SSN_OTSB_Final.pdf

Document Type: Sources Sought Notice

Solicitation No. 75N95024R00003

Project Title: PREPARATION AND DISTRIBUTION OF RESEARCH DRUG PRODUCTS

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

Contracting Office Address:

NIDA Section, Contracts Management Branch Red C/O NIH Mail Center

NIDA 3WFN MSC 6023

16071 Industrial Drive Gaithersburg, MD 20877 (20892 for USPS)

DESCRIPTION

The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), seeks Capability Statements from Other Than Small Business (OTSB) organizations for the preparation and distribution of research drug products.

This is a SMALL BUSINESS SOURCES SOUGHT NOTICE. This is NOT a solicitation, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified business sources; and (2) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The established NAICS code is 541715, Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). The U.S. Small Business Administration establishes a size standard for 541715 as 1,000 employees or less.

BACKGROUND INFORMATION AND OBJECTIVE:

For nearly three decades, the National Institute on Drug Abuse (NIDA) and its predecessor, Center for Studies of Narcotics and Drug Abuse, and NIMH have been providing to the drug abuse research community with authentic supplies of controlled and uncontrolled research chemicals and drug dosage forms. These include known stimulants, psychedelics, dissociatives, opioids, amphetamines, cannabinoids, and many other drugs which are required for non-clinical and clinical research studies.

Preparations of cannabis and formulation of dosage forms of other controlled substances are classified under the Controlled Substance Act and are generally not commercially available. Therefore, NIDA acquires these substances and drug dosage forms by laboratory synthesis and formulation and makes them available for research pertaining to substance use through the NIDA Drug Supply Program (NDSP).

The NDSP maintains an inventory of several DEA-controlled and uncontrolled drugs, and research chemicals including cocaine, heroin, amphetamines, marijuana, GHB, MDMA, delta-9-THC ampules, morphine, methadone and naloxone implant pellets, and LAAM. The NDSP also considers the preparation of dosage forms of other drugs upon request from research investigators. This may require methods development, analytical testing, specification establishment, and stability studies. Continuous efforts are made to acquire new drug formulations if required by the research community which are then added to the inventory for distribution. The stability and purity of these substances and drug dosage forms are periodically monitored to ensure that researchers are provided with pure substances, and drug dosage forms. As there continues to be a great demand for pure research compounds, NIDA will acquire and distribute in demand substances to the research community to support research in substance use and related scientific disciplines.

The NIDA Drug Supply Program plays a major role in promoting drug abuse and drug addiction research by providing to the drug abuse research community with a wide variety of authentic controlled and uncontrolled drug compounds, some of their dosage forms, and marijuana and nicotine research cigarettes for research. Through this contract NIDA plans to continue to acquire drug compounds, drug dosage forms for the NIDA drug supply inventory, to have capability to import drug compounds from international sources, to develop and prepare drug dosage forms, to have capability to manufacture marijuana and nicotine research cigarettes, to frequently analyze them for purity, and to store and distribute them for research upon NIDA authorization according to DEA regulations. Such dosage forms of controlled and uncontrolled drug compounds include morphine, methadone and naltrexone pellets of various strengths, their placebo counterparts, and various cannabinoid preparations (delta-8- and delta- 9- tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene) and other compounds of interest to the drug abuse research community.

MANDATORY REQUIREMENTS:

Since most of these drug compounds and dosage forms are Schedule I and II compounds under the Controlled Substances Act, an extensive inventory and shipment tracking system is maintained on the DISCS 2 system on NIDA’s Local Area Network.

Capable Vendors must demonstrate their capability and experience with the procurement of DEA controlled drug compounds, formulation and analysis of drug dosage forms including marijuana cigarettes and other drugs or compounds, and their storage and distribution. It is therefore essential for capable vendors to demonstrate its experience and ability to obtain DEA registration for possession, research, manufacturer, distribution, import, and export of controlled substances.

Capable vendors must demonstrate the ability to manage a DEA approved and secure storage (vault) facility to maintain an inventory of minimally 300 stock items that require refrigeration.

Capable vendors must demonstrate experience in analytical chemistry, formulation of drug dosage forms, manufacturing marijuana and nicotine research cigarettes, storage, shipping and handling of drug compounds, controlled drugs, nicotine cigarettes, and appropriate facility and equipment to perform tasks required under the proposal.

Capable vendors must demonstrate experience in the production of dosage forms for human use, and must be registered with the FDA as a pharmaceutical manufacturer for both sterile products and drug dosage forms prior to the award

Capable vendors must demonstrate extensive experience in carrying out the project tasks described below and must demonstrate the availability of adequate facilities and equipment

PROJECT REQUIREMENTS:

A Capable Vendors must demonstrate its experience and capacity to complete the following tasks:

(1) Acquire drugs and/or chemical compounds from domestic sources,

(2) Import and export drugs/chemical compounds from foreign sources,

(3) Determine the purity and stability of bulk drugs and other chemical compounds in the NIDA drug supply inventory periodically, or as required by the NIDA Contracting Officer’s Representative (COR),

(4) Develop methods to prepare and analyze drug dosage forms, such as (but not limited

to) pellets of morphine, naltrexone, methadone (of various strengths) with their placebo counterparts; cannabinoid preparations (such as, delta-8, and delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, cannabichromene); and/or any other drug of interest,

(5) Maintain active inventory of all required bulk drugs and other chemical compounds for research purposes,

(6) Store and ship bulk drugs and other chemical compounds for research as required by

NIDA,

(7) Manufacture, analyze, store, and ship marijuana cigarettes as required by NIDA, Develop, analyze, store, and ship nicotine research cigarettes (NRCs) for research as required by NIDA.

This Requirement may include the use of Options to Extend the Period of Performance and Option for Increased Quantity.

INSTRUCTIONS:

Capability statement /information sought.

Companies that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the mandatory and project requirements to NIDA. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, 4) and 5) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Documentation may include, may also include, current or past contracts with the Government and/or commercial organizations, references, (i.e., names, titles, telephone numbers), and any other information serving to document the organization's capability (e.g., awards, commendations, etc.).

THIS IS NOT A REQUEST FOR PROPOSALS: This notice is for informational 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 or otherwise pay for the preparation 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 requirements and qualifications identified in this notice; and 7) type(s) of business, if any (e.g., 8(a), Veteran-owned, service-disabled Veteran-owned, HUBZone, SDB, women-owned, or other small business).

Electronic capability statements must be submitted to Josh Lazarus and Scott Duernberger, whose contact information is included, NO LATER THAN November 16, 2023.

Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

POINTS OF CONTACT:

NAME: Scott Duernberger TITLE: Contract Specialist, NIDA EMAIL: ADDRESS: scott.duernberger@nih.gov

NAME: Josh Lazarus TITLE: Contracting Officer, NIDA EMAIL ADDRESS: josh.lazarus@nih.gov