. The project’s schedule, milestones, and progress

2. Work accomplished in prior month; and work scheduled on tasks for the next month

3. Current and anticipated problems that will impact the Contractor’s performance.

4. Proposed solutions or lessons learned in response to current and anticipated problems

5. The person-hours, percentage of effort, personnel costs, costs for experts, and other costs – for the present reporting period and year to date.

Annual Report The Contractor shall provide a written report to the Government documenting significant work activities for the preceding 12-month period. The report should detail major accomplishments, ongoing activities, lessons learned and milestones not yet accomplished for the reporting period. A section of the annual report should include a Technical Case Evaluation review. This section shall describe cases described in WG-1, including key scientific themes, and lessons learned, and should be able to function as a standalone document. As an appendix to the annual report, the Contractor shall deliver to the Government, standard operating procedures, and any user manuals. The Contractor shall submit a draft annual report 3 months before the end of the contract period for CDC review and technical guidance. The final annual report shall be delivered no later than twenty (20) calendar days immediately following the specified reporting period.

Issues Project Report The Contractor shall provide a technical report for each vaccine safety issue that they evaluated in WG-2. 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 Interim or Annual reports.

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 Travel With concurrence from CDC, the Contractor may travel to an academic meeting in the United States to present an abstract related to this activity. The Contractor may also travel to a CDC meeting, such as a CISA annual meeting or an ACIP conference.

11 Training The Contractor may receive ad hoc training by CDC staff on how to use the VAERS VPN and search tools. The Contractor may also receive training identified by the CDC IT security staff.

12 Special Considerations

12.1. Vaccine Adverse Event Reporting System (VAERS)

The Special Consideration’s VAERS section C.9.1 of the Basic PWS applies to this Task Order.

12.2. CDC Scientific Review and Clearance

The Special Consideration’s CDC Scientific Review and Clearance section C.9.3 of the Basic PWS applies to this Task Order.

12.3 Assurance of Confidentiality 308(d)

The Special Consideration’s Assurance of Confidentiality 308(d) C.9.4 of the Basic PWS applies to this Task Order.

12.4. Rehabilitation Act

The Special Consideration’s Rehabilitation section Act C.9.5 of the Basic PWS applies to this Task Order.

12.5. Information Security and Confidentiality

The HHS Acquisition Regulation (HHSAR) clauses 352.239-70, 352.239-71, 352.239-72, in section H, and the addendums to 352.239-72 in the Information Security and Confidentiality section C.9.6 of the Basic Performance Work Statement apply to this Task Order.

13 Government Furnished Property / Information The Government considers that Government owned properties need to be planned and handed back to Government, at the end of the contract period.

1. The VAERS VPN access and CDC’s internal VAERS search tool shall be returned to the Government at the Government’s discretion or at the end of the contract period. Any VAERS records including reports should be disposed of in an agreed manner or send back to Government.

14. References Miller, E, Batten B, Hampton L, Tracking Vaccine Safety Inquiries to Detect Signals and Monitor Public Concerns. Pediatrics;2011;127;S1, originally published April 18, 2011, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S87.full, accessed on February 29, 2012 2 HHS, Vaccine Adverse Event Reporting System, available at http://vaers.hhs.gov/index, accessed on October 16, 2011.

3 CDC. Influenza Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2011. Morbidity and Mortality Weekly Report (MMWR). August 26, 2011 / 60(33);1128-1132, available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6033a3.htm, accessed on February 29, 2012 4 Rowhani-Rahbar, A. et al. Biologically Plausible Risk Intervals to Assess Febrile Seizure Following Immunization with Influenza and Pneumococcal Conjugate Vaccines. Oral Presentation at the 27th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, August 17th, 201, available at https://www.pharmacoepi.org/meetings/27thconf/presentations/Biologically%20Plausible%20Risk%20Intervals%20To%20Assess%20Febrile%20Seizure%20Following%20Immunization%20with%20Influenza%20and%20Pneumococcal%20Conjugate%20Vaccines.pdf, accessed on February 29, 2012

15. Deliverables During the performance of this Task Order, the Contractor shall deliver to the CDC COR the Deliverables below.

Clinical Vaccine Safety Evaluation Technical and Support Functions

Within 1 month of award

Presentation, and when indicated during a 6 to 12 month follow up period

Within 3 months of award

Clinical Evaluation Adjunct Functions

E: Electronic COR: Contracting Officer’s Representative CO: Contracting Officer

16. SPECIFIC TASK ORDER INSTRUCTIONS (to be included as part of technical proposal response in Volume 2) In preparing the technical response portion of the Task Order proposal, the Offeror shall provide narrative and other information that is considered relevant to the work required to provide the services identified in the Task Order. The Offeror should respond to the areas listed below:

a. Clinical Case Evaluation (WG-1)

i. Using the basic Working Plan below in Appendix 1, state how you will response to the following inquiry:

A 13-month old girl was given trivalent inactivated influenza (TIV) vaccine. Per the patient’s mother, about 8 hours later the child became limp, eyes rolled back, drooled and was unresponsive; this lasted about one minute. The child was taken to the Emergency Department and on physical exam she was slightly drowsy, the temperature of 104ºF, and the pulse was 140. She was observed for 24 hours, was afebrile and had no seizure activity.

The physician wishes to know if the influenza vaccine was responsible for the adverse event and if the child should receive influenza vaccines in the future.

1. State how you will prepare the case for presentation on the Clinical Case Evaluation working group (WG-1). Describe any specific subject matter experts you would seek to involve in the working group call.

2. Describe a template outlining how you will present the case in the working group call.

3. Describe an outline of the letter that you would use, upon CDC’s request, to communicate the case review assessment to the requesting physician.

4. Describe the advice you would give to the address the physician’s inquiry

ii. The Offeror shall describe their plan for responding to a vaccine safety inquiry involving a specialized area of medicine in which the Principal Investigator does not have expertise.

b. Clinical Vaccine Safety Issues Evaluation (WG-2) CDC will assign various issues to the Clinical Vaccine Safety Issues Evaluation Working Group. The Offeror shall state their general approach for evaluating and synthesizing the following issue:

A recent study in Europe found an association of narcolepsy with a particular brand of oil-in-water emulsion adjuvanted 2009 monovalent H1N1 influenza vaccine.

The Offeror shall state an evidence-based approach for how they would assist CDC to evaluate available data from relevant sources, generate hypotheses for why this study is observing the increased risk and, and assess the biological plausibility for why an oil-in-water emulsion adjuvanted inactivated influenza vaccine and vaccines in general might increase a person’s risk for developing narcolepsy.

c. The Offeror shall describe any performance measures they will use to monitor performance, any management tools they will use, how they will ensure quality products are delivered, how they will mitigate risk. This includes describing any problems likely to occur, and plans for addressing them.

d. The Offeror shall describe the approach they would take to provide clinical experts in various disciplines to participate in the clinical working groups. This narrative should specifically describe how expertise in the following disciplines will be routinely covered: pediatrics, internal medicine, infectious diseases, neurology, allergy, and obstetrics and gynecology. In addition, the Offeror should explain how they would identify experts in other disciplines to address a wide variety of clinical cases, such as experts in inborn errors of metabolism, sleep disorders, ophthalmology, or immunology.

Appendix 1 CISA Clinical Case Evaluation Working Group - Draft Working Plan This working plan describes draft roles for three participants in the Clinical Case Evaluation function: CDC, the Lead Contractor (Task Order 1), and the Contributing Contractor(s) (Task Order 2). This draft working plan may be subject to change:

· CDC will assign vaccines safety clinical cases to the Lead Clinical Vaccine Safety Evaluation Contractor (referred to as the ‘Lead Contractor’) in the Clinical Immunization Safety Assessment (CISA) Project. These cases may include inquiries received by CDC from a variety of requestors, including physicians, health departments, and Government staff. CDC may also assign a VAERS report of interest for review.

· CDC will determine if certain cases necessitate an urgent or routine evaluation. The Lead Contractor shall evaluate the urgent cases rapidly within 3 working days and evaluate the routine cases within approximately one month. CDC will designate if the case should be reviewed via a Working Group venue.

· Following receipt of an assignment, there are three stages to a clinical case review: 1.Preparation, 2. Presentation and discussion during working group (WG-1) 3. Assessment and Communication. The Lead Contractor will be responsible for heading this process.

· Preparation: The Lead Contractor shall prepare the case for assessment and discussion. This preparation may include obtaining subject matter expertise, conducting literature reviews, and contacting the referring physician. The Lead Contractor may also conduct a VAERS case review to search for similar cases (see VAERS section in the PWS).

· The case will be prepared using a format that address pertinent issues for work group discussion.

· Presentation: The Lead Contractor will present the case on the Clinical Case Evaluation Working Group Call. The Vaccine Safety Evaluation Contributing Contractor will attend most of the WG-1 discussions and offer their expertise.

· Assessment and Communication: The Lead Contractor will provide an assessment of the case, and will produce a summary of the key findings in a letter. CDC may at its option, review this letter and may determine if the letter is sent to the requesting healthcare provider or other party. The Lead Contractor will ensure that a VAERS report is filed on all cases reviews, when feasible, and any medical records they were able to obtain are sent to CDC or an alternate address provided by CDC.

· The Lead Contractor will follow up on the case with the referring physician, such as to assess if the issue is resolved or for revaccination issues. The timing for follow-up will be based on clinical judgment and feasibility.

· The Contractor will assist CDC and health care providers to collect and transport a limited number of biological specimens obtained from individuals discussed in the working groups, to a centralized specimen repository or other laboratory.