36E79726R0016 0002.docx

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO:

Specify authority)

THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 04-22-2026 Department of Veterans Affairs OPAL / National Acquisition Center Building 37 1st Avenue, One Block North of Cermak Hines IL 60141 Department of Veterans Affairs OPAL / National Acquisition Center Building 37 1st Avenue, One Block North of Cermak Hines IL 60141 To all Offerors/Bidders

36E79726R0016

X X X x This amendment is issued to incorporate recently updated language in the solicitation Scope of Contract and in the Addendum to FAR 52.212-1 Instructions to Offerors. Offerors shall review and complete pages 2-6 of this amendment with the updated language to the solicitation, and returned signed copy by the solicitation due date/time (4/22/2026, 2:30PM CT).

All other solicitation terms and conditions remain unchanged.

SCOPE OF CONTRACT

13. MANUFACTURING FACILITIES/PLACE OF PERFORMANCE

13.1 The FDA is the Government agency responsible for providing and enforcing pharmaceutical cGMP standards for human drugs, pharmaceutical products, biologics, medical devices, chemical products, medical cylinder oxygen, reagents, diagnostics, test kits and sets included in this solicitation. Only offers from companies that have an acceptable cGMP status on record with the FDA for the facilities identified by the offeror in Section 13.7 below will be considered for award. Before a contract can be awarded, any successful offeror’s manufacturing, packaging, and any other applicable facilities shall have a current acceptable cGMP status with the FDA, or shall have had an acceptable report from the last FDA facility inspection on record for the product type offered. In the absence of a current cGMP evaluation for any of the identified facilities, an offeror is required to include with its proposal documentation on the acceptable outcome of an FDA facility inspection that occurred within two years prior to submission of the offer.

13.2 If at any time during the life of the contract, the contractor’s facility (or the source from which the contractor obtains any of the products offered on this contract), or the facility that packages the product offered in this contract is notified of violations or potential violations by the FDA, is issued a Form FDA 483, or is issued an FDA Warning Letter highlighting a failure to meet FDA cGMPs (21 CFR Part 210 and 211), the awarded contractor shall inform the Contracting Officer within 15 calendar days of the notice. At which time, the Contracting Officer will apply the procedures outlined in Section 13.3 below. Non-timely notification may result in a negative past performance rating and/or be grounds for contract termination in accordance with FAR 52.212-4(m), Contract Terms and Conditions-Commercial Products and Commercial Services, Termination for Cause.

13.3 The Contracting Officer will review the contractor’s (or its source’s) unacceptable cGMP status with appropriate VHA clinical staff and will either: 1) instruct the contractor to stop the shipment of products listed on this contract that were manufactured and/or packaged in a facility with unacceptable cGMP status, or 2) authorize the contractor to continue to supply such contract products for 90 calendar days from the date when unacceptable cGMP status was communicated to VA NAC, provided that the products have not been subjected to a consumer-level recall. An additional 90 calendar day extension may be authorized at the discretion of the Contracting Officer. Contractors are cautioned that products that were manufactured and /or packaged in a facility with unacceptable cGMP status and then shipped without written authorization from the Contracting Officer shall be returned to the contractor at the contractor’s risk and expense. The contractor shall have corrected all significant cGMP deficiencies or have an acceptable plan with the FDA for the correction of such deficiencies which led to unacceptable status by the end of the 90-calendar day authorization period and any extensions of such period granted by the Contracting Officer. Additionally, the contractor is responsible for keeping the Contracting Officer informed of all corrections made and shall provide the Contracting Officer with: 1) written documentation of the correction plan, 2) Notification from FDA of acceptance of plan, and 3) a copy of any reinspection requests and subsequent reinspection reports, upon availability. If FDA’s evaluation of contractor’s (or its source’s) compliance efforts and/or re-inspection of the non-compliant facility does not result in an acceptable rating by the FDA within 90 calendar days from the date when unacceptable cGMP status was communicated to VA NAC, or by the end of a Contracting Officer’s authorization period (whichever is the greater period of time), the contract may be terminated for cause in accordance with FAR 52.212-4(m). The contractor’s (or its source’s) failure to correct the cGMP deficiencies in a timely manner shall not constitute or give rise to any “excusable delays” pursuant to FAR 52.212-4(f). (Nothing in this section shall be read as limiting the recognized grounds upon which a Contracting Officer may terminate this contract or delete products pursuant to the applicable sections contained in the contract.)

13.4 The contractor shall use only the FDA-inspected manufacturing facilities provided in Section 13.7, below, for the duration of the contract, unless substitution of manufacturing facilities is approved by the Contracting Officer. In case of any manufacturing facility relocation or substitution of manufacturing facilities, the contractor shall immediately notify the Contracting Officer of the pending change, and the contractor shall request approval from the Contracting Officer to supply the contracted products from the new location. If the change is approved by the Contracting Officer, after an inquiry to the FDA for cGMP status of the new location, approval will be provided by means of a formal contract modification.

13.5 If the products are to be manufactured at more than one location, each manufacturing facility and each facility address shall be listed along with the products manufactured at the facility. Subcontractors (i.e., packagers, labelers, etc.) that participate in the production of the products offered on this solicitation shall also be listed along with their addresses. All facilities described in this section and listed below shall be substantially in compliance with applicable FDA cGMP standards prior to contract award.

13.6 Offeror shall identify below or by attachment (if additional space is needed), the products offered on this solicitation (products shall be identified by product name and by solicitation item number); whether the offeror manufactures the products; and/or whether the offeror is a distributor of the products offered. Refer to the solicitation’s Continuation of Standard Form 1499: Schedule of Supplies/Services for the definition of “Manufacturer” for purposes of the Letter of Commitment and current Good Manufacturing Practices (cGMP) acceptability verifications.

13.7 The offeror is required to indicate below the complete name and address(es) of the manufacturer. The offeror is also required to check the box below that is applicable to its offer. Please note that the information required below must be the name and address of the manufacturing facility, rather than the address of the foreign headquarters, distributor or agent.

( ) OFFEROR IS THE MANUFACTURER (AT THE FOLLOWING LOCATIONS) OF THE PRODUCTS OFFERED ON THIS SOLICITATION.

( ) OFFEROR IS A DISTRIBUTOR OF THE PRODUCTS OFFERED ON THIS SOLICITATION.

The offeror must maintain the same manufacturer (NDA/ANDA/BLA) for the duration of the contract period, unless the Contracting Officer makes a determination that a change in the manufacturer is acceptable. This determination may take place before or after contract award.

THE PRODUCTS WILL BE MANUFACTURED BY THE FOLLOWING COMPANY AT THE FOLLOWING LOCATIONS:

(Name of Manufacturing Company)

(Street Address) (Post Office Address Not Acceptable)

(U.S.A. Point of Contact, e-Mail Address and U.S.A Telephone Number)

(FDA Establishment Identification [FEI] number of Manufacturing Company)

PHARMACEUTICALS – PARENTERALS

PHARMACEUTICALS – PARENTERALS, STERILIZATION

ACTIVE PHARMACEUTICAL INGREDIENT

(Also known as drug substance or bulk substance)

TABLETS, CAPSULES, AND PILLS

OTHER PHARMACEUTICAL PRODUCTS

(Solutions, syrups, mixtures, powders, ointments, pastes, creams, etc.)

PACKAGING

(If product is repackaged, include both packaging and repackaging locations)

PACKING

E.2 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS --COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Instructions for Proposal Submission

7) Country of Origin and VA’s interpretation of substantial transformation of pharmaceuticals.

Offerors shall complete as applicable the certification at FAR 52.225-6. An article is a product of a country or instrumentality only if (i) it is wholly the growth, product, or manufacture of that country or instrumentality, or (ii) in the case of an article which consists in whole or in part of materials from another country or instrumentality, it has been substantially transformed into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was so transformed. See 19 U.S.C. § 2518(4)(B).

For purposes of determining compliance with the Trade Agreements Act (TAA) (19 U.S.C. § 2512), the Government will evaluate the country of origin of offered pharmaceutical products to determine if the proposed products are U.S.-made or designated country end products (designated country is defined in FAR Part 25). Products in which final manufacturing occurs in the United States will be considered U.S.-made end products, regardless of the location of the active pharmaceutical ingredient (API). Nonetheless, offerors of U.S.-made product shall disclose the API creation information requested in the solicitation’s Scope of Contract.

For products manufactured outside the United States, the Government will evaluate the manufacturing processes performed and the location of these processes to determine whether the product was substantially transformed in a designated country on a case-by-case basis. When final manufacturing of single-API pharmaceuticals occurs outside the United States, the Government generally considers the country of origin to be determined by the location of API creation. Activities such as simple blending or mixing of inactive ingredients with the API, or compressing the mixture into a tablet or similar finished dosage form, will generally not be considered to constitute substantial transformation. For pharmaceuticals with multiple APIs, the Government typically interprets the country of origin as the location where final manufacturing occurs, as multiple APIs are combined, thus undergoing substantial transformation and resulting in a new product. However, because pharmaceutical manufacturing processes may vary, the Government reserves the right to evaluate the specific manufacturing process on a case-by-case basis to determine whether a substantial transformation has occurred. Note that at no time is product repackaging considered relevant to a pharmaceutical’s country of origin.

Offerors shall provide sufficient supporting documentation with their proposal to substantiate the certified country of origin and the location of manufacturing processes relevant to the Government’s evaluation. Such documentation may include, but is not limited to, descriptions of the manufacturing processes, identification of manufacturing locations, and supporting statements from the manufacturer. In making its determination, the Government may consider relevant guidance and rulings issued by U.S. Customs and Border Protection regarding substantial transformation; however, the Government will not rely solely on such rulings. The Contracting Officer reserves the right to request additional information as necessary and will make the final determination regarding country of origin. Please reach out to the Contracting Officer specified in this solicitation for any questions concerning applicable or relevant information. Failure to provide adequate supporting documentation by the due date and time for offers or other deadlines specified by the Contracting Officer may result in the offerors’ products being determined to be end products of non-designated countries.

Solicitation language update