SOLICITATION NOTICE
A -- Enhanced Evaluation of Risk of Narcolepsy Associated with Pandemrix and Arepanrix and MF59-adjvanted H1N1 vaccines
- Notice Date
- 5/23/2013
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- 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
- SNR60110
- Archive Date
- 6/21/2013
- Point of Contact
- Sherrie N. Randall, Phone: 7704882866, Teri M Routh-Murphy, Phone: 770-488-2713
- E-Mail Address
-
iom2@cdc.gov, tnr3@cdc.gov
(iom2@cdc.gov, tnr3@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- CONTRACTING OFFICE ADDRESS:Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office, Acquisition and Assistance Branch 1, 2920 Brandywine Road, MS K-14, Atlanta, GA 30341-5539 NOTICE OF INTENT TO SOLE SOURCE: The Centers for Disease Control and Prevention (CDC) announces its intention to revise the scope of work for Contract No. 200-2012-53425 currently awarded to The Brighton Collaboration Foundation, Basel, Che, BS 4056. The Brighton Collaboration study will be expanded to include countries that used MF59-adjuvanted H1N1 studies. The European CDC has coordinated a multi-country study through the Vaccine Adverse Event Surveillance and Communication [VAESCO] Consortium) of Pandemrix and narcolepsy, which is being conducted by the Brighton Collaboration. The purpose of this project is to build upon the multi-country European CDC coordinated study (through VAESCO) on evaluation of risk of narcolepsy associated with Pandemrix, an adjuvanted monovalent influenza A (H1N1) vaccine that was widely used in Europe during the H1N1 influenza pandemic. This project also evaluates risk of narcolepsy associated with Arepanrix. In preparation for a possible large scale national H7N9 influenza vaccination program, CDC is considering using the two oil-in-water emulsion adjuvants in its stockpile (AS03 and MF59) with an H7N9 vaccine. CDC's current study with the Brighton Collaboration is focused on assessing the risk of narcolepsy following ASO3-adjuvanted H1N1 vaccines. CDC plans to expand the current Brighton Collaboration study to (1) include countries that used the MF59-adjuvanted H1N1 vaccines with large linked databases or other appropriate data sources that have data on adolescent and young adult populations to facilitate identification of narcolepsy cases and controls for participation in the study expansion and (2) assess whether there is a risk of narcolepsy following MF59-adjuvanted H1N1 vaccines. Countries with large linked databases that have data on adolescent populations (those at increased risk of narcolepsy) will be given priority to participate. This will facilitate the conduct of nested case-control studies, making the investigation more efficient and less costly. Findings from this work will result in a final report to the CDC, the European CDC (ECDC) and to the ministries of health in other participating countries. In addition, the contractor may submit findings to peer reviewed journal(s). The anticipated date to modify Contract #200-2012-53425 will be 7/1/2013. The Brighton Collaboration Foundation has been the primary contractor for the study since the start of the project and it is uniquely situated to support the Government's goal of expanding its current study and to enroll other countries to gain a better understanding of the risk of narcolepsy following MF59-adjuvanted H1N1 vaccines. The Brighton Collaboration Foundation is the only source available to rapidly implement the expansion of the ongoing study to address MF59-adjuvanted H1N1 vaccines within the critical time-frame deemed necessary. CDC intends to negotiate this requirement under the authority of FAR 6.302-1(a)(2) This notice of intent is not a request for competitive proposals. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. Interested parties who believe they possess the capabilities to satisfy this requirement should submit a capability statement demonstrating their abilities to meet this requirement. All responses shall be received by June 6, 2013, 2PM Eastern Standard Time (EST). All responses must be in writing and can be sent via email to iom2@cdc.gov. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/SNR60110/listing.html)
- Place of Performance
- Address: SPITALSTRASSE 33, BASEL CHE, 4056, Non-U.S., Switzerland
- Record
- SN03071178-W 20130525/130524000046-fbceddd0d00cf479dcd6efab4ce849e6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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