SOLICITATION NOTICE
A -- Studies to Evaluate Toxicity Following Early Life Exposure to Test Articles for the NTP
- Notice Date
- 8/6/2012
- Notice Type
- Presolicitation
- 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, 530 Davis Drive, Durham, North Carolina, 27713, United States
- ZIP Code
- 27713
- Solicitation Number
- NIHES2012154
- Archive Date
- 9/27/2012
- Point of Contact
- Jennifer Smith, Phone: 919-541-0424
- E-Mail Address
-
smithj3@niehs.nih.gov
(smithj3@niehs.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- General Information : This notice announces the intended release of solicitation number NIHES2012154. The National Institute of Environmental Health Sciences (NIEHS) is soliciting proposals for conducting toxicology studies for the NTP. These studies will support and assist the NTP research effort to evaluate the effects of early life exposure to test articles that may result in long term adverse effects. Background : The National Toxicology Program (NTP) was established within the Department of Health and Human Services and charged with coordinating toxicological testing programs within the Public Health Service of the Department. The NTP, as part of the National Institute of Environmental Health Sciences (NIEHS), is responsible for evaluating the toxic and carcinogenic potential of environmental agents that may pose a health hazard to citizens of the United States. The NTP requires support for the conduct of short- and long-term toxicity studies following pre- and postnatal exposure to a variety of test articles by various routes of exposure. This requirement is designed to study diverse agents that may include: environmental chemicals; food additives, colorants or flavorings; pharmaceuticals and herbal remedies; pesticides; ingredients found in a variety of consumer products including soaps and cosmetics; detergents and cleaners; nanomaterials; chemicals used in manufacturing or industrial settings, etc. Project Details : For each test article studied, a detailed protocol outline will be provided by the Government to the testing laboratory. In general, studies will involve daily dosing of rats or mice. The anticipated routes of administration are gavage, dosed feed and dosed water. Study duration may be from a few days up to 2 years. Some tests may begin with time-mated animals, while others will begin with non-pregnant animals. Treatment regimens, species used, endpoints to be measured, etc., may vary depending on specific chemicals to be tested and study goals. Anticipated study designs will include (1) Reproductive Assessment by Continuous Breeding (RACB), (2) NTP Modified One-Generation (MOG) studies with multiple cohorts (information on the NTP modified one-generation design may be found at http://ntp.niehs.nih.gov/ntp/About_NTP/BSC/2011/April/MOGDesign.pdf), and (3) Prenatal Developmental Toxicity studies. The RACB study includes daily dosing of breeding pairs to produce F1a, F1b and F1c litters. Offspring from F1c litters will be mated to produce F2a, F2b and F2c litters. The NTP MOG study generally begins with time-mated females delivering litters from which offspring are assigned to multiple cohorts for evaluation of a variety of endpoints including: developmental landmarks, reproductive indices, teratology, subchronic toxicity, histopathology and/or collection of biological samples. Other endpoints in the MOG such as neurotoxicity or evaluation of target organ toxicities may be required. In some cases, new testing paradigms may be developed with incorporation of unique endpoints. Award of one (1) to three (3) cost-reimbursement, level of effort type contracts is contemplated. The total estimated level of effort for each laboratory if, for example, two awards are made, is anticipated to be approximately 30,000 to 35,000 labor hours per year depending on the needs of the NTP. Each laboratory would be anticipated to conduct a mix of the above studies with more RACB and MOG studies conducted than Prenatal Developmental Toxicity studies. The mix of studies conducted may change from year to year. Mandatory Qualification Criteria: The qualification criteria establish conditions that must be met at the time of receipt of technical proposals in order for the proposal to be considered any further for award. 1. 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 as defined 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. 2. 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. Further information may be obtained from the following source: Office of Laboratory Animal Welfare Office of Extramural Research National Institutes of Health Rockledge Center I, Suite 360, MSC 7982 6705 Rockledge Drive Bethesda, MD 20817 Phone: (301) 496-7163, ext. 234 Copies of the PHS policy are available by fax at 301-402-2803 and on the internet at http://grants.nih.gov/grants/olaw/olaw.htm Anticipated Period of Performance : The anticipated period of performance is ten (10) years with an estimated start date of February 1, 2013 and ending January 31, 2023. Disclaimer and Important Notes : This is not a solicitation. The estimated issue date of the solicitation is on or about August 21, 2012 and proposals will be due 50 days after release of the solicitation. The solicitation will be posted on the FedBizOpps website. Interested firms who are unable to access the solicitation via the FedBizOpps website may request a copy of the solicitation by contacting the Contract Specialist listed herein. Please reference the solicitation number RFP# NIHES2012154 in your written request. All questions regarding this acquisition shall be submitted in writing via email to smithj3@niehs.nih.gov. Telephone inquiries will not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIEHS/NIHES2012154/listing.html)
- Record
- SN02828667-W 20120808/120806235928-f2bc3ba6c05e242dfc2eb602e16c5bd5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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