Award Notice: Performance of Good Clinical Practices (GCP) Compliant Phase II Clinical Trial of a Valproic Acid Product for Treatment of Patients with Significant Hemorrhage

Title: Performance of Good Clinical Practices (GCP) Compliant Phase II Clinical Trial of a Valproic Acid Product for Treatment of Patients with Significant Hemorrhage.

The U.S. Army Medical Research Acquisition Activity (USAMRAA), on behalf of the Joint Program Committee-6 (JPC-6), intends to issue a Request for Proposals. The proposed acquisition will provide for the development and licensure of Valproic Acid for a new indication for the treatment of patients with significant hemorrhage. This clinical development program shall be conducted in accordance with the U.S. Department of Defense (DoD) acquisition system, Food and Drug Administration (FDA) regulations and guidelines, and industry best practices. In direct support of the DoD development program, the Government is seeking to obtain clinical trial support in the performance of GCP compliant clinical trials.

This requirement will be solicited as a full and open (UNRESTRICTED) procurement utilizing the policies and procedures in the Federal Acquisition Regulation (FAR) Part 15, Contracting by Negotiation. The Government anticipates issuance of a single, Cost Plus Fixed Fee (CPFF) contract. The contract is anticipated to have a 36-month base period of performance and one, 36-month optional period of performance. The Government reserves the right to change the solicitation procedure. If for any reason, there are no successful proposals, the Government reserves the right to re-open the solicitation. A solicitation will be posted on or about May 4, 2015 to www.FBO.gov. Solicitations are to be downloaded from the website and no solicitations will be mailed. All proposals shall be sent to the address specified in the solicitation. Please email any questions to wayne.a.medina2.civ@mail.mil. No phone calls or faxes will be accepted.

System for Award Management: All Offerors submitting proposals must:

- Be registered and certified in the System for Award Management (SAM) under NAICS code 541712 prior to submission;
- Maintain an active SAM registration with current information at all times during which it has an active Federal award or a proposal under consideration by any agency;
- Provide its DUNS number and CAGE code on the proposal it submits to the agency.
- To begin a new registration in SAM, please visit the SAM website at https://www.sam.gov, and go to quote mark Registration/Update Entity quote mark icon on the home screen.

Additional market research was required for this action. Interested parties are encouraged to review the new sources sought announcement #W81XWH15WM002 released on 03/04/2015 via www.FBO.gov.

The U.S. Army Medical Research Acquisition Activity (USAMRAA), on behalf of the Congressionally Directed Medical Research Program (CDMRP), intends to issue a Request for Proposals. The proposed acquisition will provide for the development and licensure of Valproic Acid for a new indication for the treatment of patients with significant hemorrhage. This clinical development program shall be conducted in accordance with the Department of Defense (DoD) Acquisition System, FDA regulations and guidelines, and industry best practices. In direct support of the DoD development program, the Government is seeking to obtain clinical trial support by a Clinical Research Organization (CRO) in the performance of GCP compliant clinical trials.

This acquisition will be conducted as a 100% set-aside for Small Business (SB) utilizing the policies and procedures in the Federal Acquisition Regulation (FAR) Part 15, Contracting by Negotiation. The Government anticipates issuance of a single, Cost Plus Fixed Fee (CPFF) contract. The contract is anticipated to have a 36-month base period of performance and one, 36-month optional period of performance. The Government reserves the right to change the solicitation procedure. If for any reason, there are no successful proposals, the Government reserves the right to re-open the solicitation. A solicitation will be posted on or about January 30, 2015 to www.FBO.gov. Solicitations are to be downloaded from the website and no solicitations will be mailed. All proposals shall be sent to the address specified in the solicitation. Please email any questions to wayne.a.medina2.civ@mail.mil. No phone calls or faxes will be accepted.

System for Award Management: All Offerors submitting proposals must:

- Be registered and certified in the System for Award Management (SAM) under NAICS code 541712 as a Small Business prior to submission;
- Maintain an active SAM registration with current information at all times during which it has an active Federal award or a proposal under consideration by any agency;
- Provide its DUNS number on the proposal it submits to the agency.
- To begin a new registration in SAM, please visit the SAM website at https://www.sam.gov, and go to quote mark Registration/Update Entity quote mark icon on the home screen.