MODIFICATION
88 -- Breeding and Supply of Transgenic Mice Expressing Human and Bovine Prion Protein Genes
- Notice Date
- 7/29/2010
- Notice Type
- Modification/Amendment
- 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
- FDARFQ1075219
- Archive Date
- 8/17/2010
- Point of Contact
- Lisa Ko,
- E-Mail Address
-
Lisa.Ko@fda.hhs.gov
(Lisa.Ko@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- FDA RFQ1075219 This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 112990, identified as FDA RFQ1075219, is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. Hard copies will only be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. STATEMENT OF WORK Breeding and Supply of Transgenic Mice Expressing Human and Bovine Prion Protein Genes Background TSEs are a group of infectious neurodegenerative disorders characterized by the accumulation of abnormal "prion" proteins (PrP) in the central nervous system and in some peripheral organs (in some TSEs). TSEs are particularly insidious infections because infected individual can remain asymptomatic for many years before onset of overt disease, while their tissues may already contain the infectious pathogenic TSE agent. The disease is always fatal and there is no cure or screening test for blood or tissue donors. We are studying the most common human TSEs: sporadic Creutzfeldt-Jakob disease (sCJD), Gerstmann-Sträussler-Scheinker disease (GSS) and variant CJD (vCJD), and elucidating the risk of transmitting infection by FDA-regulated products in general and biologic products in particular. Variant CJD is the only form of human TSE demonstrated to have been transmitted by blood transfusions and probably by a plasma derivative; however, because blood of many animals with TSEs contains infectivity throughout much of the silent incubation period as well as during overt illness, the possible presence of small amounts of infectivity in blood of humans infected with other TSEs cannot be confidently excluded. Since the mid 1980s, FDA has considered all human TSEs to pose a potential risk of transfusion transmission. Primary transmissions of TSE infectivity from one species of animal to another species typically occur at very low rates; often fewer than 1% of exposures to a TSE agent of one species leads to infection of the new species. This species barrier can be partially overcome if infectivity is assayed in "homologous" bioassay systems (i.e., where donor and recipient animals are of the same or closely related species). Obviously, such a strategy is not possible for bioassays of human samples. Several mouse models expressing the human prion protein gene (PRNP) have been developed and shown to be highly susceptible to infections with human-derived TSE agents. Among the best transgenic (Tg) mouse models are those with targeted gene replacement ("knock-in" mice): mice genetically engineered so that a heterologous PRNP gene replaces the normal murine gene, in the natural chromosomal location with normal gene promoters and with normal levels of gene expression. Knock-in mice expressing human prion protein and bovine prion protein (very susceptible to infection with the vCJD agent-perhaps reflecting the bovine origin of most vCJD infections) are currently available only from the Neuropathogenesis Unit, TSE Research Centre (TSE-RC), Roslin Institute, Edinburgh, UK. Two Tg mouse lines expressing different human PRNP genotypes-TgHu-MM and TgHu-VV-have already been requested from TSE-RC by FDA. Mice expressing the bovine PrP gene or other Tg mice may be acquired later from other sources, contingent on contractor's initial success in breeding of TgHu mice, FDA progress in research requiring mice of various genotypes for detecting infectivity of TSE agent, and availability of funding. After consulting with CBER Veterinary Services Staff to identify space and resources needed to breed Tg mice for research at LBPUA, it became clear that this breeding program cannot be conducted at the FDA because of lack of manpower and expertise of LBPUA staff. Therefore, the program must be contracted out to a commercial company having appropriate facilities, trained personnel and experience in breeding mice at the scale needed. Scope The object of the solicitation is to obtain for the FDA a supply of healthy genetically engineered mice ("transgenic mice") bred by the contractor, the lines to originate either from frozen mouse embryos or from breeding pairs to be provided by the FDA. The mice are needed to support FDA research in various aspects of the infectious agents causing transmissible spongiform encephalopathies (TSE, prion diseases) that pose a potential risk to the safety of FDA-regulated products. The initial sub-objective of the contract will be to provide FDA with a sufficient number of transgenic mice susceptible to various forms of human TSE in order to (1) titrate the infectivity in a reference stock panel of up to five TSE agents and (2) detect the presence of the infectious agent in the blood of experimentally infected non-human primates. Five breeding pairs of each Tg mouse line (TgHu-MM and TgHu-VV) will be sent directly to the contractor from the TSE-RC, UK. The animals will be bred to yield a constant supply of at least 50 mice of each Tg line or more depending on breeding success per month. Mice of both sexes will be used by FDA. A total of 100 animals or more depending on breeding success 4 to 7 weeks old will be shipped by the contractor to LBPUA each month. Other sources of promising Tg mice may become available in the future. Tasks The contractor shall: 1. Agree to have an executed signed agreement directly with TSE-RC acknowledging that the contractor is to receive from the FDA mice provided to the FDA by TSE-RC for the sole purpose of breeding them for FDA, that FDA shall be the owner of all Tg mice bred under this contract and of their embryos, sperm and eggs and that no Tg mice or any of the progeny or eggs, sperm and embryos of mice received by or bred by the contractor will be conveyed by sale or by gift to any party other than the FDA. The contractor shall agree to retain at the end of the contract no mice or their embryos, eggs or sperm resulting from the breeding program initiated and supported under this contract. 2. Maintain and follow internal Standard Operating Procedures (SOPs satisfactory to CBER Veterinary Research Services, FDA) required for FDA to accept mice from another animal facility. 3. Conduct standard health checks, facility maintenance, cage sanitation and other customary animal husbandry according to company's internal SOPs and meeting all requirements of AALAC and the PHS Guide and Policy for animal care and FDA. 4. Breed Tg mice (Hu-MM and Hu-VV) using SOPs acceptable to FDA (see Deliverable 2 above) to ensure that FDA requirements are met. 5. Maintain mice in isolators. 6. Genotype each of five randomly selected mice before shipping the first 50 Tg mice of each genotype (10%) to ensure that no mix up of mouse lines has occurred. Genotyping shall be by PCR assay, performed as directed and agreed by LBPUA. 7. Inform the FDA Principal Investigator (PI) and FDA Contracting Officer's Technical Representative (COTR) promptly of all PCR test results. 8. Inform PI within one week if anything out of the ordinary-e.g., unexpected illnesses and facility accidents affecting the well being of the mice-involving the animals in this project is observed. 9. Ship animals according to SOP in appropriate crates to FDA laboratories located at NLRC. 10. Have and maintain capabilities to freeze mouse embryos for long-term storage (at least 1 year) and to recover at least 50% viable embryos from storage if requested. 11. Provide a project manager (PM) experienced in Tg mouse breeding and genotyping and familiar with this project to serve as point of contact for the FDA PI. 12. Provide easy online access at all times to updates on the status of the mouse colony, the number of animals currently available and the projected delivery times. 13. Accommodate changes to shipping schedule if required by FDA. If the shipping schedule is modified, the company will be informed at least one month in advance to make arrangements needed to accommodate the change. Deliverables 1. Deliver at least 50 Tg Hu-MM mice depending on breeding success per month or as otherwise instructed, beginning 90 days after receipt of breeding pairs or 120 days after receipt of frozen mouse embryos found to be viable after recovery from frozen storage. 2. Deliver at least 50 Tg Hu-VV mice depending on breeding success per month or as otherwise instructed on the same schedule as for Deliverable 1. 3. Document animal health checks monthly. 4. Report results of all PCR tests within one week of test completion 5. Submit progress reports for overall breeding program every three months to include reports of contractor's mouse-associated pathogen surveillance program. 6. All mice must undergo a health exam before being shipped to the FDA and must be accompanied by a health certificate. Mice will be examined upon arrival at the FDA, and unhealthy mice will be rejected. Period of Performance This award will be firm-fixed price and contain one (1) base year and one (1) option year as follows: Base Year: August 1, 2010 to July 31, 2011 Option Year 1: August 1, 2011 to July 31, 2012 QUALITY ASSURANCE SURVEILLANCE FDA reserves the right to reject a Tg mouse shipment if: 1. Mouse shipment arrives without health status certificate signed and approved by a qualified contractor's employee. 2. Mice did not undergo a health exam before being shipped to the FDA. 3. Mice do not pass health check when examined upon arrival at the FDA. 4. Mice appear unhealthy during the first week while under quarantine at FDA Veterinary Health Facility. EVALUATION FACTORS FOR AWARD/TECHNICAL EVALUATION CRITERIA Evaluation of Quotes The quotes will be evaluated on the following technical factors: Technical Factors: a. Past performance The contractor must have demonstrated past performance as a Tg mice breeder. Particularly, the contractor must show evidence of successful management of contracts under which the contractor provided at least 50 mice a month for at least 1 year. b. Technical expertise The contractor must have demonstrated technical expertise in breeding transgenic (tg) mice in isolators, supplying Tg mice to research laboratories, and have carrying to successful completion other mouse-breeding contracts similar to this. Breeding Tg mice requires specific training and know-how acquired after years of experience. The contractor must have at least two key personnel: one must be an employee with demonstrated experience with Tg mice breeding who is knowledgeable about the project and to serve as contact person for FDA staff; the second must be a technical service person who has experience in breeding and shipping mice. The contractor must also have appropriate technical expertise to suspend the breeding program temporarily if required by FDA while maintaining breeders to increase the breeding output later if and when requested by FDA. Cost: The Government will use price analysis techniques to evaluate price to determine that prices are fair and reasonable. The contract must explain final proposed estimated costs in a simple and clear itemized budget. Offerors are advised that an award under this Request for Quotation will be made to the Offeror whose proposal is determined by the Government to represent the best value to meet the Government's needs. The technical evaluation factors will receive paramount consideration in the selection of the Offeror for this acquisition. All evaluation factors, other than cost or price, when combined are significantly more important than cost or price. However, cost or price may become a critical factor in source selection in the event that two or more Offerors are determined to be essentially technically equal following the evaluation of all factors other than cost or price. In any event, the Government reserves the right to make an award to the Offeror whose proposal provides the best value to the Government. Vendors must be registered in the Central Contractor Register (CCR) prior to award of a contract. You may register by going to www.ccr.gov. You will need your DUN and Bradstreet number and banking information. The anticipated award date is July 26, 2010. The following FAR clauses apply to this combined synopsis/solicitation. 52.212-1 Instructions to Offers-Commercial Items, 52.212-3 Offer Representations and Certifications-Commercial Items, 52.212-4 Contract Terms and Conditions-Commercial Items, 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial items, 52.217-8 Option to Extend Services (Nov 1999). Quotations shall be submitted electronically to Lisa.Ko@fda.hhs.gov on or before August 2, 2010 at 2:00pm ET. All questions must be emailed no later than July 29, 2010, no phone inquiries will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDARFQ1075219/listing.html)
- Record
- SN02222795-W 20100731/100730000022-cfb28b8d225ef570079a9760ed964f39 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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