36C24E26Q0046 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) 240E 06- -2026 None 00240E Veterans Health Administration Regional Procurement Office East Building 32 Suite 1A1111 1010 Delafield Road Pittsburgh PA 15215-1802 00240E Veterans Health Administration Regional Procurement Office East Building 32 Suite 1A1111 1010 Delafield Road Pittsburgh PA 15215-1802 To all Offerors/Bidders

36C24E26Q0046 06-09-2026

X X X ** HOUR & DATE for Receipt of Offers is EXTENDED to: 07-01-2026 15:00 EDT X The purpose of this amendment is to extend the due date, provide questions with answers , an updated Statement of Work, an updated Price Cost Schedul e, and the u pdated Expected Imports Table for solicitation 36C24E26Q0046.

The due date for submission of quotes is hereby changed from June 24, 2026, 3pm ETD to July 01, 2026, 3pm EDT.

Please see pp. 2 for the questions with answers, pp.

for the updated SOW, and pp. 9-12 for the Price Cost Schedule T he excel document Copy of 2026 to 2032 expected impor t projection updated 062226 for the updated table is attached

All other terms and conditions of the solicitation remain unchanged.

Please fill out this Price Cost Schedule, sign and return all amendment s with your quote submission to acknowledge receipt.

Ann Marie Stewart Contracting Officer

VA-VHA-2021-9A527CD0

Questions and Answers:

1. Is there any incumbent/recompete or this is a brand-new project? If yes, could you please provide us with their award number or even if the customer bought similar services in the past.

Answer: There is an incumbent under contract number 36C24E22C0002. The Contractor was Dimangano Management Enterprise, Llc

2. The PWS (Required Services, item B) requires the vendor to be "certified to handle" Schedule I-V controlled substances. Federal law places DEA import registration on the importer of record and exempts customs brokers and carriers acting as the registrant's agents (21 U.S.C. 957(b)(1), 822(c)(2)). Please confirm this requirement is met where the contractor performs documentary clearance and CBP, FDA, and DEA coordination as agent of the DEA-registered importer of record, without taking physical custody. If a specific contractor certification is required, please identify it.

Answer: The broker only acts as an agent for VA CSP. The VA CSP holds the importers license.

3. To price the transportation line items accurately, can the government identify the port(s) of entry customarily used for these imports, and the typical shipment profile — approximate weight and volume, and required temperature range (refrigerated 2-8°C versus frozen)?

Answer: The Excel File, “2026 to 2032 expected import projection updated 062226,” Column B has the port of entry, Column G, H and I have the dimensions, quantities and weights, and Column M was added which includes the temperature.

4. The Performance Work Statement references HTSUS 9817.00.60 for research/testing imports. Please confirm the specific HTSUS provision expected to be utilized for each product listed in the shipment schedule.

Answer: After further research HTSUS 9817.00.60 as listed in the PWS does not apply. We will use the product specific HTS Code. These are listed below and in the Excel File, “2026 to 2032 expected import projection updated 062226,”

5. CBP HQ Ruling 563139 appears to allow FDA IND clinical-trial pharmaceutical imports under HTSUS 9817.85.01 when imported solely for testing, evaluation, and research purposes. Please clarify whether the Government expects these shipments to be entered under HTSUS 9817.00.60, HTSUS 9817.85.01, another Chapter 98 provision, or product-specific HTS classifications.

Answer: After further research HTSUS 9817.00.60 as listed in the PWS does not apply. It also appears the HTSUS 9817.85.01 does not apply. We will use the product specific HTS Code. These are listed below and in the Excel File, “2026 to 2032 expected import projection updated 062226,”

6. Please identify the anticipated HTSUS classification for:

· Metformin;

· Metformin Placebo;

· Semaglutide;

· Semaglutide Placebo;

· Nabiximols;

· Nabiximols Placebo;

· Epidiolex Placebo.

Answer:

· Metformin; 3004.90.00

· Metformin Placebo; 3004.90.00

· Semaglutide; removed from table

· Semaglutide Placebo; removed from table

· Nabiximols; 3004.90.9240

· Nabiximols Placebo; 3824.99.3900

· Epidiolex Placebo. 3824.99.3900

7. Will the Government provide all supporting documentation necessary to support any Chapter 98 duty-free treatment, research exemption, FDA IND exemption, or other tariff relief provisions?

Answer: VA will provide FDA / IND Study May Proceed Letter or applicable documentation which includes the IND number.

8. Are all listed products being imported under FDA Investigational New Drug (IND) applications?

Answer: Yes

9. Will the Government provide:

· IND numbers;

· Sponsor information;

· FDA correspondence;

· Intended-use declarations;

· FDA product codes;

· Research-use documentation;

· Any documentation necessary to support HTSUS Chapter 98 treatment?

· DEA

Answer: Yes

10. The Performance Work Statement states that the vendor must be certified to handle shipments that may include Schedule I–V controlled substances. Please identify the specific certification, registration, authorization, permit, or qualification required by the Government.

Answer: The broker only acts as an agent for VA CSP. The VA CSP holds the importers license.

11. Please identify the DEA schedule, if any, associated with:

· Nabiximols;

· Nabiximols Placebo;

· Epidiolex Placebo.

Answer:

· Nabiximols; Schedule 1

· Nabiximols Placebo; N/A

· Epidiolex Placebo. N/A

12. Does the Government expect the prime contractor to hold any DEA registration, or may the requirement be satisfied through the receiving VA facility, Importer of Record, or another authorized party?

Answer: The broker acts as an agent for VA CSP. The VA CSP holds the importers license. The broker will act as the Importer of Record and Consignee (Power of Attorney) for the VA CSP CRPCC.

13. Will the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center serve as the Importer of Record for these shipments?

Answer: The broker acts as an agent for VA CSP. The VA CSP holds the importers license. The broker will act as the Importer of Record and Consignee (Power of Attorney) for the VA CSP CRPCC.

14. If the VA is not the Importer of Record, please identify the expected Importer of Record.

Answer: The broker acts as an agent for VA CSP. The VA CSP holds the importers license. The broker will act as the Importer of Record and Consignee (Power of Attorney) for the VA CSP CRPCC.

15. The solicitation indicates that the VA may provide a Power of Attorney to the vendor. Please clarify whether the intent of the POA is limited to customs brokerage and import administration functions, or whether the Government anticipates the vendor exercising any authority that would otherwise belong to the Importer of Record, FDA sponsor, DEA registrant, or research institution.

Answer: The broker acts as an agent for VA CSP. The VA CSP holds the importers license. The broker will act as the Importer of Record and Consignee (Power of Attorney) for the VA CSP CRPCC. The Power of Attorney allows the broker to work with all agencies (CBP, FDA, DEA) in place of the VA CSP CRPCC for the purpose of obtaining the medication from the exporter at the port of entry and securing medications for delivery to the VA CSP CRPCC.

16. Which products require temperature-controlled transportation?

Answer: The Excel File, “2026 to 2032 expected import projection updated 062226,” Column M was added which includes the temperature.

17. For each temperature-controlled product, please provide:

Answer: The Excel File, “2026 to 2032 expected import projection updated 062226,” Column M was added which includes the temperature. Monitoring will be included in the shipment by the exporter. Excursion limits are provided in Columns M. Acceptance of excursions beyond this will be determined by VA CSP CRPCC. All excursions will be reported to VA CSP CRPCC.

18. The Expected Imports table lists multiple shipments. For pricing purposes, should each line item be considered a separate import/customs entry, or does the Government anticipate consolidating multiple drugs from the same country of origin and shipment date into a single shipment?

Answer: The only shipment that is expected to be combined are rows 6 and 7 (Nabiximols and Nabiximols Placebo)

19. Please confirm our interpretation of the shipment information. For example:

· Lines 1 and 2 appear to indicate 15.5 pallets, each weighing 15.2 kg.

· Lines 3 and 4 appear to indicate 1 pallet weighing 50 kg.

Is this interpretation correct?

Answer: Correct for Lines 1 and 2. See updated table. Lines 3, 4 and 5 are boxes with dimensions, quantity and weight per box. Total weight for Shipment 3 and 4 combined is 8x22 = 176kg. Shipment 5 is 2x300=600kg.

20. Is any re-packaging, re-labeling, warehousing, or consolidation required under this contract, or is the requirement limited to customs clearance and direct transportation to the delivery address provided?

Answer: No re-packaging, re-labeling, warehousing, or consolidation required under this contract. There may be a need for storage fees if shipment is not released by FDA. The contract requirement is limited to customs clearance and direct transportation to the delivery address provided.

21. Pharma typically is air freighted into the country. Can we assume this will be the case?

Answer: Yes

22. Should we choose ABQ (Albuquerque International Support) as the airport of entry?

Answer: The Excel File, “2026 to 2032 expected import projection updated 062226,” Column B has the port of entry.

23. If cargo is coming in via ocean - temp controlled trucking from East Coast ports of entry to New Mexico will be tight on availability and high on cost. We can accommodate for sure, but can we suggest an ocean port of entry of Houston or even Long Beach/Los Angeles?

Answer: The Excel File, “2026 to 2032 expected import projection updated 062226,” Column B has the port of entry.

24. Is there any manner in which to determine how many shipments will require temp control; how many are controlled substances etc?

Answer: The Excel File, “2026 to 2032 expected import projection updated 062226,” Column L has the temperature requirement, and Column N has the Controlled Substance Classification.

B.2 PERFORMANCE WORK STATEMENT

Title: Customs Broker Services VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center New Mexico Veterans Affairs Health Care System (NMVAHCS)

Introduction:

This requirement is for providing Customs Brokerage and transportation services to the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center located in Albuquerque, New Mexico.

Background:

The VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center requires Customs Brokerage and transportation services for import of shipments of pharmaceutical products (drugs, devices, or other related products) destined for Albuquerque, New Mexico. These materials are used in the conduct of clinical trial studies and in some cases may require special handling such as cold chain management.

Required Services A. Vendor will act as liaison between the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC), US Customs and Border Protection (US CBP), the Food and Drug Administration (FDA), or any other required agency for the purposes of importing and clearing import/export shipments of pharmaceutical products.

B. Vendor must be certified to handle shipments that may include Schedule I-V controlled substances.

C. Vendor will maintain a continuous bond throughout each contract period. During each follow-on year if contract option is exercised, vendor will renew bond. Any changes to the bond impacting the user will be communicated to the user. The expected countries of origins based on best data at the time of the initial contract solicitation are:

1. Europe

D. Vendor will provide import and transportation services from the United States port of entry to CSPCRPCC located in Albuquerque, NM. Transportation services will include ability to provide appropriate temperature controls for freight as required by the specific freight (some products require temperature logging devices).

E. Vendor will perform US Customs and Border Protection and US Food and Drug Administration (CBP and FDA) clearance and handling services to include duties, taxes, and fees for multiple imports during each specified period of performance. It is not expected that there will be tariff requirements as these products are used under an FDA IND or fall under the following section of the Harmonized Tariff Schedule of the United States (HTSUS). If a tariff is required, vendor must contact contracting officer prior to allowing. Exclusions for tariff exemptions for research product are below:

• HTSUS 9817.00.60 – Articles imported for testing, experimental, or research purposes that are not for sale or commercial use.

F. Vendor will be responsible for insuring freight during transit.

G. Vendor will provide a centralized point of contact (either phone number, email address, or fax number) for user to transmit shipment details.

H. Prior to formalizing transportation of any cargo, vendor will contact user with cost estimate so user can ensure adequate funds are available and take action to add funds to the purchase order if necessary.

Conformance Standards:

A. Vendor will perform all services in accordance with US Government guidance related to import of supplies/materials.

Hours of Coverage:

A. Federal holidays observed by the user are:

Independence Day

Normal business hours for the New Mexico Veterans Affairs Health Care System (NMVAHS):

Monday through Friday, 7:30 am - 4:00pm, except for the stated federal holidays

B. NMVAHS is unable to receive deliveries on weekends or federal holidays.

Information Security:

A. In accordance with Appendix A, Handbook 6500.6 Checklist blocks 7, the C&A requirements do not apply to this requirement, and Security Accreditation Package is not required. The nature of this requirement is technical; however, there is no information to be protected.

Other Pertinent Information or Special Considerations:

A. Delivery of shipments shall be:

VA Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center 2401 Centre Ave SE Albuquerque, NM 87106

B. Subject Matter Experts (SME) located at the Clinical Research Pharmacy Coordinating Center will coordinate shipments with vendor.

C. Expected Imports:

See attached document: Copy of 2026 to 2032 expected import projection updated 062226.

D. Prior to receipt, user will provide vendor with details to include type of material and any special handling requirements such as temperature monitoring

Period of Performance:

The period of performance shall be for one base year PLUS up to four (4) option years.

Special Considerations:

These types of services typically require the NMVAHS to provide a Power-of-Attorney (POA) for the vendor to act on behalf of the agency. The POA will require coordination between VA legal and vendor to ensure both parties agree to terms and conditions contained in the POA.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Customs Bond Contract Period: Base POP Begin: 07-15-2026 POP End: 07-14-2027 PRINCIPAL NAICS CODE: 488510 - Freight Transportation Arrangement PRODUCT/SERVICE CODE: V119 - Transportation/Travel/Relocation - Transportation: Other

Import Fees

POP Begin: 07-15-2026 POP End: 07-14-2027

Transportation of Imported Materials

POP Begin: 07-15-2026 POP End: 07-14-2027

Tariff Fees (if needed)

POP Begin: 07-15-2026 POP End: 07-14-2027

Customs Bond Contract Period: Option 1 POP Begin: 07-15-2027 POP End: 07-14-2028

Import Fees

POP Begin: 07-15-2027 POP End: 07-14-2028

Transportation of Imported Materials

POP Begin: 07-15-2027 POP End: 07-14-2028

Tariff Fees (if needed)

POP Begin: 07-15-2027 POP End: 07-14-2028

Customs Bond Contract Period: Option 2 POP Begin: 07-15-2028 POP End: 07-14-2029

Import Fees

POP Begin: 07-15-2028 POP End: 07-14-2029

Transportation of Imported Materials

POP Begin: 07-15-2028 POP End: 07-14-2029

Tariff Fees (if needed)

POP Begin: 07-15-2028 POP End: 07-14-2029

Customs Bond Contract Period: Option 3 POP Begin: 07-15-2029 POP End: 07-14-2030

Import Fees

POP Begin: 07-15-2029 POP End: 07-14-2030

Transportation of Imported Materials

POP Begin: 07-15-2029 POP End: 07-14-2030

Tariff Fees (if needed)

POP Begin: 07-15-2029 POP End: 07-14-2030

Customs Bond Contract Period: Option 4 POP Begin: 07-15-2030 POP End: 07-14-2031

Import Fees

POP Begin: 07-15-2030 POP End: 07-14-2031

Transportation of Imported Materials

POP Begin: 07-15-2030 POP End: 07-14-2031

Tariff Fees (if needed)

POP Begin: 07-15-2030 POP End: 07-14-2031

Solicitation Description: Customs brokerage and transport services in support of the Department of Veterans Affairs, Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC), located in Albuquerque, New Mexico.