SOLICITATION NOTICE
65 -- DICER I Genetic Synopsis/ Solicitation
- Notice Date
- 9/1/2016
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02RC62674-36(B)
- Point of Contact
- David H. Romley, Phone: 2402767822
- E-Mail Address
-
david.romley@nih.gov
(david.romley@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E226, Bethesda, MD 20892, UNITED STATES. Non-USPS mail such as Fedex, UPS and other private carriers please use Rockville, MD 20850. The National Cancer Institute (NCI), Clinical Genetics Branch (CGB) would like to procure on a Brand Name or Equal basis genetic testing of DICER I. This is a combined synopsis/solicitation for commercial items, prepared in accordance with 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: No. N02RC62674-36 includes all applicable provisions and clauses in effect through FAR FAC 2005-88 (May 2016) simplified procedures for commercial items. The North American Industry Classification System code is 621511 and the business size standard is $32,500,000. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. I. Description of Requirement The overall study objective is to study the patterns and determinants (clinical, genetic and environmental) of the cancers which occur in persons carrying alterations in DICER1. It is anticipated that information derived from this project will provide important new information on the pathogenesis of these specific malignancies. The specific objective of this procurement is to obtain the results of DICER1 genetic testing in order to confirm or refute the diagnosis of the DICER1 syndrome in study participants, and thus classify participants properly. TASKS a. The contractor will receive samples (blood or saliva) for DICER1 genetic testing. If the contractor is blinded to identifying information pertaining to the individuals from whom these specimens were derived, the Contractor will be prohibited from seeking such information. Therefore, from the Contractor's perspective, those samples shall be anonymous. b. The Contractor must be a CLIA‐certified laboratory, so that the results can be conveyed to the patient for use in clinical management. c. The specimens will consist of peripheral blood or saliva, collected using standard methods. d. The Contractor will extract DNA from the provided samples. e. The DNA derived from these samples will be analyzed for DICER1 sequence variants in all coding exons, +/- 10 basepairs of adjacent intronic sequence and select non-coding variants. Appropriate "next-generation" sequencing (NGS) technology will be used. In addition, deletion/duplication analysis using NGS will be used. Mean coverage depth of 350X is needed, which will ensure a minimum of 50X across all variants. Variants classified as pathogenic or likely pathogenic will be confirmed with orthogonal methods.' f. The Contractor will provide a written report for each patient, noting patient name and methods used in the assay, and other CLIA-required documentation. A table of DICER1 variants found will be provided with a determination of pathogenicity, including allele frequency in appropriate control populations. Previous published reports on discovered variants in the biomedical literature will be noted. For missense and splice variants, bioinformatic predictions of pathogenicity will be provided. The presence or absence of a pathogenic variant will be clearly stated in the report. g. The written report for DICER1 genetic test results will be returned to CGB investigators within twenty-one (21) working days from specimen receipt, except in the case of unusual problems requiring additional investigation. The exceptions must be negotiated directly via telephone discussion with the CGB investigator. h. In lieu of progress meetings, CGB will discuss any unusual results on a case-by-case basis. II. Delivery: Reports. The individual patient reports must include the CGB identification number and/or patient name, the Contractor's sample identification number, date sample obtained, date received in laboratory, and presumed diagnosis. III Payment: The number of samples will be indefinite delivery indefinite quantity (IDIQ). The minimum quantity is one (1) and the maximum quantity is one hundred and twenty five (125) DICER1 tests during the period of performance of the IDIQ contract. Payment will be made in arrears after receipt and acceptance of requested tasks. QUESTIONS ARE DUE: September 2, 2016 The purchase order will be awarded to the Lowest Price Technically Acceptable (LPTA). The award will be made on the basis of the lowest evaluated price of quotations meeting or exceeding the acceptability standards for the requirements/technical specifications stated above. The technical evaluation will be a determination based on information furnished by the vendor. The Government is not responsible for locating or securing any information which is not identified in the quote. The Government reserves the right to make an award without discussions. PROVISIONS AND CLAUSES: The following FAR provisions and clauses apply to this acquisition: FAR 52.211-6 Brand Name or Equal. (Aug 1999) (a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government's needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation (b) To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must- (1) Meet the salient physical, functional, or performance characteristic specified in this solicitation; (2) Clearly identify the item by- (i) Brand name, if any; and (ii) Make or model number; (3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and (4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications (c) The Contracting Officer will evaluate "equal" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer (d) Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation. 52.212-1 Instructions to Offerors Commercial Items (APR 2014); 52.212-2 Evaluation Commercial Items (OCT 2014): FAR clause 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS- (March 2015) WITH DUNS NUMBER ADDENDUM {52.204-6 (July 2013)}; FAR Clause 52.212-4 CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS (December 2014); FAR Clause 52.212-5: CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (March 2015). The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition; FAR Clause 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006) FAR Clause 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2015) FAR Clause 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) FAR Clause 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) FAR Clause 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644) FAR Clause 52.219-28, Post Award Small Business Program Representation (Jul 2013) FAR Clause 52.222-3, Convict Labor (June 2003) FAR Clause 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2016) FAR Clause 52.222-21, Prohibition of Segregated Facilities (Apr 2015) FAR Clause 52.222-26, Equal Opportunity (Apr 2015) FAR Clause 52.222-35, Equal Opportunity for Veterans (Oct 2015) FAR Clause 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) FAR Clause 52.222-37, Employment Reports on Veterans (Feb 2016) FAR Clause 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) FAR Clause 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) FAR Clause 52.225-1, Buy American Act--Supplies (May 2014) FAR Clause 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May 2014) Alternate II (May 2014) of 52.225-3 FAR Clause 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) FAR Clause 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013) Full text copies of the representations and certifications for other cited provisions and clauses may be obtained online at the NCI website at http://ncioa.cancer.gov/oa-internet/ or from David Romley, Contract Specialist at David.Romley@nih.gov. OFFERORS: Offers must be submitted on an SF-1449 with a completed 52.212-3 Offeror Representations and Certifications-Commercial Items-with DUNS Number Addendum, signed by an authorized representative of the offeror OR provide a copy of the valid certification registrations of the offeror's Central Contractor Registration (CCR) and Online Representations and Certifications Applications (ORCA) through www.sam.gov. Quotations must be received in the NCI-OA contracting office by 12:00 p.m. EST on September 7, 2016. Please refer to solicitation number N02RC62674-36 on all correspondence. Faxed quotations will NOT be accepted. Quotations may be submitted via email to David Romley, Contract Specialist at David.Romley@nih.gov All questions shall be in writing and may be addressed to the aforementioned individual noted above. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management through sam.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02RC62674-36(B)/listing.html)
- Place of Performance
- Address: 9609 Medical Center Drive, MSC 9776, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04252793-W 20160903/160902000427-fcea4b28ae913ff9cbe2e054a9ffbbf9 (fbodaily.com)
- Source
-
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