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Q -- Centralized Chemopreventive Agent Repository and Chemistry Support Services

Notice Date
Notice Type
541690 — Other Scientific and Technical Consulting Services
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
Solicitation Number
Archive Date
Point of Contact
Catherine Muir, Phone: (240) 276-5434, Sara M. McLaurin, Phone: 2402765438
E-Mail Address
muirca@mail.nih.gov, mclaurinsm@mail.nih.gov
(muirca@mail.nih.gov, mclaurinsm@mail.nih.gov)
Small Business Set-Aside
Contracting Office Address: U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions, 9609 Medical Center Dr., Room 1E646, Rockville, MD 20850-9700. Note: This synopsis follows a Sources Sought notice that was released on March 8, 2017 under HHS-NIH-NCI-SBSS-PCPSB-75006-45. THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE. Background: The Division of Cancer Prevention (DCP), NCI, has a long-standing pharmaceutical agent development program administered through the Chemopreventive Agent Development and Research Group (CADRG) as a Repository services unit. The object of the Repository program is to establish a centralized source of agents for use in studies by the DCP and to support the translation of promising laboratory discoveries into effective interventions for the prevention or reduction of cancer. The Repository services are integral to most of the scientific and clinical work undertaken by the Division. This procurement is to continue a well-established Repository program within the Division of Cancer Prevention (DCP) at the National Cancer Institute (NCI). The successful Contractor shall maintain a centralized source of agents and development services necessary to support chemoprevention studies for effective medical interventions in the prevention or reduction of cancer. The repository provides important logistic organization for the acquisition, tracking, storage, maintenance, testing, quality control, and distribution of investigational agents. Unless otherwise noted, all work shall be in conformance with the Food and Drug Administration's (FDA) established current Good Manufacturing Practices (cGMP) (http://www.fda.gov/AboutFDA/CentersOffices/cder/ucm095412.htm), and Good Laboratory Practices (GLP) standards (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58 ). If there are subcontracted activities needed during the development of an investigational agent, the Contractor shall audit, implement, coordinate and monitor the flow of subcontracted work so that it proceeds in the most efficient and timely manner possible. This work is currently being conducted under contract HHSN261201100046C held by MRIGlobal. Project Requirements: The purpose of the acquisition is to provide services to support many different agent development functions critical to chemoprevention research. These functions are generally described as sourcing, acquiring, documenting, storing, quality testing, custom manufacturing, packaging and labeling, distributing and tracking both pre-clinical investigational agents for basic research and clinical supplies for human clinical trials. 1) The Core Competencies required include cost estimation, agent receiving, specification setting, analytical testing, material acceptance and release, packaging and labeling, stability testing, proper environmental storage, shipping domestically and abroad, inventory tracking of clinical trial materials, agent returns and destruction or disposal of investigational agents and clinical study supplies. All information to support regulatory filings to health authorities, scientific reports for research documentation and manuscript publication will be maintained by the contractor and provided to DCP, when requested. If the contract requires specialty services for the timely development of agents identified through DCP programs (e.g., the DCP RAPID program), a well-organized and effective subcontracting administrative unit may be needed if the Offeror is unable to self-perform the required work. 2) An offeror's facility must have sufficient space for: storage of pre-clinical agents (estimated at 5,000 sq. ft. of useable space); storage of clinical study supplies (estimated at 5,000 sq. ft. of useable space); a staging/quarantine area; separate shipping and receiving rooms; and, space devoted to an analytical chemistry unit (estimated at 5,000 sq. ft.) with a detached weighing area. The space must include areas for refrigerated and other environmentally-controlled storage conditions (e.g., light protection, humidity controlled cabinets - approximately 500 sq. ft.). 3) A comprehensive and continuously updated computerized logistics management system containing inventory movements, quantities on hand, expiration or re-test information, Certificates of Analysis and analytical testing results, on all materials, must be made available electronically to the National Cancer Institute Contracting Officer's Representative (COR) on demand through a secure, password-protected, DCP-dedicated server. 4) The successful Awardee shall be required to demonstrate experience and competency in domestic and international shipping of pharmaceuticals, especially through U.S. and foreign Customs, the FDA, and other Health Authorities in accordance with applicable regulations. The successful Awardee must have experience in obtaining a Quality Persons Determination for agents shipped into the European Union. It is anticipated that this requirement will be for non-R&D support services which will include severable and non-severable services. The severable services will include inventory management which includes receipt, processing, and distribution of research materials and agents. The non-severable services will include manufacturing vaccines not commercially available for use in pre-clinical and clinical trials. This acquisition shall be acquired through full and open competitive procedures, and will be processed under FAR Part 15 - Contracting by Negotiation. The North American Industry Classification System code is 541690 (Other Scientific and Technical Consulting Services) and the business size standard is $15,000,000. The NCI anticipates awarding a single-award Indefinite Delivery/Indefinite Quantity (IDIQ) contract to the Offeror capable of performing all aspects of the work described in the Base Statement of Work (SOW.). Only one (1) award will be made as a result of the Solicitation with a 60 months base period of performance beginning on July 1, 2018. Place of Performance: The place of performance will be the Contractor's work site. Set Aside Status: None. Request for Proposal Number N02CN75014-45 will be available on or about February 22, 2018. The RFP is only available electronically and must be accessed through the FedBizOpps website (www.fbo.gov) and the National Cancer Institute homepage at http://rcb.cancer.gov/rcb-internet/index.jsp. All information required for submission of a proposal must be contained in the electronic RFP package. It is the Offeror's responsibility to monitor the above websites for the release of this RFP and amendments, if any. All responsible sources may submit a proposal, which shall be considered by the agency. This notice does not commit the Government to award a contract. Offerors are required to submit their proposals online at the NIH electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov/NCI/home/) ONLY. Proposals submitted in hard copy (paper) will not be accepted. Proposals submitted by email will not be accepted. Collect calls will not be accepted. Facsimile transmissions will not be accepted. This notice does not commit the Government to award a contract. POTENTIAL OFFERORS ARE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE RFP AND ANY POSSIBLE AMENDMENTS; FAILURE TO DO SO WILL BE AT YOUR ORGANIZATION'S OWN RISK. ALL INQUIRIES SHALL BE SUBMITTED ELECTRONICALLY TO THE CONTRACTING OFFICER LISTED AS THE POINT OF CONTACT HEREIN.
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