16-223-SOL-00108.doc

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals/bids are being requested and a written solicitation will not be issued.

The solicitation number is 16-223-SOL-00108. This solicitation is issued as a Request for Quotation (RFQ) for Brand name or equal reagents listed below. This is a firm fixed price requirement. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-89, July 14, 2016. The associated North American Industry Classification System (NAICS) Code is 325413 - In-Vitro Diagnostic Substance Manufacturing.

DHHS FDA Office of Acquisitions and Grants Services requires the following Reagents: The proposed contract action is for a brand name or equal product. The brand name, part numbers and salient characteristics of the products are:

An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to finish required representations, or reject the terms and conditions of the solicitation, may be excluded from consideration.

The government is not responsible for locating or securing any information, which is not identified in the submission. To ensure sufficient information is available, vendors must furnish as part of their proposal all descriptive material (such as cuts, illustration, drawings, or other information) necessary for the government to determine whether the product meets their requirements.

Contract type: Commercial Item-Firm Fixed Price. Simplified procurement procedures will be utilized.

FOB Point of Delivery:

FDA

10903 New Hampshire Avenue

Building 52

Silver Spring, MD 20993

The period of performance: Delivery is required 30 days after receipt of order.

The provision at 52.211-6 Brand Name or Equal applies to this solicitation.

The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items applies to this solicitation. The following addenda have been attached to this provision: None

The provision at FAR 52.212-2 Evaluation – Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows:

(i) Technical capability of the item offered to meet the Government requirement

(ii) Price.

The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the product meets the technical requirements. If the vendor proposes to modify a product so as to make it conform to the requirement of this solicitation the vendor shall include a clear description of such proposed modifications and clearly mark any descriptive materials to show modifications. The government reserves the right to make an award without discussions.

The provision at FAR 52.212-3. Offeror Representations and Certifications – Commercial Items applies to this acquisition. Offerors shall include a completed copy of FAR 52.212-3, Offeror Representations and Certifications – Commercial Items with their offers.

The clause at 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. The following addenda have been attached to the clause. None.

The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders – Commercial Items applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.203-6, 52.219-8, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.225-1.52.225-13, 52.232-33 and 52.232-34 Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.acquisition.gov.

SAM Requirements – An Offeror must be registered on System for Award Management (SAM) before an award can be made to the Offeror. If the Offeror is not registered in SAM, the Offeror must go to the SAM website at http://www.sam.gov.

The Defense Priorities and Allocations System and assigned rating are not applicable to this solicitation notice.

Applicable Numbered Note(s) None.

Offers are due in person, by mail, e-mail or fax on or before August 19, 2016 by 3:00 p.m. (Eastern Time, at Food and Drug Administration, U.S. Customhouse, 200 Chestnut Street, Philadelphia, PA 19106, Attn: Janice Heard. ph (215)717-3093, fax (215)597-4390, email: Janice.Heard@fda.hhs.gov.