JA LSF FSS Anascrop Antivenon SAM.GOV.pdf

FEDERAL SUPPLY SCHEDULE

LIMITED-SOURCES JUSTIFICATION

Acquisition Title: Phoenix Area Wide Anascorp Antivenom Injection Supplies

Agency: IHS

Acquisition Year: 2024

Author:

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Modification to Existing Purchase Order/Contract Number:

Pricing: Firm-Fixed Price Time & Materials Cost

Other:

Funds: OMA Other Funds: IHS1489441

Name of Proposed Contractor(s): Anavorx Distribution LLC

Street Address: 1710 N Shelby Oaks Dr Ste 6

City, State, Zip: Memphis, TN 38134-7403

3. Description of Supplies or Services:

The Phoenix Area Pharmacy Consultant is requesting for a Blanket Purchase Agreement (BPA) Sole Source Award to Anovorx Distribution, LLC to provide Anascorp, Centroides (Scorpion) Immune F(ab’)2(Equine), Injection on a as needed basis for 12 months for the clinics and hospitals under the Phoenix Area. Anovorx will provide a minimum of 3 vials and a maximum of 76 vials for 12-months.

Anascorp Injection is an antivenom indicted for treatment of clinical signs of scorpion envenomation. NDC #:66621-0150-02, PKG: 1X10ML, Generic Name: Antivenin, Centuronides Immune Fab2 120mg/Vil, Inj

The estimated value of the proposed action, including all options, is $

Briefly describe the supplies or services to be provided, including make & model number where appropriate. Indicate whether the item to be procured is peculiar to one manufacturer (e.g., a particular brand name, product, or a feature of a product, peculiar to one manufacturer). If applicable, include quantities of supplies or period of performance for services. Provide information for any options included in the order. If the action is a modification to an existing order, distinguish clearly between the work covered by the basic order and the work to be obtained by the proposed modification.

4. Authority:

ORDER AGAINST FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 251, et seq.); Title 40 U.S.C. 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception and for each discuss how the cited authority applies in accordance with FAR 8.405-6(c)(2)(iv).

An urgent and compelling need exists, and following the procedures would result in unacceptable delays (FAR 8.405-6(a)(1)(i)(A));

Only one source is capable of providing the supplies or services required at the level or quality required because the supplies or services are unique or highly specialized (FAR 8.405-6(a)(1)(i)(B)); or

Anovorx Distribution, LLC is the only contractor to offer ANASCORP [Centruroides (Scorpion) Immune F(ab’)2 (Equine) Injection] is an equine-derived antivenom indicated for treatment of patients with clinical signs of scorpion envenomation.

Anascorp is composed of venom-specific F(ab’)2 fragments of immunoglobulin G (IgG) that bind and neutralize venom toxins, facilitating redistribution away from target tissues and elimination from the body. Physician will initiate treatment with Anascorp Injection as soon as possible after scorpion sting in patients who develop clinically important signs of scorpion envenomation, including but not limited to loss of muscle control, roving or abnormal eye movements, slurred speech, respiratory distress, excessive salivation, frothing at the mouth and vomiting.

Anascrop Injection is widely used by the Southwest Regional Indian Health Services Hospitals and Clinics including Tucson Area, Albuquerque Area and Phoenix Area.

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole-source or limited sources procedures (FAR 8.405-6(a)(1)(i)(C)); or

An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer. (FAR 8.405-6(b);

5. Market Research:

Based on the market research conducted, there is only one small business that has the capability of performing this requirement. In addition, there is only one small business that appears qualified for a Sole Source BPA Award under VA Contract No. 36F79718D0404. Therefore, we are recommending awarding a BPA to Anovorx Distribution, LLC (Distributor) in accordance with VA Contract No. 36F79718D0404. There was no ISBEE responses and we will not be setting aside to ISBEE.

6. Actions to Increase Competition:

We posted Sources Sought Notice ID #IHS1489441-PAOAW for 7 days on SAM.GOV and we did not receive any responses.

7. Any other facts supporting the justification:

The GSA SIN number #42-2A is a Single source drug, innovator multiple source drug and any biological products identified under Section 600.3 of Title 21, CFR, is not available through GSA Advantage. Pricing information can be obtained by the VA Pharmacy Benefit Management on the VA website. See attachment VA Anascorp Pricing Big 4.

8. Technical / Requirements Certification: By my signature below, I certify that the supporting data under my review which is included in this Limited-Sources Justification is accurate and complete.

Program Manager

Name:

Position Title:

Email address:

Phone:

Program Manager Supervisor (or one level above Program Manager)

Name:

Position Title: Phoenix Area Pharmacy Consultant

Email address:

Signature

Date:

9. Best Value Determination. By my signature below, after review of the relevant documents, I have determined that the order subject to this Limited-Sources Justification represents the best value for the Government as set forth in FAR 8.404(d), and constitutes a fair and reasonable price. The basis for my determination is as follows:

The VA has already determined the prices for supplies under Schedule contracts to be fair and reasonable, FAR 8.404(d) Pricing.

10. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this sole source justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

Name: Phone:

Signature: Date: Jun 18, 2024

11. Legal Review:

All J&As equal to or greater than $68 million must have a legal review from the General Law Division of the Office of the General Counsel prior to sending it to the Department.

12. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $13.5 million value calculated including all options)):

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name: Phone:

Signature: Date:

13. Office of Small and Disadvantaged Business Utilization I have reviewed this justification and find that it adequately supports other than full and open competition.

Name: Phone:

Signature: Date:

Signed Digitally signed by Date: 2024.06.18 07:17:29 -07'00'

Signed

14. OPDIV HCA Approval (Required for proposed contract over $13.5 million but not exceeding $68 million value calculated including all options)):

Name: Phone:

Signature: Date:

(The below approval paragraph is required if the cumulative contract value, including all options, equals or exceeds $68 million.)

HHS Senior Procurement Executive (SPE) Approval Based on the foregoing justification, I hereby approve the procurement of (state supplies/services being procured) on an other than full and open competition basis pursuant to the authority of (state the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 251), as implemented by FAR 8.405-6), subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

Name: Phone:

Signature: Date: