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Monday, October 13, 2014

Radiation/Nuclear Medical Countermeasure (MCM) Product Development Support Services

https://www.fbo.gov/index?s=opportunity&mode=form&id=b7300854b58d9583be9af7e8245a367c&tab=core&_cview=1

Radiation/Nuclear Medical Countermeasure (MCM) Product Development Support Services

Solicitation Number: RFP-NIAID-DAIT-NIHAI2014005

Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases

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Solicitation Number:

Notice Type:

Synopsis:

Added: Aug 18, 2014 2:19 pm

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (HHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division Of Allergy, Immunology and Transplantation (DAIT) has a requirement for developing products for treatment of radiation injuries from exposures due to a nuclear and radiological attacks to the stage where products are eligible for advanced product development by the Biomedical Advanced Research and Development Authority or acquisition under the Project BioShield Act of 2004.

The National Institute of Allergy and Infectious Diseases intends to solicit proposals for a contract entitled "Radiation/Nuclear Medical Countermeasure Product Development Support Services" to advance the development of candidate medical countermeasures (MCMs). NIAID anticipates that research and development studies supported by this RFP will advance candidate MCMs toward eventual FDA approval or licensure for acute radiation syndrome (ARS) or delayed effects of acute radiation exposure (DEARE).

It is anticipated that candidate MCMs will enter the evaluation and development pathway at various stages, from early research to post marketing (for drugs or biologics that are already licensed or approved for other indications). The Contractor will collaborate with NIAID and, under the direction of NIAID, with organizations that have developed MCMs and with other federal authorities, including the Food and Drug Administration (FDA).

The proposals will be evaluated on the comprehensiveness, soundness, adequacy and suitability of the proposed scientific approach and methodology used to support the advancement of candidate MCMs for the mitigation or treatment of ARS/DEARE towards FDA approval or licensure under the Animal Efficacy Rule and the organizational capabilities, experience and understanding of the development of MCMs against radiological and nuclear agents. The evaluation will also be based on the adequacy of the scientific and technical personnel, facilities, equipment, Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP) and Good Clinical Practice (GCP) compliance and project management.

It is anticipated that one Indefinite Delivery Indefinite Quantity type contract will be awarded for a 5-year period of performance beginning on or about 8/1/2015. The Task Areas will include Administrative and Technical Support, Animal Model Development and Efficacy Testing of Candidate Medical Countermeasures, Nonclinical Studies in Support of IND/NDA/BLA, Phase I Clinical Studies, and Chemistry, Manufacturing and Control Support Services. The first Task Area is anticipated to encompass a cost-reimbursement, term (level of effort) Task Order and the others completion type cost reimbursement Task Orders. Options may be used to extend the period of performance of some Task Orders.

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about 9/2/2014 and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract or Task Order. No collect calls will be accepted. No facsimile transmissions will be accepted.

For this solicitation, the NIAID requires proposals to be submitted via two methods: (1)
Disc (CD or DVD) and (2) Online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or e-mail is not acceptable.

For directions on using eCPS, go to the website https://ecps.niaid.nih.gov and then click on "How to Submit."

To submit online using eCPS, offerors must have a valid NIH electronic Research Administration (eRA) Commons account, which provides authentication and serves as a vehicle for secure transmission of documents and communication with the NIAID. The eRA Commons registration process may take up to 4 weeks. For more information, please see http://era.nih.gov/applicants/how-to_steps.cfm#register."

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Solicitation 1

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Amendment 1

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Solicitation 1 Sep 02, 2014: NIHAI2014005_RFP_and...
Amendment 1 Oct 10, 2014: Amendment_One.docx

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"I have not yet begun to fight!"

Monday, October 13, 2014

Radiation/Nuclear Medical Countermeasure (MCM) Product Development Support Services

Radiation/Nuclear Medical Countermeasure (MCM) Product Development Support Services

Solicitation 1

Amendment 1

All Files

General Information

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