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The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-58, May 18, 2012.
The associated North American Industry Classification System (NAICS) Code is- 112990 - All Other Animal Production. Small Business Size Standard is $0.75 in millions of dollars. This combined synopsis/solicitation is set-aside for Small Business however any other size of business is not prohibited from submitting quotations.
Respondents are responsible for delivery in person, by e-mail, fax, mail or other delivery method their complete proposal and any additional documents before 9:00 am (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on June 15, 2012 to [email protected], Fax (870) 543-7990, or mail to the U. S. FDA, OO/OFBA/OAGS, Attention of Howard Nesmith, 3900 NCTR Road, Jefferson, AR 72079-9502.
PLEASE NOTE - The above contact information is for the Contracting Office and not necessarily the delivery address. The delivery address is indicated in the FOB Destination section below.
When appropriate, Respondents should consult with delivery providers to determine whether their documents will be delivered prior to the scheduled time.
For information regarding this solicitation, please contact Howard Nesmith by e-Mail at [email protected].
The FDA, Center for Drug Evaluation and Research (CDER), Office of Biological Products Humanized Mouse Facility requires specialized mouse strains that will permit the engraftment of human hematopoietic cells and tissue as set forth herein.
Mice suitable for engraftment shall 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
- abnormal spleen B cell follicle morphology
- spleens do not have detectable follicles
- abnormal splenic cell ratio
- two fold reduction in nucleated spleen cell numbers in comparison to Prkdcscid controls
- abnormal thymus morphology
- thymus consists mostly of stromal cells with sporadic cyst structures
- small lymph nodes
- lymph nodes in the double mutant are markedly smaller than those of homozygous Prkdcscid mice
- lymph node hypoplasia
- lymph nodes are hypocellular
- abnormal response to transplant
- mice support CD34+ human stem cell engraftment at much higher levels than Prkdcscid controls
- 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
- decreased immunoglobulin level
- no detectable immunoglobulin in mice at 394-426 days of age
- decreased leukocyte cell number
- ecrease in peripheral leukocytes at 10 weeks as compared to to Prkdcscid controls
- decreased CD4-positive T cell number
- spleens are deficient in mature T cells
- decreased CD8-positive T cell number
- spleens are deficient in mature T cells
- decreased NK cell number
- mice are deficient in cells expressing NK cell markers in comparison to Prkdcscid controls
- spleen cells from poly(I:C) stimulated 6-8 week old mice exhibit very low levels of NK cell cytotoxic activity
- 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
- decreased mature B cell number
- spleens are deficient in B220+ IgK+ B cells
- hematopoietic system phenotype
- abnormal spleen B cell follicle morphology
- spleens do not have detectable follicles
- abnormal splenic cell ratio
- two fold reduction in nucleated spleen cell numbers in comparison to Prkdcscid controls
- abnormal thymus morphology
- thymus consists mostly of stromal cells with sporadic cyst structures
- decreased leukocyte cell number
- decrease in peripheral leukocytes at 10 weeks as compared to to Prkdcscid controls
- decreased CD4-positive T cell number
- spleens are deficient in mature T cells
- decreased CD8-positive T cell number
- spleens are deficient in mature T cells
- decreased NK cell number
- mice are deficient in cells expressing NK cell markers in comparison to Prkdcscid controls
- spleen cells from poly(I:C) stimulated 6-8 week old mice exhibit very low levels of NK cell cytotoxic activity
- 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
- decreased mature B cell number
- spleens are deficient in B220+ IgK+ B cells
- decreased mean corpuscular volume
- slight decrease in packed cell volume at 10 weeks as compared to to Prkdcscid controls
- cellular phenotype
- increased cellular sensitivity to X-ray irradiation
- mice do not survive doses above or equal to 400cGy
Item #1
Female BALB/cJ Mice at 8 Weeks of Age
Quantity: 20
Unit Price: _____________________
Extended Price: _________________
Item #2
Male BALB/cJ Mice at 8 Weeks of Age
Quantity: 14
Unit Price: _____________________
Extended Price: _________________
Item #3
Female NOD.Cg-Prkdc<scid> Il2rg<tm1Wjl>/SzJ
M01 Homozygous for Prkdc<scid>, Homozygous for
Il2rg<tm1Wjl>
Mice at 8 Weeks of Age
Quantity: 100
Unit Price: _____________________
Extended Price: _________________
Item #4
Male NOD.Cg-Prkdc<scid> Il2rg<tm1Wjl>/SzJ
M03 Homozygous for Prkdc<scid>, Hemizygous for Il2rg<tm1Wjl>
Mice at 8 Weeks of Age
Quantity: 20
Unit Price: _____________________
Extended Price: _________________
Item #5
Female NOD.Cg-Rag1<tm1Mom> Il2rg<tm1Wjl>/SzJ
M01 Homozygous for Rag1tm1Mom, Homozygous for Il2rgtm1Wjl
Mice at 8 Weeks of Age
Quantity: 100
Unit Price: _____________________
Extended Price: _________________
Item #6
Male NOD.Cg-Rag1<tm1Mom> Il2rg<tm1Wjl>/SzJ
M03 Homozygous for Rag1<tm1Mom>, Hemizygous for
Il2rg<tm1Wjl>
Mice at 8 Weeks of Age
Quantity: 20
Unit Price: _____________________
Extended Price: _________________
Item #7
Male NSG BLT NOD.Cg-Prkdc<scid> Il2rg<tm1Wjl>/SzJ
M01 Homozygous for Prkdc<scid> Homozygous for Il2rg<tm1Wjl>
Mice at 8 Weeks of Age
Quantity: 50
Unit Price: _____________________
Extended Price: _________________
Item #8
Female NSG BLT NOD.Cg-Prkdc<scid> Il2rg<tm1Wjl>/SzJ
M01 Homozygous for Prkdc<scid> Homozygous for Il2rg<tm1Wjl>
Mice at 8 Weeks of Age
Quantity: 50
Unit Price: _____________________
Extended Price: _________________
Item #9
Transport Container
Quantity: 24
Unit Price: _____________________
Extended Price: _________________
GSA Contract Number (if applicable): ________________________
FOB Destination - U.S. Food and Drug Administration, Division of Veterinary Services, 9000 Rockville Pike, Bethesda, MD 20892
Contract Type - Commercial Item - Firm fixed price. Simplified procurement procedures will be utilized.
An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.
The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items applies to this solicitation.
The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows:
The Government will award the purchase order to the responsible offeror who offer conforming to the solicitation will be the most advantageous to the Government on price and other factors considered. The following factors shall be used to evaluate offers:
(i) Technical capability of the items offered to meet the Government's requirement.
(ii) Price.
The government will award the purchase order to the lowest price technically acceptable quote.
Technical capability will be determined by review of information submitted by the quoter, which must provide a description in sufficient detail to show that the product/service quoted meets the Government's requirements.
The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the service meets the technical requirements. Quotes shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offeror.
The Provision at FAR 52.212-3, Offerors Representations and Certifications-Commercial Items, applies to this acquisition. An offeror shall complete only paragraph (b) of the provision if the offeror has completed the annual representations and certification electronically at http://orca.bpn.gov.
The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition.
The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Mar 2012), applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.225-3, 52.225-13, and 52.232-33.
Clauses and provisions incorporated by reference can be obtained at https://www.acquisition.gov/far.