SOLICITATION NOTICE
B -- Human Hepatocytes and Liver Microsomes
- Notice Date
- 8/21/2006
- Notice Type
- Solicitation Notice
- Contracting Office
- RTP Procurement Operations Division (D143-01) Research Triangle Park, NC 27711
- ZIP Code
- 27711
- Solicitation Number
- PR-NC-06-10503
- Response Due
- 9/6/2006
- Archive Date
- 10/6/2006
- Small Business Set-Aside
- Total Small Business
- Description
- 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. PROPOSALS ARE BEING REQUESTED AND A WRITTEN SOLICITATION WILL NOT BE ISSUED. The solicitation number is PR-NC-06-10503, 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 05-12. 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. This procurement is for the preparation and delivery of cryopreserved human hapatocytes, pooled human liver microsomes, and frozen human liver sections and liver microsomes. The anticipated period of performance will be 36 months. A. Background. Environmental chemicals are metabolized by microsomal enzymes in the liver. The elderly may be at increased risk from environmental chemicals because they have altered liver metabolism of these chemicals. In order to assess the potential sensitivity of the elderly to environmental chemicals, we will examine the metabolism of a series of environmental chemicals in human liver samples obtained from young adult and elderly humans of both genders. This contract will consist of three tasks. The first Task is to obtain ten (10) cryopreserved human hepatocyte preparations. The second Task is to obtain eight (8) separate samples of pooled human liver microsomes. The third Task is to obtain a total of 32 human liver samples. These samples are divided into four groups of 8 that include young male adults (ages 21-45), elderly male adults (over 70 years old), young female adults (age 21-45) and elderly female adults (over 70 years old). Metabolism studies often use either cryopreserved human hepatocytes or pooled human liver microsomes. EPA will study the metabolism of prototype environmental chemicals in cryopreserved human hepatocytes and pooled human microsomes. These samples need to be obtained from the same supplier in order to ensure that all samples are handled equally and go through the same quality assurance procedures. This will ensure that the comparisons made between the pooled human microsones, the cryopreserved human hepatoctyes and the 32 individual human liver microsomes will be based on the true difference between these samples and not due to differences in sample collection, preparation and storage. The purpose of this contract is acquire gender and age specific samples from the normal supply chain of the contractor. The contractor shall not specifically recruit sample collection in order to fulfill this contractual requirement. B. Contractor Requirements. The contractor shall provide these three Task in this contract. 1. Preparation and delivery of cryopreserved human hepatocytes. 2. Preparation and delivery of pooled human liver microsomes. 3. Preparation and delivery of frozen human liver sections and liver microsomes from young adults and elderly males and females. TASK 1 - Preparation and delivery of cryopreserved human hepatocytes. Quality Assurance: The contractor shall provide a quality assurance plan prior to sample collection that describes an acceptance criteria for the liver samples as well as acceptance criteria for the hepatocyte preparation. Sample Collection: The contractor shall obtain human livers from 10 individual donors in accordance with the Common Rule, and the identity of the donors shall be kept confidential and not available to the USEPA. Information on the age, gender and ethnicity shall be provided to the USEPA. In addition, the contractor shall also provide cause of death, smoking and drinking history, and medical history, when available. The contractor shall not recruit the donors specifically for this contract. The samples collected shall be part of the contractor's normal business. Each sample shall be made from one individual donor. Sample Preparation: The contractor shall prepare cryopreserved hepatocytes consistent with the method of Lecluse et al (2005) (LeCluyse EL, Alexandre E, Hamilton GA, Viollon-Abadie C, Coon DJ, Jolley S, Richert L. Isolation and culture of primary human hepatocytes. Methods Mol Biol. 2005;290:207-29.). Samples shall have a target post-thaw yield of 4-5 million cells/sample. Each sample shall be prepared from one individual donor. Sample Delivery: The cryopreserved hepatocytes shall be delivered upon collection of all 10 individual samples. Acceptance: Upon receipt of the samples, the USEPA will notify the contractor of acceptance of the Task within 30 days. Acceptance will be based on recovery of 4-5 million cells/sample. TASK 2 - Preparation and delivery of pooled human liver microsomes. Quality Assurance: The contractor shall provide a quality assurance plan prior to sample collection that describes an acceptance criteria for the liver samples as well as acceptance criteria for the individual microsomal preparations. The criteria for the microsomal samples shall be based on markers of cytochrome P-450 activity. Sample collection: The contractor shall obtain human livers from donors in accordance with the Common Rule, and the identity of the donors shall be kept confidential and not available to the USEPA. Information on the age, gender and ethnicity shall be provided to the USEPA. In addition, the contractor shall also provide cause of death, smoking and drinking history, and medical history, when available. Each pool of microsomes shall be prepared from at least 10 different donors. The contractor shall not recruit donors specifically for this contract. The samples collected shall be part of the contractor's normal business. Sample Preparation: Upon receipt of the livers, microsomal fractions shall be prepared consistent with the method of DeVito et al 1994. The final storage buffer for the microsomes shall be 250 mM Sucrose. The contractor shall obtain 200 mg of microsomal protein in 10 mL of storage buffer for each lot of pooled microsomes. The 10 ml shall be aliquoted out into 20 vials, each containing approximately 0.5 mL. One pool is considered to be 10 mL of microsomes from at least 10 donors. The contractor shall prepare and deliver 8 different pools of human microsomes. Each pool shall contain 10 donors unique to that pool. Deliverables: The contractor shall deliver the samples on a quarterly basis until all 8 pools are delivered. Acceptance: Upon receipt of the samples, the USEPA will notify the contractor of acceptance of the Task within 30 days. Acceptance will be based on samples meeting contractor QA plan. TASK 3 - Preparation and Delivery of Frozen Human Liver Sections and Liver Cytosolic and Microsomal Fractions from Young and Elderly Adult Males and Female. Quality Assurance: The contractor shall provide a quality assurance plan prior to sample collection that describes an acceptance criteria for the liver samples as well as acceptance criteria for the individual microsomal preparations. The criteria for the microsomal samples shall be based on markers of cytochrome P-450 activity. Sample Collection: The contractor shall obtain human livers from donors in accordance with the Common Rule, and the identity of the donors shall be kept confidential and not available to the USEPA. Information on the age, gender and ethnicity shall be provided to the USEPA. In addition, the contractor shall also provide cause of death, smoking and drinking history, and medical history, when available. The contractor shall not specifically recruit donors for this contract. The samples collected should be part of the contractor's normal business. The contractor shall obtain a total of 32 livers from donors with the following criteria: 8 donors shall be young adult males between the ages of 21-45; 8 donors shall be young adult females between the ages of 21-45; 8 donors shall be elderly adults males older than 69; 8 donors shall be elderly adult females older than 69. Sample Preparation: Upon receipt of each liver, two (2) 300 mg pieces of the liver shall be collected, stored individually in appropriate vials, flash frozen in liquid nitrogen and maintained at -800C. The remaining liver shall be used to prepare cytosolic and microsomal fractions. Liver cytosolic and microsomal fractions shall be prepared consistent with the method of DeVito et al (1994). A one mL fraction of the cytosol shall be flash frozen in liquid nitrogen and stored at -800C. The final storage buffer for the microsomes shall be 250 mM sucrose. The contractor shall obtain at least120 mg of microsomal protein in 6 mL per individual. The 6 ml shall be aliquoted out into 12 vials, each containing approximately 0.5 mL. Sample Delivery: The collection of these samples is anticipated to take approximately 2 years. As such, the contractor shall ship 1-10 samples to the USEPA on a quarterly basis, until all 32 samples are delivered. Acceptance: Upon receipt of the samples, the USEPA will notify the contractor of acceptance of the Task within 30 days. Acceptance of the Task will be based on markers of cytochrome P-450 activity consistent with those proposed by the contractor?s quality assurance plan. C. Government Responsibilities: The government will supply the contractor with the following: Acceptance Notification: Upon receipt of the samples, the USEPA will notify the contractor of acceptance of the applicable task. The task will be acceptable if the microsomal enzyme activity, as demonstrated by the contractor, meets the contractor's QA acceptance criteria. 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: The Government intends to award a single contract to the responsible offeror whose technically acceptable quotation represents the best overall value to the Government based on the evaluation of the technical criteria, past performance, and price. Only those offerors submitting technically acceptable quotations shall be considered for award. 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. A. Technical Criteria: 1. Technical approach for accomplishing the statement of work (SOW) to include acceptance criteria for liver viability and microsome preparation. 2. Demonstrate ability to obtain samples as required by the SOW, specifically Task 3. 3. Evidence that sample collection is consistent with the Common Rule. 4. Demonstrate adequacy of Quality Control/Quality Assurance plans consistent with the SOW. B. Past Performance. Submit a list of 3 customers for whom like or similar services have been performed within the past 3 years. Include specific points of contact and phone numbers. Past performance will be evaluated on 1) quality of product or service; 2) timeliness of performance (ability to adhere to deadlines); and overall customer satisfaction. C. Price. Award will be made to the responsible offer or whose offer is determined the best overall value to the government, price and other factors considered. All offerors are to include with their offers 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; 52.212-5, 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: 52.222-3 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-Central Contractor Registration; 52.222-41, Service Contract Act of 1965, As Amended; 52.222-42, Statement of Equivalent Rates for Federal Hires. Any applicable wage determination(s) will be made a part of the resultant contract. 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. Click on the CURRENT SOLICITATIONS section and click on the solicitation for viewing applicable documents. Near the top of the page COMMERCIAL BUY CLAUSES AND FORMS sections are provided for your convenience. Please submit two copies of the technical proposal and 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 the US Postal Service. 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 September 6, 2006, 12:00 p.m., ET. No telephonic or faxed requests will be honored.
- Web Link
-
The Environmental Protection Agency
(http://www.epa.gov/oam/solicit)
- Record
- SN01121436-W 20060823/060821221650 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |