SOLICITATION NOTICE
A -- Radio-Labeled Drug Synthesis and Imaging Services
- Notice Date
- 8/10/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- 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
- 1061933
- Archive Date
- 9/5/2009
- Point of Contact
- Jaclyn Stielper, , Doreen Williams , Phone: 301-827-3366
- E-Mail Address
-
jaclyn.stielper@fda.hhs.gov, doreen.williams@fda.hhs.gov
(jaclyn.stielper@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- 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 05-35. This announcement constitutes the only 100% total small business set aside solicitation and a written solicitation will not be issued. This synopsis, NAICS code 541712, is to notify contractors that the government intends to issue a Firm Fixed Price Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. 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. 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. Award will be made to the party whose quote offers the best value to the Government, technical, price, and past performance considered. The Government may award this contract to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor, 2) Past Performance and 3) Price. Technical Capability and Past Performance, when combined, are significantly more important than price. This solicitation is issued as a Request for Quotation (RFQ). The Food and Drug Administration (FDA) intends to award a purchase order for radio-labeled drug synthesis and imaging services. General Duties/Description of Work 1) Project Title: PET Imaging for Drug Efficacy/Toxicity 2) Statement of Need. Background. Docetaxel has value in the treatment of several tumors, including breast and lung cancer. It would be especially desirable to identify those tumors that are likely to be sensitive to docetaxel in a disease such as breast cancer, because there are many alternative drugs that could be used if docetaxel were ineffective. Several determinants for the antitumor activity of docetaxel are known. However, the most readily investigated mechanisms of sensitivity or resistance to docetaxel appear to be the steps of celluar uptake and efflux. Because the sensitivity of tumor cells to docetaxel is directly linked to the amount of drug that accumulates inside the cell, positron-labeled docetaxel might be useful as a probe for noninvasive external imaging of uptake and retention of docetaxel. The ability of tracer amounts of radiolabeled docetaxel to evaluate the net effect of these two transport steps with this single probe is potentially a powerful tool to improve response rates and decrease unnecessary toxicity by matching drugs to tumors. The Laboratory of Clinical Pharmacology (LCP) at FDA developed a micro-synthesis demonstrating the feasibility of radiolabeling docetaxel and now allows the project to move to the next stage, preclinical studies using 11C-docetaxel including determination of dosimetry in rodents. Statement of work. The contractor shall furnish the necessary personnel, services, materials, and otherwise do all things necessary for, or incident to, the performance of work as described below. LCP will be responsible for acquisition of the labeling precursors and non-labeled antitumor drugs. I.The contractor shall work closely with the study liaison and project officer throughout the lifespan of the contract. II.The contractor shall perform appropriate pre-clinical testing (i.e. dosimetry) of 11C-docetaxel that will enable activation of a clinical protocol under RDRC or IND regulations. III.The contractor shall perform, in collaboration with LCP, imaging studies of 11C-docetaxel in tumor bearing mice that examine/explore the hypothesis that 11C-docetaxel accumulation in tumors correlates with docetaxel antitumor efficacy. These studies should demonstrate specific tumor accumulation of 11C-docetaxel (e.g. through comparison to other 11C-antitumor drug probes such as 11C-topotecan). Results of these studies will enable publication in peer-reviewed journals. Deliverables: 1. The contractor shall issue monthly status reports to the project officer and study liaison indicating progress since the last report. 2. The contractor shall develop and submit a plan of study to the to the project officer and study liaison for review prior to initiating experiments. 3. The contractor shall develop appropriate quality control testing to assure that the synthesized compound is pure and acceptable for injection in human beings. a. Develop appropriate stability testing protocols and assure that the radiopharmaceutical is sufficiently stable for use in human subjects. b. Perform appropriate pre-clinical testing (i.e. dosimetry) required for activation of a clinical protocol under RDRC or IND regulations. c. Provide written documentation of personnel qualifications and their training related to working with radiopharmaceuticals. d. If proposed human testing requires an IND, the vendor will work with LCP to write appropriate documentation for producing 11C-docetaxel in sufficient detail for successful IND or DMF filing with the FDA, including background development information, written chemistry and synthesis methods, and QA procedures to assure that the synthesized compound is pure and acceptable for injection in human beings. e. If this development project progresses to a Phase I or II trial, the documentation produced must meet the current Good Manufacturing Practices requirements for production of IND drugs. f. Provide a written plan for auditing and allowing outside auditors to visit the facility as appropriate. 4. At the completion of the project the contractor shall provide a final report that includes a summation of results of the monthly reports and conclusions drawn from the findings. Dosimetry studies: 12 animals to be scanned. Tumored animal studies: 36 animals to be scanned. Period of Performance The contract period of performance will be one (1) year from date of award. 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 Jaclyn.Stielper@fda.hhs.gov no later than August 17, 2009 at 4:30 PM EST. Telephone calls will not be accepted. QUOTATIONS DUE: All quotations are due, via email to: Jaclyn.Stielper@fda.hhs.gov, no later than 4:30 PM EST on August 20, 2009. 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 52.217-9, 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1061933/listing.html)
- Place of Performance
- Address: Contractor's Facility, United States
- Record
- SN01906354-W 20090812/090811002604-08f9165639614df4f9e9ea0380962241 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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