FDA-RFQ-1159424_Spectrometer.pdf

Solicitation Number FDA-RFQ-1159424

Part 1 - Description

The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has a requirement for a Picosecond Time-Resolved Fluorescence spectrometer to help meet its objectives. This spectrometer shall be used to measure the lifetime and rotational correlation time of proteins to determine higher-order structure and aggregation state of biopharmaceuticals.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.

This Request for Quote (RFQ) is a total small business set aside using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-80. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing. Its associated Small Business Size Standard is 500 employees.

Part 2 –Supplies or Service and Prices/Cost

2.1 Contract Type: Firm-Fixed Price

2.2 Pricing Table

Base Pricing

Manufacturer Product

Code Description Quantity Dollar Amount

PicoQuant 972001 FluoTime 300 1

PicoQuant 03210 Excitation System and components 1

PicoQuant 03212 sample chamber and detection optics and components

PicoQuant 03213 Electronics and systems software 1

PicoQuant 72020 Automated polarizer in laser /LED excitation arm 1

PicoQuant 72205 Automated filer wheel in emission arm 1

PicoQuant 931060 Additional Software license 1 PicoQuant 971400 Shipping 1 PicoQuant 971402 Installation and training 1

One (1) year warranty on parts and labor Total Firm-Fixed Price

Option Pricing Option Period

Period of Performance Description Amount

1 TBD Service Maintenance Agreement

2 TBD Service Maintenance Agreement

3 TBD Service Maintenance Agreement

4 TBD Service Maintenance Agreement

Total Firm-Fixed Price

The total price for the base and four option years is _______________.

Part 3- Description/Specifications

3.1 Background

The Division of Pharmaceutical Analysis (DPA) is responsible for helping to ensure, through biological, chemical, and/or physical assessments, the safety and efficacy of human drugs used in the United States. DPA also provides a strong scientific and analytical base to support complex FDA investigations and enforcement actions concerning the quality and authenticity of human drugs. Additionally, DPA provides leadership, and conducts and supports programs, to advance and disseminate the application of new technologies and methods, in order to assess the quality and authenticity of human drugs.

3.2 Statement of Work

The vendor shall deliver a picosecond time-resolved fluorescence spectrometer to DPA. The vendor shall install the instrument and all associated componets and shall provide installation, training, and support documentation.

The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration. The life cycle of this instrument is intended to be greater than ten years at full performance.

The entire system must be warranted for parts and labor for 12 months from the date of installation.

Software updates to be furnished at no additional cost during the warranty period. Technical support to be furnished at no additional cost during the warranty period.

3.3 Salient Characteristics of the fluorescent spectrometer

The contractor shall provide a FluoTime 300 Time-Resolved Fluorescence spectrometer “Brand Name or Equal” which includes the following characteristics.

Hardware capabilities must include:

a) Picosecond excitation source with 266 nm wavelength and high repetition rate of 50 MHz or more, computer controlled.

b) Sample chamber with temperature controlled holder for 1 cm cuvette with temperature range from 4ºC to 90ºC and magnetic stirrer.

c) MCP-PMT (microchannel plate photomultiplier tube) detector with spectral sensitivity between 160 to 850 nm.

d) Time-correlated single photon counting system with 1 ps per channel time resolution, or less

e) Emission monochromator with focal length of 150 mm, at least 5.4 nm/mm dispersion and motorized input and exit slits.

f) USB connection for all electronic units.

g) PC computer that meets requirements of software and hardware of system

h) Automated quartz polarizer for emission

i) Cables to connect all electronic units

j) Automated attenuation unit for excitation arm

Software and Dispay must include:

a) User-friendly interface.

b) Data collection and analysis software tools.

c) Data must be savable in common formats and user defined formats (text, csv, or xml).

Additional Requirements:

a) The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration. The life cycle of this instrument is intended to be greater than ten years at full performance.

b) The entire system must be warranted for parts and labor for 12 months from the date of installation. Software updates to be furnished at no additional cost during the warranty period. Technical support to be furnished at no additional cost during the warranty period.

c) Installation of the spectrometer and all components is required.

d) Onsite training on the use and features of this instrument is required.

3.4 Optional Service/Maintenance Agreement

The FDA shall have a unilateral right to exercise optional periods to continue the maintenance work described below.

Maintenance and service shall include:

• Software updates during the service agreement period

• Technical phone support

• Onsite visits for diagnosis of problem and repairs inclusive of all parts, labor, and travel expenses

• Service rendered under agreement shall be completed within 5 business days of request by Government, unless otherwise authorized.

The optional period of performance, if exercised, shall commence as follows:

Option Period of Performance

Option Year 1: Service/Maintenance Agreement To begin 1st year following receipt of equipment

Option Year 2: Service/Maintenance Agreement To begin 2nd year following receipt of equipment

Option Year 3: Service/Maintenance Agreement To begin 3rd year following receipt of equipment

Option Year 4: Service/Maintenance Agreement To begin 4th year following receipt of equipment

FAR 52.217-8, OPTION TO EXTEND SERVICES (NOVEMBER 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 period of performance of this contract.

(End of clause)

FAR 52.217-9, Option to Extend the Term of the Contract (March 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within the period of performance of the contract; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days 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 five years.

(End of clause) Part 4 – Deliveries or Performance

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.

The spectrometer and all components shall be delivered to the address below no more than five (5) months after the effective date of the contract.

Delivery Location:

ATTN: TBD

US Food & Drug Administration Division of Pharmaceutical Analysis Newstead Bldg. (DDA-1) 645 S. Newstead Ave St. Louis, Missouri 63110

The period of performance of shall one year from the effective date of the contract.

Part 5 –Contract Administration

5.1 Representative’s

The following COR will represent the Government for the purpose of this order: [TBD]

The COR is responsible for the following as required by this order: (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 evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order.

The contact information for the Contracting Officer is the following:

Sean Wybenga U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 Sean.Wybenga@fda.hhs.gov; (240) 402-7629

The contact information for the Contract Specialist is the following:

Lisa Yaw U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 Lisa.Yaw@fda.hhs.gov; (240) 402-4018 mailto:Sean.Wybenga@fda.hhs.gov mailto:Lisa.Yaw@fda.hhs.gov

The contact information for the Contractor is the following:

(TBD)

5.2 Invoice Submission

A. The Government will pay the Contractor only each respective deliverable’s firm-fixed-price delineated in the table in Subpart 3.3 above, upon successful completion, as determined by the COR, and upon submission of a proper invoice. Proper invoice submission includes following the invoice instructions below.

B. The Contractor shall submit all invoices in the manner specified below:

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

Office of Financial Services Food and Drug Administration 10903 New Hampshire Avenue

W032-Second Floor Bldg. 32, Rm. 2162, Mail Hub 2145

Silver Spring MD 20993-0002 Attn: Vendor Payments

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

Invoices submitted under this order must comply with the requirements set forth in FAR 52.232-33 (Payment by Electronic Funds Transfer – Central Contractor Registration) and the 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 of 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 a 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 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.

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

Payment will only be made on a firm-fixed-price basis.

mailto:fdavendorpaymentsteam@fda.gov

Part 6-Contract Clauses

6.1 FAR Clauses Incorporated by Reference:

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

52.202-1 Definitions (November 2013)

52.203-5 Covenant Against Contingent Fees (May 2014)

52.203-7 Anti-Kickback Procedures (May 2014)

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

52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004)

6.2 FAR Clauses in Full Text:

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items.

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) 52.222-50, 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)).

(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:

_X_ (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).

_X_ (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.)

__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2010) (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).

http://www.acquisition.gov/far/index.html https://www.acquisition.gov/sites/default/files/current/far/html/52_212_213.html#wp1179194 https://www.acquisition.gov/far/current/html/52_222.html#wp1151848 http://uscode.house.gov/ https://www.acquisition.gov/far/current/html/52_222.html#wp1151848 http://uscode.house.gov/ https://www.acquisition.gov/far/current/html/52_233_240.html#wp1113329 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://www.acquisition.gov/far/current/html/52_233_240.html#wp1113344 https://www.acquisition.gov/far/current/html/52_200_206.html#wp1137622 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t41t42+2+13++%2841%29%20%20AND%20%28%2841%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+37+408++%2810%29%20%252 https://www.acquisition.gov/far/current/html/52_200_206.html#wp1141983 http://uscode.house.gov/ https://www.acquisition.gov/far/current/html/52_200_206.html#wp1144881 https://www.acquisition.gov/far/current/html/52_200_206.html#wp1141649 http://uscode.house.gov/ https://www.acquisition.gov/far/current/html/52_200_206.html#wp1144992

__ (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 (Jan 2012) (41 U.S.C. 2313).

__ (8) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (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] __ (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—Subcontracting 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 Representation (Apr 2009) (15 U.S.C. 632(a)(2)).

__ (24) 52.219-29 Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business

Concerns (Nov 2011).

__ (25) 52.219-30 Notice of Set-Aside for Women-Owned Small Business Concerns Eligible Under the Women-

Owned Small Business Program (Nov 2011).

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

_X_ (27) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jul 2010) (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).

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

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

13496).

_X_ (34) 52.222-54, Employment Eligibility Verification (Jan 2009). (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).

__ (40)(i) 52.225-3, Buy American Act—Free Trade Agreements—Israeli Trade Act (June 2009) (41 U.S.C. 10a-

10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, Pub. L. 108-77, 108-78, 108-286, 108-302, 109- 53, 109-169, 109-283, and 110-138).

__ (ii) Alternate I (Jan 2004) of 52.225-3.

__ (iii) Alternate II (Jan 2004) of 52.225-3.

__ (41) 52.225-5, Trade Agreements (Nov 2011) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__ (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)).

_X_ (47) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul. 2013) (31 U.S.C. 3332).

__ (48) 52.232-34, Payment by Electronic Funds Transfer— System for Award Management (Jul. 2013) (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.).

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__ (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.).

__ (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.).

__ (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) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247).

__ (8) 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) [Reserved]

(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)).

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(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 (Jan 2009).

(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.

(End of clause)

6.3 HHSAR Clauses Incorporated by Reference

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:

http://www.hhs.gov/policies/hhsar/subpart301-1.html.

352.201-70, PAPERWORK REDUCTION ACT (JAN 2006)

352.202-1, DEFINITIONS (JAN 2006)

352.203-70, ANTI-LOBBYING (JAN 2006)

352.215-70, LATE PROPOSALS AND REVISIONS (JAN 2006)

352.222-70, CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY

INVESTIGATIONS (JAN 2010)

352.223-70, SAFETY AND HEALTH (JAN 2006)

352.224-70, PRIVACY ACT (JAN 2006)

352.227-70, PUBLICATIONS AND PUBLICITY (JAN 2006)

352.239-70, ELECTRONIC INFORMATION AND TECHNOLOGY ACCESSIBILITY (JAN

2010)

352.242-70 KEY PERSONNEL (JAN 2006)

352.242-71, TOBACCO-FREE FACILITIES (JAN 2006)

352.242-73, WITHHOLDING OF CONTRACT PAYMENTS (JAN 2006)

352.270-10 ANTI-LOBBYING (JAN 2006)

Part 7- Representations, Certifications, and Other Statements by Offeror or Offerors

52.212-3- INFORMATION REGARDING RESPONSIBILITY MATTERS (FEB 2012)

The offeror has completed the annual representations and certifications electronically via the SAM website accessed through https://www.acquisition.gov. After reviewing the SAM database information, the offeror verifies by submission of this offer that the representation and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications— Commercial Items, have been entered or updated in the last 12 months, are current, accurate, https://www.acquisition.gov/far/current/html/52_222.html#wp1155380 http://uscode.house.gov/ https://www.acquisition.gov/far/current/html/52_222.html#wp1155440 http://uscode.house.gov/ https://www.acquisition.gov/far/current/html/52_222.html#wp1156645 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1183820 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1183820 https://www.acquisition.gov/far/current/html/52_247.html#wp1156217 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t45t48+351+1++%2846%29%20%20AND%20%28%2846%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t45t48+351+1++%2846%29%20%20AND%20%28%2846%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+37+408++%2810%29%20%252 https://www.acquisition.gov/far/current/html/52_247.html#wp1156217 http://www.hhs.gov/policies/hhsar/subpart301-1.html https://www.acquisition.gov/ complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201)

52.211-6 Brand Name or Equal (Aug 1999)

Part 8 – Instructions to Offerors

Offerors shall include in the quote, a point of contact (name, telephone number, and email address), proposed firm-fixed-prices estimated delivery date, business size and type (e.g. small, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, etc.), Dun and Bradstreet (DUNS) number, country of manufacturing of equipment, and certification that all company information listed in the System for Award Management (SAM) database is complete, accurate, and current.

Offerors shall ensure the solicitation number is visible in the header of the email transmission of their quote.

If equipment in the quotation is different from the equipment listed in part 2, the offeror shall include a description of how it meets the salient characteristics of the brand name equipment listed in part 3 of the solicitation.

Faxed quotes will not be accepted.

Quotes must be valid through January 31, 2016.

Offerors Response Date and Time:

All quotes and revisions shall be submitted via email to Lisa.Yaw@fda.hhs.gov by or before 2:00 PM Eastern Time on Wednesday, December 16th 2015.

Award shall be made to the lowest priced technically acceptable offer mailto:Lisa.Yaw@fda.hhs.gov