B.10 Presolicitation Notice_v2.pdf

Document Type: Presolicitation Notice

Solicitation No. 75N95022R00082

Project No. N01DA-TBD

Project Title: Pharmacokinetic and Pharmacodynamic Trials for Medication

Development in SUD

Classification Code: AN11—Research & Development

NAICS Code: 541715 – Research and Development in Physical, Engineering and

Life Sciences (except Biotechnology)

Contracting Office Address

NIDA Contracts Management Branch Red, NIDA Section

National Institute on Drug Abuse (NIDA), Office of Acquisitions

National Institutes of Health c/o 3WFN MSC 6012

301 N STONESTREET AVE

BETHESDA MD 20892

Description

NIDA intends to solicit proposals for clinical pharmacology (PK/PD) trials to support the development of novel pharmacotherapies for the treatment of substance use disorders (SUD) stemming from, but not limited to, tobacco, cannabis, cocaine, methamphetamine, or opiate use or abuse. The investigational agents include new chemical entities, new biological products (monoclonal antibodies, enzymes, vaccines, etc.), and marketed drugs approved by the U.S. FDA for other indications. The

Contractor shall carry out all studies trials under pertinent FDA regulations and ICH current Good Clinical Practices (cGCP), unless determined otherwise. The

Contractor shall also follow all pertinent FDA guidelines/guidance. Because NIDA's medication development projects are directed toward urgent public health needs, all clinical trials to be conducted under this contract must be completed as quickly as possible, within the constraints of cGCP.

MANDATORY REQUIREMENTS

Listed below are mandatory qualification criteria. The qualification criteria establish conditions that must be met at time of receipt of proposals in order for your proposal to be considered any further for award.

• DEA RESEARCH REGISTRATION: This project involves the use of scheduled drugs under the Controlled Substances Act of 1970. Due to the nature of the compounds which will be evaluated under this contract, it is mandatory that the Offeror possess, at the time of proposal submission, a DEA Research Registration for Schedules I to V in order to handle substances under the Controlled Substances Act of 1970.

• FEDERAL WIDE ASSURANCE (FWA): The Offeror must have a Federal Wide

Assurance (FWA) currently accepted and approved by Health and Human Services'

(HHS) Office for Human Research Protections (OHRP) or demonstrate that it has submitted to OHRP for issuance of an Assurance. The successful offerer must comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR

Part 46 and must have a board-certified physician on the project.

NIDA anticipates that one (1) indefinite delivery, indefinite quantity (IDIQ), task order contract will be awarded with a contract ordering period of five (5) years. NIDA may award either cost reimbursement and/or fixed price task orders under this contract. These individual task orders may include options and/or options quantities. If options or option quantities are utilized for an individual task order the will be clearly defined in the Task

Order RFP and be determined and evaluated at the time of task order solicitation and award. NIDA anticipates that at least one task order will be awarded with the contract.

Future funding will be made through issuances of task orders and will be dependent on

NIDA programmatic needs and availability of funds. .

The RFP will be available electronically on or about September 23, 2022. You can access the RFP through the SAM.gov (URL: https://beta.sam.gov/search?index=opp) or through the NIDA website: (URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps). All information required for the submission of a proposal will be contained in or accessible through the RFP package.

Responses to the RFP will be due 30 days from the release date. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the

Government to award a contract.

Based upon market research, the Government is not using the policies contained in Part

12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.

Points of Contact

Primary Point of Contact:

Scott Duernberger

Contract Specialist scott.duernberger@nih.gov

Phone: (301) 594-0670

Secondary Point of Contact:

Josh Lazarus

Contracting Officer https://beta.sam.gov/search?index=opp mailto:Llakim.dubroff@nih.gov

Josh.lazarus@nih.gov

Phone: (301) 827-6923 mailto:Josh.lazarus@nih.gov