B.8 AP Attach 8 - FBO SSS Draft Pre-Sol.pdf

Acquisition Plan Attachment #8

FEDERAL BUSINESS OPPORTUNITIES SSS/DRAFT PRE-SOL

Document Type: Source Sought Notice

Solicitation No.: TBD

Project Title: Pharmacokinetic and Pharmacodynamic Trials for Medication Development in

SUD

Classification Code: A – Research & Development

NAICS Code: 541715 – Research and Development in Physical, Engineering and Life Sciences (except Biotechnology)

Contracting Office Address

NIDA Office of Acquisitions NIDA Section, Contracts Management Branch Red c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

Description

This is a SOURCES SOUGHT NOTICE to determine the availability of businesses, including small businesses (e.g., 8(a), veteran-owned small businesses, services-disabled veteran owned small businesses, HUB Zone small businesses, small disadvantaged businesses, and women-owned small businesses) having capability to support and provide resources to conduct Phase 1 clinical trials (e.g., SAD/MAD/FIH/PK/PD) in support of pharmacotherapy development for substance use disorders.

The National Institute on Drug Abuse (NIDA) supports research and development (R&D) of novel pharmacotherapies for the treatment of substance use disorders (SUD). Medication development is a long and complex process. It involves the design of new investigational compounds, preclinical evaluations, pharmaceutical development and clinical evaluations. A critical aspect of the clinical evaluations involves studies to determine the clinical pharmacokinetics (PK) and pharmacodynamics (PD) of the novel pharmacotherapies under development.

Pharmacokinetics and pharmacodynamics, which describe the relationships between dose, plasma concentration and effect, are essential for the understanding of drug action. PK and PD data are necessary for the design of safe and effective pharmacotherapies and PK/PD trials are required in every phase of pharmacotherapy development.

Specifically, NIDA is seeking capability statements from vendors with the capabilities to perform per the details below:

To conduct 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 by the COR. The Contractor shall also follow all pertinent FDA guidelines/guidances. 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. Ideally, the time from initiation of screening to the last patient last visit shall be no more than 6 months for each trial.

The Contractor shall have a Federal Wide Assurance (FWA) currently accepted and approved by the Health and Human Services (HHS) Office for Human Research Protections (OHRP). The Contractor shall carry out all the clinical studies in compliance with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR Part 46. The Contractor shall also have a board-certified physician on staff.

The clinical work to be performed may involve but shall not be limited to: preparing regulatory documents (e.g. documents for Institutional Review Board submission etc.), recruiting eligible participants, preparing clinical doses, collecting biological samples (blood, urine, feces, saliva, hair, sweat, etc.), monitoring subjective and physiological effects and adverse events, maintaining accurate and up-to-date clinical (i.e., source documents) and data (i.e., case report forms) records and transmitting data to an external data management center in a timely manner. The trial target populations shall include drug abusing populations as well as other populations as indicated by the COR.

In addition, the Contractor may be required to provide clinical support services including, but not limited to, preparing study protocols, providing data management services, performing data analyses, and preparing clinical study reports when needed.

The Contractor shall participate in meetings to discuss issues related to trial protocols and trial procedures and/or operations with NIDA staff and staff from data management, bioanalytical laboratory contractor and/or other organizations associated with the trial. The meetings may be held at the Contractor's facilities or via video or teleconference calls.

NIDA is requesting capability statements from businesses, including small businesses (e.g., 8(a), veteran-owned small businesses, services-disabled veteran owned small businesses, HUB Zone small businesses, small disadvantaged businesses, and women-owned small businesses), demonstrating their ability to perform the requirements described above. Capability statements should include any relevant experience as either prime or sub contractor performing work of a similar type and scale either for the government or in the private sector. Vendors are encouraged to provide a list of any relevant contracts they have performed that provided them with experience in performing the above tasks, including what their level of effort was for the performance. NIDA will evaluate the capability of vendors based on relevant experience in work of a similar type and scale, as well as any additional information provided by the vendor to demonstrate their capability.

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 preparing any information sent for the Government's use. Any proprietary information should be so marked. All capability statements must 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 of small business your organization classifies itself as (i.e.: women-owned, HUBZONE, etc.), if applicable.

Written capability statements must be SUBMITTED NO LATER THAN JULY 29, 2022 to the above Contracting Office Address, Attn: KJ Shaikh. Electronic capability statements will be accepted by the primary point of contact, Attn: Scott Duernberger.

Points of Contact

Primary Point of Contact:

Scott Duernberger Contract Specialist Scott.duernberger@nih.gov Phone: (301) 594- 0670

Secondary Point of Contact:

Khurram Shaikh Contracting Officer Kj.shaikh@nih.gov Phone: (301) 435-1777