SOLICITATION NOTICE
A -- Phospholipid profiling services of urine and tissue samples
- Notice Date
- 8/10/2009
- Notice Type
- Cancellation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- 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
- 1061713
- Archive Date
- 9/4/2009
- 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 325412, 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 other factors 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 described to "Meet or Exceed the Requirement," 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 phospholipid profiling services of urine and tissue samples General Duties/Description of Work The purpose of this contract is to provide measurements of the levels of potential lipid biomarkers of phospholipidosis, including 17 different phospholipids and didocosahexaenoyl (C22:6)-bis(monoacylglycerol)phosphate (BMP), using LC/MS/MS in tissue and urine samples collected in parallel from studies on the toxicogenomic response to phospholipidosis in rats. The data will allow evaluation of relationships between urinary markers and histopathological observations of drug-induced phospholipidosis in tissues. The contractor will evaluate 17 different phospholipids and di-docosahexaenoyl (C22:6) bis(monoacylglycerol)phosphate (BMP), using LCIMSIMS in tissue or urine samples from four studies, each investigating a different phospholipidotic drug. Animal Study Format: The Contractor will evaluate urine samples from independent studies within the project that involve 4 different drug treatments (designed as dose response and/or time response studies) in separate shipments. a) Evaluate an estimated 10 urine samples and 30 tissue samples per study across a time course or dose response in laboratory rats. Prepare full report per study. b.) Evaluate 4 independent studies within the project that involve different paradigm compounds. For an estimated total of 40 urine samples, 120 tissue samples and 4 full reports. i) Study 1: Evaluate an estimated 10 urine samples and 30 tissue samples across a time course or dose response in laboratory rats with drug 1 and prepare full report. ii) Study 2: Evaluate an estimated 10 urine samples and 30 tissue samples across a time course or dose response in laboratory rats with drug 2 and prepare full report. iii) Study 3: Evaluate an estimated 10 urine samples and 30 tissue samples across a time course or dose response in laboratory rats with drug 3 and prepare full report. iv) Study 4: Evaluate an estimated 10 urine samples and 30 tissue samples across a time course or dose response in laboratory rats with drug 4 and prepare full report. For a total of 120 samples and 4 full reports. The work performed under this purchase order will not exceed 120 samples. Reporting Requirements and Other Deliverable Items a) The contractor will provide a report for each study that include phospholipid and BMP levels for individual animals in each treatment group as well as group averages within 120 day of receipt of the samples for each study in the Project, along with an invoice for the work performed. Duration of Project The small acquisition will be for 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/1061713/listing.html)
- Place of Performance
- Address: Contractor's Facility, United States
- Record
- SN01906409-W 20090812/090811002653-290659bf14af10209b015b708f427aac (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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