Preclinical testing of compounds

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation number is NICHD-17-126 and is issued as a Request for Quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2005-95. The North American Industry Classification (NAICS) Code is 541380 and the business size standard is $15m. However, this solicitation is not set aside for small business. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intend to procure on a sole source basis with Frontage Laboratories, Inc., 700 Pennsylvania Drive, Exton, PA 19341 to provide in vitro metabolism with MTS-IV-39 in various preclinical species. In vitro metabolism (MET ID) of MTS-IV-39 in liver microsomes fortified with and without cytosol; and hepatocytes from mouse, rats, dogs, monkeys and humans (5 species). Perform mouse, rat, dog, monkey and human liver microsomal incubations with the compounds under different conditions (+/- NADPH, +/-cytosol). Phase 1, Phase 2 and possibly non-enzymatic pathways investigated. Conduct in vitro metabolism studies with MTS-IV-39 in the presence of cryopreserved hepatocytes from male mice, rats, dogs, monkeys and pooled (mixed gender) humans Substrate concentration at 10 ?M (so LC/UV and LC/MS profiles can be obtained, Metabolite ID of most significant metabolites - MS/MS data, interpretation of fragmentation pathways, and assignment of fragment ions). Determine P450 and non-P450 mediated metabolism of MTS-IV-39 Tentative assignment of structures of metabolites and determining the metabolic soft spots. Metabolism scheme in each species Utilizing another vendor at this point, would result in duplication of effort and additional time, as well as additional cost and not advantageous to the lab and Government. The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under authority of the 41 U.S.C. 253(c) (1), FAR 6.302. Only one responsible source and no other supplies or services will satisfy agency requirements. The offeror must include a completed copy of the provision of FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items with its offer. The provisions of FAR Clause 52.212-1 Instructions to Offerors - Commercial Items; FAR Clause 52.212-2, Evaluation - Commercial Items; FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items; and FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items - Deviation for Simplified Acquisitions applies to this acquisition. The offeror must include their Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. The clauses are available in full text at http://www.acquisition.gov/far/. Interested vendors capable of furnishing the government with the services specified in this synopsis should submit a copy of their quotation to the below address or via email to contact@example.gov. Offers must also be accompanied by descriptive literature, delivery/turnaround timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements. Quotations will be due ten calendar days from the publication date of this synopsis or by August 5, 2017 by 10 am, EST. via email or postal mail. The quotation must reference "Solicitation number" NICHD-17-126. Quotations sent by postal mail or other mailing services must be submitted to the following address: Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, MSC 1159B Bethesda, MD 20892. Attention: Verne Griffin, by the date and time mentioned above. Any questions must be sent via email to contact@example.gov and must include solicitation# NICHD-17-126 in the subject line of email. Faxed copies/responses will not be accepted. Note: In order to receive an award, contractor must be registered and have valid certification in the SAM database @www.sam.gov.