SPECIAL NOTICE
A -- Studies to Evaluate the Toxicological Effects of Test Agents in Laboratory Animals for the NTP
- Notice Date
- 8/15/2008
- Notice Type
- Special Notice
- 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, P.O. Box 12874, 79 T.W. Alexander Dr, Bldg 4401, RTP, North Carolina, 27709
- ZIP Code
- 27709
- Solicitation Number
- NIEHS2008057
- Archive Date
- 10/15/2008
- Point of Contact
- Jennifer Smith,, Phone: 919-541-0424, Latise Griffin,, Phone: 919-541-7950
- E-Mail Address
-
smithj3@niehs.nih.gov, lewisl@niehs.nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Institute of Environmental Health Sciences (NIEHS) is conducting a market survey to identify organizations with requisite qualifications and interest to provide the services stated herein. This announcement is not a request for proposals and does not commit the Government to award a contract now or in the future. No solicitation document exists at this time. The information obtained from this market survey is for planning purposes only to assist the Government in planning its acquisition strategy. Any contract that might be awarded based on information received or derived from this announcement will be the outcome of the competitive process. The Government will not pay for any costs incurred in the preparation of information for responding to this announcement. NIEHS is seeking capability statements from interested and qualified sources to conduct toxicology studies for the National Toxicology Program (NTP). A variety of study designs will be utilized including (1) carcinogenicity studies, (2) reproductive studies, and (3) developmental toxicity studies. Interested organizations must have the capability to conduct a portion of these studies with a perinatal ( in utero and lactational) exposure component for the test animals. These studies will further the mission of the NTP by testing chemicals that may pose a human health hazard such as industrial chemicals, plasticizers, flame retardants, food preservatives, drugs, pesticides and heavy metals. A chemical-specific protocol outline will be provided by the Government for each chemical studied. In general, studies will involve daily dosing of rats or mice. The route of administration may be dosed feed, dosed water, gavage, dermal, or parenteral (intraperitoneal, subcutaneous, intravenous, intratracheal). Study duration may be from a few days up to 2-years or for lifetime. Exposure may begin in utero or in young animals. Treatment regimens, species used, endpoints to be measured, etc., may vary depending on specific chemicals to be tested and study goals; therefore, flexibility in design of studies is required. In some cases, new testing paradigms may be developed with incorporation of unique endpoints. The actual mix of studies may vary each year according to the types of chemicals selected for study. However, the Government anticipates that the following mix of studies will be conducted each year: (a) up to 5 rat and mouse carcinogenicity studies with accompanying dose range-finding studies (14-and 90-day); (b) up to 5 multigeneration reproduction studies; and (c) up to 5 developmental toxicity studies with range-finding studies. The Government may also elect to conduct 3 additional range-finding studies and one additional definitive carcinogenicity, reproduction, and developmental toxicity study in each year. Organizations that submit capability statements in response to this announcement should provide information regarding its ability to meet the capability and technical requirements below: (1) Analytical chemistry capabilities necessary to support the described studies. These capabilities include, but are not limited to, identity and purity confirmation of bulk test material, dose formulation homogeneity/stability, and periodic dose analyses using analytical methods provided by the NTP. Test articles are typically provided by the Government. (2) The capability to use a Government provided data collection system for carcinogenicity studies. This system, known as the Laboratory Data Acquisition System (LDAS), was developed by the NIEHS/NTP. LDAS is a computer application with hardware uniquely designed to directly collect study data and transmit it to the Toxicology Data Management System (TDMS) database. Specifically designed software is then used to aid in the evaluation and interpretation of study results. The Government provides all hardware, equipment set-up and training for use of this system. The organization should also describe the features of their current system used to collect and report carcinogenicity study data. (3) For collection of reproductive endpoint data, such as littering data, must have a real time data management system that can provide resulting data (summary and individual animal tables) within 2 to 4 hours of collection. A description of the features of this system should be provided. (4) Ability to conduct studies in compliance with Good Laboratory Practices and in accordance with the general requirements and recommendations for laboratory animal management contained in “Specifications for the conduct of studies to evaluate the toxic and carcinogenic potential of chemical, biological and physical agents in laboratory animals for the NTP” dated October 2006 and any subsequent revisions ( http://ntp.niehs.nih.gov/files/Specifications_2006Oct1.pdf ). (5) Have a working laboratory in place for a sufficient number of years (for example, 5 to 7 years) prior to any proposal submission that will serve as evidence of experience conducting these types of studies. (6) Ability to demonstrate the capability and capacity for conducting these studies. A brief description of the size of the organization’s facilities should be provided. (7) The Principal Investigator, Toxicologist, Chemist, Veterinarian, Health and Safety Officer, and Quality Assurance Unit Officer shall be employees (i.e., not consultants or subcontractors) at the time of any contract award. 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. Interested organizations are invited to submit capability statements for conducting (1) carcinogenicity studies, (2) multigeneration reproduction studies and/or (3) developmental toxicology studies (i.e., organizations may submit capability statements for 1, 2, or all 3 components). Organizations responding to this announcement should submit a written capability statement which demonstrates relevant experience, skills, and ability to fulfill the requirements described herein. The capability statement should contain sufficient enough detail for the Government to adequately assess your organization’s experience and capabilities. Interested organizations should submit five (5) copies of their capability statement not to exceed twenty (20) pages in length, excluding standard brochures, resumes, etc., for receipt by the agency no later than 5:00pm EST, September 16, 2008. Any proprietary information should be marked as such. All respondents are requested to identify their organization’s size and type of business. Acknowledgement of receipt of responses will not be made nor will respondents be notified of the Government’s assessment of the information received. Please submit information to: Jennifer Smith, Contract Specialist National Institute of Environmental Health Sciences Post Office Box 12874 Research Triangle Park, NC 27709. Overnight address: 79 T.W. Alexander Drive, Bldg. 4401, Suite 100 Research Triangle Park, NC 27709. Inquiries will be accepted by fax, phone or e-mail.
- Web Link
-
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- Record
- SN01642170-W 20080817/080815225108-98aae69755eb44e07063082575922cef (fbodaily.com)
- Source
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