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This Pre-Solicitation opportunity from Department Of Health And Human Services was posted on August 5, 2021. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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

Closed
NIAID-NOI21-2086466Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

Active Opportunities Like This One

NAICS: 325414
Federal
Foot and Mouth Disease (FMD) Vaccine Antigen Concentrate (VAC)
Solicitation # 12639527R0001
Solicitation 12639527R0001 is a request for proposals issued by the USDA Animal and Plant Health Inspection Service (APHIS) for an Indefinite Delivery Indefinite Quantity (IDIQ) contract. The requirement covers the purchase, storage, and production of Foot and Mouth Disease (FMD) Vaccine Antigen Concentrate (VAC), the conversion of Government-owned VAC into usable finished vaccines, and the direct purchase of finished vaccines. The contract has a ceiling price of 800 million dollars and a long-term performance horizon, featuring five one-year ordering periods starting approximately December 1, 2026, with conversion and delivery of finished vaccines extending through November 30, 2044. The scope of work requires the contractor to produce VAC capable of yielding at least 1.0 million doses and maintain these materials on their premises under strict quality control and temperature standards. Because live FMDV is a Tier 1 Select Agent, the contractor must hold a select agent authorization issued by CDC/APHIS. Finished vaccines must be packaged to maintain temperatures between 2 to 8 degrees Celsius for 24 hours and include electronic temperature monitors. Award will be based on the most advantageous offer considering technical capability, past performance from the last five years, and fair and reasonable pricing. Proposals must be submitted electronically to Stephen Tees by November 10, 2026, at 1700 CT, organized into four separate volumes.
Mrpbs Minneapolis Mn

POSTED

20 days ago

DEADLINE

in 20 days

General Info

NAICS

325414 - Biological Product (except Diagnostic) Manufacturing

Place of Performance

Rockville, MD, 20852, USA

Set-Aside

NONE

Documents

1

Vendor+Representation+52.204-24+Oct+2020.pdf

PDF

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Timeline

PhaseClosed
Posted

Presolicitation

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health Niaid
Contacts1 person available
OfficeBETHESDA, MD, 20892, USA
Office AddressBETHESDA, MD, 20892, USA
Contacts

Full Description

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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.

More opportunities from Department Of Health And Human Services → National Institutes Of Health Niaid

Same awarding agency

NAICS: 541715
Federal
2027 NIAID DMID Omnibus Broad Agency Announcement: Development of Medical Interventions for Infectious Diseases
Solicitation # HHS-NIH-NIAID-BAA2026-1
The National Institute of Allergy and Infectious Diseases (NIAID) is soliciting proposals under Broad Agency Announcement HHS-NIH-NIAID-BAA2026-1 to advance the research and development of medical interventions for infectious diseases. This initiative focuses on three primary research areas: the development of needle-free vaccine candidates through early-phase clinical trials; the creation of safe and effective therapeutic candidates for serious infectious diseases, including those resistant to current antimicrobial therapy; and the innovation of in vitro diagnostic technology platforms capable of rapid, automated detection of a broad panel of priority viral pathogens. The program emphasizes alignment with NIH priorities regarding biosafety, biosecurity, and the use of non-animal testing methods. Proposals must be submitted electronically via the NIAID eCPS website by December 8, 2026, at 3:00 PM Eastern Time. Technical proposals are limited to 75 pages and will be evaluated by a peer review group based on technical merit, with the technical plan and personnel qualifications being of paramount consideration. Awards are not based on a common Statement of Work; instead, offerors must propose their own technical plans, milestones, and cost structures using a base and option period format. The resulting contracts will require an accounting system compliant with generally accepted accounting principles and will involve rigorous government inspection and acceptance based on the successful completion of critical milestones.
Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

POSTED

12 days ago

DEADLINE

in about 2 months
View Details

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