Inactive
Notice ID:75N93024R00004
Sources Sought Notice Information Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice i...
Sources Sought Notice Information Introduction 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. Background The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), supports research to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research for the investigation, control and prevention of diseases caused by all infectious agents. Support for basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics is provided through a variety of research grants and contracts as described in the following link: https://www.niaid.nih.gov/research/resources. The development and introduction of new vaccines and biologics against potential agents of bioterrorism, drug-resistant pathogens, emerging and re-emerging infectious diseases, as well as infectious diseases prevalent in resource-limited countries remain a high public health priority. To assist in filling these public health gaps, the NIAID requires a product development-oriented program to provide preclinical development support for multiple vaccine and biologic candidates. The solicitation will be a third recompete originating with the first award of NIAID Contract Number HHSN272201200005I in 2012 to Advanced Bioscience Laboratories. A second recompete resulted in the award in 2018 to a pool of three Contractors: (1) Advanced Bioscience Laboratories – Contract HHSN272201800009I, (2) International AIDS Vaccine Initiative (IAVI) – Contract HHSN272201800010I, and (3) IDT Biologics – Contract HHSN272201800011I. This sources sought notice provides for the re-competition of these support activities to be continued under the resultant award. Purpose and Objectives The purpose of the solicitation is to support development of multiple vaccine and other biologic candidates as medical countermeasures against infectious diseases. Note that the candidates will be provided from academia, the private sector, or other sources. The requested activities are commonly associated with product construction and development through manufacture of clinical trial material to support Phase I/II clinical trials. In addition, this solicitation seeks to support product assessments and product development plans focusing on activities required to support candidate entry into Phase I/II clinical trials. Finally, the intent is to provide individual gap filling services on a case-by-case basis, rather than supporting a single product candidate through an entire preclinical development pathway. These services are intended to support: A wide variety of investigators in a number of scientific areas obtain critical data needed to acquire additional funding, gain prospective partnerships (either for further development or to support Phase I/II trials), fulfill regulatory requirements, and support Phase I/II clinical studies. NIAID priority activities including manufacture and characterization of reagents and products to support government supported clinical trials such as those supported by IDCRC. Manufacture of critical reagents and clinical trial material to support the wider scientific community and non-government sponsored projects. Project Requirements The NIAID recognizes that a single organization or institution may not have the full spectrum of expertise or facilities required to perform all activities set forth in the Statement of Work nor have expertise in the wide array of candidate products that NIAID may seek to support. Consequently, NIAID anticipates awarding multiple IDIQ contracts to organizations that best meet the overall qualifications needed to fulfill the technical requirements of the Task Areas of the solicitation. Offerors may submit proposals to a single Task Area or multiple Task Areas. Offerors may propose to extend internal expertise and resources by including the expertise and resources of other organizations or persons through subcontracts, partnerships, consortia agreements, and/or use of consultants. However, an awarded Contractor shall be responsible for ALL work performed and shall be responsible for project planning, initiation, implementation, management, and communication; evaluation, selection, and management of subcontractors; and for all deliverables specified in the contract and each awarded Task Order. The Government anticipates both single and/or multiple awards for each Task Area. The solicitation will include the following Task Areas: • Task Area A: Product Development Plans and Other Analyses (Landscape, Feasibility) • Task Area B: Product Development & Manufacture of Non-GMP Material • Task Area C: Bank Optimization and Master Banks • Task Area D: Engineering and GMP Material Offerors may respond to one or multiple Task Areas. Offerors will only be considered for Task Area(s) that they include in their proposal. Offerors must respond to all Sample Task Orders within a task area and will be evaluated on their ability to support proposed work within the task area and sample task order. Individual Task Orders for specific tasks will be issued after award of the Parent Contract. In cased of multiple offerors, all offerors will be provided a Request for Task Order Proposal and offered the opportunity to submit a Task Order proposal. The Contractors shall provide the services required to support development and manufacturing services for vaccines, other biologics, vaccine components, and reagents. The services provided shall support manufacture of material to support preclinical, nonclinical, and Phase I/II clinical studies. Contractors shall also provide appropriate documentation and support for Product Development Plans and other product assessments. These tasks shall be conducted in accordance with quality oversight within all applicable and current Federal, state, and local laws, codes, ordinances, and regulations, as well as all PHS Safety and Health provisions. In addition, task areas C and D require compliance with regulatory requirements applicable for manufacture of Phase I/II clinical trial material including, but not limited to, Electronic Records, Good Laboratory Practices (GLP), cGMP [21 CFR Parts 11, 58, 210, and 600]. Task areas C and D may also require compliance with international regulations as defined by ICH, EMA, WHO, and other regulatory bodies. In the event of a Public Health threat and/or emergency, the Contractor may be required to: • Manufacture critical reagents or components to support assay development and other support under devices regulations. • Support vaccines, other biological products, or critical reagents that are intended for product development use in animals that constitute a disease reservoir for pathogen(s) that pose a public health risk. • Support efforts associated with zoonotic diseases. • Provide support outside of Phase I/II clinical trials. Anticipated period of performance The anticipated award will be an IDIQ Contract with a seven-year ordering period (10 years for Task Area A). The anticipated start date is on/or about May 1, 2025. Other important considerations Assume responsibility for the following list of activities which represents an estimate of tasks the Offerors should assume to perform under during the 7 year ordering period. Task Area A: Product Development Plans and other Feasibility Studies = 10 Task Orders Task Area B: Product Development & Manufacture of Non-GMP Material = 14 Task Orders Task Area C: Bank Optimization and Master Banks = 14 Task Orders Task Area D: Engineering and GMP Material = 4 Task Orders Capability statement / information sought Capability Statements should clearly convey information regarding the respondent’s capabilities including: (1) technical expertise and ability to perform tasks identified in the SOW, (2) personnel, project management systems and quality systems including in-house capability, (3) facilities, equipment and other resources, (4) Breadth and capacity to perform the work. Capability statements should include: (1) a summary of completed projects of similar nature to the SOW and (2) corporate experience and examples of prior completed Government contracts, references, and other related information. Interested Contractors must submit a capability statement describing their company’s experience and ability to perform this effort that includes the following: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) proposed biosketches for key personnel, including the Principal Investigator, that reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; (5) demonstrated ability to carry out the work; (6) adequacy of the documented experience with, and appropriateness of plans for: (a) receiving, formatting, storing and shipping compounds and biological agents; (b) technology transfer processes; (c) shipping, handling and storing of reagents and formulated vaccine and biologic products, and highly infectious Select Agents; (d) shipping, handling and storing of highly infectious Select Agents; (e) experience working with potential biohazards, toxic chemicals, and radioisotopes; and (f) adequacy of the plan for training, implementation, and monitoring of safety procedures; (7) availability of adequate facilities, equipment, and resources with sufficient capacity necessary to safely and efficiently accomplish the work described in the Statement of Work in a timely manner, to include documented access to BSL-2, BSL-3, and BSL-4 facilities; (8) perform work in accordance with the following guidelines: “Biosafety in Microbiological and Biomedical Laboratories”, Centers for Disease Control and Prevention and the National Institutes of Health, Fifth Edition 2007 (http://www.cdc.gov/biosafety/publications/bmbl5/index.htm); Federal Guidelines for Research involving Recombinant DNA molecules at http://oba.od.nih.gov/rdna/nih_guidelines_oba.html); and Recommendations for the Safe Handling of Cytotoxic Drugs, NIH Publication No. 92-2621 and the NIH Guidelines for the Laboratory Use of Chemical Carcinogens, NIH Publication No. 81-2385. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed five pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one inch on each edge of the paper. Print setup should be single sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Required Business Information: • Unique Entity Identifier (UEI) • Company Name. • Company Address. • Company Point of Contact, Phone and Email address. • Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought. • Do you have a Government approved accounting system? If so, please identify the agency that approved the system. • Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://sam.gov/content/home. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern’s name and address). Number of Copies: Please submit one (1) electric copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Andrew Cherry, Contracting Officer at cherryan@niaid.nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify SBSS-HHS-NIH-NIAID-75N93024R00004. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 12:00 PM (Eastern Prevailing Time) on Friday, December 8, 2023. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. Disclaimer and Important Notes This notice does not obligate the Government to award an IDIQ contract or Task Order 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 response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”
