Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF AUGUST 07, 2021 SAM #7189
SOLICITATION NOTICE

65 -- Investigational Products GLA-SE Adjuvant Formulation and ID93 for DAIDS-funded Clinical Trials

Notice Date

8/5/2021 2:06:23 PM
 

Notice Type

Presolicitation
 

NAICS

325414 — Biological Product (except Diagnostic) Manufacturing
 

Contracting Office

NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
 

ZIP Code

20892
 

Solicitation Number

NIAID-NOI21-2086466
 

Response Due

8/10/2021 8:00:00 AM
 

Archive Date

08/25/2021
 

Point of Contact

Julie Yun
 

E-Mail Address

julie.yun@nih.gov
(julie.yun@nih.gov)
 

Description

This is a Pre-solicitation Notice, not a request for quotations (RFQ). The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis to procure ID93 and GLA-SE investigational vaccine products. Market research has indicated that there is only one supplier who can meet the government�s requirement. The purpose of this acquisition is to acquire GLA-SE and ID93 investigational vaccine products for a NIAID/Division of AIDS(DAIDS)-sponsored Phase 2a/2b clinical trial. This ACTG/HVTN study will evaluate ID93 and the adjuvant GLA-SE as part of the clinical development plan for the vaccine product ID93+GLA-SE. Data generated by this clinical study will fulfill NIAID�s mission �to better understand, treat, and ultimately prevent immunologic, and allergic diseases�, such as AIDS and TB, and will support vaccine and adjuvant development. ID93 and GLA-SE use proprietary technology unique to the supplier that cannot be replicated or acquired using other sources. The clinical research and trial limits NIAID from using other vaccine products and sources since it is specific to these two products. The statutory authority for this sole source requirement is 41 U.S.C. 3304(a)(1) as implemented by FAR 6. 302-1 only one responsible source and no other supply or service will satisfy agency requirements. THIS IS NOT A REQUEST FOR QUOTATIONS (RFQ). All responsible sources that could provide comparable supplies may submit a capability statement that will be considered by email (subject line to reference NIAID-NOI21-2086466) to Julie Yun at julie.yun@nih.gov by 11:00AM EDT on�August 10, 2021. Sources must also certify that they do not provide covered telecommunications equipment or services to the Government and do not use these equipment or services by completing the attached document titled �Vendor Representation 52.204-24 Oct 2020."" Any responses received after the closing date of this notice will not be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. SPECIAL NOTICE Quoters are advised that the Government may share your information with non-government personnel who are assisting with the evaluation of responses. The exclusive responsibility for source selection will reside with the Government. By submitting your response, you will be consenting to disclosure of your offer to non-government personnel for purposes of evaluation.
 

Web Link

SAM.gov Permalink
(https://beta.sam.gov/opp/1033f812733a4ccca3628ffa0d14e343/view)
 

Place of Performance

Address: Rockville, MD 20852, USA

Zip Code: 20852

Country: USA
 

Record

SN06087100-F 20210807/210805230129 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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