SOLICITATION NOTICE
A -- Research for Inhalation Toxicology of Environmental Chemicals
- Notice Date
- 4/20/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Environmental Health Sciences, Office of Acquisitions, Office of Management P.O. Box 12874, 79 T.W. Alexander Dr, Bldg 4401, RTP, NC, 27709
- ZIP Code
- 27709
- Solicitation Number
- NIH-ES-06-05
- Response Due
- 6/26/2006
- Archive Date
- 7/11/2006
- Description
- The National Institute of Environmental Health Sciences (NIEHS) is soliciting proposals for the purpose of operating the Respiratory Toxicology Group (RTOX) inhalation facility and performing animal studies. This includes setting up the inhalation facility in a suitable building provided by the contractor; conducting the daily operation of the exposure facility; operating an animal facility; and conducting studies as directed by study protocols. The mandatory qualification criteria of the inhalation facility being located within 15 minutes driving time of the NIEHS main campus, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709 must be met at the time of award. Anticipated Solicitation release date is May 8, 2006. The contractor shall provide 1) an inhalation exposure facility and staff dedicated exclusively to the support of NIEHS studies; 2) on-site space for the NIEHS Respiratory Toxicology Group which is independently secured from the rest of the facility; and 3) all components of the Inhalation Facility and the support areas including offices and laboratories shall be located on one site. The technical capabilities of the inhalation exposure facility have been tailored specifically to support the research needs of the Respiratory Toxicology Group and other groups within the Institute. Flexibility is a major factor in the design and operation of the exposure facility. The specific types of inhalation studies to be performed will be entirely dependent on the Institute?s needs for inhalation research. Exposure systems have been designed to allow configuration for a variety of study designs with a minimum of custom modifications. Computer control of exposures provides a safe, well controlled, and well-documented exposure environment. The contractor shall maintain complete and up-to-date documentation of all technical aspects of the facility design and operations. An inhalation facility is composed of four (4) distinct work areas - exposure, animal care, technical support, and staff areas. For estimating purposes the facility should include the following: Total approximate facility space = 13,000 square feet which include the following: (note: a. through o. below are minimums which do not equal total approximate facility space) a. RTOX space ? Three (3) office spaces of 150 square feet each; 60 square feet of space for file cabinets; wet lab space furnished as biochemical laboratory 1 room (400 square feet); cell culture laboratory (200 square feet), equipment storage area (100 square feet);] b. Eight (8) exposure rooms totaling 2618 square feet; c. Minimum of fifteen (15) animal housing rooms totaling 2160 square feet; d. Two (2) necropsy rooms totaling 500 square feet; e. 200 square feet for surgery/special procedures; f. Two (2) change/locker rooms, clean/dirty access totaling 800 square feet; g. 500 square feet for equipment wash area; h. 100 square feet for chemical preparation area; i. 400 square feet for analytical chemistry support laboratory; j. 400 square feet for biochemical instrumentation laboratory; k. 300 square feet for electronics laboratory; l. 150 square feet for ADP work area; m. 2450 square feet storage space; n. 240 square feet for animal care staff room; o. Five (5) offices of 150 square feet each (750 sq ft). Note: Approval of final configuration of the facility rests with the government. The contractor shall maintain compliance with Federal, State and Local laws, and NIH regulations such as the following: 1)The Laboratory Animal Welfare Act of 1966 (P.L. 89-544 as amended in 1970, 1976, and 1985) http://www.nal.usda.gov; 2) Standard Operating Procedures for Laboratory Animal Management that conform to the most recent versions of PHS and other public guidance. 3) NIH Office of Laboratory Animal Welfare (OLAW); 4) Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC); 5) NIEHS Laboratory Health and Safety Minimum Requirement for Contractors; 6) ?Guide for the Care and Use of Laboratory Animals? (NRC, 1996); 7) FDA ?Good Laboratory Practices for Nonclinical Laboratory Studies? (CFR 21 Part 85) It is anticipated the resulting cost-reimbursement, level-of-effort contract will be for a period of four (4) year and three (3), two (2)-year option periods. For estimating purposes the Government estimated the level-of effort at 43,524 direct labor hours per year as follows: Professional ? 9579 direct labor hours ;Technical - 7440 direct labor hours); Animal Husbandry Staff ? 26,040 direct labor hours; Administrative Support - 465 direct labor hours. The specific studies will be designed based on research requirements originating within the NIEHS. It is not possible to anticipate the specific projects in advance. A. The following describe the anticipated nature of the work. 1. The contractor shall be prepared to conduct whole-body inhalation exposure to 2 different gases (24 hours per day for up to 4 consecutive days), nose-only exposures to one liquid aerosol (30 minute exposure per group, three groups per day for up to seven days), whole body exposure to a second liquid aerosol (180 minute exposure per group, three groups per day, twice per week for up to two weeks), non-inhalation (e.g. single oropharyngeal aspiration) exposure to 1 or 2 chemicals. These studies may run simultaneously and consecutively. It shall be necessary to conduct several studies while simultaneously preparing the other exposure rooms for exposures to begin immediately after one of the ongoing exposures is completed. 2. Mice and rats will be the primary test species. A large number of genetically-modified mouse strains will be used. Provisions should be available for use of immuno-compromised animals, and for occasional breeding of one or two mouse strains. 3. Dose Animals The principal route of treatment is by inhalation, either whole body or nose only. The exposure regimen may be six (6) hours per day, five (5) days per week, excluding holidays. For studies involving extensive sample collection, exposures of some animals shall be staggered by one day; in these cases exposures shall be conducted six (6) days per week. Exposures of six (6) hours per day duration shall be completed by 2:30 P.M. so that animals will be available for use by NIEHS researchers after the daily exposure. Special studies may require exposures of longer duration or on weekends and holidays. A continuous 23.5 hours/day exposure regimen for up to four (4) days/week shall be necessary for some studies. Because these exposures must run unattended at night, the appropriate remote monitoring systems must be in place to ensure that personnel are notified immediately if any deviations in airflow or chemical concentrations occur. Studies may require treatment by intratracheal instillation, oropharyngeal aspiration, gavage, injection, implants, dermal exposure, feed, or drinking water. 4. Collection of Data and Samples The data and biological sample collection requirements will be specified in each research protocol. Requirements in recent studies have included: a. weekly or bi-weekly collection of body weights and in-life observations on each animal using an automated weighing system b. performing necropsies associated with terminal sacrifices or moribund sacrifices. c. whole body perfusion with fixative. d. collection of blood from a jugular cannula, cardiac puncture, or orbital bleeding (for kinetic studies multiple samples shall be collected during and after exposure) e. collection of tissues for biochemical analysis, or histopathological evaluation. f. collection of tissues for DNA or RNA isolation. g. collection of bronchoalveolar lavage fluid from mice and rats. 5. The contractor shall measure some experimental endpoints as specified in the research protocols. In all cases the PO will provide the experimental design in a project protocol. The contractor shall be responsible for the animal handling and shall provide the expertise in the operation of the analytical equipment necessary to conduct the measurements. The specific end points to be measured shall depend on the needs of the government. These measurements require the setup, calibration, and routine operation of analytical equipment including gas chromatographs (GC's), unrestrained plethysmographs, blood gas analyzer, plate readers, and a high pressure liquid chromatography (HPLC) system. Endpoints may include but are not limited to: a. the analysis of samples of tissues and biological materials for indigenous compounds, the exposure compound and it?s metabolites. b. pulmonary function measurements (Buxco system) c. the loading by particulates and the effect on pulmonary clearance mechanisms d. enzyme activity in tissues or biological fluids e. blood gas measurements in rats and mice f. blood hemoglobin, oxyhemoglobin, carboxyhemoglobin measurements in rats and mice. The contract will include Government Furnished Equipment (GFE) such as computers and specialized inhalation equipment. Contractor provided material shall include genetically altered rats/mice; general office supplies; animal supplies such as tyvek suits,feed, and bedding; all anesthetics, drugs and controlled substances used in veterinary medicine.
- Record
- SN01031692-W 20060422/060420220432 (fbodaily.com)
- Source
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