Combined_Synopsis_Solicitation.doc

COMBINED SYNOPSIS/SOLICITATION

SERVICE MAINTENANCE, REPLACEMENT AND REMOVAL OF CONSUMABLE SYSTEM COMPONENTS ON DI WATER SYSTEMS

General Information

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice.

This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-95.

The associated North American Industrial Classification System (NAICS) code for this procurement is 811219 with a small business size standard of $20.5 million.

The U. S Food & Drug Administration, Office of Acquisitions and Grants Services is requesting quotes for the procurement of service maintenance, replacement and removal of consumable system components on DI Water Systems. The Government intends to award a Firm Fixed-Price Contract for the items described below.

All interested companies shall provide quotation(s) for the following:

Background:

The De-Ionized (DI) water system is used to support scientific analysis of Food, Feed and other products regulated by the US Food and Drug Administration. This system must be maintained to provide water that is between 3 – 10 megohms-CM at room temp. To ensure this capability is maintained within the limits specified below, FDA requires that preventative maintenance, replacement of depleted consumable supplies and worn out parts be performed throughout the year.

Salient Characteristics:

1. Each quarter the system shall be inspected and adjusted as necessary by the vendor to maintain peak performance. In addition to inspection and adjustments, the vendor is responsible to adhere to a minimum required schedule for various replaceable/consumable components that shall be replaced by the vendor in accordance with a schedule provided by the FDA below, or as deemed necessary by the vendor in consultation with the FDA system monitor or co-monitor, to ensure operational performance is maintained within the specifications stated above until the next scheduled quarterly maintenance visit.

2. Any operational system or component parameter found to be outside those specified or otherwise stated by the original equipment manufacturer to be other than required to ensure reliable system operation within the operational DI system specifications stated above, shall be reported to the FDA system monitor, or assistant monitor immediately, along with any recommended corrective actions that may be required to return or maintain the system within the required operational parameters stated above.

a. No corrective action or component replacement that will incur additional costs outside the scope of this procurement shall be implemented by the vendor without the express approval of the Contracting Officer of record for this Purchase Order, after consultation with the designated COR (e.g. primary system monitor, assistant system monitor or Admin Officer), and FDA management.

3. At the start of this order, the vendor shall perform a one-time Mechanical Function Check and provide FDA with a written report on the condition of each component, listed in the system description and statement of need below, as to conformance with normal operating parameters for each component and component system, and against the FDA provided Annex 2 DI Water System performance standards. The purpose of the function check is to determine the operational status of the system and identify any problems that could result in future down time so preventative maintenance can be accomplished to avoid future system outages.

4. FDA requires inspection of the components on a quarterly basis. Results of each Inspection shall be provide as a written report (See Attachment for Format) as to how the components are performing within the defined operational range for each component, as well as on a system wide level against the resistivity and purity levels.

5. Additional Requirements that are in common with all three DI Systems (e.g. System, A System B and System C) are as follows:

a. Vendor will remove/dispose of all used bulbs, filters, Resin, Carbon and Media tanks after each replacement.

A. Annex 2 System Description and Statement of Need:

The following is a list of systems/components that need to be maintained to ensure full operational capability in accordance with the specified operating parameters:

a. 6400 gallon per day RO Water System

b. 14” Simplex Softener

c. 14” Simplex Carbon

d. 12” Simplex Multi-Media Filter

e. 5000 Gallon Storage Tank

f. Tank Level Switch

g. Pump

h. 24gpm UV System

i. 20” 1mic PreFilter

j. 30” 5-Round 0.2mic Final Filter

k. 20” 0.2mic Vent Filter

l. 3.6cft Mixed Bed Worker Tank

m. 3.6cft Mixed Bed Polisher Tank System A Statement of Requirements:

1. At a minimum the Mechanical Function Check will include a review of, report on, and recommendations to SRL regarding any maintenance that may be deemed necessary or prudent with regard to the following:

a. Reverse Osmosis Membrane performance

b. Reverse Osmosis Membrane Regeneration efficiency

c. UV intensity

d. Filtration efficiency

2. Vendor shall provide a one-time Systems Operation Orientation and User Training to the primary and alternate Annex 2 systems monitors.

3. On a quarterly basis the vendor will perform the following:

a. Test Feed Water Chemistry (TDS, Chlorine, Hardness, Temperature)

b. Test RO Feed Water Chemistry (TDS, Chlorine, Hardness, Temperature

c. Verify and Test RO Performance (Product Quality, Product Flow, Reject %, Reject Flow

d. Verify Tank Level Switch and Low Level Pump Switch are Operational

e. Test SDI Water Quality Specs-Within 1 Meg

f. Perform Pump Function Check

g. Perform Softener Function Check

h. Perform Carbon Function Check

i. Perform MMF Function Check

j. Perform UV Function Check

k. Document Site, Record Readings and Deliver to Customer

4. On a quarterly basis the vendor shall provide and install the following parts/components:

a. 1 - 3.6cft Mixed Bed SDI Worker Tank*

b. 1 - 3.6cft Mixed Bed SDI Polisher Tank*

c. * Extra tanks for a. and b. above to be available, if required, as a separate unfunded CLIN or via purchase by Govt IMPAC at contract pricing.

5. Every six months/on a semi-annual basis the vendor shall provide and install the following:

a. 1 - MP2SL 24gpm UV bulb

6. Once annually the vendor will provide and install the following:

a. 1- 20” 1 mic Pre-filter

b. 1 - 30” 5-Round 0.2 mic Final Filter for SS Housing

c. 1- 20” 0.2 mic Vent Filter

B. System B, Annex 1 System, Statement of Need and Description:

The following is a list of systems/components that need maintenance to ensure full operational capability in accordance with the specified operating parameters:

a. SDI React Carbon 3.6 CF Fiberglass Std POT

b. 2 – SDI Mixbed1 3.6 CF

c. UV Sterilizer Lamp – 3084 LM Low

d. 20 “ 1UM Cartridge No Gasket PP

e. 20” 0.2 UM Cartridge CDE 0 Asym Ploy

f. Pump

System B Statement of Requirements:

1. At a minimum the Mechanical Function Check will include a review of, report on, and recommendations to FDA regarding any maintenance that may be deemed necessary or prudent with regard to the following:

a. UV intensity

b. Filtration efficiency

2. Vendor shall provide a one-time Systems Operation Orientation and User Training to the primary and alternate Annex 1 systems monitors.

3. On a quarterly basis the vendor will perform the following:

a. Test SDI Water Quality Specs-Within 1 Meg

b. Perform Pump Function Check

c. Perform Carbon Function Check

d. Perform MMF Function Check

e. Perform UV Function Check

f. Document Site, Record Readings and Deliver to Customer

4. On a quarterly basis the vendor shall provide and install the following parts/components:

a. 1 – 20” 1UM CART No Gasket PP

5. Every six months/on a semi-annual basis the vendor shall provide and install the following:

a. 1 - 3084LM Low UV Sterilizer Bulb

b. 1 – 20” 0.2UM CDE 0 ASYM POLY

c. 1 - 3.6CF SDI MIXBD Fiberglass STD POT

d. 1 – 3.6 CF SDI Reactive Carbon Fiberglass STD POT

6. Once annually the vendor will perform the following:

a. Test Silica

C. System C, Crawford System, Statement of Need and Description:

The following is a list of systems/components that need maintained to ensure full operational capability in accordance with the specified operating parameters:

a. SDI React Carbon 3.6 CF Fiberglass Std POT

b. 2 – SDI Mixbed1 3.6 CF

c. UV Sterilizer Lamp – 3050

d. 20 “ 1UM Cartridge No Gasket PP

e. 20” 0.2 UM Cartridge CDE 0 Asym Ploy

f. Pump

System C Statement of Requirements:

1. At a minimum the Mechanical Function Check will include a review of, report on, and recommendations to the FDA regarding any maintenance that may be deemed necessary or prudent with regard to the following:

a. UV intensity

b. Filtration efficiency

2. Vendor shall provide a one-time Systems Operation Orientation and User Training to the primary and alternate Annex 1 systems monitors.

3. On a quarterly basis the vendor will perform the following:

a. Test SDI Water Quality Specs-Within 1 Meg

b. Perform Pump Function Check

c. Perform Carbon Function Check

d. Perform MMF Function Check

e. Perform UV Function Check

f. Document Site, Record Readings and Deliver to Customer

4. On a quarterly basis the vendor shall provide and install the following parts/components:

a. 1 – 20” 1UM CART No Gasket PP

5. Every six months/on a semi-annual basis the vendor shall provide and install the following:

a. 1 – 20” 0.2UM CDE 0 ASYM POLY

b. 1 - 3.6CF SDI MIXBD Fiberglass STD POT

c. 1 – 3.6 CF SDI Reactive Carbon Fiberglass STD POT

6. Once annually the vendor will perform the following:

a. Test Silica

7. Once annually the vendor shall provide and install the following parts/components

a. 1 – 3050 UV Sterilizer Bulb

Pricing Schedule

Place of Performance

Food and Drug Administration

60 8th Street, NE Atlanta, GA 30309

FAR 52.212-4 - Contract Terms and Conditions -- Commercial Items (Jan 2017) is hereby incorporated by reference

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Items. (Jan 2017)

(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 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:

__ (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 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (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).

__ (13) [Reserved]

_X_ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

__ (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 (Nov 2016) (15 U.S.C. 637(d)(2) and (3)).

__ (17)(i) 52.219-9, Small Business Subcontracting Plan (Nov 2016) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Nov 2016) of 52.219-9.

__ (iii) Alternate II (Nov 2016) of 52.219-9.

__ (iv) Alternate III (Nov 2016) of 52.219-9.

__ (v) Alternate IV (Nov 2016) 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).

_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 (Oct 2016) (E.O. 13126).

_X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (28) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

_X_ (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).

_X_ (31) 52.222-37, Employment Reports on Veterans (Feb 2016) (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).

_X_ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (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) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (Oct 2016). (Applies at $50 million for solicitations and resultant contracts issued from October 25, 2016 through April 24, 2017; applies at $500,000 for solicitations and resultant contracts issued after April 24, 2017).

Note to paragraph (b)(35): By a court order issued on October 24, 2016, 52.222-59 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, GSA, DoD and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

__ (36) 52.222-60, Paycheck Transparency (Executive Order 13673) (OCT 2016).

__ (37)(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.)

__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

__ (40)(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.

__ (41)(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.

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

__ (43)(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.

_X_ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).

__ (45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

__ (46) 52.223-21, Foams (Jun 2016) (E.O. 13693).

_X_ (47) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

__ (48)(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.

__ (49) 52.225-5, Trade Agreements (Oct 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (50) 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).

__ (51) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

__ (52) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (53) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

__ (54) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (55) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

_X_ (56) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (57) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (58) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

__ (59) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (60)(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) 52.222-17, 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).

__ (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 (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 (Oct 2015) (41 U.S.C. 3509).

(ii) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (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 (l) of FAR clause 52.222-17.

(iv) 52.222-21, Prohibition of Segregated Facilities (Apr 2015)

(v) 52.222-26, Equal Opportunity (Sept 2016) (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 (Feb 2016) (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)

52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O 13627). Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and 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).

(xvi) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (Oct 2016) (Applies at $50 million for solicitations and resultant contracts issued from October 25, 2016 through April 24, 2017; applies at $500,000 for solicitations and resultant contracts issued after April 24, 2017).

Note to paragraph (e)(1)(xvi): By a court order issued on October 24, 2016, 52.222-59 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, GSA, DoD and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

(xvii) 52.222-60, Paycheck Transparency (Executive Order 13673) (Oct 2016)).

(xviii) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xix) 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.

(xx) 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.

HHSAR

Clause No.

Title and Date

352.211-3 Paperwork Reduction Act. (Dec 2015)

352.203-70 Anti-lobbying. (Dec 2015)

352.222-70 Contractor cooperation in equal employment opportunity investigations. (Dec 2015)

352.223-10 Safety and Health (Dec 2015)

352.224-70 Privacy Act. (Dec 2015)

352.227-70 Publications and Publicity. (Dec 2015)

FDA THREE-WAY-MATCHING INVOICE CLAUSE

A.

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 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 - 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;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) The contractor shall include the Contract Line Item/Funding line item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed

(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/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

(xi) Name and telephone number of the FDA Contracting Officer (CO) and the Technical Point of Contact (TPOC) or other program center/office point of contact, as referenced on the order/contract;

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

C.

An electronic invoice shall be 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:

Food and Drug Administration/ Office of Financial Services, 10903 New Hampshire Ave

WO32 - Second Floor, MAIL HUB 2145

Silver Spring, MD 20993-0002

Attn: Vendor Payments

Phone 301-827-ERIC (3742)

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 (SAM) DATABASE) AND/OR OTHER APPLICABLE FAR CLAUSES SPECIFIED HEREIN.

Award shall be made to the quoter, whose quotation, is the lowest priced technically acceptable. FDA will first evaluate all Offerors’ prices, then evaluate the apparent lowest-priced quote/proposal for acceptability under the technical and past performance factors (if applicable). If the lowest-price Offeror was evaluated as unacceptable, FDA would then consider the acceptability of the next lowest-price Offeror, continuing this process as necessary.

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

· FAR 52.212-1, “Instructions to Offerors–Commercial Items” Jan 2017

· FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items” Jan 2017 Offerors must complete annual representations and certifications on-line at http://orca.bpn.gov in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items.” If paragraph (j) of the provision is applicable, a written submission is required.

52.204-7 -- System for Award Management. (Oct 2016)

(a) Definitions. As used in this provision—

“Electronic Funds Transfer (EFT) indicator” means a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the commercial, nonprofit, or Government entity to establish additional System for Award Management records for identifying alternative EFT accounts (see subpart 32.11) for the same entity.

“Registered in the System for Award Management (SAM) database” means that—

(1) The Offeror has entered all mandatory information, including the unique entity identifier and the EFT indicator, if applicable, the Commercial and Government Entity (CAGE) code, as well as data required by the Federal Funding Accountability and Transparency Act of 2006 (see subpart 4.14), into the SAM database;

(2) The offeror has completed the Core, Assertions, and Representations and Certification, and Points of contact sections of the registration in the SAM database;

(3) The Government has validated all mandatory data fields, to include validation of the Taxpayer Identification Number (TIN) with the Internal Revenue Service (IRS). The Offeror will be required to provide consent for TIN validation to the Government as a part of the SAM registration process.

(4) The Government has marked the record “Active”.

“Unique entity identifier” means a number or other identifier used to identify a specific commercial, nonprofit, or Government entity. See www.sam.gov for the designated entity for establishing unique entity identifiers.

(b)

(1) By submission of an Offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the SAM database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation.

(2) The Offeror shall enter, in the block with its name and address on the cover page of its offer, the annotation “Unique Entity Identifier” followed by the unique entity identifier that identifies the Offeror’s name and address exactly as stated in the offer. The Offeror also shall enter its EFT indicator, if applicable. The unique entity identifier will be used by the Contracting Officer to verify that the Offeror is registered in the SAM database.

(c) If the Offeror does not have a unique entity identifier, it should contact the entity designated at www.sam.gov for establishment of the unique entity identifier directly to obtain one. The Offeror should be prepared to provide the following information:

(1) Company legal business name.

(2) Tradestyle, doing business, or other name by which your entity is commonly recognized.

(3) Company physical street address, city, state and Zip Code.

(4) Company mailing address, city, state and Zip Code (if separate from physical).

(5) Company telephone number.

(6) Date the company was started.

(7) Number of employees at your location.

(8) Chief executive officer/key manager.

(9) Line of business (industry).

(10) Company Headquarters name and address (reporting relationship within your entity).

(d) If the Offeror does not become registered in the SAM database in the time prescribed by the Contracting Officer, the Contracting Officer will proceed to award to the next otherwise successful registered Offeror.

(e) Processing time, which normally takes 48 hours, should be taken into consideration when registering. Offerors who are not registered should consider applying for registration immediately upon receipt of this solicitation.

(f) Offerors may obtain information on registration at https://www.acquisition.gov.

52.217-5 Evaluation of Options. (July 1990)

Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

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 10 days.

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

(a) The Government may extend the term of this contract by written notice to the Contractor within 10 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 20 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 5 years.

52.232-40 Providing Accelerated Payments to Small Business Subcontractors. (Dec 2013)

(a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

All quotations, shall be sent to the Daniel Weingarten at Daniel.Weingarten@fda.hhs.gov.

This is an open-market combined synopsis/solicitation for equipment as defined herein. The government intends to award a purchase order as a result of this combined synopsis/solicitation that shall include the terms and conditions set forth herein. To facilitate the award process, ALL quotes shall include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoter shall list exception(s) and rationale for the exception(s).

Submission shall be received not later than July 21, 2017 at 12:00 P.M. Eastern Time at Daniel.Weingarten@fda.hhs.gov. The deadline for questions is July 17, 2017 at 12:00 PM Eastern Time. Late submissions shall be deemed unacceptable.

Point of Contact

Daniel Weingarten

240-402-7625

Daniel.Weingarten@fda.hhs.gov

FDA/OAGS/DAP

Contract Specialist/Contracting Officer 15 | Page