SOLICITATION NOTICE
R -- Storage and Distribution of Clinical Agents
- Notice Date
- 3/7/2012
- Notice Type
- Presolicitation
- NAICS
- 493190
— Other Warehousing and Storage
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- N02CO31001-27
- Archive Date
- 4/27/2012
- Point of Contact
- Charlotte L. McCormack, Phone: 3014353757, Lisa A. Hill, Phone: 3014966987
- E-Mail Address
-
mccormackc@mail.nih.gov, hilll1@mail.nih.gov
(mccormackc@mail.nih.gov, hilll1@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE. The Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), Office of Acquisitions intends to solicit proposals from sources to perform receipt, storage, distribution and final disposition of clinical agents. 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 shall receive, store, and distribute commercial and investigational agents for open-label and double-blind, placebo-controlled clinical trial use from manufacturers and suppliers throughout the world. Agents consist of chemotherapeutic agents, biologic products (e.g., cytokines, monoclonal antibodies, oncolytic viruses, gene therapy, and vaccines), small-molecule targeted agents and other therapeutic anticancer agents. On average the Contractor will receive approximately 360 agent shipment receipts per year (approximately 340 from domestic sources and 20 from international sources). The total number of unit packages of agent received in these shipment receipts may range between 400,000 to 700,000 unit packages of agent per year. The total number of unit packages of agent received in approximately 20 of these agent shipment receipts may run in the tens-of-thousands of unit packages of agent (e.g. 20,000 - 40,000 per shipment receipt). On average, approximately 600,000 unit packages of agent may be maintained in storage at any one time, but can vary greatly depending on the activities of the Program. Approximately 40,000 agent orders per year will be shipped to clinical trial sites worldwide. The contractor shall store agents in a secure, monitored, fire protected warehouse under specified environmental and controlled temperature conditions (room temperature, refrigerated, and frozen at both 20oC and 70oC). Storage areas and storage units for quarantine and active agent inventory must be physically separate areas. Storage areas must be accessible to a loading dock for receiving and shipping agent shipments and able to accommodate pallet shipments and other large shipping containers. The acquisition will contain Mandatory Criteria that must be met at time of proposal submission: • The Offeror must possess and maintain an Environmental Protection Agency (EPA) Generator of Hazardous Waste permit and any state and local permits (if necessary) for its facility, for storing toxic/hazardous substances and generation and transportation of Hazardous Waste and Medical Pathological Waste for disposal. A copy of the Offeror's State and Federal Hazardous Waste Permit for the proposed facility must be provided. A copy of all other State and Local Municipality mandated hazardous waste and medical waste permits and certificates must be provided. The Offeror must have at least one individual with an up-to-date U.S. Department of Transportation (DOT) Hazmat training certificate on the premises at all times during all hours the repository is open. A copy of the U.S. DOT Hazmat training certificate for each certified individual must be provided. The contractor must possess and maintain any state and local permits or licenses (if necessary) for its facility for storing and distributing investigational drugs for the life of the contract. A copy of the Offeror's State Board of Pharmacy Distributor's License must be provided. A copy of all other State and Local Municipality mandated permits or licenses must be provided. • All pharmacists performing work under the contract must have a current active license, in the state (or District of Columbia) in which the repository is located. The Offeror must provide copies of all pharmacists' state licenses. • The Offeror shall have at least one individual with an up-to-date IATA Dangerous Goods Certification of Training on the premises at all times during all hours the repository is open and on call after hours for emergency shipments. The Offeror must provide IATA Dangerous Goods Certification Training certificates for all certified individuals. • The Offeror shall provide dedicated separate continuous facility space in support of this proposed contract. Storage areas shall be accessible to a loading dock for receiving and shipping. A detailed floor plan of the facility shall be submitted with that space proposed for use under this proposed contract clearly identified. The floor plan of the proposed facility must include dimensions drawn to scale, and proposed location of equipment and operational areas identified. The services will be acquired through full and open competition under NAICS 493190. It is anticipated that a cost-reimbursement, completion type contract will be awarded with a 1-year base period and 4 (four) 1-year options of performance beginning on or about December 1, 2012. The RFP will be available electronically on or about March 30, 2012 and may be accessed through the FedBizOpps at www.fbo.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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02CO31001-27/listing.html)
- Place of Performance
- Address: To Be Negotiated, United States
- Record
- SN02690977-W 20120309/120307235255-75cec1ddd2db17a55da61d5461f45981 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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