FDA-SOL-1240233.pdf

FDA-SOL-1240233

Solicitation Number FDA-SOL-1240233

Subject: Service Maintenance to an Illumina MiSeq Instrument

PART 1 – DESCRIPTION

The U.S. Food and Drug Administration’s (FDA) Administration’s Winchester Engineering and Analytical Canter (WEAC) has a need for preventive maintenance and repair services on an Illumina MiSeq instrument (serial number M06960).

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 announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.

This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-76. The North American Industry Classification System (NAICS) code for the proposed acquisition is 811219, Other Electronic and Precision Equipment Repair and Maintenance, with a small business size standard of $20.5 million. This is a full and open requirement; there are no set-asides.

PART 2 – SERVICES AND SUPPLIES AND PRICES

2.1 CONTRACT TYPE: FIRM-FIXED-PRICE

2.2 Pricing Table

Contract Line Item Number

(CLIN)

Service and Supply Description Firm-Fixed-Price*

0001 Base Year: Service Maintenance $ 1001 Option Year 1: Service Maintenance $ 2001 Option Year 2: Service Maintenance $ 3001 Option Year 3: Service Maintenance $ 4001 Option Year 4: Service Maintenance $

TOTAL MAXIMUM POTENTIAL FIRM-

FIXED-PRICE

*The firm-fixed-prices are inclusive of all costs, such as labor, travel, materials, and replacement parts. Payment for the respective firm-fixed-prices are only authorized upon successful completion of the applicable CLIN, including delivery and acceptance of all task and deliverables, as determined by the FDA Technical Point of Contact (TPOC) and upon submission of a proper invoice. Proper invoice submission includes following the invoice instructions below.

PART 3 – DESCRIPTION/SPECIFICATIONS

3.1 Background

Winchester Engineering and Analytical Center (WEAC) is in need of preventative maintenance and repair services for an existing Illumina MiSeq instrument. The contractor shall provide needed preventative maintenance as well as coverage for device malfunctions, software updates, and virtual and onsite support as needed.

The Illumina MiSeq, serial number M06960, was purchased in 2020 to be used in the analysis of regulatory samples. The instrument is under the base warranty that expires June 8, 2021.

3.2 Scope of Work

The Contractor shall provide preventative maintenance service (at least one visit per year) as well as unlimited repairs as needed on Illumina MiSeq instrument, serial number M06960. Additionally, the contract should cover instrument malfunctions and any needed repairs (Contractor is responsible for all parts, labor and any travel costs) as well as technical support.

3.3 Specifications, Tasks, and Deliverables

The Contractor shall provide routine preventative maintenance services will prolong the life of the instrument and ensure it functions properly. Any needed repairs for the instrument will be completed in a timely fashion, thus allowing WEAC to continue to perform its mission.

Through this contract the Government will obtain the following:

• One base year of preventative maintenance and repair services with an additional 4 option years.

• At least one (1) annual preventative maintenance visit per year

• On site and virtual support, as needed

• Emergency on-site repair visits

• Replacement Reagents for Instrument Failures

• Replacement Parts

• Hardware/Software Updates

Minimum Performance Requirements

• Contractor shall have an on-site response of two Business Days or less (for issues that cannot be solved remotely). All work shall be performed Monday-Friday 8:30 a.m.-5:00 p.m.

• Contractor shall provide at least one preventative maintenance (PM) visit shall be included per contract year. This visit shall be inclusive of all parts, labor, travel, consumables, and supplies which are necessary to complete the OEM’s suggested PM protocol. Service engineers which perform this service shall trained by the OEM. The vendor shall also include coverage for software and firmware updates.

• Contractor shall cover all costs associated with parts, labor, travel

• Contractor shall provide regular software updates/upgrades at no additional cost to the Government. Illumina proprietary software only, excludes 3rd party software and software subscriptions; excludes hardware necessary to upgrade system compatibility

• Unlimited onsite emergency service visits for problems that cannot be solved remotely.

Trade and Service Specifications

• Any replacement components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration.

• Any replacement components and/or equipment shall be warranted for parts and labor for a minimum of 12 months from date of formal government acceptance. The warranty must include unlimited telephone/e-mail support for questions regarding operation.

• Contractor shall schedule any service visits at least 48 hours in advance.

The TPOC will approve all tasks and deliverables.

3.4 Place of Performance

All services will be performed at ORA/WEAC in Winchester, Massachusetts.

U. S. FDA Winchester Engineering and Analytical Center Attn: POC to be identified at time of award 109 Holton Street Winchester, MA 01890

3.5 Service Records and Reports

The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA PROJECT OFFICER and Contract Specialist, not later that the 5th work day following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed).

3.6 Period of Performance

The order’s period of performance is one year from the effective date of the order with four one year option periods.

The FDA has a unilateral right to exercise the following four one year option periods under the same terms and conditions agreed to in the base period.

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

OPTION PERIOD FROM THE EFFECTIVE DATE OF THE ORDER

Base Year Base Year (June 9, 2021-June 8, 2022)

Option Year 1 One Year (June 9, 2022-June 8, 2023) Option Year 2 Two Years (June 9, 2023-June 8, 2024) Option Year 3 Three Years (June 9, 2024-June 8, 2025)

Option Year 4 Four Years (June 9, 2025-June 8, 2026)

FAR 52.217-9, OPTION TO EXTEND THE TERM OF THE CONTRACT (MARCH

2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within the period of performance of the contract; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five years and six months.

(End of clause)

FAR 52.217-8, OPTION TO EXTEND SERVICES (NOVEMBER 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within the period of performance of this contract.

(End of Clause)

3.7 Contract Administration

The FDA Technical Point of Contact (TPOC)

The following TPOC will represent the FDA for the purpose of this order: (To Be Determined Upon Award of Order)

The TPOC is responsible for the following: (1) monitoring the Contractor’s technical progress, including surveillance and assessment of performance and recommending to the FDA Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

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

The contact information for the FDA Contract Specialist is the following:

Nina Montgomery U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Road Beltsville, MD 20705 Nina.Montgomery@fda.hhs.gov Telephone: (240) 402-8086

The contact information for the Contractor is the following: [TBD]

3.8 Payment and Invoicing

The Government will pay the Contractor only for the CLINs’ firm-fixed-prices delineated in the pricing table in Subpart 2.2 above and only upon successful completion of the CLIN, including delivery and acceptance of all deliverables, as determined by the TPOC, and upon submission of a proper invoice. Proper invoice submission includes following the invoice instructions below.

INVOICE INSTRUCTIONS

A. The Contractor shall submit all invoices to the addresses and in the manners specified below:

(I) Attn: Vendor Payments

Office of Financial Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

FDAVendorPaymentsTeam@fda.hhs.gov

(II) One copy to the TPOC clearly marked as a “Courtesy Copy Only:”

ATTN: (To be determined upon contract award); TPOC Address:

Email: XXXXX@fda.hhs.gov

Acceptable methods of delivery include mail, hand delivery, and email. Please submit all invoices by email in adobe portable document format (pdf) whenever possible.

mailto:Nina.Montgomery@fda.hhs.gov mailto:XXXXX@fda.hhs.gov

B. Invoices submitted under these contracts must comply with the requirements set forth in FAR 52.232-33 (Payment by Electronic Funds Transfer— System for Award Management (SAM) (Jul 2013)) and the other applicable FAR clauses specified herein. The Contractor shall maintain current, accurate, and complete information in the SAM database, as displayed on the SAM website, until receipt of final payment under their contract.

To constitute a proper invoice, the invoice must be submitted on Contractor letterhead and include the following:

(I) Name and address of the Contractor;

(II) Invoice date and number;

(III) Order number;

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

(V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading;

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

(VII) Name and address of official to whom payment is to be sent (must be the same as that in the order or in a proper notice of assignment) (VIII) Name, title, and phone number of person to notify in event of a defective invoice;

(IX) Taxpayer Identification Number (TIN);

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

(XI) Name and telephone number of the FDA TPOC; and (XII) Any other information or documentation required by the order.

C. Questions regarding invoice payments shall be directed to the FDA Payment Office at the following mail and email addresses and phone numbers:

Office of Financial Services

10903 New Hampshire Avenue W032, Second Floor Mail Hub 2145 Building 32, Room 2162 Silver Spring MD 20993-0002 Attn: Vendor Payments Phone Numbers: (301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov

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

3.9 FAR Clauses Incorporated by Reference

mailto:fdavendorpaymentsteam@fda.gov

FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)

This order 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 address:

http://www.acquisition.gov/far/

52.212-4, Contract Terms and Conditions-Commercial Items (May 2014) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (December 2013) 52.242-17, Government Delay of Work (April 1984)

3.10 FAR Clause by Full Text

FAR 52.212-5, CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS - COMMERCIAL ITEMS (JUL 2014)

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

(1) 52.222-50, Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g)).

Alternate I (AUG 2007) of 52.222-50 (22 U.S.C. 7104(g)).

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

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (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:

(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).

(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).

_X_ (10) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Public Law 112-74, section 740 of Division C of Pub. L.

111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L.

110-161).

(11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C.

657a).

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

(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.

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

(17) (i) 52.219-9, Small Business Subcontracting Plan (Jul 2013) (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 (July 2010) 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) (i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Oct 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer).

(ii) Alternate I (June 2003) of 52.219-23.

(22) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting (Jul 2013) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

(23) 52.219-26, Small Disadvantaged Business Participation Program—Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

(24) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).

_X_ (25) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

(26) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

(27) 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_ (28) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_X (29) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (JAN 2014) (E.O. 13126).

_X (30) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

_X_ (31) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

_ (32) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212).

X_ (33) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.

793).

_ (34) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212).

_ (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_ (36) 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.)

(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) (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.

(39) (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.

(40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C.

8259b).

(41) (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_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011).

_ (43) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

(44) (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.

(45) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (46) 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).

(47) 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. 2303 Note).

(48) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C.

5150).

(49) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

(50) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

(51) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

X_ (52) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management

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

(53) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

(54) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

(55) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

(56) (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) 52.222-41, 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).

_X_ (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 (Sep 2008) (31 U.S.C. 5112(p)(1)).

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

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

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

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

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

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

(ii) 52.219-8, Utilization of Small Business Concerns (May 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 (1) 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) 52.222-17, 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) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(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.

(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)

3.11 HHSAR Clauses Incorporated by Reference

This order incorporates the following U.S. Department of Health and Human Services Acquisition Regulation (HHSAR) 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 the following website:

http://www.hhs.gov/policies/hhsar/.

352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (January 2010) 352.231-71, Pricing of adjustments (January 2001)

3.12 CONFLICTS OF INTEREST

The Contractor shall warrant that, to the best of its knowledge and belief, and except as otherwise disclosed in its quote, it does not have any actual, potential, or apparent conflict of interests pertaining to the subject procurement, as described in FAR Subpart 9.5 and HHS and FDA policies, for its organization, employees, or subcontractors proposed to be working under procurement.

After award of an order for this procurement, if the Contractor discovers an actual, potential, or apparent conflict of interest with respect to this procurement, it shall make an immediate and full disclosure in writing to the FDA Contracting Officer and TPOC for this order, including a description of any actions the Contractor has taken or proposes to take to avoid, neutralize, or mitigate any conflict of interest. The Contractor shall act impartially and objectively and must avoid actions that would cause a reasonable person to question their impartiality or engage in activities that may result in an unfair competitive advantage.

The Government reserves the right to exercise any remedy available at law or equity, including termination of the order for cause or convenience, should the Government determine remedial action is necessary to address any actual, potential, or apparent conflict of interest.

Contractors shall include a clause substantially similar to this conflicts of interest clause in any subcontract.

PART 4 – INSTRUCTIONS TO OFFERORS

Offerors shall include the following in their quote:

• Point of contact (name, telephone number, and email address),

• Proposed firm-fixed-prices (i.e. complete the pricing table in Subpart 2.2),

• Certification that all company information listed in the System for Award Management

(SAM) is complete, accurate, and current.

• Affirmation of the lack of conflicts of interest or information related to any actual, potential, or apparent conflicts of interest which may affect the offeror’s ability to perform this requirement in an impartial and objective manner or that may result in an unfair competitive advantage in accordance with the Conflicts of Interest terms in Section 3.

• Business size and type (e.g. small, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, etc.),

• Dun and Bradstreet (DUNS) and Taxpayer Identification (TIN) numbers, and

• Service Contract Labor Standards exemption certification in accordance with 52.212-

3(k)(1).

http://www.hhs.gov/policies/hhsar/

Offerors Response Date and Time All quotes and revisions shall be submitted via email to nina.montgomery@fda.hhs.gov by or before 10:00 AM Eastern Time on Tuesday, May 25, 2021.

NOTE: LATE QUOTES WILL NOT BE EVALUATED.

FAR PROVISIONS INCORPORATED BY REFERENCE

FAR 52.252-1, SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

(FEBRUARY 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 address:

FAR 52.212-1, Instructions to Offerors - Commercial Items (April 2014), applies to this acquisition and is incorporated by referenced. Please pay special attention to 52.212-1(b)(3-7) to ensure the FDA has sufficient information to determine whether an offer is technically acceptable to perform all tasks and provide all deliverables delineated above.

FAR 52.212-3, Offeror Representations and Certifications -- Commercial Items (May 2014) (According to this provision, “[a]n 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”).

Please note 52.212-3(k)(1) is applicable to this procurement. Please provide a certification affirming this exemption from the Service Contract Labor Standards.

FAR 52.217-5, Evaluation of Options (July 1990)

The FDA will evaluate quotes and make an award decision based on the lowest evaluated price meeting or exceeding the technical acceptability standards delineated above.

mailto:nina.montgomery@fda.hhs.gov http://www.acquisition.gov/far/ http://www.acquisition.gov/