SOLICITATION NOTICE
88 -- Laboratory Animals
- Notice Date
- 5/2/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 112990
— All Other Animal Production
- 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
- FDA-SOL-08-00623a
- Point of Contact
- David - Kordel,, Phone: 301-827-7166
- E-Mail Address
-
david.kordel@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- Classification Code: 88 Subject: Laboratory Animals Solicitation Number: FDA-SOL-08-00623 Response Date: May 19, 2008 Contact Points: David Kordel, 301-827-7166 DESCRIPTION: THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5. This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-24. The associated North American Industrial Classification System (NAICS) code for this procurement is 112990 for full and open competition. The FDA intends to issue a purchase order for a vendor who can develop and provide knockout mice during a 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. QUESTIONS DEADLINE: all questions must be received by email (david.kordel@fda.hhs.gov) before 5:00 pm (1600) EST on May 9, 2008. Delivery terms shall be FOB Destination. FOB Destination means the contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order; and pay all charges to the specified point of delivery. Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor "Meeting or Exceeding the Requirement," and 2) Price. Technical Capability and Price are of equal importance. Evaluation of Technical Capability shall be based on the information provided in the quotation. Quoters shall include the manufacturer, make and model of the product, manufacturer sales literature or other product literature which CLEARLY DOCUMENTS that the offered product meets or exceeds the specifications stated herein. FAR provisions can be found on the following website: http://www.arnet.gov. The following provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors-Commercial Items; 52.225-2 Buy American Certificate; 52.212-4 Contract Terms and Conditions-Commercial Items; 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items including subparagraphs: 52.222-3, Convict Labor 52.222-19, Child Labor-Cooperation with Authorities and Remedies 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity 52.222-36, Affirmative Action for Workers with Disabilities 52.222-50, Combating Trafficking in Persons 52.225-1, Buy American Act--Supplies 52.225-13, Restrictions on Certain Foreign Purchases 52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration. This is Full and Open business Combined Synopsis/Solicitation for laboratory animals as defined herein. The Government intends to award a Purchase Order as a result of this Combined Synopsis/Solicitation that will include the terms and conditions that are set forth herein. In order to facilitate the award process, ALL quotes shall include a statement regarding the terms and conditions herein as follows: The offeror shall state “The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition.” OR The offeror shall state “The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following: Offeror shall list exception(s) and rationale for the exception(s) Additionally, all quotes shall include price (s); FOB point; a poc (name and telephone number); GSA contract number if applicable; delivery date (delivery date is of the utmost importance); business size; and payment terms. Delivery shall be to FDA, Laurel, MD 20708. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and be received by 10:00 AM (1000) EST on 19 May 2008 to the attention of David Kordel, david.kordel@fda.hhs.gov. Offerors shall ensure the RFQ number is visible in the header of the email. FAX QUOTES SHALL NOT BE ACCEPTED.
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