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A -- HPV Type 16/18 Vaccine Trial in Costa Rica

Active
NO1-CP-11005Federal

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The Hormonal and Reproductive Epidemiology Branch (HREB) of the Division of Cancer Epidemiology and Genetics (DCEG) at the National Cancer Institute (NCI) plans to modify Contract No. N01-CP-11005, which supports the HPV Type 16/18 Vaccine Trial in Costa Rica conducted in partnership with Fundacion INCIENSA. This modification involves extending the contract by three years and increasing its total cost due to an unexpected delay in the availability of adequate GMP-grade HPV vaccine supplies required for the continuation of the trial. Additionally, the contract adjustment addresses the need to implement ethically mandated cross-over vaccination and the exit of participants from the trial, which were not anticipated at the study’s outset. The contract modification will be negotiated under a sole-source authority based on FAR 6.302-1 due to the unique circumstances related to the vaccine trial and its requirements. Although this notice is not a formal request for competitive proposals, the government invites interested parties to express their interest and capability within 45 days of the notice publication. Responses will be considered solely to determine whether a competitive procurement process should be conducted, with the final decision resting with the government. The contracting officers responsible for this action are Sharon J Miller and Karen C. McFarlane, who can be contacted for further information.

General Info

Contract N01-CP-11005 extended three years, increased cost for HPV vaccine trial delays and ethical changes.

Agency

N/A

NAICS

325414 - Biological Product (except Diagnostic) Manufacturing

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

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PhasePresolicitation
Posted

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Organization & Contact Information

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AgencyN/A
Contacts2 people available
OfficeN/A
Organization / Agency
N/A
Office AddressN/A
Contacts
Sharon J MillerContracting Officer
Karen C McFarlaneContracting Officer

Full Description

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The Hormonal and Reproductive Epidemiology Branch (HREB) of the Division of Cancer Epidemiology and Genetics (DCEG) of the National Cancer Institute (NCI) intends to negotiate with the Fundacion INCIENSA, Costa Rica, a modification to Contract No. N01-CP-11005, - HPV Type 16/18 Vaccine Trial in Costa Rica to extend the contract for three years and increase the total cost of the contract due to an unforeseen three year delay in providing adequate amounts of GMP grade HPV vaccine for the trial; and to accomplish the ethically mandated cross-over vaccination and exit of trial participants not originally anticipated at the beginning of the study. Authority: 41 USC 253(c)(1), as set forth in FAR 6.302-1. See numbered note 22. Numbered note 22 applies as follows: The proposed contract modification is for supplies or services which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302. Interested parties may identify their interest and capability to respond to this requirement or submit proposals. This notice of intent is not a request for competitive proposals. However, all proposals received within 45 days (30 days if issued under an existing basic ordering agreement) after the date of publication of this synopsis will be considered by the Government. A determination by the Government not to compete the proposed contract modification based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether or not to conduct a competitive procurement. No collect calls with be accepted.

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Mrpbs Minneapolis Mn

POSTED

20 days ago

DEADLINE

in 21 days
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