SPECIAL NOTICE
A -- Potential for Environmental and Therapeutic Agents to Induce Immunotoxicity
- Notice Date
- 5/17/2011
- Notice Type
- Special Notice
- 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 Environmental Health Sciences, Office of Acquisitions, Office of Management, 530 Davis Drive, Durham, North Carolina, 27713, United States
- ZIP Code
- 27713
- Solicitation Number
- NIHES2011131(WH)
- Point of Contact
- WANDA M. HOLLIDAY, Phone: 919-541-0943
- E-Mail Address
-
hollida1@niehs.nih.gov
(hollida1@niehs.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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." Background The National Toxicology Program (NTP) organizes and conducts a comprehensive testing and research program focused on determining potential human health hazards due to exposure to chemicals, drugs or environmental agents. The Toxicology Branch supports these efforts through testing contracts which: (1) develop and establish methods with predictive value for identifying potentially immunotoxic chemicals and drugs; (2) examine selected agents employing a defined panel; and (3) conduct mechanistic studies to define the cellular and molecular events associated with immunotoxicity. Immunotoxicity is used to describe the potential of an environmental agent, therapeutic drug, and in some instances, biological materials, to alter the normal structure and/or function of the immune system as determined by established immunological techniques. Immunotoxicity can be divided into three major research areas: (1) studies of altered hematopoietic or immunological events associated with exposure of humans and animals to chemical or therapeutic agents, including altered host resistance; (2) studies of respiratory or dermal hypersensitivity responses resulting from xenobiotic exposures; and (3) studies on the ability of chemical or therapeutic agents to induce or exacerbate autoimmune disease (Dean et al., 1994). The tasks in any resultant contract will be designed to address these research areas. Purpose and Objectives The purpose of this requirement will be to support and assist the efforts of the NTP to determine the effects of certain chemicals, drugs, or other environmental agents on the immune system. Independently, and not as an agent of the Government, any resultant contractor shall provide all the necessary services, qualified personnel, materials (including animals), equipment, and facilities not otherwise provided by the Government as needed to examine the immune system in laboratory animals following exposure to xenobiotics. The Government will only provide the chemicals or therapeutics on an "as needed basis". Project requirements The Tasks that will be performed under this requirement involve the utilization of a comprehensive immune testing panel that evaluates the major components of the immune system for potential suppression or enhancement, as well as hypersensitivity and autoimmunity. To screen for the potential of a test article to modulate the systemic immune response, the contractor should be able to assess non-specific, humoral- and cell-mediated immunity using functional measures as described in Luster et al., 1988 (Fundam Appl Toxicol 10:2-19) that quantitate immune system performance. For selected compounds that are demonstrated to be positive in the screening studies, the contractor should be able to assess the performance of the hematopoietic system in generating specific stem cell populations and to evaluate resistance to disease and neoplasia using established models as part of more definitive studies. The contractor should be able to evaluate changes in immune cell numbers and hematological parameters. These endpoints will be evaluated in 4-6 treatment groups of approximately 8 mice or rats following a 28-day adult exposure paradigm or following exposure from approximately day 6 of gestation through post natal day 42. To assess the potential for a test article to induce dermal sensitization, the contractor should be able to evaluate the test compound in 4 treatment groups of 8 mice using a combined irritancy and local lymph node assay, and 4 treatment groups of 8 mice in the mouse ear swelling test. The contractor should also be able to evaluate the potential for selected test articles to alter the development and progression of autoimmune disease using established models. The contractor will be expected to use the appropriate positive controls for each type of study. Summary of Studies to be Conducted under the Base Contract Study Type Anticipated Number of Studies per Year Immunomodulation (Screening) 4 Immunomodulation (Definitive) 2 Hypersensitivity 4 Autoimmunity 1 Developmental Immunotoxicity 4 Anticipated period of performance The Base Contract is anticipated from July 1, 2012 to June 30, 2015 with 7 optional 1 year periods of performance. If all options are exercised the period of performance shall extend through June 30, 2022. Other important considerations All testing performed under this contract shall be conducted in accordance with GLP guidelines and where appropriate, NTP specifications (NTP, 2011). The contractor must have a currently functioning laboratory with demonstrated capability in conducting immunotoxicity studies. Evaluation of the potential for an individual test article to modulate systemic immunity, hypersensitivity, developmental immunotoxicity and autoimmunity will be considered single tasks with the understanding that multiple immune function tests will be conducted as part of a single task. The actual number of tasks will vary based on programmatic needs and availability of funds. Information sought Respondents, please provide opinion(s) about the difficulty and/or feasibility of proposing the potential requirement as a fixed price acquisition. Provide possible solutions and approaches that may currently exist in the marketplace for procuring the outlined services under fixed price terms. Submission requirements Responses must be received by May 31, 2011, 3:00pm EST. Submit responses to the Contract Specialist identified above. The information can be provided in writing or electronically in Adobe PDF or Microsoft Word format. If hard copies are provided please submit an original and four (4) copies. Telephonic and facsimile responses will not be accepted. Limit responses to seven (7) pages maximum. Include the solicitation number and title in your response. Respondents are also 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 addresses), and size and type of business (e.g., 8(a), HUBZone, WOSB, SDVOSB, etc.) "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. Any solicitation resulting from the analysis of information obtained will be announced to the public in Federal Business Opportunities in accordance with the FAR Part 5. 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).
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-
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- Record
- SN02449763-W 20110519/110517234456-d42ac84dcdde9a598c5c302a56de7303 (fbodaily.com)
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