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

This is a notice issued on behalf of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) by the National Institute of Child Health and Human Development (NICHD), Office of Acquisitions, NIH, DHHS, UNITED STATES.

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. There is no solicitation 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. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization not considered a small business under the applicable NAICS code should not submit a response to this notice.

Background: The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking capability statements from small business organizations (NAICS 541715; small business size standard is 1000 employees) with experience in pre-clinical medications testing in rats.

The 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.

One contract is envisioned for this requirement which will support blind medication testing on alcohol drinking, negative affect measures and pain measures, in rats made alcohol dependent using the CIE model. The contract will 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.

Purpose and Objectives: 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 include the following:

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.

Anticipated Period of Performance: A contract is being contemplated for the requirement with a one-year base period and four option years, beginning September 1, 2018.

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.

Information Requested: Information submitted should be relevant and specifically addressed to each of the following qualifications:

1. Experience: An outline of previous work specific to the requirements and tasks listed above;

2. Personnel: Name, professional qualifications and specific experience of scientist and/or technical personnel who may be assigned as Principal Investigator (PI) and other key positions; and,

3. Facilities: Availability and description of facilities and equipment required to conduct the work.

4. Other: Any other specific and relevant information that would improve the Government's consideration and evaluation of the information presented is desirable.

Capability Statements Requirements: 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.

Capability Statements must demonstrate the following:

1. Experience and expertise relevant to conducting rodent studies of alcohol effects and anxiety.

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 required to clarify interpretation of test compounds effects on alcohol drinking.

3. 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.

4. Evidence of access, and possession of, or a reasonable plan to obtain specialized supplies and facilities required to perform the animal tests is needed.

5. Appropriate knowledge of and facilities capable of housing and caring for rats in a clean, safe, appropriate environment are necessary for the specific requirements regarding the use of rats in preclinical studies.

6. Ability to provide 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 and required.

7. Ability to provide staffing to include an individual who will hold the project director role, who 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.

Past Performance Information: Documentation should include, but not be limited to a minimum of two (2) contracts and include names, titles, contract number, price or cost, the Statement of Work, telephone numbers of Project and Contracting Officers, and any other information serving to document the organization's capability to perform the project requirements.

Information Submission Instructions: Organizations shall provide an electronic version only of their response to this notice. Responses shall include the organization's name, address, point of contact, size of business pursuant according to the NAICS code and must address all the technical information requested. The page limit is 15 pages using a font size of 10 or larger. Responses will assist the Government in selecting the appropriate acquisition mechanism.

Additionally, the response must provide answers to the following questions:

1. Is your organization a small business under NAICS Code 541715?

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?

This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. This is not a Request for Proposals. The Government DOES NOT intend to award a contract based on responses under this announcement. Interested parties shall not be reimbursed for costs associated with preparation of their responses. Any proprietary information should be so marked.

All capability statements sent in response to this Small Business Sources Sought notice must be submitted (via email) to the Point of Contact below in MS Word or Adobe Portable Document Format (PDF). The subject line must specify NIH-NICHD-2018-05. Facsimile responses will not be accepted. Electronically submitted capability statements are due no later than 4:00 PM (Eastern Prevailing Time) on Wednesday,  April 4, 2018. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME MAY NOT BE CONSIDERED.