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This Government Contract opportunity from Department Of Health And Human Services was posted on September 19, 2022. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

BARDA Radiological and Nuclear (RADNUC) Animal Model and Medical Countermeasures (MCM) Development

Awarded
75A50121R00017Federal

Contract Overview

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

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Solicitation # RFA-AI-28-012
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1 day ago

DEADLINE

in 3 months
NAICS: 541714
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Solicitation # RFA-AI-28-005
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National Institutes Of Health

POSTED

1 day ago

DEADLINE

in 3 months

AI Contract Overview

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The Biomedical Advanced Research and Development Authority (BARDA), under the Department of Health and Human Services, is seeking Good Laboratory Practices (GLP) facilities to establish or utilize animal models for developing radiological and nuclear medical countermeasures (MCMs). These models must closely mimic human pathophysiological responses to radiation to serve as valid surrogates for testing efficacy, adhering to the FDA Animal Rule which allows for product approval based on animal data when human clinical trials are unethical or infeasible. Eligible laboratories must hold all necessary federal, state, and local licenses for clinical irradiation facilities and the handling of select agents and radionuclides. Mandatory requirements include AAALAC accreditation or equivalent, a USDA animal research facility license, and a proven track record of completing at least one GLP study. Applicants must demonstrate the capability to conduct studies in both small and large animal models, though subcontracting is permitted to expand these capabilities.

General Info

Contract Value

$75,000

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance

DC, USA

Set-Aside

NONE

Award Issued Date

Documents

0

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Timeline

1 update
PhaseAwarded
Posted

Presolicitation

Type Changed

Presolicitation → Solicitation

Notice updated

Notice details unchanged. Attachments may have changed.

Awarded

Contract was awarded

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → Barda - Aspr / Daappo / Barda Dcma
Contacts2 people available
OfficeWASHINGTON, DC, 20515, USA

Full Description

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The Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), seeks appropriate Good Laboratory Practices (GLP) facilities that are adequate and available to establish new or use existing animal models for the development of radiological and nuclear MCMs. In these models, the radiation exposure should be comparable to that which produces the human disease or condition and the pathophysiological mechanism of its toxicity should be reasonably well-understood and mimic the human disease/condition as closely as possible. These models will be used to test the efficacy of potential RadNuc MCMs. The mechanism of action of the countermeasure will also need to establish the utility of the animal model as a surrogate for humans. Laboratories must meet the following mandatory eligibility criteria to be considered: Evidence of Federal, State, and/or local licenses as required for the operation and control of a clinical level irradiation facility with qualified personnel for the operation, assigned safety restrictions, domestic and instrument calibration per licensed Health Physics authority. Evidence of Federal, State, and/or local licenses as required for the storage, use, and disposal of select agents such as chemical agents and radionuclides and training of all associated staff responsible for the use of such material. Evidence of accreditation or licensure of the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation or equivalent. Evidence of U.S. Department of Agriculture (USDA) animal research facility license, or equivalent. Completion of at least one good laboratory practice (GLP) study. Evidence of capability to conduct either small or large (or both) animal model studies. Provided plan for conducting studies in two animal models, with at least one being a large animal model. Subcontracting is an available option to expand capabilities. HHS, through the interagency Public Health Emergency and Medical Countermeasure Enterprise (PHEMCE) is responsible for the integration of requirements for the advanced development and procurement of MCMs for CBRN threats specified by the Department of Homeland Security as material threats. The HHS PHEMCE Strategy for Chemical, Biological, Radiological, and Nuclear Threats (HHS PHEMCE Strategy), published in the Federal Register on March 20, 2007 describes the strategic policy goals and objectives for identifying requirements and establishes the priorities for the development of the MCMs. The HHS PHEMCE Implementation Plan for Chemical, Biological, Radiological, and Nuclear Threats (HHS PHEMCE Implementation Plan), published in the Federal Register on April 2007 with subsequent updates between December 2012 and 2017, delineates HHS MCM priorities for research, development and acquisition to address the highest priority CBRN threats. The development of animal models is a key element in the development of MCM for CBRN threats, particularly since efficacy of products against most of these threats cannot be verified using human clinical studies. In 2002 and 2015, the FDA amended its regulations for drugs and biologics to permit approval or licensure of medical countermeasures based on substantial evidence of effectiveness in animals when adequate and well-controlled efficacy studies in humans cannot be conducted because it would be unethical to expose healthy human volunteers to lethal or disabling toxic CBRN substances, and relevant field efficacy trials in humans are not feasible. This change in the regulations (21 CFR 314.600 for drugs and 21 CFR 601.90 for biologics), commonly referred to as the - Animal Rule, made the design and conduct of adequate efficacy studies in appropriate animal models of paramount regulatory importance, since the inference of efficacy in humans is based on efficacy data derived in animals. The primary demonstration of safety of the MCM (drug or biologic) is conducted in human clinical studies, although non-clinical data will also be used to evaluate safety.

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Request for Proposals (RFP) - BARDA Vaccine Medical Countermeasures for Pandemic Influenza Preparedness & Response
Solicitation # 75A50126R00001_RFP_NPIVS_27
The Biomedical Advanced Research and Development Authority (BARDA) is soliciting proposals for the Vaccine Medical Countermeasures for Pandemic Influenza Preparedness and Response Program. The primary objective is to maintain a permanent readiness posture and commercially sustainable warm-base production capacity for the rapid manufacture of vaccines, antigens, and adjuvants during public health emergencies. Selected contractors will be responsible for producing countermeasures against influenza and other viruses with pandemic potential, generating necessary analytical, nonclinical, clinical, and chemistry, manufacturing, and controls data for FDA submission, and preparing candidate vaccine viruses. To be eligible, offerors must demonstrate successful experience in influenza vaccine manufacturing, evidenced by holding a U.S. influenza vaccine license or having submitted a Biologics License Application to the FDA. The contract is structured as an IDIQ with a five-year base period and a five-year option, totaling a potential 120-month ordering period. Award decisions will be based on the Highest Technically Rated Offerors with a Fair and Reasonable Price methodology, with a critical requirement for offerors to achieve a High Confidence rating in capabilities. Key deliverables include the submission of comprehensive manufacturing and supply chain continuity plans, surge readiness assessments, and strict adherence to CGMP guidelines and ASPR security requirements. Performance is monitored through a BARDA dose tracker, and final acceptance is contingent upon the submission of final reports and verified temperature control documentation during delivery. Invoicing is conducted quarterly via the Department of Treasury Invoice Processing Platform.
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