SOURCES SOUGHT
A -- Support of the Research Effort to Evaluate the Toxic and Carcinogenic Potential of Test Agents in Lab Animals for the NTP
- Notice Date
- 12/12/2012
- 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
- NIHES2013160
- Archive Date
- 1/12/2013
- Point of Contact
- Jennifer Smith, , Melissa M Gentry,
- E-Mail Address
-
smithj3@niehs.nih.gov, gentry1@niehs.nih.gov
(smithj3@niehs.nih.gov, gentry1@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 and carcinogenicity studies following exposure to a variety of test agents by various routes of exposure. This requirement is designed to study diverse agents that may include: environmental chemicals; chemicals used in manufacturing or industrial settings; naturally occurring chemicals; food additives, preservatives, colorants or flavorings; pharmaceuticals, botanically- and non botanically-based dietary supplements; herbicides, fungicides, and pesticides; ingredients found in a wide variety of consumer products including soaps, lotions, perfumes and cosmetics; chemicals used in detergents and cleaners, etc.; naturally occurring and synthetic fibers, nanomaterials including carbon nanotubes; metals; plasticizers; flame retardants; mold or mold components; or other agents not specified at this time. Purpose: NIEHS is seeking capability statements from interested and qualified small businesses to conduct toxicology and carcinogenicity studies for the NTP. These studies will support and assist the NTP research effort to evaluate toxicity and carcinogenicity of test agents studied. Project Details: Ongoing and recurring evaluations shall be conducted to evaluate the toxicity and carcinogenicity of test agents by various routes of exposure. For each test agent a detailed protocol outline will be provided by the Government to the testing laboratory. The design of studies assigned to the contract will vary as needed depending on the individual test agents, route(s) of exposure, and endpoints to be evaluated. Studies will typically utilize Harlan Sprague Dawley rats and B6C3F1/N mice; however, other stocks/strains or other species may be utilized. Study duration may be from a few days up to 2-years or lifetime; exposure may begin in utero or in young animals; the route of administration may be inhalation (whole body or nose only), oral (dosed feed, dosed water, gavage), dermal or parenteral (intraperitoneal, subcutaneous, intravenous, intratracheal). Endpoints to be evaluated may include signs of toxicity in life (survival, body weight, food/water consumption, clinical observations), clinical pathology (hematology and clinical chemistry), organ weights, gross and histopathology, and determination of concentration of the test article blood, tissues and excreta). Test agents will typically be provided to the contractor. For inhalation studies, the contractor shall develop methods for characterizing identity and purity to be conducted prior to the start and during the course of the studies. In addition, methods for exposure generation and monitoring of chamber concentrations shall be developed and validated by the contractor. For routes other than inhalation, chemical reanalysis (identity and purity) and dose formulation and analysis methods will typically be provided to the contractor, and test agents will typically have been evaluated for identity and purity (for routes other than inhalation) prior to shipment to the contractor. The contractor will be required to demonstrate method performance prior to starting the studies. Details for typical study designs and for individual routes of administration are found in 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 dated January 2011 and any subsequent revisions ( http://ntp.niehs.nih.gov/ntp/Test_Info/FinalNTP_ToxCarSpecsJan2011.pdf ). Award of a cost-reimbursement, level of effort type contract is contemplated. The total estimated level of effort is anticipated to be between 50,000 to 100,000 labor hours per year, including options, depending on the needs of the NTP. The laboratory would be anticipated to provide support to the NTP toxicity and carcinogenicity testing effort by conducting approximately 2-4 prechronic toxicity studies and 2-4 chronic toxicity and carcinogenicity studies per year. The mix of routes and study types may change from year to year. Mandatory Qualification Criteria: The Contractor shall have the ability to conduct studies that are compliant with Good Laboratory Practice (GLP) regulations and have an AAALAC accredited laboratory and demonstrate compliance with the NIH guide for Care and Use of Laboratory Animals by the time of proposal submission. In addition, the Contractor shall have a PHS Assurance from the NIH Office of Laboratory Animal Welfare (OLAW) by the time of contract award. Anticipated Period of Performance: The anticipated period of performance is ten (10) years with an estimated start date during the 1st quarter of Fiscal Year 2014. 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 routes of exposure of recent prechronic and chronic toxicity and carcinogenicity studies conducted, and personnel for toxicology, exposure/engineering (inhalation exposure), chemistry, clinical pathology, histopathology, laboratory animal management, Quality Assurance, Health and Safety and other professional and technical staff 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 Toxic and Carcinogenic Potential of Chemical, Biological and Physical Agents in Laboratory Animals for the National Toxicology Program dated January 2011 and any subsequent revisions (http://ntp.niehs.nih.gov/ntp/Test_Info/FinalNTP_ToxCarSpecsJan2011.pdf). (4) Inhalation exposure and analytical chemistry capabilities required to perform the work outlined above. 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 4:00pm EST, December 28, 2012. 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 only at the address provided below. Jennifer Smith, Contract Specialist 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/NIHES2013160/listing.html)
- Record
- SN02947779-W 20121214/121212235052-425ace3e13f765d8160bc459ec243d76 (fbodaily.com)
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-
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