SOLICITATION NOTICE
B -- Validation of High Throughput Assays
- Notice Date
- 10/7/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Environmental Protection Agency, Ord Service Center/Nheerl, Rtp Procurement Operations Division, Research Triangle Park, NC 27711
- ZIP Code
- 27711
- Solicitation Number
- RFQ-RT-04-00009
- Response Due
- 10/22/2003
- Archive Date
- 11/22/2003
- Point of Contact
- Point of Contact, Ardra Morgan-Kelly, Purchasing Agent, Phone (919) 541-3670
- E-Mail Address
-
Email your questions to U.S. Environmental Protection Agency
(morgan.ardra@epa.gov)
- Description
- NAICS Code: 541990 NAICS CODE: 541990 THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6 AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION. QUOTES ARE BEING REQUESTED AND A WRITTEN SOLICITATION WILL NOT BE ISSUED. The solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular 01-15. The associated North Industry Classification System (NAICS) is 541990 and the business size standard is $5.0 million. Full and open competitive procedures will be unutilized. A firm, fixed price purchase order using Simplified Acquisition Procedures is anticipated to result from the award of this solicitation. This procurement is for the Validation of high throughput assays for prolactin, IgG, TNF-alpha, IL-6, leptin, triglycerides, glucose and estradiol for use with fresh breast milk. STATEMENT OF WORK: A. Background: The US Environmental Protection Agency is initiating studies to advance the current methods used in measurement of endogenous and exogenous components of breast milk (Methods Advancement in Milk Analysis - MAMA). The Human Studies Division of the National Health and Environmental Effects Research Laboratory (NHEERL) (located at 104 Mason Farm Rd. Chapel Hill, NC 27514), will collect breast milk and other body fluids from 20-25 women. This study has received UNC IRB approval. The obtained fluids will be analyzed for 8 endogenous components, all of which have no commercial assays available for them, to determine if milk may be frozen at -20 or -80 C and retain accurate measurements of the actual input to the child (fresh sample). The fluids will also be used to measure the concentrations of many exogenous (environmental) components and to determine how those contaminants are partitioned throughout the body fluids. These endpoints are of interest for the development of hypotheses in the up-coming, multi-Agency endorsed, National Children's Study. The EPA will publish the results of this study without releasing any propriety contractor information. B. Contractor Requirements: The Contractor shall: 1. Provide all reagents and equipment, project management and administration, and senior research technologist required to validate assays for prolactin, immunoglobulin G, tumor necrosis factor-alpha, interleukin-6, leptin, triglycerides, glucose, and estradiol for use with fresh breast milk. a. Provide milk sample preparation methods for each assay b. Determine assay precision 1. Precision shall not exceed 15% CV; LOQ 20% CV 2. Use 95% confidence intervals for data evaluation c. Determine assay accuracy using spike recovery d. Determine assay linearity using dilusional recovery 2. Apply time not used on quick validation of one assay toward more time consuming assays (estimated time is 200 hours) 3. Inform Project Officer more than a week in advance of unsuccessful efforts at validation. 4. Retain all intellectual property for the protocols used in assays developed. 5. Provide daily transportation for samples from the UNC facility to contractor location. 6. Measure levels of endogenous milk components in fresh and frozen breast milk samples provided through the MAMA study following development of these reliable assays for use with milk. All samples shall be run in duplicate.7. Measure breast milk and serum samples from the MAMA study within 8 hours of collection. C. Government Responsibilities: The EPA will: 1. The EPA will develop a reliable assay using a commercially available source for secretory immunoglobulin A and will share this data with the contractor. 2. Provide advice or verbal assistance in troubleshooting difficult assays, if consulted. 4. Provide the samples from the MAMA study to the contractor by noon, plus or minus one hour, on the designated date. 5. Publish the results from this study in a peer-reviewed journal as quickly as possible upon study completion and data analyses. D. Reporting requirements: Validations: 1. Provide the EPA Project Officer with copies of raw data (duplicate values, means, SD, CV, range) and analyses proving assay validities. 2. Provide weekly feedback on assay development via phone. Sample Analysis: 1. Provide publication quality raw data to the EPA Project Officer within 3 weeks of analyzing the individual samples. SELECTION CRITERIA: The EPA will select a vendor based upon both cost and technical factors so that the Agency receives the best value for this purchase with Technical, Past Performance and Price equally important. Selection will be based on the following criteria: 1. Technical - The offeror shall demonstrate their approach and knowledge to fulfill the requirements specified in the Statement of Work. The offeror shall have in place all 8 of the required assays mentioned in section B.1 of the SOW, for use with serum. The offeror shall demonstrate successful completion of assay validations and provide proof that these assays are reliable. The offeror shall provide a detailed technical approach that demonstrates their ability to perform the requirements needed for validation of these same assays for breast milk, meeting the criteria outlined in the sections B.1-3. The offeror shall demonstrate their ability to provide assessment of fresh milk samples within 8 hours after sample collection. 2. Past Performance - The offeror shall demonstrate successful past performance of the prime and any major subcontractors as evidenced by the submission of at least 3 references for similar efforts with regard to size and complexity to this effort during the last 3 years and points of contact with phone numbers for those POCs. The following FAR provisions shall apply to the solicitation: 52.212-1, Instructions to Offerors -- Commercial Items. All offerors are to include with their offer a completed copy of provision 52.212-3, Offeror Representations and Certifications--Commercial Items. The following FAR clause applies to the acquisition: 52.212-4, Contract Terms and Conditions--Commercial Items. The following additional FAR clauses which are cited in Clause 52.212-5 are applicable to this acquisition: 52.222-21, Prohibition of Segregated Facilities ; 52.222-26, Equal Opportunity, 52.222-35, Affirmative Action for Special Disabled and Vietnam Era Veterans; 52.222-36 Disabled Veterans and Veterans of the Vietnam Era; 52.222-19, Child Labor-Cooperation with Authorities and Remedies; 52.222-51, Buy American Act--Balance of Payments Program; 52.232-34, Payment of Electronic Funds Transfer. COMMERCIAL BUY CLAUSES AND FORMS are provided for your convenience at EPA's website: http://www.epa.gov/oam/rtp-cmd. Please submit to Ardra Morgan-Kelly, @ (919) 541-4273(fax) or email: morgan-kelly.ardra@epa.gov phone:(919) 541-3670 All offers are due by Oct 22, 2003 1:00pm, EDT
- Record
- SN00449079-W 20031009/031007213243 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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