Research Project Compliance with Biosafety Regulations

This Intent to Sole Source announcement is posted in accordance with FAR 5.2Â - Synopses of Proposed Contract Actions. Background - The proposed procurement is to ensure the Veterans Affairs Maryland Health Care System (VAMHCS) research projects are compliant with biological safety regulations and policies.

Services will include consultation on existing and future regulations and requirements for research projects to be compliant with biosafety requirements; inspections to ensure compliance with regulations and providing corrective training for any deficiencies discovered. Research and Development projects are required to be compliant with all Biosafety regulations which are reported to several research oversight bodies. Professional services for research projects to be compliant with Biosafety requirements. Services that will be provided are:

compliance consultations from the Biosafety Officer, Assistant Biosafety Officer, Biosafety Specialist and Biosafety Research Specialist as needed; assistance in reviewing, editing, and crafting the Veterans Affairs Maryland Health Care System Biosafety Policies and Procedures for research projects as well as responding to inquiries for such policies and procedures; staffing committees which are involved in research biosafety policies and procedures; assisting with compliance of the VAMHCS recombinant DNA research program and the Select Agent program; and inspections to ensure compliance with regulations and training for research staff discovered to be deficient.

Objective VAMHCS will have direct access to the professional and technical services of the University of Maryland Environmental Health and Safety Bio-Safety team mentioned above to assist in the review and development of bio-safety-related VAMHCS Research Service policies and procedures. The Bio-Safety team will assist in responding to inquiries regarding bio-safety-related policies and procedures from regulatory officials or agencies.

The Bio-Safety team will provide compliance assistance for the VAMHCS recombinant DNA research program and the VAMHCS Select Agent program. Unique Qualifications The Department of Veterans Affairs requires continuous research project support service for a responsible source. University of Maryland Environmental Health and Bio-Safety is one of the institutes within the VA geographical area with direct knowledge and understanding of the VA Bio-Safety requirements and regulations.

To conduct research a number of separate oversight bodies must perform initial and periodic continuous review of the research activities and should there be any findings the oversight bodies pass them between one another to agree upon recommendations. Those recommendations are then reviewed and considered by the committees and institutional officials who are locally responsible for the conduct of the research.

The VAMHCS has established Memorandums of Understanding (MOUs) with the University of Maryland, Institutional Review Board (UM IRB), with the University of Maryland, Institutional Animal Care and Use Committee (UM IACUC), and with the University of Maryland, Institutional Biosafety Committee (UM IBC) to serve as their IRB, IACUC and IBC of record.

Award information - Solicitation No. 36C24525Q0106 will be presented to the contractor in accordance with the sole source authority at FAR 6.302-3 as a fixed-price contract. The period of performance shall be for one base year plus four option years. Option ordering periods are exercised as required and are not guaranteed. The anticipated Period of Performance reads as follows:

Base Ordering Period (Est. Award date):

12/1/2024 11/30/2025 Est. Option Year 1:

12/1/2025 11/30/2026 Est. Option 2:

12/31/2026 11/30/2027 Est. Option 3:

12/31/2027 11/30/2028 Est. Option 4: 12/31/2028 11/30/2029 If anyone requests additional information or would like to obtain a copy of the solicitation, please contact: Veronica B. Dillard, veronica.dillard@va.gov.