U. S. Environmental Protection Agency, Contracts Management Division (MD-33), Attn: ORDSC, Research Triangle Park, NC 27711

R -- PRELIMINARY VALIDATION OF TWO EXPERIMENTAL PROTOCOLS DESIGNED TO SCREEN TOXICANTS FOR POTENTIAL ENDOCRINE-DISRUPTIVE ACTIVITY SOL AC5001 POC Marsha B. Johnson, Contract Specialist (919/541-0952)/Barbara H. Stearrett, Contracting Officer (919/541-3113) WEB: Click here to visit the site that has information about, http://www.epa.gov/oam/rtp_cmd. E-MAIL: Click here to contact the Contract Specialist via, johnson.marsha@epa.gov. THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS 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; QUOTES ARE BEING REQUESTED AND A WRITTEN SOLICITATION WILL NOT BE ISSUED. The solicitation number is AC5001, and the solicitation is being issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 97-11. The Environmental Protection Agency (EPA) anticipates that the contract will be awarded as a result of a total small business set-aside. A firm-fixed-price purchase order is anticipated to result from the award of this solicitation. The EPA reserves the right to award multiple orders. The associated Standard Industrial Classification (SIC) code is 8731, with a size standard of 500 employees. This procurement is for preliminary validation of two experimental protocols designed to screen toxicants for potential endocrine-disruptive activity. The 1996 passage of the Food Quality Protection Act (FQPA) and the Safe Drinking Water Act (SDWA) mandated EPA to develop a screening and testing strategy for endocrine disrupting chemicals (EDCs) within two years, to implement the plan by August 1999, and to report to Congress on the program's progress by August 2000. The legislation also cites the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA) as statutes under which the EPA will implement an endocrine screening and testing strategy. In 1996, under the Federal Advisory Committee Act (FACA), the EPA established the Endocrine Disruptors Screening and Testing Advisory Committee (EDSTAC) to address the technical and policy issues associated with EDC screening and testing. To detect EDCs and quantify their effects in the most time and cost-efficient manner, the Committee has recommended a tiered approach consisting of 1) sortingchemicals based on existing data to assess what additional testing is required; 2) prioritizing those chemicals to proceed to the screening stage; 3) conducting screening (Tier 1) to detect chemicals and mixtures capable of interacting with the estrogen/androgen/thyroid (EAT) hormonal systems; 4) conducting testing (Tier 2) to identify, characterize, and quantify endocrine-mediated adverse effects; and 5) using the results to assess the potential hazards the EDC could pose to exposed populations. In September 1998, the Committee issued two protocols for Tier 1 screening which can be found at http//www.epa.gov/oam/rtp_cmd. The Office of Pesticide Programs has charged the Reproductive Toxicology Division with the first phase of validating these protocols, which is to identify protocol-specific model test compounds and procure the services of an independent, commercial laboratory to test these compounds under Good Laboratory Practices (GLP). As such, this contract is designed to: 1) provide a preliminary validation of the two EDSTAC protocols (including identification of any unforeseen complications requiring protocol revision); 2) assess the robustness of the protocols to potential intralaboratory and interstrain sources of variation; and 3) provide documentation regarding the standard operating procedures laboratories are to follow when implementing the protocols. The Contractor shall conduct the two protocols which can be found at the above website as blind studies as follows: 1) "Research Protocol for Assessment of Pubertal Development and Thyroid Function in Juvenile Male Rats" using the following seven treatments, each administered by daily gavage at a single dosage level: a) one vehicle control (2.5 ml corn oil/kg/day), b) 100 mg flutamide/kg/day, c) 80 mg methyl testosterone/kg/day, d) 240 mg propylthiouracil (PTU)/kg/day, e) 100 mg ketoconazole/kg/day, f) 30 mg pimizide/kg/day, and g) 1000 mg dibutylphthalate/kg/day. 2) "Research Protocol for Assessment of Pubertal Development and Thyroid Function in Juvenile Female Rats" shall be conducted using the following seven treatments, each administered by daily gavage at a single dosage level: a) one vehicle control (2.5 ml corn oil/kg/day), 0.005 mg ethynyl estradiol/kg/day, c) 10 mg ICI-182780 (also known as Faslodex or ZD9238)/kg/day, d) 240 mg propylthiouracil (PTU)/kg/day, e) 100 mg ketoconazole/kg/day, f) 30 mg pimizide/kg/day, and g) 1000 mg dibutylphthalate/kg/day. (The EPA reserves the right to adjust the above dosage levels and/or substitute test compounds until the time of award based on the latest knowledge regarding the toxicity of the above compounds.) In consideration of manpower constraints, the Contractor shall kill the animals over two days (i.e., postnatal days 42 and 43 for the female protocol, days 53 and 54 for the male protocol), provided selection of animals is balanced across all treatment groups. Toward this end, weaned offspring shall be housed 3 per cage (i.e., 2 cages/strain/ treatment/replicate) to facilitate separation for necropsy. Finally, the Contractor shall ship to the EPA at least 500 ul of serum from each animal in both protocols collected at the time of kill (trunk blood to be supplemented by cardiac puncture, if necessary). Serum samples shall be collected in 1.7 ml siliconized microcentrifuge tubes clearly labeled with an indelible marker (e.g., Sarstadt catalogue #95-954) and shipped on dry ice by express carrier to the following address: Dr. Ralph Cooper, US EPA/NHEERL/RTD, MD-72, 2525 NC Highway 54, Durham, NC 27713. Within 6 months from the date of award, the Contractor shall provide from the first replicate a report containing: 1) copies of all raw data; 2) the results from the preliminary data analyses; 3) a summary of the data analyses; 4) a summary of histological findings; and 5) a detailed description of the methods used in conducting the study, including: i) how the dissections were performed, ii) the development landmarks used, iii) necropsy methods used, iv) how animals were sacrificed, and v) how the radioimmunoassays were performed. Within 12 months from the date of award, the Contractor shall provide the above items 1-4 for the second replicate and a complete data analysis, including estimation of variability between replicates. The awardee must possess the following technical capabilities: 1.) QA practices at or exceeding GLP criteria for animal toxicology studies; 2.) Substantial corporate experience and timeliness in protocol validation for governmental agencies, supported by references; 3.) Personnel experienced in assessments of the effects of toxicants on hormonally-mediated processes in small laboratory animals, supported by references; 4.) Existing technical personnel able to execute the bioassays outlined in this solicitation; and, 5.) Knowledge of the EDSTAC process and recommended tiered testing scheme. The contractor shall provide EPA with a firm fixed price for each of the protocols (contract line items) found at http://www.epa.gov/oam/rtp_cmd. The following FAR provisions apply to this solicitation: 52.212-1, Evaluation-Instructions to Offerors-Commercial; 52.212-2, Evaluation-Commercial Item. Evaluation criteria to be included in paragraph (a) of provision 52.212-2 are as follows: (i) technical capability to meet the Government requirements; (ii) past performance; (iii) price, in decreasing order of importance. Technical and past performance, when combined, are significantly more important than price. 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 clause applies to this acquisition: 52.212-4, Contract Terms and Conditions-Commercial Items. The following additional FAR clauses which are cited in clauses 52.212-5 are applicable to the acquisition: 52.203-6, Restrictions on Subcontractor Sales to the Government, with Alternate I; 52.203-10, Price or Fee Adjustment for Illegal or Improper Activity; 52.219-14, Limitation on Subcontracting; 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. Also, Clause 52.222-41, Service Contract Act of 1965, As amended (41 U.S.C. 351, et seq.) is applicable to this procurement. Any wage determination(s) applicable to this procurement in the locality of the awardee will be incorporated into the resultant contract. Cost and technical information should be submitted in separate proposals. Please submit two copies of the technical proposal and two copies of the cost proposal to Marsha B. Johnson, Contract Specialist, U.S. Environmental Protection Agency, MD-33, Research Triangle Park, NC 27711. Courier Delivery Address is: U.S. Environmental Protection Agency, Receptionist-Administration Bldg. Lobby, Attn: Marsha B. Johnson, 79 Alexander Drive, Research Triangle Park, NC 27709. All offers are due by August 20, 1999, 4:00 p.m. ET. No telephonic or faxed requests will be honored. See Note 1. Posted 07/30/99 (W-SN361346). (0211)

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