SNOTE | B | Justifiication for Other ull and Open Competition

FBO DAILY ISSUE OF OCTOBER 06, 2009 FBO #2873
SPECIAL NOTICE

B -- Justifiication for Other ull and Open Competition

Notice Date: 10/4/2009
Notice Type: Special Notice
NAICS: 541618 — Other Management Consulting Services
Contracting Office: Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
ZIP Code: 30341-4146
Solicitation Number: 200-2002-00732
Point of Contact: Cherie J. Katin,
E-Mail Address: chk5@cdc.gov
(chk5@cdc.gov)
Small Business Set-Aside: N/A
Description: Justification for Other than Full and Open Competition "Source Selection Information - see FAR 2.101 and 3.104" Identification of the agency and contracting activity. Federal agency and contracting activity. HHS, Centers for Disease Control and Prevention Sponsoring organization. National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID), Division of Health Care Quality Promotion (DHQP), Immunization Safety Office (ISO) Project Officer information. •· Project Officer name. Julianne Gee •· Mailing address. 1600 Clifton Rd, MS D-26 Atlanta GA 30333 •· E-mail address. jgee@cdc.gov •· Telephone number. 404.639.1885 Nature and/or description of the action being approved. Acquisition purpose and objectives. The purpose of this acquisition is a modification to CDC's current vaccine safety contract with America's Health Insurance Plans (200-2002-00732) to expand vaccine safety monitoring activities for pandemic H1N1 vaccine through new data sources. This is an urgent H1N1 activity to ensure that the safety of the new H1N1 vaccine is monitored appropriately and critical vaccine safety information is obtained. Project background. CDC currently has a contract for monitoring and evaluating the safety of vaccines with America's Health Insurance Plans (AHIP). Through this contract, CDC is able to evaluate the safety of vaccine through various systems which include the Vaccine Safety Datalink (VSD) Project, the Clinical Immunization Safety Assessment (CISA) network, and the Vaccine Analytic Unit's Anthrax Vaccine safety project. In addition, the contract has included smaller activities which also assess the safety of vaccines. The VSD, however, is the largest of these three data systems in this contract in which the population it covers is approximately 9.2 million managed care members annually. The work that has been conducted within the VSD to monitor the safety of new vaccines has been paramount to the national vaccine safety infrastructure. This project has created a method for rapid active surveillance, called rapid cycle analysis. It has allowed vaccine safety monitoring to occur in near real time, where information is collected on a weekly basis. Rapid active surveillance is a critical component of the overall H1N1 vaccine effort as HHS and CDC prepare to launch a National vaccination campaign to protect Americans. VSD, however, is limited in that it does not reach sufficient numbers to make rapid assessments of rare adverse events within small subpopulations to guide National policy determinations. Therefore, to complement the existing VSD H1N1 vaccine safety study and reach a larger population through other systems, HHS seeks to use existing infrastructure and expertise through America's Health Insurance Plans (AHIP) to quickly set up, coordinate and successfully manage new and expanded vaccine safety monitoring systems for the H1N1 vaccination program. Utilizing AHIP to administer two new expanded vaccine safety rapid active surveillance systems is critical to the success of the H1N1 pandemic vaccination safety monitoring plan and best positions the US government and the American people to be aware of the risks as well as understand the safety profile of this vaccine in an effort to protect the nation. Description of the supplies or services required to meet the agency's needs (including the estimated value). Project title. Modification to Contract 200-2002-00732 for H1N1 Vaccine Safety Activities Project description. •· Requirement type. q Research & development (R&D) q R & D support services √ Support services (non-R&D) q Supplies/equipment q Information technology (IT) q Construction q Architect-engineer (A & E) services q Design-build q Other (specify): ____________________ •· Type of action. q New requirement q Follow-on √ Other (specify): _ Contract Modification- new work ____ •· Proposed contract/order type. q Firm-fixed-price q Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ √ Cost-plus-fixed-fee q Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ q Time and materials q Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ q Other (specify): ___________ q Completion Form q Term form •· Acquisition identification number. Modification to Contract 200-2002-00732 Total estimated dollar value and performance/delivery period. The current total estimated contract value to include unexercised options is $207,399,433. This modification will be an estimated increase to contract value of up to an additional $7,000,000 making the new contract estimated total value, $214,399,433. Period of performance will be beginning immediately upon contractor notification and continuing for a 1 year period of performance. Identification of the statutory authority permitting other than full and open competition. √ This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(2) as set forth in Federal Acquisition Regulation (FAR) 6.302- 2, Unusual and Compelling Urgency. q This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996. q This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a). Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited. Name and address of the proposed contractor(s). America 's Health Insurance Plans 601 Pennsylvania Ave., NW South Building, Suite 500 Washington, DC 20004 Nature of the acquisition and proposed unique qualifications of the contractor(s). In 2002, as part of the enhancement of its vaccine safety program, CDC entered into a ten year contract that allowed for each vaccine safety project to be managed by a private organization. Through a full and open competitive process, AHIP was deemed to have the strongest proposal and identified to be the vendor most advantageous for the government. In its 7 th year of leading this contract and managing this contract, AHIP has successfully allowed CDC fulfill its mission in conducting important vaccine safety work conducted through VSD and CISA. AHIP has gained further unique expertise through collaborations on similar work to the VSD with other contracts including privately funded studies. They have partnered with other health plans on similar projects, which have included many of the same large national and regional health plans that will be needed to conduct this work. AHIP's relationships with its member health plans has offered the opportunity to expedite the process of initiating important public health activities as well as expanding the pool of potential participating health plans as needed if and when conditions warrant expanded efforts. Based on their unique expertise and knowledge with this work combined with the current contract, AHIP is the only contractor currently positioned to respond to the H1N1 vaccine safety monitoring requirements we urgently have. Given that one of the projects requires rapid implementation of an active surveillance system with large health plans not currently participating in the VSD project as well as identification of an experienced data coordination center to conduct weekly analyses, it would be impossible for a vendor other than AHIP to accomplish the needed tasks with such a short timeline. AHIP has the existing relationships with health plans throughout the US to initiate programs such as this and is able to coordinate and manage a large scale project without needing ample start-up time to learn about the project. The other project is to use an automated web based system to conduct rapid active surveillance of H1N1 vaccine. Through this project, CDC's monitoring efforts will be enhanced as this system will reach vaccine recipients that may not be captured through its traditional vaccine surveillance systems. AHIP currently has a 2 year subcontract in place with John's Hopkins University to actively monitor season influenza vaccine safety through the use of an automated system. This system that can be easily modified and expanded to reach a larger population during the H1N1 vaccination program. AHIP is uniquely positioned to respond to a large scale request in a short timeline, making them the only possible entity to could successfully implement an automated H1N1 active surveillance system on an expedited schedule. The time sensitive nature of initiating an additional safety surveillance system on a large scale for the H1N1 vaccination program limits the ability to explore additional options. The existing vaccine safety contract with CDC provides a ready mechanism for initiating work on an expedited schedule. AHIP is able to start this work rapidly in order to respond to the national H1N1 vaccination program which is slated to begin in September or October 2009. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies. Because this action is being undertaken with the authority of Unusual and Compelling Urgency (FAR 6.302-2), the Government is not required to synopsize prior to taking action (See FAR 2.202(a)(2). However, the Government will ensure transparency in the contracting process by posting the approved JOFOC within 30 days of award, in accordance with FAR 6.305 (b). It has been determined that AHIP is the only source that is practicable from which to solicit a proposal for this short duration on time requirement. The current vaccine safety contract with AHIP will be re-competed in 2012. CDC has all intentions of allowing a sufficient transition time between contracts to ensure full and fair competition for the follow on effort. 7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. It is anticipated that the current contract costs/pricing will provide a reasonable basis for comparing and negotiating costs since established pricing has been reviewed and determined fair and reasonable. Detailed costs and supporting documentation will be required in the proposal so that individual costs can be determined allowable and allocable to the contract. 8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted. The 2009 H1N1 influenza pandemic has prompted an expedited mass vaccination program in the United States. Due to the unusual and compelling urgency of this circumstance, the proposed H1N1 vaccine surveillance action must be developed and executed within a narrow time frame. Due the fact that compromising this time frame would constitute a direct risk to the Government, the already-established relationship with AHIP was deemed optimal. As such, no market research has been conducted. 9. Any other facts supporting the use of other than full and open competition. For reasons indicated above, the Government has determined America's Health Insurance Plans (AHIP), the only source that could reasonably mobilize the expanded active surveillance processes on a large scale within the required timeframe. If the contract modification does move forward immediately, the impact would be tremendous. It is estimated that an additional 50 million number of covered lives would be monitored for adverse events following vaccination during this year's H1N1 vaccination program. Vaccine safety monitoring has been considered a national priority in the planning and execution of the H1N1 vaccination program. In 1976, there was an outbreak of swine flu in which the Government mobilized a national vaccination campaign. Reports of deaths and neurologic problems, especially the rare Guillan Barre syndrome, eventually suspended the vaccination program. Often cited as the "Swine Flu Fiasco", there have been many lessons learned about mass pandemic influenza vaccination programs. Thus, the current administration would like to ensure that the Government is able to actively and rapidly monitor adverse events among as many people as possible during this current H1N1 vaccination program. 10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition. No other sources have expressed an interest, in writing, in the proposed acquisition. 11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services. The proposed project will only be conducted during the one year from the date of award. There are no intentions to continue work through this mechanism beyond the 12 month period of performance. The current contract with AHIP, that will be modified by this action ends in 2012 and will be re-competed. CDC will allow for sufficient transition time between contracts to ensure full and fair competition for the follow on effort. CDC considered the authorities of 10 U.S.C 2304(c)(1) as implemented in FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy the agency requirements. However it was determined that the urgent nature of this requirement could not be delayed and that a use of 6.302-1 would be disingenuous to the subsequent competition, for which there is time to conduct and if based on the results of the competition, transition support to another successful offeror. 12. Program office certification. This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government's minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete. Official Name & Title Signature Date Project Officer Julianne Gee, MPH Epidemiologist ISO, DHQP, NCPDCID /S/ 8/25/09 Project Officer's Immediate Supervisor Frank DeStefano, MD MPH ISO Director ISO, DHQP, NCPDCID /S/ 8/26/09 Head of the Sponsoring Program Office Denise Cardo, MD Director of DHQP, NCPDCID /S/ 8/26/09 13. Contracting Officer certification. This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete. Official Name & Title Signature Date Contracting Officer Nancy M. Norton Contracting Officer, CDC Procurement and Grants Office /S/ 8/28/09 14. Chief of the Contracting Office and Head of the Contracting Activity signature(s). Official Name & Title Signature Date Chief of the Contracting Office Alan A. Kotch Director, CDC Procurement and Grants Office N/A Head of the Contracting Activity Alan A. Kotch Director, CDC Procurement and Grants Office /S/ 8/28/09 15. Competition Advocate signature. Official Name & Title Signature Date Competition Advocate James D. Seligman Competition Advocate /S/ 9/1/09 16. HHS Senior Procurement Executive signature. Official Name & Title Signature Date HHS Senior Procurement Executive N/A
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/200-2002-00732/listing.html)
Place of Performance: Address: Washington, District of Columbia, 20004, United States; Zip Code: 20004
Record: SN01979647-W 20091006/091004233052-aaba7a5df3ab7a2c57aa173c6c4c30ac (fbodaily.com)
Source: FedBizOpps Link to This Notice
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B -- Justifiication for Other ull and Open Competition