Statement_of_Work_Kid_Risk_Inc_6-19-2015_-_Redacted.pdf

STATEMENT OF WORK

Title: Support of Decision Making for Global Switch from tOPV to bOPV using Integrated Modeling

Period of Performance: 12 Months from Date of Award

SECTION 1 – BACKGROUND

Polio is a crippling and potentially fatal infectious disease and is considered by the World Health Organization to be a Public Health Emergency of International Concern (PHEIC) with a target of eradication by 2015 and polio free certification date of 2018. There is no cure, but there are safe and effective vaccines. CDC Director Thomas Friedan, MD, MPH, has made polio eradication an agency-wide priority. CDC recognizes polio as a global public health emergency with the CDC Director the Emergency Operations Center having been activated for the last 32 months for global polio response activities.

The United States Congress has included a significant increase in polio funding for fiscal year 2014 onwards with a mandate to work with all government and non-government partners to eradicate polio. CDC is one of five partners working in the Global Polio Eradication Initiative (GPEI) providing technical and financial support to implement polio eradication activities. Given the World Health Assembly’s mandate to eradicate polio, CDC, as a Global Polio Eradication Initiative (GPEI) partner, is committed to eliminating all possible chains of transmission of polio virus, including those that begin with use of the oral polio vaccine (OPV). Without eliminating use of OPV, starting with withdrawal of the type 2 component of OPV from use globally, it will not be possible to sustain interruption of polio virus.

Trivalent OPV (tOPV), which contains attenuated types 1, 2, and 3 polio viruses, has played a key role in efforts to eradicate wild polio virus, leading to the likely eradication of type 2 wild polio virus in 1999 and type 3 wild polio virus in 2012. However, in rare cases tOPV’s attenuated polio virus strains, particularly the type 2 component, can mutate into circulating vaccine derived polioviruses and cause outbreaks of paralytic polio circulating vaccine derived polioviruses.

Withdrawal of tOPV from use, starting with its type 2 component, is essential for ultimately eradicating polio.

The Global Polio Eradication Initiative (GPEI) is currently planning a coordinated global switch from tOPV to a bivalent Oral Polio Vaccine which only contains attenuated types 1 and 3 polio viruses (bOPV). This switch is currently planned for April 2016. The switch will involve the synchronized replacement of tOPV with bOPV for routine immunization and polio vaccination campaigns in the more than 156 countries currently using OPV. If successful, the switch will eliminate the long-term risk from circulating vaccine derived type 2 polioviruses (cVDPV2s) derived from tOPV while minimizing the short-term risk cVDPV2 outbreaks as immunity to type 2 poliovirus begins to wane.

However, the switch involves trade-offs between multiple considerations, such as the desirability of stockpiling large amounts of tOPV in countries to avoid pre-switch shortages vs. the advantages of limiting the amount of tOPV in a country to minimize the likelihood that tOPV will be used post-switch and cause new outbreaks of cVDPV2 paralytic polio.

Given these trade-offs, and the difficulties of coordinating a synchronized switch across more than 156 countries, many of which have weak immunization systems, understanding how different decisions in planning and implementing the switch will affect the probability of post-switch polio outbreaks is essential. However, the relevant detailed analyses have not yet been performed. Since GPEI currently plans to provide detailed guidance on the switch over the next several months and to ask countries to have completed detailed national plans for the switch by September 2015, such analyses are needed as soon as possible.

SECTION 2 – PURPOSE

CDC and the contractor will work to quantitatively estimate the consequences of different problems in synchronizing and executing the global tOPV to bOPV switch to identify which components of the switch plan need to be prioritized and to inform responses to problems. These estimates will be shared with GPEI partners, including WHO, UNICEF, Rotary International, and the Bill and Melinda Gates Foundation, as well as national governments.

The project will provide estimates of the probabilities of WPV1 or cVDPV2 outbreaks following a number of scenarios, including:

- A population with a given level of immunity to type 2 polio and sanitation continues to use tOPV for various amounts of time after its neighbors have ceased using tOPV

- A population fails to vaccinate with either tOPV or bOPV for various amounts of time due to a stockout before or after its neighbors have switched to using bOPV

- After a period of variable length of no tOPV use, various amounts of tOPV are accidentally used among a population, taking into account the level of sanitation and the amount of immunity to type 2 poliovirus at the time of the switch

Estimates of the probabilities of WPV1 or cVDPV2 outbreaks associated with additional scenarios, including ones which involve responses to the problems examined in the initial scenarios, may need to be examined as well.

GPEI plans to ask countries to complete draft country switch plans by September 30, 2015, so the initial results of this project need to be completed by July-August 2015 in order to allow dissemination of the results in enough time to affect planning

SECTION 3 – SCOPE OF WORK

The contractor will provide all labor, materials, and equipment required to complete the tasks outlined below. The contractor may require travel or communications with CDC to obtain materials needed to complete the estimates relevant to planning the switch.

SECTION 4 – TASKS TO BE PERFORMED

1. Identify and define relevant scenarios involving problems of executing and synchronizing the global switch from trivalent to bivalent OPV which could increase the probabilities of WPV1 and cVDPV2 outbreaks after the switch o CDC staff will assist in identifying and defining those scenarios o Scenarios involving undetected cVDPV2s that are in existence prior to the switch will not be specifically addressed by this project given the prior work in this area. Only cVDPV2s that arise de novo as a result of problems with switch execution or synchronization need to be addressed o Scenario results may need to be directly comparable to results previously published in peer-reviewed journals on risks of cVDPV outbreaks following use of OPV for outbreak response in context of cessation of routine OPV use

2. Identify and define parameters and parameter values, including point estimates and ranges of values, to be included in the probability models of the likelihood of WPV1 and cVDPV2 outbreaks resulting from various problems in executing and synchronizing the switch o CDC staff may assist in identifying and defining model parameters o Relevant parameter values may be reused from previous polio-related modeling projects o As the tOPV to bOPV switch will occur in more than 156 countries, hypothetical or idealized countries or groups of countries may be modeled instead of actual countries

3. Calculate estimates of the risks of WPV1 or cVDPV2 outbreaks arising from problems executing or synchronizing the switch o Estimates should include multiple sensitivity analyses in which multiple variables are assessed.

Analyses should facilitate identification of the key variables affecting the probability of post-switch WPV1 or de novo cVDPV2 outbreaks

4. Write preliminary report describing model results

5. Refine models based on feedback on preliminary results, methods of improvement identified by contractor during generation of initial results

6. Investigate up to three additional scenarios of importance identified during the course of the project o Additional scenarios may be identified by contractor or CDC staff and may be in response to developments in the GPEI

7. Write article(s) describing models and results for publication in peer-reviewed literature. Results may need to be directly comparable to results previously published in peer-reviewed journals on risks of cVDPV outbreaks following use of OPV for outbreak response in context of cessation of routine OPV use

8. Provide monthly progress reports of no more than three pages due by day 10 of the following month, detailing current status of individual project activities. The report shall contain information about the progress toward activities, goals and objectives and any obstacles or issues that must be addressed so that work proceeds on schedule. The contractor must bring any delays in schedule to the Project Officer’s attention within two days and not rely on routine communication, e.g., bi-weekly calls and monthly reports. The monthly progress report shall include a spreadsheet that includes: the date; invoice, contract, and task order numbers; title of the task or sub-task; description of the task; starting date; completion date; cumulative funds expended and balance; and appropriate comments or notes. This spreadsheet is also referred to as the Budget Tracker.

o Submission of individual monthly progress reports may be waived at the discretion of the Project Officer.

9. Throughout the duration of the project, the contractor shall conduct bi-weekly calls of up to 60 minutes with CDC staff to discuss progress and any challenges that may delay deliverables and seek feedback about the activities.

o Bi-weekly calls may be cancelled or rescheduled with the agreement of both the contractor and the Project Officer.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

Not Applicable

SECTION 6 – PERIOD OF PERFORMANCE

12 Months from Date of Award

SECTION 7 – PLACE OF PERFORMANCE

The contract will be performed at the contractor’s facility.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

Items Description Qty/No.

of Copies Delivery Date Deliver To

Initial plan of work Contractor’s description of how it plans to proceed with project

1 Two weeks after Date of Award

CDC Project Officer

Description of scenarios to be modeled

Contractor’s description of the scenarios to be modeled, reflecting input from CDC staff

1 Three weeks after Date of Award

CDC Project Officer

Parameters and parameter values for models

Contractor’s assessment of the relevant parameters for each model and the values to be used for those parameters

1 Five weeks after Date of Award

CDC Project Officer

Preliminary estimates from models

Contractor’s results from models, reflecting input from CDC staff

1 Six weeks after Date of Award

CDC Project Officer

Preliminary report on initial scenarios

Contractor’s preliminary report on results from models of initial scenarios

1 Two months after Date of Award

CDC Project Officer

Final report on initial scenarios

Contractor’s final report on results from models of initial scenarios

1 Five months after Date of Award

CDC Project Officer

Additional model results

Analyses on up to three additional scenarios as required

Up to 3 As needed through 12 months after Date of Award

CDC Project Officer

Scientific manuscript(s)

Report on results for publication in peer-reviewed journal

At least 1 12 months after Date of Award, may be completed earlier

CDC Project Officer

Monthly progress report

Report on progress and challenges with project tasks.

At least 1 every month unless waived by Project Officer

Within 10 days of end of previous month

CDC Project Officer

Conference call Discussion of project tasks, progress, and challenges

At least 1 every 2 weeks unless cancelled or rescheduled by Project Officer

Bi-weekly, to begin within 2 weeks of Date of Award

CDC Project Officer

SECTION 9 – TRAVEL

Travel by the contractor may be necessary to prevent results of analyses to CDC staff or to GPEI partners. All travel will be in accordance with the Federal Travel Regulations. The travel CLIN will be cost reimbursable.

SECTION 10 – SPECIAL REQUIREMENTS

Record System number: 09-20-0136, 09-20-0161, GSA/GOVT-4

Remarks: The Privacy act may be applicable under SORN 09-20-0136, to protect any personally identifiable information and medical records of any U.S. citizens that the contractor will have access to during the performance of task order requirements. The Privacy Act may be applicable under SORN 09-20-0161, Records of Health Professionals in Disease Prevention and Control Training Program to protect any personally identifiable information collected on any U.S. citizen training program participants. The Privacy Act may be applicable under GSA?GOVT-4, to protect any personally identifiable information collected related to government-sponsored travel activities. Under CFR 352.224-70, the Contractor must protect the confidentiality of proprietary, sensitive, and Personally Identifiable Information (PII) information of U.S. citizens that the contractor may come in contact with during the performance of the task order requirement.

Along with CDC’s other standard commercial clauses, the following special clauses will be applicable to this purchase order and the full text of which may be accessed electronically at this/these address (es):

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm http://www.hhs.gov/policies/hhsar/subpart301-1.html http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm http://www.hhs.gov/policies/hhsar/subpart301-1.html

NOTE: After selecting the appropriate regulation above, at the “table of Contents” page, conduct a search for the desired regulation reference using your browser’s FIND function. When located, click on the regulation reference

(hyperlink).

FAR 52.224-1 - Privacy Act Notification (Apr 1984)

FAR 52.224-2 - Privacy Act (Apr 1984)

HHSAR 352.239-70 - Standard for Security Configurations (Jan 2010)

HHSAR 352.239-71 - Standard for Encryption Language (Jan 2010)

HHSAR 352.239-72 - Security Requirements for Federal Information Technology Resources (Jan 2010)

SECTION 11 – REFERENCE MATERIALS

Section 508 of the Rehabilitation Act (29 USC 794d). Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. All final deliverables must comply with applicable Section 508 accessibility standards, and CDC reserves the right to reject deliverables that fail to meet the standards. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW or PWS, shall be the responsibility of the contractor or consultant retained to produce the Web- suitable content or communications material. Regardless of format, all electronic documents must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities.

The following Section 508 provisions apply to the content or communications material identified in this SOW or PWS:

36 CFR 1194.22, .31, and .41

Documents must be in unlocked form. Acceptance checklists for various file formats are available at http://www.hhs.gov/web/508/index.html

SECTION 12 – PROJECT OFFICER INFORMATION

The Project Officer for this procurement is:

Edgar E Garcia Centers for Disease Control and Prevention Global Immunization Division 1600 Clifton Rd NE, Mail Stop MS A-04 Atlanta, Georgia 30329

Telephone Number: 404-639-1927 Fax Number: 404.248.4295 E-mail Address: GVR8@CDC.GOV

Preferred method of communication: E-mail

SECTION 13 – MILESTONE PAYMENT SCHEDULE FOR PERFORMANCE-BASED PAYMENTS. In accordance with FAR 52.232.32, Performance Based Payments (April 2012), upon successful completion of an event, the Contractor may request performance-based payments. The determination of eligibility for receipt of payment will be made by the Contracting Officer upon written certification from the Project Officer that the performance milestone has been met. It is anticipated that each milestone payment will approximate the estimated timeline listed below but variation is anticipated and eligibility for payment could occur sooner or later depending upon the time of completion of the designated milestone. Milestone payments are subject to the terms of FAR 52.232-32.

The contractor is invited to propose a Milestone Payment Schedule for this contract along with its proposed payment percentage allocations for each scheduled payment below based upon offeror’s total proposed price. As part of the negotiated process, CDC may provide a different Milestone Schedule and payment percentages. The final Milestone Payment Schedule will be negotiated between the parties and included in the contract award. If the parties do not agree http://www.hhs.gov/web/508/index.html to a Milestone Payment Schedule, then the purchase order will be priced as “One Job” and the order payable upon the completion of all work described in the Statement of Work.

MILESTONE EVENT ESTIMATED TIMELINE PAYMENT %*

[Insert Milestone Event] [Insert Estimated Timeline for Completion – Upon

[Insert Milestone Event]

[Insert Milestone Event]

[Insert Milestone Event]

[Insert Milestone Event]

[Insert Milestone Event]

[Insert Milestone Event]

[Insert Milestone Event]

[The FAR requires that the Government hold back 10% of the price of the award for the final invoice. This percentage can be aligned to the final task, deliverable or performance period or simply be a hold back.]

On or before the end of the performance period

10%

Total 100%

*Milestone event payments may be allocated on a monthly or other periodic basis as long as a completed task, event or deliverable is associated with that payment (i.e., monthly report, monthly data pull, etc.). Payments will not be made on the sole basis of the passage of time.