Inactive

Title of Project: Developing the knowledge base on immune correlates of protection for parenteral influenza vaccines Introduction. This is a Sources Sought notice. This is NOT a solicitation for propo... Title of Project: Developing the knowledge base on immune correlates of protection for parenteral influenza vaccines Introduction. This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of qualified sources; Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The NAICS code for this Sources Sought Notice is: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) Background. The Centers for Disease Control and Prevention (CDC)- Influenza Division in the National Center for Immunization and Respiratory Diseases (NCIRD), is seeking to assess the feasibility of obtaining services for developing and updating databases of published and unpublished immunogenicity and clinical outcomes data for second-generation and traditional egg-based parenteral influenza vaccines and implementing analytic methods including mediation analyses to evaluate potential immune correlates of protection. Purpose and Objectives. This initiative seeks to produce estimates of protective levels of antibodies associated with protection against influenza illness caused by circulating influenza viruses. This objective will be achieved by applying statistical techniques to estimate immune correlates to protection as new data on vaccine effectiveness, immune protection and population immunity against circulating influenza viruses become available each season. Project Scope. Advancing knowledge of immune correlates of protection against influenza involves regular updates and review of newly published and unpublished immunogenicity and clinical outcomes data for second-generation egg and non egg-based versus traditional standard dose inactivated influenza vaccines, and for influenza mRNA vaccines as data become available. Of interest to the government are all data comparing immunogenicity and effectiveness of different influenza vaccines, comparing immunologic assays and serologic antigens, and correlating immune responses to levels of protection against circulating influenza viruses. Regularly updated reports will inform critical analyses of new information obtained each influenza season that will be summarized every six months. As an independent organization and not as an agent of the Government, the Contractor shall furnish all necessary personnel and data use agreements to perform these services. The Contractor shall have primary expertise to advance improvements in understanding correlates of protection and relative immunogenicity and durability of immune response of licensed and recommended vaccines. CDC will have final approval regarding publications, presentations, and products developed as a result of this contract. The specific responsibilities regarding the development of publications, presentations and products will be negotiated on a case-by-case basis. See a draft Statement of Work (SOW) attached to this announcement. Anticipated period of performance. The period of performance will be two years. Capability Statement/Information Sought. PAGE LIMIT 10 PAGES. Interested firms are requested to submit a capability statement, which shall include documentation of the ability to perform the requirements and information on previous successfully completed contracts for the same type of work. The capability statement shall specifically address the criteria listed below ONLY. Please note that capability statementss that only include marketing material will not be considered or reviewed. Your opinion about the difficulty and or feasibility of the potential requirement(s) or proposed acquisition, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts; Your staff expertise, including your availability, experience, and formal and other training; include a discussion on your proven track record for the type of work as per the SOW; Your current in house capability and capacity to perform the work; specifically, describe your experience conducting systematic literature reviews and meta-analyses of randomized clinical trial and immunogenicity study data. Principal investigators are expected to have published studies relevant to the proposed work in peer-reviewed scientific journals. The contractor should have experience establishing data use agreements with vaccine manufacturers and study investigators to share unpublished data relevant to the proposed work. Finally, project leads must have experience in statistical and analytic methods required for the proposed work.Completed projects in the last 5 years of similar size and scope; Corporate experience and management capability; Provide any examples of prior completed Government contracts, reference, and other related information; Recommendations for a different NAICS code. If so, please explain? Information Submission Instructions: Please include a cover page with the following business information. The cover page does not count against the page limit for the capability statement. Company name and address; UEI number and CAGE Code, as registered in the System for Award Management (SAM) at http://www.SAM.gov/; Do you have a government-approved accounting system? If so, please identify the agency that approved this system; Business Size and Type of Business (e. g., small business, 8(a), woman owned, veteran owned, etc.). Technical point of contact including name, title, address, telephone number, and email address of the individual(s) who can verify the demonstrated capabilities identified in the response; Contracts’ point of contact including name, title, address, telephone number, and email address; In your opinion, can this work fit under a GSA Schedule? If so, which GSA Schedule? Please provide the schedule number. Page Limitation: Capability Statements shall be limited to TEN (10) single-spaced pages not including cover page. Pages shall be formatted as follows: MS Word, 8 ½ x 11, 12 pitch, Times New Roman font with one (1) inch margins. Response Due Date: Submit capability statements via email to Ada C. torres Vega, Contract Specialist at cbp0@cdc.gov. Should you have any questions concerning this sources sought, please direct your questions in writing to the Contracting Specialist Ada C. Torres Vega at cbp0@cdc.gov. The government will not respond to oral questions. Responses must be submitted no later than 5:00 pm, Eastern Standard Time (EST) by Friday March 1st, 2024. Capability statements will NOT be accepted after the due date. No telephonic or facsimile responses will be accepted. The Government will not provide feedback on capability statements and we will not return capability statements received. 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 on sam.gov. 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). Response is strictly voluntary. It is not mandatory to submit a response to this notice to participate in any formal RFP process that may take place in the future. However, it should be noted that information gathered through this notice may significantly influence our acquisition strategy. All interested parties will be required to respond separately to any solicitations posted as a result of this Sources Sought notice. We appreciate your interest and thank you in advance for responding to the Sources Sought.