FDA-SOL-FY21-1240743.pdf

FDA-SOL-FY21-1240743

Portable Process Analytical Technology Tool with Integrated Raman Spectroscopy, Microscopy and Particle Size System with Delivery, Installation and Training

PART 1 – Description

This is a Combined Synopsis/Solicitation for Commercial Items prepared in accordance with the format in FAR Subparts

12.6 and 13.5 and as supplemented with additional information included in this notice. This Request for Quotation (RFQ) announcement constitutes the only solicitation that will be issued; a quote is being requested and a written solicitation will not be issued. The government contemplates a Firm-Fixed Price Purchase Order resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-05 dated March 10, 2021.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 – Analytical Laboratory Instrument Manufacturing; the small business size standard is 500 employees. The requirement is being solicited full and open competition.

PART 2 – Supplies or Services and Prices/Costs

The U.S. Food and Drug Administration (FDA), Division of Product Quality Research (DPQR) is requesting a portable process analytical technology (PAT) tool with integrated Raman spectroscopy, microscopy and particle size system. The requested equipment will be used as an advanced, innovative PAT tool to monitor the manufacture of active pharmaceutical ingredients (API) during crystallization process to support the FDA regulatory mission. The system shall include all accessories, installation, shipping and a 12-month manufacturer’s warranty.

Pricing Table:

Line Item

Description

Qty.

Price

1 Portable Process Analytical Technology Tool with Integrated Raman Spectroscopy, Microscopy and Particle Size System including 12-month warranty

1 $

2 Installation 1 $

3 Training 1 $

4 Shipping and Inside Delivery 1 $

TOTAL $

PART 3 -Technical Requirements/Salient Characteristics

The Portable Process Analytical Technology Tool with Integrated Raman Spectroscopy, Microscopy and Particle Size System shall “meet or exceed” the following salient characteristics/specifications. Offerors shall include a technical brochure or otherwise reference the specific equipment, capabilities and characteristics referenced below. All of the following are minimum requirements. Equivalent requirements that differ from the below requirements must be justified by the proposing vendor and evaluated prior to award. The system must be a newly manufactured unit, not used and refurbished or previously used for demonstration.

The system shall include and/or meet the following components:

Portable Process Analytical Technology Tool with Integrated Raman Spectroscopy, Microscopy and Particle Size System

Item 1: Basic PAT system

• Portable, in-process high resolution microscope, particle size & physical property analyzer single PAT probe.

• Field of view = 900 um diameter

• Wetted temperature range = -10 to 100°C (condensation removal purge required < 4 °C), pressure limit 6 bar, conduit length=2.6m

• Turbidity with minimum 14-bit dynamic range, 50 images/sec, minimum, 12-bit image capture and 14-bit dynamic range

• Probe tip of less than 12mm for small ID tubing, and minimum probe length of 270 mm.

Item 2: Integrated Raman spectroscopy system

• Spectral Range: 200 cm-1 to 3300 cm-1 (350-3300 c-1 with Blaze); Laser Power up to 495 mW.

• Particle Focused Raman channel for 785 nm excitation and collection spectrometer.

• The 785nm Raman spectrometer is simultaneous with Blaze Microscopy & Analytics.

Item 3: Software control

• Windows 10-based control system

• Basic Software Package for Chord Length Distribution & Trends from 1D Optical Edge to Edge Chords; HDR

Turbidity; Microscopy with image selection.

• The instrument’s software shall have the capability of electronic records of maintenance and errors.

• The software shall include data analysis and interactive diagnostic capabilities for troubleshooting and improved serviceability.

• A flat screen monitor shall be provided with the system. The monitor shall include an LCD display of ≥ 19 inches.

Item 4: Delivery, Installation, and On-site training The vendor shall cover all costs associated with the following:

• System crating, shipping, and delivery.

• Full system software and peripheral installation.

• On-site hardware and software training.

Warranty The contractor shall provide a full manufacturer’s warranty for coverage on all non-consumable items and parts including on-site service visits for warranty repairs, factory-certified replacement parts, and labor and travel costs for a certified technician for a 12 month (one year) period after date of award at no additional cost to the government.

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 number and contractor name. The contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. All equipment shall be new not used or refurbished.

PART 5 – Inspection and Acceptance

Portable Process Analytical Technology Tool with Integrated Raman Spectroscopy, Microscopy and Particle Size System

The Contracting Officer’s Representative (COR), to be provided at time of award, will perform inspection and acceptance of equipment to be provided. For the purpose of this Part the COR is the authorized representative of the Contracting Officer. Inspection and acceptance will be performed at the location identified in part 6.

Acceptance is communicated in writing unless otherwise indicated in writing by the Contracting Officer or COR within 30 days of receipt. The instrument shall not be accepted until specifications herein have been confirmed.

PART 6 – Deliveries or Performance

Satisfactory performance of this contract shall be deemed to occur upon delivery and confirmation of specifications described in Part 3 of this RFQ and upon acceptance by the Contracting Officer, or the COR, of these products. 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 White Oak Campus Attn: [Adil Mohammad] WO Building 62; Loading Dock Silver Spring, MD 20993

Equipment Installation Location:

Food and Drug Administration White Oak Campus Attn: [Adil Mohammad] WO Building 64; Room 1083 Silver Spring, MD 20993

Delivery must occur during regular business hours (Monday-Friday) between 8:30 AM and 4:00 PM, excluding Federal holidays (See Part 9) and weather-related closures in accordance of the delivery location time zone (Eastern Time, Central Time, or Pacific Time). Delivery staff must have photo ID to enter building. Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. The Contractor shall provide the FDA with one (1) week’s scheduling notice prior to delivery.

Period of Performance The equipment shall be delivered 30 days from contract award unless the government approves a different delivery schedule. The manufacture warranty shall begin at the date of award.

PART 7 – Contract Administration Data

Contracting Officers Representative (COR) The COR, to be determined upon contract award, will represent the Government for the purpose of this contract.

The COR is responsible for:

(1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

Portable Process Analytical Technology Tool with Integrated Raman Spectroscopy, Microscopy and Particle Size System

(2) interpreting the Statement of Work and any other technical performance requirements;

(3) performing technical evaluation as required;

(4) performing technical inspections and acceptances required by this contract; and

(5) assisting in the resolution of technical problems encountered during performance.

Contracting Officer (CO) The Contracting Officer is the only person with authority to act as agent of the Government under this contract.

Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFQ; (2) modify or extend the period of performance;

(3) change the delivery schedule;

(4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or

(5) otherwise change any terms and conditions of this contract.

Contracting Officer: Linda Troutman 60 8th Street, NE Atlanta, GA 30309 Linda.Troutman@fda.hhs.gov 404-253-1258

IT PURCHASING REQUIREMENTS:

NOTE to Contractor: Before the task order is awarded, FDA is required to get pre-approval of all the IT hardware and/or software-firmware-freeware from the FDA Chief Information Officer (CIO). For IT hardware, this includes any device that processes or stores data, or is controlled by data (computers/data switches, etc.), but does not include passive hardware (rack, network cables, power supplies/cords, etc.). This will require the applicable Vendor to provide a complete list of hardware and/or software-firmware-freeware that the Vendor will use in fulfilling this task order.

This list will need to include:

1. IT hardware: manufacture, nomenclature and model number

2. Software (all types): manufacture, nomenclature and version number

Item(s) rejected by the CIO will need to be changed and the replacement item(s) would need to go through the same approval process.

Security

Contractors must either be escorted or be badged to HSPD 12 standard during instrument installation and IQ/OQ.

Software required to control instrument shall be COTS must be approved on FDA MAT List prior to award.

PART 8 - FAR and HHSAR CLAUSES

52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulation (FAR) System, 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://farsite.hill.af.mil/.

mailto:Linda.Troutman@fda.hhs.gov http://farsite.hill.af.mil/

Portable Process Analytical Technology Tool with Integrated Raman Spectroscopy, Microscopy and Particle Size System

52.212-1 Instructions to Offerors – Commercial Items applies with the following addenda: Period for Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2017.

52.212-2 Evaluation – Commercial Items (Oct 2014) 52.212-3 Offeror Representations and Certifications—Commercial Items (May 2014)

An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov . If an offeror has not completed the annual representations and certifications electronically at the System for Award

Management (SAM) website, the offeror shall complete only paragraphs (c) through (o) of this provision

FAR Clauses in Full Text

52.212-5 Contract Terms And Conditions Required To Implement Statutes Or Executive Orders Commercial Items (Feb 2016)

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

(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

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

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)).

b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

(2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509).

(3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009).

_X_ (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).

http://www.acquisition.gov/

Portable Process Analytical Technology Tool with Integrated Raman Spectroscopy, Microscopy and Particle Size System

(7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L.

111-117, section 743 of Div. C).

_X_ (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).

(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.

_X_ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

(ii) Alternate I (Jan 2011) of 52.219-4.

(13) [Reserved]

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

(ii) Alternate I (Nov 2011).

(iii) Alternate II (Nov 2011).

(15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

(ii) Alternate I (Oct 1995) of 52.219-7.

(iii) Alternate II (Mar 2004) of 52.219-7.

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

(17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 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.

Portable Process Analytical Technology Tool with Integrated Raman Spectroscopy, Microscopy and Particle Size System

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

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

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

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

657f).

_X_ (22) 52.219-28, Post Award Small Business Program Representation (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 (Apr 2015).

_X_ (28) 52.222-26, Equal Opportunity (Apr 2015) (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).

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

_X_ (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

Portable Process Analytical Technology Tool with Integrated Raman Spectroscopy, Microscopy and Particle Size System

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 Television (Jun 2014) (E.O.s 13423 and 13514).

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

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

(39) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (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 (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

(45) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

Portable Process Analytical Technology Tool with Integrated Raman Spectroscopy, Microscopy and Particle Size System

(46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

(47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C.

5150).

(48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C.

2307(f)).

(49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

X_ (50) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332).

(51) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul

2013) (31 U.S.C. 3332).

(52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

(53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

(54) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631).

(ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or executive orders applicable to acquisitions of commercial items:

(1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495)

(2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.).

(3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C.

chapter 67).

(4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67).

(5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

(6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67).

Portable Process Analytical Technology Tool with Integrated Raman Spectroscopy, Microscopy and Particle Size System

(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 2014) (E.O. 13658).

(9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).

(10) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)).

(d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract.

If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(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.

Portable Process Analytical Technology Tool with Integrated Raman Spectroscopy, Microscopy and Particle Size System

(iii) 52.222-17, Non-displacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

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

(v) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

(vi) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (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 (Jul 2014) (38 U.S.C. 4212).

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

Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(x) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67).

(xi)

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

(B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627).

(xii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.)

(xiii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67)

(xiv) 52.222-54, Employment Eligibility Verification (Aug 2013).

(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (E.O. 13658).

(xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

Portable Process Analytical Technology Tool with Integrated Raman Spectroscopy, Microscopy and Particle Size System

(xviii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of Clause)

(End of clause)

HHSAR Clauses HHSAR clause full text can be accessed electronically at: http://farsite.hill.af.mil/vfhhsara.htm 352.203-70 Anti-Lobbying (Dec 2015) 352.208-70 Printing and Duplication (Dec 2015) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations. (Dec 2015)

PART 9 – 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) http://farsite.hill.af.mil/vfhhsara.htm

Portable Process Analytical Technology Tool with Integrated Raman Spectroscopy, Microscopy and Particle Size System with Delivery, Installation and Training

Part 10– Instructions to the Offerors

Technical Acceptability Criteria

The Government will evaluate the contractor’s quote for technical acceptability based on the following:

1) Offers shall provide specifications confirming the instrument meets the technical salient characteristics/specifications and requirement in accordance of this RFQ and Part 3 of this RFQ and

2) The offeror shall state their ability to “meet or exceed” the salient characteristics/ technical specifications and requirements in accordance of this RFQ. Also, the contractor shall provide an itemized price listing (detail listing) of parts, equipment, and other items that equals the cost of the equipment.

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. You will need your Tax ID, DUNS Number and banking information.

Vendors who are not registered in SAM will not be eligible for award. The Government reserves the right not to negotiate and award without discussion.

INSTRUCTIONS TO OFFEROR FOR PROPOSAL SUBMISSION

FAR 52.212-1 Instructions to Offerors—Commercial Items (OCT 2018)

PROPOSAL SUBMISSION FORMAT:

***Proposal shall be in 2 volumes: 1 Technical and 2 Price. The volumes shall be separate and complete.

The volumes shall be separate and complete, so that evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in volume 1***.

Quotes should explain why and how their instrument meets or exceeds each detailed technical requirement and include supportive data and descriptions wherever possible.

The total number of pages for the technical quote shall not exceed ten (10) pages, using 1” margins, single spaced, font type Time New Roman, and a font size of 12.

***The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote or proposal. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition**.

http://www.sam.gov/

Portable Process Analytical Technology Tool with Integrated Raman Spectroscopy, Microscopy and Particle Size System with Delivery, Installation and Training

QUESTIONS DEADLINE: Interested offerors shall submit questions electronically to Linda.Troutman@fda.hhs.gov no later than April 19, 2021 at 10:00 a.m. Eastern Standard Time.

Please include the company name, FDA solicitation number, and “Question(s)” in the subject line.

No Phone Calls Please.

QUOTES DUE: All quotes are due, electronically via email to Linda.Troutman@fda.hhs.gov no later than April 26, 2021, 10:00 a.m. Eastern Standard Time. Please include the company name, FDA solicitation number in the subject line.

mailto:to%20Linda.Troutman@fda.hhs.gov mailto:to%20Linda.Troutman@fda.hhs.gov mailto:Linda.Troutman@fda.hhs.gov