FBO_-_Arch_Probes_3781.pdf

FDA-16-SOL-1163781

PART 1 – GENERAL INFORMATION

This is a Combined Synopsis/Solicitation for Commercial Items prepared in accordance with the format in FAR Subpart 12.6. This Request for Quotation (RFQ) announcement constitutes the only solicitation that will be issued; quotes are being requested and a written solicitation will not be issued. This requirement is being solicited as a small business set aside and the Government contemplates a Firm- Fixed Price Purchase Order will result from this solicitation in accordance with FAR 52.211-6, Brand Name or Equal. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-82 dated June 8, 2015.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334516. Its associated Small Business Size Standard is 1,000 employees.

Brand Name or Equal:

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

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

Description of Supplies or Services

The Food and Drug Administration (FDA)’s Detroit Laboratory (DET-LAB) requires the purchase of 0.5mm and 0.25mm OptiDiss UV/Vis fiber optic probes to run dissolution analyses on pharmaceutical medications for shelf life and drug survey samples for use with existing hardware and software. These probes need to work with existing Opt-Diss 405 Fiber Optic In-Situ UV dissolution testing system. The probes will allow the Detroit Laboratory to respond to testing requirements in a timely and efficient manner. Specifications of the Arch Probes needed to fulfill our method data quality objectives are listed below:

Pricing Table:

Line Item

Item Qty

Unit Price

0001 Arch Probes 0.5mm arch length for Distek Opt- Diss system, or Equal -6-

Arch Probes 0.25mm arch length for Distek Opt- Diss system, or Equal

-6-

0003 One Year Warranty -6-

-NSP-

Total $

PART 3 – DESCRIPTION

Salient Characteristics:

** Offerors shall address each of the salient characteristics in order to be considered. ** Any brand name items identified in the Product Description shall be considered brand name or equivalent.

Opt-Diss 0.5mm Arch Probes

• Arch probes at 0.5mm path length to work with the existing Distek Opt-Diss systems.

• Must be compatible with the current Opt-Diss 405, connected to a 6 bath Symphony 7100 bathless dissolution system.

• Must work with 900 milliliter glass vessels.

Opt-Diss 0.25mm Arch Probes

The laboratory requires 6 arch probes at 0.25mm path length to work with the existing Distek Opt-Diss systems installed in the laboratory. These will work with the current Opt-Diss 405, connected to a 6 bath Symphony 7100 bathless dissolution system. They must work with 900 milliliter glass vessels.

(One-Year) Warranty:

• The contractor shall provide a minimum of a one-year manufacturers warranty for the arch probes.

General Specifications:

• The system must be a newly manufactured unit, not used and refurbished or previously used for demonstration.

PART 4 – PACKING, MARKING AND SHIPPING

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/order number and contractor name. The contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

PART 5 – INSPECTION AND ACCEPTANCE

The Project Officer will perform inspection and acceptance of equipment and services to be provided.

The Project Officer – to be determined upon contract award - is the authorized representative of the Contracting Officer.

PART 6 – DELIVERIES OR PERFORMANCE

Deliveries:

Satisfactory performance of this contract shall be deemed to occur upon delivery, inspection, and acceptance. Deliveries required by the contractor shall be made F.O.B. destination within 30 days from receipt of the award of order to the addresses/addressees listed below:

Delivery Location:

Food and Drug Administration 300 River Place, Suite 6900 Detroit, MI 48207 Attn: Philip Klimkewicz @ 313-393-8268

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 4:30 p.m. Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. The Contractor shall provide the Project Officer with a one-week notice scheduling notice prior to setup of the laboratory instrument and component parts.

Period of Performance:

The equipment shall be delivered, installed, and in proper working conditions within 30 days from the date of contract award, unless the government approves a different delivery schedule.

PART 7 – CONTRACT ADMINISTRATION DATA

The following personnel will represent the Government for the purpose of this contract:

Elyse Kennedy 5630 Fishers Lane Rockville, MD 20857 Elizabeth.Kennedy@fda.hhs.gov 240-402-7600

The following Contract Specialist is the point of contact for this solicitation:

Cynthia Lopez 5630 Fishers Lane Rockville, MD 20857 Cynthia.Lopez@fda.hhs.gov 240-402-7681

FDA Invoice Requirements:

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

Office of Financial Services

Food and Drug Administration 10903 New Hampshire Ave

WO32 – Second Floor Mail Hub 2145

Silver Spring, MD 20993-0002 Attn: Vendor Payments

301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.gov

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

(I) Name and address of the contractor;

(II) Invoice date and invoice number;

(III) Purchase Order/Award Number;

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

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

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

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

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

(IX) Taxpayer Identification Number (TIN).

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

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

An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (I) through (XII) of this clause must be included in the electronic invoice.

Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

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

PART 8 – SPECIAL CONTRACT REQUIREMENTS

Government Holidays

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

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

December (Christmas Day)

PART 9 - CONTRACT CLAUSES

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 this/these address (es): https://acquisition.gov/far/

52.212-4 - Contract Terms and Conditions – Commercial Items (Dec. 2014)

FAR Clauses in Full Text

52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Mar. 2015)

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

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

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

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

__ (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).

__ (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).

https://acquisition.gov/far/ https://acquisition.gov/far/current/html/52_207_211.html#wp1146366 https://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://acquisition.gov/far/current/html/52_233_240.html#wp1113344 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_200_206.html#wp1137622 http://uscode.house.gov/ http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_200_206.html#wp1141983 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_200_206.html#wp1144881 https://acquisition.gov/far/current/html/52_200_206.html#wp1141649 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_200_206.html#wp1151163 https://acquisition.gov/far/current/html/52_200_206.html#wp1151299 https://acquisition.gov/far/current/html/52_207_211.html#wp1140926

__ (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 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.

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

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

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

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

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

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

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

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

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657 f).

__ (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).

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

13627).

https://acquisition.gov/far/current/html/52_207_211.html#wp1145644 https://acquisition.gov/far/current/html/52_217_221.html#wp1135955 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1135955 https://acquisition.gov/far/current/html/52_217_221.html#wp1135970 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1135970 https://acquisition.gov/far/current/html/52_217_221.html#wp1136004 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1136017 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1136017 https://acquisition.gov/far/current/html/52_217_221.html#wp1136017 https://acquisition.gov/far/current/html/52_217_221.html#wp1136032 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1136058 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1136058 https://acquisition.gov/far/current/html/52_217_221.html#wp1136058 https://acquisition.gov/far/current/html/52_217_221.html#wp1136058 https://acquisition.gov/far/current/html/52_217_221.html#wp1136174 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_217_221.html#wp1136175 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1136186 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1136387 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1139913 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1144950 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_217_221.html#wp1144420 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_222.html#wp1147479 https://acquisition.gov/far/current/html/52_222.html#wp1147630 https://acquisition.gov/far/current/html/52_222.html#wp1147656 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 https://acquisition.gov/far/current/html/52_222.html#wp1160019 https://acquisition.gov/far/current/html/52_222.html#wp1151848 http://uscode.house.gov/

__ (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 (AUG 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

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

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

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

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

__ (37)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

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

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

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

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

_X_ (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) (E.O. 13513).

_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 (June 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)).

https://acquisition.gov/far/current/html/52_222.html#wp1151848 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_222.html#wp1156645 https://acquisition.gov/far/current/html/Subpart%2022_18.html#wp1089948 https://acquisition.gov/far/current/html/52_223_226.html#wp1168892 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_223_226.html#wp1168892 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t41t42+250+1286++%2842%29%20%20AND%20%28%2842%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_223_226.html#wp1168933 https://acquisition.gov/far/current/html/52_223_226.html#wp1168933 https://acquisition.gov/far/current/html/52_223_226.html#wp1194330 https://acquisition.gov/far/current/html/52_223_226.html#wp1194330 https://acquisition.gov/far/current/html/52_223_226.html#wp1194323 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_223_226.html#wp1179078 https://acquisition.gov/far/current/html/52_223_226.html#wp1179078 https://acquisition.gov/far/current/html/52_223_226.html#wp1188603 https://acquisition.gov/far/current/html/52_223_226.html#wp1192900 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_223_226.html#wp1169038 http://uscode.house.gov/ http://uscode.house.gov/ http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t17t20+1727+50++%2819%29%20%20AND%20%28%2819%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t17t20+1727+50++%2819%29%20%20AND%20%28%2819%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/ http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_223_226.html#wp1169038 https://acquisition.gov/far/current/html/52_223_226.html#wp1169038 https://acquisition.gov/far/current/html/52_223_226.html#wp1169038 https://acquisition.gov/far/current/html/52_223_226.html#wp1169151 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t17t20+1727+50++%2819%29%20%20AND%20%28%2819%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t17t20+1727+50++%2819%29%20%20AND%20%28%2819%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_223_226.html#wp1169608 https://acquisition.gov/far/current/html/52_223_226.html#wp1192524 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+1445+65++%2810%20U.S.C.%202302%20Note%29%20%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+1445+65++%2810%20U.S.C.%202302%20Note%29%20%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_223_226.html#wp1173773 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t41t42+250+1286++%2842%29%20%20AND%20%28%2842%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_223_226.html#wp1173393 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t41t42+250+1286++%2842%29%20%20AND%20%28%2842%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_232.html#wp1153230 http://uscode.house.gov/ http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_232.html#wp1153252

_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).

_X_ (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:

[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).

__ (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 https://acquisition.gov/far/current/html/52_232.html#wp1153351 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_232.html#wp1153375 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_232.html#wp1153445 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_233_240.html#wp1113650 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t05t08+2+3++%285%29%20%20AND https://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+t09t12+37+408++%2810%29%20%252 https://acquisition.gov/far/current/html/52_247.html#wp1156217 https://acquisition.gov/far/current/html/52_222.html#wp1160021 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_222.html#wp1153423 http://uscode.house.gov/ http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_222.html#wp1148260 http://uscode.house.gov/ http://uscode.house.gov/ 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 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)

(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) _X_(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 and E.O 13627).

(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).

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 https://acquisition.gov/far/current/html/52_222.html#wp1160019 https://acquisition.gov/far/current/html/52_222.html#wp1160019 https://acquisition.gov/far/current/html/52_222.html#wp1160021 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_222.html#wp1151848 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_222.html#wp1151848 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_222.html#wp1155380 http://uscode.house.gov/ 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#wp1156645 https://acquisition.gov/far/current/html/52_223_226.html#wp1192524 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+1445+65++%2810%20U.S.C.%202302%20Note%29%20%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+1445+65++%2810%20U.S.C.%202302%20Note%29%20%20%20%20%20%20%20%20%20%20 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_223_226.html#wp1183820 https://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://acquisition.gov/far/current/html/52_247.html#wp1156217 https://acquisition.gov/far/current/html/52_222.html#wp1163027

(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.

HHSAR Clauses

HHSAR 352.203-70 Anti-lobbying (Dec. 2015) HHSAR 352.208-70 Printing and Duplication (Dec. 2015) HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec. 2015)

PART 10 - SOLICITATION PROVISIONS

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

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

www.acquisition.gov/far

52.211-6 – Brand Name or Equal (Aug. 1999) 52-212-1 - Instructions to Offerors – Commercial Items (Apr. 2014) 52.212-2 - Evaluation -- Commercial Items (Oct. 2014)

PART 11– INSTRUCTIONS TO THE OFFERORS

The provision 52.212-1 incorporated above is tailored as follows. Quotations are due 04/08/2016 at 1:00 p.m. (Eastern Time). Send via email in native (Word/Excel) and PDF format to the Contract Specialist, Cynthia Lopez (Cynthia.Lopez@fda.hhs.gov). Send any Questions, via email, to the Contract Specialist no later than 04/06/2016 at 1:00 p.m. (Eastern Time).

SAM: All interested offerors shall be registered in the System for Award Management (SAM), if the offeror is not registered in SAM, please visit https://www.sam.gov . Your will need your Tax ID, DUNS Number and banking information. Vendors who are not registered in SAM will not be eligible for award.

Quotes shall be valid until the end of the fiscal year, September 30, 2016.

PART 12 – GENERAL EVALUATION INFORMATION:

The provision 52.212-2 incorporated above is completed as follows. FDA will evaluate quotes received in response to this RFQ on using the low-price-technically-acceptable (LPTA) methodology. To be determined “Technically Acceptable” the offeror must meet or exceed all salient characteristics. The proposal must outline all characteristics of the statement of work. FDA will make the award to the offeror whose proposed equipment meets all salient characteristics and whose overall price is the lowest.

http://www.acquisition.gov/far mailto:Cynthia.Lopez@fda.hhs.gov) https://www.sam.gov/