36E79723R0018_1.docx

Presolicitation Notice

GENERAL INFORMATION

SET-ASIDE

PLACE OF PERFORMANCE

POSTAL CODE

COUNTRY

CONTACT INFORMATION

OPAL / National Acquisition Center Building 37 1st Avenue, One Block North of Cermak Hines, IL 60141

POINT OF CONTACT*

Contract Specialist Ray Roldan Raymond.Roldan@va.gov 708-786-4930

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

Presolicitation Notice

PRE-SOLICITATION NOTICE: The VA National Acquisition Center intends to issue Request for Proposal (RFP) 36E79723R0018 for an unrestrictive procurement for Ranibizumab for the Department of Veterans Affairs (VA), Bureau of Prisons (BOP), and Indian Health Service (IHS). The VA will award one contract per product group to the responsible offeror(s) who will be able to provide an uninterrupted source of supply for the contracted proposed item within a product group or groups. Offerors are not required to submit an offer for both groups; however, the offeror must meet all contract requirements for each item offered. One award will be made for each Group - Group I and Group II - for the base years and all four option years. The contract item(s) will be distributed through the VA’s Pharmaceutical Prime Vendor Program. Offerors must state the exact name (name that appears on label) by which the drug will be supplied and have an NDC number that is unique to the offeror. Solicitation 36E79723R0018 will be electronically issued in commercial product format in accordance with FAR Part 12 on or about June 29, 2023, with a tentative closing date of July 13, 2023. The NAICS code for this procurement is 325412. Any future amendments and other miscellaneous documents will be available electronically for download at the following URL: www.sam.gov. No paper copies of the solicitation will be available, and no telephone requests for paper copies of the solicitation will be accepted. Interested offerors are advised to continuously check this URL for any changes to this solicitation. All responsible sources may submit an offer that if timely received, will be considered. The point of contact for this procurement is Ray Roldan. Questions can be e-mailed to: raymond.roldan@va.gov.

The estimated annual requirement is as follows:

GROUP I RANIBIZUMAB 0.3MG/0.05ML INJ,OPTH

GROUP II RANIBIZUMAB 0.5MG/0.05ML INJ,OPTH

*Proposed biosimilar products must be biological products licensed by the FDA under 42 U.S.C § 262 and must meet all biosimilar criteria described in 42 U.S.C. § 262. Additionally, Biosimilars Products must be FDA approved as a biologic medication that is compared to the innovator (the original biologic) and listed as a biosimilar to the innovator in the FDA Purple Book (https://purplebooksearch.fda.gov/).

Offers of covered drugs (including biologics that fall within 21 CFR § 600.3) will only be considered for award if the Offeror has an executed Master Agreement (MA) and Pharmaceutical Pricing Agreement (PPA) (which includes the proposed drug products/National Drug Codes (NDCs)) on file with the VA National Acquisition Center, Federal Supply Schedule (in accordance with 38 U.S.C. § 8126(h)(4)(B)). Furthermore, in order to be considered for award under this solicitation, all proposed covered drug products/NDCs must be present on the Offeror’s FSS contract or interim agreement by the solicitation due date and time. Offers failing to meet these criteria will be rejected and receive no further consideration.

Presolicitation Notice