Notice of Intent Meningococcal Group B Vaccine Research.pdf
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This document is a Notice of Intent to Sole Source issued by the Uniformed Services University of the Health Sciences (USU). USU intends to award a sole-source, cost-plus fixed fee contract to the Henry Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) for collaborative studies, specifically a phase II randomized, placebo-controlled study to assess the efficacy of the meningococcal Group B vaccine rMenB+OMV NZ (Bexsero©, GSK) in preventing gonococcal infection.
The sole-source justification is based on 10 U.S.C. 178, which authorizes HJF to enter into contracts with USU for cooperative medical research, consultation, and education. USU claims HJF is the only source capable of executing the required observational and epidemiological protocols due to holding the previous award. The notice invites alternative sources to submit evidence that competition would be advantageous to the government, cost-effective, and not time-prohibitive. Respondents must submit their proposals via email, though no specific response deadline is provided in the document.
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Notice of Intent to Sole Source
The Uniformed Services University of the Health Sciences (USU) is the Nation's federal health sciences university and is committed to excellence in military medicine and public health during peace and war.
We provide the Nation with health professionals dedicated to career service in the Department of Defense and the United States Public Health Service and with scientists who serve the common good.
We serve the uniformed services and the Nation as an outstanding academic health sciences center with a worldwide perspective for education, research, service, and consultation; we are unique in relating these activities to military medicine, disaster medicine, and military medical readiness. USU is located in Bethesda, MD on the grounds of the Naval Support Activity Bethesda.
The mission of USU is to provide the highest quality education programs in the health sciences to those selected individuals who demonstrate dedication to a health profession career in the Uniformed Services. As such, it is essential USU provide the necessary training and equipment required for our students to become successful doctors and nurses and to be able to provide the best care possible for our soldiers and to support our research efforts.
Intended Recipient: The Henry Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) 6720A Rockledge Drive, Suite 100, Bethesda, MD 20817
Intent to Sole-Source: USU intends to award a sole-source, cost-plus fixed fee award for collaborative studies that include execution of a phase II randomized, placebo-controlled study, to assess efficacy of meningococcal Group B vaccine rMenB+OMV NZ (Bexsero©, GSK) in preventing gonococcal infection.
Sole Source Justification: 10 U.S.C. 178 (enacted under PL 98-36) established the “Foundation for the Advancement of Military Medicine”, later renamed the “Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) and, under section (g)(1), authorized it to “enter into contracts with the Uniformed Services University of the Health Sciences for the purpose of carrying out cooperative enterprises in medical research, medical consultation, and medical education, including contracts for provision of such personnel and services as may be necessary to carry out such cooperative enterprises.” This authority is being exercised because the required simultaneous execution of multiple observational and epidemiological protocols for USU is solely available from the source that held the previous award with USU. The Henry M. Jackson Foundation is the only source that can provide the required services and award to any other source would result in unacceptable delays.
In accordance with FAR 5.207(c)(16)(ii), all responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. Responses to this notice must demonstrate clear and convincing evidence that competition would be advantageous to the Government, would not be cost or time prohibitive, and that the interested potential Offeror can supply the aforementioned requirement. Information received will be considered for the purposes of determining whether to conduct a competitive procurement. The Government will not be responsible for any costs incurred by responding to this notice.
Responses must be received via email to the point of contact no later than the response time listed in the notice.
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