S02 36C26224Q0007 Solicitation.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C26224Q0007 08-25-2023

David Odne 562-766-2328 09-01-2023

15:00 PDT

36C262

Department of Veterans Affairs

Network Contracting Office 22

4811 Airport Plaza Drive

Suite 600

Long Beach CA 90815

X 100

X

541611

$24.5 Million

N/A

X

36C262

Department of Veterans Affairs

Cooperative Studies Program

Clinical Research Pharmacy Coordinating

2401 Centre Avenue SE

Albuquerque NM 87106

Department of Veterans Affairs

Network Contracting Office 22

4811 Airport Plaza Drive

This is accomplished through the

Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp

This is mandatory and the sole method for submitting invoices.

Contractor to perform Good Practice GXP Auditing Services for the Cooperative Studies Program at the New Mexico VA

Healthcare System located at 2401 Centre Avenue, SE

Albuquerque, NM 87106.

X X

X 1

Arcelia Medina

Contracting Officer

36C26224Q0007

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.3 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.4 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.5 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.6 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JUN 2023)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 STATEMENT OF WORK

D.2 WAGE DETERMINATION

D.3 ATTACHMENT LIST

SECTION E - SOLICITATION PROVISIONS

E.1 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.3 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED

BY REFERENCE (JAN 2008)

E.4 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C262 Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment

Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 JB __________________ __________________

GXP Audit : prep, audit, report

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 541611 - Administrative Management and General Management Consulting Services PRODUCT/SERVICE CODE: R704 – Support Management: Auditing

GXP Audit: prep, audit, report

Contract Period: Option 1 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 541611 - Administrative Management

PRODUCT/SERVICE CODE: Support Management: Auditing

Contract Period: Option 2 POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 541611 - Administrative Management

Contract Period: Option 3 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 541611 - Administrative Management

Contract Period: Option 4 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 541611 - Administrative Management

GRAND TOTAL __________________

B.3 DELIVERY SCHEDULE

ITEM NUMBER DELIVERY DATE

0001 - 4001 SHIP TO: Department of Veterans Affairs Cooperative Studies Program:

Clinical Research 2401 Centre Ave SE

MN 87106

USA

10-01-2023 TO

09-30-2028

MARK

FOR:

Christina Jobson

(405) 456-3103 christina.jobson@va.gov

SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have 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 following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

FAR

Number

Title Date

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

DEC 2022

52.217-8 OPTION TO EXTEND SERVICES NOV 1999

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

MAR 2023

C.2 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR

2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 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 one (1) year.

C.3 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of

Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

C.4 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT

REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a

Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National

Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting

Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office.

Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

C.5 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT

2020)

The Contracting Officer reserves the right to designate an Administrative Contracting Officer

(ACO) for the purpose of performing certain tasks/duties in the administration of the contract.

Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Addendum to 52.212-4)

C.6 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (JUN 2023)

(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) 52.232–40, Providing Accelerated Payments to Small Business Subcontractors (MAR

2023) (31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(7) 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:

[] (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. 4655).

[] (2) 52.203–13, Contractor Code of Business Ethics and Conduct (NOV 2021) (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.)

[] (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) 52.204–27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L. 117–328).

[] (9) 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).

[] (10) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters

(OCT 2018) (41 U.S.C. 2313).

[] (11) [Reserved]

[] (12) 52.219–3, Notice of HUBZone Set-Aside or Sole-Source Award (OCT 2022) (15

U.S.C. 657a).

[] (13) 52.219–4, Notice of Price Evaluation Preference for HUBZone Small Business

Concerns (OCT 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[] (14) [Reserved]

[X] (15)(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.

[] (16)(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.

[] (17) 52.219-8, Utilization of Small Business Concerns (OCT 2022) (15 U.S.C. 637(d)(2) and (3)).

[] (18)(i) 52.219–9, Small Business Subcontracting Plan (OCT 2022) (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.

[] (19)(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.

[] (20) 52.219–14, Limitations on Subcontracting (OCT 2022) (15 U.S.C. 657s).

[] (21) 52.219-16, Liquidated Damages—Subcontracting Plan (SEP 2021) (15 U.S.C.

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

[] (22) 52.219–27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside

(OCT 2022) (15 U.S.C. 657f).

[X] (23) (i) 52.219–28, Post-Award Small Business Program Rerepresentation (MAR 2023)

(15 U.S.C. 632(a)(2)).

[] (ii) Alternate I (MAR 2020) of 52.219–28.

[] (24) 52.219–29, Notice of Set-Aside for, or Sole-Source Award to, Economically

Disadvantaged Women-Owned Small Business Concerns (OCT 2022) (15 U.S.C. 637(m)).

[] (25) 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 (OCT 2022) (15

U.S.C. 637(m)).

[] (26) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15

U.S.C. 644(r)).

[] (27) l(26) 52.219–33, Nonmanufacturer Rule (SEP 2021) (15 U.S.C. 657s).

[X] (28) 52.222-3, Convict Labor (JUN 2003) (E.O. 11755).

[X] (29) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (DEC 2022)

(E.O. 13126).

[X] (30) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[X] (31)(i) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

[] (ii) Alternate I (FEB 1999) of 52.222-26.

[] (32)(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] (33)(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.

[] (34) 52.222–37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

[] (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act

(DEC 2010) (E.O. 13496).

[X] (36)(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).

[] (37) 52.222-54, Employment Eligibility Verification (MAY 2022). (E. O. 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.)

[] (38)(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.)

[] (39) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential

Hydrofluorocarbons (JUN 2016) (E.O. 13693).

[] (40) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and

Air Conditioners (JUN 2016) (E.O. 13693).

[] (41)(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.

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

[] (ii) Alternate I (JUN 2014) of 52.223-14.

[] (43) 52.223-15, Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C.

8259b).

[] (44)(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] (45) 52.223–18, Encouraging Contractor Policies to Ban Text Messaging While Driving

(JUN 2020) (E.O. 13513).

[] (46) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

[] (47) 52.223-21, Foams (JUN 2016) (E.O. 13693).

[] (48)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

[] (ii) Alternate I (JAN 2017) of 52.224-3.

[] (49)(i) 52.225-1, Buy American—Supplies (OCT 2022) (41 U.S.C. chapter 83).

[] (ii) Alternate I (OCT 2022) of 52.225–1.

[] (50)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (DEC 2022)

(19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19

U.S.C. chapter 29 (sections 4501-4732), Public Law 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 [Reserved].

[] (iii) Alternate II (DEC 2022) of 52.225-3.

[] (iv) Alternate III (JAN 2021) of 52.225-3.

[] (v) Alternate IV (OCT 2022) of 52.225-3.

[] (51) 52.225–5, Trade Agreements (DEC 2022) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

[X] (52) 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).

[] (53) 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. Subtitle A, Part V, Subpart G Note).

[] (54) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (NOV 2007) (42 U.S.C.

5150).

[] (55) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (NOV

2007) (42 U.S.C. 5150).

[X] (56) 52.229–12, Tax on Certain Foreign Procurements (FEB 2021).

[] (57) 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. 3805).

[] (58) 52.232-30, Installment Payments for Commercial Products and Commercial Services

(NOV 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

[X] (59) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management

(OCT 2018) (31 U.S.C. 3332).

[] (60) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award

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

[] (61) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).

[] (62) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).

[] (63) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C.

637(d)(13)).

[] (64)(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:

[X] (1) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

[X] (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).

Employee Class Monetary Wage-Fringe Benefits 01420 - SURVEY WORKER (Interviewer) 01420 - SURVEY WORKER (Interviewer)

SUPERVISOR

GS-5, Step 2/$18.85 GS-5, Step 3/$19.45

[] (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) (29 U.S.C 206 and 41 U.S.C. chapter 67).

[] (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to

Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (MAY

2014) (41 U.S.C. chapter 67).

[] (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to

Contracts for Certain Services—Requirements (MAY 2014) (41 U.S.C. chapter 67).

[X] (7) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026

(JAN 2022).

[X] (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) 52.204–27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of

Division R of Pub. L. 117–328).

(vi) 52.219–8, Utilization of Small Business Concerns (OCT 2022) (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.

(vii) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

(viii) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

(ix) 52.222–35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

(x) 52.222–36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

(xi) 52.222–37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

(xii) 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.

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

(xiv)(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).

(xv) 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).

(xvi) 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).

(xvii) 52.222-54, Employment Eligibility Verification (MAY 2022) (E. O. 12989).

(xviii) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026

(JAN 2022).

(xix) 52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2022) (E.O. 13706).

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

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

(xxi) 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. Subtitle A, Part V, Subpart G Note).

(xxii) 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.

(xxiii) 52.232–40, Providing Accelerated Payments to Small Business Subcontractors (MAR

2023) (31 U.S.C. 3903 and 10 U.S.C. 3801). Flow down required in accordance with paragraph

(c) of 52.232–40.

(xxiv) 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.

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR

ATTACHMENTS

D.1 STATEMENT OF WORK

1. Contract Title:

1.1. Auditing to current Good Practice (GXP) standards

2. Background:

2.1. Quality audits in the pharmaceutical industry are essential to ensure compliance with regulatory requirements and give confidence to customers that products are of the best quality and efficacy. Audits by an external vendor are a means for assessing compliance with the established objectives defined in the quality system and thus paving the way for the continuous improvement program by providing feedback to management. These audits: determine outliers and focus first in this area, protect against customer complaints, reveal variation, and identify and correct problem areas.

2.2. The Cooperative Studies Program (CSP) utilizes audits by external parties to ensure it is in regulatory compliance in the conduct of Clinical Trials for the department of

Veterans Affairs. Good Practice (GXP) auditing is an essential tool used in Clinical

Trials that ultimately supports the results published. The last GXP surveillance was a gap analysis conducted in 2019 at one of the five CSP Coordinating Centers (CSPCC) and the CSP Clinical Research Pharmacy Coordinating Center (CSPCRPCC). It is essential that external reviews of GXP processes are periodically conducted to validate the ongoing work of CSP Clinical Trials in keeping updated with changes to the industry standards.

3. General Requirements:

3.1. Each year the vendor shall perform an audit with a focus as detailed below. The audit plan will be based on current ICH guidelines and FDA guidance.

3.2. The vendor will coordinate the audit agenda with CSPCRPCC focal point at least four weeks prior to the visit.

3.3. The Scope of the audits will focus on the annual topics and include the following:

3.3.1. Reviewing the specific Procedures covering the processes

3.3.2. Documentation Practices

3.3.3. Training records

3.4. Year 1: cGMP processes

3.4.1. Manufacturing

3.4.2. Packaging

3.4.3. Quality Control (QC)

3.4.4. Quality Assurance (Bioanalytics)

3.4.5. Corrective and Preventive Actions (CAPA)

3.4.6. Environmental Management

3.5. Year 2: Good Distribution Process (GDP)

3.5.1. Shipping

3.5.2. Receiving

3.5.3. Calibration

3.5.4. Biorepository

3.5.5. Vendor qualification

3.6. Year 3: Computer System Validation (CSV)

3.6.1. Electronic Records

3.6.2. Electronic signatures

3.6.3. GXP-related Systems

3.6.4. Change Control

3.6.5. Quality Management System (QMS)

3.6.6. Management Review

3.7. Year 4: Good Clinical Practice

3.7.1. Monitoring

3.7.2. Auditing

3.7.3. Study Design and Management

3.8. Year 5: Good Pharmacovigilance Practices

3.8.1. Regulatory Correspondence

3.8.2. Study participant safety Reporting Serious Adverse Events (SAE) and

Unexpected Adverse Events (UADE)

4. GXP Audit Reports

4.1. The audit objective and subjective findings should address:

4.1.1. Data Integrity

4.1.1.1. Documentation Practices

4.1.1.2. Compliance to regulations

4.1.1.3. Adherence to procedures

4.1.2. Quality Assurance and Control

4.1.3. Data, Data Analysis and Reports

4.1.4. Computerized Systems: w/ Validation, 21 CFR Compliance, Software

Development, Change Control Security, Back Ups and Recovery Plan.

4.1.5. Human Subject Protection

4.1.6. Training

4.1.6.1. Onboarding

4.1.6.2. Qualifications of the Staff

4.1.7. Opportunities for Improvement

4.1.8. Culture

4.1.9. Standardization

4.2. GXP Audit Reports shall be completed within thirty (30) working days after audit.

5. Statement of Work:

5.1. Vendor will perform annual Good Practice (GXP) audits of the Cooperative Studies Program’s Clinical Research Pharmacy Coordinating Center (CSPCRPCC). Audit Reports will be both Objective and Subjective and the Subjective observations will include opportunities for improvement.

5.2. This contract is for one audit per contract year and includes the ability to perform additional GXP process audits during the contract period upon receipt of a formal task order issued by the Contracting Officer (CO) to the Contractor.

6. Government-Furnished Equipment / Government-Furnished Information:

6.1. No government equipment will be used by the awarded Contractors.

7. Other Pertinent Information

7.1. Regulatory expertise as defined in 21 CFR Parts 11, 50, 54, 56 and ICH Guideline

Good Clinical Practice (E6) is required. The contractor should produce professional certification supporting expertise to conduct GCP gap Analysis in response Request for

Proposals (RFPs).

7.2. The CSPCRPCC (Pharmacy) is currently certified as a Drug Establishment by the US

Food and Drug Administration (FDA) and in compliance with ISO 9001:2015, ISO

20387, and ISO 21500.

7.3. Identification of Possible Follow-on Work.

7.4. If additional audit requirements are identified during a contract period, the contracting officer will award a separate Task Order against the contract.

7.5. This contract capability will be performed upon receipt of a formal task orders issued by the Contracting Officer (CO) to the Contractor.

7.6. Identification of Non-Disclosure Requirements.

7.7. There is no sensitive information which will be disclosed to the contractor other than limited employee names and VA email addresses.

8. Place of Performance:

Department of Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 2401 Centre Ave SE Albuquerque, NM 87106

9. Government Holidays observed include:

New Year’s Day: January 1

Martin Luther King ‘s Birthday: Third Monday in January

President’s Day: Third Monday in February

Memorial Day: Last Monday in May

Juneteenth Independence Day: June 19

Independence Day: July 4

Labor Day: First Monday in September

Columbus Day: Second Monday in October

Veterans Day: November 11

Thanksgiving Day: Fourth Thursday in November

Christmas Day: December 25

D.2 WAGE DETERMINATION

SCA Wage Determination #: 2015-5443, Revision 20, Date: July 21, 2023. Reference: SAM.gov Wage Determinations

D.3 ATTACHMENT LIST

See attached document: VA Form 10091, VA - FSC VENDOR FILE REQUEST FORM.

https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fsam.gov%2Fcontent%2Fwage-determinations&data=05%7C01%7C%7C5a59bc9b4aff4a5cbb0408daae234faf%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C638013763920345797%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=NSy6Cl2t%2BT6RMrvLIuMGAx2hpZ06nhcX7tB5E%2BLDhfo%3D&reserved=0

SECTION E - SOLICITATION PROVISIONS

E.1 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

Provisions that are incorporated by reference (by Citation Number, Title, and Date), have 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 following provisions are incorporated into 52.212-1 as an addendum to this solicitation:

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS

Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 90 days from the date specified for receipt of offers.

Offerors are notified that VA Form 10091, FMS Vendor File Request Form and W-9 (See attached documents). Request for Taxpayer Identification Number and Certification shall be securely faxed to the VA Financial Service Center at (512) 460-5221, and also be submitted with their quote. Failure to include this information may eliminate the offeror from award consideration or considerably delay the award.

System for Award Management: IAW FAR 52.212-4 (t) Contractors submitting offers are required to be registered in the SAM database to be considered for award of a contract.

Amendments to this Solicitation: Contractors are encouraged to monitor the Contract Opportunities website with respect to this solicitation, all amendments to this Solicitation will be posted on the website.

Submittal Instructions: The offerors package must be labeled with the Contractor’s name and business address of firm, the solicitation number, and point of contact to include name, telephone, and email address. The Government is not responsible for identifying inconsistencies between the two and may rely on either version at its discretion.

The Contractor is advised that all submissions and related materials become the property of the U.S. Government and will not be returned. A Contractor’s offer, if accepted by the Government, will form binding parts of the contract that results from this solicitation. Therefore, care must be taken to properly address the requirements set forth in this RFQ.

Offerors should review this entire solicitation before submitting an offer to ensure that their offers meet all requirements.

Each Offeror shall submit only one offer which addresses all Government requirements outlined in this solicitation. Offerors shall submit their offers with a cover letter, by date and time noted on the first page of the SF1449 in block 8. The contractor shall submit their offer electronically to david.odne@va.gov.

• No Zip Files will be accepted https://sam.gov/content/home https://sam.gov/content/opportunities https://sam.gov/content/opportunities mailto:david.odne@va.gov

• Facsimile offers will not be accepted

Vendor Point of Contract: Submit the name of the individual who can answer questions about the offeror to include First and Last names, telephone number, and email address.

Content Organization:

Each offer submitted shall include the following documentation in-order to be considered for award deviating from this requirement may exclude your offer from award:

File #1: General Information and Price/Cost Schedule:

The offeror shall submit their pricing within the schedule, Section B, of the SF 1449. The offeror shall properly complete the solicitation document (SF 1449) along with any amendments (SF 30), if any are issued. Complete Blocks 12, 17a 30a, 30b, and 30c of the Standard Form 1449.

File #2: Special Standards of Responsibility:

Contractor shall submit valid proof of having all the technical capabilities of meeting the contract standards in a summary format.

Past Performance: The Government reserves the right to use data obtained from other sources as well as information provided in the offerors submission, including information contained in the Contractor Performance Assessment Reporting System (CPARS) and Federal Awardee Performance and Integrity Information System (FAPIIS). The past performance evaluation will assess the relative risks associated with an offeror’s likelihood of success in fulfilling the solicitation’s requirements as indicated by the Offeror’s record of past performance. The past performance evaluation may be based on the Contracting Officer’s knowledge of and previous experience with the service being acquired.

Questions: All questions must be in writing & emailed to david.odne@va.gov. All questions must be received no later than 3:00 PM Pacific Standard Time, 2 business days prior to the closing of this solicitation. The Government reserves the right to not answer questions not meeting this timeline if doing so would result in an amendment requiring an extension of the solicitation and to extend would not be in the best interest of the Government. All responses to questions will be incorporated into a written amendment posted on Contract Opportunities.

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY

REFERENCE (FEB 1998)

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

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Provision)

FAR

Number

Title Date https://cpars.cpars.gov/cpars/app/home_input.action https://cpars.cpars.gov/cpars/app/home_input.action https://cpars.cpars.gov/cpars/app/home_input.action mailto:david.odne@va.gov https://sam.gov/content/opportunities

52.204-7 SYSTEM FOR AWARD MANAGEMENT OCT 2018

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE

REPORTING

AUG 2020

52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

MAR 2023

E.3 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES

INCORPORATED BY REFERENCE (JAN 2008)

The following provisions or clauses incorporated by reference in this solicitation must be completed by the offeror or prospective contractor and submitted with the quotation or offer.

Copies of these provisions or clauses are available on the Internet at the Web sites provided in the provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference, or the clause at FAR 52.252-2, Clauses Incorporated by Reference. Copies may also be obtained from the contracting officer.

[Contracting officer shall list all FAR and 48 CFR Chapter 8 (VAAR) provisions and clauses incorporated by reference that must be completed by the offeror or prospective contractor and submitted with the quotation or offer.]

(End of Provision)

(End of Addendum to 52.212-1)

E.4 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

See Addendum to FAR 52.212-2 Basis for Award

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the

Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of Provision)

ADDENDUM TO 52.212-2 EVALUATION-COMMERCIAL ITEMS (NOV 2021)

Basis For Award

This procurement is being conducted pursuant to FAR Part 13 procedures. The Government intends to award a contract resulting from this solicitation to the responsible offeror whose offer, conforming to the solicitation, offers the lowest price, whose offered price does not exceed the amount of funding available for the procurement, and whose offered price is found to be reasonable. Price alone is the sole evaluation factor. In addition to the general standards of responsibility found at FAR 9.104-1, in accordance with FAR 9.104-2, the special standards of responsibility described below apply to this procurement. Offerors who fail to meet any special standard of responsibility will not be eligible to receive contract award.

Special Standards of Responsibility -The following special standards of responsibility apply to this procurement:

Contractor shall submit valid proof of having all the technical capabilities of meeting the contract standards in a summary format.

Past Performance – Satisfactory performance information available on data independently obtained from Government and commercial sources to include Past Performance Information Retrieval System (PPIRS) and Federal Awardee Performance and Integrity Information (FAPIIS). Offeror will receive a neutral rating if no past performance information is found.

Cost/Price - The Government will evaluate offers for award purposes on the total cost to determine that cost is fair and reasonableness.

Evaluation Process - Offers will be evaluated in the following manner. The lowest-priced offer will be identified. The lowest-priced offer will be evaluated to determine if the offered price exceeds the amount of funding available for the procurement. If the offered price does not exceed the amount of funding available for the procurement, the offered price will be evaluated to determine if it is reasonable. If the offered price is found to be reasonable, the offeror who submitted this offer will be identified as the “successful offeror.” The contracting officer will then determine if the successful offeror is responsible using the general standards of responsibility and the special standards of responsibility applicable to this procurement. If contract award cannot be made to the successful offeror, the contracting officer will evaluate the next lowest-priced offer following the procedures described above. This process will continue until a contract award can be made, or the contracting officer determines that no contract award can be made.

The contracting officer may find all offers not acceptable and cancel the solicitation if the lowest-priced offer exceeds the amount of funding available for the procurement. The contracting officer may likewise find an offer under evaluation, as well as all remaining offers not acceptable and cancel the solicitation if the offer currently under evaluation exceeds the amount of funding available for the procurement.

In addition to submitting their pricing, offerors must also establish their qualifications and demonstrate their ability to perform all services pertaining to this solicitation.

The Government anticipates adequate price competition and intends to award without discussions with respective offerors. However, the Government reserves the right to conduct discussions if deemed in its best interest.

A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of Addendum 52.212-2)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management

(SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

(a) Definitions. As used in this provision—

Covered telecommunications equipment or services has the meaning provided in the clause

52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance

Services or Equipment.

Economically disadvantaged women-owned small business (EDWOSB) concern means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are…