NIAID Virology Quality Assurance
ID: 75N93024R00030Type: Sources Sought
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NIAIDBETHESDA, MD, 20892, USA

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (541715)

PSC

HEALTH R&D SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH (AN12)
Timeline
    Description

    The National Institute of Allergy and Infectious Diseases (NIAID) is soliciting proposals for the Virology Quality Assurance (VQA) program under RFP number 75N93024R00030, aimed at enhancing quality assessment for virologic testing in clinical trials related to HIV and other viral pathogens. The program requires contractors to provide comprehensive quality assurance services, including performance validation reports and progress updates, while adhering to strict federal regulations and ethical standards concerning human subjects in research. This initiative is critical for establishing robust quality controls in virology testing, thereby supporting public health responses and ongoing research efforts. Proposals are due by April 8, 2025, at 3:00 PM EST, and interested parties should direct inquiries to Shawnice Williams at shawnice.williams@nih.gov or Ashley Kinderdine at ashley.kinderdine@nih.gov for further clarification.

    Point(s) of Contact
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    Posted
    The document is an amendment to RFP No. 75N93024R00030 for the "NIAID Virology Quality Assurance," issued by NIAID under the NIH. The amendment, dated January 13, 2025, does not alter the proposal due date of April 8, 2025, and adds seven attachments, detailing the requirements for submitting proposals electronically. The main focus of the RFP is to solicit proposals for laboratory quality assurance programs for virologic assays related to HIV and other viral pathogens, ensuring accurate lab performance through proficiency testing and real-time validation controls. The Statement of Work (SOW) delineates responsibilities for conducting rigorous quality assessments, including the implementation of performance standards, statistical evaluations, and the maintenance of quality control materials. The contractor must navigate regulatory responsibilities, manage donor programs, and maintain a donor pool for acquiring necessary biological samples while ensuring compliance with ethical standards. Furthermore, provisions are made for potential contract extensions and increases in scope to cater to emerging healthcare challenges. This solicitation underscores NIAID's commitment to enhancing lab capabilities in virology for clinical applications while supporting ongoing research and public health responses.
    Amendment #2 to RFP No. 75N93024R00030 pertains to the “NIAID Virology Quality Assurance” project, issued by the National Institute of Allergy and Infectious Diseases (NIAID). The amendment, dated March 7, 2025, maintains the proposal due date of April 8, 2025, at 3:00 PM EST. Key modifications include updates to Article B.4 regarding the System for Award Management (SAM) statements, clarification on shipping and packaging cost assumptions, and the inclusion of an updated FAR clause (52.204-8) related to annual representations and certifications. Notably, Section 3.3 on shipping and packaging is clarified to indicate that it does not add to the work's shipping costs but is part of a breakdown. Offerors are required to acknowledge receipt of this amendment in their proposals, and all other solicitation terms remain unchanged. This amendment emphasizes the federal government's ongoing efforts to refine proposal processes and ensure clarity for potential bidders involved in government contracting.
    The National Institute of Allergy and Infectious Diseases (NIAID) is soliciting proposals for the Virology Quality Assurance (VQA) program under RFP number 75N93024R00030, issued on January 8, 2025, with a proposal deadline set for April 8, 2025. The program aims to provide comprehensive quality assessment for virologic testing in clinical trials related to HIV and other viral pathogens. Proposals must adhere to strict submission guidelines and address various deliverables, including performance validation reports and progress updates throughout the contract period. The contract includes options for increased support in response to public health emergencies and additional laboratory demands. Key requirements also emphasize confidentiality, adherence to federal regulations, and compliance with the protection of human subjects in research. The contractor must ensure proper reporting and invoicing practices within the prescribed frameworks outlined in the solicitation. This initiative highlights the government's commitment to establishing robust quality controls in virology testing while facilitating collaborations across health agencies. Stakeholders are encouraged to direct questions to the contract specialist prior to the deadline.
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