SOURCES SOUGHT
A -- In Vitro Assessments of Antimicrobial Activity
- Notice Date
- 12/13/2016
- 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
- HHS-NIH-NIAID-SBSS-17-NIHAI2017091
- Point of Contact
- Jason Alexander Aroz, Phone: 301-761-7468, George W. Kennedy, Phone: 240-669-5170
- E-Mail Address
-
Jason.Aroz@nih.gov, kennedyg@mail.nih.gov
(Jason.Aroz@nih.gov, kennedyg@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction/Synopsis 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), 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 to support in vitro testing to assess the therapeutic potential of compounds in order to advance our understanding of infectious diseases as well as advance the development of therapeutics for infectious diseases. This is a follow-on of the successful IDIQ contracts awarded in FY11 that served in vitro needs throughout DMID. In 2011, seventeen awards were made under the In Vitro Assessment for Antimicrobial Activity IDIQ contract program. The NIAID DMID established the In Vitro Assessments for Antimicrobial Activity program to continue, under a single contract, several existing resource support programs and to expand into new areas. Awarded contracts were divided into model-specific pools: Part A - Bacteria and Fungi; Part B - Viruses; Part C - Parasites and Vectors; Part D - Toxins; and Part E - Central Data Management System. Purpose and Objectives NIAID supports nearly all stages of the product development pipeline from in vitro therapeutic evaluation through advanced therapeutic and vaccine testing and manufacturing using multiple support services contracts. The anticipated solicitation addresses a critical stage in this pipeline by providing an efficient means to assess the therapeutic potential of compounds through in vitro testing. The overarching goal of the In Vitro Assessments of Antimicrobial Activity program is to provide a broad and flexible range of in vitro assessment capabilities to the extramural research community to evaluate promising candidate countermeasures against the more than 270 pathogens, toxins, and vectors (PTVs) that are within the purview of DMID. In vitro assay capabilities include: product screening, assay development, in vitro models that mimic in vivo administration of candidate compounds, and culturing difficult to grow pathogens in vitro. These capabilities will allow the NIAID to respond to changing priorities as scientific and public health needs shift, including rapid responses to public health emergencies. In addition to meeting the needs of extramural researchers, it is anticipated that contracts resulting from the anticipated solicitation will provide crucial data that may be used by NIAID 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 procurement by the Strategic National Stockpile. NIAID anticipates awarding multiple Indefinite Delivery, Indefinite Quantity (IDIQ) contracts to organizations that have the capabilities required to fulfill the technical requirements of the Task Areas of the anticipated solicitation. Offerors will be considered for contracts only in the Task Area(s) included in their proposal. Sample Task Orders provided in the RFP are solely to evaluate Offeror responses and capabilities. A successful Contractor may compete for task orders only in the Task Area(s) in which they are selected for award. The Task Areas of the anticipated solicitation are as follows: Task Area A - Bacteria, Fungi, and Toxins Task Area B - Viruses Task Area C - Parasites and Vectors Task Area D - In Vitro Models that Mimic In vivo Exposures of Candidate Compounds Task Area E - Development of New Techniques to Culture Difficult to Grow Pathogens For the purposes of this Notice the following definitions apply: • Assays - in vitro procedures for determining biological activity of a substance by measuring its effect on an organism, tissue, cell, enzyme or receptor preparation. In addition in vitro procedures for determining the concentration, and/or purity of a substance. • Products - broadly defined and include therapeutic substances targeting the host or the pathogen. • Pathogens - bacteria, viruses, parasites, and fungi, particularly NIAID Category A, B and C list of Priority Pathogens (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens ) • Toxins - microbial toxins as they relate to human disease including toxins that are produced by or listed on NIAID Category A, B and C list of Priority Pathogens. • Vectors - arthropods (usually insects) or mollusks that carry pathogens from infected to uninfected hosts. • Reagents - biochemical, genomic, molecular, cellular, and immunologic materials integral to research on these pathogens, toxins and vectors. Project requirements This requirement will enable DMID to provide a broad and flexible range of in vitro assay capabilities for human infectious diseases or diseases of human importance caused by infectious agents, including but not limited to: product screening, assay development, and development of improved systems for culturing difficult to grow pathogens in vitro. These capabilities will allow the NIAID to respond to changing priorities as scientific and public health needs shift, including rapid responses to public health emergencies. Performance Standards: Critical performance standards include the ability to design and develop new in vitro assay procedures, refine or modify current in vitro assay procedures, or use available in vitro assay procedures to screen products for activity against infectious disease pathogens, toxins and/or vectors. Products to be screened will be provided to the Contractor by the Government or by third-party organizations. The Contractor shall perform special studies, e.g., combination drug testing, mechanism of action studies targeting specific steps in pathogen replication, toxin activity, and other more detailed testing. Assays pertinent to special studies shall be designed, developed, compared to existing assays, standardized, validated and performed, as necessary. Contractors shall update existing assays to allow for state-of-the art evaluation of products. Assay characterization shall include: the development of positive and negative controls; optimization of assay parameters; qualification of assays with a variety and appropriate number of study samples; other studies to explore whether new assays provide meaningful data for the intended purpose; quality assurance testing of reagents, as appropriate. Standards also include the performance of techniques that allow one to re-create dynamic pharmacokinetics profiles, with concentration increases and decreases expected during the course of in vivo administration of the candidate compound over a range of dosing duration and frequency. In order to produce and characterize new or difficult to cultivate pathogens, the Contractor shall systematically search for and document conditions under which these pathogens grow in vitro. 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 necessary to conduct work with hazardous biological materials in compliance with all Federal and NIH regulations in accordance with current Biosafety in Microbiological and Biomedical Laboratories (BMBL), guidelines available at: http://www.cdc.gov/biosafety/publications/bmbl5/index.htm, and where applicable, compliant with the Select Agent Regulations through the Centers for Disease Control (CDC) and/or the United States Department of Agriculture (USDA) (42 CFR Part 73, 7 CFR Part 331, and/or 9 CFR Part 121). • Demonstrated ability to carry out the work; • Adequacy of the documented experience with, and appropriateness of plans for the general technical approach to product screening, assay development, and development of improved systems for culturing difficult to grow pathogens in vitro. How to Submit a Response / Page Limitations: Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed five (5) pages, excluding resumes, describing the company's experience and ability to perform this effort which includes the following: (1) a summary list of similar work previously performed or being performed; (2) demonstrated scientific and technical ability to carry out the work; (3) the professional qualifications and specific experience of staff who may be assigned to the requirement; and (4) a general description of the facilities and other resources needed to perform the work. Tailored capability statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement. 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. • 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://www.sam.gov/index.html/#1. 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 Jason Aroz, Contract Specialist, at Jason.Aroz@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify HHS-NIH-NIAID-SBSS-17-NIHAI2017091. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 5:00pm EST on January 3, 2017 (01/03/2017). 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIAID/HHS-NIH-NIAID-SBSS-17-NIHAI2017091/listing.html)
- Place of Performance
- Address: Office of Acquisitions, DEA, NIAID, NIH, HHS, 5601 Fishers Lane, 3rd Floor, MSC 9821, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04350039-W 20161215/161213234328-883074fb3665bb76bfbea6c73919146d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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