FDA-SOL-1160661.pdf

Solicitation Number: FDA-SOL-1160661

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 05-66. 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/Center for Food Safety and Applied Nutirtion (CFSAN) requires a PR2 1800 system which performs immunoassays using electrochemiluminescent (ECL) detection, for use in the select agent laboratory. This ECL detection platform uses reporter molecules, such as ruthenium (II) trisbipyridal [Ru(bpy)32+] attached to biological conjugates (e.g., antibodies) for various biothreat agents. These reporter molecules undergo electron-transfer reactions when stimulated by an electrode and emit light. PR2 1800 system, with its improved ECL signaling technology, provides more sensitive detection at very low concentration and has a wider dynamic range than standard fluorescence or colorimetric ELISAs. This fully automated and proven technological platform and kits are available for several biothreat agents including Botulinum Toxin, A, B and E.

2.2. Contract Type

2.2.1. Firm-Fixed Price Purchase Order.

2.3 Pricing:

CLIN Part# Description (Brand Name or Equal) Qty/UOI Price 1001 I82AA-1 PR2 Model 1800, Package C Instrument 1 ea $

2001 W81XX-

Option Period 1: SECTOR PR2 Model 1800 Total Service Package.

1 ea $

2002 W81XX-

Option Period 2: SECTOR PR2 Model 1800 Total Service Package.

1 ea $

2003 W81XX-

Option Period 3: SECTOR PR2 Model 1800 Total Service Package.

1 ea $

2004 W81XX-

Option Period 4: SECTOR PR2 Model 1800 Total Service Package.

1 ea $

3001 SHIP Shipping and Handling 1 ea $ Total Value $

PART 3 – TECHNICAL REQUIREMENTS

3.1 FUNCTIONAL SPECIFICATIONS

The contractor shall provide a brand name (Manufacturer: Mesoscale Diagnostics) or equivalent system with the following Saliant Characteristics:

1. Multiple agents (toxins, viruses and bacteria) from a single sample can be measured

2. Electrochemiluminescence (ECL) signal detection technology

3. Plate based immunoassay system capable of 96-well (9, 16, and 25 spot) multiplex plates

4. Plate read time at least ~ 7 minutes

5. Dynamic assay range of 10^5 over the spectrum of assays

6. Temperature range 15-30 C minimum

7. Automated data Analysis and reporting of results

PART 4 – PACKING, MARKING AND SHIPPING

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

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 of system and software, 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 described in PART 3 of this solicitation and upon delivery and acceptance by the Contracting Officer Representative (COR), of all deliverables required within PARTS 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) 5100 Paintbranch Parkway College Park, MD 20740

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. EASTERN 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: TBD Email Address:

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 mailto:William.Lee@fda.hhs.gov

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

Name:

Email:

Phone#

7.2. INVOICE SUBMISSION

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

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;

mailto:fdavendorpaymentsteam@fda.gov

(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

52.212-4 Contract Terms and Conditions - Commercial Items (Feb 2012) 52.203-5 Covenant Against Contingent Fees (Apr 1984) 52-233-2 Service of Protest (Sep 2006) 52.247-35 F.O.B. Destination within Consignee Premises (Apr 1984)

FAR CLAUSES BY FULL TEXT

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (Jan 2013)

(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) 52.222-50, 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)).

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

(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) (Pub. L. 108-77, 108-78).

(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. 253g and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

__ (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 (Aug 2012) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) 52.204-11, American Recovery and Reinvestment Act—Reporting Requirements (Jul 2010) (Pub. L. 111-5).

X_(6) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Dec 2010) (31 U.S.C. 6101 note).

__ (7) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Feb 2012) (41 U.S.C. 2313).

__ (8) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Pub. L. 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161).

__ (9) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C.

657a).

__ (10) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (11) [Reserved]

_X_ (12)(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).

__ (13)(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.

__ (14) 52.219-8, Utilization of Small Business Concerns (Jan 2011) (15 U.S.C. 637(d)(2) and (3)).

__ (15)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2011) (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 (Jul 2010) of 52.219-9.

__ (16) 52.219-13, Notice of Set-Aside of Orders (Nov 2011)(15 U.S.C. 644(r)).

__ (17) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

__ (18) 52.219-16, Liquidated Damages—Subcon-tracting Plan (Jan 1999) (15 U.S.C.

637(d)(4)(F)(i)).

__ (19)(i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Oct 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer).

__ (ii) Alternate I (June 2003) of 52.219-23.

__ (20) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting (Dec 2010) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

__ (21) 52.219-26, Small Disadvantaged Business Participation Program— Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

__ (22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657 f).

__ (23) 52.219-28, Post Award Small Business Program Rerepresentation (Apr 2012) (15 U.S.C. 632(a)(2)).

__ (24) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Apr 2012) (15 U.S.C. 637(m)).

__ (25) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Apr 2012) (15 U.S.C. 637(m)).

_X_ (26) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_X_ (27) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Mar 2012) (E.O. 13126).

_X_ (28) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

X_ (29) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

_X_ (30) 52.222-35, Equal Opportunity for Veterans (Sep 2010)(38 U.S.C. 4212).

_X_ (31) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C.

793).

__ (32) 52.222-37, Employment Reports on Veterans (Sep 2010) (38 U.S.C. 4212).

__ (33) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

__ (34) 52.222-54, Employment Eligibility Verification (Jul 2012). (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) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C.

8259b).

__ (37)(i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (Dec 2007) (E.O. 13423).

__ (ii) Alternate I (Dec 2007) of 52.223-16.

_X_ (38) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).

_X_ (39) 52.225-1, Buy American Act—Supplies (Feb 2009) (41 U.S.C. 10a-10d).

_X_ (40)(i) 52.225-3, Buy American Act—Free Trade Agreements—Israeli Trade Act (Nov 2012) (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 (Mar 2012) of 52.225-3.

__ (iii) Alternate II (Mar 2012) of 52.225-3.

__ (iv) Alternate III (Nov 2012) of 52.225-3.

__ (41) 52.225-5, Trade Agreements (Nov 2012) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (42) 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).

__ (43) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C.

5150).

__ (44) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

__ (45) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

__ (46) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

__ (47) 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration (Oct 2003) (31 U.S.C. 3332).

__ (48) 52.232-34, Payment by Electronic Funds Transfer—Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332).

__ (49) 52.232-36, Payment by Third Party (Feb 2010) (31 U.S.C. 3332).

__ (50) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (51)(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 Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Act—Price Adjustment (Multiple Year and Option Contracts) (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Act—Price Adjustment (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

_X_ (5) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (Nov 2007) (41 351, et seq.).

_X_ (6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services—Requirements (Feb 2009) (41 U.S.C. 351, et seq.).

__ (7) 52.222-17, Nondisplacement of Qualified Workers (Jan 2013) (E.O.13495).

__ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub.

L. 110-247).

__ (9) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 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) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

(ii) 52.219-8, Utilization of Small Business Concerns (Dec 2010) (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 (Jan 2013) (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 (Sep 2010) (38 U.S.C. 4212).

(vi) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).

(vii) 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.

(viii) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

(ix) 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)).

(x) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 U.S.C.

351, et seq.).

(xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.).

(xii) 52.222-54, Employment Eligibility Verification (Jul 2012).

(xiii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub.

L. 110-247). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xiv) 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.

HSAR CLAUSES INCORPORATED BY REFERENCE

HHSAR Clause Description Date 352.202-1 Definitions (Jan 2006) 352.203-10 Anti-lobbying (Jan 2006) 352.224-70 Privacy Act (Jan 2006) 352.228-7 Insurance--Liability to third persons (Dec 1991) 352.233-71 Litigation and claims (Jan 2006) 352.237-71 Criminal Control Act (Jan 2006) 352.242-73 Withholding of contract payments (Jan 2006) 352.242-71 Tobacco-free Facilities (Jan 2006) 352.242-74 Final decisions on audit findings (Apr 1984) 352.270-1 Accessibility of meetings, conferences, (Jan 2001) and seminars to persons with disabilities

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 22 February 2016.

RFQ Due Date and Time: All quotes shall be submitted via email and be received by 4:30 PM (1630) Eastern Time on 24 February 2016. Late quotes will not be evaluated. Offerors shall ensure the RFQ number is visible in the header of the email.

FAR Provision:

52.212-3 Offeror Representations and Certifications—Commercial Items.

An offeror shall only complete paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. If an offeror has not completed the annual representations and certifications electronically at the ORA website, the offeror shall complete only paragraphs (c) through (m) of this provision

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 (June 2008) 52.211-6, Brand Name or Equal (Aug 1999).

Quote Format The cover letter shall include; FOB point; a POC (name and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS code 334516; delivery date (delivery date is of the utmost importance); business size; and payment terms.

9.1. Technical Capability

9.1.1. The Offeror shall demonstrate that their system meets all of the functional specifications in

PART 3.

9.2. Past Performance

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

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, 2.3.

PART 10 - EVALUATION FACTORS FOR AWARD

EVALUATION FACTORS

The offeror's ability to demonstrate/describe the following factors as noted in PART 9.

10.1. Technical Capability

10.1.1. The Offeror has demonstrated that their system meets all of the functional specifications in PART 3.

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 Government will evaluate the total price of all contract line items.

10.3.2. The Offeror has submitted complete pricing as indicated in PART 2, 2.3.

AWARD CRITERIA:

The Government will evaluate the quote to ensure that it is technical acceptable in accordance with the requirements in PART 3 and that the price is fair and reasonable from the Offeror.

Award will be made to the party whose quote offers the best value to the Government, technical capability, past performance and price considered. The Government may award this contract to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability, 2) Past Performance and 3) Price. Technical Capability when combined with Past Performance is significantly more important than price. When all factors are equal, price becomes the determining factor.

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (Jan 2013)