Small & Any Other Size Business Are Encouraged To Respond

The U.S. Food and Drug Administration (FDA), Jefferson Laboratories, in Jefferson, Arkansas, is conducting market research to support the Center for Biologics Evaluation and Research (CDER) for starting a humanized mouse facility which will require specialized mouse strains that will permit the engraftment of human hematopoietic cells and tissue.

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
- lymph tissues are severely depleted of lymphoid cells (MGI Ref ID J:109833)
- abnormal spleen B cell follicle morphology
-- spleens do not have detectable follicles (MGI Ref ID J:109833)
- abnormal splenic cell ratio
--two fold reduction in nucleated spleen cell numbers in comparison to Prkdcscid controls (MGI Ref ID J:109833)
- abnormal thymus morphology
-- thymus consists mostly of stromal cells with sporadic cyst structures (MGI Ref ID J:109833)
- 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
- mice support CD34+ human stem cell engraftment at much higher levels than Prkdcscid controls (MGI Ref ID J:109833)
- 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
- no detectable immunoglobulin in mice at 394-426 days of age (MGI Ref ID J:109833)

• decreased leukocyte cell number
- decrease in peripheral leukocytes at 10 weeks as compared to to Prkdcscid controls (MGI Ref ID J:109833)
- decreased CD4-positive T cell number
-- spleens are deficient in mature T cells (MGI Ref ID J:109833)
- decreased CD8-positive T cell number
-- spleens are deficient in mature T cells (MGI Ref ID J:109833)
- 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)
- 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)
- 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
- spleens do not have detectable follicles (MGI Ref ID J:109833)

• abnormal splenic cell ratio
- two fold reduction in nucleated spleen cell numbers in comparison to Prkdcscid controls (MGI Ref ID J:109833)

• abnormal thymus morphology
- thymus consists mostly of stromal cells with sporadic cyst structures (MGI Ref ID J:109833)

• decreased leukocyte cell number
- decrease in peripheral leukocytes at 10 weeks as compared to to Prkdcscid controls (MGI Ref ID J:109833)
- decreased CD4-positive T cell number
-- spleens are deficient in mature T cells (MGI Ref ID J:109833)
- decreased CD8-positive T cell number
-- spleens are deficient in mature T cells (MGI Ref ID J:109833)
- 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)
- 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)
- decreased mature B cell number
-- spleens are deficient in B220+ IgK+ B cells (MGI Ref ID J:109833)

• decreased mean corpuscular volume
- 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
- mice do not survive doses above or equal to 400cGy (MGI Ref ID J:109833)

Item #1
Female Mice, 8 Weeks Old: 000651 - BALB/cJ
Quantity: 20

Item #2
Male Mice, 8 Weeks Old: 000651 - BALB/cJ
Quantity: 14

Item #3
Female Mice, 8 Weeks Old: 005557
NOD.Cg-Prkdc<scid> Il2rg<tm1Wjl>/SzJ
M01 Homozygous for Prkdc<scid>, Homozygous for Il2rg<tm1Wjl>
Quantity: 100

Item #4
Male Mice, 8 Weeks Old: 005557
NOD.Cg-Prkdc<scid> Il2rg<tm1Wjl>/SzJ
M03 Homozygous for Prkdc<scid>, Hemizygous for Il2rg<tm1Wjl>
Quantity: 14

Item #5
Female Mice, 8 Weeks Old: 007799
NOD.Cg-Rag1<tm1Mom> Il2rg<tm1Wjl>/SzJ
M01 Homozygous for Rag1tm1Mom, Homozygous for Il2rgtm1Wjl
Quantity: 100

Item #6
Male Mice, 8 Weeks Old: 007799
NOD.Cg-Rag1<tm1Mom> Il2rg<tm1Wjl>/SzJ
M03 Homozygous for Rag1<tm1Mom>, Hemizygous for Il2rg<tm1Wjl>
Quantity: 20

Item #7
Female Mice: 735557
NSG BLT NOD.Cg-Prkdc<scid> Il2rg<tm1Wjl>/SzJ
M01 Homozygous for Prkdc<scid> Homozygous for Il2rg<tm1Wjl>
Quantity: 50

Item #8
Male Mice: 735557
NSG BLT NOD.Cg-Prkdc<scid> Il2rg<tm1Wjl>/SzJ
M03 Homozygous for Prkdc<scid> Hemizygous for Il2rg<tm1Wjl>
Quantity: 50

Item #9
SMF0001
Production Transport Container
Quantity: 24

Item #10
Male & Female Research Mice: 100367
BLT Project Mice

Firms believing they offer an equivalent mice to the above specifications are encouraged to respond electronically via email to the attention of Howard Nesmith at [email protected] on or before August 24, 2011 by 9:00 AM (Central Time) with no less than the following information:

• Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; [North American Industry Classification System (NAICS) Code is 112990 - All Other Animal Production. Small Business Size Standard is $0.75 in millions of dollars.
• Sufficient descriptive literature that unequivocally demonstrates that offered products meet or exceed above specifications.
• Though this is not a request for quote, informational pricing may be submitted.

The government is not responsible for locating or securing any information, not identified in the response.

For information regarding this market research effort, please contact Howard Nesmith at [email protected].

Disclaimer and Important Notes
This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality
No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Notice of Intent
In the event no responses (included no acceptable response) received to this market research effort this will serve as the notice effort to enter into a sole source contract with The Jackson Laboratory.