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 NIH-NICHD-15-043 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 2005-81. The North American Industry Classification (NAICS) Code is 541380 and the business size standard is $14M. 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) intends to contract on a sole source basis with Myriad RBM , 3300 Duval Road, Austin, TX 78759 to provide biomarker testing of Cerebral Spinal Fluid (CSF) samples. SEE ATTACHED FOR PRODUCT/DESCRIPTION/QUANTITY.
The testing to be done by Myriad RBM is in support of a FDA regulated therapeutic trial. This procurement will purchase multiplexed assays that include biomarkers that will be used to monitor potential therapeutic efficacy of 2-hydroxypropyl-β-cyclodextrin in treating Niemann Pick C1 patients. Sole source to Myriad because of the following:

Myriad RBM has done prior testing for a protocol which included pediatric control CSF samples. Use of another company would require redoing a control set. It would be prohibitively expensive to repeat these pediatric controls, the availability of control pediatric CSF is extremely limited. The NICHD would have to recollect many control samples prior to being able to proceed. Prior testing included patients that enrolled in this therapeutic trial. Thus use of alternative company would not allow us to compare with longitudinal data collected under our Natural History protocol. This would be a major limitation that would require repeating the prior assays with a new company. Again this would be duplication of expense and would utilize a limited resource.

Because this data may be used to support a new drug application, it must be done under strict laboratory conditions. These include Clinical Laboratory Improvement Amendments and Commission on Office Laboratory Accreditation certification and participation in College of American Pathologists internal proficiency testing.

For experimental and regulatory validity the assays must be rigorously controlled. This is critical for longitudinal comparison to existing data. Myriad RBM obtains an 8-point standard curve and includes multilevel controls with every assay. All analytes must be validated to medical laboratory standards.

For experimental and regulatory validity rigorous quality control must be applied. Specifically, Levey-Jennings charts and Westgard rules to measure assay performance longitudinally for assay acceptance criteria.

To increase precision robotic liquid handlers should be utilized and to avoid sample errors all sample data should be tracked and maintained within an automated laboratory information management system.

With regards to the specific analytes, this testing will give us information on 108 analytes from 400 microliters of CSF. Obtaining the necessary information from a minimal volume of CSF is critical in order to maximize the information that can be obtained from the available specimens that have to be collected via an invasive procedure. As outlined above, use of another company would be both expensive due to the need to repeat testing and would waste valuable samples.

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.
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 product specified in this synopsis should submit a copy of their quotation to the below address or via email to [email protected]. Offers must also be accompanied by descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all of the foregoing requirements. Quotations will be due fifteen (15) calendar days from the publication date of this synopsis or by May 14, 2015 by 12:00pm EST. via email or postal mail. The quotation must reference "Solicitation number" NIH-NICHD-15-043. 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, 6100 Executive Boulevard, Room 5C01, Bethesda, MD 20852. Attention: Patricia Haun, by the date and time mentioned above. Any questions must be sent via email to [email protected] and must include solicitation# NIH-NICHD-15-043 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.

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