SOLICITATION NOTICE
A -- Scientific and Technical Consulting Services for ErbB-kinase Expertise
- Notice Date
- 8/26/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting 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
- FDA-RFQ-1073511
- Archive Date
- 9/29/2010
- Point of Contact
- ZetherineGore, Phone: (301) 827-5093
- E-Mail Address
-
zetherine.gore@fda.hhs.gov
(zetherine.gore@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 05-44. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code, 541690 is to notify contractors that the government intends to issue a Purchase Order for the following statement of work. The requirement is solicited as a full and open competition. 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. 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 Quotation (RFQ) No. 1073511. The requirement is for scientific and technical services for the research investigation of multiplex protein arrays for detecting biomarkers predictive of chemotherapy sensitivity-resistance in breast carcinoma patients. 1. SCOPE OF WORK FDA has the expertise in the design and development of multiplex immunoassays for protein quantification. However, FDA requires subject matter expertise and access to independently verified real-world samples to validate the FDA designed multiplex assays used in this context. The FDA requires the Contractor to have excess to the drug compounds lapatinib and erlotinib and expertise in using them, have access to multiple human carcinoma cell lines, initially 4 separate cell lines- 2 sensitive and 2 resistant, and have the ability to independently verify the presence and activation state of the selected biomarker molecules mentioned (initially: erbB1, erbB3, Akt, Erk ½) in various human carcinoma cell lines. The Contractor shall assist FDA with biomarker selection (up to 10) and provide appropriate samples that are independently validated for biomarker presence in treated cells. FDA will be responsible for the design and optimization of multiplexed antibody arrays as an analytical means of analyzing and quantifying the proximal signaling events through biomarker detection and quantification. The event biomarkers are involved in ErbB-kinase pathway to predict anti-tumor activity and clinical response to therapy. The Contractor shall characterize and assess a limited selection of cell lines for drug response before shipment to the FDA. 2. STATEMENT OF WORK The Contractor shall provide FDA with subject matter expertise and support throughout the period of collaboration on the selection of suitable biomarkers (up to 10) involved in the ErbB-kinase pathway for predicting anti-tumor activity and clinical response to therapy. The Contractor shall provide FDA with drug exposed cell line samples (initially 4 separate cell lines- 2 sensitive and 2 resistant) for analysis, which the Contractor shall characterize using alternative technologies (including Western Blot and/or SECTOR System analysis -Platform from MESO Scale Discovery) were appropriate. The Contractor shall expose known sensitive and resistant cell lines to the drug therapies, using their pre-determined protocol of exposure. The Contractor shall then process and store the samples appropriately for shipment to and analysis by the FDA. Sample numbers must be statistically relevant to validate the FDA designed multiplex antibody array. It may be necessary to make design modifications during the course of the contract if warranted by results. The Contractor shall recommend biomarker targets to be included in the FDA designed multiplex antibody array. The Contractor shall have access to laboratory facilities and expertise that will allow them to validate biomarker levels in samples prior to shipment to the FDA. Biomarkers shall be measured by Western Blot and where appropriate the SECTOR System analysis -Platform from MESO Scale. 3. DELIVERIES The Contractor shall ship drug exposed cell line samples to the Contracting Officer's Technical Representative (COTR) at an FDA facility in Silver Spring, Maryland. The COTR will perform inspection and acceptance of materials and services provided. All deliverables required under the contract shall be packaged, marked and shipped in accordance with Government specification. At a minimum, all deliverables shall be marked with the contract number and contractor name. All deliverables shall be delivered F.O.B. Destination. The Contractor shall provide a written midterm and final status report to the COTR and the Contracting Officer. The midterm report shall consist of the samples provided to the FDA and the independent characterization of the samples using Western Block and Western Blot and SECTOR System analysis -Platform from MESO Scale. The final report shall consist of a summary of all samples and data provided to the FDA during the period of performance and expert advice and recommendations. Specific delivery addresses will be included in any resultant contract. Inspection and acceptance of materials and services provided will be performed by the COTR. 4. ACCESS TO NON-PUBLIC INFORMATION All contractor and subcontractor employees are required to sign the Contractor's Commitment to Protect Non-Public Information (NPI) Agreement (Form FDA 3398) provided as an attachment to this contract. If a person who has signed this agreement resigns, is dismissed, or is otherwise no longer working on this contract, the Contractor shall notify the FDA Project Officer and the Contracting Officer. Any new contractor or subcontractor employee assigned to this contract shall sign the form, and the Contractor shall hand-deliver it to the Contracting Officer ten (10) days prior to said new employee's commencement of work on this contract. The prime contractor, subcontractors, and consultants shall not be provided nor possess non-public information in any form unless written approval has been granted, nor shall they have unaccompanied access to an FDA facility unless a facility clearance has been granted. Briefings An FDA representative (typically, the Project Officer) will conduct an orientation briefing for the contractor and subcontractor employees. The briefing will stress: (1) the importance of protecting non-public information; (2) specified computer/IT requirements as outlined in the DHHS Automated Information Systems Security Program Handbook; and (3) the consequences of unauthorized disclosure of non-public information. Briefing updates will be conducted annually. The contractor shall brief all contractor employees, subcontractors and consultants regarding the sensitivity of the information to be handled under the contract and of their responsibility to protect it. The briefing shall stress that the information is non-public and shall not be disclosed to any unauthorized party. The contractor shall conduct an updated briefing annually and shall submit a report to the FDA Project Officer within ten (10) days after the briefing which includes: an outline of the briefing; copies of any briefing materials; the date the briefing was conducted; and the names of the attendees. If this is an information technology/telecommunications (IT/TC) contract, in addition to the above briefings, the FDA Project Officer and the FDA Center/Office Information Systems Security Officer (ISSO) will brief contractor and subcontractor personnel on security measures required pertinent to any hardware/software being utilized. Furthermore, appropriate contractor and subcontractor personnel shall attend training courses as directed by the FDA to fulfill requirements of the Computer Security Act of 1987. These courses are generally one (1) day in length, and attendance at one (1) course is sufficient. This training will be provided at no cost to the contractor. 5. PERFORMANCE PERIOD The contract performance period will be for 10 months. 6. EVALUATION FACTORS FOR AWARD The technical proposal will receive paramount consideration in the selection of the Contractor for this procurement. In the event that the technical reveals that two or more offerors are approximately equal in technical ability, then price will become a significant factor. The Government reserves the right to make an award to the best advantage of the Government, price and other factors considered. The evaluation will be based on the completeness, thoroughness of the offer and the demonstrated capabilities of the Offeror in relation to the needs of the Statement of Work as set forth in this solicitation. The merits of each offer will be evaluated. Each quote shall document the feasibility of successful implementation of the requirements of the RFQ. Offerors must submit information sufficient to evaluate their quote based on the Evaluation Criteria listed below. Evaluation Criteria a. Offerors shall demonstrate their specific subject matter expertise in multiple biomarkers involved in the ErbB-kinase pathway for predicting anti-tumor activity and clinical response to anti-EGFR targeted therapies. Offerors shall site previously conducted studies and/or publications characterizing cell response of multiple biomarkers to clinical therapies through Biomarker screening assays. b. Offerors shall describe in detail their access to the drug compounds and cells lines with known sensitive and resistant responses to the therapeutic drugs, i.e. sample preparation. c. Offerors shall provide specific information that addresses their access to laboratory facilities and expert resources to validate biomarker levels in samples to be shipped to FDA. 7. PRICING: The Offeror's fixed price shall be provided for the entire performance period and shall include all materials, personnel, indirect, and any other direct costs. The Offeror's quote shall name the proposed personnel and labor categories, the proposed level of effort, and list the proposed materials and supplies and their cost. Upon acceptance of contract deliverables and after receipt of a proper invoice, the negotiated fixed contract price will be paid in equal monthly installments. 8. 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. 9. 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. 10. DEADLINE FOR SUBMISSION OF QUESTIONS All questions pertaining to this solicitation must be submitted via email to zetherine.gore@fda.hhs.gov by 12:00 p.m. EST on Wednesday, September 1, 2010. 11. QUOTATION DUES: All quotations are due no later than 12:00 p.m., EST on Tuesday, September 14, 2010. Quotations must be received electronically and be in PDF format. Quotations must not exceed 15 pages. The 15-page limitation includes all information. Submit quotations to: zetherine.gore@fda.hhs.gov No telephone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-RFQ-1073511/listing.html)
- Place of Performance
- Address: Performance shall be off-site at the Contractor's facility., United States
- Record
- SN02256102-W 20100828/100826235845-95d3211cb19f61cab47ec89e6c38d3c0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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