Combined Synopsis-Solicitation_1252314.pdf

COMBINED SYNOPSIS/SOLICITATION

FDA-SOL-1252314

SMALL BUSINESS SET ASIDE

General Information Solicitation Number: FDA-SOL-1252314 Posted Date: July 28, 2022 Current Response Date: August 10, 2022

The U.S. Food & Drug Administration (FDA), Office of Acquisitions and Grants Services is requesting to procure one (1) High-Performance Liquid Chromatography (HPLC) Instruments for Color Certification Program. The Government intends to award a Firm Fixed-Price Purchase Order for the items described below (LINs 1-4).

DESCRIPTION:

The objective of this requirement is to acquire eight (8) new HPLC instruments. This acquisition will replace eight (8) Waters Alliance 2690/2695 Separations FDA’s Color Certification Program that is at risk of obsolescence. The existing instruments will be removed from the Color Certification Program’s Waters service contract in exchange for the new instruments.

The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC)

2022-06. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A

SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is FDA-SOL-1252314 and is being issued as a Request for Quote (RFQ). Prospective offerors are responsible for downloading the solicitation and any amendments from SAM.gov. The associated North American Industrial Classification System (NAICS) Code is 334516: Analytical Laboratory Instrument Manufacturing.

BACKGROUND:

FDA’s Color Certification Program assures the safe use of certified color additives (synthetic dyes and pigments) in foods, drugs, cosmetics, and certain medical devices. Certified color additives are listed in 21 CFR Parts 74 and 82 together with specifications for their impurities. HPLC is the primary technique used by certification chemists to determine levels of subsidiary colors, intermediates, and related impurities, which range from a few percentage points to nanograms per gram.

Currently there is a service contract in place for the preventative maintenance and repair of Waters instruments used for the certification of color additives, including the HPLC instruments at risk of obsolescence. This service contract allows for the addition of new Waters instruments to the service contract and for the removal of Waters instruments currently on the service contract. Therefore, eight HPLC systems will be acquired to replace eight of the Color Certification Program’s existing older Waters Alliance HPLC models.

1) Minimum Salient Characteristics:

A. Shall include the following HPLC specifications

1. Shall provide eight (8) HPLC instruments. Note: these instruments will replace eight (8)

Waters Alliance 2690/2695 Separations Modules.

2. Shall install the instruments and provide training on the instrument’s operation to the Color

Certification Program’s chemists.

3. The system shall support an automated start-up program which readies the system by automatically priming solvent lines and the fluidic paths.

4. The system flow path shall be compatible with a pH range of 1 to 12.5.

5. Total system bandspread (4σ) for the system shall be ≤ 65 μL.

6. The total system dwell volume, as measured at the 50% point in a step gradient, shall be ≤ 1,350μL.

7. The gradient delay volume, as measured at the lift-off point in a step gradient, shall be ≤1,000 μL.

8. The system shall support leak sensors. Drips shall be managed through a drip tray which shall direct all leaks to either the front or rear of the instrument and then into a suitable waste container.

9. The system shall support fully integrated diagnostics with 96 hours of diagnostic data preserved. Data channels need to include individual pump piston pressures, system pressure, sample compartment temperature, column temperature and ambient temperature.

10. The total system shall have a combined audible noise of no greater than 65 dBA.

11. The system shall be capable of automatically synchronizing or decoupling the injection start from the start of the gradient.

12. The system shall support the columns designed and developed for the system by the same manufacturer.

13. The system shall include an automated 8-port 3-position column switching valve assembly with mounting bracket and includes all necessary tubing.

14. The system shall be compatible with the Waters 2998 Photodiode Array (PDA) detector.

15. The system shall be eligibile for coverage under the Waters Total Assurance Plan.

B. Shall include the following Pump specifications:

1. The pump shall be capable of delivering aqueous and organic solvents at operating pressures up to 9,500 psi over its entire flow range.

2. The pump shall have integrated vacuum degassing of all mobile phase lines.

3. The pump shall provide quaternary solvent blending of up to four solvents.

4. The pump shall have an optional solvent selection valve for automated and unattended selection of up to six solvents.

5. The pump shall support flow ramping, settable from 0.01 to 30.00 minutes to gradually reach flow rates up to 5.000 mL/min.

6. The pump shall be able to support flow rates as low as 0.001 mL/min and as high as 5.000 mL/min.

7. The pump shall automatically synchronize with the injection start to enhance retention time reproducibility.

8. The pump must have automatic and continuous compressibility compensation for the solvents, requiring no user intervention.

9. The pump shall have integrated and programmable pump seal wash.

10. The pump shall be able to automatically select between multiple dwell volumes by user selection within the instrument method editor

11. The pump shall be able to program both isocratic and gradient methods

12. The pump shall be able to program gradient methods directly in terms of pH, percent organic solvent, and salt concentration.

13. The pump shall have a flow accuracy of +/- 1.0%.

14. The pump shall have a flow precision of ≤0.075% RSD or +/- 0.02 min SD, whichever is greater

15. The pump shall be capable to deliver a minimum of eleven gradient curve profiles.

16. The pump must have a pressure pulsation of ≤1.0% or 25 psi, whichever is greater.

17. The pump must have a compositional precision of 0.15% RSD or +/- 0.04 min SD, whichever is greater.

C. Shall provide the following Sample Manager specifications:

1. The injector shall be capable of injecting samples dissolved in aqueous and/or organic solvents at operating pressures up to 9,500 PSI.

2. The injector shall have an integrated and programmable needle wash.

3. The injector shall have measurable carryover of less than 0.002% or less (measured by UV).

4. The injector shall aspirate samples with an accuracy of +/- 0.2 μL.

5. The sample compartment temperature shall be settable from 4 to 40°C.

6. The injector shall have the ability to automatically dilute samples.

7. The injector shall have the ability to automatically withdraw from several sample vials and dispense into a single vial.

8. The injector shall be capable of injection volumes from 0.1 to 1000.0 μL.

9. The sample compartment shall be able to accommodate both HPLC vials and/or well plates

(96 / 384 well).

10. The injector precision shall be equal to or less than 1.0% RSD from 0.5 to 0.9 μL; 0.5% RSD from 1.0 to 4.9 μL; and <0.25% RSD from 5.0 to 1000.0 μL.

11. The injector linearity shall be equal to or better than 0.999 correlation coefficient over its entire injection range.

D. Shall provide the following Column Manager specifications:

1. The column compartment connective fittings shall be reusable and adjustable and withstand pressures up to 9,500 PSI and 5.0 mL/min.

2. The column compartment shall be able to support columns up to 30 cm in length.

3. The column compartment shall be able to accommodate columns as wide as 7.8 mm ID.

4. The column compartment shall support optional column selection, up to 3 columns.

5. The column compartment shall be able to cool down to 4°C.

6. The column compartment shall be able to heat up to 65°C.

7. The column compartment shall have temperature accuracy of +/- 0.5°C.

8. The column compartment shall have temperature stability of +/- 0.3°C.

9. Heat time, as measured at the column temperature probe, shall not exceed 35 minutes when heating from ambient to 60°C ± 2°C (no flow).

10. Cool time, as measured at the column temperature probe, shall not exceed 30 minutes when cooling from 60°C to 20°C ± 2°C (no flow).

11. Heat time, as measured at the column temperature probe, shall not exceed 30 minutes when heating from 20°C to 60°C ± 2°C (no flow).

2) Minimum Software Salient Characteristics:

A. Shall include one (1) year 1 basic service/warranty coverage of software updates including onsite repairs at no additional cost to the government.

B. Shall have software that is capable of providing real-time monitoring and automatic notification instrument performance as well as diagnostic information for expedited problem resolution and minimized down time.

C. Shall have the ability to be compatible with Waters Empower software.

D. Shall have the ability provide full maintenance information such as counters for total solvent usage, number of injections.

3) Minimum Warranty Requirements:

A. Shall include one (1) year warranty for parts and labor from the date of acceptance.

B. Shall include a full system insallation.

C. Shall include on-site maintenance services for one (1) year from the date of acceptance at no additional cost to the government.

D. Shall include troubleshooting capabilities based on complete knowledge of the entire instrument, immediate access to certified replacement parts, and immediate access to improvements and new procedures provided by the original vendor and manufacturer.

E. Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/index.html or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/accessibility-checklists/index.html.

4) Minimum Training Requirements:

• Shall provide on-site training for ten (10) End Users on the instruments operation for the Color

Certification Program’s chemists.

• Shall be administered by an OEM certified engineer.

5) PRICING:

All charges must be included in the quote. Any charges presented after contract award shall be unacceptable.

LIN DESCRIPTION QUANTITY PRICE

1 HPLC Instruments for Color Certification Program 1 EA $

2 Software 1 EA $ 3 Warranty 1 YR $ 4 On-site Training for 10 End Users 1 EA $

GRAND TOTAL to include both delivery and installation = (FOB-Destination)

A. INSPECTION AND ACCEPTANCE:

1. The Contracting Officer’s Representative (COR) or COR’S Designee will perform inspection and acceptance of the delivery, installation and software training, and , if necessary, the repair services or corrections to be provided by the Contractor.

• For the purpose of this PART, is the authorized representative of the Contracting

Officer (to be added at time of award).

2. NOTE to Contractor – IT Purchase Requirments: Before the purchase 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 purchase order.

a. This list will need to include:

i. IT hardware: manufacture, nomenclature and model number

ii. 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.

https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html

B. PLACE OF PERFORMANCE:

1. FOB-Destination

Food and Drug Administration 4300 River Road College Park, MD 20740

2. Delivery shall be no later than 30 days after contract award.

3. Hours of Delivery 9:00am – 4:00pm (Monday-Friday, excluding holidays and weekends).

C. CONTRACT ADMINISTRATION DATA:

A. Contracting Officers Representative (COR)

1. The following COR will represent the Government for the purpose of this contract: (To Be

Determined).

2. 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; (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.

B. 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.

The contact information for the Contracting Officer:

Nicole Craig nicole.craig@fda.hhs.gov

D. INVOICE SUBMISSION:

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov mailto:nicole.craig@fda.hhs.gov http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and

(2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred:

1. Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

2. Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

3. Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

4. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

5. Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

6. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

7. Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

ii. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

iii. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

E. 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) June (Juneteenth) July (Independence Day)

September (Labor Day) October (Columbus Day) November (Veterans Day) November (Thanksgiving) December (Christmas Day)

a. In addition to the days designated as holidays, the Government observes the following days:

(1) Any other day designated by Federal Statute

(2) Any other day designated by Executive Order

(3) Any other day designated by the President’s Proclamation

When any such day falls on a Saturday, the following Monday is observed. Except for designated around-the-clock or emergency operations, Contractor personnel will not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor will not charge any holiday as direct charge to the award.

b. It is understood and agreed between the Government and the Contractor that observance of such days by Government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation except as set forth within the award.

c. Nothing in this clause abrogates the rights and responsibilities of the parties relating to stop work provisions as cited in other sections of this contract.

F. EVALUATION AWARD CRITERIA:

The Government shall award this contract to the Lowest Priced, Technically Acceptable (LPTA). FDA reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value and discussions are not necessary.

G. PROVISIONS and CLAUSES:

HHSAR Clauses Incorporated by Reference: Read the full text of the HHSAR Clauses as stated below, see https://www.acquisition.gov/hhsar

HHSAR Clause Description/Date 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations/(Dec 2015) 352.232-71 Electronic Submission of Payment Requests (Feb 2022)

(a) Definitions. As used in this clause- Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

352.239-73 Electronic and Information Technology Accessibility Notice/(Dec 2015) https://www.acquisition.gov/hhsar

FAR CLAUSES

52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one of 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 https://www.acquisition.gov/far/part-52

52.212-4 -- Contract Terms and Conditions -- Commercial Items. Contract Terms and Conditions

-- Commercial Items (Nov 2021)

52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -

- Commercial Items (May 2022).

As prescribed in 12.301(b)(4), insert the following clause:

(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 products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Nov 2021) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment . (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.233-3, Protest After Award (Aug 1996) ( 31 U.S.C. 3553).

(6) 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 products and commercial services:

[Contracting Officer check as appropriate.]

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Nov 2021) ( 41 U.S.C. 4704 and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) ( 41 U.S.C.

3509)).

_ X _ (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.)

https://www.acquisition.gov/far/part-52 http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/12.htm#P120_20015

_ X _ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (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).

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment . (Nov 2021) ( 31 U.S.C. 6101 note).

__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) ( 41 U.S.C. 2313).

__ (10) [Reserved].

__ (11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Sep 2021) ( 15 U.S.C. 657a).

__ (12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Sep 2021) (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 Set-Aside (Nov 2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-6.

__ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-7.

_X_ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) ( 15 U.S.C. 637(d)(2) and (3)).

__ (17) (i) 52.219-9, Small Business Subcontracting Plan (Nov 2021) ( 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 (Jun 2020) of 52.219-9.

__ (v) Alternate IV (Sep 2021) of 52.219-9.

__ (18) (i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) ( 15 U.S.C. 644(r)).

__ (ii) Alternate I (Mar 2020) of 52.219-13.

__ (19) 52.219-14, Limitations on Subcontracting (Sep 2021) ( 15 U.S.C. 637s).

__ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) ( 15 U.S.C.

637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Sep 2021) ( 15 U.S.C. 657f).

__ (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (Sep 2021) ( 15 U.S.C. 632(a)(2)).

__ (ii) Alternate I (Mar 2020) of 52.219-28.

__ (23) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Sep 2021) ( 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 (Sep 2021) ( 15 U.S.C. 637(m)).

__ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) ( 15 U.S.C. 644(r)).

__ (26) 52.219-33, Nonmanufacturer Rule (Sep 2021) ( 15U.S.C. 637(a)(17)).

_X_ (27) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

_ X _ (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2022) (E.O.13126).

_ X _ (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_ X_ (30) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

__ (ii) Alternate I (Feb 1999) of 52.222-26.

_ X_ (31) (i) 52.222-35, Equal Opportunity for Veterans (Jun 2020) ( 38 U.S.C. 4212).

__ (ii) Alternate I (Jul 2014) of 52.222-35.

_X_ (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) ( 29 U.S.C. 793).

__ (ii) Alternate I (Jul 2014) of 52.222-36.

_X_ (33) 52.222-37, Employment Reports on Veterans (Jun 2020) ( 38 U.S.C. 4212).

_X_ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_ X _ (35) (i) 52.222-50, Combating Trafficking in Persons (Nov 2021) ( 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).

__ (36) 52.222-54, Employment Eligibility Verification (Nov 2021) . (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 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) 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 (Jun2014) of 52.223-14.

__ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (May 2020) ( 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 (Jun 2020) (E.O. 13513).

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

__ (46) 52.223-21, Foams (Jun2016) (E.O. 13693).

__ (47) (i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).

__ (ii) Alternate I (Jan 2017) of 52.224-3.

_X_ (48) 52.225-1, Buy American-Supplies (Nov 2021) ( 41 U.S.C. chapter 83).

__ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (Nov 2021) ( 41 U.S.C.chapter83, 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 (Jan 2021) of 52.225-3.

__ (iii) Alternate II (Jan 2021) of 52.225-3.

__ (iv) Alternate III (Jan 2021) of 52.225-3.

__ (50) 52.225-5, Trade Agreements (Oct 2019) ( 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (51) 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2021) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (52) 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. 2302Note).

__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov2007) ( 42 U.S.C.

5150).

__ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) ( 42 U.S.C. 5150).

__ (55) 52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

__ (56) 52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (Nov 2021) ( 41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (57) 52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021) ( 41 U.S.C. 4505, 10 U.S.C. 2307(f)).

_ X _ (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) ( 31 U.S.C. 3332).

__ (59) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) ( 31 U.S.C. 3332).

__ (60) 52.232-36, Payment by Third Party (May 2014) ( 31 U.S.C. 3332).

__ (61) 52.239-1, Privacy or Security Safeguards (Aug 1996) ( 5 U.S.C. 552a).

__ (62) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) ( 15 U.S.C.

637(d)(13)).

__ (63) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) ( 46 U.S.C. 55305 and 10 U.S.C. 2631).

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

__ (iii) Alternate II (Nov 2021) 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 products and commercial services:

__ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) ( 41 U.S.C. chapter67).

__ (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) (Aug 2018) ( 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) ( 29U.S.C.206 and 41 U.S.C. chapter 67).

__ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment -Requirements (May 2014) ( 41 U.S.C. chapter 67).

__ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) ( 41 U.S.C. chapter 67).

__ (7) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

__ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

__ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) ( 42 U.S.C. 1792).

(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 , as defined in FAR 2.101, on the date of award of this contract , 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 products or commercial services. 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 (Nov 2021) ( 41 U.S.C.

3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Nov 2021) (Section 1634 of Pub. L. 115-91).

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment . (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) ( 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 the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

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

(vii) 52.222-26, Equal Opportunity (Sep 2015) (E.O.11246).

(viii) 52.222-35, Equal Opportunity for Veterans (Jun 2020) ( 38 U.S.C. 4212).

(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) ( 29 U.S.C.

793).

(x) 52.222-37, Employment Reports on Veterans (Jun 2020) ( 38 U.S.C. 4212).

(xi) 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.

(xii) 52.222-41, Service Contract Labor Standards (Aug 2018) ( 41 U.S.C. chapter 67).

(xiii) (A) 52.222-50, Combating Trafficking in Persons (Nov 2021) ( 22 U.S.C. chapter 78 and E.O 13627).

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

(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment -Requirements (May2014) ( 41 U.S.C. chapter 67).

(xv) 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).

(xvi) 52.222-54, Employment Eligibility Verification (Nov 2021) (E.O. 12989).

(xvii) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

(xix) (A) 52.224-3, Privacy Training (Jan 2017) ( 5 U.S.C. 552a).

(B) Alternate I (Jan 2017) of 52.224-3.

(xx) 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).

(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) ( 42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) ( 46 U.S.C. 55305 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 products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations.

Alternate I (Feb 2000). As prescribed in 12.301(b)(4)(i), delete paragraph (d) from the basic clause, redesignate paragraph (e) as paragraph (d), and revise the reference to "paragraphs (a), (b), (c), or (d) of this clause" in the redesignated paragraph (d) to read "paragraphs (a), (b), and (c) of this clause".

Alternate II (Jan 2022) . As prescribed in 12.301(b)(4)(ii), substitute the following paragraphs (d)(1) and (e)(1) for paragraphs (d)(1) and (e)(1) of the basic clause as follows:

(d)(1) The Comptroller General of the United States , an appropriate Inspector General appointed under section 3 or 8 G of the Inspector General Act of 1978 ( 5 U.S.C. App.), or an authorized representative of either of the foregoing officials shall have access to and right to—

(i) Examine any of the Contractor ’s or any subcontractors’ records that pertain to, and involve transactions relating to, this contract ; and

(ii) Interview any officer or employee regarding such transactions.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), and (c), of this clause, the Contractor is not required to flow down any FAR clause in a subcontract for commercial products or commercial services, other than—

(i) Paragraph (d) of this clause. This paragraph flows down to all subcontracts, except the authority of the Inspector General under paragraph (d)(1)(ii) does not flow down; and

(ii) Those clauses listed in this paragraph (e)(1). Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(A) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) ( 41 U.S.C. 3509).

(B) 52.203-15, Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5).

(C) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Nov 2021) (Section 1634 of Pub. L. 115- 91).

(D) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment . (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(E) 52.219-8, Utilization of Small Business Concerns (Oct 2018) ( 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 the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

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

(G) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

(H) 52.222-35, Equal Opportunity for Veterans (Jun 2020) ( 38 U.S.C. 4212).

(I) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) ( 29 U.S.C. 793).

(J) 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.

(K) 52.222-41, Service Contract Labor Standards (Aug 2018) ( 41 U.S.C. chapter 67).

(L) ___ (1) 52.222-50, Combating Trafficking in Persons (Nov 2021) ( 22 U.S.C. chapter 78 and E.O 13627).

___ (2) Alternate I (Mar 2015) of 52.222-50 ( 22 U.S.C. chapter 78 and E.O. 13627).

(M) 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).

(N) 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).

(O) 52.222-54, Employment Eligibility Verification (Nov 2021) (Executive Order 12989).

(P) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

(Q) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

(R) (1) 52.224-3, Privacy Training (Jan 2017) ( 5 U.S.C. 552a).

(2) Alternate I (Jan 2017) of 52.224-3.

(S) 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).

(T) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (Jun 2020) ( 42 U.S.C.

1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(U) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) ( 46 U.S.C. 55305 and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

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 any time before the contract expires.

(End of Clause)

52.225-1 Buy American Certificate.

As prescribed in 25.1101(a)(2), insert the following provision:

BUY AMERICAN CERTIFICATE (FEB 2021)

(a)

(1) The Offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a domestic end product.

(2) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products.

(3) The terms "domestic end product," "end product," and "foreign end product" are defined in the clause of this solicitation entitled "Buy American-Supplies."

(b) Foreign End Products:

Line Item No. Country of Origin

[List as necessary]

(c) The Government will evaluate offers in accordance with the policies and procedures of part 25 of the Federal Acquisition Regulation.

(End of provision) https://www.acquisition.gov/far/part-25#FAR_25_1101 https://www.acquisition.gov/far/part-25#FAR_Part_25 https://www.acquisition.gov/far/part-25#FAR_Part_25

H. INSTRUCTIONS TO OFFEROR FOR PROPOSAL SUBMISSION FORMAT:

FAR 52.212-1 Instructions to Offerors—Commercial Items (Nov 2021)

1. 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.

2. The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e.

email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

3. 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.

4. 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.

5. Price Quotes shall be FOB Destination including shipping and handling expense.

6. Offeror shall include a price breakout for all components for Items 1 THROUGH 4 WHICH

INCLUDED THE EXTENDED TOTAL (See pricing table to be completed) to include detailed description, catalog part/number, quantity, and unit price of each item to be eligible for award, all line items must be quoted.

7. The Vendor shall indicate if the minimum salient characteristics have been met to be considered responsive for this requirement.

8. The government is not responsible for locating or securing any information which is not identified in the proposal. To ensure information is available, offerors shall furnish as part of their quote, all descriptive material necessary for the Government to unequivocally.

9. Period of acceptance of offers: The offeror agrees to hold the prices in its offer firm until September 15, 2022.

QUESTIONS DEADLINE: Interested offerors shall submit questions electronically to nicole.craig@fda.hhs.gov no later than August 1 2022, 8:00 a.m.