SOLICITATION NOTICE
B -- Immunohistochemical Evaluation of Aerosolized MWCNT
- Notice Date
- 3/15/2016
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Acquisition and Assistance Field Branch (Morgantown), 1095 Willowdale Road, Morgantown, West Virginia, 26505
- ZIP Code
- 26505
- Solicitation Number
- 000HCCCB-2016-95056
- Archive Date
- 4/30/2016
- Point of Contact
- Rebecca S Mullenax, Phone: 304-285-5880, Desiree Harris, Phone: 301-458-4629
- E-Mail Address
-
rmullenax@cdc.gov, huq9@cdc.gov
(rmullenax@cdc.gov, huq9@cdc.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Title: Immunohistochemical Evaluation of Aerosolized MWCNT The Centers for Disease Control and Prevention (CDC) and the National Institute for Occupational Safety and Health (NIOSH), Health Effects Laboratory Division, Toxicology and Molecular Biology Branch, Morgantown, WV intends to award a sole source firm fixed price purchase order to WIL Research Laboratories, LLC, 1407 George Road, Ashland, Ohio 44805-8946 for Immunohistochemical Evaluation of Aerosolized MWCNT (Multi-Walled Carbon Nanotube Tissues. CLIN 0001: Portions of lung issues and tissue masses from the controls and multi-walled carbon nanotube (MWCN) exposed mice will be mounted on slides and stained with hematoxylin and eosin then sent to vendor for pathological evaluation. Please see Statement of Work below: Statement of Work Project Objectives This contract will be used to determine the dose response of inhaled multi-walled carbon nanotube-induced lung cancer. Identification of pathological changes indicative of cancer in the mice exposed to a low dose of a DNA damaging agent followed by a dose response of multi-walled carbon nanotubes or to MWCNT only will be compared to tissues from mice exposed to the DNA damaging agent or to air (Molecular Carcinogenesis Laboratory, Toxicology and Molecular Biology Branch, NIOSH, Morgantown, WV). For this purpose, portions of lung tissues and tissues masses from the controls and MWCNT-exposed mice will be mounted on slides and stained with Hematoxylin & Eosin (H&E) and sent to vendor for pathological evaluation. Molecular biology and biochemical investigations will be conducted in our laboratory using the remainder of the tissue samples. The original contract was to examine 576 slides. Preliminary data has indicated that the tumors per mouse was greater than expected therefore the analysis would require 5 slides per mouse lung rather than 1. The number of slides was increased. The number of animals analyzed was reduced to 456 mice and the mice anticipated with serosal tumors increased to 10 mice. We would do each lung lobe separately for 5 slides in order to make analysis of the numerous tumors in each lobe possible. We therefore will submit 5 slides for each mouse lung and one slide for each serosal tumor. Technical Requirements The tissue samples will be mounted on slides and stained with H&E stain, one tissue section per slide, on site (NIOSH, Morgantown, WV). The slides will then be submitted to vendor for pathologic analysis. The total number of slides would be approximately 456 X 5 =2,280. I would also like to plan for 10 serosal tumors. That would elevate the total number of slides to approximately 2,290 from the anticipated number of slides of 576. Half to be sent to the Vendor before August 1, 2016 and half to be shipped to the Vendor before January 10, 2017, with a final report provided on February 28, 2017. Vendor will forward to us a hard copy report of their analysis. The slides will be returned following submission of the final report of the project. Vendor requires full information on the study, which will include study design, ID numbers and fates of animals, copies of necropsy sheets containing gross lesions noted at necropsy, clear instructions on tissues and procedures required. Based on the H&E analysis, pathologists at WIL will determine whether each dose of inhaled MWCNT resulted in histolopathological changes indicative of carcinogenesis. The pathological findings will be used to determine the dose response of inhaled MWCNT. The contract includes analysis of approximately 2,290 slides. Additionally, the contract includes approximately 10 publication quality photomicrographs of representative tumors/lesions. Background and Need Our laboratory has completed a study in which mice were exposed to inhaled multi-walled carbon nanotubes (MWCNT) using a two stage model of lung cancer. In the two stage study, mice exposed to a low dose of a DNA damaging agent followed by MWCNT had a high incidence of lung adenocarcinoma as well as a low but significant incidence of malignant serosal tumors consistent with the diagnosis of sarcomatous mesothelioma. An ongoing dose response study of inhaled MWCNT has demonstrated the development of lung tumor lesions and presumptive mesothelioma lesions. Since the levels of MWCNT that are capable of developing lung cancer and serosal lesions are not known, we wish to collaborate with vendor to examine formalin fixed paraffin embedded serosal tumors and lung cancer to determine if lower doses of inhaled MWCNT result in the development of mouse lung adenocarcinomas and malignant serosal tumors. Project Objective The purpose of this acquisition is to obtain services for the identification of histochemical markers of mouse lung adenocarcinoma, mesothelioma and sarcoma. These results will determine if the exposure of mice to a dose response of 3 doses of MWCNT results in the development of lung adenocarcinoma and mesothelioma in mice exposed to inhaled MWCNT. The results of this study will provide data relevant to evaluating the levels of MWCNTs poses a risk for the development of lung cancer and/or mesothelioma in humans. The quantification of hazard will support risk assessment, assist in establishing exposure standards and safe handling practices, and guide development of an appropriate MSDS for users. Scope of Work The vendor will conduct histopathological evaluations of mouse lungs adenocarcinoma and presumptive mesothelioma lesions compared to human lung adenocarcinoma, mesothelioma and sarcoma that have been characterized by immunohistochemical markers. Technical Requirements For histopathological studies, mouse tissues with lungs that have been exposed to multi-walled carbon nanotubes that have been embedded in paraffin will be cut into 5 micron sections. The sections of these tissues will be mounted on slides. One slide of each sample will be stained with hematoxylin and eosin (H&E). The pathologist conducting the evaluations or a member of his lab must be experienced in the identification of lung hyperplasia, focal adenomatous hyperplasia, mesothelioma, sarcoma and lung adenocarcinoma. 1. Approximately 1,145 slides of lung and serosa for microscopic evaluation will be sent to the pathologist along with microscope slides of H&E-stained tracheobronchial lymph nodes, a few to be examined at the discretion of the pathologist, to aid in the distinction between benign and malignant tumors. 2. When the second set of animals are euthanized and the tissues prepared, a second batch of approximately 1,145 slides will be sent to vendor. Microscope slides of H&E-stained tracheobronchial lymph nodes will also be sent to the vendor, a few to be examined at the discretion of the pathologist, to aid in the distinction between benign and malignant tumors. 3. A final written report describing the findings, and which may include up to 10 publication-quality photomicrographs of representative lesions, will be prepared for publication in collaboration with the study. Reporting Schedule Teleconferences as well as written reports will be done to discuss the study results. Special Considerations The current purchase request is to conduct histopathological evaluations of mouse tissues to determine if exposure to a varied concentrations of multi-walled carbon nanotube (MWCNT) via whole body induces a dose response of hyperplasia, focal adenomatous hyperplasia, lung cancer and/or serosal tumors consistent with the diagnosis of malignant mesothelioma. Government Furnished Property NIOSH will supply the mouse tissues on microscope slides stained with H&E to the vendor. Deliverables Individual activities will be tracked by the NIOSH project officer and each activity will have its own set of milestone, goals and deliverables. 1. Approximately 1,145 H&E-stained lung and serosal slides for microscopic evaluation will be sent to the vendor by August 1, 2016. Glass microscope slides of H&E-stained tracheobronchial lymph nodes will also be sent to the vendor, a few to be examined at the discretion of the pathologist, to aid in the distinction between benign and malignant tumors. The analysis with interim pathology report will be completed by August 28th. When the pathologist has sent the analysis of the slides to the project officer, 33% of the funds will be disbursed. 2. Approximately 1,145 H&E-stained lung and serosal slides for microscopic evaluation will be sent to the vendor by January 10, 2017. Glass microscope slides of H&E-stained tracheobronchial lymph nodes will also be sent to the vendor, a few to be examined at the discretion of the pathologist, to aid in the distinction between benign and malignant tumors. The analysis with interim report will be completed by January 27, 2017. When the pathologist has sent the analysis of the slides to the project officer, 33% of the funds will be disbursed. 3. On February 28, 2017, the Final Report, which may include up to 10 publication-quality photomicrographs, will be sent. When the project office approves the report, a third and final payment of 33% will be made. Payment Schedule Phase 1: The analysis with interim pathology report will be received by August 28th. Upon completion of Phase 1 the vendor will be paid 33%.. Phase 2: Upon completion of Phase 2, the vendor will be paid 33%. Phase 3: The Final Report will be received on February 28, 2017 and may include up to 10 publication quality photomicrographs of representative tumors/lesions. Upon completion of Phase 3, the vendor will be paid 33%. This contract action is for a product for which the government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b) and 10 U.S.C 2304(c) (1). Interested persons may identify their interest and capability to respond to the requirement or submit proposals. The notice of intent is not a request for competitive quotations; however, all quotations/responses received within (15) days of the issuance of this notice will be considered by the Government. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation/response should be e-mailed to purchasing agent Rebecca Mullenax at rmullenax@cdc.gov by COB on March 30, 2016. FAR Reference: FAR 5.207 - Preparation and transmittal of synopses under (c) (15), (c) (16) (i) a
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