Medical Countermeasures Clinical Studies Network - RFP-13-100-SOL-00008

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ATTENTION: The RFP for Medical Countermeasures Clinical Studies Network - RFP-13-100-SOL-00008 is now posted on 04/01/2013. Please see attachment.

The Department of Health and Human Services (HHS), Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA), seeks to establish a Medical Countermeasure Clinical Studies Network of clinical contract research organizations to facilitate Medical Countermeasure (MCM) product development. These contracts will establish a network of providers to satisfy the clinical service requirements of BARDA. This network will complement the efforts of the National Institute of Allergy and Infectious Diseases (NIAID).

HHS, through ASPR and BARDA, contemplates multiple awards of Indefinite Delivery Indefinite Quantity (IDIQ) contracts for:

1) Clinical Study Services - Awardees will provide clinical research services including full service capabilities to execute a clinical trial as a service to BARDA. These studies will clinically evaluate Chemical, Biological, Radiological, Nuclear (CBRN), Pandemic Influenza (PI) and/or Emerging Infectious Disease (EID) MCMs. These studies may be Phase 1, 2, 3, or 4 or combinations of these Phases. Clinical research services may include, but are not limited to the following components:

• Planning and pre-study activities
• Safety monitoring
• Document creation and management
• Clinical trial execution
• Identification and contractual agreements with clinical research vendors to support studies as needed
• Data management and Biostatistics
• Quality metrics
• Clinical site management

2) Clinical Trial Response Readiness - Task Orders may contain preparedness and response components that require contractors to plan for or respond to during a public health emergency. Task Orders may require the development and implementation of a detailed plan to permit the initiation of a clinical study within a predefined timeframe.

Awardees will provide clinical services in support of the execution of adequate and well controlled Food and Drug Administration regulated trials, either Phase 1 - 4, or trials during a public health medical emergency. Clinical services will support the evaluation of CBRN, PI, and EID medical countermeasures. Studies may include healthy adults, pediatric, elderly and other populations with special medical requirements. Study timelines will be specified in the Task Order (e.g. routine or urgent). Awardees will support targeted clinical studies relevant to BARDA's vision to create a nation with the capability to respond quickly and effectively to deliberate, natural and emerging threats by providing a range of clinical study services that can be used by BARDA and development partners of BARDA.

The solicitation will describe the required form and content of proposals. Offerors will be required to respond to Sample Request for Task Order Response (RTOR) documents as part of their proposal.

The anticipated period of performance will be for a base period of up to two years or 24 months. The government will have the option to extend the period of performance for up to three years, for a total possible period of performance of five years or 60 months. Additional details and requirements will be described in the solicitation.

Mandatory Criteria for Eligibility:

Offerors must meet the following mandatory criterion for eligibility for an award:

Documented completion of a therapeutic, device or vaccine clinical study under a FDA Investigational New Drug (IND) application in the last 5 years from protocol development through final clinical study report.

Pre-solicitation Notice Objective:

This Pre-solicitation Notice is issued pursuant to FAR Subpart 5.2. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This Pre-solicitation Notice does not commit the Government to contract for any supply or service whatsoever. Further, AMCG is not at this time seeking proposals, and will not accept unsolicited proposals.

A Request for Proposals (RFP) will be available electronically through the FedBizOpps website on or about March 30, 2013, with proposals being due on or about May 14, 2013. Any responsible offeror may submit a proposal that will be considered by the Government. 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. All responses should be identified with the RFP number, name of firm, size standard of the firm, name of requestor, mailing address, telephone number, fax number, and email address, and should be submitted to the Point of Contact(s) identified in this notice.

Multiple awards may result from this solicitation with an estimated award date of around September 2013.

Furthermore, all respondents must be registered in the System for Award Management (SAM) https://www.sam.gov and have their records updated in the Central Contractor Registry (CCR).