CISAAttachment J.2 5_24_2012.docx

ATTACHMENT J.2

PERFORMANCE WORK STATEMENT

CISA SAMPLE TASK ORDER # 2

Subject to FAR 52.232-18 Availability of Funds

Title of Project: CISA Clinical Vaccine Safety Evaluation - Contributing 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. Task Order 2 describes the functions for the Contributing Contractor(s).

The Contributing Contractor will be a part of the Clinical Vaccine Safety Evaluation Activity. The Role of the Lead Contractor is described in Sample Task 1, in detail. In brief, the Lead Contractor will coordinate the Clinical Vaccine Safety Evaluation Activity. CDC will assign case reviews to the Lead Contractor. The Lead Contractor will lead the scientific and public health activities for the clinical case reviews regarding vaccine safety. CDC may at its option, request the Contributing Contractor to participate, but not lead, the clinical case reviews. CDC will assign vaccine safety issue to the Contributing Contractor and request their assessment. CDC may at its option request the Contributing Contractor to lead or assist with the issues assessment.

The Clinical Vaccine Safety Evaluation functions will usually be conducted through two Working Groups (WGs). We describe below the scope of work of Task Order 2 for the Contributing Contractor’s 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 Contributing 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 (AEFI).

7. Scope Based on technical guidance from CDC, the Contractor will conduct the Clinical Vaccine Safety Evaluation Activity work through two Working Groups (described below) and individual expert review. CDC will determine which cases or topics should be addressed in each Working Groups; some topics could be applicable to both Working Groups.

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. CDC may request that the Contractor also participate in any WG-1 discussions. In addition, these WG calls may be attended by the other 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 contribute to development of summaries of cases that are reviewed. Input from WG-1 will be used to help produce a summary of each case reviewed. Input from WG-1 will also be used to help produce an annual report summarizing all the cases and any lessons learned. The Contractor will contribute to develop of these reports. In addition, under the technical 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 Immunization Safety Office and the Lead Contractor’s Principal Investigator. CDC may also request that the Contractor participate in any WG-2 discussions. In addition, these calls may be attended by other CDC staff, and other subject matter experts. While WG-1 focus 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 or review current studies or other scientific projects. It may also 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 produce project reports to CDC for issues that are assessed.

Clinical Vaccine Safety Evaluation Contributing Contractor Functions With technical direction from CDC and in collaboration with the Lead Contractor, the Contractor shall perform the clinical evaluation activities described below, in the technical requirements section.

Clinical Case Evaluation (WG-1) The Contractor will participate and contribute their expertise for the scientific reviews of clinical cases. CDC will specify which cases should be reviewed with the Contractor.

Vaccine Safety Issues Evaluation (WG- 2) The Contractor will lead or contribute to assessments of vaccine safety issues. CDC will make assignments to the Contractor and will designate if the Contractor should lead or contribute to these assessments by providing their expertise.

8. Technical Requirements The Contractor, with technical direction from CDC and in collaboration with the Lead Contractor, shall accomplish the following:

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

a. CDC may, at its option, request the Contractor to contribute to a case evaluation.

b. The Contractor shall usually participate and provide their expertise for the scientific review of the clinical AEFI cases during the WG-1. There will be approximately one WG-1 call per week.

c. The Contractor shall submit any relevant discussion materials to the CISA internal website or another specified venue.

d. CDC may, at its option, request that the Contractor review summary case assessments or letters about the clinical case evaluation.

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

a. CDC will make assignments to the Contractor or other parties to lead the assessment of specific vaccine safety issues. If the Contractor receives the assignment, they shall be involved in leading the technical evaluation of the vaccine issue, and not be involved in arranging the logistics for the working group conference call.

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

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

ii. If requested, the Contractor shall present the issue on the working group call. The WG will be used to help further assess the vaccine safety issue in some, but not all, situations. The Contractor shall state the results of the assessment and conclusions for the topic assigned. The Contractor will 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.

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

v. The Contractor may develop manuscripts about the vaccine safety issues reviewed, under the technical guidance of CDC.

3. Clinical Vaccine Safety Evaluation - Adjunct Activities

a. The Contractor shall participate, as coordinated by the Lead Contractor, in the development of an Emergency Response 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.

b. The Contractor shall provide the appropriate facilities and other equipment for conducting the Task Order. This includes the appropriate office facilities, record keeping, computer hardware and software, communication, and conferencing equipment.

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 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, and other costs – for the present reporting period and year to date.

Annual Reports 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. 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 instructions for all technical documents (including, case summaries) in possession of the Contractor at Task Order completion.

10 Travel With concurrence from CDC, the Contractor may travel to an academic meeting within 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 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/early/2011/04/18/peds.2010-1722M.abstract, 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 4Rowhani-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 contract, the Contractor shall deliver to the CDC CISA COR

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) The Offeror shall describe their general strategy for providing guidance for cases discussed during the Clinical Case Evaluation WG-1. Assume during a WG call the following inquiry from a practicing clinician was reviewed: Can my patient with asthma who is receiving steroids, safely receive a live vaccine? Briefly explain how you would contribute to WG discussions and what additional information you would seek.

b. Clinical Vaccine Safety Issues Evaluation (WG-2) CDC will assign various issues to the Clinical Vaccine Safety Issues Evaluation WG-2). The Offeror shall state their general approach for evaluating and synthesizing the following issue: Can persons who were diagnosed with Guillain–Barré syndrome (GBS), either following or not following vaccination, safely receive future vaccines.