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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 07, 2013 FBO #4274
SPECIAL NOTICE

B -- Notice of Intent to Sole Source (460) Immunodeficient Mice Strain

Notice Date

8/5/2013
 

Notice Type

Special Notice
 

NAICS

541711 — Research and Development in Biotechnology
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

SOL1120020
 

Archive Date

8/28/2013
 

Point of Contact

Mary Rose A. Nicol, Phone: 3018277183
 

E-Mail Address

MaryRose.Nicol@fda.hhs.gov
(MaryRose.Nicol@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

The US Food and Drug Administration (FDA) intends to negotiate on a sole source basis with The Jackson Laboratory - East, 610 Main Street, Bar Harbor, ME 04609 US under the authority of FAR 6.301-1, for the purchase of 460 Immunodeficient Mice Strains. These Mutant mice combine the features of the NOD/ShiLtJ background, the severe combined immune deficiency phenotype9rag or scid) and IL2 receptor gamma chain deficiency. As a result, the NOD.Cg-Prkdc scid 112rgtmWjl/SzJ MICE lack mature T cells, B cells, or functional NK cells, and are deficient in cytokine signaling, leading to better engraftment of human hematopoietic stem cells and peripheral-blood mononuclear cells than any other published mouse strain. The purchase of these Mice is critical to for the completion of an FDA Medical Counter Measure Award to assess the safety and efficacy of MCM. Once engraftment is complete, the mice can be utilized in experiments for human pathogens such as Influenza, and for drugs such as biologics and therapeutic proteins. Mice suitable for engraftment must have the following features: Genotype Il2rgtm1Wjl/Il2rgtm1Wjl Prkdcscid/Prkdcscid NOD.Cg-Prkdcscid Il2rgtm1Wjl/Sz Phenotype Immune system phenotype • abnormal immune system organ morphology o lymph tissues are severely depleted of lymphoid cells (MGI Ref ID J:109833) o abnormal spleen B cell follicle morphology  spleens do not have detectable follicles (MGI Ref ID J:109833) o abnormal splenic cell ratio  two fold reduction in nucleated spleen cell numbers in comparison to Prkdcscid controls (MGI Ref ID J:109833) o abnormal thymus morphology  thymus consists mostly of stromal cells with sporadic cyst structures (MGI Ref ID J:109833) o small lymph nodes  lymph nodes in the double mutant are markedly smaller than those of homozygous Prkdcscid mice (MGI Ref ID J:109833)  lymph node hypoplasia  lymph nodes are hypocellular (MGI Ref ID J:109833) • abnormal response to transplant o mice support CD34+ human stem cell engraftment at much higher levels than Prkdcscid controls (MGI Ref ID J:109833) o human CD45+ cells comprise almost 50% of cells in the spleen, approximately 35% in bone marrow and thymus, and 6% in blood at 10 weeks post-engraftment (MGI Ref ID J:109833) • decreased immunoglobulin level o no detectable immunoglobulin in mice at 394-426 days of age (MGI Ref ID J:109833) • decreased leukocyte cell number o decrease in peripheral leukocytes at 10 weeks as compared to to Prkdcscid controls (MGI Ref ID J:109833) o decreased CD4-positive T cell number  spleens are deficient in mature T cells (MGI Ref ID J:109833) o decreased CD8-positive T cell number  spleens are deficient in mature T cells (MGI Ref ID J:109833) o decreased NK cell number  mice are deficient in cells expressing NK cell markers in comparison to Prkdcscid controls (MGI Ref ID J:109833)  spleen cells from poly(I:C) stimulated 6-8 week old mice exhibit very low levels of NK cell cytotoxic activity (MGI Ref ID J:109833) o decreased immature B cell number  flow cytometric analysis indicates that spleen cells exhibit a reduction in B220+ IgK- immature B cells in comparison to Prkdcscid controls (MGI Ref ID J:109833) o decreased mature B cell number  spleens are deficient in B220+ IgK+ B cells (MGI Ref ID J:109833) • hematopoietic system phenotype • abnormal spleen B cell follicle morphology o spleens do not have detectable follicles (MGI Ref ID J:109833) • abnormal splenic cell ratio o two fold reduction in nucleated spleen cell numbers in comparison to Prkdcscid controls (MGI Ref ID J:109833) • abnormal thymus morphology o thymus consists mostly of stromal cells with sporadic cyst structures (MGI Ref ID J:109833) • decreased leukocyte cell number o decrease in peripheral leukocytes at 10 weeks as compared to to Prkdcscid controls (MGI Ref ID J:109833) o decreased CD4-positive T cell number  spleens are deficient in mature T cells (MGI Ref ID J:109833) o decreased CD8-positive T cell number  spleens are deficient in mature T cells (MGI Ref ID J:109833) o decreased NK cell number  mice are deficient in cells expressing NK cell markers in comparison to Prkdcscid controls (MGI Ref ID J:109833)  spleen cells from poly(I:C) stimulated 6-8 week old mice exhibit very low levels of NK cell cytotoxic activity (MGI Ref ID J:109833) o decreased immature B cell number request will not be acc  flow cytometric analysis indicates that spleen cells exhibit a reduction in B220+ IgK- immature B cells in comparison to Prkdcscid controls (MGI Ref ID J:109833) o decreased mature B cell number  spleens are deficient in B220+ IgK+ B cells (MGI Ref ID J:109833) • decreased mean corpuscular volume o slight decrease in packed cell volume at 10 weeks as compared to to Prkdcscid controls (MGI Ref ID J:109833) • cellular phenotype • increased cellular sensitivity to X-ray irradiation o mice do not survive doses above or equal to 400cGy (MGI Ref ID J:109833) • humanized with autologous CD34+ HSC and thymus The NAICS Code is: 541711. This notice is not a request for competitive quotes; no solicitation document is available and telephone request will not be accepted. However, interested sources may submit descriptive literature, fully documenting their capability to provide 460 Immunodeficient Mice strains which will be considered by the agency. A determination to compete this procurement is based on response(s) to this notice is solely within the discretion within the Government. It is anticipated that award may be issued to the Jackson Laboratory within approximately 15 days after the date of this notice unless the Government determines that any other organization has the capability to meet this requirement. All responses must be received no later than 12:00 PM EDT On August 13, 2013 to the attention of MaryRose.Nicol@fda.hhs.gov
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/SOL1120020/listing.html)
 

Place of Performance

Address: 8800 Rockville Pike, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN03137233-W 20130807/130805234454-49db59e49b8580909d8ca635aaf8f306 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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