StorageDist Source Sought Notice_final.pdf

Sources Sought Notice Number: HHS-NIH-NCI-SBSS-ETSB-00007-10

STORAGE AND DISTRIBUTION OF CLINICAL AGENTS

This is a Small Business Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding:

(1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The requirement is assigned a code of 493190 in the NAICS, and the size standard for such requirement is $30.0 Million per annum.

The capability statements submitted in response to this notice should also include an indication of current certified business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern’s name and address) as well as the eligible business name, point of contact, address and DUNS number (See Section F. Capability Statement for more information). An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

This Small Business Sources Sought Notice (SBSS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted.

A. Background

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 (20-25oC), refrigerated (2-8oC), 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.

This acquisition is a re-competition of contract HHSN261201800002C awarded to Fisher BioServices. Previous contracts for this initiative that were awarded to Fisher BioServices include: HHSN261201300009C (March 8, 2013 - January 31, 2018) and HHSN261200622000C (December 1, 2005 -March 7, 2013).

B. Purpose and Objectives

The Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), is seeking sources to perform and be responsible for the receipt, storage, distribution and final disposition of clinical investigational agents in support of cancer clinical trials sponsored and/or funded by the DCTD, CTEP, NCI. The Contractor shall prepare written policies and Standard Operating Procedures (SOPs) and work instructions that govern operations of the facility and activities associated with this requirement. The policies, SOPs and work instructions shall cover areas including, but not limited to, operational, validation, quality and safety aspects of the work.

C. Project Requirements

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 will 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.

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.

D. Anticipated Period of Performance

It is anticipated that one (1) cost-reimbursement term (level-of-effort) contract will be awarded with a base period of one (1) year plus four (4) additional one-year option periods beginning on or about February 1, 2023. Since the Government anticipates awarding a cost reimbursement contract for this requirement, in accordance with the requirements of FAR 16.301-3, the awardee will need to have an adequate accounting system prior to the award. It is also anticipated that the resultant contract may include options for Increased Capacity, Phase-In and Phase-Out Transitions.

E. Other Important Considerations

Mandatory Qualification Criteria:

Capability Statements must clearly document your ability in the following area:

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).

F. Capability Statement

The Government encourages interested qualified small business organizations to submit a tailored capability statement which demonstrates their abilities to provide the specifics of this requirement as outlined in Section C. along with appropriate documentation supporting claims of meeting Mandatory Qualification Criteria in Section E. above. Organizations that submit capability statements in response to this notice shall clearly document and demonstrate the offeror’s capabilities in Facilities & Equipment Management, Personnel Qualifications, and Organizational Support & Experience.

The Capability Statements submitted in response to this notice shall not exceed 15 single-sided pages (including all attachments, resumes, charts, etc.), must be presented in a single -space format using 12-point font size minimum and shall clearly detail the ability to perform the aspects of the notice described above. The Capability Statements will be reviewed only by NIH personnel and will be held in a confidential manner. The Capability Statements must reference the sources sought notice number and include the following information on the cover page:

1. Name and Address of the Company, DUNS number.

2. Primary Business Point of contact with name, title, address, phone, fax and email.

3. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.), as validated via the System for Award Management (SAM). All offerors must be registered in the SAM, located at http://www.sam.gov/.

4. Please indicate if your organization will need to utilize the expertise and resources of subcontractors and specialized consultants to perform the full spectrum of requested activities.

5. Examples of similar, prior completed Government contracts, the dollar value of that work, and other related information.

G. Information Submission Instructions

The Capability Statements must be submitted no later than March 30, 2022, at 3 PM EST.

All responses must be received by the specified due date and time in order to be considered.

CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT

BE CONSIDERED.

The Capability Statements shall be submitted electronically (via e-mail) to Mesfin Alemayehu, Contract Specialist, at mesfin.alemayehu@nih.gov and Pooja Rathore, Contracting Officer, at pooja.rathore@nih.gov. The capability statements must be in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify the notice number: HHS-NIH-NCI-SBSS-ETSB- 00007-10.

No collect calls or facsimile transmissions will be accepted.

H. Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the mailto:mesfin.alemayehu@nih.gov mailto:pooja.rathore@nih.gov 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 Government wide point of entry:

sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses:

Contracting Officer: Pooja Rathore Email Address: pooja.rathore@nih.gov

Contracting Officer: Mesfin Alemayehu Email Address: Mesfin.alemayehu@nih.gov

I. 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).

mailto:pooja.rathore@nih.gov mailto:Mesfin.alemayehu@nih.gov