The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has released a new Request for Proposals (RFP) for the Patient Safety Monitoring in International Laboratories (pSMILE) program. Issued by NIAID’s Office of Acquisitions, this solicitation seeks to strengthen the quality, reliability, and regulatory compliance of international clinical laboratories supporting NIAID-funded research. pSMILE plays a critical role in ensuring that laboratory-generated data used in global infectious disease research meets rigorous patient safety and Good Clinical Laboratory Practice (GCLP) standards, ultimately supporting NIH’s mission to advance public health worldwide.
Overview of the pSMILE Solicitation
The pSMILE program supports NIAID’s Division of AIDS (DAIDS) and its global research portfolio focused on human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), related co-infections, and comorbidities. The selected contractor will provide comprehensive laboratory monitoring services to ensure participating international laboratories adhere to GCLP requirements and are capable of producing high-quality, reliable data for NIAID-supported clinical trials. These efforts directly underpin NIH’s long-term goal of achieving an AIDS-free generation.
Under this solicitation, the awardee will be responsible for activities including laboratory audits, action plan development, protocol analyte list reviews, method validation support, and ongoing performance monitoring. The scope of work emphasizes operational continuity with the existing SMILE program, while enabling scalability as NIAID research needs expand. The contractor must demonstrate strong technical expertise, robust quality management systems, and the ability to manage complex international laboratory networks in resource-diverse settings.
Program Structure and Period of Performance
The pSMILE contract is structured as a multi-year effort, with a base period of one year and up to 6 exercisable options totaling 7 years of performance. The scope of Year 1 activities is expected to continue throughout each subsequent contract year. Importantly, the solicitation includes Options 7 through 27 to increase the level of effort by adding laboratories over time, with each option corresponding to the integration of additional labs and associated staffing increases. This structure allows NIAID to scale laboratory oversight in response to evolving global research demands.
Key Proposal Dates and Milestones
Offerors should pay close attention to the following critical dates:
- Solicitation Issue Date: January 26, 2026
- Deadline for Submission of Questions: February 9, 2026 (3:00 PM ET)
- Proposal Due Date: March 12, 2026 (3:00 PM ET)
Proposals must be submitted in strict accordance with the packaging, formatting, and delivery instructions outlined in the solicitation attachments. Late submissions will not be considered.
Funding Expectations and Awards
While the total contract value is not explicitly stated, the scope, duration, and option structure indicate a long-term service contract supporting global laboratory infrastructure. The contract’s period of performance may extend up to seven years, with annual options exercised at the Government’s discretion to support additional laboratories and increased monitoring activities.
Why pSMILE Matters for Global Health
At its core, pSMILE safeguards the integrity of laboratory data used in international clinical research. By ensuring laboratories meet stringent quality and safety standards, the program protects research participants, strengthens regulatory confidence, and accelerates the development of life-saving interventions for HIV and other infectious diseases. Reliable laboratory data is foundational to sound clinical decision-making, and pSMILE’s work directly supports NIH’s ability to translate research into real-world health outcomes.
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