PREVENT Cancer Preclinical Drug Development Program: Preclinical Services for Biopharmaceutical Product Development & Manufacturing (CGMP)

Special Notice: Request for Information PREVENT Cancer Preclinical Drug Development Program: Preclinical Services for Biopharmaceutical Product Development and Manufacturing (CGMP) HHS-NIH-NCI-RFI-TSB-87006-18 Contracting Office Address: Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions, Riverside Five, Suite 400, 8490 Progress Drive, Suite 400, Frederick, MD 21701-4998. This is a Request for Information (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this RFI is to obtain knowledge and information for project planning purposes. Interested parties are expected to review this notice and the attached draft Request for Proposal (RFP), which includes the draft Statement of Work (SOW), to familiarize themselves with the requirement of this project; failure to do so will be at your firm's own risk. Background: The NCI PREVENT Cancer Preclinical Drug Development Program (PREVENT; http://prevention.cancer.gov/major-programs/prevent-cancer-preclinical) is a peer-reviewed research program managed by the Division of Cancer Prevention (DCP) with its primary mission to advance the preclinical development of cancer-preventive interventions and intermediate biomarkers toward clinical trials. The overall objective of the current acquisition is to provide a structured approach to drug and vaccine development, from discovery to the clinic. To achieve these goals, the proposed acquisition is for a multiple-award Indefinite Delivery Indefinite Quantity (IDIQ) pool as described below, and outlined in greater detail in the attached draft RFP. Purpose & Objectives: The purpose of this Request for Information is to obtain knowledge and information for project planning from organizations and firms that interested in and capable of performing the work described herein. NCI recently solicited for Preclinical Services for Biopharmaceutical Product and Manufacturing (also referred to as the PREVENT Current Good Manufacturing Practices or CGMP Pool) in support of the PREVENT Program under RFP N01CN77019-18, substantively the same as outlined in the attached draft RFP, and did not receive any proposals in response to the CGMP portion of the solicitation. Based on the attached draft RFP, we are seeking input from Industry in three areas: (1) general level of interest; (2) factors that may have deterred potential offerors from proposing; and (3) recommendations as to what could be done to remedy the lack of response from Industry. The Government invites specific feedback about any overly restrictive or problematic issues with the requirement and/or SOW or other concerns regarding this proposed acquisition, including but not limited to: contract type, terms and conditions, planning schedules, feasibility of the requirement (SOW, performance and/or data issues), and the suitability of proposal instructions and evaluation criteria. The Government, at their sole discretion, may contact interested parties that respond to this inquiry to conduct additional exchange of information and/or market research, prior to the release of any resulting solicitation. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information received. Since this is a RFI, no evaluation letters, results and/or responses will be issued to the respondents. As a result of this RFI, the NCI may issue additional Sources Sought notices and/or a Request for Proposal (RFP). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claim against the NCI shall arise as a result of a response to this Request for Information or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement(s). Project Requirements: The PREVENT Preclinical Services for Biopharmaceutical Product Development and Manufacturing or CGMP pool encompasses four main technical task areas: (1) product development planning and evaluation; (2) analytical assay development and product characterization; (3) process development and related activities; and (4) CGMP manufacture, related activities and documentation, as described in detail in the SOW attached to the draft RFP. The key objective of the PREVENT CGMP Pool is to provide preclinical product development and CGMP manufacturing support for candidate cancer preventive vaccines for preclinical and clinical testing. There are no mandatory qualification criteria for the CGMP Pool and there are no incumbent contractors for the CGMP Pool. Anticipated Period of Performance: It is anticipated that any award(s) that may result from any future solicitations issued for this requirement will be multiple-award Indefinite Delivery/Indefinite Quantity (IDIQ) contracts. Task orders issued under this IDIQ contract are anticipated to be cost-plus-fixed-fee (CPFF) and/or Firm Fixed Price (FFP). The duration of the IDIQ contract(s) will be for approximately a four to five (4-5) year period. The anticipated start date is on or about April 2019. If a RFP is issued, the NCI anticipates that up to six (6) IDIQ awards may result from the issuance of any RFP. NAICS Code and Size Standard: In the event a RFP is issued, the 2017 NAICS code for this acquisition is 541714, Research & Development in Biotechnology (except Nanobiotechnology), which has a size standard of 1,000 employees. Information Sought: All interested and capable sources are invited to submit detailed feedback to inform the development of future acquisitions. Evaluation of submissions will assist the Government in determining the acquisition strategy for this procurement. Do not provide comments and questions that are marked proprietary. Comments and questions to this RFI are not offers and cannot be accepted by the Government to form a binding contract. Contractors are solely responsible for all expenses associated with responding to this RFI. Capability statements for qualified sources with the personnel, facilities, equipment and experience to meet the requirements in the attached, draft SOW are not requested at this time and review of any capability statements received will be at the Government's sole discretion. Information Submission Instructions: 1. Page Limitations: A written submission is required in response to this RFI. There is no page limitation for this RFI; however, please provide the business concern's name, Small Business Administration size standard(s), point of contact and contact information (email and phone), organization's address, and DUNS number with any response. 2. Delivery Point: All information sent in response to this Request for Information notice must be submitted electronically (via email) to Carrie Mills, Contract Specialist at carrie.mills@nih.gov AND to Nicole Belanger, Contracting Officer at belangern@mail.nih.gov in Microsoft Word or Adobe Portable Document Format (PDF). The subject line must specify HHS-NIH-NCI-RFI-TSB-87006-18. Facsimile responses will not be accepted. 3. Common Cut-Off Date: Electronically submitted responses are due no later than 10:00 AM (Eastern Prevailing Time) on Monday July 23, 2018. 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. 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 response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).