Histopathology Services to Support On-going Small Animal Product Efficacy Studies for Viruses with Pandemic Potential

Introduction

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement.

Project Summary

The National Institute of Allergy and Infectious Diseases (NIAID) Division of Microbiology and Infectious Diseases (DMID) supports research to better understand, treat, and ultimately prevent infectious diseases caused by virtually all infectious agents, except HIV. Within DMID, the Office of Biodefense, Research Resources and Translational Research (OBRRTR) supports biodefense and emerging infectious disease countermeasure development through contracts, supports translational research centers and partnerships, and provides preclinical development services, from reagents, assays, and animal models to product-specific services for vaccines, therapeutics and diagnostics.

NIAID plays a key role in the Antiviral Program for Pandemics, which is a multiagency effort aimed at combatting viruses such as SARS-CoV-2 that have the potential to create pandemics. In this role, NIAID supports and facilitates the development of products to treat or prevent infection. A frequent feature of infection with these viruses is changes to cellular structures in affected tissues such as the lung, liver or brain.  To visualize these changes, tissues are preserved, immobilized, sectioned, and stained on slides that can be examined and images captured using a specialized microscope.  Current efforts involve testing products in small laboratory species (i.e., mice, hamsters, guinea pigs, etc) therefore the specialists who evaluate these slides are veterinary pathologists and the technical experts who generate the slides are histology technicians.  The Government seeks commercially available veterinary pathology services to evaluate and interpret slides, capture representative images and report their findings to meet the requirements of product efficacy testing performed under existing IDIQ contracts. In addition, the Government seeks capability in producing stained slides from fixed rodent tissues. OBRRTR seeks professional histopathology services, including evaluation of tissue slides for appearance of pathological abnormalities associated with infection and generation of an audited pathology report of the findings, as well as preparation of stained slides derived from fixed rodent tissues.  The evaluation of slides should be performed by a board-certified veterinary pathologist and the preparation of the slides should be performed by experienced histopathology technicians. Studies should be tracked using Provantis or similar non-clinical evaluation software.  Although these are specialized requirements, they are not unique as there are vendors in the commercial marketplace that can provide these services. 

These services will be dependent on slides and tissues provided by contractors in the Preclinical Models of Infectious Diseases IDIQ pool.  As such, the schedule and throughput of the services to be contracted here may be affected by and may affect the schedule and throughput of these other contractors.

The base period is expected to include five (5) studies evaluating tissue pathology. The Option period is expected to include five (5) studies evaluating tissue pathology. Each period includes the optional task of producing stained slides from fixed rodent tissues and evaluation of tissue pathology. The typical number of animals per study is sixty (60); some studies will have a maximum size of seventy (70). There will be up to four (4) slides of tissues per animal. The target tissues may be lung, liver, spleen or brain.

Delivery and Anticipated Period of Performance

Base Period:               9/3/2024 – 9/2/2025

Option Period 1          9/3/2025 – 9/2/2026

Deliverables are due 30 days after receipt of prepared slides and 60 days after receipt of fixed tissues.

Options

Additional option quantities will be included in this order during both the base and option periods. In each period, there will be 10 options for 1 additional study evaluating tissue pathology. In each period, there will be 5 options for 1 additional study requiring production of stained slides from fixed rodent tissues and evaluation of tissue pathology.

Capability Statement/Information Sought

If your organization has the potential capacity to provide the required histopathology services, pathology reporting, and preparation of stained slides derived from fixed rodent tissues, which meet the minimum requirements and performance capabilities listed above and in the attached Draft Statement of Work (SOW), please provide the following information:

1. Organization name, address, point of contact, email address, website address, telephone number, UEI number
2. Company location(s) and number of years company has been in business
3. Type of business (e.g., 8(a), HUBZone, Other than Small, etc.)  pursuant to the applicable NAICS code
4. Type of ownership for the organization
5. Identification of any Best-In-Class contract vehicles including Government Wide Acquisition Contracts (GWAC) (e.g., GSA schedule) they may possess or are aware of that would support this possible requirement. If your organization does not provide the products/services under a GWAC, please identify availability as OPEN MARKET ONLY.
6. Tailored capability statement addressing the capability to meet NIAID’s minimum requirements as outlined in the Draft SOW. Capability document must be no more than six pages.
7. Evidence of personnel with the following required credentials and experience:
   1. Doctor of Veterinary Medicine from an accredited school of veterinary medicine (or similar if degreed from a foreign institution; must document equivalence of the degree requirements). 
   2. Board certification in Veterinary Pathology through the American College of Veterinary Pathologists (or similar organization if degreed from a foreign institution; must document equivalence of the certifications).
   3. Documented experience in pathology associated with laboratory animal species (e.g., American College of Laboratory Animal Medicine (ACLAM) diploma).
8. Documented experience with:
   1. Generating Good Laboratory Practice (GLP) quality pathology reports, including effective imaging of key physiological structures
   2. Identifying and describing histopathological features of respiratory infections
   3. High-throughput analysis of prepared slides
   4. Quality control and quality assurance standards and their successful implementation
9. Please describe any customary commercial contract terms or conditions that you feel would make any resulting contract more effective if applicable.

Submission Instructions

Interested businesses who consider themselves qualified to meet NIAID’s requirement are invited to submit a response to this Sources Sought Notice by August 19, 2024, at 11:00 AM ET. All responses under this Sources Sought Notice must be emailed to seth.schaffer@nih.gov.

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in SAM.gov.  However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).