N01DA-23-8939 Sources Sought Notice.pdf

Sources Sought - N01DA-23-8939

Title: Toxicological Evaluations of Potential Medications to Treat Drug Abuse

The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), is seeking capability statements from qualified Small Business organizations (NAICS code 541715, small business size standard is 1000 employees). For details of Small Business Size Standards see http://www.SBA.gov).

This is a SMALL BUSINESS SOURCES SOUGHT NOTICE to determine the availability of ALL small businesses (e.g., 8(a), Veteran-owned small businesses, service-disabled Veteran-owned small businesses, HUBZone small businesses, small disadvantaged businesses, women-owned small businesses, and other small businesses) to fulfill the needs of NIH and NIDA for this future requirement.

A. General Requirements:

The NIDA Medications Discovery and Toxicology Branch has the mission to facilitate, through preclinical medications discovery and safety assessment efforts, the translation of basic research findings into pharmacotherapies for the treatment of substance use disorders. When preclinical development candidates are identified, this contract provides a resource for the development of safety data that support filing Investigational New Drug (IND) applications and New Drug Application(s) (NDA) to the U.S.

Food and Drug Administration (FDA). In this context, the primary objective of this research and development contract is to support preclinical safety pharmacology studies and preclinical acute and repeat dose toxicology studies in rodents, rabbits, dogs and/or nonhuman primates (monkeys) on test articles that are potential pharmacotherapies (medications) to treat substance use disorders. It is anticipated that NIDA will use the results of these preclinical studies in IND and NDA filings with the FDA in accordance with FDA Guidances, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines and Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) regulations.

B. Specific Requirements:

1. The Contractor shall conduct acute drug interaction safety studies in rodents.

2. The Contractor shall conduct cardiovascular safety interaction studies in conscious, unrestrained telemetered dogs or monkeys.

3. The Contractor shall conduct drug interaction safety studies in rodents to measure effects on respiration (blood gasses and blood pH).

4. The Contractor shall conduct drug interaction safety studies in rodents to measure effects on ventilation.

5. The Contractor shall utilize ex vivo tissue preparations to determine the effects of potential medications on cardiac conductance (hERG channel assays and action potential duration tests).

6. The Contractor shall conduct mutagenicity studies.

7. The Contractor shall conduct acute and repeat dose toxicity studies in the rat and/or mouse by the intravenous and oral (gavage) routes of administration.

8. The Contractor shall conduct acute and repeat dosing toxicity studies in dogs and/or monkeys.

9. Offerors must be able to verify the identity of the bulk substance through High Performance

Liquid Chromatography (HPLC), Gas Chromatography (GC), and Nuclear Magnetic Resonance Spectroscopy (NMR).

10. Offerors must possess experience conducting rodent, dog and non-human primate GLP studies designed to evaluate the safety of test compounds in the presence of common drugs of abuse, including ethanol, cocaine, methamphetamine, and opiates.

11. After the Request for Proposals (RFP) is issued, and prior to award, each offeror must:

• Be accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International.

• Demonstrate its understanding and compliance with the NIH Guide for the Care and Use of Laboratory Animals.

• Show that it has an Animal Welfare Assurance on file with the Office of Extramural Research, Office of Laboratory Affairs (OLAW; see http://grants.nih.gov/grants/olaw/olaw.htm).

C. Mandatory Evaluation Criteria:

To handle test substances under the Controlled Substances Act of 1970, and prior to award, each offeror must possess a U.S. Drug Enforcement Administration (DEA) Registration for Schedules II to V. In addition, each offeror must either possess, or demonstrate the ability to obtain prior to award, DEA Registration for Schedule I controlled substances.

D. Information Required for Sources Sought:

Information sent should be relevant and specific in the technical area under consideration, on each of the following qualifications:

(1) Experience: An outline of previous projects, specific GLP work performed and any in-house research and development effort;

(2) Personnel: Professional qualifications and specific experience of scientists and technical personnel who may be assigned as principal investigator and/or project director;

(3) Facilities: Availability and description of special facilities required to perform toxicological and cardiovascular studies that support the development of potential pharmacotherapies for the reduction of substance abuse;

(4) Any other specific and relevant information about this procurement that would improve our consideration and evaluation of the information presented is desirable.

Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform the above tasks. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner.

Documentation may include, but is not limited to, contracts both Government and commercial organizations performed, references, i.e., names, titles, telephone numbers, and any other information serving to document the organizations capability, e.g. awards, commendations, etc.

THIS IS NOT A REQUEST FOR PROPOSALS: This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for the preparation https://olaw.nih.gov/resources/publications/guide-care-2011.htm https://olaw.nih.gov/resources/publications/guide-care-2011.htm http://grants.nih.gov/grants/olaw/olaw.htm of any information sent for the Government's use. Any proprietary information should be so marked. All capability statements should provide the following: 1) company name and address; 2) point of contact,

3) phone/fax/email; 4) NAICS Code(s), 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) type(s) of business, if any (e.g.:

small, Veteran-owned, service-disabled Veteran-Owned, women-owned, 8(a), Small Disadvantaged Business (SDB), and Historically Underutilized Business Zone (HUBZone).

Written capability statements must be submitted to Polina Klimenkova at polina.klimenkova@nih.gov NO LATER THAN 11 am EST November 18, 2022.

mailto:polina.klimenkova@nih.gov