B01 Request for Information Chemical Compound disposition.pdf

SUBJECT: Small Molecule Compound Collection Optimization and Disposal

REQUIRING ACTIVITY NAME: Walter Reed Army Institute of Research (WRAIR), Experimental Therapeutics Branch

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

• General Services Administration (GSA)

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 review the place of performance requirements. 1.6 Place of Performance:

The work to be performed under this contract will be performed at the Contractor’s facilities in Cumberland, MD.

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 hardcopies 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.

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.svincek.civ@health.mil no later than 11:00AM EST on Thursday, 24 July 2025.

mailto:sharew.hailu.civ@health.mil mailto:jaclyn.p.svincek.civ@health.mil

DRAFT PWS

PERFORMANCE WORK STATEMENT (PWS)

Small Molecule Compound Collection Optimization and Disposal for

Walter Reed Army Institute of Research (WRAIR), Experimental Therapeutics Branch

8 July 2025

Part 1 General Information

1. General: This is a non-personal service(s) contract under which the personnel rendering the service(s) are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

1.1 Description of Services/Introduction: This is a non-personal service(s) contract to downsize and optimize WRAIR’s small molecule compound collection that is housed at a contractor leased and operated facility with the goal of retaining a chemically diverse screening collection of 25,000-50,000 compounds and an additional 3,000-5,000 compounds that support current research projects. Service shall include review of the current collection, identification of compounds to be disposed, and disposal of approximately 350,000-375,000 chemical samples.

1.2 Background: The Walter Reed Army Institute of Research (WRAIR) provides unique research capabilities and innovative medical solutions to a range of Force Health Protection and Readiness challenges currently facing United States (U.S.) Service Members, along with threats anticipated during future operations.

Through both times of peace and war, infectious diseases have killed, sickened, and disabled far more Service Members than bombs and bullets. WRAIR has created a model of vaccine and therapeutic development that is unique, nimble, and responsive to dynamically evolving infectious disease threats of military importance. WRAIR, with its unparalleled expertise, facilities, and international network, has developed many vaccines and drugs in use today by military and civilian medicine around the globe.

In addition to protecting against infectious disease threats, WRAIR conducts basic and applied research that promotes psychological resilience, enhances neurological functioning, and improves operational readiness among U.S. Service Members. By using a continuum of research from basic science to applied field studies, WRAIR creates innovative solutions to enhance Service Members’ resilience and recovery. Research in military psychiatry and neuroscience has been an integral part of WRAIR's portfolio for more than 70 years. WRAIR researchers are recognized leaders in operational medical research for the military in a number of fields, including brain trauma, blast exposure, deployment stressors, and sleep management.

WRAIR’s Experimental Therapeutics (ET) branch is a drug discovery and development enterprise created to protect military personnel from death, disease, and injury and meet Army and Department of Defense (DoD) mission requirements. WRAIR-ET has a 75-year legacy of excellence in small molecule drug development, with over 65 Investigational New Drug (IND) applications submitted to the U.S. Food and Drug Administrations (FDA). WRAIR-ET applies its core competencies of medicinal, synthetic, and analytical chemistry as well as clinical pharmacology to all therapeutic areas within the Medical Research and Development Command's portfolio.

WRAIR currently maintains a collection of ~400,000 small molecule samples that have been amassed over decades of drug discovery research. This collection is currently housed and maintained by a contractor in their contractor-leased, contractor-run facility in Cumberland, MD.

Due to changing research priorities, safety posture, and a constrained fiscal environment, WRAIR is currently looking to downsize and optimize the contents of the repository to yield a screening collection, with a target range of 25,000-50,000 molecules that are selected based on pharmacological properties and chemical diversity. In addition, WRAIR will retain 3,000-5,000 samples from current research projects which are stored at the repository to utilize the contractor’s compound management services. All other samples currently in the collection will be disposed of.

To reach this goal of an optimized screening collection, a significant effort is required to select current compounds in the collection for retention and then dispose of the remaining compounds.

While the chemicals stored at the repository have primarily been used for drug screening purposes, the diversity of chemicals used in legacy screens was broader than what would be considered for modern pharmacological screening. Further, the repository has also been used for storage of laboratory chemicals and reagents that are outside the scope of drug development.

Therefore, the collection has a broad range of chemical classes that must be considered when developing a disposal plan.

1.3 Scope/Period of Performance (PoP):

1.3.1 Scope: The Contractor shall provide non-personal service(s). This shall include providing personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform services as described in the Performance Work Statement (PWS) and associated contract documents. The Contractor shall perform to the standards and acceptable quality levels (AQLs) identified in this PWS and associated contract documents.

1.3.2 Period of Performance (PoP):

The PoP for this requirement shall be as follows:

Base Period 30 September 2025 – 29 September 2026 Option Period One 30 September 2026 – 30 March 2027

1.4 Objectives: The objective of this contract is to provide services to downsize and optimize WRAIR’s small molecule compound collection with the goal of retaining a chemically diverse screening collection of 25,000-50,000 compounds and 3,000-5,000 compounds that support current research projects and to dispose of all samples that are not retained. All compounds not retained will be disposed of in full compliance with all applicable laws and regulations include those of the Environmental Protection Agency (EPA), DoD, Department of Health Agency (DHA), and the Maryland Department of the Environment (MDE).

1.5 General Information:

1.5.1 Quality Control Plan (QCP):

The Contractor’s existing quality assurance system shall be utilized in accordance with Federal Acquisition Regulation (FAR) 12.208.

1.5.1.1 Analysis of quality control and timeliness of submittals (i.e., deliverables) shall be provided to the COR within 30 days upon completion of each option period or task order (A.001).

1.5.1.2 The Contractor shall inform the COR of issues or potential issues that might affect the performance within 48 hours of identifying those issues. Verbal reports shall be followed up by written reports within two days (A.002).

1.5.2 Quality Assurance: The Government will evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the AQLs (performance thresholds).

1.5.3 Recognized Holidays: The following provides information on recognized holidays for the purpose of the PWS. If submittal of any documentation (e.g., deliverables, submittals, etc.)

deadlines fall on a holiday, the closest work day prior to the holiday will apply as the deadline for submittal.

1.5.3.1 United States (U.S.) Holidays: The contractor shall not be required to perform services on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander New Year’s Day January 1st M. L. King Memorial Day 3rd Monday in Jan Presidents’ Day 3rd Monday in February Memorial Day Last Monday in May Juneteenth June 19th Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veteran’s Day November 11th Thanksgiving Day 4th Thursday in November Christmas Day December 25th

1.5.4 Operating Hours: RESERVED

1.5.5 Training Holidays: RESERVED

1.6 Place of Performance: The work to be performed under this contract will be performed at the Contractor’s facilities in Cumberland, MD.

1.7 Security Requirements: RESERVED

1.8 Program/Project Management and Reporting:

1.8.1 Post Award Conference/Periodic Progress Meetings: The Contractor shall attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The CO, COR, and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance.

At these meetings the CO will apprise the Contractor of how the Government views the Contractor's performance and the Contractor shall apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the Government.

The Contractor shall attend, participate in, and furnish input to scheduled and unscheduled meetings, conferences, and briefings that relate to the functions and services herein as required by the Government to provide effective communication and impart necessary information. The Contract Manager or designated representative shall attend meetings as requested by the Government. Meeting attendees shall at times include Contractor managerial, supervisory, and other personnel knowledgeable of the subject matter. Meetings may start or end outside of regular duty hours.

1.9 Contracting Officer’s Representative (COR): Refer to Part 2 of this PWS for the definition of a COR. As determined by the CO, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the Contractor by the CO. The designation letter states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates, or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is not authorized to obligate the Government. If the work is not written in the contract, the COR is not authorized to request new work. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract, perform inspections necessary in connection with contract performance, maintain written and oral communications with the Contractor concerning technical aspects of the contract, issue written interpretations of technical requirements, including Government drawings, designs, specifications, monitor Contractor's performance and notifies both the CO and Contractor of any deficiencies, coordinate availability of Government property, and coordinate site entry of Contractor personnel.

1.10 Key Personnel: RESERVED

1.11 Identification of Contractor Employees: All Contractor personnel attending meetings, answering Government telephones, and working in other situations where their Contractor status is not obvious to third parties must identify themselves, to include proper marking of signature blocks in correspondence, to avoid creating an impression in the minds of members of the public that they are Government officials. The Contractor shall ensure that all documents or reports, produced by Contractors are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

1.11.1 Contractor Workspace: RESERVED

1.11.2 Contractor Identification Badges: RESERVED

1.12 Contractor Travel: RESERVED

1.13 Other Direct Costs (ODCs): RESERVED

1.13.1 Invoices: The Contractor shall submit invoices monthly to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice (A.003).

1.14 Data Rights: Rights to all technical data (including, but not limited to documents and materials) and computer software (including, but not limited to source code) produced under this contract are governed by Defense Federal Acquisition Regulation Supplement (DFARS) clauses 252.227-7013, 252.227-7014, 252.227-7015, and 252.227-7019. Documents and materials produced under this contract may not be used or sold by the Contractor without written permission from the CO. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.15 Non-Disclosure Requirements: RESERVED

1.15.1 Non-Disclosure Statements: RESERVED

1.16 Protection of Government and Contract Information: Per Public Use Notice of Limitations stated by Defense Imagery Management Operations Center and contained at www.dimoc.mil/resources/limitations/, the Contractor shall not cite any information (e.g., contract information, pictures, locations, etc.) obtained through this contract on any hard copy or digital marketing tools to include its company website.

1.17 Organizational Conflict of Interest (OCI): RESERVED

1.18 Phase In /Phase Out Period: RESERVED

1.19 Safety: The following provides information pertaining to safety and accident prevention:

http://www.dimoc.mil/resources/limitations/

1.19.1 The Contractor shall maintain a safe workplace and comply with occupational health and safety rules and regulations. Contractor employees are required to attend safety training(s) relative to his/her position. The Contractor shall comply with Occupational Safety and Health Administration Standard number 1904.32 and maintain an OSHA 300A log for all reportables (greater than first aid, lost time, lost days, transfer). The Contractor shall provide a quarterly report of all mishaps, regardless of class or reportability. In addition, the Contractor shall deliver the annual OSHA 300A report by February 1 of each year. (A.004).

1.19.2 Safety Laws and Regulations: RESERVED

1.20 Environmental Compliance:

1.20.1 Individuals working with hazardous waste shall have received the following training:

• On the job or classroom instruction on the proper hazardous waste management and emergency procedures for the waste handled at the facility.

1.20.2 In case of a spill of hazardous waste, the contractor shall have personnel available with the following training:

• 40-hour Hazardous Waste Operations and Emergency Response (HAZWOPER) and be current in the recertification process. The certification(s) must be provided to the CO and COR upon award and upon any changes in personnel working on the project.

(A.005)

1.20.3 Individuals preparing shipping documents shall have received the following training:

• Department of Transportation (DOT) manifest training in accordance with 49 CFR

172 Subpart H and must be current in the recertification process. The certification(s) must be provided to the CO and COR upon award and upon any changes in personnel working on the project. (A.005)

1.21 Required Training: RESERVED

1.22 Performance or Delivery in a Foreign Country: RESERVED

1.23 Notice to Proceed: RESERVED

1.24 Electromagnetic Compatibility Directive: RESERVED

1.25 Government Property (GP) and Services: RESERVED

1.26 Conventional Forces Europe (CFE) Treaty Verification Inspection: RESERVED

PART 2

DEFINITIONS & ACRONYMS

2. Definitions and Acronyms

2.1 Definitions: Although not inclusive of every term used within this PWS, the following provides a list of definitions used throughout this PWS and commonly used in the acquisition field.

Contracting Officer (CO) – Means a person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings on behalf of the Government.

Note: The only individual who can legally bind the Government.

Contracting Officer's Representative (COR) – As defined in Defense Federal Acquisition Regulation Supplement (DFARS) 202.101, means an individual designated and authorized in writing by the CO to perform specific technical or administrative functions. DoD Instruction (DoDI) 5000.72, Part II Definitions states the following when defining a COR: “Defined in subpart 202.101 of Reference (f). Any individual delegated responsibilities pursuant to subpart 1.602-2 of Reference (e), regardless of local terminology, must be certified in accordance with this instruction. For example, local terminology can be COR, CO’s technical representative, technical point of contact, technical representative, alternate COR, administrative COR, assistant COR, line-item manager, task order manager, quality assurance personnel, quality assurance evaluator, or COR management.” In addition, AR 70-13, Chapter 2, paragraph 2-2g, states, in part, the following when providing other surveillance support personnel to assist the COR when needed, “…These other surveillance support personnel may serve as on-site representatives of the COR in performance of actual contract surveillance if they meet all COR requirements and have been appointed by the CO as alternate CORs.”

Contractor – Means a supplier or vendor awarded a contract to provide specific supplies or service to the Government. The term used in this contract refers to the prime.

Contractor-acquired Property - Means property acquired, fabricated, or otherwise provided by the Contractor for performing a contract and to which the Government has title.

Day – Means, unless otherwise specified, a calendar day.

Defective Service – Means a service output that does not meet the standard of performance associated with the Performance Work Statement.

Deliverable – Means anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

Government-furnished Property – As reflected in FAR 52.245-1, Government-furnished Property “means property in the possession of, or directly acquired by, the Government and subsequently furnished to the Contractor for performance of a contract. Government-furnished property includes, but is not limited to, spares and property furnished for repair, maintenance, overhaul, or modification. Government-furnished property also includes Contractor-acquired property if the Contractor-acquired property is a deliverable under a cost contract when accepted by the Government for continued use under the contract

Government Property (GP) - Means all property owned or leased by the Government.

Government property includes both Government-furnished and Contractor-acquired property.

Government property includes material, equipment, special tooling, special test equipment, and real property. Government property does not include intellectual property and software.

Property Administrator - Means an authorized representative of the CO appointed in accordance with agency procedures, responsible for administering the contract requirements and obligations relating to Government property in the possession of a Contractor.

Physical Security – Means that part of security concerned with physical measures designed to safeguard personnel; to prevent unauthorized access to equipment, installations, material, and documents; and to safeguard against espionage, sabotage, damage, and theft.

Quality Assurance (or Government Contract Quality Assurance) – Means the various functions, including, inspection, performed by the Government to determine whether a Contractor has fulfilled the contract obligations pertaining to quality and quantity.

Quality Assurance Surveillance Plan (QASP) – Means the key Government-developed surveillance process document, and is applied to Performance-Based Service Contracting (PBSC). The QASP is used for managing Contractor performance assessment by ensuring that systematic quality assurance methods validate that Contractor quality control efforts are timely, effective, and are delivering the results specified in the contract or task order. The QASP directly corresponds to the performance objectives and standards (i.e., quality, quantity, timeliness) specified in the PWS. It provides specific details on how the Government will survey, observe, test, sample, evaluate, and document Contractor performance results to determine if the Contractor has met the required standards for each objective in the PWS. The QASP, with very few if any exceptions, is an internal to Government document.

Quality Control – Means all necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

Statement – Means the specific results-based activities required to satisfy HLOs. A statement contains a result, the context of the statement, and the required action(s). Statements focus on “what” is to be accomplished; however, they are not prescriptive in describing “how” the outcome is to be achieved. Each HLO may have several statements to flesh out the areas necessary to meet the objective. Statements are similar to Level 3 in a Work Breakdown Structure.

Subcontractor – Means one that enters into a contract with a prime Contractor. The Government does not have privity of contract with the subcontractor.

Work Day - The number of hours per day the Contractor provides services in accordance with the contract.

Work Week - Monday through Friday, unless otherwise specified.

2.2 Acronyms: Although not inclusive of every term used within this PWS, or that may be included in an acquisition, the following provides a list of acronyms commonly used in the acquisition field.

AHA Activity Hazard Analysis AO Authorizing Official AOR Area of Responsibility AQL Acceptable Quality Level AR Army Regulation CAC Common Access Card CFR Code of Federal Regulations CO Contracting Officer COR Contracting Officer’s Representative COMAR Code of Maryland Regulations CUI Controlled Unclassified Information DA Department of the Army DFARS Defense Federal Acquisition Regulation Supplement DHA Defense Health Agency DoD Department of Defense DoDD Department of Defense Directive DOT Department of Transportation ET Experimental Therapeutics Branch EPA Environmental Protection Agency FAR Federal Acquisition Regulation FDA U.S Food and Drug Administration GFP Government Furnished Property GP Government Property HAZWOPER Hazardous Waste Operations and Emergency Response HIPAA Health Insurance Portability and Accountability Act of 1996 IA Information Awareness IAC Installation Access Control IACO Installation Access Control Office IACS Installation Access Control System IAVA Information Assurance Vulnerability Alert IAVB Information Assurance Vulnerability Bulletins ID Identification IGE Independent Government Estimate IT Information Technology IND Investigational New Drug JTR Joint Travel Regulation LQG Large Quantity Generator

MD Medical Devices MDE Maryland Department of the Environment MDS Medical Device System OCI Organizational Conflict of Interest ODC Other Direct Costs OEM Original Equipment Manufacturer OSHA Occupational Safety and Health Administration OPSEC Operations Security PII Personally Identifiable Information PoP Period of Performance PRS Performance Requirements Summary PWS Performance Work Statement QASP Quality Assurance Surveillance Plan QCP Quality Control Program RA Requiring Activity RCRA Resource Conservation Recovery Act SAM System for Award Management SCR Service Contract Report STIG Security Technical Implementation Guides SME Subject Matter Experts SMILES Simplified Molecular Input Line Entry System SQG Small Quantity Generator TMDE Test, Measurement, and Diagnostic Equipment TSD Treatment, Storage, Disposal USAMRDC United States Army Medical Research and Material Command U.S. United States U.S.C. United States Code WAWF Wide Area Work Flow WRAIR Walter Reed Army Institute of Research

PART 3

GOVERNMENT PROPERTY (GP) AND SERVICES

3. Government Property and Services RESERVED

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. Contractor Furnished Property and Services

4.1 General: The Contractor shall furnish all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform services as described in the PWS and associated contract documents.

4.2 Secret Facility Clearance: RESERVED

4.3 Materials: The Contractor shall provide all materials needed in the performance of this contract.

4.4 Vehicles and Equipment: The Contractor shall provide all necessary vehicles and equipment to perform the work described in this PWS. Contractor's vehicles and equipment used in the performance of this contract shall meet all local, state and federal traffic, safety, and environmental requirements. The Contractor shall not use any Government-owned tools, materials, or parts to maintain Contractor vehicles and equipment without prior written approval of the CO. The COR may inspect the Contractor’s vehicles and equipment at any time.

4.5 Background Checks: RESERVED

PART 5

SPECIFIC TASKS

5.1 Basic Services: The Contractor shall provide services for downsizing and optimizing WRAIR’s small molecule compound collection that is currently stored at a contractor’s facility in Cumberland, MD in accordance with contract W81XWH-22-C-0014. Service shall include review of all samples in the current collection, identification of compounds to be disposed of, and disposal of approximately 350,000-375,000 chemical samples in accordance with all applicable laws and regulation, include those of the EPA and MDE. The contract shall also perform house-keeping activities on the remaining samples to optimize storage and usability of the retained collection.

5.2 Tasks: Tasks consist of the following:

5.2.1 Develop a Disposal Plan

5.2.1.1 The contractor shall develop a Disposal Plan (A.006) that includes:

a. The schedule

b. Processes that will be used to characterize waste for samples that have an available chemical structure [Simplified Molecular Input Line Entry System (SMILES)] or a resolvable chemical or product name

c. Processes that will be used to characterize waste for samples that do NOT have an available chemical structure (SMILES) or a resolvable chemical or product names

d. Documentation of accreditation for chemical waste characterization testing

e. Name and documentation of licensing and permits for company that will transport waste

f. Processes that will be used for treatment and/or disposal of samples

g. Locations and names of treatment, storage, and disposal (TSD) company that will be used

h. Documentation of licensing and permits for TSD company that will be used

i. Example disposal documents including Manifests, Land Disposal Restrictions, Return

Manifests, Certificate of Disposal, etc.

5.2.1.2 The contractor shall be cognizant of the amount of waste generated at their facility monthly and shall ensure that they meet all applicable EPA and MDE regulations for the quantity of waste being generated and accumulated at their facility.

a. The contractor shall be cognizant of the three categories of Resource Conservation Recovery Act (RCRA) generators that are differentiated by the amount of hazardous waste they generate per calendar month. Specific requirements for generators can be located in 40 CFR 262. The generation quantities associated with each generator type are:

Requirement Large Quantity Generator Small Quantity Generator Very Small Quantity Generator

Monthly hazardous waste generation rate

≥1,000 kg/mo nonacute waste ≥1 kg/mo acute wastes ≥100 kg/mo acute cleanup residues

>100 but <1,000 kg/mo nonacute waste ≤1 kg/mo acute wastes ≤100 kg/mo acute cleanup residues

≤100 kg/mo nonacute wastes ≤1 kg/mo acute wastes ≤100 kg/mo acute cleanup residues

b. The contractor shall be cognizant of the two categories of MDE generators, differentiated by the amount of hazardous waste they generate per calendar month or accumulate at any time. Specific requirement for generators can be located in Code of Maryland Regulations (COMAR) 26.13.03. The generation quantities associated with each generator type are:

Requirement Fully regulated Maryland Small Quantity Generator Monthly hazardous waste generation rate

≥100 kg/mo nonacute waste or ≥1 kg/mo acute wastes or ≥100 kg/mo acute cleanup residues

≤100 kg/mo nonacute wastes and ≤1 kg/mo acute wastes and ≤100 kg/mo acute cleanup residues

5.2.1.3 The contractor shall ensure that in any calendar month their operating schedule does not generate or accumulate hazardous waste in amounts that exceed the thresholds for which they are able to operate under according to EPA and MDE regulations.

a. If the contractor operates as a Small Quantity Generator (SQG) or a Large Quantity Generator (LQG), the contractor shall provide copies of their RCRA Site ID and documentation of compliance. (A.007)

b. If, during the assessment and categorization of samples, the contractor determines that the disposal of the samples specified within the PWS cannot be accomplished within the specified Period of Performance (POP) without exceeding the thresholds of the EPA or MDE quantity generator level that the contractor’s facility is currently able to operate under, the contractor shall notify the COR and CO immediately.

5.2.2 Assessment of Collection for Chemical Disposal Decisions

5.2.2.1 The contractor shall complete an assessment of the current collection and designate which samples will be disposed of. The contractor shall perform this assessment for all samples in the collection guided by criteria listed in the PWS and set forth by WRAIR subject matter experts (SMEs) but shall rely on their own expertise in making final disposal decisions based on agreed upon disposal criteria.

5.2.2.2 The contractor shall prioritize assessment and disposal of samples into three phases.

a. Disposal Phase 1 shall include for disposal all compounds which have safety, regulatory, or compliance concerns. Criteria for disposal shall include:

• Safety or regulatory concerns

• Non-compliance with contractor’s facility or corporate policies

• Non-compliance with WRAIR’s repository governance strategy

b. Disposal Phase 2 shall include for disposal all compounds which are not suitable for inclusion in a drug screening collection. Criteria for disposal shall include:

• Compounds with no pharmacological value

• Compounds not in a format that is suitable for research (e.g. formulated drugs)

• Degraded compounds

• Insufficient quantity on hand

c. Disposal Phase 3 shall include for disposal all compounds not already disposed of in phase 1 or phase 2, and which will not be retained for the drug screening collection or in support of current research projects.

WRAIR will provide the contractor with the list of samples that are to be retained in support of current research projects. It is anticipated that this list will be approximately 3,000-5,000 samples.

The contractor shall perform cheminformatics and diversity analyses of the compounds not disposed of in Disposal Phases 1 or 2 to identify an optimized, chemically diverse drug screening collection of 25,000-50,000 compounds for retention. It is anticipated that the down-selection to the final set will be an iterative process and require feed-back from WRAIR SMEs. Criteria for selection for the drug screening collection shall include:

• Chemical diversity

• Drug-likeness

• Quantity on hand

• Commercial availability

• Age and condition of sample

5.2.2.3 The contractor shall coordinate virtual meetings with WRAIR SMEs, as needed, to gather input on disposal criteria and to provide updates on the outcomes based on the agreed-upon criteria.

5.2.2.4 Prior to finalizing disposal decisions for each phase, the contractor shall provide a list of the samples identified and criteria that were utilized to the COR. WRAIR SMEs will review the list only for the purposes of evaluating whether the criteria utilized met the requirements and intent of WRAIR and if the agreed upon criteria were applied appropriately (A.008).

5.2.3 Categorization of Compounds for Waste

5.2.3.1 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.

5.2.3.2 The contractor shall make waste determinations in accordance with EPA and MDE guidelines for all samples they designate as waste. Of particular importance is accurate determination of compounds that must be classified as RCRA hazardous waste when they are disposed of as acute (e.g. P-listed) hazardous waste.

5.2.3.3 The contractor shall use chemical structure (e.g. SMILES), salt form, and product or chemical names for making categorization decisions.

5.2.3.4 It is anticipated that a subset of the samples in the collection which are only identified by product or chemical name (i.e., lacking a defined chemical structure) will have names than cannot be resolved.

a. The contractor shall perform sample testing to identify waste characterizations for all samples designated as waste that lack sufficient data to categorize.

b. Hazardous waste characterization testing performed by the contractor shall comply with be EPA and MDE regulations, to include SW-846 (Hazardous Waste Test Methods).

c. If the contractor sends samples off site for analysis for hazardous waste characterization, the contractor shall use a lab with sampling procedures that are recognized by an accrediting organization that EPA recognizes such as NIHA, LAP, LLC, A2LA, PJLA, ANAB, or IAS.

5.2.4 Disposal of Samples Designated as Waste

5.2.4.1 The contractor shall only designate a sample as waste after its container has been physically removed from stock, the compound is no longer orderable, and the sample is being prepared for disposal.

a. Prior to removing samples from stock or designating them as waste, the contractor shall review RCRA, EPA, DOT, and all other relevant federal, state or local laws and regulations to ensure proper handling, packaging, and scheduling can be adhered to.

b. Samples that have an ordering hold while awaiting further review and that are still physically located in inventory shall not be considered waste.

5.2.4.2 The contractor shall manage, coordinate, package, transport and dispose of all samples they have designated as waste IAW EPA and MDE. This shall include disposal of approximately 375,000 samples (bottle/vial/etc.).

5.2.4.3 Through the actions taken by the contractor listed in this PWS which result in the samples becoming waste, the contractor shall be a co-generator of the waste and shall complete and sign all forms and documents necessary for their disposal as the waste generator, including the hazardous waste manifests that accompany each shipment.

5.2.4.4 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 are generated through this effort.

5.2.4.5 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 MRDC’s Environmental Compliance Office.

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

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

5.2.4.8 The Contractor shall prepare and provide all required Uniform Hazardous Waste Manifests to all required parties (EPA, Generators, Transporter, etc.) per 40 CFR 262 (A.009).

5.2.4.9 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 (A.009).

5.2.4.10 The contractor shall provide the COR with electronic copies of all disposal documentation including Manifests, Land Disposal Restrictions, Return Manifests, Certificate of Disposal, etc. (A.010).

5.2.4.11 The contractor shall provide a Disposal Report listing all disposed containers at the end of each phase (A.011).

5.2.4.12 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.

5.2.5 Housekeeping Activities

5.2.5.1 The contractor shall perform housekeeping activities for samples that remain at the storage facility after the disposal has been completed. These activities shall include the following:

a. Unless specifically required by regulation, the contractor shall remove individual containers from outer containers that were used for secondary containment.

b. The contractor shall affix labels with machine-readable barcodes for all retained containers lacking them.

c. The contractor shall rebottle samples in oversized containers for retention of a reduced quantity in an appropriately sized container.

d. The contractor shall realign retained containers in the storage units to minimize storage space.

5.2.5.2 After completion of all disposal and other housekeeping activities, the contractor shall perform a 100% physical inventory of all remaining containers to ensure 100% accountability.

a. The physical inventory shall include the final position of all samples within the inlays in the contractor’s storage unit.

b. A final inventory report shall be provided to the COR upon completion of the inventory (A.011).

5.3 Service Contract Reporting. RESERVED

PART 6

APPLICABLE PUBLICATIONS

6. Applicable Publications (Current Editions):

6.1 Security and Safety Related Publications:

• 40 CFR 262 Standards Applicable to Generators of Hazardous Waste

• 40 CFR 268.40 Applicability of treatment standards

• 40 CFR 261.2 Solid Waste

• 40 CFR 261.4 Exclusions from the definition of solid waste

• 49 CFR 172 Regulation for the transportation of hazardous materials

• COMAR 26.13.03 Code of Maryland Regulations

• SW-846 Hazardous Waste Test Methods

6.2 Medical Maintenance Publications: RESERVED

6.3 Publications Related to Research Involving Human Subjects: RESERVED

6.4 Publications Related to Animal Use: RESERVED

PART 7

ATTACHMENT AND TECHNICAL EXHIBIT LISTING

7. Attachment and Technical Exhibit List

7.1 Technical Exhibit A – Performance Requirements Summary

7.2 Technical Exhibit B – Deliverables Schedule

TECHNICAL EXHIBIT A

Performance Requirements Summary (PRS)

PERFORMANCE

OBJECTIVE

STANDARD PERFORMANCE

THRESHOLD

ACCEPTABLE

QUALITY

LEVELS (AQLs)

METHOD

OF

SURVEIL

LANCE

PRS #1

Hazardous Waste Characterization

PWS 5.2.3.1

The contractor shall characterize all hazardous waste into appropriate RCRA categories

Zero deviation from standard

Period Inspection

PRS #2

Hazardous Waste Manifest and Shipping Documents

PWS 5.2.4.8, 5.2.4.9

The contractor shall complete hazardous waste manifest and shipping documents that are 100% accurate for waste in each shipment, and ensure all packaging and transport is in accordance with DOT regulations.

Zero deviation from standard

Periodic Inspection

PRS #3

Hazardous Waste Transport

PWS 5.2.4.2

The contractor shall package and transport all hazardous waste in accordance with DOT regulations.

Zero deviation from Standard

Periodic Inspection

PRS #4

Hazardous Waste disposal

The contractor shall treat or dispose of all hazardous waste in accordance with EPA and MDE regulations

Zero deviation from the standard

Periodic Inspection

TECHNICAL EXHIBIT B

DELIVERABLES SCHEDULE

Deliverable Frequency Medium/Format Submit To A.001

Analysis of Quality Control and Timeliness of Submittals

(Para 1.5.1.1)

Due within 30 days upon completion of each option period or Task Order

Electronic document (MS Word, MS Excel, or PDF)

COR

A.002

Performance Issues or Potential Issues Report

(Para 1.5.1.2)

Verbal report due within 48 hours of identifying potential issues; written report due within 2 days thereafter

Electronic document (MS Word, MS Excel, or PDF)

COR

A.003

Invoices

(1.13.1)

Due monthly Electronic document (MS Word, MS Excel, or PDF)

WAWF

A.004

OSHA 300A

(Para 1.19.1)

Report of mishaps due quarterly, annual 300A due by 1 February each year

Electronic document (MS Word, Excel, or

PDF)

COR

A.005

Environmental Compliance Training

(Para 1.20.1, 1.20.2

Due upon award Electronic document (MS Word, Excel, or

PDF)

COR

A.006

Disposal Plan

(Para 5.2.1.1)

Draft plan due with proposal and final plan is due within 30 days of contract award

Electronic document (MS Word, Excel, or

PDF)

COR

A.007

Generator Compliance Documents

(Para 5.2.1.3)

Due at time of operation Electronic document (MS Word, Excel, or

PDF)

COR

A.008

List of Samples Identified for Disposal

(Para 5.2.2.4)

Prior to finalizing disposal decisions for each phase

Electronic document (MS Word, Excel, or

PDF)

COR

Deliverable Frequency Medium/Format Submit To A.009

Uniform Hazardous Waste Manifests and Shipping Documents

(Para 5.2.4.8, 5.2.4.9)

At time of waste shipment Electronic document (MS Word, Excel, or

PDF)

All required parties (EPA, Generators, Transporter, etc.)

A.010

Disposal Documents

(Para 5.2.4.10)

Within 30 days of samples being disposed

Electronic document (MS Word, Excel, or

PDF)

COR

A.011

Disposal Report

(Para 5.2.4.11)

Within 30 days of completion of each disposal phase

Electronic document (MS Word, Excel, or

PDF)

COR

A.012

Final Inventory Report

(Para 5.2.5.2.b.)

Within 30 days of completion of 100% physical inventory.

Electronic document (MS Word, Excel, or

PDF)

COR