JOFOC QUVA 503B IV NARCOTICS 04.2026_FG.pdf

Attachment C

Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity.

HHS, National Institutes of Health

b. Sponsoring organization.

Clinical Center, Pharmacy Department

c. COR information.

COR name: Fortin Georges Mailing address: 10 Center Drive Bldg 10/Room 1C166 E-mail address: rdecederfe@nih.gov Telephone number: 301-496-9358

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

Purchase of 503b compounded INTRAVENOUS (IV) Narcotics for patient care

b. Project background.

The National Institutes of Health (NIH) Clinical Center (CC) is a clinical research hospital providing all medical services for patients participating in human research protocols of the NIH. The CC Pharmacy department provides a range of pharmaceutical care services to inpatients and outpatients enrolled in clinical trials. The CC Pharmacy department is responsible for acquiring the supply of medications required for patient care.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title.

Purchase of compounded INTRAVENOUS (IV) Narcotics for patient care

b. Project description.

Purchase medication for patient care.

• Requirement type.

❑ Research & development (R&D)

❑ R & D support services

❑ Support services (non-R&D) ❑ Supplies/equipment

R & D support services

❑ Information technology (IT) ❑ Construction

❑ Architect-engineer (A & E) services

❑ Design-build

❑ Other (specify): ____________________

• Type of action.

New requirement ❑ Follow-on

❑ Other (specify): ______________________

• Proposed contract/order type.

Firm-fixed-price ❑ Other fixed-price (specify, e.g., fixed-price award-fee, fixedprice incentive-fee): __________ ❑ Cost-plus-fixed-fee ❑ Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ ❑ Time and materials ❑ Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ❑ Other (specify):

___________ ❑ Completion Form ❑ Term form

• Acquisition identification number.

c. Total estimated dollar value and performance/delivery period.

The current cost of IV narcotics varies between drug, concentration and volume.We are requesting a blanket purchase agreement with a base year for an initial $110,000 and 4 optional years beginning 2026 for a total of $684,000.

These medications will be used by Clinical Center for patient care.

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United

States Code (U.S.C.) 3304(a)(1) as set forth in Federal Acquisition

Regulation (FAR) 6.302-1 – Only One Responsible Source and No

Other Supplies or Services Will Satisfy Agency Requirements.

❑ This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

❑ This acquisition is conducted under the authority of the Services

Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

QUVA PHARMA, INC.:1327585

3 SUGAR CREEK CENTER BOULEVARD SUITE 250

SUGAR LAND,TX,774782576

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

The manufacturer (QUVA PHARMA, INC) has not designated other distributors of IV narcotics in the U.S.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

Pricing is set by the manufacturer and the quote provide on manufacture order portal.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Market research has been conducted with only two responses, from QUVA, the known COMPOUNDER and distributor for these IV narcotics. Through trade shows, continuous learning seminars and trade journals, the CC Pharmacy

Department stays abreast of the industry and is current on the availability of singular distribution outlets for these medications.

9. Any other facts supporting the use of other than full and open competition. This medication can be compounded by compounding pharmacies in good standing with the FDA cannot be found via the normal prime vendor distribution process at this time.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

At the time of this document preparation no other vendors have expressed any interest in the acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

The CC Pharmacy Department will continue to monitor the market as well as new

PBA’s and GWAC’s to determine if the distribution channels for this medication has changed. If new distribution channels emerge for this medication we will inquire into the potential capability of the vendor’s ability to supply the medication. A Sources Sought Notice will be posted at that time to determine the total market availability.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

COR Fortin Georges

Chief, Pharmaceutical Procurement Section

COR

Immediate Supervisor

Saly Gabriel

Chief, Pharmacy Department

Head of the Sponsoring

Program Office

Saly Gabriel

Marilyn Farinre

Operations Chief, Pharmacy Department

13. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official Name & Title Signature Date

Chief of the

Office

Head of the

Activity

15. Competition Advocate signature.

Official Name & Title Signature Date

Competition Advocate

16. HHS Senior Procurement Executive signature.

Official Name & Title Signature Date

HHS Senior Procurement

Executive