SOLICITATION NOTICE
R -- Storage and Distribution of Clinical Agents
- Notice Date
- 6/29/2017
- 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, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CM71017-38
- Point of Contact
- Margo Katzper, , Rukshani Levy,
- E-Mail Address
-
mkatzper@mail.nih.gov, rukshani.levy@nih.gov
(mkatzper@mail.nih.gov, rukshani.levy@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- PRE-SOLICITATION NOTICE 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 the NCI to support the mission of improving the lives of cancer patients by finding better ways to treat, control, and cure cancer. Through a variety of funding mechanisms, CTEP funds an extensive national and international program of cancer research consisting of the intramural program at the NIH Clinical Center and extramurally at academic medical centers, hospitals, clinics and physician offices. CTEP attempts to forge broad collaborations within the research community and works extensively with the pharmaceutical/biotechnology industry to effectively develop new cancer treatments. In further efforts to control cancer, new anticancer agents are made available as rapidly and widely as possible for patient treatment. To support the conduct of clinical trials, a non-research, repository service contract to provide for receipt, storage, distribution, and final disposition of all clinical agent supplies in support of the CTEP drug development program is required. PMB, in providing pharmaceutical support for cancer clinical trials, manages the Contractor that maintains and operates a clinical agent repository facility and project team to receive, store, distribute, and dispose of clinical agent supplies for the conduct of clinical trials world-wide. The proposed contract will 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. Some of the major activities of the contractor 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. Contractor shall receive, inventory and return all documentation requested by the supplier to confirm receipt and condition of the shipment and convert all shipment receipt documentation into electronic pdf format for record storage and retention by the Government. 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 (cGMP). The Contractor shall also provide continuous monitoring and recording of such storage conditions to guarantee and document continuous proper storage. In addition, the Contractor shall meet and adhere to all applicable State and Federal Regulations related to storage and distribution of clinical agents. 3. Shipping/Distribution The Contractor shall, as needed or requested, transport, ship, or electronically transmit documents, agents, and other contract related materials to the Contracting Officer's Representative (COR) and PMB. 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 (FDA) Regulations and Individual State Boards of Pharmacy. Staff preparing shipments of agents classified as dangerous goods or infectious substances shall be certified in Dangerous Good (DG) shipping. At least one U.S. DOT Hazmat trained and International Air Transportation Association (IATA) certified staff member shall 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 shall 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 bottles, vials, and other formulations of study agents for placebo-controlled, blinded clinical trials. 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. The Contractor shall be responsible for the 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. In addition, the Contractor shall store returned agents at room temperature, separate from active inventory clinical supplies, until final disposition. 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 Contractor shall perform ongoing physical inventories of clinical agent supplies to prevent inventory discrepancies. OPTIONS Option A - Phase-In Transition/ Inventory Transfer The Contractor shall prepare and submit a Phase-in plan to the COR and the CO for review at the time of proposal submission. The final plan shall be approved by the COR and CO within 10 calendar days of the contract award. The plan shall include, but not be limited to, plans for maintaining continuity of operations, transitioning of taking over contract activities, details on the receipt of transferred files and document records, transfer of agent inventory and Government-furnished equipment (if applicable) and installation, validation and qualification of said equipment. Option B - Phase-Out Transition The Contractor shall prepare and submit a Draft Phase-out Plan to the COR and the CO 90 days prior to contract's expiration date. The draft Phase-Out Transition plan shall describe the Contractor's strategy for transferring work from this contract to a successor contract, in the event a final transition would be required. The plan shall include, but not be limited to, details on the transfer of filed material and documents and the transfer of agent inventory and Government-furnished equipment (if applicable). Option C: Increased Work Capacity NCI anticipates the number of clinical agents in development as well as the number of clinical trial sites will go up during the period of performance of this contract, resulting in increased receipt, storage, labeling, distribution and disposal of clinical agents being managed by the contractor. The increased capacity options provide for activities that are within the scope for expanded activities during the performance of this contract. Option C would take the need into consideration and provide for an increased capacity of 25% per year. 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 solicitation: 1. The Contractor must provide a facility in accordance with 21 CFR 211, Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals, Subpart C, Buildings and Facilities. Copies of floor plans to scale with notation and location of all work areas and equipment must be provided. Per FDA Regulation 21 CFR Part 211- Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations. This contract will store and distribute drug products, so must comply with this regulation. See: 21 CFR Part 211 Subpart C. 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. Copies of permits must be provided. This contract will generate hazardous waste that requires proper transport and disposal. The contractor must follow regulatory requirements set forth as a generator of hazardous waste per 40 CFR Part 262. See: 40 CFR Part 262. 3. The Contractor must possess and maintain any state permits or licenses as required for its facility to operate and for storing and distributing marketed and investigational agents for the life of the contract. Copy of the appropriate license type for the facility from the State Board of Pharmacy in which the facility resides must be provided at the time of proposal submission. Copies of permits or licenses or exemptions for other states must be provided by the end of the contract phase-in period. This Contractor will serve as a distributor/third party logistics provider and arrange for transport of drugs through interstate commerce. The appropriate license type for each state is required per Food Drug and Cosmetics Act. See: Food Drug and Cosmetics Act 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, 2018. The RFP will be available electronically on or about July 17, 2017 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. Contracting Office Address: 9609 Medical Center Drive Bethesda, Maryland 20852 Primary Point of Contact: Margo Katzper Contract Specialist mkatzper@mail.nih.gov Secondary Point of Contact: Rukshani Levy Contracting Officer Rukshani.levy@nih.gov
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