SPECIAL NOTICE
A -- Targeted Testing Using In vitro or Lower Phylogenic Organism
- Notice Date
- 2/1/2013
- Notice Type
- Special Notice
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Environmental Health Sciences, Office of Acquisitions, Office of Management, 530 Davis Drive, Durham, North Carolina, 27713, United States
- ZIP Code
- 27713
- Solicitation Number
- NIEHS2113
- Archive Date
- 3/2/2013
- Point of Contact
- Patrick P Barbour, Phone: 919-541-7596
- E-Mail Address
-
barbourp@niehs.nih.gov
(barbourp@niehs.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Request for Information "Targeted Testing Using In vitro or Lower Phylogenetic Organism" "This is a Request for Information (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this RFI is to obtain knowledge and information for project planning purposes." a. Background In its 2004 Roadmap for the 21st Century (http://ntp.niehs.nih.gov/go/future), the NTP established as one of its goals the development of a high throughput/high content screening program using assays that have been demonstrated to be reliable and relevant for estimation of toxicity. In addressing this goal, NTP/NIEHS entered into a Memorandum of Understanding (MOU) in 2008 with the US Environmental Protection Agency (EPA) and the National Human Genome Research Institute (NHGRI) to collaborate in a research enterprise (Tox21) to develop, validate, and translate innovative chemical testing methods that characterize toxicity pathways. This MOU was expanded in 2010 to include the US Food and Drug Administration (FDA). In support of this collaborative effort, the NTP needs to screen chemicals and complex mixtures for biological activity relevant to toxicity pathways using in vitro assays (biochemical, cell-based, or 3D tissue constructs) and/or in vivo platforms that use lower phylogenetic organisms. The breadth of assays envisioned as potentially useful is extensive. The cost to establish and maintain a wide variety of such assays at NIEHS for the relatively small number of chemicals that might be identified for periodic screening throughout the fiscal year would be excessive. Therefore, the NTP has identified the need to establish a contract with a single organization that would be able to screen, or have screened, relatively small numbers of chemicals/mixtures using existing, commercial-off-the-shelf or modified commercial-off-the-shelf assays to be identified based on the evolving needs of the NTP Program. It is not the intent of this effort to develop and/or validate new assays. Results from these assays will be used to prioritize chemicals/mixtures of interest for more extensive toxicological characterization. This contract is independent of, but the assays selected may overlap with the assays/platforms conducted in support of the EPA's ToxCast Program (http://epa.gov/ncct/toxcast/). The Contractor shall be required to perform as many as 15 distinct assays/platforms per year using in vitro assays (biochemical, cell-based, or 3D tissue constructs) and/or in vivo platforms using lower phylogenetic organisms, testing sets of approximately 20-100 chemicals per assay/platform. b. Purpose and Objectives The objective of this requirement is to perform testing of chemicals or chemical mixtures in a variety of in vitro (biochemical, cell-based, or 3D tissue constructs) or in vivo (using lower phylogenetic organisms) assay systems of complex and diverse biological capacity to measure chemical effects on critical pathways, processes, and phenotypes relevant to human toxicity to inform the direction of future NTP research efforts. These assays shall be biochemical, cell, tissue, or organism based culture systems with complex biological capacities such as xenobiotic metabolism, differentiation of cells, cell-to-cell signaling, gene expression, and/or epigenetic changes. Possible culture systems could include primary cells, stable cell lines, pluripotent cells, organotypic cultures, and 3D tissue constructs derived from various species/strains, possibly including human cell lines/tissues, or simple but whole organisms useful for evaluating the effects of environmental compounds. The endpoints measured in assays should provide mechanistic data that delineates critical toxicity pathways and quantifies cellular response to chemical exposures. Many of the types of compounds to be assayed may be only weakly active; therefore, the Contractor shall incorporate a plan for determining the maximally tolerated concentration, as defined as the highest concentration at which the compound can be tested without non-specific interference with the assay. c. Project Requirements A single Contract award is envisioned to perform testing of NIEHS-provided chemicals or chemical mixtures in commercially available assays meeting the Government's requirement. The Contractor be responsible for the: 1) Review of all protocols provided by the Contracting Officer's Representative (COR) to ensure that the assays performed as described will result in useful, interpretable, publication quality data; 2) Testing of NIEHS-provided chemicals or chemical mixtures in required assays and completion of COR-identified statistical analyses of the test results; and 3) Preparation of draft and draft final study reports, including documentation of Quality Assurance and Quality Control measures, for submission and approval by the COR. The Contractor shall perform testing of chemicals or chemical mixtures in a variety of in vitro (biochemical, cell-based, or 3D tissue constructs) or in vivo (using lower phylogenetic organisms) assay systems with complex and diverse biological capacities in order to measure chemical effects on critical pathways, processes, and phenotypes relevant to human toxicity as specified by the COR. Each specification may include multiple assays of a similar type (e.g., nuclear receptor assays could focus on the estrogen, androgen, and thyroid receptors). Each assay shall be defined as a unique set of features including, but not restricted to, organism/cell type; molecular target; toxicity pathway; and/or assay-/platform-specific conditions, and may require the capacity for xenobiotic metabolism, differentiation of cells, cell-to-cell signaling, gene expression, or epigenetic changes. Assays shall be in-house developed, commercial-off-the-shelf, or modified commercial-off-the-shelf and previously demonstrated to be reliable and relevant for its intended purpose. Assays identified in the EPA ToxCast Program (http://epa.gov/ncct/toxcast/) are representative, but not all inclusive, of the type of assays that may be performed under this requirement. It is anticipated that the Contractor shall be responsible for testing a minimum of 20 and a maximum of 100 chemicals/mixtures per assay (provided by the Government), with a maximum of 15 assays to be performed per year. Assays shall be performed in 6-, 12-, 24-, 48-, 96-, 384-, or 1536-well plate format, or other agreed-upon format, at up to 10 treatment concentrations, with up to 3 exposure durations. New assay development is not intended under the terms of this contract; however, emerging assays with sufficient evidence of reliability may be considered. Commercial-off-the-shelf assays may need minor modifications to meet the needs of the Government. The requirements for each assay [project scope including goals of the study, assay type, specific chemicals to be assayed, recommended protocols, quality and reporting requirements and documentation, analysis methods, etc.] will be defined by the COR and provided to the Contractor prior to initiation of any assay or platform. Independently, and not as an agent of the Government, the Contractor shall furnish all qualified personnel, materials, facilities, and equipment to provide services to the Government, with the exception that the Government will supply all test chemicals. Reporting Requirements and Deliverables The Contractor shall submit to the COR for approval minutes of all meetings, either face-to-face, conference-call, or web-based, as well as Draft and Final Draft Study Reports, to include materials and methods, results, summary data, raw data, and documented deviations from SOPs and protocols, for each study. Reports shall contain the following information (at a minimum) for each set of test articles assayed, in electronic files on compact disc (CD), digital video disk (DVD), email or other mutually agreed upon digital means and in Government compatible format: compound key; assay name; assay date; cell/organism type; cell type/organism species; endpoints measured; description of endpoints; positive control identity; positive control bioactivity results; estimates of maximally tolerated concentrations for each compound; compound screening concentrations; screening results, treated and controls, raw data; compound bioactivity results, well level, expressed as percent of control; annotated images obtained during screening (if applicable); short assay protocol; and QA/QC test results. Other deliverables include Contractor protocols and SOPs appropriate to meet the assay requirements as detailed by the COR, Draft Quarterly Progress Reports, Final Quarterly Reports, Draft Annual Report, Final Annual Report, Summary of Salient Results, Annual Utilization Report, Final Invention Statement. d. Anticipated Contract Type and Period of Performance It is anticipated that the Government will make one Firm Fixed Price type of award consisting of a unit price per assay. The anticipated period of performance shall be for one year (12 months) 2013 through 2014 for the base year of the award, with four (4) one year options (2014 through 2018) for a total of five (5) years if all optional periods of performance are exercised. e. Other important considerations The Government will require a variety of different assays. Chemical compounds are to be treated as hazardous and potentially carcinogenic. The contractor, and/or subcontractor(s) if applicable, should have experience handling hazardous and carcinogenic chemicals safely and disposing of waste safely. The Principal Investigator (PI) should have adequate experience in preparing and managing data organization as demonstrated by an advanced degree in laboratory-based research programs and publication of scientific data, and analysis at a level for publication in peer-reviewed journals. It is preferred that the PI have experience with management of subcontractors, since it is anticipated that resources may be required of multiple subcontractors. Offerors should have a plan for QA/QC of all data acquired under the anticipated contract from in-house and/or subcontracted sources. It is anticipated that a final report shall be submitted upon the completion of each assay, and that quarterly status reports will be required to document the on-going and future progress of the contract. f. Information sought The NTP is seeking information from qualified organizations to provide the scientific and logistical expertise necessary to assist the NTP in conducting Targeted Testing Using In vitro or Lower Phylogenetic Organisms. In response to this announcement NTP requests: 1. Opinions regarding the difficulty and/or feasibility of the potential requirement and/or proposed acquisition (such as contract type, pricing, etc.), possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts. 2. General information, which estimates the effort or time that may be required for an experienced organization to complete the work, identified above. Note: this information is for planning purposes only, DO NOT include detailed estimates; 3. Other information that may be helpful in developing or finalizing the acquisition requirements; 4. Respondents are asked to provide the following: DUNS number, organization name, address, technical and administrative points of contact (including names, titles, addresses, telephone and fax numbers, and e-mail address), NAICS code, and size and type of business (e.g., 8(a), HUBZone, WOSB, SDVOSB, etc.). 5. Information packets should not exceed twenty (20) pages in length, excluding standard brochures. Telephone and facsimile responses will not be accepted. Electronic or hard-copy (4 copies) information packages are acceptable. Electronic information shall be in Microsoft Word, Adobe PDF, Microsoft Power Point, or other Microsoft compatible format sufficient to clearly read the information provided (electronic submitters need only send one copy) to barbourp@niehs.nih.gov 6. Please include a cover page, identify the technical and administrative points of contact for the organization, including names, titles, addresses, telephone and fax numbers, e-mail addresses, and organization name, and 7. Information packages shall be submitted for receipt within (15) days from the date of the announcement, February 15, 2013 at 4:00 pm EST. g. Confidentiality "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. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. 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. 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/NIEHS/NIEHS2113/listing.html)
- Place of Performance
- Address: N/A, United States
- Record
- SN02978230-W 20130203/130201234813-8c123673b5e003c69893f96b630bdacd (fbodaily.com)
- Source
-
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