Preclinical Medications Screening in Dependence Models of Alcohol Use Disorder

Introduction
This notice is issued by the NICHD Office of Acquisitions on behalf of the National Institute on Alcohol Abuse and Alcoholism (NIAAA).

This is a Small Business Sources Sought (SBSS) notice. It is not a Request for Proposal (RFP). 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 purposed acquisition. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible or if it is necessary to proceed through full and open competition. All size organizations are encouraged to respond. Small business organizations must have their size status certified by the Small Business Administration (SBA). The NACIS code is 541715 with a size standard of 1000 employees.

Description

The NIAAA currently supports a preclinical medication efficacy testing program to foster discovery of medication targets and lead compounds to treat Alcohol Use Disorder. The program is supported by three contracts. This notice is for the re-competition of Contract HHSN275201400004C with the Medical University of South Carolina, to test medications on alcohol drinking mice made dependent through chronic exposure to cycles of alcohol vapor exposure and withdrawal (CIE model), as well as on other models as needed. It involves the blind testing of compounds on excessive alcohol drinking in mice using models of alcohol dependence. The anticipated contract will use mechanisms having intellectual property conditions favorable to compound providers from industry to eliminate a major barrier to testing optimized compounds having preclinical, as well as clinical toxicology data, and stimulate interest by the pharmaceutical industry in developing high quality, marketable compounds for Alcohol Use Disorder.

The scope of the contract is for blind testing of reference compounds, compounds of interest, and proprietary compounds supplied to NIAAA from industry suppliers, in mice using standardized models of excessive alcohol drinking driven by alcohol dependence and in other models, as requested. The requirement also involves compound storage, preparation and administration to subjects, data collection and recording, data analysis and reporting subsequent to said testing. This work is for severable services to support testing capacity of up to four (4) compounds per year over the next five (5) years.

Capability Statements submitted as a result of this announcement should demonstrate the offerors' qualifications, and experience, specifically providing evidence as to their capability to perform this requirement with particular attention to the areas below.

Information should be pertinent and specific in the technical area under consideration and will be assessed based on the following:

1. Personnel/Management: Adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. The following should be addressed:

• Ability to provide staffing to include name and professional qualifications of individual who will hold the project director role, 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.

• Knowledge of and experience in the field of alcoholism research or other relevant areas necessary to carry out the project, i.e., compound 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.

• 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.

2. Facilities: Availability and description of special facilities and equipment required and available to perform in the technical areas under consideration, including computer equipment and software, and a statement regarding industrial security clearance. Appropriate knowledge of and facilities capable of housing and caring for mice in a clean, safe, appropriate environment is necessary for the specific requirements regarding the use of mice in preclinical studies. Evidence of access, and possession of, or a reasonable plan to obtain specialized supplies and facilities required to perform the animal tests.

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.

3. Past Performance: Past performance is considered essential. In addition to demonstrating that the above qualifications have been met, interested parties must provide an outline of previous projects, specific work previously performed or being performed and any in-house research and development effort relevant to conducting rodent studies of alcohol effects and anxiety. Documentation should include at least three (3) projects of similar size and complexity.

4. Other: Any other pertinent information, as pertains to this area of procurement, that would enhance the Government's assessment of the information submitted.
Interested organizations that believe they possess the capabilities necessary to undertake this project should submit an electronic version of their response to this notice addressing the areas above. Capability statements must identify the organization's DUNS number and business status as it correlates with SAM registration (i.e., educational institution, non-profit, large business, small business, 8(a), or other corporate or non-corporate entity and respond to the following questions:

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

b. Does your firm qualify as a small disadvantaged small business?

c. If disadvantaged, is your firm certified under section 8(a) of the Small Business Act?

d. Are you a certified HUBZone firm?

e. Are you a woman-owned or operated business?

f. Are you a certified Service-Disabled Veteran Owned or Veteran Owned?

Please limit responses to five (5) pages or less in MS Word or Adobe Portable Document Format (PDF). Any proprietary information should be so marked. Capability Statements sent in response to this notice must be submitted electronically via email to the Point of Contact identified below. The subject line must specify NIH-NICHD-2019-08 and must be received no later than 4 PM Eastern Time on Thursday, February 14, 2019.

Late responses will not be accepted. This notice is strictly market research and the Government will not entertain any questions. No collect calls will be accepted. Respondents will not be notified of the results of the evaluation.

We appreciate your interest and thank you in advance for responding to this Small Business Sources Sought Notice.

Point of Contact

Patricia N. Hanacek, Contract Specialist, NICHD Office of Acquisitions, NIAAA Contracts Management Branch, phone 301-594-6226, email: hanacekp@mail.nih.gov.

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