The Food and Drug Administration (FDA) intends to award a Purchase Order on a sole source basis to Illumina, Inc, 5200 Illumina Way, San Diego, CA 92122 for two (2) HumanMethylation450 DNA Analysis BeadChip Kits with 48 samples each. This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; no request for quote (RFQ) is available and a written solicitation will not be issued. Not withstanding, any firm that believes it is capable of providing the required items as stated herein may submit a capability statement to document its ability to provide the required item. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. In doing so, interested sources must submit technical capabilities/comparability, pricing, and other information that demonstrates their ability to meet the Government's needs to the point of contact located herein. A determination to compete this procurement based on a response to this notice is solely within the discretion of the government. The government intends to issue a Purchase Order in accordance with FAR PART 13.106 for the requirement under Simplified Acquisition Procedures. The solicitation number is 1123269.

Sole source determination is based on the need for compatibility with the existing iScan Illumina System. The Government believes a source change from the manufacturer of the equipment the kit will be used in would yield an unusable consumable causing failure to provide the required analysis of over 300 kidney samples.

The associated North American Industry Classification System (NAICS) Code is- 334516- Analytical Laboratory Instrument Manufacturing. Acquisition is being conducted as full and open.

The Food and Drug Administration intends to solicit and negotiate a Firm-Fixed Price order with only one source under the authority of FAR 13.106-1(b) for the following.

Scheduled items include:

2 - HumanMethylation450 DNA Analysis BeadChip Kits with 48 samples each

Delivered to: 3900 NCTR Road, Jefferson, AR 72079

Delivery within: 30 Days ARO

Clauses set forth in this order are current through FAC 2005-69 dated August 1, 2013. Clauses incorporated by reference can be found at:

http://www.acquisition.gov/far/
http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html
http://www.hhs.gov/asfr/ogapa/acquisition/policies/files/caac-consultation-accelerated-payment-gsa.pdf

The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items applies to this solicitation.

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

(i) Technical capability/compatibility of the item with the existing system it will be
used in without compromising research to be conducted using the kits.
(ii) price.

Award will be made to the lowest priced technically acceptable offeror.

Technical capability/compatibility will be determined by review of information submitted by the Offeror, which must provide a description in sufficient detail to show that the items quoted meet the Government's requirement and do not pose a compatibility issue with the existing equipment. Offers including other than brand name shall include evidence/demonstration that the product has and will work with the existing iScan Illumina System without complications or interruptions in the research to be conducted with the kits.

The government is not responsible for locating or securing any information, which is not identified in the quote. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the service meets the technical requirements. Quotes shall include technical specifications, descriptive material, literature, brochures, and other information corresponding to the item being procured, which demonstrates the capabilities of the Offeror to provide an effective product for use as intended in research.

The Provision at FAR 52.212-3, Offeror's Representations and Certifications-Commercial Items, applies to this acquisition.

The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. Addenda to this clause are as follows:

Other Terms and Conditions

Inspection and Acceptance

The supplies delivered hereunder shall be inspected and accepted at destination by the contracting officer's representative (COR) specified at award. If the supplies are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer.

Invoice Submission

Payment terms net 15 days after government acceptance of the supplies/services.

Invoices shall be submitted to the attention of the Office of Financial Services identified below and contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions.

I. An original and two (2) copies shall be submitted to:

FDA/OC/OA/OFO/OFS
Attn: Division of Payment Services
3900 NCTR Road, HFT-324
Building 50, 6th floor, suite 616
Jefferson, AR 72079
Phone: (870) 543-7446
Fax 870-543-7224

An electronic invoice can be emailed to the following address:
[email protected]

II. One copy each to the Contracting Officer and Contracting Officer Representative (COR) or other program center/office designee, clearly marked "courtesy copy only":

Questions regarding invoice payments should be directed to the FDA payment office at phone or email reference provided above.

Questions relating to when payment will be received should be directed to the FDA payment office at the email below or at (870) 543-7446 or (870) 543-7042. [email protected].

The following clauses are incorporated by reference:

• FAR 52.232-99, Providing Accelerated Payment to Small Business Subcontractors (DEVIATION) is applicable.

• HHSAR Clauses: 352.222-70 and 352.231-71 are applicable to this solicitation.

The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: (b) 52.204-10, 52.219-4, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.223-18, 52.225-3 I, 52.225-13 and 52.232-33.

Offerors may submit a capability statement to document its ability to provide the required services, on or before August 28, 2013 by 9:00 am (Central Standard Time in Jefferson, Arkansas). The statements must reference solicitation number 1123269. The Offers are due in person, by postal mail, fax or email at the Food and Drug Administration, NCTR/OSS/OFFAS, HFT-320, 3900 NCTR Road, Jefferson, AR 72079-9502.

For information regarding this solicitation, please contact Crystal McCoskey at (870) 543-7267, FAX (870) 543-7990 or email [email protected].

Bid Protests Not Available