36C26224Q1676.docx
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- Attached to
- 6505--Pluvicto
- Solicitation number
- 36C26224Q1676
About this file
This document is a Sources Sought Notice from the Department of Veterans Affairs (VA) for the drug Pluvicto, which is an FDA-approved treatment for prostate cancer.
The VA is seeking sources capable of providing Pluvicto, which must be Lu-177 Vipivotide Tetraxetan, indicated for adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). The treatment regimen should be every 6 weeks for up to 6 doses. Offerors must have the required NRC, agreement state, and FDA licenses. The VA is conducting market research to identify potential qualified sources and their size status under NAICS code 325412. Respondents are asked to provide their capabilities, size status, manufacturing/distribution information, pricing, and other details. Responses are due by August 13, 2024 at 10:00 AM PT. This notice is not a solicitation, and any future solicitation will require separate responses.
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Text version
Sources Sought Notice Sources Sought Notice
| SUBJECT* |
| Pluvicto |
GENERAL INFORMATION
| CONTRACTING OFFICE’S ZIP CODE* |
| 90815 |
| SOLICITATION NUMBER* |
| 36C26224Q1676 |
| RESPONSE DATE/TIME/ZONE |
| 08-13-2024 10:00 PACIFIC TIME, LOS ANGELES, USA |
| ARCHIVE |
| 30 DAYS AFTER THE RESPONSE DATE |
| RECOVERY ACT FUNDS |
| N |
SET-ASIDE
| PRODUCT SERVICE CODE* |
| 6505 |
| NAICS CODE* |
| 325412 |
| CONTRACTING OFFICE ADDRESS |
| Department of Veterans Affairs |
Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815
POINT OF CONTACT*
Peter Kim peter.kim33@va.gov
(562) 844-7484
PLACE OF PERFORMANCE
| ADDRESS |
| Department of Veterans Affairs |
VA Greater Los Angeles Healthcare System
11301 Wilshire Blvd
Los Angeles CA
| POSTAL CODE |
| 90073 |
| COUNTRY |
| USA |
ADDITIONAL INFORMATION
AGENCY’S URL
URL DESCRIPTION
AGENCY CONTACT’S EMAIL ADDRESS
EMAIL DESCRIPTION
DESCRIPTION
This is a SOURCES SOUGHT ANNOUNCEMENT ONLY. It is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract. Responses to this sources-sought notice must be in writing. The purpose of this sources-sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential businesses interested and capable of providing the services described below. After review of the responses to this sources-sought, a solicitation announcement may be published. Responses to this sources-sought synopsis are NOT considered adequate responses for a solicitation announcement.
SOURCES SOUGHT/RFI DESCRIPTION
This is NOT a solicitation announcement. This is a sources sought notice, purpose of which is to gain information about potential qualified sources and their size classification relative to NAICS 325412 (size standard of 1,250 Employees). Responses to this Sources Sought Notice will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought notice, further sources sought notices and/or a solicitation or other announcements may be published.
The Department of Veterans Affairs (VA) is seeking sources capable of providing Pluvicto which is an FDA-approved drug to treat prostate cancer patients.
The following list of characteristics is intended to be descriptive, not restrictive, of the supplies/services that are required.
Must be FDA approved.
Must be Lu-177 Vipivotide Tetraxetan.
Must be indicated for treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).
Should be a treatment regimen of every 6 weeks for up to 6 doses.
Offeror must have US Nuclear Regulatory Commission (NRC) and/or agreement state Radioactive Material License (RAM) and applicable Food and Drug Administration (FDA) license to produce and distribute radiotherapy for human administration, and applicable RAM license to receive, and dispose of radioactive waste.
If your company is interested and capable of providing the required supplies/services, please provide the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions:
(1) Submit your capabilities statement illustrating how your organization can/cannot meet the list of SALIENT CHARACTERISTICS. For instances where your company cannot meet the SALIENT CHARACTERISTICS, please explain. For instances where your company can meet the DRAFT/SALIENT CHARACTERISTICS/SOW requirement(s), please show how your company meets/exceeds each requirement.
(2) Please review the list of SALIENT CHARACTERISTICS and provide any additional feedback or suggestions. If none, please reply as N/A.
(3) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran-Owned Small Business (SDVOSB), Veteran-Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc.
(4) Is your company considered small under the NAICS code identified in this sources sought notice?
(5) Are you the manufacturer, authorized distributor, and/or can your company provide a solution to the required supplies/services described in the list of SALIENT CHARACTERISTICS?
(6) If you are a large business, do you have any designated/authorized distributors? If so, please provide their company name, telephone, point of contact and size status (if available).
(7) If you’re a small business and you are an authorized distributor/reseller for the items identified above, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified.
(8) Limitations on Subcontracting: How does your business ensure compliance with the limitations on subcontracting as outlined in 13 CFR § 125.6?
(9) Are the items you are identifying/providing considered Commercial of the Shelf (COTS) items as defined in FAR Part 2.101 under commercial items?
(10) Non-Manufacturer Rule: If applicable, can you confirm your business complies with the Non-Manufacturer rule? Specifically, does your company: Provide a product from a small business manufacturer or processor? Not exceed 500 employees? Primarily engage in the retail or wholesale trade and normally sell the type of item being supplied? Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice?
(11) Please indicate whether your product conforms to the requirements of the Buy American Act?
(12) What is your lead time to deliver a single unit with all components? Is there scale in lead time with greater quantities? Please elaborate.
(13) Does your company have the required licenses/certifications? Please specify what licenses/certifications have been obtained.
(14) Does your company have a Federal Supply Schedule (FSS) GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract? If so, please provide the contract number(s).
(15) If you are an FSS GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract holder, are all the items/solutions you are providing information about available on your schedule/contract? Please state if all or some items are available on the contract.
(16) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award.
(17) Please provide your SAM.gov Unique Entity ID/Cage Code number.
Responses to this notice shall be submitted via email to peter.kim33@va.gov. Telephone responses will not be accepted. Responses must be received no later than Tuesday August 13, 2024 at 10AM PT.
All responses to this sources sought notice will be used for planning purposes only. Responses to this sources sought notice are not considered a request to be added to a prospective bidders list or to receive a copy of the solicitation. If further sources sought notices and/or a solicitation or other announcement is issued as a result of the information provided from this sources sought notice, all interested parties must respond to the specific posting separately IAW the specifications of that announcement.
| *= Required Field |
| Sources Sought Notice |
Sources Sought Notice
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