SOLICITATION NOTICE
A -- Evaluation and Testing Services (ETS) for Vaccines and other Biologics for Infectious Diseases
- Notice Date
- 5/27/2011
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- NIAID-DMID-NIHAI2010092
- Archive Date
- 6/28/2011
- Point of Contact
- Michael Welsh, Phone: (301) 451-2569, Deborah J. Anderson, Phone: 201-402-2234
- E-Mail Address
-
welshmi@mail.nih.gov, deborah.anderson@nih.gov
(welshmi@mail.nih.gov, deborah.anderson@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 (DMID) has a requirement for a contractor to provide a suite of preclinical, nonclinical, and clinical testing services for vaccines and other biologic products. While the overall suite of testing services is comprehensive, the intent is to provide individual services on a case-by-case basis for a diverse collection of vaccine and biological product candidates, rather than carry a single product candidate through an entire preclinical development pathway. These services are intended to help a wide variety of investigators in a broad 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/III trials), fulfill regulatory requirements, and complete studies needed to apply for an IND and enter Phase I/II/III trials. Description Research supported by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives 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 other than HIV. Support for basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics is provided through a variety of research grants and contracts. DMID also supports an array of research resources and services to assist investigators, including programs that provide or make available genomic data and technologies; organisms and state-of-the-art reagents; biocontainment facilities; and preclinical and clinical translational research services (http://www3.niaid.nih.gov/research/resources/dmid). 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 coordinated evaluation and testing services program to provide preclinical, nonclinical, and clinical testing support for multiple vaccine and biologic candidates that emerge from academia, the private sector, or other sources. The suite of testing services will encompass those activities commonly associated with the testing of vaccine and biologic products for infectious disease required for Investigational New Drug (IND) application and/or Biologic License Application (BLA). Consequently, DMID recognizes that to obtain the full spectrum of expertise or facilities required to perform all activities set forth in this solicitation, individual organizations will likely need the expertise and resources of other organizations or persons through consortia agreements, partnerships, subcontracts, and/or consultants. The 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 this contract and each awarded Task Order. Purpose and Objectives: The purpose of this solicitation is to establish a NIAID resource entitled "Evaluation and Testing Services (ETS) for Vaccines and Other Biologics for Infectious Diseases" that provides a suite of preclinical, nonclinical, and clinical testing services for vaccines and other biologic products. While the overall suite of testing services is comprehensive, the intent is to provide individual services on a case-by-case basis for a diverse collection of vaccine and biological product candidates, rather than carry a single product candidate through an entire preclinical development pathway. These services are intended to help a wide variety of investigators in a broad 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/III trials), fulfill regulatory requirements, and complete studies needed to apply for an IND and enter Phase I/II/III trials. Project Requirements: The Contractor shall provide DMID with a broad and flexible range of proactive and developmentally-oriented capabilities to provide testing services to support preclinical, nonclinical, and clinical studies for promising products when such products emerge from investigator-initiated research studies or other sources identified by DMID Program staff. These testing capabilities support early feasibility through Phase III clinical studies to 1) provide the ability to combine, develop, test, evaluate and refine different evaluation and testing technologies from multiple developers; 2) create capacity for the evaluation and testing of candidate vaccines and other biologics for infectious diseases and/or related toxins; 3) increase the Federal Government's response to emerging disease threats; and 4) improve surge capabilities. The Contractor shall also provide appropriate documentation and support for pre-IND, IND, and BLA submissions. DMID will issue a Task Order Request for Proposal after determination of a specific need that is appropriate to the Statement of Work. The Contractor shall be prepared to develop a response in which the Contractor specifies the methods it will employ in accomplishing the key components of each Task Order and the associated costs. The needs, funding, product maturity and timelines of the product as specified in the Task Order establishes requirements for compliance with current Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP) [21 CFR Parts -11, -58, -210, -211, -600]. For the purposes of this contract, the following definitions shall apply: • Vaccines - An antigenic preparation used to render an organism immune to an infectious disease by inducing or increasing immunity for prophylaxis and/or therapy. Vaccine products include but are not limited to synthetic peptides, recombinant proteins, nucleic acids, viral-like particles, vector-based vaccines, as well as live, modified, killed, and/or attenuated bacteria, viruses, and other organisms. • Vaccine Components - An antigen-enhancing substance (i.e. adjuvant) or a delivery system (i.e. needle free dermal patch) that is used during dose administration to enhance the immune response of a vaccine. • Other Biologics - Therapeutic preparation made from living organisms or the components of living organisms and are most likely regulated by CBER. Biologics include but are not limited to allergenics; antitoxins; blood and blood products; and cellular and gene therapy products. For the purposes of this contract, challenge material for non-clinical, preclinical, and clinical trials will also be included in the definition of biologics. The services shall be directed at the following: • diseases caused by pathogens and toxins on the National Institute of Allergy and Infectious Diseases (NIAID) Category A, B, and C Priority Pathogens list (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/Pages/CatA.aspx) • emerging and re emerging infectious diseases; • antimicrobial resistant and multi drug resistant infections; • other bacterial infections; • fungal infections; • viral infections excluding HIV; and • parasitic diseases. The Contractor shall be required to carry out the Scope and Activities defined in the following five Task Areas: (1) Administrative, Management and Technical Support: One Task Order will be assigned under this Task Area. The Task Order will be a cost-reimbursement, term (level of effort) type contract with a Base Period of 12 months and multiple Options to extend the Base Period of Performance in 12-month increments up to a total of 10 years to continue the same requirement. The contractor is REQUIRED to provide a total level of effort of 902 total direct labor hours per year based on a Work Year of 1920 productive work hours (excluding vacation, holiday, sick leave) for a period of performance of 10 years (Base period plus nine, one-year Options). The scope of this Task Area's activities includes the ability to facilitate ad hoc meetings and provide ad hoc reporting as part of general administrative, management, and technical support activities that are not Task Order specific. (2) Assay Development: The scope of Task Area 2 includes the design, development, qualification and validation of in vitro and in vivo assays as needed for characterization and testing of a vaccine, vaccine component, or other biologic. Other activities under this task area include method assessment/feasibility studies, method comparability studies, redevelopment or improvement of existing assays, and technology transfer of assays to/from other facilities. The Contractor shall conduct tasks in accordance with quality oversight that is appropriate to the phase of product development; under the appropriate level of biocontainment (BSL-2, BSL-3, BSL-4); and within all applicable and current Federal, state, and local laws, codes, ordinances and regulations, as well as all PHS Safety and Health provisions. The Contractor shall be responsible for the acquisition, care, and housing of animals in an appropriate level bio-containment facility, and ensuring all work is conducted in accordance with the Animal Welfare Act and Public Health Service Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/phspol.htm), including the implementation of an animal care and use program and an animal use protocol approval process. (3) Immunogenicity and Efficacy Testing: The scope of activities under Task Area 3 includes designing and performing IND-enabling immunogenicity and efficacy trials for products, using established animal models and supporting assays needed in the conduct of immunogenicity and efficacy trials. This scope includes testing performed under FDA and ICH guidelines for Animal Rule. The decision regarding which animal species to be used and any requirements for specific pathogen free (SPF) animals shall be made jointly by the COTR and the Contractor, with the COTR having final authority. The decision whether these studies will be performed in compliance with GLP (21 CFR 58) will be determined by the COTR and identified in the Task Order. The Contractor shall conduct tasks in accordance with quality oversight that is appropriate to the phase of product development; under the appropriate level of biocontainment (BSL-2, BSL-3, BSL-4); and within all applicable and current Federal, state, and local laws, codes, ordinances and regulations, as well as all PHS Safety and Health provisions. The Contractor shall be responsible for the acquisition, care, and housing of animals in an appropriate level bio-containment facility, and ensuring all work is conducted in accordance with the Animal Welfare Act and Public Health Service Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/phspol.htm), including the implementation of an animal care and use program and an animal use protocol approval process. (4) Clinical and Nonclinical Sample Testing: The scope of activities under Task Area 4 includes testing clinical and non-clinical samples provided from internal and external sources. This scope includes providing reagent control, assay control, assay monitoring, and statistical review to support the conduct of the analysis. The Contractor shall conduct tasks in accordance with quality oversight that is appropriate to the phase of product development; under the appropriate level of biocontainment (BSL-2, BSL-3, BSL-4); and within all applicable and current Federal, state, and local laws, codes, ordinances and regulations, as well as all PHS Safety and Health provisions. (5) Safety and Toxicity Testing: The scope of activities under Task Area 5 includes designing and performing IND-enabling Good Laboratory Practice (GLP) compliant testing of products as required prior to initiating human clinical trials. This scope includes testing of candidate products for safety and toxicity by in vitro tests, small animals studies, and studies in non-human primates as required by the FDA. This scope also includes any additional testing required by the FDA which may include biodistribution studies and reproductive toxicology studies. These studies shall be performed in accordance with GLP regulations (21 CFR 58). The Contractor shall conduct tasks in accordance with quality oversight that is appropriate to the phase of product development; under the appropriate level of biocontainment (BSL-2, BSL-3, BSL-4); and within all applicable and current Federal, state, and local laws, codes, ordinances and regulations, as well as all PHS Safety and Health provisions. The Contractor shall be responsible for the acquisition, care, and housing of animals in an appropriate level bio-containment facility, and ensuring all work is conducted in accordance with the Animal Welfare Act and Public Health Service Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/phspol.htm), including the implementation of an animal care and use program and an animal use protocol approval process. Task Order(s) may be comprised of only one Task Area or may be a combination of multiple Task Areas. Agency Contracting Officer's Technical Representative (COTRs) and scientists will collaborate with the Contractor in all awarded Task Orders. Technical Requirements will be defined in the individual Task Orders. The list below represents the average number of specific tasks offerors should assume to perform each year under the contract. This list is provided to indicate the general scope of work of this contract. Assume that the period of performance of task orders may range from less than one year to multiple years. Task Title Estimated Area No. of Awards/Year 1 Administrative, Management, and Technical Support Activities - Sample Task Order 1 1 2 Assay Development - Sample Task Order 2 7 3a Immunogenicity & Efficacy - Sample Task Order 3 1.5 3b Immunogenicity in Mice - BSL-2 5 4a Clinical Sample Analysis - Sample Task Order 4 1 4b Clinical Sample Analysis - Non-Flu 3.5 5 Safety and Toxicity Testing - Sample Order 5 5 NIAID anticipates awarding a single Indefinite Delivery Indefinite Quantity (IDIQ) contract to one organization that meets the overall qualifications needed to fulfill the technical requirements of the solicitation, providing a guaranteed minimum award. Task orders for specific tasks requiring specialized expertise will be issued after the award of the IDIQ contract for an ordering period of seven years beginning on or about June 21, 2012. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about June 13, 2011, and may be accessed through FedBizOpps http://www.fbo.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.
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