SOURCES SOUGHT
A -- Pre-Clinical Models of Infectious Diseases
- Notice Date
- 10/2/2015
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, 3rd Floor, MSC 9821, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- RFP-NIAID-DMID-NIHXXX
- Point of Contact
- Brian Madgey, Phone: 240-627-3712, Stanley Knight, Phone: 240-669-5181
- E-Mail Address
-
madgeyba@mail.nih.gov, knights@niaid.nih.gov
(madgeyba@mail.nih.gov, knights@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 541711 with a size standard of 500 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 that threaten the lives of millions of people. 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 in an effort 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 ( http://www.niaid.nih.gov/labsandresources/resources/dmid/Pages/default.aspx ). The current NIAID Animal Models of Infectious Diseases program is one of DMID's preclinical services resources and has supported the development and refinement of several animal models of infectious diseases, models that were subsequently 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 also 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. In addition to meeting the needs of extramural researchers, this program provides crucial data to be used by our partners at other agencies in DHHS. Such data will facilitate the advancement of promising candidate medical countermeasures against priority bioterror agents to approval or licensure, and, in some cases, eventual deposit in the Strategic National Stockpile. As background, in 2010, 38 institutions were awarded base contracts under the Animal Models of Infectious Diseases IDIQ contract program. This program integrated services that had been provided via a number of smaller stand-alone contracts: In Vitro and Animal Models for Emerging Infectious Diseases and Biodefense, TB Vaccine Testing and Research Materials, Animal Models for Prevention and Treatment of Hepatitis B & C, Animal Models of Human Viral Infection for Evaluation of Experimental Therapeutics, Schistosomiasis Research Reagent Resource Center, and Filariasis Research Resource Center. In addition to incorporating the objectives of these individual contracts, the overarching goal of the Animal Models of Infectious Diseases contract was to provide capability in a broad range of animal models for use in evaluating promising candidate countermeasures (vaccines, therapeutics, diagnostics) against the more than 270 infectious agents that are in the purview of DMID. The amalgamation of animal model programs has allowed cost savings and deletion of redundant activities, and the breadth of the existing contractor pool has enabled a rapid and effective response to emerging infectious disease and emergency preparedness priorities. Awarded contracts were divided into 4 model-specific pools: Part A - Small animal models of infectious diseases Part B - Small animal models of infectious diseases - with the capability to conduct studies compliant with regulations set forth in 21CFR58: Good Laboratory Practices Part C - Non-human primate models of infectious diseases Part D - Non-traditional animal models of infectious diseases Going forward, the Preclinical Models of Infectious Diseases program will include non-traditional animal models as well as models that could serve as replacements for animals in product screening and efficacy studies. The 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 - Non-traditional and Animal Replacement Models of Infectious Diseases 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: 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 will include 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. 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. 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, pharmacodynamics, and protection against challenge. 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 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: includes but is not limited to: Domestic livestock: horses, cattle, goats, sheep, chickens, ducks, turkeys, geese Wildlife species: marmots, deer, bats Companion species: dogs, cats Invertebrates: snails, non-parasitic nematodes Aquatic: zebrafish Animal replacement: organs on chips, artificial complex cell systems Products: prevention agents such as vaccines or microbicides; therapeutics targeting the host or the pathogen, including conventional drugs, immunotherapeutics, and therapeutic vaccines; and diagnostics. 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). Reagents: biochemical, genomic, molecular, cellular, and immunologic materials integral to research on these pathogens, including the pathogenic agent or toxin itself; these may be required to be generated to support a study or as a deliverable. The services shall be directed at the following: 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 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. (baboons); Callithrix, spp. (marmosets) Non-traditional animal models: includes, but is not limited to: Domestic livestock: horses, cattle, goats, sheep, chickens, domestic fowl Wildlife species: marmots, deer, bats Companion species: dogs, cats Invertebrates: snails, parasitic nematodes, insect vectors of human disease Aquatic: zebrafish Animal replacement: organs on chips, artificial complex cell systems The services shall be directed at, but not be limited to, the following areas of emphasis: •• 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 and Infectious Diseases (NIAID) Emerging Infectious Diseases/Pathogens list: list http://www.niaid.nih.gov/topics/biodefenserelated/biodefense/pages/cata.aspx ; 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, and Coccidioides; •• Non-Biodefense Bacteria, including non-tuberculous Mycobacterial spp., Streptococcus pneumoniae, Mycoplasma pneumonia, Chlamydophila pneumonia, Haemophilus, spp., and Legionella, spp. ; •• Non-Biodefense Viruses, including: RSV, human metapneumovirus, parainfluenza virus, Hepatitis B and C viruses, Herpesviruses (HSV 1 and 2, CMV, VZV, HHV-6/7); papillomaviruses; enteroviruses; adenoviruses; •• Fungal diseases, including invasive aspergillosis, candidiasis, cryptococcosis, mucormycosis, pneumocystis pneumonia; •• Neglected tropical diseases, including: filariasis, trachoma, leprosy, schistosomiasis, and trichomoniasis; and •• Sexually transmitted infections, including: chlamydia, bacterial vaginosis, 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 Company Name Company Address Company Po int of Contact, Phone and Email address Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) ap propriate 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 Brian Madgey, Contracting Officer, at madgeyba@mail.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 4:30 p.m. (Eastern Prevailing Time) on October 22, 20 15. 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 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 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)."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIAID/RFP-NIAID-DMID-NIHXXX/listing.html)
- Place of Performance
- Address: 5601 Fishers Lane, 3rd Floor, MSC 9821, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03913055-W 20151004/151002234507-d91ca24563bab04a332d5275e23e34c2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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