EHIME 1993934.pdf

Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold

Brand-Name: Protea-Science Center at Ehime University

Project Title: Production of recombinant malarial PfHAP2 protein to support transmission-blocking vaccine development

I . Identification of the agency and contracting activity

DHHS, NIH, NIAID, LMVR

11. Description of the project, and supplies or services required to meet the agency's needs (including the estimated value)

B. Project Background:

The Malaria Immunology Section (MIS) at Laboratory of Malaria and Vector Research (LMVR) has been working on malaria transmission-blocking vaccine (TBV) development, and evaluating a potential of PfHAP2-based vaccines as TBV candidates. This project has been led by the MIS and the collaborater, the Proteo-Science Center (PROS) at Ehime University in Japan, will provide protein production service that the MIS cannot perform 'Hn-house". Making Plasmodium falciparum malaria proteins_ with correct conformations is different in general, and the PROS is one of the few laboratories in the world capable of producing the malaria antigens using their novel wheat-germ cell-free expression system. In our previous studies, recombinant PfHAP2 proteins made by PROS could induce functional antibodies in mice and rabbits. To uncover the mechanism of action, we need more PfHAP2 proteins for immunization (make more anti-PfHAP2 antibodies) and for in vitro/ex vivo assays. Before PROS produced multiple versions of PfHAP2 proteins, but this time they will provide the most promission one (and a HisGST control protein), but more quantity, to support the project.

C. Procurement Description

Using the PfHAP2 proteins, MIS will performe immunization studies, and various in vitro/ex vivo assays, such as immunofluorescence assay, standerd membrane-feeding assay, in-house.

Ill. Identification of the statutory authority permitting other than full and open competition (SELECT ONE)

� 41 USC 1901(a)(l) a n d FAR Par t 13.106-1: Brand-name

□ 41 USC 501 a n d FAR Pa rt 8. 4 O 5 -6: Federal Supply Schedule ( FSS), limited competition

□ An urgent and compelling need exists, and following the procedures would result in unacceptable delays

Only one source is capable of providing the supplies or serviees required at the level of quality required because the supplies or services are uniqu�i or highly speclaliz_ed; or

□ In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable

Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole-source or limited-sources procedures.

Important Note: The statutory authorities listed below will rarely ever be used in NIH. Before selecting one of these authorities, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

□ 41 USC 253(c)(2) and FAR Part 6.302-2: Unusu al & co mp e lling urgenc y D 41 USC 253(c)(3) and FAR Part 6.302-3: Industrial mo b ilization; or engin e ering, d eve lo pmental, or res e arc h capab ility; or exp ert s ervic es

□ 41 USC 253(c)(4) and FAR Part 6.302-4: International agre e ment

D 41 USC 253(c)(5) and FAR Pa rt 6. 3 0 2-5: Authoriz ed or requ ired b y statu te

□ 41 USC 253(c)(6) and FAR Part 6.302-6: National s e curity

□ 41 USC 253(c)(7) and FAR Part 6.302-7: Pu blic interest

IV. De monstration that the pro posed brand name produ ct's sali ent characteristics (sp e c ific fe atures, qu aliti es and /or the nature o f the acqu is ition) requ ires us e o f the authority c ited.

To perform this project, we must use recombinant proteins which have shown to induce functional antibodies in immunized animals. If we switch the PfHAP2 proteins at this moment, we need to re-evaluate the quality of proteins again

(i.e., perform additional animal immunization studies with a new protein, and evaluate whether the new one is as good as

PROS's PfHAP2, by various assays). Therefore, we cannot use the proteins from other sources for the new project.

In this study, PROS will provide protein production service for one PfHAP2 antigen and a control protein, then we will generate anti-PfHAP2 antibodies and perform various in vitro/ex vivo assays in-house.

V . De termination by the Contracting Officer that the antic ipated cost/pric e to the Government will b e fa ir and re asonable.

The price is determined to be fair and reasonable based on:

Price reasonableness determination will be included in the acquisition file.