SOURCES SOUGHT
A -- Studies to Evaluate Toxicity Following Early Life Exposure to Test Articles for the National Toxicology Program
- Notice Date
- 10/6/2011
- Notice Type
- Sources Sought
- 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
- NTP2012001
- Archive Date
- 11/5/2011
- Point of Contact
- Jennifer Smith, Phone: 919-541-0424, Terry Wyche, Phone: 919-541-7950
- E-Mail Address
-
smithj3@niehs.nih.gov, wychetl@niehs.nih.gov
(smithj3@niehs.nih.gov, wychetl@niehs.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- General Information : This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. 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. Purpose : NIEHS is seeking capability statements from interested and qualified small businesses to conduct 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. 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 or more cost-reimbursement, level of effort type contract is contemplated. The total estimated level of effort for each laboratory if, for example, two awards are made, is anticipated to be between 25,000 to 50,000 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 Contractor shall have an AAALAC accredited laboratory and the ability to conduct studies that are compliant with Good Laboratory Practice (GLP) Regulations for non-clinical laboratory studies. Anticipated Period of Performance : The anticipated period of performance is ten (10) years with an estimated start date of October 1, 2012 and ending September 30, 2022. Submitting a Capability Statement : Organizations that submit capability statements in response to this announcement should provide general information regarding the ability to meet the technical requirements below: (1) The capability to meet the mandatory qualification criteria. (2) The capability and capacity for conducting these studies; include a brief description of the size of the organization's facilities, number and type of recent reproductive/developmental toxicity studies conducted, and key personnel, including study directors with experience in performing studies similar to those described here. (3) Have a working laboratory in place for a sufficient number of years to serve as evidence of experience conducting these types of studies. A working laboratory means that the facility has in place essential features necessary to conduct toxicology studies in compliance with Good Laboratory Practices and in accordance with the requirements contained in "Specifications for the conduct of studies to evaluate the reproductive and developmental toxicity of chemical, biological and physical agents in laboratory animals for the NTP" dated 2011 and any subsequent revisions (http://ntp.niehs.nih.gov/ntp/Test_Info/FinalNTP_ReproSpecsMay2011.pdf) (4) For collection of reproductive endpoint data, such as littering data, the organization should have a real time data management system that can provide resulting data (summary and individual animal tables) within 2 to 4 hours of collection. (5) 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 concentration analyses using analytical methods provided by the NTP. (Test articles will be provided by the Government.) Organizations responding to this announcement should submit a written capability statement that 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. Standard company brochures will not be considered a sufficient response to this sources sought synopsis. In the capability statement, respondents should provide their size status for the NAICS Code (541712) and whether or not they are a certified HUBZone, 8(a), Woman-Owned, Small Disadvantaged and/or Service Disabled Veteran-Owned or Veteran-Owned Small Business concern. Technical and administrative points of contact should also be provided. Due Date, Delivery and Number of Copies : Interested organizations should submit three (3) 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, October 21, 2011. Documents submitted electronically or by fax will not be accepted. 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: 530 Davis Drive MD K1-05 Durham, NC 27713 Inquiries will be accepted by e-mail at the address provided below. Jennifer Smith, Contract Specialist Phone: 919-541-0424 Email: smithj3@niehs.nih.gov Disclaimer and Important Notes : This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The Government will not pay for any costs incurred in the preparation of information for responding to this notice. CONFIDENTIALITY. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIEHS/NTP2012001/listing.html)
- Place of Performance
- Address: Not Applicable, United States
- Record
- SN02603910-W 20111008/111006234805-a885e9f02eaba9a37b22077c51667659 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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