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BARDA Animal Model Development of Chemical, Biological, Radiological, and Nuclear; Influenza; and Emerging Infectious Disease Medical Countermeasures

Solicitation Number: RFP-BARDA-10-100-SOL-00025
Agency: Department of Health and Human Services
Office: Office of the Secretary
Location: Acquisitions Management, Contracts, & Grants (AMCG)
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There have been modifications to this notice. To view the most recent modification/amendment, click here
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RFP-BARDA-10-100-SOL-00025
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Award
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Added: Aug 13, 2010 2:15 pm
The Department of Health and Human Services(HHS) through the Biomedical Advanced Research and Development Authority (BARDA) requires the development of animal models for the development of medical countermeasures for Chemical, Biological, Radiological, Nuclear (CBRN); Influenza; and Emerging Infectious Diseases. The mission and priorities of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) are articulated in the PHEMCE Implementation Plan https://www.medicalcountermeasures.gov/BARDA/PHEMCE/enterprise/strategy/strategy.aspx.

The Pandemic and All-Hazards Preparedness Act, signed into law on December 19, 2006, codifies HHS as the lead of Federal public health and medical response to public health emergencies and National Response Plan incidents and specified that one of the duties of the HHS Assistant Secretary for Preparedness and Response is to oversee advanced research, development, and procurement of qualified countermeasures and qualified pandemic or epidemic products. Section 319L (a)(6): Advanced Research and Development subsection (b) "activities includes": ii) Design and development of tests or models, including animal models, for such testing.


The development of animal models is a key element in the successful development of medical countermeasures for CBRN, influenza, and emerging infectious agents, particularly since efficacy of products against most of these threats could never be verified using clinical studies. In 2002, 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 agents, 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.


BARDA anticipates that contracts awarded from this RFP will serve to facilitate the animal model development of medical countermeasures and/or supportive reagents and assays for regulatory acceptance in the U.S.


The anticipated period of performance for any resultant contracts will be for a total of up to 60 months. Additional details and requirements will be described in the solicitation. A Request for Proposal (RFP) will be available electronically through the FedBizOpps on or about September 7, 2010, with proposals being due on or about October 22, 2010. Any responsible offeror may submit a proposal that will be considered by the Government. This notice does not commit the Government to the award of a contract. It is the offeror's responsibility to monitor this internet site ( www.fbo.gov ) for the release of this solicitation as well as any amendments. Potential offerors will be responsible for downloading their own copy of the solicitation and any amendments via this website. No collect calls will be accepted. No facsimile transmissions will be accepted. See Government-Wide Numbered Note 26. All responses should be identified with the RFP number, name of firm, name of requestor, mailing address, telephone number, fax number, email address and should be submitted to the Contracting Office Address identified in this notice. Multiple awards may result from this solicitation with an estimated award date of April 2010.

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Amendment 1

Type:
Mod/Amendment
Posted Date:
September 17, 2010
Description: Solicitation

Amendment 2

Type:
Mod/Amendment
Posted Date:
September 23, 2010
Description: This amendment is issued to correct the due date for proposals, announce the location and security requirements for the Pre-proposal Conference and to make other minor corrections to the solicitation.

Amendment 3

Type:
Mod/Amendment
Posted Date:
October 15, 2010
Description: This modification is issued to make changes to the solicitation and post responses from the Pre-Proposal Conference.
Description: PowerPoint Presentation from the Pre-Proposal Conference, 8 October 2010.
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Office of the Assistant Secretary for Preparedness & Response (ASPR)
Department of Health and Human Services
395 E Street, SW, Rm 1075.45
Washington, District of Columbia 20024
United States
:
Darrick A Early,
Contracting Officer
Phone: 202-260-0293
:
Jeannett W. Jackman,
Contract Specialist
Phone: 2024200829