Pre-solicitation Notice - Storage and Distribution of Clinical Agents.pdf

PRE-SOLICITATION NOTICE ID: 75N91022R00007

Note: This synopsis follows a Small Business Sources Sought notice that was released on March 15, 2022 under HHS-NIH-NCI-SBSS-ETSB-00007-10.

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION

WILL BE ISSUED ON A LATER DATE.

TITLE: STORAGE AND DISTRIBUTION OF CLINICAL AGENTS

The Pharmaceutical Management Branch (PMB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), is charged with providing pharmaceutical support for clinical trials sponsored and/or funded by CTEP, DCTD, NCI. The DCTD sponsors intramural and extramural research for the clinical evaluation and development of potentially effective cancer treatments. CTEP administers, coordinates, and funds these clinical trials, as well as supports other clinical research initiatives. The program fosters collaborations within the cancer research community and works extensively with the pharmaceutical and biotechnology industries.

The Contractor provides a facility and project team that is responsible for the receipt, storage, distribution, and final disposition of clinical investigational agents in support of these clinical trials. The Contractor shall also maintain specialized expertise in the management, labeling and distribution of clinical supplies for double-blind placebo-controlled trials. The Contractor shall receive, store, and distribute marketed and investigational agents, such as chemotherapeutic agents, biologic products (e.g., cytokines, monoclonal antibodies, oncolytic viruses, gene therapy, vaccines), small-molecule targeted agents and other therapeutic anticancer agents. The Contractor shall receive and inspect agents according to applicable regulations as they are received from manufacturers and suppliers world-wide. Agents are inventoried and stored in a secured, monitored, fire-protected warehouse under specified environmental and controlled temperature and humidity conditions (controlled room temperature (20-25 oC), refrigerated (2-8 oC), and frozen -20oC and -70oC; humidity < 60 %). Electronic record keeping accompanies each step of the receipt, storage, distribution, and final disposition processes for each unit of agent using PMB’s electronic inventory management system, AURORA and the Contractor’s temperature and humidity monitoring system. Agents may require relabeling or addition of supplemental labeling as necessary to meet U.S.

Food and Drug Administration (FDA) regulations and NCI guidelines for completeness and clarity. This requirement also requires handling, storing, shipping, and disposing of hazardous, biologic, and infectious agents. The data generated under this contract will be the property of the Government. Data generated must be maintained per US Food and Drug Administration Investigational New Drug (FDA IND) Regulations 21 CFR 312.

Some of the major activities under this contract include:

1. Receipt of Clinical Agents

The Contractor shall receive shipments of agents from a variety of domestic and international sources, including but not limited to, manufacturers, distributors, and pharmaceutical companies. Clinical Agent storage areas shall be accessible to a loading dock for receiving agent shipments and be able to accommodate receipt of pallet shipments and other large shipping containers (larger than pallets). Receipt of commercial drug products shall be performed in accordance with the FDA Drug Supply

Chain Security Act. Contractor shall store all agents at their proper storage conditions immediately upon receipt and inspect the contents and condition of shipment in accordance with applicable standards. Contractor shall execute and return all documentation requested by the supplier to confirm receipt and condition of the shipment (e.g., temperature data monitors, temperature data logs, confirmation of receipt documents, etc.) and provide electronic copies of the executed documents to the COR and the PMB responsible pharmacist for the agent on the same day as receipt of the agent.

2. Storage of Clinical Agents

The Contractor shall store each unit package of agent in a secured, humidity and temperature-controlled warehouse with a non-water-based fire-protection system, at each agent's required storage condition in accordance with current Good Manufacturing Practices. Storage conditions include -70˚C, -20 to -10˚C, 2 to 8˚C, and controlled humidity (<60%) and room temperature (20 to 25˚C). Contractor shall have equipment and storage unit validation and temperature mapping quality control processes in-place for all storage conditions. The Contractor shall also provide continuous monitoring and recording of such storage conditions to guarantee and document continuous proper storage. Contractor shall provide physically separate storage areas and storage units within the facility for quarantine inventory (agent supplies that are no longer suitable for clinical use) versus active clinical agent inventory (agent supplies that are suitable for clinical use). The Contractor shall ensure that required storage conditions are always maintained and ensure the physical security of all agents in storage.

In addition, the Contractor shall meet and adhere to all applicable State and Federal Regulations related to storage of clinical agents.

3. Shipping/Distribution of Clinical Agents

The Contractor shall, as needed or requested, transport, ship, or electronically transmit documents, agents, and other contract related materials to the COR and pharmacists at the PMB. As requested by the COR, Contractor shall ship agents to consignees in the quantity specified and in accordance with all Federal, State and Local regulations and licensing requirements with all required documentation, labeling, and packaging in accordance with Good Storage and Distribution Practices for Drug Products. The Contractor shall also ship agents to consignees worldwide in the quantity specified and in accordance with all Federal, State and Local regulations and licensing requirements, with all required documentation, labeling and packaging in accordance with Good Shipping Practices. The agents shall be shipped in a manner that assures safe arrival and continued viability of the agent supplies upon receipt of the shipment at the clinical trial site.

Contractor shall have Quality Control and Quality Assurance policies and procedures in place for all steps of the packaging and shipping process. Contractor shall possess and maintain all required licenses and permits to distribute agents domestically and internationally as required by the Food and Drug Administration Regulations and individual State Boards of Pharmacy. Shipment of commercial drug products shall be performed in accordance with the FDA Drug Supply Chain Security Act. the Contractor shall electronically store all shipping records and shipment documentation associated with the performance of the contract

Staff preparing shipments of agents classified as dangerous goods or infectious substances must be certified in Dangerous Good (DG) shipping. At least one U.S. DOT Hazmat trained and International Air Transportation Association (IATA) certified staff member must be present on-site at all times during normal repository business hours.

Contract staff available for emergency shipment requests after normal hours and on weekends must also be U.S. DOT Hazmat and IATA certified in DG shipping.

4. Receipt/Labeling/Dispensing of Blinded Study Agent Supplies

The Contractor shall receive, store, and inventory shipments of drug product formulations of study agents for blinded studies. The Contractor shall provide a dedicated space for performing blinded studies activities (including storage) and only blinded studies activities shall be performed in that space. Upon receipt, agent product containers shall be carefully checked to ensure that the active agent and placebo agent product labeling is indeed blinded. The Contractor shall dispense PMB-authorized and approved patient-specific orders including printing and checking individual, blinded container labels and dispensing logs, pulling the appropriate study agent (agent or placebo), labeling each container, performing quality control validations, and shipping of the agent as specified.

Patient-specific and blinded study agent labels shall be affixed on-site. The quality control validation must be performed by a licensed pharmacist prior to shipping.

5. Labeling of Open-Label Agents

The Contractor shall re-label or affix additional labeling to unit packages of agents, such as bottles, ampules, or vials, or secondary packaging per cGMP and as specified by the COR as necessary to meet U.S. FDA Regulations for investigational agents and NCI labeling guidelines for completeness and clarity. Labels shall be affixed on-site prior to agent distribution. Appropriate record keeping and quality control measures shall be required according to cGMP regulations.

6. Processing and Disposal of Returned Agents

Contractor shall receive recalled, expired, or unused agents returned from clinical investigators. Contractor shall process returned agents in conformance with Local, State, and Federal regulations. In addition, the Contractor shall store returned agents at room temperature, separate from active inventory clinical supplies, until final disposition. The contractor shall prepare returned agents for disposal and destruction as requested by the

COR.

7. Final Disposition of Clinical Agents

The Contractor shall be responsible for the final disposition (e.g., destruction of

Hazardous or Biohazardous Waste or Medical Pathological Waste or return to the manufacturer) of any non-distributed agent and destruction (e.g., Hazardous or Biohazardous Waste or Medical Pathological Waste) of any agent returned to the repository from clinical trial sites, as directed by the COR and in accordance with all applicable Local, State and Federal regulations.

8. Inventory Control

The Contractor shall perform, and report limited, ad hoc inventory checks as requested by the COR to resolve inventory discrepancies on an as needed basis.

MANDATORY QUALIFICATION CRITERIA

The Mandatory Qualification Criteria establish conditions that must be met at the time of initial proposal submission as determined by the Contracting Officer for your proposal to be considered any further for award. The following Mandatory Qualification Criteria apply to this requirement:

1. The Contractor must provide a facility in accordance with 21CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, Subpart C, Buildings and Facilities.

2. The Contractor must possess and maintain a Federal Environmental Protection

Agency (EPA) Generator of Hazardous Waste ID number and any other required state and local permits required for its facility to operate as a generator of Hazardous Waste and Medical Pathological Waste for storage and preparation for transport for disposal.

3. The Contractor must possess and maintain any state licenses as required for its facility to operate and for storing and distributing marketed and investigational agents for the life of the contract and must be registered with the FDA in accordance with the Drug Supply Chain Security Act (DSCSA).

The services will be acquired through full and open competition. It is anticipated that one (1) cost-reimbursement contract will be awarded as a result of the solicitation with a base period of one (1) year plus four (4) additional one-year option periods beginning on or about February 1, 2023. In addition, there will be options for increased capacity, options for Phase-in of 60 days and Phase-out of 90 days. The NAICS Code for this requirement is 493190.

The Solicitation will be available electronically on or about July 14, 2022 and may be accessed via Contract Opportunities at sam.gov. All responsible sources may submit a proposal which will be considered by the Agency. This notice does not commit the Government to award a contract.

No collect calls will be accepted. No facsimile or email transmissions will be accepted. IT IS

THE OFFERORS’ RESPONSIBILITY TO MONITOR THE ABOVE INTERNET SITE FOR

THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS.