SOURCES SOUGHT
A -- National Toxicology Program Carcinogenicity Studies of Radio Frequency Radiation in Rats and Mice Exposed in Reverberation Chambers
- Notice Date
- 4/30/2003
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Environmental Health Sciences, Research Contracts Branch, DERT P.O. Box 12874, 79 T.W. Alexander Dr, Bldg 4401, RTP, NC, 27709
- ZIP Code
- 27709
- Solicitation Number
- Reference-Number-NIH-ES-SS-03-17
- Archive Date
- 6/14/2003
- Point of Contact
- PHIL JONES, SUPERVISORY CONTRACTING OFFICER, Phone 919-541-0426, Fax 919-541-2712, - Carolyn Flowers, Procurement Technician, Phone 919-541-0425, Fax 919-541-2712,
- E-Mail Address
-
jonesp@niehs.nih.gov, flowers3@niehs.nih.gov
- Description
- The National Toxicology Program (NTP) is seeking research and development sources capable of conducting toxicology and carcinogenicity studies for the National Toxicology Program of radio frequency radiation (RFR) in rats and mice. In these studies, unrestrained and individually caged animals shall be exposed to modulated RFR signals in reverberation chambers. In addition to the specialized expertise and facility needed to properly set up and monitor RF electromagnetic fields in reverberation chambers, additional expertise, facilities and equipment will be needed to evaluate a variety of toxicologic endpoints in large groups of experimental animals. Because of the extensive use of wireless communication devices and because RFR exposure guidelines are based on protection from acute injury from thermal effects, there is an urgent need for long-term exposure studies on RFR for the evaluation of potential human health effects. Consequently, these studies shall be initiated and completed in a timely fashion. SCOPE OF WORK A reverberation chamber is a shielded room having an excitation antennae and ventilation panels. In addition, a rotating paddle creates a statistically homogeneous electromagnetic environment. Because the NTP studies may require up to 300 animals individually caged (in plastic cages on plastic cage racks) in each chamber and because of needs for spatial separation of animal cages from each other and from conducting surfaces during exposures, the dimensions of each reverberation chamber will be approximately 6.7 meters (L) x 5.2 meters (W) x 4.2 meters (H). Further, these studies may require 4 power levels plus a sham at 2 separate frequencies; thus, the facility must be able to house 9-10 reverberation chambers of the dimensions indicated above. Animals shall remain individually caged in the reverberation chambers during the nonexposure periods. The Government will provide the reverberation chambers, signal generators, amplifiers, antennas, digital and analog wave synthesizers, isotropic field probes, stirring paddles, ventilation panels, computers for control of the internal environment and data acquisition, and software and user manuals for collection of data into the Toxicology Data Management System. The organization submitting capability statements must have sufficient laboratory space to accommodate the reverberation chambers and capability of setting up the chambers with proper environmental and lighting conditions as well as of monitoring the uniformity of the internal electromagnetic fields. Engineers from the National Institute of Standards and Technology have worked with the NTP to demonstrate the feasibility of this approach. They will be available for consultation in the set up and monitoring of the chamber environments and to calibrate the field probes. It is anticipated that preliminary studies of 2-7 weeks duration plus lifetime studies in rats and mice shall be conducted at two separate frequencies (one in the range of 900 MHz and the other at approximately 1900 MHz). Measurements of animal whole body temperature at the end of a daily exposure shall be taken at various intervals of these studies. Because large differences in dosimetry can occur when animals of different sizes are exposed together in the same chamber, separate exposures shall be needed for studies in rats and mice. The lifetime studies (exposure until survival in sham groups reaches 20%) shall include interim sacrifices at one or two time points. The preliminary studies and/or the interim sacrifices shall include the following evaluations: histopathology including special staining techniques such as for brain albumin leakage, hematology, clinical chemistry including measurements of serum melatonin and other hormone levels, metabonomic urinalysis, sperm morphology and vaginal cytology, micronuclei, and neurotoxicity. Because these studies may include gestational exposures, information must be included on rat and mouse breeding capabilities at the facility. All studies shall be performed in accordance with the Good Laboratory Practice Regulations established by the FDA for Non-clinical Laboratory Studies (FDA Good Laboratory Practice Regulations for Non-clinical Laboratory Studies; Final Report (Fed. Register, Vol 52, # 172, Friday September 4, 1987, pp 33768-33782; 21 CFR Part 58) and the "Specifications for the Conduct of Studies to Evaluate the Toxic and Carcinogenic Potential of Chemical, Biological and Physical Agents in Laboratory Animals for the National Toxicology Program (NTP)" dated September 2000, "Guide for the Care and Use of Laboratory Animals, NRC, 1996," and "Laboratory Animal Welfare Act of 1966 (P.L. 89-544) as amended in 1970, 1976, and 1985." In addition, the facility must be AALAC (Association and Accreditation of Laboratory Animal Care) accredited and have a functional Animal Care and Use Committee. An NTP contractor will provide serology testing as part of an infectious disease surveillance program. REQUIRED CAPABILITIES Organizations submitting capability statements must have a working laboratory in place capable of performing the types of studies indicated above. A Principal Investigator, Electrical Engineer, Toxicologist, Pathologist, Laboratory Animal Veterinarian, Health and Safety Officer, and Quality Assurance Unit Officer are disciplines necessary. The daily interaction and constant coordination of efforts needed among these discipline areas throughout the in-life portion of the studies makes it critical that they be physically and organizationally together. Specifically, requirements include: 1) principal investigator who is experienced in conducting toxicologic studies and in the management and coordination of multidisciplinary projects, 2) electrical engineer and technicians who can set up reverberation chambers for RFR exposures and monitor the uniformity of the internal electromagnetic fields, 3) pathologist, prosectors, histology technicians who are experienced in rodent studies, 4) veterinarian and animal care technicians who are experienced in studies in rats and mice with ability to collect blood for clinical pathology determinations including serum hormone measurements, prepare blood smears for micronucleus determinations, collect urine for metabonomic urinalysis, and perform necropsies for reproductive system effects (vaginal cytology, sperm motility and counts), and 5) adequate facilities and equipment for lab animal management and to perform RFR studies and routine histopathology. The facility must have capabilities for cleaning cage racks, cages, water bottles, and feeders. The breadth of measures in these studies may require subcontracting some of the work. Organizations shall have the necessary facilities, personnel, equipment, and capability in-house or through subcontract to perform the following evaluations: General Toxicology. The ability to perform specific toxicologic evaluations such as clinical pathology determinations including serum hormone levels, micronucleus determinations, metabonomic urinalysis, and reproductive system effects (vaginal cytology, sperm motility and counts). Neurotoxicity. Demonstrated expertise in CNS histopathology and immunohistochemistry. The study design protocol has not been finalized, but may include other neurological measurements. Contractors responding to this announcement should also discuss their capability in conducting standardized functional observational battery for clinical signs, auditory startle, learning and memory, and collecting motor activity data on juveniles and adult rats on automated apparatus. This is a request for submission of capability statements only at this time so that we may evaluate your R&D capabilities. THIS IS NOT A REQUEST FOR PROPOSALS (RFP). Organizations having the toxicologic research and engineering capabilities identified above and facilities necessary for the performance of this work are invited to submit a capability statement (as defined below) to the procuring office listed in this notice within 30 calendar days from the date of publication of this notice in the FedBizOpps. Capability statements shall include: (1) the professional qualifications of scientific and technical personnel who would be assigned to perform these toxicity and carcinogenicity studies, (2) a description of the general and specific facilities (include floor plans for all facilities that would be used to support these studies, labeled to their function and proximity to the exposure facility) and equipment for the proposed studies, (3) an organizational chart and a general description of the firm=s ability to perform toxicity and carcinogenicity studies of RFR in rats and mice, including animal breeding and the special evaluations indicated above, (4) an outline of previous multidisciplinary projects similar to the one specified here that have been conducted by your firm, including a synopsis identifying the work that was performed and the time period during which it was performed, (5) a description of proposed subcontractors including qualifications of their staff, a description of their facilities, and a list of relevant toxicology projects performed for the prime contractor, and (6) other pertinent information. Qualifications of staff and subcontractors should be furnished in the form of curriculum vitae. The number of pages submitted in response to this announcement should not exceed 30 pages plus appendix of supportive documentation. The anticipated North American Industry Classification System (NAICS) Code for the proposed subsequent acquisition is 541710. The small business size standard is 500 employees. Capability statements shall include the type of organization (e.g., sole proprietorship, partnership, corporate entity - tax exempt, corporate entity - not tax exempt, etc.), small business representation (e.g., small business, small disadvantaged business, women-owned small business, veteran-owned small business, service-disabled veteran-owned small business HUBZone small business), and size representation (e.g., number of employees). This synopsis is for planning purposes only and does not commit the Government to pay for the information requested, issue a solicitation, or award a contract. No solicitation documents exist at this time. Any subsequent solicitation for an R&D contract will by synopsized in the FedBizOpps. Organizations responding to this advance notice will be added to the solicitation mailing list for any subsequent solicitation. An original and 5 copies of the requested information should be submitted to: If using the U.S. Postal Service - National Institute of Environmental Health Sciences, Research Contracts Branch, DERT, P.O. Box 12874, Research Triangle Park, NC 27709; if using a delivery service or hand-delivered - National Institute of Environmental Health Sciences, Research Contracts Branch, DERT, 79 T.W. Alexander Drive, Building 4401, Room 149A, Research Triangle Park, NC 27709. Facsimile (fax) responses will not be accepted. See Numbered Note 26.
- Record
- SN00314904-W 20030502/030430213343 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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