B01 Request for Information (RFI) Chemical Compound disposition.pdf

Request for Information PANDHA-26-P-0000-043362 Small Molecule Compound Library Storage

SUBJECT: Small Molecule Compound Library Storage

REQUIRING ACTIVITY NAME: Walter Reed Army Institute of Research (WRAIR), Center for Infectious Disease Research

THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR

QUOTATIONS (RFQ); IT IS STRICTLY A REQUEST FOR INFORMATION (RFI).

NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL

BE CONSIDERED IN RESPONSE TO THIS REQUEST FOR INFORMATION (RFI). NO

CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT.

DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly.

Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained.

RFI AVAILABILITY: In accordance with FAR Part 10 Market Research, this RFI is to ensure responsible and constructive exchanges with industry while complying with existing law and regulation that does not provide an unfair competitive advantage to particular firms or violate the procurement integrity requirements.

This RFI is being made available through the following platforms to maximize market research to target Prime Contractors to perform:

• SAM.Gov

CAPABAILITY STATEMENT INSTRUCTIONS: Interested parties are asked to respond to this RFI and submit a capabilities statement that supports the focus of this RFI.

Please submit written responses via email in Microsoft Office or PDF format. All responses should be complete: in 12-point font; and not to exceed 5 pages total, including graphics, tables, and appendices.

No hard copies shall be accepted. No written solicitation document is available at this time. Telephone requests will not be honored, and no bidders list shall be maintained.

CURRENT OPERATIONAL ENVIROMENT: The Government’s chemical inventory is currently maintained at a contractor-owned and contractor-controlled facility (Specs Chemical Services, LLC.). The inventory includes unique chemicals that are actively being processed under a separate disposal contract expected to continue through approximately March 2028. Because the storage inventory and the materials undergoing disposal are intermingled, respondents should describe their proposed approach for assuming responsibility for the storage requirement, including any access requirements to contractor-controlled facilities, transition methodology, required Government support, schedule impacts, and associated risks.

RFI QUESTION: If your firm is not the current storage contractor, describe how your firm would accomplish transition of the storage requirement while the chemical inventory remains co-located and intermingled with materials subject to the ongoing disposal contract at a contractor-owned facility. Adress any assumptions regarding access to contractor-controlled property, segregation of inventory, transfer of custody, schedule, cost, regulatory compliance and safety.

CONTACT INFORMATION: No questions will be addressed. All information regarding Capabilities Statements or any other proprietary information relative to this RFI shall be submitted via email to sharew.hailu.civ@health.mil and jaclyn.p.diaz.civ@health.mil no later than 10:00AM EST on Wednesday, 22 July 2026.

REQUIREMENT BACKGROUND AND TASKS

This is a non-personal services contract to provide storage and management of the Walter Reed Army Institute of Research’s (WRAIR) small molecule compound library for the WRAIR, Center for Infectious Disease Research (CIDR).

Description of requirement/introduction: The contractor shall provide the personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and all other items and non-personal services necessary to perform Small Molecule Compound Library.

Over its rich history of research and drug development, WRAIR amassed a collection of small molecule compounds that contained approximately 400,000 samples with nearly 300,000 unique chemical structures. This collection includes molecules that have been acquired from a variety sources, but many have been synthesized specifically for drug development research conducted at the WRAIR and are not available from other sources. In conjunction with this compound library, the WRAIR maintains a proprietary database of efficacy and ADMET (absorption, distribution, metabolism, excretion and toxicology) data from research that has been conducted using these compounds. The WRAIR continues to use this data and this compound library in ongoing drug development and discovery efforts.

In 2025, the WRAIR began a project to optimize and downsize this collection with the goal of retaining a chemically diverse screening library of 25,000 compounds and up to 3,000 additional compounds that directly support active or recent research projects. The optimization and downsizing of the collection are independent from this award, but samples pending disposal under that contract will require storage under this requirement pending their disposal, which is scheduled to be completed in March 2027.

Furthermore, the retention of an additional 25,000 compounds from the full collection is mailto:sharew.hailu.civ@health.mil mailto:jaclyn.p.diaz.civ@health.mil currently being considered for a special short-term project that would require their storage for one to two years followed by their disposal.

Objectives: The objective of this contract is to store and manage the WRAIR’s current collection of compounds, as well as new molecules acquired by the WRAIR for drug development research, and to provide services to allow the use of the compounds by the WRAIR researchers and its collaborators.

Scope: The scope of this work is to provide management and secure storage of chemical samples under appropriate environmental conditions and to prepare and ship requested amounts of these chemical samples to the WRAIR or its collaborators at various Continental United States (CONUS) or Outside the Continental United States (OCONUS) locations. The contractor shall maintain a full inventory of samples on hand that includes amount of material remaining. Up to 53,000 containers of chemicals may be retained for storage for the full contracting period, with an additional 100,000 containers stored through their disposal scheduled to be completed by the end of March 2027. An average of 500 new samples shall be received per year, and the contractor shall distribute approximately 1,000 samples per year.

Period of Performance (PoP):

Base Period December 10, 2026 - December 9, 2027

Option Period One December 10, 2027 – December 9, 2028

Option Period Two December 10, 2028 - June 9, 2028

Place of performance: The majority of work shall be performed off-site at the Contractor’s facility located at Specs Chemical Services, LLC 14900 Burbridge Rd SE, Cumberland, MD.

General Requirements

The Contractor shall provide all the necessary personnel, facilities, supplies and resources necessary to perform the requirements listed below.

For the purpose of receipt and storage of compounds, a sample shall be considered any non-separable container that contains one or more chemical compounds. For example, a multi-well plate constructed from a single piece of plastic shall be considered a single sample, but each compound in a multi-well plate with removable inserts that require separate management would be a unique sample.

For the purposes of preparation of compounds for shipment, a sample shall be considered any individual chemical compound that must be prepared individually for shipment. When an entire container is requested for shipment, the entire container shall be considered a single sample, regardless of whether the container is separable. For example, if multiple compounds are requested and the contractor weighs and transfers them into inserts into a multi-well plate for shipment, each compound would be considered a sample, but if a multi-well plate that is already in inventory is requested without any transfer of material, the entire plate, even if the plate has removable inserts, shall be considered a single sample.

The contractor shall not be required to receive or store any compounds or substances regulated by the United States Drug Enforcement Administration (DEA). This includes those scheduled in 21 C.F.R. § 1308 and § 1310.02 or listed on the schedules of The United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances; or The United Kingdom Misuse of Drugs Act. regulated by the United States Department of Transportation (DOT) as a Class 1 Explosive or Class 7 Radioactive material restricted by the Chemical Weapons Convention (CWC).

The contractor shall provide a quarterly report to the COR that includes:

• Summary of activities during the reporting period

• Inventory Data: number of containers in inventory, total change in inventory since previous report, number of new containers received, number of samples shipped

• Quarterly Chemical Evaluation Report

• List of Disposed Containers

• Results of inventory audits

Compliance Requirements

The contractor shall adhere to and be in compliance with all of the most up-to-date, relevant regulations and guidelines and shall possess the necessary licenses and permits for Small Molecule Compound Library Storage including the storage and shipment of compounds and chemical samples. At a minimum the contractor shall meet the following requirements:

• The contractor shall store and ship compounds according to all applicable federal, state and local regulations.

• The contractor shall have the capability to ship all materials from the state in which the Small Molecule Compound Library Storage is located to CONUS and OCONUS locations. Use of commercial shipping services is an acceptable means to meet this requirement.

The contractor shall review incoming chemicals for:

• DOT Shipping Restriction

• DEA Schedule Drugs

• Chemical Warfare Convention

• Facility specific storage policies and regulations

The contractor shall notify the COR and submitter of any regulatory or safety concerns of compounds prior to shipment of compounds.

If a shipment is sent to the repository prior to review of chemical structures by the contractor, the contractor shall reject receipt of the shipment, unless an immediate review can be completed to ensure that there are no regulatory or safety concerns with the arriving samples.

Storage of Compounds and Chemicals Samples

The contractor shall store and maintain under the following appropriate storage conditions:

• Up to 28,000 containers including the WRAIR’s optimized screening library and chemical samples from active studies

• Compounds awaiting disposal under contract HT942525PE050, scheduled to be completed by March 31, 2027.

• Up to 25,000 containers of compounds designated for special projects

New compounds and chemical samples that are received throughout the period of performance of this agreement, as described below in section (Receipt of New Compounds and Chemical Samples).

The contractor shall use a Laboratory Information Management System (LIMS) to maintain relevant, accurate, and current records including, but not limited to, identity, amount on hand, physical location, shipping history, and sample and container identifiers that cross reference to the WRAIR records for all compounds and chemical samples in stock.

The contractor shall provide on at least a monthly basis or make available for download through a web-based system updated inventory records in an open source, machine readable file format that can be used to update the WRAIR in-house records.

The contractor shall store compounds under applicable federal, state, and local regulations.

The contractor shall store the chemical samples under their individual required storage conditions at -20 °C or room temperature and monitor the storage conditions to guarantee continuous proper storage.

The contractor shall develop Safety Data Sheets (SDSs) as needed for all samples shipped from the Small Molecule Compound Library Storage.

The contractor shall utilize a mechanism for sample control and tracking that logs all sample access and container movements.

The contractor shall conduct audits at least annually of empty positions in the inlays and all containers accessed since the previous audit to ensure correct bottle positioning.

The contractor shall propose and implement a quality control assessment procedure for identifying compounds that should be disposed of, which includes but is not limited to old and expired samples, polymerized samples, and decomposed samples.

Receipt of New Compounds and Chemical Samples

The contractor shall provide a web-interface that allows the WRAIR researchers to electronically submit all required data for compounds to be added to the WRAIR’s collection of chemical samples being stored at the contractor’s facility.

The contractor shall provide shipping of chemicals to the Small Molecule Compound Library Storage from the WRAIR, its partners, or collaborators from various CONUS or OCONUS locations.

Shipping and delivery expenses provided by third party couriers or commercial delivery services shall be on a cost reimbursable basis as an ODC. The contractor shall be required to provide documentation of costs in the form of the third-party invoices with shipping and delivery receipts.

The contractor shall ensure all shipping conforms to all laws and regulations governing the shipping of hazardous substances and drugs and will provide all required shipping labels and instruction as needed on how to properly package and ship samples to meet laws and regulatory requirements.

The contractor shall refuse shipment and immediately notify the COR of any compounds or substance which cannot be received or stored at the contractor’s facility due to any relevant laws, regulatory requirements, or licensure requirements or which are outside the scope of this agreement.

Upon receipt of compound or chemical samples, the contractor shall review the accuracy of the submitted records versus what was received and notify the COR if there are any discrepancies, and upon verification of the COR, take any necessary corrective action in the contractor’s LIMS.

The contractor shall receive and in-process approximately 500 new compounds or chemical samples annually. Compounds and chemical samples sent to the Small Molecule Compound Library Storage will be in various forms including but not limited to vials, jars, and plates, and will vary in size from a few milligrams to kilograms, with the majority being less than 100 milligrams.

The contractor shall process receipt of new compounds within one (1) business day of arrival at the contractor’s facility.

The contractor shall print and affix a barcode label that matches the barcode in the WRAIR’s records to any sample that does not already have a readable barcode.

The contractor shall be prepared to handle surge capacity to receive up to 500 additional new samples annually. These additional samples shall be above the baseline specified and shall be invoiced against a surge Contract Line-Item Number

(CLIN).

Compound Preparation, Shipping and Delivery

The contractor shall provide a web-based ordering interface that allows the WRAIR researchers to view inventory and place orders for samples stored at the contractor’s facility.

The ordering interface shall confirm availability of the requested amounts at the time of order.

The contractor shall prepare and ship up to 1,000 compounds and chemical samples annually as requested by the WRAIR Small Molecule Program to the WRAIR and its partners and collaborators in various CONUS and OCONUS locations. Shipment sample sizes are typically in the 1 mg to 5 g range, though larger amounts may be requested on an as needed basis.

The contractor shall ensure timely preparation and shipment of compound orders.

Shipments to locations in the Maryland, D.C., and Virginia areas shall be processed, shipped, and received within three business days. Shipments to any other CONUS or OCONUS locations shall be processed and shipped out within 2 business days.

The contractor shall transfer the requested amount of compound or chemical sample to shipping containers. Amounts delivered shall be within a 10 percent (%) coefficient of variance (CV) of the requested amount.

The contractor shall record and provide the actual mass of samples with each shipment to the appropriate level of precision. For samples requested below 5 mg, the precision must be within 10 %. For samples greater than 5 mg, the contractor shall weigh samples within the specifications of the balance or as directed by the

WRAIR.

Balance(s) used for measurement shall be calibrated according to the manufacturer’s specifications and shall have an accuracy of ± 1 % for the mass of compound being requested.

The contractor shall ensure all compound and chemical samples are properly packaged in an appropriate container based on sample size and chemical reactivity.

The contractor shall provide all sample and shipping containers, and any other supplies necessary to ensure the safe shipping and arrival of each package shipped.

The contractor shall provide special handling for heat and/or light sensitive and labile chemicals and drugs. Compounds and chemical samples requiring dry ice shall be sent by express carriers.

The contractor shall ensure all shipping conforms to all laws and regulations governing the shipping of hazardous substances and drugs.

The contractor shall provide paper copies of compound information, Safety Data Sheets (SDS) and any other required documents with the shipment of samples when needed or requested by the Government.

The contractor shall email electronic copies of the shipment packing list that includes the order number, the container barcodes, the source container barcodes and lot numbers, the mass of each sample, and other relevant data as requested by

WRAIR.

The contractor shall be prepared to handle surge capacity to prepare and ship up to 1,000 additional samples annually. These additional samples shall be above the baseline specified (Shipment sample sizes are typically in the 1 mg to 5 g range, though larger amounts may be requested on an as needed basis) and shall be invoiced against a surge CLIN.

Evaluation of chemicals

The contractor shall evaluate all compounds being sent to the repository prior to shipment and all chemicals stored at the repository to ensure compliance with all relevant safety and regulatory concerns for storage at the contractor’s facility.

The contractor shall provide a chemical evaluation that provides the procedures that will be utilized for evaluation of safety and regulatory compliance that includes:

• Procedures that will be utilized for evaluation of safety and regulatory compliance

• Software that will be utilized

• Procedures that will be used to ensure knowledge bases are kept up to date for current regulatory requirements

• List of regulatory policies that will be assessed

The contractor shall use a software tool such as ChemAxon’s Compliance Checker, or equivalent, to assess structures for regulatory compliance for all incoming samples and for the full collection on a quarterly basis with the most recently published policy updates. Additional software tools may also be used for other assessments at the discretion of the contractor.

The contractor shall provide an assessment report of each chemical evaluation (incoming samples and quarterly evaluation) that includes:

• the sample barcodes that were assessed,

• the procedure used to complete the assessment,

• the version of any software used,

• the date of regulatory standards used in the assessment

• the date the assessment was completed

• all findings identified

• justification for any finding determined to be false positive

Assessment reports for incoming samples shall be provided at time of assessment, and reports for quarterly chemical evaluations shall be included in the quarterly report.

Plating Services

The contractor shall provide plating services for solubilization, QC analysis, and reformatting services for three plating projects as described below:

• Base Year: Up to 25,000 samples to include solubilization, QC analysis, and reformatting.

• Base Year: Up to 15,000 samples to include solubilization and reformatting. Results of QC analysis performed by WRAIR shall be used to guide wells that need to be reformatted.

• Option Year 1: Up to 25,000 samples to include solubilization, QC analysis, and reformatting.

Solubilization, QC analysis and reformatting services may be requested separately by the Government (e.g. samples that are plated and solubilized may not require QC analysis or reformatting by the contractor).

Solubilization

The contractor shall provide solubilization services to weigh out and solubilize samples to be placed in 96-well plates.

The contractor shall weigh out the samples to be plated and record the mass to 3 significant digits.

The contractor shall adjust solvent volume added to each sample using the recorded masses to obtain the requested final concentration.

The contractor shall solubilize samples in dimethyl sulfoxide (DMSO) unless a different solvent is mutually agreed upon.

The contractor shall create a stock plate and one daughter plate for QC analysis from each completed stock plate.

The contractor shall provide data files containing compound information, including WRAIR lot numbers, final concentration, solvent, plate/well locations, and other relevant data in a mutually agreed upon format, such as comma separated value (csv) text files or Microsoft Excel (xlsx) files.

QC analysis

The contractor shall evaluate the quality of each plated sample using a liquid chromatography/mass spectrometry (LC/MS) analysis.

The contractor shall determine the mass and percent purity of each plated compound.

The contractor shall provide data files containing compound information and results of the QC analysis in a mutually agreed upon format, such as comma separated value (csv) text files or Microsoft Excel (xlsx) files.

Reformatting and Replating

The contractor shall provide reformatting services to create new master plates based on cherry picked, plated samples that passed the QC analysis or met other criteria, as determined by WRAIR.

The contractor shall transfer samples from approximately 65% of wells from original master plates to the reformatted master plates.

The contractor shall create a master plate and five daughter assay plates from each completed master plate after it has been reformatted.

Disposal services

The contractor shall provide three tiers of disposal service:

• The contractor shall dispose of up to 500 containers per year of waste chemicals not regulated under the Resource Conservation and Recovery Act (RCRA) as hazardous waste as part of the base operations for storage and maintenance of the compound collection.

• The contractor shall dispose of additional waste chemicals not regulated under RCRA in excess of the 500 containers listed above (paragraph a.)

and any waste chemicals containing RCRA regulated hazardous waste on a cost reimbursable basis as an ODC.

• The Contractors shall dispose of up to 25,000 compounds at the conclusion of special projects.

The contractor shall assess the DOT shipping restrictions and waste categories for all lists of compounds and chemical samples and other waste recommended for disposal and determine if they can be disposed through standard chemical waste disposal or will need to be disposed of as an ODC.

Containers requiring disposal may be identified by the contractor or the government, but the contractor shall provide a list of containers with the tier of disposal service and planned method of disposal for review by the government prior to disposal.

The Contractor shall categorize compounds for disposal and shipment based on criteria to include the RCRA, DOT shipping regulations, and all other relevant federal, state or local laws and regulations.

The Contractor shall make waste determinations in accordance with Environmental Protection Agency (EPA) and Maryland Department of Environment (MDE) guidelines for all samples designate as waste.

The contractor shall manage, coordinate, package, transport and dispose of all samples designated as waste in accordance with EPA and MDE.

The contractor shall coordinate disposal through a waste disposal company that has all necessary licenses and permits to transport, treat, and dispose of the hazardous and non-hazardous waste that is generated through this effort.

For waste material regulated by RCRA, the contractor shall adhere to treatment standards listed in 40 CFR 268.40 for disposal decisions. However, prioritization for all waste should be given to recycling or destruction by incineration when possible.

Any disposal of samples at a landfill shall be by exception and will require approval by WRAIR’s or the Medical Research and Development Command’s (MRDC) Environmental Compliance Office.

The contractor shall prioritize recycling samples when available. WRAIR encourages the contractor to recycle any unused commercial chemical products. Recycled chemicals may not be subject to RCRA control (40 CFR 261.2 and 40 CFR 261.4).

The contractor shall adhere to all transportation and packaging requirement per 49 Code of Federal Regulations (CFR).

The contractor shall prepare and provide all required Uniform Hazardous Waste Manifests to all required parties (EPA, Generators, Transporter, etc.) per 40 CFR 262.

The contractor shall prepare and provide Shipping Documentation required under 49 CFR 172, or similar, in the event, the above Uniform Hazardous Waste Manifests, is not required.

The contractor shall provide the COR with electronic copies of all disposal documentation including Manifests, Land Disposal Restrictions, Return Manifests, Certificate of Disposal, etc.

The contractor shall clean up and remediate any spills or release of waste resulting from the work outlined in the PWS and shall properly dispose of remediation waste in accordance with all applicable federal, state, and local laws and regulations.

The contractor shall include a listing of all disposed containers as part of the quarterly report for any reporting period that containers were disposed in.

The Contractor shall conduct post-disposal housekeeping activities for any disposal effort that includes removal of greater than 10% of the containers on hand. These housekeeping activities shall include:

• The Contractor shall realign retained containers in the storage units to minimize storage space.

• The Contractor shall perform a 100% physical inventory of all remaining containers to ensure 100% accountability.

• The Contractor shall provide a final inventory report shall be provided to the COR upon completion of the inventory that includes the final position of all samples within the inlays in the Contractor’s storage unit.

Transition Services

The final option period for this award is envisioned as a six-month transition period that will only be fully executed in the event that the incumbent is not awarded a follow-on contract at the end of option period one.

The contractor shall implement the transition plan to include packaging and shipping of all WRAIR samples to their future location. The contractor shall assist the Government in planning and implementing a complete transition from this contract to a future provider. This shall include formal coordination with Government staff, successor staff, and management; delivery of copies of existing policies and procedures; and delivery of required documents, metrics, and statistics. The transition-out plan shall include, but is not limited to, the following items:

• Coordination with Government representatives.

• Review, evaluation, and transition of current support activities.

• Transition of historical data.

• Transfer of all business and technical documentation.

• Transfer of inventory and historic shipping records

• Preparation of Government samples for shipment

• Provide final summary report.

Shipping shall be by commercial carriers as a cost reimbursable ODC.

Alignment of services to anticipated CLINs:

CLIN Description Level of Services 0001 Storage and Management of Base

Collection Store: 28,000 containers Process/Ship: 1000 containers Receive: 500 containers Dispose: 500 containers

(ODC)

Other Direct Costs (Shipping/Disposal)

Commercial Shipping Chemical Waste Disposal

(OPTION)

Surge Capacity for Base Operations Process/Ship: 1000 containers Receive: 500 containers

(OPTION)

Storage and Management of Compounds Designated for Special Project

Store: 25,000 containers

(OPTION)

Disposal of Compounds at Conclusion of Special Project

Dispose: 25,000 containers Housekeeping Activities

(OPTION)

Housekeeping Activities following special project disposal

Realign storage and 100% inventory

(OPTION)

Plating Services Project with QC Solubilization: 25,000 samples QC Analysis: 25,000 samples Reformatting: 16,250 samples Daughter Plating: 5 /master plate

(OPTION)

Plating Services Project without QC Solubilization: 15,000 samples Reformatting: 9,750 samples Daughter Plating: 5 /master plate

0009 Storage and Management of Compounds Awaiting Disposal

Store: 100,000 containers

1001 Storage and Management of Base Collection

Store: 28,000 containers Process/Ship: 1000 containers Receive: 500 containers Dispose: 500 containers

(ODC)

Other Direct Costs (Shipping/Disposal)

Commercial Shipping Chemical Waste Disposal

(OPTION)

Surge Capacity for Base Operations Process/Ship: 1000 containers Receive: 500 containers

(OPTION)

Storage and Management of Compounds Designated for Special Project

Store: 25,000 containers

(OPTION)

Disposal of Compounds at Conclusion of Special Project

Dispose: 25,000 containers Housekeeping Activities

(OPTION)

Housekeeping Activities following special project disposal

Realign storage and 100% inventory

(OPTION)

Plating Services Project with QC Solubilization: 25,000 samples QC Analysis: 25,000 samples Reformatting: 16,250 samples Daughter Plating: 5 /master plate

2001 Storage and Management of Base Collection

Store: 28,000 containers Process/Ship: 500 containers Receive: 250 containers Dispose: 250 containers

(ODC)

Other Direct Costs (Shipping/Disposal)

Commercial Shipping Chemical Waste Disposal

(OPTION)

Surge Capacity for Base Operations Process/Ship: 500 containers Receive: 250 containers

(OPTION)

Storage and Management of Compounds Designated for Special Project

Store: 25,000 containers

(OPTION)

Disposal of Compounds at Conclusion of Special Project

Dispose: 25,000 containers

2006 Preparation of Collection for Relocation

Package: 28,000 containers