Preclinical Medications Screening in Dependence, Affect and Pain Models of Alcoholism

This notice is issued on behalf of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) by the National Institute of Child Health and Human Development, Office of Acquisitions, NIH, DHHS, UNITED STATES. This is a Research & Development (R&D) 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 all qualified sources, including small businesses, to perform a potential R & D requirement. As such, this notice is also seeking Small Business 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. Responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. This requirement is assigned a code of 541715 in the North American Industry Classification System (NAICS), and the size standard of 500 employees. All qualified organizations are encouraged to submit capability statements in response to this Sources Sought Notice. THERE IS NO SOLICITATION CURRENTLY AVAILABLE. THIS SOURCES SOUGHT NOTICE IS STRICTLY FOR MARKET RESEARCH PURPOSES. If full and open competition is ultimately pursued, responses to this synopsis will be used to aid in establishing small business subcontracting goals. This notice shall not be construed as a RFP or as any commitment or obligation on the part of the Government to issue a solicitation. The Government does not intend to award a contract on the basis of this request, so proposals will not be considered. No reimbursement will be made for any costs associated with providing information in response to this synopsis or any follow-up information requests. Background The National Institute on Alcohol Abuse and Alcoholism (NIAAA) currently supports a preclinical medication efficacy testing program to foster discovery of medication targets and lead compounds. The program is supported by two contracts: One contract supports testing medications in alcohol preferring rat strains. The second supports testing in alcohol drinking mice made dependent through chronic exposure to cycles of alcohol vapor exposure and withdrawal (CIE model), as well as in other models, as needed. Although the program supports testing in mice and rats, it currently does not support the CIE model in rats that would allow direct comparison of drug effects in mice and rats using the same model. This requirement is to support blind medication testing on alcohol drinking, negative affect measures and pain measures, in rats made alcohol dependent using the CIE model. The contract would support testing capacity of four (4) compounds per year over the next five (5) years. It will use mechanisms having intellectual property conditions favorable to compound providers when acquiring compounds from industry. This will eliminate a major barrier to testing optimized compounds and will stimulate interest by the pharmaceutical industry in developing high quality, marketable compounds for alcoholism. The project objectives are as follows: 1. To assess effects of proprietary compounds in standardized models of alcohol dependence-induced alcohol intake, negative affect and pain sensitivity using both male and female rats as subjects. 2. To implement testing of proprietary compounds in a battery of - control tests designed to aid in evaluating the selectivity and specificity of drug effects on alcohol intake in both male and female rats as subjects. 3. When requested, to assess effects of proprietary compounds on: (a) consumption of other fluids (sucrose); (b) general locomotor activity and interactions with alcohol; (c) alcohol induced hypnotic effects; and (d) alcohol pharmacokinetics, as measured by effects on blood alcohol elimination rates. 4. To collect, analyze, and display test data and provide compound study reports. The data generated will be used in the identification of compounds for further development. Project Requirements 1. Compound Testing Test effects of compounds provided by NIAAA in voluntary limited-access drinking of unsweetened ethanol solutions in rats made dependent through repeated cycles of ethanol vapor exposure and withdrawal based on information provided by NIAAA. Two bottle choice or operant self-administration methods may be used. If requested by NIAAA, Contractor may have to purchase reference compounds for testing. All details of experimental protocols will be subject to the Government's concurrence. 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 test drug reached and engaged the intended target. 2. Compound Storage and Administration 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 degree 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. 3. Data Analysis and Reporting Statistical analysis of the data, and preparation of a summary of the testing conditions and results including graphical displays is required. Interpretation of results written in language that can be understood by scientists not having specialized training in alcohol or addiction research is necessary. 4. Data Recording Electronic record keeping of all proposed and/or tested experimental protocols, 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, with notations regarding their status, is required. A copy of any protocol shall be available to the Government upon request 5. Data Maintenance and Storage Electronic versions of Laboratory notebooks (including raw data) and any electronic data files generated, inclusive of all coded proprietary test compounds received for evaluation under the contract are required. 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 shall 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 shall 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 Any interested sources are requested to submit a written capability statement demonstrating their qualifications and experience, specifically providing evidence of their ability to perform the project requirements reflected in this notice. The Capability Statement 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) and answer the following questions: 1. Is your organization a small business under NAICS Code 541712? 2. Does your firm qualify as a small disadvantaged small business? 3. If disadvantaged, is your firm certified under section 8(a) of the Small Business Act? 4. Are you a certified HUBZone firm? 5. Are you a woman-owned or operated business? 6. Are you a certified Service-Disabled Veteran Owned or Veteran Owned business? Also provide the name and telephone number of a point of contact having knowledge of the submitted information. 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, including 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. Submissions will be reviewed for their experience and expertise relevant to conducting rodent studies of alcohol effects and anxiety and 2) knowledge of, and experience in, the field of alcoholism research or other relevant areas necessary to carry out the project. Specific to these tests, depending 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. Respondents must 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 suppliers of proprietary compounds. Evidence of access, and possession of, or a reasonable plan to obtain specialized supplies and facilities required to perform the animal tests is needed. Appropriate knowledge and facilities capable of housing and caring for rats in a clean, safe, appropriate environment are necessary. Specific requirements regarding the use of rats in preclinical studies apply. 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. 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. Submission Information Interested organizations that believe they possess the capabilities necessary to undertake this project should submit Capability Statement electronically via e-mail as a portable data file (PDF) to the NIAAA Contract Specialist identified as the point of contact below by Friday, February 16, 2018 at 4 PM EST. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME MAY NOT BE CONSIDERED. No collect calls or facsimile transmissions will be accepted. There is a 10-page limit, (excluding resumes) and submissions must be in a single-spaced document, using a 12-point font size. Any proprietary information should be so marked. After the Government's assessment of responses, a pre-solicitation notice and solicitation may be published on the Federal Business Opportunities website. Responses to this notice will not be considered adequate responses to a solicitation. Respondents will NOT be notified of the results of the Government's assessment and Capability Statements will not be returned. This is strictly market research and the Government will not entertain any questions. We appreciate your interest and thank you in advance for responding to the Sources Sought. A solicitation release date is pending the results of this notice. The Government anticipates a single award for severable services for a 12-month base contract plus four (4) option periods.