SOLICITATION NOTICE
B -- SCREENING FOR HEPATOCYTES
- Notice Date
- 8/2/2004
- Notice Type
- Solicitation Notice
- Contracting Office
- Environmental Protection Agency, Rtp Procurement Operations Division, 109 T W Alexander Drive, Rtp, NC 27711
- ZIP Code
- 27711
- Solicitation Number
- RFQ-RT-04-00369
- Response Due
- 8/20/2004
- Archive Date
- 9/20/2004
- Point of Contact
- Point of Contact, Jennifer Hill, Purchasing Agent, Phone (919) 541-3083
- E-Mail Address
-
Email your questions to U.S. Environmental Protection Agency
(hill.jennifer@epa.gov)
- Description
- NAICS Code: 541710 THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL SERVICES PREPARED IN ACCORDANCE WITH THE FORMAT IN SUBPART 12.6, AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION. QUOTATIONS ARE BEING REQUESTED AND A WRITTEN SOLICITATION WILL NOT BE ISSUED. The solicitation number is RFQ-RT-04-00369, and the solicitation is being issued as a 100% small business set-aside competition Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 01-24. The associated North American Industry Classification System (NAICS) Code 541710, which has a size standard of 500 employees to qualify as a small business, is applicable. A firm, fixed-price contract is anticipated to result from the award of this solicitation. This procurement is for the screening for hepatocytes from the date of award through September 30, 2005. A number of chemicals activate the CAR and PXR pathways in rats and mice. Activation of these pathways leads to a variety of biochemical and toxicological effects. Recent evidence suggests that there are species differences in the structure activity relationship for activating this pathway between mice, rats and humans. This contract is for EPA to obtain RNA samples from fresh mouse, rat and human primary hepatocytes exposed to environmental chemicals. The RNA will be used to characterize activation of CAR/PXR pathways. The contractor is required to perform three phases of work: 1. Initial dose range finding study. 2. A dose response study in rat hepatocytes. 3. A dose response study in human hepatocytes. The following minimum and maximum number of chemicals are anticipated. Minimum number of chemicals - 6; Maximum number of chemicals - 10. Phase 1. Initial Dose Range Finding Studies in Rat Hepatocytes. 1. Obtain rat hepatocytes. The contractor will certify that the animals were treated in accordance to NIH guidelines. Males and females of either Sprague-Dawley, Wistar or Long Evans rat strains may be requested. Rats will be approximately 60 days old at time of hepatocyte isolation. 2. Rat gender and strain will be specifically requested for each study by the USEPA. 3. Culture hepatocytes according to the method of LeCluyse et al (1996, 2000). Rat hepatocytes should be plated at a density of 3.5 x 106 cells/60 mm plate. Hepatocytes should be cultured for 2-3 days prior to exposure to test chemicals. 4. In the pilot study, hepatocytes from one (1) rat will be isolated and dose response assessment shall be performed. 5. Expose hepatocytes. For each test chemical there will be eight (8) treatment groups as follows: 1 - vehicle control; 2 -7 treatment with various concentrations of test chemicals; 8 - Pregnenlone 16-alpha carbonitrile (50 M) (positive control). 6. For each treatment group there shall be two 60 mm plate at a density of 3.5 x 106 hepatocytes/plate. Thus for each test chemical there shall be 8 treatment groups run in duplicate, resulting in 16 plates of treated hepatocytes. One plate shall be used for isolation of RNA and the second shall be used for the determination of hepatotoxicity. 7.Cells will be treated for three consecutive days with test chemicals. 8. The cells shall be harvested 24 hours after the last treatment for isolation of RNA and determination of hepatotoxicity. 9. Hepatotoxicity shall be determined by measurements of release of alanine aminotransferase into the media or an equivalent measure of hepatotoxicity. 10. The contractor shall isolate the RNA from one 60 mm plate for each treatment group. The RNA must be free of genomic DNA (confirmed by lack of PCR amplicon), highly pure (A260/280 > 1.7) and not degraded (28S/18S rRNA ratio of > 1.5). 11. The contractor shall send the RNA on dry ice by overnight mail. Phase 2-Dose Response Studies in Rat Hepatocytes 1. Obtain rat hepatocytes. The contractor will certify that the animals were treated in accordance to NIH guidelines. Males and females of either Sprague-Dawley, Wistar or Long Evans rat strains may be requested. Rats will be approximately 60 days old at time of hepatocyte isolation. 2. Rat gender and strain will be specifically requested for each study by the USEPA. 3. Culture hepatoctyes according to the method of LeCluyse et al (1996). Rat hepatocytes should be plated at a density of 3.5 x 106 cells/60 mm plate. Hepatocytes should be cultured for 2-3 days prior to exposure to test chemicals. 4. Expose hepatocytes. For each test chemical there will be 6 (six) treatment groups as follows: 1 - vehicle control; 2 - low dose test chemical; 3 - mid dose test chemical; 4 - high dose test chemical;5 - Pregnenlone 16-alpha carbonitrile (50 M) (positive control);6 - Pregnenlone 16-alpha carbonitrile (50 M) plus high dose test chemical. 5. For each treatment group there shall be two 60 mm plate at a density of 4 x 106 hepatocytes/plate. Thus for each test chemical there shall be 6 treatment groups run in duplicate, resulting in 12 plates of treated hepatocytes. 6. Cells will be treated for three consecutive days with test chemicals. 7. The cells shall be harvested for RNA or microsomal isolation, 24 hours after the last treatment with test chemical. 8. The contractor shall isolate the RNA. The RNA must be free of genomic DNA (confirmed by lack of PCR amplicon), highly pure (A260/280 > 1.7) and not degraded (28S/18S rRNA ratio of > 1.5). 9. The contractor shall send the RNA on dry ice by overnight mail. Phase 3-Dose Response Studies in Human Hepatocytes. 1. Obtain human hepatocytes from 3 different donors. The contractor will certify that the human material was collected and that the identify of the source(s) of the material is being protected in a manner consistent with the Common Rule. 2. Culture individual donor hepatoctyes according to the method of LeCluyse et al (1996,2000). Human hepatocytes should be plated at a density of 4 x 106 cells/60 mm plate. Hepatocytes should be cultured for 2-3 days prior to exposure to test chemicals. 3. Expose individual donor hepatocytes. Dose response studies for each test chemical shall be performed on each donor hepatocyte. For each test chemical there will be 6 (six) treatment groups as follows: 1 - vehicle control; 2 - low dose test chemical; 3 - mid dose test chemical; 4 - high dose test chemical; 5 -Rifampicin (10 M) (positive control);6 - Rifampicin (10 M) plus high dose test chemical. 4. For each treatment group there shall be two 60 mm plate at a density of 4 x 106 hepatocytes/plate. Thus for each test chemical there shall be 6 treatment groups run in duplicate, resulting in 12 plates of treated hepatocytes. 5. Hepatocytes will be treated for three consecutive days with test chemicals. 6. The hepatocytes shall be harvested for RNA or microsomal isolation, 24 hours after the last treatment with test chemical. 7. The contractor shall isolate the RNA. The RNA must be free of genomic DNA, as confirmed by lack of PCR amplicon, and, highly pure (A260/280 > 1.7) and not degraded (28S/18S rRNA ratio of > 1.5). 8. The contractor shall send the RNA to the USEPA on dry ice by overnight mail. Deliverables: Phase 1. Within 60 days of receiving test chemicals from the USEPA, the contractor shall provide the USEPA with the following: 1)Dose response data on measurements of hepatotoxicity; 2)RNA at the purity requested. The RNA must be free of genomic DNA (confirmed by lack of PCR amplicon), highly pure (A260/280 > 1.7) and not degraded (28S/18S rRNA ratio of > 1.5); 3) The contractor shall provide the data demonstrating the purity of the RNA. Phase 2. Within 60 days of receiving test chemicals and dose levels to be tested from the USEPA, the contractor shall provide the USEPA with the following: 1)Dose response data on measurements of hepatotoxicity; 2)RNA at the purity requested. The RNA must be free of genomic DNA (confirmed by lack of PCR amplicon), highly pure (A260/280 > 1.7) and not degraded (28S/18S rRNA ratio of > 1.5); 3) The contractor shall provide the data demonstrating the purity of the RNA. Phase 3 Within 60 days of receiving test chemicals and dose levels to be tested from the USEPA, the contractor shall provide the USEPA with the following: 1) Dose response data on measurements of hepatotoxicity; 2) RNA at the purity requested. The RNA must be free of genomic DNA (confirmed by lack of PCR amplicon), highly pure (A260/280 > 1.7) and not degraded (28S/18S rRNA ratio of > 1.5); 3) The contractor shall provide the data demonstrating the purity of the RNA. Acceptance: Upon receipt of the RNA samples and/or data, the USEPA has 30 days to notify the contractor of acceptance of the work performed. Performance will be acceptable if the RNA meets the purity requirements described above. Government Responsibilities. The government will supply the contractor with the following: 1. Appropriate dilutions of test chemicals in saline, DMSO or other vehicle. 2. The government shall provide MSDS sheets for each test chemical. 3. The chemicals to be tested are pesticides and flame retardants that have already been approved by the USEPA and are marketed in the US. The acute toxicity of these chemicals shall be above 1 mg/kg in rodents. 4. Acceptance: Upon receipt of the RNA samples and/or data, the USEPA has 30 days to notify the contractor of acceptance of the work performed. Offerors shall provide a price quote for each phase as described above. The following FAR provisions apply to this solicitation: 52-212-1, Instructions to Offerors-Commercial Items; 52.212-2, Evaluation-Commercial Items. Evaluation criteria to be included in paragraph (a) of provision 52.212-2 are as follows: 1)Technical approach to accomplish the statement of work to include: a.) Adequacy of facilities and methods of hepatocyte isolation, culturing techniques, and RNA isolation methodologies. b.)Demonstrated evidence of peer reviewed publications on treating rat and human hepatocytes with P-450 inducers and determination of cytochrome P-450 mRNA from rat and human hepatocytes; publications on isolating mRNA from rat and human hepatocytes; or publications on studies that are similar. c.)Adequacy of procedures to ensure that human hepatocytes are obtained consistent with the Common Rule and that the identity of the subjects will not be available to the EPA. 2)Demonstrated adequacy of the Quality Control/Quality Assurance Plan consistent with the statement of work. 3)Past Performance - Submit a list of 3 customers for whom like or similar services have been performed within the past 2 years. Include specific points of contact and phone numbers. Past Performance will be evaluated on a) quality of service; b) timeliness of performance; and c) overall customer satisfaction. 3)Price. Award will be made to the offeror whose offer is determined the best overall value to the government, price and other factors considered. For the purpose of this best value evaluation of technically acceptable proposals, technical capabilities and past performance, when combined, are significantly more important than price. 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 clauses apply to this acquisition: 52.212-4, Contract Terms and Conditions-Commercial Items; 52.246-11, Higher Level Contract Quality Requirement, 1552.233-70, Protection of Human Subjects, 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items and the following additional FAR clauses which are cited in Clause 52.212-5: 52.203-6 Restrictions on Subcontractor Sales to the Government, Alt I; 52.219-6, Notice of Total Small Business Set-Aside; 52.219-8, Utilization of Small Business Concerns; 52.219-14, Limitations on Subcontracting; 52.222-3, Convict Labor; 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 Affirmative Action for Handicapped Workers; 52.222-37, Employment Reports on Special Disabled Veterans and Veterans of the Vietnam Era; 52-232-33, Payment by Electronic Funds Transfer. The completed Representations and Certifications should be included with the price quotation. All technical questions are to be forwarded via email to the Contracting Officer at the following email address: hill.jennifer@epa.gov. Offerors should review the Statement of Work and other information posted with this Request for Quotation on EPA's website at the following address: http://www.epa.gov/oam/rtp_cmd. Scroll down to the REQUEST FOR QUOTATIONS section and click on the solicitation. Scroll down below that section to COMMERCIAL BUY CLAUSES AND FORMS which are provided for your convenience. Please submit four copies of the technical proposal and two copies of the price proposal to Jennifer B. Hill, Contracting Officer, U.S. Environmental Protection Agency, RTP Procurement Operations Division (D143-01), Research Triangle Park, NC 27711 if using US Post Office. Courier delivery address is U.S. Environmental Protection Agency, Attn: Jennifer B. Hill, RTP Procurement Operations Division (D143-01), 4930 Page Road, Durham, NC 27703. All offers are due by August 20, 2004, 12:00 p.m.,EDT. No telephonic or faxed requests will be honored.
- Record
- SN00635137-W 20040804/040802212505 (fbodaily.com)
- Source
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