Justification (JA) Final REDACTED.pdf

CUI//SP-PROCURE//FEDCON

Control Number: 25-MRCO-W-331

CUI//SP-PROCURE//FEDCON

JUNE 2025

JUSTIFICATION REVIEW DOCUMENT

FAR Part 13 Justification and Approval

Simplified Procedures for Certain Commercial Items

Program/Equipment: Radiopharmaceuticals for Brooke Army Medical Center (BAMC) Department of Radiology, Nuclear Medicine Service located at Joint Base San Antonio (JBSA) Fort Sam Houston, Texas (TX).

Authority: Title 41 United States Code (U.S.C.) §1901(e)(2) as implemented in Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii), sole source (including brand name), under the authority of the simplified procedures for certain commercial items

Amount: The estimated maximum amount for this purchase order is $590K, (including all option periods).

Prepared by: Derrick J. Johnson

Contract Specialist E-mail: derrick.j.johnson2.civ@health.mil Date: 30 JUL 2025

Contracting Officer: Marc A. Flores

Contracting Officer E-mail: marc.a.flores3.civ@health.mil Date: 30 JUL 2025

Technical: Melissa S. Perry Contracting Officer Representative E-mail: melissa.s.perry7.civ@health.mil Date: 30 JUL 2025 mailto:derrick.j.johnson2.civ@health.mil mailto:marc.a.flores3.civ@health.mil mailto:melissa.s.perry7.civ@health.mil

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FAR Part 13 Justification and Approval

Simplified Procedures for Certain Commercial Items

1. Requiring Activity: BAMC Department of Radiology, Nuclear Medicine Service located at JBSA-Fort Sam Houston, TX.

2. Contracting Activity: Medical Readiness Contracting Office, West (MRCO-W), 3551 Roger Brooke Drive, JBSA-Fort Sam Houston, TX.

3. Description of Action: Request approval to award a $590K noncompetitive five-year (base and four one-year options) Firm-Fixed-Priced (FFP) purchase order to, Sun Pharmaceutical Industries Inc, CAGE: 0PUV4, 2 Independence Way, Princeton, New Jersey, 08540-6620, contingent upon the availability of FY26 Defense Health Program funds.

4. Description of Supplies/Services: The Department of Nuclear Medicine Service at BAMC requires Radiopharmaceutical products that are essential for imaging in the nuclear medicine department. The following are description of items, quantities, and estimated prices:

Item Quantity Delivery Date Estimated Unit

Price Estimated Value

Sulfur Colloid (5vials pack)

30 30 Sep 2026 $2,483.25 $74,497.50

Pyrophosphate (5vials pack)

5 30 Sep 2026 $337.10 $1,685.50

Mebrofenin (5vial pack)

15 30 Sep 2026 $325.00 $4,875.00

Mebrofenin (30vial pack)

2 30 Sep 2026 $1,950.00 $3,900.00

MDP (30 vial pack) 5 30 Sep 2026 $2,408.00 $12,040.00

MDP (5 vial pack) 6 30 Sep 2026 $401.40 $2,408.40

Mertiatide (5vial pack) 5 30 Sep 2026 $1,495.00 $7,475.00

Base Year $106,881.40

Period Period of Performance (POP) Estimated Value Base 01 Oct 2025 through 30 Sep 2026 $106,881.40

Option 1 01 Oct 2026 through 30 Sep 2027 $112,225.47 Option 2 01 Oct 2027 through 30 Sep 2028 $117,836.74 Option 3 01 Oct 2028 through 30 Sep 2029 $123,728.58 Option 4 01 Oct 2029 through 30 Sep 2030 $129,915.01

Total Estimated Cost $590,587.20

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5. Authority Cited: Title 41 U.S.C. §1901(e)(2) as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name), under the authority of the simplified procedures for certain commercial items.

6. Reason for Authority Cited:

a. Background: The pharmaceuticals to be used in procedures in the nuclear medicine clinic must be prepared in a United States Pharmacopeia (USP) 825 compounding environment and able to be delivered to the installation for use. A USP 825 compounding environment refers to the facilities and spaces where radiopharmaceuticals are prepared, compounded, dispensed, and repackaged, adhering to the standards outlined in USP General Chapter 825. These standards ensure the safety of both personnel handling these hazardous drugs and patients receiving them. The environment includes specific requirements for facilities, engineering controls, personnel training, and procedures.

b. There are no alternatives to the use of these particular pharmaceuticals provided by

Sun Pharmaceutical Industries Inc. The radiopharmaceuticals are not available from wholesale supply sources (e.g. General Services Administration, Defense Logistics Agency, Department of Veterans Affairs, and military control points). In accordance with FAR 13.501(a)(1), there is only one responsible source, and no other supplies or services will satisfy the specific agency requirements. Sun Pharmaceutical Industries Inc is the sole supplier of pharmaceuticals requested in this requirement.

c. Impact if not approved: Failure to approve this justification would jeopardize the mission of BAMC, the Department of Nuclear Medicine, and its military community. By not providing the required radiopharmaceuticals for use in imaging in the nuclear medicine department.

7. Efforts to Obtain Competition: The Contracting Officer posted a Notice of Intent to sole source on 18 July 2025 with no replies. Any bids or proposals received shall be considered.

a. Effective competition: Based on market research and the results of the Notice of

Intent, competition is not anticipated for this requirement. The J&A will be posted within 14 days after contract award. The Government will continue to assess the market for new entrants.

b. Subcontracting competition: Due to the nature of the requirement, subcontracting opportunities are not available.

8. Actions to Increase Competition: Due to the short half-life of these radioactive pharmaceuticals a pharmacy must be able to meet delivery and distribution requirements.

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This action is a follow-on to contract W81K00-20-A-0014. Under the previous Justification and Approval (Control No. 24-RHCO-C-272) the paragraph, “Actions to Increase Competition” stated: “For future actions, the Government will reassess the market for available vendors…, A Special Notice of Intent for the proposed limited source award will be posted on Federal Business Opportunities, (Now sam.gov), for which any responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency for future requirements.” The actions stated previously were considered and market research revealed that no other source could provide these items, therefore actions to increase competition were accomplished. Also, stated above, a Notice of intent was posted on 18 July 2025 with no replies.

For future actions, the Government will continue to reassess the market for available vendors who may have come into the market for these radiopharmaceuticals, including but not limited to, issuing a Sources Sought Notice to determine market availability for brand name or equal requirements. A Special Notice of Intent for the proposed limited source award will be posted on System for Award Management (SAM) for which any responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency for future requirements. When the current requirement reaches the end of its time frame, becomes obsolete, or when equivalent appropriate products become available, every effort shall be made to increase competition and therefore an evaluation shall also be made concerning pertinent services. BAMC, in conjunction with the Army Medical Command (MEDCOM), will continue to evaluate the capabilities of other vendor's services to provide items that are of the best value to the Government. The Government will continue to seek new resources that will satisfy these requirements through continued market research, requests for Statements of Capability, and telephonic inquiries.

9. Market Research: In accordance with FAR Part 10 and DFARS 210.001, market research was conducted by the requiring activity in May 2025, and by the contract specialist in July 2025. A search of the Small Business Administration’s (SBA) Dynamic Small Business Search (DSBS), using North American Cartographic Information Society (NACIS) Code 325412 (Pharmaceutical Preparation Manufacturing) and key words “Radiopharmaceuticals” to identify small businesses and determine potential set-asides or subcontracting possibilities. No sources were identified. Also, the Defense Logistics Agency (DLA) Pharmacy Prime Vendor Program does not provide these radiation drugs.

10. Interested Sources: To date, no other sources have written to express an interest

11. Other Facts:

a. Procurement history.

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PERRY.MELISSA Digitally signed by

.S.1063554444

PERRY.MELISSA.S.1063554444

Date: 2025.09.05 12:21:49 -04'00'

Contract Number Contractor Procurement

Method Amount (est.) Period of

Performance W81K0020A0014 Sun Pharma, Inc Sole Source

FAR

13.501(a)(1)(ii))

$100,000 BPA 01-Oct-2020 to 30-Sep-2025

1. The contract numbers and dates of all awarded contracts for these same requirements. W81K0020A0014 awarded on 17 September 2020.

2. The competitive status of these actions. Sole source.

3. Authority previously cited if less than full and open competition was used. FAR 13.501(a)(1)(ii))

4. If any prior contract for this requirement was accomplished using full and open competition or full and open competition after exclusion of sources, include a detailed explanation of the changed circumstances causing this action to now limit the sources. Not applicable.

5. An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. Not applicable.

6. An explanation of protests received, if applicable, and actions taken in response to the protest. Not applicable.

b. b. Other facts. Not applicable.

12. Technical / Requirements Certification: I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Melissa Perry, Contracting Officer’s Representative melissa.s.perry7.civ@health.mil

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable. This determination will be made in accordance with FAR 13-106-3(a)(2)(ii) ‘Comparison of the Proposed Price with Prices Found Fair and Reasonable on Previous Purchases’ and FAR 13.106-3(a)(2)(vi) ‘Comparison to an Independent Government Estimate.’

mailto:melissa.s.perry7.civ@health.mil

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Digitally signed by

FLORES.MARC.ANTHONY.113178

Date: 2025.09.05 13:38:44 -05'00'

Marc A. Flores Contracting Officer

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

FLORES.MARC.ANT

HONY.1131785980

Marc A. Flores

Digitally signed by

FLORES.MARC.ANTHONY.1131785980

Date: 2025.09.05 13:39:05 -05'00'

Contracting Officer

FLORES.MARC.ANT

HONY.1131785980