SOURCES SOUGHT
A -- Potential for Environmental and Therapeutic Agents to Induce Immunotoxicity
- Notice Date
- 6/28/2011
- Notice Type
- Sources Sought
- 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
- Archive Date
- 8/5/2011
- 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 Research and Development (R & D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R & D requirement. 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. This work is currently being conducted under contract N01-ES-55538 held by Virginia Commonwealth University. 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". This requirement shall also involve the development, evaluation, and validation of novel assays to determine the potential of xenobiotics to induce alterations in immune parameters and the investigation of the mechanistic basis for chemical-induced perturbations of immune function. 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. 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. The contractor will be expected to use the appropriate positive controls for each type of study. In addition, any resultant contract will also require delivery of a monthly status report, animal use protocols, an annual report and a study report for each test article. 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. A currently functioning laboratory means that the facility has in place essential features necessary to conduct immunotoxicology studies of test articles designated by the NTP involving large groups of mice and rats (i.e. environmentally controlled animal rooms and appropriate exposure equipment). The laboratory must have the clinical laboratory equipment, tissue culture, necropsy, and histology facilities necessary to conduct the work described herein, and staff with appropriate expertise to expose, care for, and process large numbers of animals. In addition, all offerors must have AAALAC accredited animal facilities in which to conduct the studies. Electronic documents and reports are anticipated to be included in the deliverables of the resultant contract. When acquiring Electronic and Information Technology (EIT), the government is obligated to meet the accessibility standards at 36 CFR Part 1194 and Section 508 of the Rehabilitation Act of 1973. Section 508 service requirements for Information Content are applicable for this requirement and must address 36 CFR Part 1194, Subpart D, Information, Documentation and Support. Information about Section 508 is available at http://www.section508.gov/. Capability statement / Information sought. Interested organizations are required to submit five (5) hard copies of their capability statement, not to exceed fifteen (15) pages in length that clearly details the ability to perform the aspects of the notice described above and should be tailored to the "Project Requirements and Other Considerations", as concise as possible. Responses should include information regarding: (a) staff expertise, including availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; and (d) corporate experience and management capability. Each response should also include the following business information: a. DUNS number b. Organization Name c. Company Address d. Point of Contact (including name, title, addresses, telephone number, fax number and Email address) e. Business size f. Socio-economic status g. Teaming Agreements (if necessary) Standard product brochures will not be considered a sufficient response to this sources sought synopsis. Telephone and facsimile responses will NOT be accepted. All information must be received by NIEHS no later than: July 28, 2011, 4:00 PM, EST. Mail information to: Wanda M. Holliday, Contract Specialist, National Institute of Environmental Health Sciences, OM, Office of Acquisitions, P.O. Box 12874, RTP, NC 27709. For express delivery, send to: Wanda M. Holliday, Contract Specialist, National Institute of Environmental Health Sciences, OM, Office of Acquisitions, 530 Davis Drive, Morrisville, NC 27560. Telephone number: (919) 541-0943. Submit all questions in writing, via email to: hollida1@niehs.nih.gov. All questions must be submitted no later than 4:00 p.m. EST on July 13, 2011. Telephone inquiries will NOT be accepted. " 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)." Interested offerors may register at http://www.fedbizopps.gov to receive notification when the solicitation and any amendments are issued and available for downloading. Please note that the General Services Administration provides the notification service as a convenience and does not guarantee that notifications will be received by all persons on the mailing list. Therefore, we recommend that you monitor the FedBizOpps site for all information relevant to desired acquisitions. If the Internet option is not available to you, you may receive a hard copy of the solicitation and any amendments (via U.S. Mail) by faxing your request to (919) 541-5117 or by emailing your request to hollida1@niehs.nih.gov.
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