FDA-SOL-1145121.pdf

Solicitation Number: FDA-SOL-1145121

PART 1 – DESCRIPTION

THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERICAL ITEMS

PREPARED IN ACCORDANCE WITH THE FORMAT I FART SUBPART 12.6 –

STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR

COMMERICAL ITEMS - AS SUPPLEMENTED WITH ADDITIONAL INFORMATON

INCLUDED IN THIS NOTICE. THIS ANNOUNCMENT CONSTITUTES THE ONLY

SOLICITATION: QUOTATION ARE BEING REQUESTED, AND A WRITTEN

SOLICITATION DOCUMENT WILL NOT BE ISSUED. THIS SOLICITATION IS BEING

ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-79. This requirement is for Total Small Business Set-Aside concerns. The associated North American Industrial Classification System (NAICS) code for this procurement is 334516. Its associated Small Business size standard is 500 employees.

PART 2 – SUPPLIES OR SERVICES AND PRICES

2. DESCRIPTION OF SUPPLIES & SERVICES

2.1. The FDA/ Office of Regulatory Affairs has a requirement for, brand name or equal, a fully automated microbial identification system along with additional identification database software and service agreements to decrease isolate preparation and identification time from DNA sequencing, and give a definitive answer rather than having to spend time analyzing and comparing data before determining the identification of the isolate. This rapid molecular system will enhance the Pacific Regional Lab-Southwest (PRL-SW’s) ability to complete the analysis of their regulatory samples more rapidly.

2.2. Contract Type

2.2.1. Firm-Fixed Price Purchase Order.

2.3. Contract Funding Notice as prescribed in FAR 52.232-18 Availability of Funds (Apr 1984).

2.4. Pricing:

Systems, System Software and Validation Services CLIN Model# Description Qty/

UOI

Unit Price

Price

0001 91391 GEN III Omnilog Plus ID System. 1 ea $ $ 0002 90919 On-Site Validation Service 1 ea $ $ 0003 90835 OL Rls 2.3 MI for Win 7 OS Validation

Manual w/50 Micro-Plates and Lids 1 ea $ $

0004 39833 Validation Manual, GEN III MS, Win 7, w/25 Micro-Plates and Lids, Irridated

1 ea $ $

Identification Databases Software 0005 22730D GEN III Database (GN & GP) 1 ea $ $ 0006 22605D Yeast (YT) Database 1 ea $ $ 0007 22606D Filamentous Fungi (FF) Database 1 ea $ $ 0008 22607D Anaerobic (AN) Bacteria Database 1 ea $ $

Shipping Charges 0009 FRGHT01 Freight $

Service Agreements CLIN Description Qty/

UOI

Unit Price

Price

Option Year 1: Service Agreement 12 Mos $ $ Option Year 2: Service Agreement 12 Mos $ $ Option Year 3: Service Agreement 12 Mos $ $ Option Year 4: Service Agreement 12 Mos $ $

Total Value: (Systems, System Software, Validation Services, Identification Databases Software, Shipping Charges and Service Agreements).

PART 3 – DESCRIPTION

3.1. TECHNICAL REQUIREMENTS

The contractor shall provide a brand name or equivalent system with the following minimum salient characteristics:

3.1.1. Systems, System Software

1. Identification system, all components shall be at least 110V-120V, 50-60Hz, 5 amps

a. Incubator/Reader

i. Operating temperature range of 22°C (+2°C) to 45°C (+2°C) with external temperature control

ii. capacity for up to 50 micro-plates

iii. diagnostic self-test

b. Microplate reader

c. Filters: 405nm, 450nm, 490nm, 630nm, 750nm

d. Dust cover

e. Windows 7 Computer with a 21 CFR Part 11 data management software system already installed

f. Serial cables

g. Compatible printer

h. LCD flat panel monitor

i. Turbidimeter

j. User guide/manual (may be web based)

k. On-site training for four (4) analysts on the use of the instrument to be performed within 90 days of installation.

l. One year warranty for full replacement of the instrument for any all manufacturer defects, or if two service calls are warranted within the first year.

3.1.2. Validation Services

1. System installation shall include IQ/OQ on-site validation service.

2. Validation manuals shall be provided with associated consumables including sterile microplates with lids.

3.2.1. Identification Databases Software

The contractor shall provide Identification Databases Software which identifies the following:

a) Yeast

b) Filamentous Fungi

c) Gram positive and Gram negative anaerobic Bacteria

d) Gram positive and Gram negative aerobic Bacteria

3.3.1. Standard Manufacturer Warranty/Service Agreement

a) The standard manufacturer’s warranty shall not take effect until inspection and acceptance of delivered systems and installation has been completed.

b) The optional service agreements shall not be exercised until expiration of the standard manufacturer’s warranty.

c) The contractor shall provide pricing for optional service agreements for four additional option years. This shall not obligate the FDA to purchase the service agreements. The service agreements shall including annual preventive maintenance and performance qualification (PQ) and cover all parts, labor, travel and a PQ report. Unlimited, free technical support by phone or internet shall be included as well.

PART 4 – PACKING, MARKING AND SHIPPING

4. All deliverables required under this contract shall be in accordance with FAR Part 52.212-4.

At a minimum, all deliverables shall be marked with the contract number and contractor name.

4.1. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

PART 5 – INSPECTION AND ACCEPTANCE

5. The Contracting Officer’s Representative (COR) will, in accordance with FAR 52.212-4, perform inspection and acceptance of all laboratory equipment and accessories at time of installation.

5.1. For the purpose of this PART, (COR – To be determined after award) is the authorized representative of the Contracting Officer.

5.2. Inspection and acceptance will be performed at: the location identified in Part 6.3.

5.3. Acceptance is communicated in writing and is contingent upon successful delivery, installation and function of the equipment.

PART 6 – DELIVERY LOCATION

6. DELIVERIES

6.1. Satisfactory performance of this contract shall be deemed to occur upon delivery of the system and databases described in PART 3 of this solicitation and upon delivery and acceptance by the Contracting Officer, or the COR, of all deliverables required within PART 3 of this contract.

6.2. Deliveries required by the contractor shall be made F.O.B. destination to the Address/addresses listed below:

6.3. DELIVERY POINT:

The U.S. Food and Drug Administration Attn: (To be determined after award) 19701 Fairchild Irvine, CA 92612-2506

6.4. Unless otherwise specified, deliveries shall be made to the Delivery Point specified above, Monday through Friday (excluding Federal Holidays) between the hours of 8:30 a.m. and 5:30 p.m. PACIFIC TIME only.

PART 7: CONTRACT ADMINISTRATION

7.1. CONTRACTING OFFICERS REPRESENTATIVE (COR)

7.1.1. The COR is responsible for: (1) monitoring the Offeror'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.

7.1.2. The contact information for the Contracting Officer Representative (COR):

Name:

Email:

Phone:

7.1.3. 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 Offeror any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

7.1.4. The contact information for the Contracting Officer:

William Lee William.lee@fda.hhs.gov 301-443-5863

7.1.5. The contact information for the Contractor Point-of-Contact:

Name:

Email:

Phone#

7.2. INVOICE SUBMISSION

3-Way Invoicing :

A. The Contractor shall submit one original copy of each invoice to the address specified below:

Office of Financial Services Food and Drug Administration

W032- Second Floor

MAIL HUB 2145

10903 New Hampshire Avenue Bldg 32, Rm# 2162, Mail Hub 2145

Silver Spring MD 20993-0002 Attn: Vendor Payments

(301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov mailto:fdavendorpaymentsteam@fda.gov

B. 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 – Central Contractor Registration) and/or 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 shipping, 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/award, 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 the 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.

C. Questions regarding invoices shall be directed to the FDA at the telephone number provided above.

PART 8 - CONTRACT CLAUSES

FAR CLAUSES INCORPORATED BY REFERENCE

52.252-2 Clauses Incorporated by Reference (FEB 1998)

This contract incorporates one of more clauses 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. Also, the full text of a clause may be accessed electronically at www.acquistion.gov/far/index.html

52.204-18, Commercial and Government Entity Code Maintenance (Nov 2014) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Aug 2013).

52.212-4, Contract Terms and Conditions - Commercial Items (Dec 2014) http://www.acquistion.gov/far/index.html

52.219-28, Post Award Small Business Program Representation (Jul 2013) 52.232-23, Assignment of Claims (May 2014) 52-233-3, Protest After Award (Aug 1996)

FAR CLAUSES BY FULL TEXT

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—

COMMERCIAL ITEMS (DEC 2014)

(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) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

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

(4) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004)"(Public Laws 108-77 and

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:

[Contracting Officer check as appropriate.]

__ (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 (June 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.

__ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

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__ (ii) Alternate I (JAN 2011) of 52.219-4.

__ (13) [Reserved] _X_ (14)(i) 52.219-6, Notice of Total Small Business Set-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.

_X_ (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)).

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

__ (20) 52.219-16, Liquidated Damages—Subcon-tracting 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. 657 f).

_X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (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 (Feb 1999).

_X_ (28) 52.222-26, Equal Opportunity (Mar 2007) (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).

__ (33) 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.)

__ (34)(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.)

__ (35)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.

13423 and 13514).

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

__ (36)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (E.O. 13423 and 13514).

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

__ (37) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b).

__ (38)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (JUN 2014)

(E.O. 13423 and 13514).

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

_X_ (39) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving

(AUG 2011) (E.O. 13513).

__ (40) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

_X_ (41)(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.

__ (42) 52.225-5, Trade Agreements (NOV 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (43) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (44) 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).

__ (45) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (46) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007)

(42 U.S.C. 5150).

__ (47) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002)

(41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (48) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (49) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management

(Jul 2013) (31 U.S.C. 3332).

__ (50) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award

Management (Jul 2013) (31 U.S.C. 3332).

__ (51) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

__ (52) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (53)(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:

[Contracting Officer check as appropriate.] __ (1) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and

41 U.S.C. chapter 67).

__ (3) 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).

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__ (4) 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).

__ (5) 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).

__ (6) 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).

__ (7) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O.13495).

__ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42

U.S.C. 1792).

__ (9) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008) (31 U.S.C. 5112(p)(1)).

__ (10) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (Executive Order

13658).

(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 (l) of FAR clause 52.222-17.

(iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

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

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

(vii) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212) https://acquisition.gov/far/current/html/52_222.html#wp1148274 http://uscode.house.gov/ http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_222.html#wp1155380 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_222.html#wp1162590 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_222.html#wp1147587 https://acquisition.gov/far/current/html/52_223_226.html#wp1183820 http://uscode.house.gov/ http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_233_240.html#wp1120023 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+1665+30++%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_222.html#wp1163027 https://acquisition.gov/far/current/html/52_215.html#wp1144470 https://acquisition.gov/far/current/html/Subpart%204_7.html#wp1082800 https://acquisition.gov/far/current/html/52_200_206.html#wp1141983 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_217_221.html#wp1136032 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_217_221.html#wp1136032 https://acquisition.gov/far/current/html/52_222.html#wp1147587 https://acquisition.gov/far/current/html/52_222.html#wp1147587 https://acquisition.gov/far/current/html/52_222.html#wp1147711 https://acquisition.gov/far/current/html/52_222.html#wp1158632 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t37t40+200+2++%2838%29%20%20AND%20%28%2838%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_222.html#wp1162802 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+2+78++%2829%29%20%20AND%20%28%2829%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_222.html#wp1148123 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+2+78++%2829%29%20%20AND%20%28%2829%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20

(viii) 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.

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

(x) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(xi) 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).

(xii) 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).

(xiii) 52.222-54, Employment Eligibility Verification (AUG 2013).

(xiv) 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).

(xv) 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.

(xvi) 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.

(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (Executive Order 13658).

(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

52.217-7 Option to Extend Services (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.

52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor;

provided that the Government gives the Contractor a preliminary written notice of its intent to extend before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years.

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HSAR CLAUSES INCORPORATED BY REFERENCE

HHSAR Clause Description Date 352.201-70 Paperwork Reduction Act (Jan 2006) 352.222-70 Contractor Cooperation in Equal (Jan 2010) Employment Opportunity Investigations 352.227-70 Publications and Publicity (Jan 2006)

PART 9 - INSTRUCTIONS TO THE OFFERORS

RESPONSE DATES and TIMES QUESTIONS DEADLINE: All questions shall be received by email (william.lee@fda.hhs.gov) before 4:30 pm (1630) EASTERN TIME on 26 February 2015.

RFQ Due Date and Time: All quotes shall be submitted via email and be received by 4:30 PM (1630) Eastern Time on 04 March 2015. Late quotes will not be evaluated. Offerors shall ensure the RFQ number is visible in the header of the email.

FAR Provisions Incorporated by Reference This contract incorporates one or more 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. Also, the full text of a clause may be accessed electronically at:

www.acquisition.gov/far/index.html:

52.212-1, Instructions to Offerors - Commercial Items (Apr 2014) 52.211-6, Brand Name or Equal (Aug 1999).

52.252-2, Clauses Incorporated by Reference (Feb 1998)

Quote Format The cover letter shall include; FOB point; a POC (name and telephone number); a statement from the offeror verifying that they are Registered with the System for Award Management (SAM) under NAICS code 334516; delivery date; business size; and payment terms.

9.1. Technical

9.1.1. The Offeror shall demonstrate that their system meets the minimum salient characteristics in PART 3.1.1.

9.1.2. The Offeror shall demonstrate that their Identification Databases Software meets the minimum salient characteristics in PART 3.2.1.

http://www.acquisition.gov/far/index.html

9.1.3. The Offeror shall demonstrate the ability to provide service agreements in accordance with the minimum salient characteristics in PART 3.3.1.

9.2. Past Performance

9.2.1. Past Performance. Instructions – A narrative description the Offeror’s overall past performance for the same or similar requirement. Submissions shall not exceed two for experience provided. In addition to the narrative described above, for each contract provide the following information:

Name of at least 2 references (Federal Government agency, local Government and/or Commercial customer) as it relates to this requirement; Contact information (telephone and email address)

9.3 Price

9.3.1 The Offeror shall complete the pricing table as indicated in PART 2, 2.4.

PART 10 - EVALUATION FACTORS FOR AWARD

10.1. Technical

10.1.1. The Offeror has demonstrated that their system meets the minimum salient characteristics in PART 3.1.1.

10.1.2. The Offeror has demonstrated that their Identification Databases Software meets the minimum salient characteristics in PART 3.2.1.

10.1.3. The Offeror has demonstrated the ability to provide service agreements in accordance with the minimum salient characteristics in PART 3.3.1.

10.2 Past Performance

10.2.1. The Government will evaluate the extent to which the Offeror’s past performance demonstrates overall client satisfaction on current and previous contracts. Ratings for this section are Pass, Fail or Neutral (no past performance history).

10.3 Price

10.3.1. The Offeror has submitted complete pricing as indicated in PART 2, 2.4.

AWARD CRITERIA:

Award will be made on the basis of the lowest evaluated price of quotes meeting or exceeding the acceptability standards for non-price factors.