Inactive

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 Envigo Global Servi... 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 Envigo Global Service Inc (Envigo), 310 Swamp Bridge Road, Denver PA 17517. Envigo 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 November 2022. DESCRIPTION BARDA seeks to acquire NHPs that will be housed and managed in the Offeror’s facilities prior to shipment to one of network labs (specific locations TBD, all U.S.). Offerors should be capable of meeting all four of the requirements provided herein, including NHP, Pre-Shipment, Housing and Shipment Requirements. NHP Requirement: Offeror should have NHPs available for purchasing by BARDA that meet the following criteria: Amount: A minimum of 22 NHPs Species: Cynomolgus macaques Origin: Cambodia Age: 24-35 months All NHPs acquired herein should currently be in the United States and released from quarantine within 30 days of contract award. Pre-Shipment Requirement: Prior to shipping NHPs to BARDA DNCD’s network laboratory for nonclinical studies, the Offeror should be capable of performing the following: Tattoo animals for identification purposes. Test NHPs for common internal and external parasites. Tuberculosis (TB) testing: at least three TB tests (0.1 cc MOT interpalpebrally) at 10- to 14-day intervals during quarantine. NHPs should be tested and serologically negative for Herpes B virus, simian immunodeficiency virus (SIV), simian retrovirus (SRV), and simian T-cell leukemia virus (STLV). NHPs should be documented negative within 45 days of shipment to network lab. PCR for SRV-1 and SRV-2 documented negative within 45 days of shipment to network lab. Fecal testing (nematodes): All fecal samples must be individual samples (not pooled). Fecal testing to be conducted ~2 weeks prior to shipment to network lab. Measles: Vaccination or positive measles virus (MV) titer required. If an animal has a negative measles titer, it should receive a measles vaccination (Vanguard) after completion of TB testing. Chagas: NHPs must be negative for Chagas via PCR and ELISA testing within 45 days of shipment to network lab. Parasite treatment: PO fenbendazole should be given for five days. Fecal culture (no pooling) for Salmonella and Shigella. Documented negative within 45 days of shipment to network lab. Animals may still be acceptable for shipment after treatment and a negative re-culture. This will be determined on a case-by-case basis. Filovirus testing: Documented negative test within 45 days of shipment. Klebsiella testing: cultures from rectal and oropharyngeal swabs. All testing results should be provided to BARDA with ample time to review before shipment. Housing Requirement: BARDA requires the Offeror to have the capability to house the NHPs within the Offeror’s facilities for a minimum of 2 years. Requirements for housing include: Semi-annual testing: Body weight and BCS Physical exam Tuberculosis test Touch-up tattoos Deworming and moxidectin Hair-coat assessment Annual Testing: Virology panel (SRV, STLV, SIV, Herpes B) and MV titer Chagas (PCR and ELISA) Shipment Requirement: The Offeror should be capable of shipping NHPs to BARDA DNCD’s network laboratory upon request. Only Envigo is capable to perform this task as it is the only organization with the current domestic capacity to fulfill BARDA’s NHP needs within the necessary timeframe. Envigo 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 requirement would not fulfill the Government’s immediate need and would cause unacceptable delays in fulfilling the agency’s requirements. RELEASE OF SOLICITATION The Government is soliciting Envigo Global Service Inc. directly using a Request for Quotation. The RFQ is not available through the Government Point of Entry. Interested parties may request the Letter RFQ 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 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 Envigo Global Service Inc (Envigo), 310 Swamp Bridge Road, Denver PA 17517. Envigo 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 October 2022. DESCRIPTION BARDA seeks to acquire NHPs that will be housed and managed in the Offeror’s facilities prior to shipment to one of network labs (specific locations TBD, all U.S.). Offerors should be capable of meeting all four of the requirements provided herein, including NHP, Pre-Shipment, Housing and Shipment Requirements. NHP Requirement: Offeror should have NHPs available for purchasing by BARDA that meet the following criteria: Amount: A minimum of 22 NHPs Species: Cynomolgus macaques Origin: Cambodia Age: 24-35 months All NHPs acquired herein should currently be in the United States and released from quarantine within 30 days of contract award. Pre-Shipment Requirement: Prior to shipping NHPs to BARDA DNCD’s network laboratory for nonclinical studies, the Offeror should be capable of performing the following: Tattoo animals for identification purposes. Test NHPs for common internal and external parasites. Tuberculosis (TB) testing: at least three TB tests (0.1 cc MOT interpalpebrally) at 10- to 14-day intervals during quarantine. NHPs should be tested and serologically negative for Herpes B virus, simian immunodeficiency virus (SIV), simian retrovirus (SRV), and simian T-cell leukemia virus (STLV). NHPs should be documented negative within 45 days of shipment to network lab. PCR for SRV-1 and SRV-2 documented negative within 45 days of shipment to network lab. Fecal testing (nematodes): All fecal samples must be individual samples (not pooled). Fecal testing to be conducted ~2 weeks prior to shipment to network lab. Measles: Vaccination or positive measles virus (MV) titer required. If an animal has a negative measles titer, it should receive a measles vaccination (Vanguard) after completion of TB testing. Chagas: NHPs must be negative for Chagas via PCR and ELISA testing within 45 days of shipment to network lab. Parasite treatment: PO fenbendazole should be given for five days. Fecal culture (no pooling) for Salmonella and Shigella. Documented negative within 45 days of shipment to network lab. Animals may still be acceptable for shipment after treatment and a negative re-culture. This will be determined on a case-by-case basis. Filovirus testing: Documented negative test within 45 days of shipment. Klebsiella testing: cultures from rectal and oropharyngeal swabs. All testing results should be provided to BARDA with ample time to review before shipment. Housing Requirement: BARDA requires the Offeror to have the capability to house the NHPs within the Offeror’s facilities for a minimum of 2 years. Requirements for housing include: Semi-annual testing: Body weight and BCS Physical exam Tuberculosis test Touch-up tattoos Deworming and moxidectin Hair-coat assessment Annual Testing: Virology panel (SRV, STLV, SIV, Herpes B) and MV titer Chagas (PCR and ELISA) Shipment Requirement: The Offeror should be capable of shipping NHPs to BARDA DNCD’s network laboratory upon request. Only Envigo is capable to perform this task as it is the only organization with the current domestic capacity to fulfill BARDA’s NHP needs within the necessary timeframe. Envigo 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 requirement would not fulfill the Government’s immediate need and would cause unacceptable delays in fulfilling the agency’s requirements. RELEASE OF SOLICITATION The Government is soliciting Envigo Global Service Inc. directly using a Request for Quotation. The RFQ is not available through the Government Point of Entry. Interested parties may request the RFQ 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