Research Project Compliance with Biosafety Regulations

SOURCES SOUGHT NOTICE ONLY. Department of Veterans Health Administration, Network Contracting Office 5 is conducting market research only to determine the availability of qualified Contractors capable of reviewing research protocols and inspecting research areas for Biosafety compliance. Research and Development projects are required to be compliant with all Biosafety regulations which are reported to several research oversight bodies.

Responses will be used to determine the appropriate strategy for a potential acquisition. Please clearly identify any information your company considers sensitive or proprietary. This notice is issued solely for information and planning purposes - it does not constitute a Request for Quotation (RFQ), or a promise to issue an RFQ in the future. This notice does not commit the U.S. Government to contract for any supply or service.

Further, the U.S. Government is not seeking quotes, or proposals at this time and will not accept unsolicited quotes in response to this Sources Sought Notice. The U.S. Government will not pay for any information or administrative costs incurred in response to this notice. Submittals will not be returned to the responder.

A. GENERAL INFORMATION 1. Title of Project: Research Project Compliance with Biosafety Regulations 2. Program Description: The proposed procurement is to ensure the Veterans Administration 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; staffing of Biosafety committees.

3. Scope of Work:

Professional Services: VAMHCS research personnel will have direct access to the professional and technical services of the University of Maryland Baltimore Environmental Health and Safety Biosafety team.

The team will consist of- Biosafety Officer, University of Maryland, Baltimore Assistant Biosafety Officer, University of Maryland, Baltimore Biosafety Specialist, University of Maryland, Baltimore Research Specialist, University of Maryland, Baltimore Policy and Procedure work will include- Assist in the review and development of VAMHCS Research Service policies and procedures for Biosafety compliance. Assist in the review and development of standard operating procedures.

Assist in responding to inquiries regarding Biosafety-related policies and procedures from regulatory officials or agencies. Committee Work and Consultation Services will include- The UMB Biosafety Officer or their alternate will serve as a voting member of the VAMHCS Subcommittee on Research Safety (SRS). The UMB Biosafety Officer or their alternate, upon invitation of VAMHCS management, will attend meetings where the VAMHCS biosafety program is reviewed or discussed.

Compliance assistance for the VAMHCS recombinant DNA research program. Compliance assistance with the VAMHCS Select Agent program. Such assistance specifically excludes any UMB person being named as the VAMHCS Responsible Official for select agents. A member of the UMB Bio-safety team will conduct twice-yearly audits of VAMHCS research labs (including BSL-3 laboratories) in accordance with VAMHCS practices and procedures. Laboratory Audits will be conducted along with VAMHCS Safety staff.

This function does not include certifications or corrective actions for any noted deficiencies nor any repairs to defective equipment. However, training will be provided in either classroom and/or on-line settings to VAMHCS staff following the discovery of deficiencies. 5. Specific Tasks. Task 5.1 a member of the University of Maryland Baltimore Environmental Health and Safety Biosafety team will reply to inquiries from VAMHCS research personnel in one business day.

Task 5.2 - the University of Maryland Baltimore Environmental Health and Safety Biosafety team will assist in the review and development of VAMHCS Research Service policies, standard operating procedures, and responding to inquiries from regulatory officials or agencies for Biosafety compliance.

Task 5.3 - the University of Maryland Baltimore Environmental Health and Safety Biosafety team will serve as a voting member of the VAMHCS Subcommittee on Research Safety (SRS) and attend other meetings where VAMHCS Biosafety matters are reviewed and discussed Task 5.4 - the University of Maryland Baltimore Environmental Health and Safety Biosafety team will audit the physical VAMHCS research space twice a year for Biosafety compliance assurance.

Should deficiencies be discovered the University of Maryland Baltimore Environmental Health and Safety Biosafety team will provide remedial training for VAMHCS research personnel to be compliant with Biosafety requirements.

6. Performance Monitoring: Compliance will be verified by the VAMHCS Research Compliance Officer (RCO) during annual audits of biosafety protocols and during completion of the annual Medical Center Director s Checklist by the SRS Coordinator. Additionally, the Veterans Health Administration Office of Research Oversight will inspect the VAMHCS Biosafety program during regularly scheduled site visits. Responses must be submitted by 3:00 PM (EDT) November 8, 2024. All information regarding Capabilities Statements or any other proprietary information relative to this source sought shall be submitted via email to veronica.dillard@va.gov.