Centralized Chemopreventive Agent Repository and Chemistry Support

SMALL BUSINESS SOURCES SOUGHT NOTICE Notice Number: HHS-NIH-NCI-SBSS-PCPSB-75006-45 Title: Centralized Chemopreventive Agent Repository and Chemistry Support 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. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. 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. This has been assigned NAICS code 541690 - Other Scientific and Technical Consulting Services which has a size standard of $15,000,000. 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. 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 [subcontracted] 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 will be needed. 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 Project Officer/Contracting Officer's Technical Representative on demand through a secure, password-protected, DCP-dedicated server. 4) The Contractor will 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 Contractor must have experience in obtaining a Quality Persons Determination for agents shipped into the European Union. CAPABILITY CRITERIA - Capabilities will be judged based on the following criteria: 1. History of key personnel having prior experience as a team in core competencies including providing supplies for clinical trials. 2. Proof of adequate facility space 3. Demonstration of a working computerized logistics management system 4. Demonstrated experience with international shipping of pharmaceuticals A copy of the draft Statement of Work (SOW) pertaining to this requirement, which is subject to revisions, is attached to this notice. Anticipated Period of Performance: The period of performance for this contract would be 5 years. The anticipated start date is August 1, 2018. Capability Statement/Information Sought: Respondents are expected to have the expertise, personnel, and systems to meet requirements of the draft Statement of Work (SOW). Tailored Capability Statements shall demonstrate a clear understanding of the tasks specified in the attached draft SOW. The Capability Statements will be evaluated based on the information provided in relation to the project requirements and the current capability to: 1) perform the work in the attached Draft Statement of Work; 2) staff education, training, experience, expertise and knowledge; 3) prior completed projects and Government contracts of a similar nature; 4) corporate experience and management; and 5) computing infrastructure. Information Submission Instructions: Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed fifteen (15) total single-spaced pages including all attachments, resumes, charts, etc. (12 point font size at a minimum), that clearly details the firm's ability to perform and that addresses the specific requirements described above and the draft Statement of Work (SOW). Tailored capability statements should also include an indication of current certified small business status. Please provide your DUNS number, organization name, address, point of contact, including names, titles, addresses, telephone, fax numbers, email addresses, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code on the first page of your capability statement. Number of Copies/Delivery Point: All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to Miguel Diaz, Contracting Officer, at miguel.diaz@nih.gov either in MS Word, or searchable Adobe Portable Document Format (PDF). The email subject line must specify HHS-NIH-NCI-SBSS-PCPSB-75006-45. Facsimile and telephone responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 4:00PM EST on March 23, 2017. 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. CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your responses. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).