Inactive

SUMMARY This is a notice of a proposed contract action issued in accordance with FAR 5.203(a). The Government intends to issue a contract without providing for full and open competition to Battelle Me... SUMMARY This is a notice of a proposed contract action issued in accordance with FAR 5.203(a). The Government intends to issue a contract without providing for full and open competition to Battelle Memorial Institute, 505 King Ave Columbus, OH 43201. Battelle is the only responsible source and no other supplies or services will satisfy agency requirements (see FAR 6.302-1). The Government plans to award this contract in July 2021. DESCRIPTION In December 2019, a novel (new) coronavirus known as SARS-CoV-2 was detected in Wuhan, Hubei Province, People’s Republic of China, causing outbreaks of the coronavirus disease COVID-19 that has now spread globally. The Secretary of HHS declared a public health emergency on January 31, 2020, under Section 319 of the Public Health Service Act (42 U.S.C. 247d), in response to COVID-19. On March 13, 2020, the President of the United States, pursuant sections 01 and 301 of the National Emergencies Act (52 U.S.C. 1601 et seq.) and consistent with Section 1135 of the Social Security Act, as amended (42 U.S.C. 1320b-5), proclaimed that the COVID-19 outbreak in the United States constitutes a national emergency. The objective of this study is to explore immune correlates of protection in rhesus macaques across different vaccines with different doses being evaluated within each vaccine. Vaccine candidates will be provided by Moderna, Novavax, Janssen and Sanofi Pasteur. The study will be conducted under an approved quality management plan. The study will be conducted in compliance with 21CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies), Office of Laboratory Animal Welfare (OLAW) regulations and BARDA Project Quality Requirements. Exceptions to GLP compliance will be described in the study protocol. Only Battelle is capable to perform this task as it is a continuation of previous work issued under contract 75A50121P00027. Battelle is the only organization that has the current capabilities and capacity to ensure timely execution of the studies without a gap period. In addition, any attempt of another organization seeking to perform this study would cause substantial duplication of cost and time to establish the study, which would present to the Government and unacceptable delays in fulfilling the agency’s requirements. RELEASE OF SOLICITATION The Government is soliciting Battelle directly using a Letter Request for Proposals (RFP). The Letter RFP is not available through the Government Point of Entry. Interested parties may request the Letter RFP from the Primary Point of Contact. Responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by BARDA. CONTRACTING OFFICE ADDRESS Biomedical Advanced Research and Development Authority (BARDA) Assistant Secretary for Preparedness and Response (ASPR) Department of Health and Human Services (HHS) Thomas P. O’Neill Federal Building 200 C Street SW Washington, DC 20024