Inactive

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

Inactive

This notice is issued on behalf of the National Institute of Alcohol Abuse and Alcoholism (NIAAA) by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Office of Acqu... This notice is issued on behalf of the National Institute of Alcohol Abuse and Alcoholism (NIAAA) by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Office of Acquisitions, Acquisition Resources Branch, NIH, DHHS, UNITED STATES. It is a Small Business Sources Sought Notice (SBSSN). This notice is not a request for proposals and 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, including whether a set-aside is possible or if the requirement will be pursued through full and open competition. Small business organizations must have their size status is certified by the U.S. Small Business Administration (SBA). The NAICS code is 541715 with a size standard of 1000 employees. Description NIAAA currently supports a preclinical medication efficacy testing program to foster discovery of medication targets and lead compounds. The program is supported by three contracts. The first contract (75N94019C00008) is with the Medical University of South Carolina (MUSC) and is a follow-on to two previous contracts (HHSN267200700038C and HHSN275201400004C) 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 in other drinking models as needed. The second contract (75N94019C00009) is with Indiana University, is a follow-on to two previous contracts (HHSN267200700037C and HHSN275201400005C) and supports test medications in alcohol preferring rat strains (tests medications in alcohol preferring P and HAD1 rats selectively bred for alcohol preference). The third contract (HHSN275201800006C) was awarded to the Louisiana State University Health Sciences Center (LSUHSC) for blind medication testing on alcohol drinking, and negative affect and pain measures in the chronic intermittent ethanol (CIE) exposure model in rats made alcohol dependent using the CIE model. The contract was needed to allow for direct comparison of drug effects in mice and rats using the same model used in the first two active contracts that will be expiring 2024. It supports testing capacity of four (4) compounds per year and uses mechanisms having intellectual property conditions favorable to compound providers when acquiring compounds from industry to eliminate a major barrier to testing optimized compounds and to stimulate interest by the pharmaceutical industry in developing high quality, marketable compounds for Alcohol Use Disorder (AUD). The contract was awarded on September 27, 2018, as a base contract with four 12-month option periods, and is expiring on September 26, 2023. This procurement will be for the re-competition of the requirement to meet current and anticipated future needs under NIAAA’s Medication Development Program in the Division of Neuroscience and Behavior (DNB). The follow-on contract for the blind testing on excessive alcohol drinking, hyperalgesia (pain) and negative affect in rats using models of Alcohol Use Disorder (AUD) for severable services for a 12-month base contract plus four 12-month option periods beginning on or about September 27, 2023. The NIAAA is seeking capability statements from interested and qualified Small Business potential sources for this project entitled, “Preclinical Medications Screening in Dependence, Affect and Pain Models of Alcoholism”. Capability statements submitted in response to this announcement should demonstrate the offeror’s qualifications, specifically their capability to: • To assess compounds effects in standardized models of elevated alcohol intake in rats exposed to chronic intermittent ethanol; • To assess compound effects on negative affect and pain measures in alcohol dependent rats; and, • To collect, analyze, and display test data and report them to designated NIAAA personnel. 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. Responses to this notice 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 1000 employees. All qualified organizations are encouraged to submit a capability statement to perform the technical requirements below. TECHNICAL REQUIREMENTS Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services qualified personnel, material, equipment, and facilities not otherwise provided by the Government, as needed to perform this Statement of Work. Specifically, the Contractor shall perform the activities and requirements below. A. Compound Related Activities 1. Compound Testing Based on study design information, such as drug dose, drug preparation instructions, and pretest administration interval provided by the Contracting Officer’s Representative (COR), the Contractor shall test effects of compounds in standardized models of voluntary limited-access drinking of unsweetened ethanol solutions, negative affect and pain sensitivity in male and female rats made dependent through repeated cycles of ethanol vapor exposure and withdrawal. Two-bottle choice or operant self- administration methods may be used. When compounds are provided by the COR, they will be supplied by a Material Transfer Agreement. In all other instances, the Contractor shall purchase the materials for testing. Minimally, testing protocols shall 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 shall evaluate whether the test drug reached and engaged the intended target when possible. When requested, the Contractor shall assess effects of proprietary compounds on: (a) locomotor activity and interactions with alcohol; (b) alcohol induced hypnotic effects; and (c) alcohol pharmacokinetics, as measured by effects on blood alcohol elimination rates. 2. Compound Storage and Administration The Contractor shall store compounds supplied to them by the COR, as well as proprietary materials acquired from industry suppliers, such that they cannot be readily accessed by personnel outside the Principal Investigator’s laboratory. The Contractor shall provide adequate storage conditions, including -70° C freezers, on site. The Contractor shall be responsible for providing all necessary reagents and supplies necessary for administering test medications according to instructions supplied by the COR. 3. Data Analysis and Reporting The Contractor shall perform statistical analysis of the data and prepare a summary of the testing conditions and results including 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 shall be submitted to the Contracting Officer (CO) and COR (along with copies of raw data, if requested) 30 calendar days after the completion of the medication test. Compound reports shall be submitted in accordance with Paragraph E.1. below. 4. Data Recording Throughout the life of the contract, the Contractor shall maintain an electronic file of all experimental protocols. Protocols shall be written in accordance with lab management practices, with all details of the experiment recorded in such a way that another lab could replicate the study exactly. The electronic file shall contain all protocols proposed and/or tested during the duration of the contract and shall include notations regarding their status. A copy of any protocol shall be available to the CO and COR upon request. 5. Data Maintenance and Storage The Contractor shall retain, for the duration of this contract, all laboratory notebooks in electronic format (which shall include electronic 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 electronic laboratory notebook entries and electronic copies of raw data. On or before the expiration date of this contract, when instructed by the CO, the Contractor shall submit these items in electronic format to the COR and CO. The Contractor shall not enter data from studies unrelated to this contract in the electronic notebooks or on disks containing data generated under this contract. B. Animal Welfare This contract involves the use of rats as test subjects. Therefore, the Contractor shall have the appropriate knowledge and facilities capable of housing and caring for mice in a clean, safe, appropriate environment. Further, the Contractor shall follow those specific requirements regarding the use of rats in preclinical studies in accordance with PHS Policy on Humane Care and Use of Laboratory Animals located at https://olaw.nih.gov/policies-laws/phs-policy.htm, as stated in the various related clauses and Articles in this contract. C. Special Contract Requirements 1. General Technical Requirements This contract involves the use of rats as test subjects. Therefore, the Contractor shall have the appropriate knowledge and facilities capable of housing and caring for rats in a clean, safe, appropriate environment. Further the Contractor shall follow those specific requirements regarding the use of rats in preclinical studies as stated in the various related clauses and Articles in this contract. 2. Special Contract Requirements In accordance with the Intellectual Property Option to the Provider clause of the contract, the Contractor will be free to publish data developed under this contract on compounds and materials (Materials) that are specified by the CO, in consultation with the COR, 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 shall agree not to publish data regarding proprietary test Materials unless the COR obtains permission from the submitter. 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 Contractor subject invention conceived or first actually reduced to practice 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, nonprofit, 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 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? Also provide the name and telephone number of a point of contact having knowledge of the submitted information. The Capability Statement should include: A) Total number of employees; B) 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 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 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 will be 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’s 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 Capability Statements shall be submitted electronically via e-mail as a portable data file (PDF) to the NIAAA Contract Specialist/Contracting Officer identified as the point of contact below by April 28, 2023, at 5:00 pm, Eastern Standard Time (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-single sided or five (5) double sided page limit, (excluding resumes) and submissions must be in a single-spaced document, using a 12-point font size. Any proprietary information should be marked. Also include the name and telephone number of a point of contact having knowledge of the submitted information. After the Government’s assessment of responses, a pre-solicitation notice and solicitation will be published on the Sam.Gov 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. The Government will not pay for any costs incurred in the preparation of information for responding to this notice. We appreciate your interest and thank you in advance for responding to this Small Business Sources Sought Notice. A solicitation release date is pending the results of this notice. The Government anticipates a single award.