SOURCES SOUGHT
A -- Preclinical Medications Screening in Genetic Models of Alcoholism
- Notice Date
- 9/4/2013
- 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-2014-03-PDM
- Point of Contact
- Paul McFarlane, Phone: 301-443-3041
- E-Mail Address
-
pmcfarlane@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. The purpose of this notice is to obtain information regarding the availability and capability of business sources and whether there are any small businesses with the requisite capabilities to perform this requirement under the North American Industry Classification System (NAICS) code identified below. Responses to this notice, in the form of capability statements, will assist the Government in determining the appropriate acquisition method, including whether the project should set-aside for small businesses. The NAICS code for this requirement is 541711 [ Research and Development in Biotechnology ]. The size standard in number of employees is 500. Background To address the present and anticipated future needs of NIAAA's Medication Development Program, DNB's Preclinical Medication Efficacy Testing Program seeks to award a contract to continue a contract for the blind testing of reference compounds (including those previously tested by the National Institute on Alcohol Abuse and Alcoholism Clinical Investigations Group (NCIG) program) and proprietary compounds in P rats and HAD1 rats selectively bred for alcohol preference. 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. Project Requirements To assess effects of proprietary compounds in standardized models of alcohol intake in two (2) rat lines selectively bred for alcohol dependence. To 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. Compound Testing On the basis of information provided by NIAAA, the Contractor shall test effects of compounds submitted to them by NIAAA staff members in voluntary limited-access 2 bottle choice drinking paradigms using alcohol-preferring P rats and HAD1 rats. If requested by NIAAA, contractor shall purchase reference compounds for testing. All details of experimental protocols shall be subject to the concurrence of the NIAAA Project Officer. Minimally, testing protocols should conform to the following standards: a) Justification of sample size, including power calculation; b) blind testing; and c) random or stratified assignment of subjects to experimental conditions. The Contractor may be asked to evaluate whether the interventional drug reached and engaged the intended target when possible. Compound Storage and Administration The Contractor shall store compounds supplied to them by NIAAA such that they cannot be readily accessed by personnel outside the Principle Investigator's laboratory. Adequate storage conditions, including -70 ° C freezers when noted, shall be available on site. The Contractor shall be responsible for providing all necessary reagents and supplies necessary for administering test medications according to instructions supplied by NIAAA. Ongoing Paradigm Validation and Control Tests The Contractor shall further validate voluntary limited-access 2 bottle choice drinking paradigms and additional alcohol consumption, reinforcement and reward paradigms as requested by NIAAA. This may include periodic tests with reference compounds designated by the NIAAA Project Officer. In addition, control tests may be requested by NIAAA including examining effects of a test compound on sucrose drinking, ethanol-induced locomotor stimulant and depressant effects, ethanol-induced soporiphic effects, and ethanol pharmacokinetics (BEC elimination). These tests will be performed and reported upon completion. Data Analysis and Reporting The Contractor shall perform appropriate statistical analysis of the data, and prepare a summary of the testing conditions and results including appropriate graphical displays. Reports shall also include interpretation of results written in language that can be understood by scientists not having specialized training in alcohol or addiction research. The report is to be submitted to the NIAAA Project Officer (along with copies of raw data if requested), fourteen (14) days after the completion of the medication test. Data Recording Throughout the life of the contract, the Contractor shall maintain a binder of all experimental protocols. Protocols shall be written using a strong scientific standard, with all details of the experiment recorded in such a way that another lab could replicate the study exactly. The binder shall contain all protocols proposed and/or tested during the duration of the contract, and shall include notations with regard to their current status. A copy of any protocol shall be available to the NIAAA Project Officer upon request. Data Maintenance and Storage The Contractor shall retain, for the duration of this contract, all laboratory notebooks (which shall include hard copies of raw data) and any electronic data files generated under this contract, as well as all coded proprietary test compounds received for evaluation under this contract. Electronic data files shall be labeled and recorded in a manner that allows their association with corresponding laboratory notebook entries and hard copies of raw data. On or before the expiration date of this contract, if so instructed by the NIAAA Project Officer, the contractor shall ship these items to the NIAAA Project Officer. The contractor shall not enter data from studies unrelated to this contract in notebooks or on disks containing data generated under this contract. 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 Project Officer 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 by 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 Project Officer obtains permission from the submitter. 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 contractor subject invention conceived or first actually reduced to practice using a provider's proprietary Materials. Transition Plan Within 150 calendar days of the contract's expiration date, the Contractor shall submit to the COR and the Contracting Officer (CO) a written draft transition plan outlining the following activities with dated milestones for completion of each activity. Status of any ongoing contract projects with anticipated completion dates Plan for transferring all contract-related electronic data to the NIAAA COR Plan for transferring all contract-related hard copy data (i.e. experimental protocols binders, etc. as described in the Data Analysis and Reporting and Data Recording elements of this statement of work) to the NIAAA COR Plan for final disposition of all contract Materials (i.e. Third Party Compounds and other Materials kept in minus 70 freezer(s) and in other storage locations to the NIAAA COR.) Response Guidelines Business concerns that possess the capabilities necessary to undertake the aforementioned efforts should submit documentation of their capabilities to the contact point person named herein. Reference the sources sought notice number identified herein. This "capability statement" should include: 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as they relate to the requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, 4) an outline of previous research projects in which the organization and proposed personnel have participated, 5) Past Performance documentation, which should include, but not be limited to, a minimum of two (2) contracts performed for either Government or commercial organizations, 6) proof that the business performs work in the cited NAICS code. References shall include for each contract: names, titles, contract number, total price or cost, telephone numbers of government Contracting Officer's Representatives and Contracting Officers, 7) any other information considered relevant to this program; and 8) If the respondent is a small business concern, identify their size standard as concurred in by the Small Business Administration. The capability statement shall not exceed 15 single sided printed pages in length in a 12-point font size, minimum. Double sided printing is acceptable. No proprietary or confidential business data should be submitted in response to this notice. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses regarding the submitted information. Capability statements must only be submitted electronically (i.e. via e-mail) to the point of contact listed herein, in either MS-Word or Adobe Portable Document Format (PDF), no later than Monday, September 23, 2013 at 3PM local time. Capability statements that do not provide sufficient information will not be considered. Responses received after that time will not be considered. This notice does not obligate the Government to award a contract nor to pay for the information provided in responses. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate, including the use of non-proprietary technical information in any resultant solicitation. Organizations responding to this notice should ensure its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. The Government is under no obligation to acknowledge receipt of the information received or to provide feedback to respondents with respect to any information submitted. After the Government's review 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 plans to award one (1) contract for a period of five (5) years on or about September 1, 2014.
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- Record
- SN03173691-W 20130906/130904235811-76c10d08868f554e62ea26957d52dd57 (fbodaily.com)
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