36C25525A0003.docx

SUBJECT*

New iDose Contract l STL

GENERAL INFORMATION

SOLICITATION NUMBER*

Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

POINT OF CONTACT*

Contracting Officer Juszczak, Janie Janie.juszczak@va.gov 913-946-1966

ADDITIONAL INFORMATION

EMAIL DESCRIPTION

DESCRIPTION

The Department of Veterans Affairs, Veterans Health Administration, Network Contracting Office 15 intends to award a sole source firm-fixed price contract under the authority of 41 U.S.C 253(c) (1) – FAR 6.302-1 Only One Responsible Source to AVEDRO, INC. (Glaukos Corporation), 26600 Aliso Viejo Parkway, Aliso Viejo, CA 92656 on behalf of the St. Louis VA Medical Center, 915 N. Grand Blvd.

St. Louis MO, 63106 for iDose TR 75MCG IMPLANT TRADE NAME / GENERIC NAME: TRAVOPROST 75MCG IMPLANT / NATIONAL DRUG CODE (NDC): 25357-0100-01.

The Government intends to award a firm-fixed price Basic Ordering Agreement (BOA) for a total of five (5) one-year ordering periods. The NAICS code is 325412 (Pharmaceutical Preparation Manufacturing) with a size standard of 1,300 Employees. The corresponding Product Service Code is 6505 (Drugs and Biologicals).

Interested firms may express their interest by providing a capabilities statement no later than October 24, 2024 at 10AM Central Standard Time. The capabilities statement must provide clear and unambiguous evidence to substantiate the capability of the party to provide the required supply and/or services in accordance with the statement of requirement. Those interested firms must indicate whether they are large, small, small-disadvantaged, 8(a) or woman owned business and whether they are U.S. or foreign owned. Respondents who submit proprietary data shall clearly mark the data with appropriate markings.

The Government will not pay for any information submitted as a result of this notice. This notice shall not be construed as an obligation on the part of the Government to acquire any supplies and/or services. Verbal responses are not acceptable and will not be considered.

This notice of intent to award a sole source contract is being issued for information purposes only and does not constitute a solicitation or request for competitive proposals. A determination not to compete this proposed contract upon responses to this notice is solely within the discretion of the Government. There will be no solicitation available for competitive proposals as market research has determined these services are only available from a single source without an unacceptable delay or duplication of cost and no other type of services will satisfy agency requirements.

Special Notice Special Notice If a firm believes it is capable of meeting the Government's requirement, it may identify their interest and capability to the Contracting Officer. The point of contact for this action is Contracting Officer Janie Juszczak, who can be reached at janie.juszczak@va.gov. Phone calls will not be accepted. The Network Contracting Office 15 address is: VA Heartland Network 15, Network Business Office, Contracting Office, 3450 South. 4th Street, Leavenworth, KS 66048.

Special Notice

Statement of Work (SOW) iDose TR 75MCG IMPLANT TRADE NAME / GENERIC NAME: TRAVOPROST 75MCG IMPLANT / NATIONAL DRUG CODE (NDC): 25357-0100-01

Background iDose TR is a pharmaceutical device approved by the FDA (NDA 218010) to be used as an intracamerally implanted device that contains a formulation of travoprost. This pharmaceutical assists with open-angle glaucoma and ocular hypertension and is currently being used by the Veterans Affairs Hospital. Previously, Prosthetics facilitated the ordering of this product. It was recently determined that because the pharmaceutical contained in the implant, it would now be facilitated by Pharmacy Service.

Objective and Specific Aims Objective: Procure iDose TR units for the St. Louis VAMC Pharmacy department.

Specific Aim #1: The Pharmacy department will procure iDose TR units when needed to have in stock for the Ophthalmology Department to use for patients with open-angle glaucoma and/or ocular hypertension.

Specific Aim #2: The iDose TR units will be implantable devices that contain the pharmaceutical travoprost. iDose TR will deliver continuous prostaglandin analog therapy directly into the anterior chamber for long-term intra ocular pressure (IOP) control with proven safety and patient tolerability.

Specific Aim #3: Each unit will contain Medical Grade Titanium implant reservoir, be biocompatible, and MRI Conditional. The pre-loaded single-dose inserter will have a backstop, grasper, retentions sleeve, and iDose TR implant. The unit will also contain a release button that releases the iDose TR implant.

Specific Aim #4: The implant will be designed to remain fixed & stable positioned parallel to the iris, away from the corneal endothelium.

Delivery Location:

St. Louis VA Medical Center 915 N. Grand Blvd.

St. Louis MO, 63106

• Deliveries will be made Monday-Friday (excluding holidays which are listed below) between the hours of 7:00 AM and 4:30 PM, except in the case of emergency.

Federal Holidays are as follows and include any other days specifically declared by the President Of the United States to be deemed a holiday.

• Access to the VAMC location during non-business hours shall be obtained by contacting the AOD located in the Emergency Department who will contact VA Police to accompany the delivery Person to the nuclear medicine department and supervise the delivery.

Responsibilities

VA:

1. Responsible for procuring the iDose TR units and securing them in pharmacy approved locations (i.e. Pyxis machine, etc.)

2. Inspect each iDose TR unit prior to securing in approved pharmacy locations to ensure there is no damage to the unit.

3. If a unit is damaged, the VA Pharmacy will return the unit in a timely manner in exchange for a non-damaged unit.

Collaborator:

1. Responsible for delivering the iDose TR units to either John Cochran VAMC or the Jefferson Barrack VAMC in a timely manner.

2. Ensures each iDose TR unit is safe and packaged appropriately for pharmaceutical delivery.

3. Ensures each iDose TR unit contains Travoprost in the implant.

4. Ensures that each iDose TR unit works properly before delivery.

Local Reporting If an Adverse or Serious adverse event, or unanticipated problem occurs with the delivery of the iDose TR unit, it will be reported to the Contracting Officer, Contracting Officer Representative, the Procurement Pharmacist, and Pharmacy Management, along with the Contracting POC.