Potential for Environmental and Therapeutic Agents to Induce Immunotoxicity

Amendment #1 is attached

See the Attached Solicitation and associated documents.

The deadline for submission of proposals is 4:30 p.m. EST on November 14, 2012.

Submit all questions in writing via email to the address provided in the solicitation no later than 3:00 p.m. EST on October 20, 2012.  TELEPHONE INQUIRIES WILL NOT BE ACCEPTED.

Attachment numbers 1 through 6, 10, and 20 through 22 are hereby attached. For all other attachments, use the links provided in Section J of the solicitation. 

This notice announces the intended release of solicitation number NIHES2012157. NIHES2012157 is a reissue of solicitation number NIHES2011131 which was previously issued on April 23, 2012.

The National Institute of Environmental Health Sciences (NIEHS) is soliciting proposals 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 of laboratory animals following exposure to xenobiotics.

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.

The contractor shall:
(1) screen for the potential of a test article to modulate the systemic immune response; (2) assess the performance of the hematopoietic system in generating specific stem cell populations; (3) evaluate resistance to disease and neoplasia using established models as part of more definitive studies; and (4) evaluate changes in immune cell numbers and hematological parameters. These endpoints will be evaluated in mice or rats.

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.

Summary of Tasks & Task Description
Task I-A -  Evaluation of the Potential to Induce Immunotoxicity
Task I-B - Definitive Studies in Immunomodulation and Evaluation of Host Resistance Endpoints
Task II - Evaluation of the Potential to Induce Hypersensitivity
Task III - Evaluation of the Potential to Influence the Development and/or Progression of Autoimmune Disease
Task IV - Evaluation of Immunomodulation in the Developing Immune System
Task IV - Evaluation of Additional Xenobiotics on an as Needed Basis
Task VI - Development and/or Evaluation of New and Improved Technology

Tasks I - V are defined as the Core Studies of this contract and shall be conducted as specified in Part 58 "Good Laboratory Practices for Non-Clinical Studies (Federal Register, Friday, December 22, 1978, Part II and any late interpretations published by the FDA).

MANDATORY QUALIFICATION CRITERIA
Mandatory qualification criteria will apply to this requirement. The qualification criteria establish conditions that must be met at the time of receipt of Technical Proposals by the Contracting Officer in order for the proposal to be considered any further for award. The following Mandatory Qualification Criteria apply to this requirement:

GLP COMPLIANCE
The NTP requires that these studies be conducted in compliance with FDA GLP regulations as specified in Part 58 "Good Laboratory Practices for Non-clinical Laboratory Studies". All laboratories (including proposed subcontractors) performing core work/core studies as defined herein and in the Statement of Work are required to meet this mandatory qualification criterion.
The offeror shall include information and documentation that demonstrates evidence of the testing laboratory's current compliance with the provisions of 21 CFR 58. Such documentation may include (but is not limited to):
a) FDA 482-Notice of Inspection Forms, as evidence that general surveillance inspections and/or directed inspections have occurred.
b) Establishment Inspection Report (EIR) forms issued to document the results of any inspections.
c) Any adverse findings or Form 483 reports issued.
d) History (number, time-frame and evidence) of GLP studies conducted if documentation from a regulatory agency such as the above a, b or c cannot be provided.

ANIMAL WELFARE
The offeror and any proposed subcontractors that conduct work involving the use of live animals must have an AAALAC-accredited animal facility. Offerors shall also have a PHS Assurance from the NIH Office of Laboratory Animal Welfare (OLAW). The Assurance number shall be provided with the proposal. The offeror must demonstrate their compliance with the NIH Guide for Care and Use of Laboratory Animals
NOTICE TO OFFERORS: This solicitation is being reissued with revised evaluation criteria and minor clarifying revisions based on inquiries submitted by prospective offerors for the original solicitation. Prospective offerors are advised to review the revised RFP and SOW closely in order to address the current requirement.

OTHER INFORMATION
This contract is expected to consist of a one year base period with nine one-year options, as well as optional quantities for additional immunotoxicological studies. It is anticipated that one cost reimbursement ID/IQ type award will be made with an anticipated award date of June 1, 2013. The proposed contract will be issued using full and open competition. The North American Industry Classification System (NAICS) code for this procurement is 541712 with a corresponding size standard of 500 employees. The Government intends to make an award using the procedures for competitive negotiated acquisitions as authorized in FAR Part 15.

This is NOT a solicitation. The estimated issue date of the solicitation is October 5, 2012 and proposals will be due about 30 days after the solicitation release date. The solicitation will be posted on the Fed Biz Opps website. Interested firms who are unable to access the solicitation via the Fed Biz Opps website may request a copy of the solicitation from Wanda Holliday at: hollida1@niehs.nih.gov. Please reference the solicitation number RFP# NIHES2012157 on your written request. All questions regarding this acquisition shall be submitted in writing via email to: hollida1@niehs.nih.gov. Telephone inquiries will not be accepted.