SOURCES SOUGHT
R -- Storage and Distribution of Clinical Agents
- Notice Date
- 2/2/2017
- Notice Type
- Sources Sought
- 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
- N02CM7101738
- Point of Contact
- Pooja Rathore, , Rukshani Levy,
- E-Mail Address
-
pooja.rathore@nih.gov, rukshani.levy@nih.gov
(pooja.rathore@nih.gov, rukshani.levy@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 $27.5 Million per annum. Responses 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 Paragraph 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. 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 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. This acquisition is a re-competition of contract HHSN261201300009C awarded to Fisher BioServices. Previous contracts for this initiative that were awarded to Fisher BioServices include: contract HHSN261200622000C (December 1, 2005 to March 7, 2013), N02-CM-97028 (December 1, 1998 to November 30, 2005) and N02-CM-47021 (March 21, 1994 - November 30, 1998). 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. 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. Contractor will 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. The Contractor will also provide continuous monitoring and recording of such storage conditions to guarantee and document conti¬nuous 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 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 Regulations and individual State Boards of Pharmacy. 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 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. 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 Contractor shall perform ongoing physical inventories of clinical agent supplies to prevent inventory discrepancies. 9. Options: Increased Work Capacity Over the course of the contract, additional options may be exercised for additional in-scope work capacity base on high-priority tasks determined by the Cancer Therapy Evaluation Program. D. Anticipated Period of Performance 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. 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 and State Environmental Protection Agency (EPA) Generator of Hazardous Waste permit and any state and local permits required for its facility to operate for generation of Hazardous Waste and Medical Pathological Waste for disposal, and for storing toxic/hazardous substances. 3. The Contractor must have at least one individual with current U.S. DOT Hazmat training on the premises at all times during all hours of operation of the repository facility and on call after hours for emergency shipments. 4. The Contractor must have at least one individual with a current IATA Dangerous Goods Certification of Training on the premises at all times during all hours of operation of the repository facility and on call after hours for emergency shipments. 5. The Contractor must possess and maintain any state and local permits or licenses as required for its facility for storing and distributing marketed and investigational agents for the life of the contract. 6. All pharmacists performing work under the contract shall have a current active license in the state or District of Columbia in which the repository is located. F. Capability Statement Interested qualified business organizations should submit a tailored capability statement which demonstrates their abilities to provide the specifics of this requirement as outlined in Paragraph C. along with appropriate documentation supporting claims of meeting Mandatory Qualification Criteria in Paragraph E. above. Organizations that submit capability statements in response to this notice shall clearly document and demonstrate capabilities in Facilities & Equipment Management, Personnel Qualifications, and Organizational Support & Experience. Capability Statements submitted in response to this notice are not to exceed 15 single-sided pages (including all attachments, resumes, charts, etc.) presented in a single -space format using 12-point font size minimum. Responses will be reviewed only by NIH personnel and will be held in a confidential manner. Responses must reference the sources sought number and include the following: 1. Current certified business status 2. Name and Address of the Company, DUNS number. 2. Point of contact with name, title, address, phone, fax and email. 3. Examples of prior completed Government contracts, references, the dollar value of that work, and other related information; 4. List of organizations to whom similar types of services have been previously provided and the dollar value of that work. G. Information Submission Instructions Please respond by e-mail with a capability statement to Pooja Rathore at pooja.rathore@nih.gov by February 17, 2017 at 3:00 PM EST. All capability Statements must be in MS Word or Adobe Portable Document Format (PDF). All responses must be received by the specified due date and time in order to be considered. 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 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 Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. 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). Contracting Office Address: NCI Office of Acquisitions 9609, Medical Center Drive Rockville, MD-20850
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