SOURCES SOUGHT
A -- Preclinical Medications Screening in Dependence Models
- Notice Date
- 11/8/2013
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NIAAA-SSN-2014-02-PNH
- Point of Contact
- Patricia N. Hanacek, Phone: 301-594-6226, Paul McFarlane, Phone: 301-443-3041
- E-Mail Address
-
hanacekp@mail.nih.gov, pmcfarlane@mail.nih.gov
(hanacekp@mail.nih.gov, pmcfarlane@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction This notice is issued on behalf of the NIAAA by the National Institute of Child Health and Human Development, Office of Acquisitions, NIH, DHHS, UNITED STATES. This is a Research & Development Sources Sought Notice. This is not a solicitation for proposals, proposal abstracts, or quotations. This notice does not commit the Government to award a contract now or in the future. No solicitation is available at this time. The purpose of this notice is to obtain information regarding: (1) the availability and capability of all 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 according to the North American Industry Classification System, (NAICS) Code for the proposed acquisition. Responses to the information requested will assist the Government in determining the appropriate acquisition method. All size organizations are encouraged to respond. However, small business organizations must provide proof that their size status is certified by the Small Business Administration. The NAICS code is 541711 with a size standard of 500 employees. Background The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks a contractor to address the present and anticipated future needs of NIAAA's Medication Development Program. The Division of Neuroscience and Behavior's (DNB) Preclinical Medication Efficacy Testing Program seeks to re-compete a contract for the blind testing of reference compounds and proprietary compounds on alcohol drinking in mice using models of various aspects of alcohol dependence. The contract will use mechanisms having intellectual property conditions favorable to compound providers. This will eliminate a major barrier to testing optimized compounds having preclinical, as well as clinical toxicology data, and will stimulate interest by the pharmaceutical industry in developing high quality, marketable compounds for alcoholism. Overall, the contractor will assess effects of proprietary compounds in standardized models of alcohol dependence-induced alcohol intake using mice for subjects. Specifically, the contractor will be required to test effects of compounds submitted to them by NIAAA staff members in voluntary limited-access 2 bottle choice drinking of unsweetened ethanol solutions in mice made dependent through repeated cycles of ethanol vapor exposure and withdrawal. The contractor will also develop and implement testing of proprietary compounds in additional mouse models, which may include drinking in the dark (DID), intermittent access drinking model, alcohol deprivation model (ADE), and conditioned place preference (CPP) models. The contractor will also collect, analyze and display data from these tests and report them to designated NIAAA personnel. The data generated by this contract will be used in the identification of compounds for further development. Capability statements must conform to the Response Guidelines stated herein and should demonstrate a respondent's qualifications and experience, specifically providing evidence of their capability to perform the following requirements: Specific Project Requirements 1) Performing all studies and statistical analyses, 2) ensuring the quality of study data, 3) preparing final compound study reports, and 4) providing scientific expertise on the development of experimental protocols, if deemed necessary. Respondents must demonstrate ability to implement required tests in animal models of alcoholism (in particular, voluntary limited-access 2 bottle choice drinking of unsweetened ethanol solutions in mice made dependent through repeated cycles of ethanol vapor exposure and withdrawal) and possession of, or a reasonable plan to obtain specialized supplies required to perform these tests. Specific to these tests, d epending on testing outcomes and the nature of the compound tested, additional tests may be required to clarify interpretation of test compounds effects on alcohol drinking. At the request of the Contracting Officer's Representative (COR), effects of test medication will be performed in subject animals to evaluate effects on taste, consumption of caloric fluids, effects on locomotion and effects on alcohol pharmacokinetics. These tests are anticipated to use conventional methodologies and may include medication effects on sucrose, saccharine or quinine intake; effects on locomotion; effects on loss of righting reflex; and other relevant tests. Respondents must also demonstrate understanding of how animal models may be used to identify promising medication for the treatment of alcoholism and discussion of issues involving collaborations with supplies of proprietary compounds. The individual who will hold the project director role must have an advanced academic degree (i.e. Ph.D., M.D.), with expertise in the field of neuroscience or behavioral pharmacology and support from grants, cooperative agreements, and/or contracts awarded by federal or non-federal organizations is required. This individual must have experience testing experimental compounds for the treatment of addiction in animal models and experience in project management in the conduct of animal studies relevant to testing of therapeutics. On-site laboratory space, analytical equipment, mandatory organizational/ institutional status of having obtained, or capability of obtaining, an approved Animal Welfare Assurance from the NIH Office of Laboratory Animal Welfare (OLAW) and bioinformatics and computer resources necessary to perform the project are required. Access to safe vaporous alcohol delivery systems capable of achieving and maintaining precise dependence-producing blood-alcohol levels in rates or mice is required. Offerors will need to provide evidence of access, or a feasible plan to acquire required equipment, animals and facilities necessary to perform this project. Special Contract Requirements While the Contractor will be free to publish data developed under this contract on compounds and materials (Materials) that are specified by the NIAAA as publicly available, most of the Material provided to the Contractor will be proprietary to third parties. Data generated from testing and evaluation of these Materials will also be considered to be proprietary to the provider. Unless these data are protected, third parties are not likely to make their proprietary Materials available for testing and evaluation under the contract. Accordingly, the Contractor must agree not to publish data regarding proprietary test Materials unless the COR obtains permission from the provider. Additionally, in order to encourage third parties to submit their proprietary Materials for evaluation and testing, the Contractor must agree to offer the provider an option to an exclusive license to any subject invention conceived or first actually reduced to practice in the performance of work under this contract using a provider's proprietary Materials. Response Guidelines Interested organizations that believe they possess the aforementioned capabilities should submit a written Capability Statement via e-mail as a portable data file (PDF) t o the Point of Contact named herein. Responses must reference this sources sought notice number. Limit responses to 10 single-sided or five (5) double-sided pages. Any proprietary information should be so marked. Submissions must be received no later than Friday, November 22, 2013 at 4PM local time. Capability statements must identify the business status of the organization (i.e. educational institution, non-profit, large business, small business, 8(a), or other corporate or non-corporate entity). Also include the name and telephone number of a point of contact having knowledge of the submitted information. Capability statements that do not provide sufficient information or submitted after the date and time above will not be considered. Collect calls will not be accepted. The Capability Statement should include: A) the total number of employees, B) the professional qualifications of scientists, medical experts, and technical personnel as they relate to these requirements, C) an outline of previous or ongoing research projects in which the organization and identified personnel have participated and any in-house research and development efforts; [ Past performance documentation may include, but is not limited to, a minimum of two (2) contracts performed for either Government or commercial organizations. These references shall include, for each contract, names, titles, contract number, total price or cost, phone numbers of government Contracting Officer's Representatives and Contracting Officers.] D) a description of general and specific facilities and equipment available, including computer equipment and software, [Include a statement regarding industrial security clearance. ] E) proof that the business performs work in the cited NAICS code; and F) any other information considered relevant to these requirements. Capability Statements will be assessed on the pertinence and technical capabilities as they related to this requirement, specifically: 1) Experience/Past Performance, 2) Personnel, 3) Facilities; and 4) any other specific and pertinent information that may enhance the Government's assessment of the respondent's capabilities. After the Government's assessment of responses, pre-solicitation and solicitation notices may be published on the Federal Business Opportunities website. Responses to this notice shall not be considered adequate responses to a solicitation. A solicitation release date is pending the results of this notice. The Government anticipates awarding one contract for this requirement, for a 5-year period, in late fiscal year 2014.
- Web Link
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- Record
- SN03231439-W 20131110/131108233900-9a3afcb0812bbb2f105da81b112b728d (fbodaily.com)
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