RFQ_for_PHAT_System.doc

Subject: Brand Name or Equal PHAT System w/Raman Microscope Solicitation Number: FDA-16-1159330 Part 1 – Description

1.1 This is a Request for Quotation (RFQ) for: Brand Name or Equal PHAT System w/Raman Microscope

1.2 The associated North American Industrial Classification System (NAICS) code for this procurement is 334516.

Part 2 – Supplies or services and Prices/Costs

2.1 Description of Equipment/Services

Total

Part 3 – Description/Specifications/Work Statement

3.1 Scope of Work

FDA requires one (1) PhAT System w/Raman Microscope (PSRM). The PSRM will allow whole drug product analysis and will support FDA’s regulatory research role. This instrumentation will strongly support the division’s facilitation of New Drug Application and abbreviated New Drug Application review processes.

3.2 Specifications:

FDA requires a PSRM with the following specifications:

One (1) standalone, portable Raman instrument with large spot size (1, 3, and 6mm) to capture product quality information in various solid dosage forms is required.

Raman instrument PhAT system shall have the following capabilities:

· Spectrometer

· Very high throughput, f <2

· Data acquisition range 150-1825cm-1 Raman shift and spectral resolution of 4cm-1

· holographic transmission type high throughput grating and transmission optics for enhanced stability of spectrograph

· Holographic notch filter capable of filtering laser line greater than 6 optical density.

· Rejected notch spectral bandwidth should be less than 350 cm-1 and edge width less than 150cm-1

· Small footprint spectrometer and light weight

· Fully integrated turnkey system

· Thermoelectrically cooled CCD camera with an array dimension of 1024 pixel in the wavelength dispersion axis

· Laser

· Diode laser which works at 785 nm operating wavelength.

· Fiber optic probe and other accessories

· Spectrometer should interface the sample through fibre optic cable

· Length of fiber optic cable should be 3m or more (not including probe length) and easily replaceable if need to be

· Must have more than 45 collection fiber to collected Raman signal from the large illuminated spot

· Probe head should contain optical filtering, suitable probe head adapter must be included

· Interchangeable end optics at probe head, which can produce spot size of 6mm, 3mm and 1mm

· Appropriate immersion optics with sapphire window that can handle temperature and pressure ranges: (-)40 to (+)200 °C and 0.9-10 bar pressure

· Enclosed sample Compartment

· Calibration

· System must have calibration accessories for calibrating laser wavelength, spectrometer wavelength axis, and intensity

· Computer and Software

· System should be compatible to computer with appropriate software to reliably calibrate, control, collect, and process the collected data, including other peripherals required to smoothly run the instruments.

· Raman Microscope must be 100% compatible with PhAT system and DPQR’s current Kaiser brand name small-spot analyzer model RXN2-785 (S/N 007219) and RXN2-785 (S/N 007166).

· Multimodal sampling and operation capability

· Optical microscope with 5 piece nosepiece that can be cetered

· Probehead interface with spot size 1,3,and6mm

· Shielded motorized XYZ stage

· Accompanies with well plate holder and 24 position tablet mountable plates and their associated software and other necessary software for microscopy

· Microscope objectives with 50X and 20X magnification with their numerical apertures and working distances corresponds to (0.75, 0.35) and (0.37mm, 24mm), respectively.

· Additional probe head for spot size 6mm for microscope

The contractor shall also provide installation and training of FDA scientists on the equipment.

Part 4 – Inspection and Acceptance 4.1 The Contracting Officer’s Representative (COR) (see Part 6) will perform inspection and acceptance of materials to be provided at location in Part 5.

Part 5 – Deliverables or Performance

5.1 Delivery

The equipment shall be shipped to the following location 10-12 weeks of contract award:

Food and Drug Administration 10903 New Hampshire Ave WO Bldg 64 Loading Dock Silver Spring, MD 20993 Part 6 – Contract Administration Data

6.1 Contracting Officers Representative (COR) The following COR will represent the Government for the purpose of this contract:

(To Be Determined at the Time of Award)

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. The Government may unilaterally change its COR designation.

6.2 Contract Specialist

The contact information for the Contracting Specialist is:

Tara Hobson

5630 Fishers Lane, Room 2115

Rockville, MD 20857

Tara.Hobson@fda.hhs.gov

(240) 402-7586 Fax: (301) 827-7101

6.3 Contracting Officer

The contact information for the Contracting Officer is:

Department of Health and Human Services

Food & Drug Administration, OAGS

Attn: Tara Hobson, Room 2115

5630 Fishers Lane

Rockville, MD 20857

Phone: (240) 402-7586 Tara.Hobson@fda.hhs.gov

6.4 Contractor Point of Contact

The contact information for the Contractor Point of Contact is: (To Be Determined at the Award of the Contract)

Name:

Address:

Phone Number:

Email:

6.5 INVOICE SUBMISSION

The Contractor shall submit all invoices to all addresses in the manner specified below:

(I) One original and one copy to the approving official:

U.S. Food and Drug Administration Office of Acquisitions and Grants Services

ATTN: Tara Hobson, CO/CS

5630 Fishers Lane Room 2042, HFA-500

Rockville, Maryland 20857

E-mail: Tara.Hobson@FDA.HHS.GOV *** Acceptable methods of delivery include: mail, hand delivery and email (II) One copy to the contracting officer technical representative (COTR) or other program center/office designee, clearly marked “courtesy copy only”:

U.S. Food and Drug Administration ATTN: (To Be Determined at the Award of the Contract) 10903 New Hampshire Avenue, Building #64 Silver Spring, MD 20993 E-mail: @FDA.HHS.GOV

*** Acceptable methods of delivery include: mail, hand delivery and email 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 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;

(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 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 Technical Representative (COTR) or other program center/office point of contract, as referenced on the purchase order;

(XII) Any other information or documentation required by the purchase order/award.

(XIII) Contractor is □ is not □ required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) List of all invoices submitted to date under the subject award, including the following:

(1) Invoice number, amount, and date submitted

(2) Corresponding payment amount and date received

(b) Total amount of all payments received to date under the subject contract or order

(c) And, for definitized contracts or orders only, total estimated amounts yet to be invoices for the current, active period of performance C.

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.

D.

Questions regarding invoice payments should be directed to the FDA Payment Office at:

Office of Financial Services Food and Drug Adminstration

10903 New Hampshire Ave

WO32-Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

Attn: Vendor Payments

PART 7-CONTRACT CLAUSES

7.1 52.252-2 Clauses Incorporated by Reference (FEB 1998)

This contract incorporates one or 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.acquisition.gov/far/index.html

52.212-4 Contract Terms and Conditions-Commercial Items (MAY 2015)

7.2 FAR Clauses by Full Text 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Jan 2016)

(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 (Nov 2015)

(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 (Oct 2015) (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).

___ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Oct 2015) (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).

___ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) (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).

___ (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.

_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 2015) (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 2015) 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).

_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, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

___ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (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 2016) (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).

___ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

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

___ (31) 52.222-37, Employment Reports on Veterans (Oct 2015) (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) (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).

___ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O. 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 (Oct 2015) 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 (Oct 2015) (E.O.s 13423 and 13514).

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

___ (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513).

_X__ (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 2015) (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 (Oct 2015) (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 $700,000 ($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 (Oct 2015) (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 (Oct 2015) (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 (Oct 2015) (E. O. 12989).

(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (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.

52.217-8 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 the term of the contract.

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 at any time within the term of the contract.

(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.

Part 8– Instructions to the Offerors

8.1 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:

FAR Clause

Description

Date

52.212-1

Instructions to Offerors –

(OCT 2015)

Commercial Items

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

FAR Clause

Description

Date

52.212-3

Offeror Representations (Nov 2015)

And Certifications-

Commercial Items

Questions Deadline: All questions shall be received via email tara.hobson@fda.hhs.gov before 5:00 pm (1700) EASTERN TIME on January 21, 2016.

RFQ Due Date: All quotes and revisions shall be received via email to tara.hobson@fda.hhs.gov before 12:00 PM (1200) EASTERN TIME on February 03, 2016. Offerors shall ensure the RFQ number is visible in the header of the email.

Fax quotes shall not be accepted.

All Offerors shall be registered in the System Award Management (SAM) prior to the award of the contract. You may register by going to www.sam.gov.

8.2 Technical Proposal

1) The Offeror shall demonstrate that they can meet all the specifications in Part 3.2.

2) The Offeror shall demonstrate that they can provide one year warranty.

3) The Offeror shall demonstrate that they can provide onsite/online training and support.

4) The Offeror shall demonstrate that they can provide assistance with experimental troubleshooting or system replacement.

8.3 Past Performance The Offeror shall identify three projects that it has performed within the last three years for the same or similar requirements.

8.4 Price Proposal The price proposal shall represent the Offeror’s response to the requirements of the solicitation.

The Offerors ability to complete pricing table in Part 2.1.

PART 9 – Evaluation Factors for Award

9.1 Evaluation Factors

The Government will evaluate the quote to ensure that it is technically 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 proposal offers the best value to the Government, Technical, Past Performance, and Price will be considered. The Government may award this contract other than lowest price technically acceptable offer. The Government will evaluate information based of 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.

9.2 Technical Capability

1) The Offeror meets and exceeds the capability can meet all the specifications in Part 3.2.

2) The Offeror meets and exceeds the capability they can provide one year warranty.

3) The Offeror meets and exceeds the capability they can provide onsite/online training and support.

4) The Offeror meets and exceeds the capability assistance with experimental troubleshooting or system replacement.

9.3 Past Performance

The offeror has demonstrated that they have identified three projects that have performed within the last three years for the same or similar requirements.

9.4 Price

The price proposal shall represent the Offeror’s response to the requirements of the solicitation.

The Offerors ability to complete pricing table in Part 2.1.

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