SOLICITATION NOTICE
99 -- Expansion and validation of in vitro assays for detection of events predictive of leukemogenic potential
- Notice Date
- 6/1/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 561410
— Document Preparation Services
- 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
- REQ1041415
- Point of Contact
- Monifa N Coleman, Phone: 301-827-7164
- E-Mail Address
-
monifa.coleman@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-25. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 561410, 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. The Food and Drug Administration intends to award a purchase order on a sole source basis to: Medizinishe Hochschule Hannover. Not withstanding, any firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services, which will be considered if received by the second (2nd) calendar day following the appearance of this announcement. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. 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. This solicitation is issued as a Request for Quote (RFQ) The Government’s period of performance is for one (1) year effective ARO. The Food and Drug Administration (FDA) intends to award a purchase order for the expansion and validation of in vitro assays for detection of events predictive of leukemogenic potential of retroviral vector from pre-clinical or clinical samples. The Statement of Work is as follows: Objective: Define the optimal parameters and target cell for an in vitro assay method that is reproducible, sensitive, and quantifiable in detection of retroviral vector-mediated cell transformation. Scope of Work: Identify the target cell type, in 3 steps. 1) Identify the primary hematopoietic cell source that provides a reliable and sensitive measure of transformation due to vector-mediated insertional mutagenesis. Different hematopoietic cell lineages will be analyzed for their relative sensitivity to transformation after vector transduction in an established replating assay. 2) Using different retroviral vectors varying in the types of regulatory elements included in the backbone, the mechanism of transformation as a function of vector backbone will be determined. Analysis of frequency of transformation events in the optimized assay and mapping of genomic integration sites will be used to elucidate the mechanism associated with different regulatory elements. The results will be used to rationally design various types of integrating vectors that can circumvent the mechanisms identified as primary drivers of transformation events. 3) Clonal lines (murine or human) carrying specific oncogenes will be established and tested for reversion of transformation due to down-regulated expression of the oncogene using inducible promoters, thus making the transformation phenotype conditional. These cells will be examined for resistance to oncogene down-regulation as a result of insertional mutagenesis – perhaps leading to an unrestricted, highly reproducible cell line for the transformation assay Period of Performance: One (1) year effective ARO. PAYMENT SCHEDULE: Payment will be made in monthly installments based on level of effort (hours worked). CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to Monifa.Coleman@fda.hhs.gov no later than June 3, 2008, 2:00pm EST. QUOTATIONS DUE: All quotations are due, via email to: Monifa.Coleman@fda.hhs.gov, no later than 2:00pm, EST on June 6, 2008. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to Monifa.Coleman@fda.hhs.gov. No phone calls will be accepted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=a742987e296c9cbc2323bc5c3a20112c&tab=core&_cview=1)
- Place of Performance
- Address: Hannover Medical Schoo, Carl-Neuberg-Str. 1, OE 6960l, Non-U.S., Germany
- Record
- SN01584432-W 20080603/080601213039-a742987e296c9cbc2323bc5c3a20112c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |