1152408_FBORFQ_08252015.pdf

FDA-15-223-SOL-1152408 Kits

PART 1

This is a Combined Synopsis/Solicitation for Commercial Items prepared in accordance with the format in FAR Subparts 12.6 and 13.5 and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation that will be issued; a quote is being requested and a written solicitation will not be issued.

PART 2

The solicitation number is FDA-15-223-SOL-1152408 and this solicitation is issued as a request for quotation

(RFQ).

PART 3

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-83 dated July 2, 2015. This is an unrestricted procurement and the government anticipates awarding a single-award Indefinite Delivery, Indefinite Quantity (IDIQ) Contract with Firm-Fixed Price Delivery Orders resulting from this solicitation.

The associated North American Industrial Classification System (NAICS) code for this procurement is 325413, In- Vitro Diagnostic Substance Manufacturing; the small business size standard is 500 employees.

PART 4

Brand Name or Equal This is a brand name or equal acquisition; in accordance with FAR 52.211-6, to be considered for award, offers of equal products must meet the salient physical, functional, or performance characteristics provided in the statement of requirements. In order to be considered an “equal” solution, any alternative solution proposed must be able to perform in strict accordance with the salient operational and technical features described below.

PART 5

Base Pricing Table:

Line Item Kit Unit Price

1001 Salmonella $ 1002 Listeria $

1003 QCV $

PART 6

The U.S. Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) field laboratories currently perform over 120,000 individual analyses for the presence of pathogens in food. Isolates from these samples are identified and confirmed as pathogens using the Vitek Immunodiagnostic Assay System (VIDAS ) instrument.

The VIDAS immunoassay instrument uses a single-dose, off-the-shelf, reagent strip system which contains the antigens or antibodies for the specific pathogen with all necessary reagents for the reaction. This solid phase system is both the pipettor and reagent transfer device and aspirates all reagents, eliminating sample or reagent cross-contamination. VIDAS uses the enzyme-linked flourescent assay (ELFA) principle which combines the enzyme-linked immunosorbent assay (ELISA) test method with a final fluorescent reading with an on-board QC program to validate its readings. ORA requires Salmonella, Listeria and QCV kits compatible with existing VIDAS instrumentation for continued analysis for a five (5) year ordering period.

The government reserves the right to issue the proposed order in its totality or any portion thereof at time of award. The contract will have a ceiling value of $3 million. The FDA intends to award a task order under this ID/IQ when it awards the base ID/IQ. This will satisfy the guaranteed minimum.

Minimum Performance Requirements:

• Test kits must be compatible with existing VIDAS instrumentation.

• Test kits must be ready-to-use Solid Phase Receptacle (SPR) coated with antibodies against Salmonella, and Listeria specific antigens

• Test kits must have a minimum expiration date of at least 6 months

• Each laboratory shipment of kits will be of the same lot number

• Assay strips must contain 10 wells, be foil-sealed and labeled o Labels must contain a barcode that identifies assay code, kit lot number and expiration date o Strip Well 1 must be empty for sample, control or standard introduction and have perforated foil for ease of sample introduction o Strip well 2 must contain 400 uL of prewash solution o Strip wells 3-5 and 7-9 must contain 600 uL of wash buffer o Strip well 6 must contain 400 uL of conjugate o Strip well 10 must contain a cuvette with substrate in which a flourometric reading can be performed

• Kits must contain:

o Assay standard and controls containing purified and inactivated organism specific antigen + preservative + protein stabilizer o Assay positive controls o Assay specific confidence interval o Assay negative control containing TRIS with buffered saline and tween, pH 7.6 o Specification sheet containing the factory master calibration data required for test calibration on the instrument used for pathogen detection

• Kits must allow assay interpretation using existing VIDAS automated readers and store all pertinent lot and reagent information within the reader

PART 7

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. All equipment shall be new not used or refurbished. Each laboratory shipment of kits will be of the same lot number. Any other requirements above those stated here will be provided at the Task Order level.

The Point of Contact (POC) for each location (COR) will perform inspection and acceptance of supplies. For the purpose of this PART, (COR – to be provided upon contract award) is the authorized representative of the Contracting Officer. Inspection and acceptance will be performed at the locations identified in part 6.

Acceptance is communicated in writing unless otherwise indicated in writing by the Contracting Officer or COR within 30 days of receipt.

Satisfactory performance of this contract shall be deemed to occur upon completion of delivery and confirmation of requirements described at the Task Order level and/or upon acceptance by the each location’s POC, of these products. Deliveries shall be made F.O.B. destination to the address listed below:

Delivery Locations (Points of Contact for each shall be provided at time of award):

Lab Address NRL 158-15 Liberty Avenue, Jamaica, NY 11433 SRL 60 Eighth Street NE, Atlanta, GA 30309 SAN-LAB 1431 Harbor Bay Pkwy, Alameda, CA 94502 DEN-LAB Denver Federal Ctr, Bldg #20, Denver, CO 80225 ARL 3900 NCTR Road, Jefferson, AR 72079 PRL-NW 22201 23rd Dr. SE, Bothell, WA 98021 PRL-SW 19701 Fairchild, Irvine, CA 92612 WEAC 109 Holton St, Winchester, MA 01890 DET-LAB 300 River Place Suite 5900 Detroit, MI 48207 PEV 1800 Eller Drive, Ste 425, Ft. Lauderdale, FL 33316

Delivery Schedule:

Delivery schedule will be determined at the task order level. The COR may contact the vendor to reduce or cancel a predetermined shipment no less than 2 (two) weeks before the scheduled delivery date as needed.

Only the COR is permitted to made reductions or cancellations to shipment amounts. Please see and bid upon Task Order #1, attached.

Unless otherwise specified, deliveries shall be made to the Delivery Points specified above, Monday through Friday (excluding Federal Holidays, see Part 9) between the hours of 8:30 a.m. and 4:30 p.m. in accordance of the delivery location time zone (Eastern Time, Central Time, or Pacific Time). Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day.

Period of Performance The initial item shipment shall be delivered 30 days after date of award or by September 30, 2015, whichever occurs sooner unless the government approves a different delivery schedule. The items shall not be accepted until confirmation that performance requirements have been met. The period of performance shall be a 5 year ordering period starting from the date of award.

PART 8

The Provision at 52.212-3 Offeror Representations and Certifications—Commercial Items (May 2014) applies to this acquisition. An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website (https://sam.gov), the offeror shall complete only paragraphs (c) through (o) of this provision

PART 9

FAR Clauses in Full Text

52.212-4 Contract Terms and Conditions -- Commercial Items (May 2015) applies with the following addenda:

FDA Invoice Requirements:

The contractor shall submit one (1) original copy of each invoice to the address specified below:

Office of Financial Services Food and Drug Administration

10903 New Hampshire Ave WO32 – Second Floor

Mail Hub 2145 Silver Spring, MD 20993-0002

Attn: Vendor Payments

301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.gov

Invoices submitted under this contract must comply with the requirements set forth in FAR clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and address of the contractor;

(II) Invoice date and invoice number;

(III) Purchase Order/Award Number;

(IV) Description, quantity, unit of measure, unit price and extended price supplies delivered or services performed, including (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures;

(V) Shipping number and date of shipment, including the Bill of Lading number and weight of shipment if shipped on Government Bill of Lading;

(VI) Terms of any discount for prompt payment offered;

(VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order or in a proper notice of assignment);

(VIII) Name, title, and phone number of person to notify in event of defective invoice;

(IX) Taxpayer Identification Number (TIN).

(X) Electronic Funds Transfer (EFT) banking information, including routing transit number of financial institution receiving payment and the number of the account into which funds are to be deposited;

(XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact as referenced on the purchase order; and (XII) Any other information or documentation required by the purchase order/award.

An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (I) through (XII) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

Questions regarding invoice payments shall be directed to the FDA Payment Office at telephone number provided above.

(End of Clause)

52.212-5 Contract Terms And Conditions Required To Implement Statutes Or Executive Orders Commercial Items (May 2015)

a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Dec 2014)

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19 U.S.C.

3805 note))

b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509).

___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009).

_X_ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-

282) (31 U.S.C. 6101 note).

___ (5) [Reserved]

___ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L.

111-117, section 743 of Div. C).

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Aug 2013) (31 U.S.C. 6101 note).

___ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

___ (10) [Reserved]

___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

___ (ii) Alternate I (Nov 2011) of 52.219-3.

_X_ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

___ (ii) Alternate I (Jan 2011) of 52.219-4.

___ (13) [Reserved]

___ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

___ (ii) Alternate I (Oct 1995) of 52.219-7.

___ (iii) Alternate II (Mar 2004) of 52.219-7.

__ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)).

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2014) (15 U.S.C. 637 (d)(4)).

___ (ii) Alternate I (Oct 2001) of 52.219-9.

___ (iii) Alternate II (Oct 2001) of 52.219-9.

___ (iv) Alternate III (Oct 2014) of 52.219-9.

___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

___ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

___ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C.

657f).

___ (22) 52.219-28, Post Award Small Business Program Representation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

___ (24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)).

_X_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_X_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126).

_X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

_X_ (29) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212).

_X_ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

_X_ (31) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212).

_X_ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O.

13496).

_X_ (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

___ (ii) Alternate I (Mar 2015) of 52.222-50, (22 U.S.C. chapter 78 and E.O. 13627).

_X_ (34) 52.222-54, Employment Eligibility Verification (Aug 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

___ (35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (36) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514

___ (ii) Alternate I (Jun 2014) of 52.223-13.

___ (37) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-14.

___ (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

__ (39) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Jun 2014) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-16.

_X_ (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O.

13513).

__ (41) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

___ (42) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43).

___ (ii) Alternate I (May 2014) of 52.225-3.

___ (iii) Alternate II (May 2014) of 52.225-3.

___ (iv) Alternate III (May 2014) of 52.225-3.

___ (43) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (44) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

___ (45) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

___ (46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C.

5150).

___ (48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C.

2307(f)).

___ (49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__X_ (50) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (51) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

___ (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (54) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631).

___ (ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or executive orders applicable to acquisitions of commercial items:

___ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495)

___ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.).

___ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C.

chapter 67).

___ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67).

___ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

___ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67).

___ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67).

___ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (E.O. 13658).

___ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).

___ (10) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)).

(d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract.

If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509).

(ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

(iv) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(v) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

(vi) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212).

(vii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(viii) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212).

(ix) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(x) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67).

(xi) ____ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

___ (B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627).

(xii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.)

(xiii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67)

(xiv) 52.222-54, Employment Eligibility Verification (Aug 2013).

(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (E.O. 13658).

(xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xviii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of Clause)

52.216-18 ORDERING (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from (Date of Award) through (Five Years from date of award).

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered “issued” when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

(End of clause)

52.216-19 ORDERING LIMITATIONS (OCT 1995)

(a) Minimum order. The Government meets the minimum amount by awarding the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of the total not-to-exceed (NTE) amount for the IDIQ line item;

(2) Any order for a combination of items in excess of the total not-to-exceed amount for the IDIQ line item; or

(3) A series of orders from the same ordering office within 14 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 30 days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of clause)

52.216-22 INDEFINITE QUANTITY (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the “maximum.” The Government shall order at least the quantity of supplies or services designated in the Schedule as the “minimum.”

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after 6 months after the end of the ordering period of the IDIQ task order placed against this contract.

(End of clause)

52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulation (FAR) System, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at:

http://farsite.hill.af.mil/.

52.211-6 Brand Name or Equal (Aug 1999) 52.216-18, Ordering (Oct 1995) applies 52.216-55 Indefinite Quantity 52.217-9 Option to Extend the Term of the Contract.(Mar 2000) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) applies

HHSAR Clauses HHSAR clause full text can be accessed electronically at: http://farsite.hill.af.mil/vfhhsara.htm HHSAR 352.203-70 Anti-lobbying (Jan 2006) HHSAR 352.222-70 Contract cooperation in equal employment opportunity investigations (Jan 2010) HHSAR 352.231-71 Pricing of Adjustments

52.252-1 -- Solicitation Provisions Incorporated by Reference. (Feb 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

FAR – www.acquisiton.gov HHSAR - http://farsite.hill.af.mil/vfhhsara.htm

FAR Provisions:

52.212-3 Offeror Representations and Certifications—Commercial Items (May 2014

HHSAR Provisions:

352.215-1 Instructions to Offerors – Competitive Acquisition

Solicitation Provisions In Full Text

52.216-27 Single or Multiple Awards (Oct 1995)

The Government may elect to award a single delivery order contract for the same or similar supplies or services to two or more sources under this solicitation.

PART 10

Contracting Officers Representative (COR)

The COR, to be determined upon contract award, will represent the Government for the purpose of this contract.

The COR is responsible for:

(1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

(2) interpreting the Statement of Work and any other technical performance requirements;

(3) performing technical evaluation as required;

(4) performing technical inspections and acceptances required by this contract; and

(5) assisting in the resolution of technical problems encountered during performance.

Contracting Officer (CO)

The Contracting Officer is the only person with authority to act as agent of the Government under this contract.

Only the Contracting Officer has authority to:

(1) direct or negotiate any changes in the RFQ;

(2) modify or extend the period of performance;

(3) change the delivery schedule;

(4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or

(5) otherwise change any terms and conditions of this contract.

Contracting Officer:

Phillip Frame 5630 Fishers Lane Rockville, MD 20853 Phillip.Frame@fda.hhs.gov 204.402.7578

Contract Specialist:

Aimee Swann 5630 Fishers Lane Rockville, MD 20853 Aimee.Swann@fda.hhs.gov 240.402.7607

Government Holidays Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) or OPM.gov due to inclement weather.

January (New Year’s Day) September (Labor Day) January (Martin Luther King Day) October (Columbus Day) February (President’s Day) November (Veterans Day) May (Memorial Day) November (Thanksgiving) July (Independence Day) December (Christmas Day)

PART 11

The provision at 52.212-1 Instructions to Offerors – Commercial Items applies with the following addenda:

Period for Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2015.

SAM:

All interested offerors shall be registered in the System for Award Management (SAM), if the offeror is not registered in SAM, please visit https://www.sam.gov. You will need your Tax ID, DUNS Number and banking information. Vendors who are not registered in SAM will not be eligible for award. The Government reserves the right not to negotiate and award without discussion.

Quote Preparation Instructions:

Offerors shall submit a quotation for the base ID/IQ contract (base quote), based on completion of the Base Pricing Table in Part 5 and a Task Order Quote based on completion of the Task Order 1 Pricing Table located in Attachment 1. The Offeror must provide detailed (itemized) price quotes. The itemized pricing must include description of item, unit price and total price.

The Base Quote shall include:

1. Unit Prices for the Salmonella, Listeria and QCV kits for the 5 year ordering period

The Task Order Quote shall include:

2. Unit and Total prices for each line item in the proposed quantities of the Salmonella, Listeria and QCV kits for all base and option years

3. Total pricing for each year (base year and option years 1-4)

4. Total pricing for the entire contract (pricing for all years)

5. FOB point;

6. Contractor’s Point of Contact (name and telephone number);

7. Offeror statement verifying that they are SAM Registered under the appropriate NACIS code

8. Delivery dates;

mailto:Aimee.Swann@fda.hhs.gov

9. Business size; and

10. Payment terms

The Government anticipates award of an Indefinite Delivery/Indefinite Quantity contract with a five year ordering period utilizing firm-fixed price Task Orders to the lowest price technically acceptable (LPTA) offeror who can meet the specifications listed in this Request for Quote (RFQ).

All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number FDA-15-223-SOL-1152408. Quotes are due via email to the point of contact listed below on or before September 1, 2015 by 3:00 pm ET. Questions are to be submitted via email to the point of contact listed below on or before August 28, 2015 12:00pm ET.

Point of Contact: Aimee Swann at 240-402-7607 or email at Aimee.Swann@fda.hhs.gov.

PART 12

The provision at 52.212-2 Evaluation – Commercial Items applies. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows:

The Government will award a contract resulting from this solicitation to the responsible offeror whose proposal meets the specifications listed under this solicitation and is the lowest priced proposal received in response to this solicitation. Therefore, award will be made to offeror whose proposal is determined to be Lowest Price Technically Acceptable.

Technical Acceptability Criteria:

The Government will evaluate the contractor’s quote for technical acceptability based on the following:

1. Offerors shall provide sufficient documentation in their quotation detailing that the supplies meets the performance requirements in accordance of Parts 4 and 6 of this RFQ and the general requirements of this RFQ .

2. Offerors shall provide confirmation that they are able to meet the proposed delivery schedule in Task Order 1/Attachment 1 and the requirements of Part 7 of this RFQ.

3. Offerors shall provide a Base Price Quote and a Task Price Order Quote by completing the pricing tables in Parts 5 and Attachment 1, respectively.

4. Offerors shall provide a Quote to include all required information in Part 8 in Base and Task Order quotes.

Attachment 1

Task Order #1: Base Year, September 2015-August 2016 Please propose based on the below task order. Each laboratory shall receive the below projected quantities of Salmonella and QCV kits on a monthly basis and the proposed quantities of Listeria kits on the a quarterly basis with initial delivery by September 30, 2015.

Task Order #1 Pricing Table:

Line Item Kit Delivery

Frequency

Total Annual Quantity

(All Locations)

Line Item Unit Price

Line Item Total Price Total Year Pricing

Base Year: 9/2015-9/2016

1001 Salmonella Monthly 1176 $ $

S 1002 QCV Monthly 408 $ $

1003 Listeria Quarterly 492 $ $

I. Option Year 1: 9/2016-9/2017

2001 Salmonella Monthly 1176 $ $

S 2002 QCV Monthly 408 $ $

2003 Listeria Quarterly 492 $ $

II. Option Year 2: 9/2017-9/2018

3001 Salmonella Monthly 1176 $ $

S 3002 QCV Monthly 408 $ $

3003 Listeria Quarterly 492 $ $

III. Option Year 3: 9/2018-9/2019

4001 Salmonella Monthly 1176 $ $

S 4002 QCV Monthly 408 $ $

4003 Listeria Quarterly 492 $ $

IV. Option Year 4: 9/2019-9/2020

5001 Salmonella Monthly 1176 $ $

S 5002 QCV Monthly 408 $ $

5003 Listeria Quarterly 492 $ $

TOTAL CONTRACT PRICE: S

Proposed Delivery Schedule

Location

PEV NRL SRL

SAN-

LAB

DEN-

LAB

PRL-

SW

ARL

PRL-

NW

WEAC

DET-

LAB

Total Est.

Quantity

Total Annual

Quantity

Salmonella – Monthly:

(9/2015- 8/2015)

5 12 10 10 12 8 8 8 5 20 98 1176

QCV kits – Monthly:

(9/2015- 8/2015)

2 5 3 2 4 4 3 4 3 4 34 408

Listeria – Quarterly:

9/2015, 12/2015, 3/2015, 6/2015

0 30 15 5 10 8 8 2 5 40 123 492

Delivery Locations (Points of Contact for each shall be provided at time of award):

Lab Address

NRL 158-15 Liberty Avenue, Jamaica, NY 11433

SRL 60 Eighth Street NE, Atlanta, GA 30309

SAN-LAB 1431 Harbor Bay Pkwy, Alameda, CA 94502

DEN-LAB Denver Federal Ctr, Bldg #20, Denver, CO 80225

ARL 3900 NCTR Road, Jefferson, AR 72079

PRL-NW 22201 23rd Dr. SE, Bothell, WA 98021

PRL-SW 19701 Fairchild, Irvine, CA 92612

WEAC 109 Holton St, Winchester, MA 01890

DET-LAB 300 River Place Suite 5900 Detroit, MI 48207

PEV 1800 Eller Drive, Ste 425, Ft. Lauderdale, FL 33316