Inactive

Introduction The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to ... Introduction The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of Microbiology and Infectious Diseases has a requirement to provide and develop animal models in order to advance our understanding of infectious diseases as well as advance the development of therapeutics and vaccines for infectious diseases. Description The National Institute of Allergy and Infectious Diseases (NIAID) supports and facilitates research that focuses on understanding, treating and, ultimately, preventing infectious, immunologic, and allergenic diseases. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports and facilitates research to understand, control and prevent human disease caused by infectious agents. Basic, applied and translational research to develop and assess therapeutics, vaccines, and diagnostics is supported through research grants, cooperative agreements, and contracts. In turn, DMID further supports and facilitates research ongoing under these funding mechanisms and through other programs via an array of preclinical and clinical resources and services to support multiples stages of the product development pipeline. These resources and services include genomic and gene sequencing services, provision of high quality biological materials, biocontainment facilities, and pre-clinical and clinical translational research resources (https://www.niaid.nih.gov/research/resources). The current NIAID Preclinical Models of Infectious Diseases IDIQ contract program is one of DMID’s preclinical services resources and supports the development and refinement of animal models and animal replacement models of infectious diseases, models that subsequently are used to evaluate candidate medical countermeasures against these diseases. In addition, these contracts facilitate regulatory submissions, patents, and other intellectual property applications by extramural investigators who request evaluation of their products. This program serves the DMID mission of supporting investigator-initiated research by providing critical data needed to apply for grant or other funding. Finally, these contracts enable product developers and sponsors to make key go/no-go decisions for candidate therapeutics, vaccines, and diagnostics. In addition to meeting the needs of extramural researchers, this program provides crucial data to our DHHS agency partners. These data will facilitate the advancement of promising candidate medical countermeasures against priority biodefense and emerging infectious agents to approval or licensure, and, in some cases, eventual deposit in the Strategic National Stockpile. As background, In 2017, 32 institutions were awarded base contracts under the Preclinical Models of Infectious Diseases IDIQ contract program. This program was a re-competition of her Animal Models of Infectious Diseases IDIQ contract program, and its overarching goal was to provide capability in a broad range of animal and animal replacement models for use in evaluating promising candidate countermeasures (vaccines, therapeutics, diagnostics) against the broad range of infectious agents that are in the purview of DMID. The breadth of the existing contractor pool has enabled a rapid and effective response to emerging infectious diseases, such as COVID-19, and emergency preparedness priorities. Awarded contracts were divided into 3 model-specific pools: Part A – Small animal models of infectious diseases Part B – Non-human primate models of infectious diseases Part C – Non-traditional animal models and animal replacement models of infectious diseases The Preclinical Models of Infectious Diseases program will continue to provide the capability and capacity to develop and employ animal and animal replacement models (e.g., organ-on-a-chip technology) of infectious diseases for screening and product evaluation and addresses a critical stage in this pipeline by bridging in vitro testing and eventual clinical evaluation, including as needed, studies conducted under the guidance of 21 CFR 58, “Good Laboratory Practices”. In addition, for candidate products that are unable to be assessed for clinical efficacy in phase II or III trials for ethical or practical reasons, contracts awarded under this solicitation will enable regulatory approval or licensure via the guidance of the FDA’s Animal Efficacy Rule (21 CFR 314.610 and 601.91). This anticipated solicitation will award multiple IDIQ base contract awards to successful offerors proposing a general approach to the requirements under one Contractor pool. Successful Offerors will have qualified for the pool to compete for eventual task order awards in one or more of the following areas: Task Area A – Small Animal Models of Infectious Diseases Task Area B – Non-Human Primate Models of Infectious Diseases Task Area C – Animal Replacement and Non-traditional Animal Models of Infectious Diseases Task Area D – Generation and Distribution of Specialized Reagents Contracts are anticipated to organizations that represent the best value to the Government for the full suite of services. For the purposes of this solicitation, the following definitions apply: Animal replacement tissue technologies derived from human or animal tissue (in particular lung, liver, immune system, brain, skin/soft tissue or gastrointestinal tissues): • Organoids • Organs on chips • Artificial complex cell systems • Microphysiological systems • Tissue technologies derived from animals, in particular, non-human primates (for the purposes of bridging data from in vivo models with clinical data) Evaluation: encompasses advanced testing after a product has been screened and demonstrated as efficacious in the same or lower animal models; activities include dose refinement, measurement of host response, pharmacokinetics (in infected animals), pharmacodynamics (in infected animals), and therapeutic efficacy or immune protection against challenge. Model development: a novel systematic effort to reproduce a clinical syndrome caused by an infectious agent in an animal species following challenge with the agent and includes median lethal and/or infectious dose determination, natural history of infection, and serial pathogenesis studies. Model refinement: a systematic effort to improve the performance of an existing animal model that reproduces a clinical syndrome caused by an infectious agent; to adapt an existing animal model that reproduces a clinical syndrome caused by one infectious agent to a different, but related, infectious agent; to adapt an existing animal model to optimize its ability to support product screening or evaluation following challenge with the infectious agent. Non-human primate models: new and old-world species, including but not limited to Macaca, spp. (cynomolgus, Rhesus, pig-tailed); Chlorocebus, spp. (African green monkeys, vervets); Aotus, spp.; Papio, spp.; Callithrix, spp. (marmosets) Non-traditional animal models including but not limited to: • Domestic livestock: horses, cattle, goats, sheep, fowl • Wildlife species: marmots, wild rodents, deer, bats • Invertebrates: snails, parasitic nematodes, parasitic protozoa, insect vectors of human disease • Aquatic: zebrafish • HFIM Pathogens: infectious bacteria, viruses, parasites, fungi, toxins, and other agents such as prions that cause clinical syndromes in humans (surrogate human pathogen/animal combinations may be used for diseases where human pathogens cannot be studied in animal models) Products: agents for the prevention of infectious diseases such as vaccines or microbicides; therapeutics targeting the host or the pathogen, including conventional drugs, immunotherapeutics, and therapeutic vaccines; and diagnostics (Also referred to as candidate medical countermeasures or countermeasures.) Reagents: biochemical, genomic, molecular, cellular, and immunologic materials integral to research on pathogens, including the pathogenic agent or toxin itself requiring an in vivo model for production (e.g., hybridomas, monoclonal antibodies, otherwise unculturable organisms, live vectors) Screening: encompasses early-stage or first-in-animal testing for product effectiveness in animals; activities include rudimentary testing of product effectiveness after challenge, determination of maximum tolerated dose, and minimum effective dose. Small animal models: includes but is not limited to traditional laboratory rodent species (mice, rats, hamsters, gerbils (including jirds), guinea pigs), transgenic, humanized knock-out, and knock-in mouse strains, cotton rats, laboratory rabbit varieties, and laboratory ferrets The services encompass the following: Small animal models: • development of new and refinement of existing models amenable for evaluating candidate countermeasures; • evaluation of candidate countermeasures, including but not limited to, maximum tolerated dose, minimum effective dose, safety, efficacy, pharmacokinetics, pharmacodynamics Non-human primate models: • development of new and refinement of existing models amenable for evaluating candidate countermeasures; • evaluation of candidate countermeasures, including but not limited to, maximum tolerated dose, minimum effective dose, safety, efficacy, pharmacokinetics, pharmacodynamics Animal replacement models and non-traditional animal models: • development of new and refinement of existing models amenable for evaluating candidate countermeasures; • evaluation of candidate countermeasures, including but not limited to, maximum tolerated dose, minimum effective dose, safety, efficacy, pharmacokinetics, pharmacodynamics • studies to bridge animal and animal replacement model Generation and Distribution of Specialized Reagents including but not limited to: • Production of live life cycle stages for parasitic infections (e.g., eggs, pupae, larvae, adult stage parasites) • Production of live vectors that support life cycle stages of parasitic infections (e.g., mosquitoes, ticks, fleas, black flies, sand flies, tsetse flies, reduviid bugs) • Tissues required for isolation of otherwise unculturable infectious agents or toxins that can be distributed as reagents • Production of monoclonal and polyclonal antibodies and hybridomas in mice Model species that are not listed with the individual Task Areas above, but are requested for development or demonstrated as necessary for testing medical countermeasures following award, will be taken under advisement by the Government, and task order requirements involving these model species may be developed on a case-by-case basis as long as they are determined to represent benefit to the Government. The services shall be directed at, but not be limited to, the following areas of emphasis: • RNA viruses with the potential to cause pandemics from the following viral families: o Bunyaviridae o Coronaviridae o Enteroviridae (in particular, EV-D68 and EV-71) o Filoviridae o Flaviviridae (in particular dengue and West Nile viruses) o Paramyxoviridae (in particular Hendra and Nipah viruses) o Togaviridae • Antimicrobial resistant and multi-drug resistant infections, including Methicillin- Resistant Staphylococcus aureus, Vancomycin-Resistant Enterococcus, Carbapenem-Resistant Enterobacteriaceae, Acinetobacter baumanii, Pseudomonas aeruginosa, and Clostridium difficile •Diseases caused by pathogens and toxins on the National Institute of Allergy andInfectious Diseases (NIAID) Emerging Infectious Diseases/Pathogens list:http://www.niaid.nih.gov/topics/biodefenserelated/biodefense/pages/cata.aspx ; inparticular, influenza, viral hemorrhagic fevers (including arthropod-borne viruses),arthropod-borne encephalitis viruses, rabies, and Mycobacterium tuberculosis (includingMDR and XDR strains), Bordetella pertussis, Group A Streptococcus; •Fungal diseases, including invasive aspergillosis, candidiasis, coccidioidomycosis,cryptococcosis, mucormycosis , pneumocystis pneumonia; •Non-Biodefense Bacteria, including Chlamydophila pneumonia, Haemophilus, spp.,Legionella, spp, non-tuberculous Mycobacterial spp., Streptococcus pneumoniae, •Non-Biodefense Viruses, including: adenoviruses Hepatitis B and C viruses, Herpesviruses(HSV 1 and 2, CMV, VZV, HHV-6/7), human metapneumovirus, respiratory syncytial virus,papillomaviruses, parainfluenza virus; •Neglected tropical diseases, including: filariasis, leprosy, schistosomiasis, trachoma,trichomoniasis; and •Sexually transmitted infections, including bacterial vaginosis, chlamydia, and gonorrhea 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. Contractors shall perform the work described in one or more Task Areas. Contractors may need to be supported to a certain extent by the expertise and resources of other organizations or persons through consortia agreements, partnerships, subcontracts, and/or consultants. However, contractors 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 this contract and each awarded Task Order. Any responsible Offeror may submit a proposal which will be considered by the Agency. This NIAID solicitation will be issued for full and open competition. The RFP will be available electronically on/about December 28, 2022 and may be accessed through sam.gov. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website https://ecps.niaid.nih.gov and then click on "How to Submit." To submit online using eCPS, offerors must have a valid NIH electronic Research Administration (eRA) Commons account, which provides authentication and serves as a vehicle for secure transmission of documents and communication with the NIAID. The eRA Commons registration process may take up to 4 weeks. For more information, please see https://www.era.nih.gov/register-accounts/register-in-era-commons.htm.”

Inactive

Introduction This is a Small Business Sources Sought notice. This is NOT a request for proposal and does not commit the Government to award a contract now or in the future. No solicitation is availabl... Introduction This is a Small Business Sources Sought notice. This is NOT a request for proposal and does not commit the Government to award a contract now or in the future. No solicitation is available at this time. All small business organizations (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) are encouraged to respond to this notice. Small business organizations must have their size status certified by the Small Business Administration. The purpose of this notice is to obtain information regarding the availability and capability of qualified small business sources to develop and employ animal and animal replacement models of infectious diseases for screening, product evaluation and eventual clinical evaluation. Additionally, the purpose of this notice is to assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The NAICS code is 541714 with a size standard of 1000 employees. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Description The National Institute of Allergy and Infectious Diseases (NIAID) supports and facilitates research that focuses on understanding, treating and ultimately preventing infectious, immunologic, and allergenic diseases. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports and facilitates research to understand, control and prevent human disease caused by infectious agents. Basic, applied, and translational research to develop and assess therapeutics, vaccines, and diagnostics is supported through research grants, cooperative agreements, and contracts. In turn, DMID supports and facilitates research ongoing under these funding mechanisms via an array of resources and services. These include genomic and gene sequencing services, provision of high-quality biological materials, biocontainment facilities, and pre-clinical and clinical translational research resources (https://www.niaid.nih.gov/research/resources). NIAID supports nearly all stages of the product development pipeline from in vitro therapeutic evaluation to advanced therapeutic and vaccine testing and manufacturing through multiple support services contracts. By providing the capability and capacity to develop and employ animal and animal replacement models of infectious diseases for screening and product evaluation, the current solicitation addresses a critical stage in this pipeline by bridging in vitro efficacy testing and eventual clinical evaluation. In addition to meeting the needs of extramural researchers, contracts resulting from this solicitation will support the NIAID Pandemic Preparedness Plan by developing and deploying preclinical models to evaluate therapeutics targeting viruses with the potential to cause pandemics. Further, these contracts are anticipated to provide crucial data to be used by our DHHS agency partners to facilitate the advancement of promising candidate medical countermeasures against priority emerging and bioterror agents through approval or licensure and, in some cases, eventual deposit in the Strategic National Stockpile. In 2017, 32 institutions were awarded base contracts under the Preclinical Models of Infectious Diseases IDIQ contract program, which was a re-competition of the Animal Models of Infectious Diseases IDIQ contract program. Its overarching goal was to provide capability in a broad range of animal and animal replacement models to evaluate the efficacy of promising candidate countermeasures (vaccines, therapeutics, diagnostics) against the full range of infectious agents that are in the purview of DMID. The breadth of the existing contractor pool has enabled a rapid and effective response to emerging infectious diseases such as COVID-19, and other emergency preparedness priorities. Awarded contracts were divided into 3 model-specific pools: Part A – Small animal models of infectious diseases Part B – Non-human primate models of infectious diseases Part C – Non-traditional animal models and animal replacement models of infectious diseases The current IDIQ contract program has supported the development and refinement of several animal models of infectious diseases that were used to evaluate candidate medical countermeasures against these diseases. In addition, these contracts facilitated regulatory submissions, patents, and other intellectual property applications by extramural investigators requesting evaluation of their products under these contracts. This program served the DMID mission of supporting investigator-initiated research by providing critical data needed to apply for grant or other funding. Finally, these contracts enabled product developers and sponsors to make key go/no-go decisions for candidate therapeutics, vaccines, and diagnostics. 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 this solicitation. The Government anticipates awards to those organizations with the best qualifications whether in one, two, three or four task areas. Organizations will be considered for contracts only in the Task Area(s) included in their proposals. Sample Task Orders are provided in the RFP solely to evaluate Offeror responses and capabilities. Successful Offerors will have qualified to compete for eventual task order awards in one or more of the following areas: Task Area A – Small Animal Models of Infectious Diseases Task Area B – Non-Human Primate Models of Infectious Diseases Task Area C – Animal Replacement and Non-traditional Animal Models of Infectious Diseases Task Area D – Generation and Distribution of Specialized Reagents 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. Contractors may need to be supported to a certain extent by the expertise and resources of other organizations or persons through subcontracts, partnership or consortia agreements, and/or use of consultants. However, Contractors 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 this contract and each awarded Task Order. Contracts are anticipated to organizations that represent the best value to the Government for the full suite of services and also to organizations proposing one or more of the Task Areas. For the purposes of this solicitation, the following definitions apply: The services encompass the following: Small animal models: development of new and refinement of existing models amenable for evaluating candidate countermeasures; evaluation of candidate countermeasures, including but not limited to, maximum tolerated dose, minimum effective dose, safety, efficacy, pharmacokinetics, pharmacodynamics Non-human primate models: development of new and refinement of existing models amenable for evaluating candidate countermeasures; evaluation of candidate countermeasures, including but not limited to, maximum tolerated dose, minimum effective dose, safety, efficacy, pharmacokinetics, pharmacodynamics Animal replacement models and non-traditional animal models: development of new and refinement of existing models amenable for evaluating candidate countermeasures; evaluation of candidate countermeasures, including but not limited to, maximum tolerated dose, minimum effective dose, safety, efficacy, pharmacokinetics, pharmacodynamics studies to bridge animal and animal replacement model Generation and Distribution of Specialized Reagents (including but not limited to): Production of live life cycle stages for parasitic infections (e.g., eggs, pupae, larvae, adult stage parasites) Production of live vectors that support life cycle stages of parasitic infections (e.g., mosquitoes, ticks, fleas, black flies, sand flies, tsetse flies, reduviid bugs) Tissues required for isolation of otherwise unculturable infectious agents or toxins that can be distributed as reagents Production of monoclonal and polyclonal antibodies and hybridomas in mice Model species that are not listed with the individual Task Areas above, but are requested for development or demonstrated as necessary for testing medical countermeasures following award, will be taken under advisement by the Government, and task order requirements involving these model species may be developed on a case-by-case basis as long as they are determined to represent benefit to the Government. The services shall be directed at, but not be limited to, the following areas of emphasis: RNA viruses having pandemic potential from the following viral families: Bunyaviridae, Coronaviridae, Enteroviridae (in particular, EV-D68 and EV-71), Filoviridae, Flaviviridae (in particular dengue and West Nile viruses), Paramyxoviridae (in particular Hendra and Nipah viruses), Togaviridae Antimicrobial resistant and multi-drug resistant infections, including Methicillin- Resistant Staphylococcus aureus, Vancomycin-Resistant Enterococcus, Carbapenem-Resistant Enterobacteriaceae, Acinetobacter baumanii, Pseudomonas aeruginosa, and Clostridium difficile Diseases caused by pathogens and toxins on the NIAID Emerging Infectious Diseases/Pathogens list: list https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens ; in particular, influenza, viral hemorrhagic fevers (including arthropod-borne viruses), arthropod-borne encephalitis viruses, rabies, and Mycobacterium tuberculosis (including MDR and XDR strains), Bordetella pertussis, Group A Streptococcus; Fungal diseases, including invasive aspergillosis, candidiasis, coccioidomycosis, cryptococcosis, mucormycosis, pneumocystis pneumonia; Non-Biodefense Bacteria, including Chlamydophila spp, Haemophilus, spp., and Legionella, spp.; non-tuberculous Mycobacterial spp., Streptococcus pneumoniae; Non-Biodefense Viruses, including adenoviruses, Hepatitis B and C viruses, Herpesviruses (HSV 1 and 2, CMV, VZV, HHV-6/7); human metapneumovirus, respiratory syncytial virus, papillomaviruses, parainfluenza virus; Neglected tropical diseases, including: filariasis, leprosy, schistosomiasis, trachoma, and trichomoniasis; and Sexually transmitted infections, including bacterial vaginosis, chlamydia, and gonorrhea. Anticipated period of performance It is anticipated that multiple award Indefinite Delivery/Indefinite Quantity contracts will be awarded with a seven year ordering period. Capability statement / information sought Capability Statements should clearly convey information regarding the respondent’s capabilities including: (1) staff expertise, including their availability, experience, and formal and other training; (2) current in-house capability and capacity to perform the work; (3) prior completed projects of similar nature; and (4) institutional/corporate experience and management capability. Interested respondents must submit a capability statement describing their company’s experience and ability to perform this effort that includes the following: a summary list of similar work previously performed; the professional qualifications and specific experience of staff who may be assigned to the requirement; resumes for proposed key personnel, including the Principal Investigator, that reflect education, and previous work relevant to the proposed requirement; documented adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity; documented adequacy and appropriateness of proposed organization and staffing to ensure efficient planning, initiation, implementation, conduct, and completion of all activities, including plans for communication and sharing of research resources; a general description of the facilities and other resources needed to perform the work, including: the availability of adequate accredited animal facilities, with biocontainment appropriate for the pathogens proposed availability of equipment necessary for the proposed animal studies; and adequacy of the institutional biosafety program. demonstrated ability to carry out the work; adequacy of the documented experience with, and appropriateness of plans for: animal model studies, to include conduct of product efficacy studies, animal model development, and supportive measurements (immunological, pharmacological, clinical, pathological, etc.); technical approach to pathogen production and characterization, including overall understanding of the pathogen and its behavior in animal models. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed [7] 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: DUNS number/ UEI number 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 http://www.sam.gov/. This indication should be clearly marked on the first page of your Capability Statement (preferably placed under the eligible small business concern’s name and address). Number of Copies: Please submit one (1) electronic 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 Ignacio Reyes, Contracting Officer, at ignacio.reyes@nih.gov and to Harun Ali, Contract Specialist, at harun.ali@nih.gov in MS Word or Adobe Portable Document Format (PDF). Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:30 p.m. (Eastern Prevailing Time) on November 07, 2022. 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 will be published at 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).