Added: Apr 16, 2008 8:01 am
FDA-SOL-08-00623
This is a SOURCES SOUGHT NOTICE to determine the availability and capability of certified Small Businesses to identify and develop a knockout mouse for the Food and Drug Administration (FDA). The Government is seeking qualified Small Businesses. This is planned as a Small Business SET ASIDE on a competitive basis.
The purpose is to have sources that can develop and provide knockout mice during the 15-24 month study. The vendor performance period will be two years. Due to a diminishing number of available ivermectin-sensitive Collie colonies, it is becoming difficult for drug sponsors to get the dogs needed to test the safety of new avermectins. Therefore alternative screening procedures are needed to identify potential P-gp substrates and to address safety concerns. The second phase of the study will develop alternative in vivo and in vitro models that may be used in lieu of ivermectin-sensitive Collies to confirm the safety of new and combination new animal drug products. By the end of the second year, FDA plans to have identified in vitro systems that can be used to identify P-gp substrates. However, since in vivo toxicity and tissue variation in gene expression need to be considered, an in vivo model is also needed. The vendor shall need to demonstrate technical approach to develop a knockout mouse model (in vivo) and knockout mammalian cell lines (in vitro) that exhibit homozygous recessive and heterozygous genotype for the canine mdr1-/- mutation. The vendor shall provide a detailed strategy of the development including methodology, feasibility, and appropriateness of the proposed methods together with any unique or imaginative approaches for the development of the model systems. The vendor shall also provide:
(a) Provide the specifics of the approach to develop knockout mice.
(b) Strategies of deleting the mouse mdr1a and mdr1b genes and replacing with a heterozygous and homozygous genotype for the canine mdr1 mutation.
(c) Provide the specifics of development of the gene construct.
(d) Details on what methods are going to be used to insert artificial DNA into the chromosomes contained in the nuclei of ES cells.
(e) Provide the specifics of ES identification and testing.
(f) Provide the specifics of confirming successful creation of clones.
(g) Provide the background and experience of the staff of the laboratory facility.
(h) Provide an estimate of the time that it would take to complete project.
(i) Provide estimated charges of unsuccessful production of construct(s), cell line(s), and mice.
(j) Provide information on how project deliverables will be monitored.
(k) Provide vender s policy the intellectual property transfer of the cell lines and mice produced.
(l) Provide estimated cost of housing and breading.
The vendor shall submit the following deliverables:
1. Constructs developed with the mutated canine mdr1 +/-, and mdr1-/-.
2. ES cell lines with the deletion of the mouse mdr1a and mdr1b genes and the insertions of the canine mdr1 +/-, and mdr1-/- construct.
3. Two knockout mice mdr1 +/-, and mdr1-/- model.
4. Delivery of models in 15-24 months.
Vendors must submit a capability statement (five page limitation) describing their company s experience and ability to perform this work.
A two year contract is expected. The NAICS code for this effort is 112990. Interested offerors must provide (1) company s name, mailing address, e-mail address, telephone and fax numbers, website address, and point of contact (2) a summary list of similar work previously performed or being performed; (3) the professional qualifications and specific experience of staff who may be assigned to the requirement; resumes for proposed key personnel should be included; (4) provide Small business firm certification by SBA) (submit copies of any documentation such as letters or certificates to indicate the firm s status); (5) DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). (6) Companies must be registered in the Central Vendor Registry (CCR at www.ccr.gov) to be considered as a potential source; (7) identification of the firm s GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are requested and (8) if the company has a government approved accounting system, identify the agency that approved the system.
This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or indication the Government will contract for the work contained in this announcement. No reimbursement will be made for any costs associated with providing information in response to this announcement and any follow-up information requests. Responses to this announcement will not be returned, nor will there be any discussions or debriefings of any responses. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. Responses must be sent to this notice no later than 10:00 a.m. EST on April 21, 2008 submitted by email to the attention of David Kordel, Contract Specialist at the above stated address.
