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

This notice follows Sources Sought Notice 75N4023R00010 released on April 24, 2023. It is issued in advance of the Request for Proposal (RFP) No. 75N94023R00010 entitled, “Preclinical Medications Screening in Dependence, Affect and Pain Models of Alcoholism” and is being 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.

THIS IS A PRESOLICIATION NOTICE ISSUED IN ADVANCE OF THE REQUEST FOR PROPOSAL. THIS IS A RESEARCH AND DEVELOPMENT (R&D) CONTRACT REQUIREMENT and is NOT an NIH grant opportunity.

Description:

NIAAA supports a preclinical medication efficacy testing program to foster validation of medication targets and discovery of lead compounds relevant to AUD therapeutics. The current contract, HHSN275201800006C, with the Louisiana State University Health Science Center (LSUHSC) was awarded in 2018 as a one-year base contract with four (4) 12-month option periods. It supports medication testing on measures of alcohol drinking, negative affect, and pain using in the chronic intermittent ethanol (CIE) vapor exposure model in rats and expires September 26, 2023.

To address the present and anticipated future needs of NIAAA’s Medication Development Program, the LSUSC contract is being recompeted to continue supporting work within the same scope, i.e., medication testing in rats using the CIE model and alcohol drinking, pain, and negative affect measures. It will implement the testing capacity of 2-3 compounds per year over the next five years. The contract 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 data generated will be used in 
the identification of compounds for further development.

The requirements within this statement of work (in attached SOW) are considered severable for the base and each 12-month option period.

The goals of the proposed contract are:

•  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.

•  To collect, analyze, and display test data and report them to designated NIAAA  personnel.

Animal Care and Use: The Offeror shall establish and provide resources for an animal care and use program that is managed in compliance with applicable federal, state, and local laws and regulations, such as:

•  Animal Welfare Regulations (9 CFR, 1985/1989) 

https://www.nal.usda.gov/awic/final-rules-animal-welfare-9-cfr-parts-1-2-and-3

•  Guide for the Care and Use of Laboratory Animals 8th ed., National Research Council, 2011

http://www.ncbi.nlm.nih.gov/books/NBK54050/

Public Health Service Policy on Humane Care and Use of Laboratory Animals, revised 2015.

https://grants.nih.gov/grants/olaw/references/phspol.htm.

To demonstrate compliance with the above policies and guidance, Offerors shall submit with their Technical Proposal: 1) a copy of your organization’s most recent letter from NIH’s Office of Laboratory Animal Welfare (OLAW) documenting approval of a valid Animal Welfare Assurance, and 2) a copy of your organization’s most recent USDA Animal Welfare Act registration certificate.

The solicitation is anticipated to result in a single cost-reimbursement contract award. The duration of the contract will be a one-year base period, with four subsequent one-year option periods, for a total period of performance of five years. Award is anticipated on or about September 27, 2023.

The NAICS code for this acquisition is 541715, Research & Development (R&D) in the Physical, Engineering, and Life Sciences, which has a size standard of 1,000 employees. THIS ACQUISTION IS UNRESTRICTED (NOT A SET-ASIDE FOR SMALL BUSINESSES).

Place of Performance:
The place of performance will be the Contractor’s work site.

Set Aside Status:
None.

The solicitation, RFP 75N94023R00010 with the specifics of the project, as well as information pertinent to the development of an offeror's proposal, will be available electronically through the SAM.Gov website at: https: //sam.gov/. It is anticipated that electronic release of the solicitation will be on or about June 27, 2023, and will be due at 5:00 PM EST on or about July 27, 2023.

No paper solicitation will be available. All information required for submission of a proposal will be contained in the electronic Request for Proposal (RFP) package. No collect calls will be accepted, nor will facsimile transmissions be accepted. It is the offeror’s responsibility to monitor the above-mentioned sites for release of the solicitation and any amendments. All qualified organizations are encouraged to respond with a contract proposal which shall be considered by the agency.

POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITIATION AND FOR ROUTINELY CHECKING THE SITE FOR ANY AMENDMENTS THAT MAY BE ISSUED. FAILURE TO DO SO WILL BE AT THE FIRM’S OWN RISK. ALL INQUIRIES SHALL BE SUBMITTED ELECTRONICALLY TO THE CONTRACTING OFFICER LISTED AS THE POINT OF CONTACT HEREIN.

This advertisement does not commit the United States Federal Government to award any contract pursuant to this announcement nor pay for any costs associated with preparation and submission of a proposal.