Regulatory Support for Cancer Prevention Agent Development

SOURCES SOUGHT (Small Business): On behalf of the National Cancer Institute (NCI), Division of Cancer Prevention (DCP) TITLE: - Regulatory Support for Cancer Prevention Agent Development INTRODUCTION The National Institutes of Health (NIH) National Cancer Institute (NCI), Division of Cancer Prevention (DCP) is issuing this Sources Sought as a means of conducting market research to invite participation from all Small Business concerns that are engaged in related activities, and appreciates responses from all capable and qualified Small Business companies having an interest in and would have the capability of supporting a requirement to provide qualified regulatory and technical services on behalf of the Division of Cancer Prevention (DCP) at the National Cancer Institute (NCI). Technical Support is required to gather, interpret, and summarize the vast amount of preclinical and clinical data associated with potential cancer preventive agents. The mission of the DCP is to plan and direct cancer prevention research, including testing promising agents in human clinical trials as part of a drug development program. Such testing falls under the purview of regulatory agencies such as the Food and Drug Administration (FDA) and requires certain documentation for the use of the investigational agents. This effort encompasses the collection, preparation, submission, and continual update of regulatory data. The intention is to procure these services on a competitive basis THIS REQUIREMENT WILL BE SET ASIDE FOR CERTIFIED SMALL BUSINESSES. All Small Business set-aside categories will be considered. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. PLACE OF PERFORMANCE. It is anticipated that this work for DCP will primarily be conducted at the Shady Grove Office located at 9609 Medical Center Drive, Rockville MD 20850; however, that is not a requirement for the contractor; work for this effort will primarily be conducted at the contractor's facility. PERIOD OF PERFORMANCE. The anticipated period of performance consists of one 12-month base period and four 12-month option periods. DISCLAIMER THIS SOURCES SOUGHT IS FOR INFORMATIONAL PURPOSES ONLY. THIS IS NOT A - REQUEST FOR PROPOSAL (RFP) TO BE SUBMITTED. IT DOES NOT CONSTITUTE A SOLICITATION AND SHALL NOT BE CONSTRUED AS A COMMITMENT BY THE GOVERNMENT. RESPONSES IN ANY FORM ARE NOT OFFERS AND THE GOVERNMENT IS UNDER NO OBLIGATION TO AWARD A CONTRACT AS A RESULT OF THIS ANNOUNCEMENT. NO FUNDS ARE AVAILABLE TO PAY FOR PREPARATION OF RESPONSES TO THIS ANNOUNCEMENT. ANY INFORMATION SUBMITTED BY RESPONDENTS TO THIS TECHNICAL DESCRIPTION IS STRICTLY VOLUNTARY. RESPONSES WILL NOT BE RETURNED TO THE RESPONDER. NOT RESPONDING TO THIS NOTICE DOES NOT PRECLUDE PARTICIPATION IN ANY FUTURE REQUEST FOR RFP, IF ANY ISSUED. IF A SOLICITATION IS RELEASED, IT WILL BE SYNOPSIZED ON THE GOVERNMENT-WIDE POINT OF ENTRY (GPE). IT IS THE RESPONSIBILITY OF POTENTIAL OFFERORS TO MONITOR THE GPE FOR ADDITIONAL INFORMMATION PERTAINING TO THIS REQUIREMENT. AQUISITION BACKGROUND: The U.S. National Cancer Institute, Division of Cancer Prevention at the National Institutes of Health located in Bethesda Maryland is responsible for the planning and directing of cancer prevention research, including testing promising agents in human clinical trials as part of a drug development program. The NCI DCP will support the current capability primarily through the conduct of technical and regulatory expertise by collection, preparation, submission of and the continual update of regulatory documentation. REQUIRED CAPABILITIES. For specific details, please refer to the draft Statement of Work (SOW) incorporated as an attachment to this announcement. a. Regulatory Submissions - The contractor shall submit regulatory reports to support the Government's Chemoprevention agent development and clinical research program. b. IND Submissions - The Contractor shall compile and submit IND applications as required by FDA. A portion of this information will come from the DCP databases to include protocols, protocol amendments, Serious Adverse Event (SAE) reports, Annual Reports, FDA forms 1571, additional chemistry and manufacturing information, and toxicology information. The Contractor shall file IND documents in electronic Common Technical Format (eCTD) to the FDA and utilize such software and licenses necessary to fulfill this requirement. c. Drug Master Files (DMF) - The Contractor shall review and update the DCP Drug Master File (DMF) on the anniversary date of this contract. The Contractor shall submit draft DMF to DCP for review and approval. d. Regulatory correspondence and administrative tracking - The Contractor shall prepare, review, maintain, and track correspondence related to regulatory submissions. e. Safety Activities - The Contractor shall provide regulatory support for safety data (adverse event) review, processing, and submission to regulatory agencies and investigators. f. Maintenance of collaborating research agreement records - The Contractor shall maintain all files of agreement documents and other documents from pharmaceutical companies. The Contractor shall create and maintain data about the status and nature of the collaborative agreement documents, which will include correspondence between the DCP, potential and actual collaborators, and tracking of special requirements for research activities conducted under collaborating research agreements. g. Coordination and Documentation of Regulatory Meetings - The Contractor shall assist the Government in scheduling, facilitating, and attending meetings to support DCP's regulatory affairs, agent development, and clinical research programs. h. Document Management - The Contractor shall manage regulatory documents (such as INDs and DMFs) in accordance with regulations, laws, and guidance. I. Regulatory review, reporting and advisory activities - Perform regulatory and safety reviews of chemoprevention protocols and amendments as directed by DCP Protocol Information Office (PIO). The contractor shall provide Subject Matter Experts (SMEs) to participate in the development of informatic system design and development. SMEs shall be available to advise on regulatory issues that may arise from agent development and clinical research activities. j. Process and Quality Assurance/Quality control Standard Operating Procedures (SOP's) - The contractor shall prepare and submit SOP, establish written plans for quality assurance and quality control of data and activities outlined in the SOW. k. Information Management Systems - The contractor shall provide information technology services to include support for dedicated software and hardware for DCP's regulatory affair operations. All technology platforms shall integrate with DCP's current information management systems that support agent development regulatory efforts to include data and information collection, management, analysis, and communication. l. Review of Informed Consent Documents - The Contractor shall review informed consent documents of the first approved protocol version provided by the AOs for accuracy and adherence to the approved language. m. Transition - The Contractor shall assist in the transition of the existing contract to a successor contract If your organization has the potential capacity to perform these contract services, please provide the following information: 1) Organization name, address, email address, Web site address, telephone number, and size and type of ownership for the organization; and 2) Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. If significant subcontracting or teaming is anticipated to deliver technical capability, organizations should address the administrative and management structure of such arrangements. The Government will evaluate market information to ascertain potential market capacity to: 1) provide services consistent, in scope and scale, with those described in this notice and otherwise anticipated. 2) secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements. 3) implement a successful project management plan that includes compliance with tight program schedules, cost containment, event and tracking performance, hiring and retention of key personnel, risk mitigation, and 4) provide support under a service acquisition contract. ELIGIBILITY. The applicable NAICS code for this requirement is 541690 - - Other Scientific and Technical Consulting Services and the applicable small business size standard is $16.5M. The Product Service Code is R499 - - Support - Professional: Other ADDITIONAL INFORMATION AND SUBMISSION DETAILS (CAPABILITIES STATEMENT). A draft Statement of Work (SOW Attachment 1) is provided for review. Interested parties are requested to submit a capabilities statement of no more than ten (10) pages in length in Times New Roman font of not less than 10 pitch. The deadline for response to this request is no later than 3:00 pm, Eastern Daylight Time (EDT), May 25, 2022. 1) This documentation must address at a minimum the following items: 2) What type of work has your company performed in the past in support of the same or a similar requirement? 3) Can or has your company managed a task of this nature? If so, please provide details 4) Provide detailed experience with qualified Technical and Regulatory work and the ability to prepare Standard Operating Procedures (SOPs) and establishing/implementing written quality assurance plans and quality control of data. 5) Can you demonstrate the ability to provide qualified personnel and technicians on the first day of contract award, as well as additional administrative support? 6) Can or has your company managed a team of subcontractors before? If so, please provide details. 7) What specific technical skills does your company possess which ensure successful capabilities to perform the tasks stated above? 8) If you are a certified Small Business, please note that under a Small-Business Set-Aside, in accordance with FAR 52.219-14, the small business prime must perform at least 50% of the work themselves in terms of the cost of performance. Please provide an explanation of your company's ability to perform at least 50% of the tasks described in the draft SOW for the Period of Performance, which is anticipated to be one 12-month base period and four 12month option periods. 9) Respondents to this notice must indicate whether they qualify as a certified Small Business Concern. Please provide a statement including status, company name and address, Commercial and Government Entity (CAGE) code, Tax Identification number and company profile, to include number of employees, annual revenue history, office locations, Unique Entity Identifier (UIE) number, etc. Your response to this Sources Sought, including any capabilities statement, shall be electronically submitted to the Contract Specialist, Sheila Ramos, in either Microsoft Word or Portable Document Format (PDF), via email at sheila.ramos@nih.gov . All data received in response to this Sources Sought that is marked or designated as corporate or proprietary will be fully protected from any release outside the Government. No phone calls will be accepted. QUESTIONS OR REQUESTS FOR CLARIFICATION. Only electronically submitted questions and requests for clarifications regarding this Sources Sought will be accepted and must be submitted to the contract specialist identified above no later than 3:00 PM Eastern Daylight Time (EDT) May 18, 2022. The Government is not committed nor obligated to pay for the information provided, and no basis for claims against the Government shall arise resulting from a response to this Sources Sought.