Inactive
Notice ID:75N95024R00003
The National Institute on Drug Abuse (NIDA) intends to solicit proposals under full and open competition from qualified and capable offerors having the ability to perform the following services: Acqui...
The National Institute on Drug Abuse (NIDA) intends to solicit proposals under full and open competition from qualified and capable offerors having the ability to perform the following services: Acquire drugs and/or chemical compounds from domestic sources, Import and export drugs/chemical compounds from foreign sources, 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), 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, Maintain active inventory of all required bulk drugs and other chemical compounds for research purposes, Store and ship bulk drugs and other chemical compounds for research as required by NIDA, 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, Develop, prepare and amend current NIDA Drug Master File (DMF) on marijuana, and marijuana cigarettes and Tobacco Product Master File (TPMF) on nicotine research cigarettes (NRCs) annually or as needed by the NIDA COR. 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. Independently and not as an agent of the Government, the Contractor shall furnish all necessary labor, facilities, materials (except experimental bulk drugs and drug products), supplies, equipment, and services (except as otherwise specified herein) and perform the work as generally described above. Bulk drug substances will generally be provided by the Government at the time of approval of the delivery schedule by the Contracting Officer’s Representative. This is a follow-on procurement to Contract Number 75N95019D00042 titled “Preparation and Distribution of Research Drug Products". 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 at the task order level 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. B. Mandatory Criteria: 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 Registration: In order to handle substances under the Controlled Substances Act of 1970, the successful offeror must possess a current DEA registration for schedule II to V substances prior to submission of the proposal and demonstrate the capability to obtain DEA registration for Schedule I controlled substances prior to award of the contract. In addition the successful offeror must also possess DEA registration for research, manufacturer, distribution, import, and export of controlled substances. The offeror must demonstrate prior to the award the availability of a DEA approved and secure storage (vault) facility to maintain an inventory of approximately 300 stock items that require refrigeration. cGMP Compliance: All manufacturing facilities (prime and/or subcontractor) must comply with the FDA’s current Good Manufacturing Practices (cGMP). A copy of the most recent FDA cGMP inspection report (and/or a table referencing the inspection history by the FDA and if findings were noted) for all proposed manufacturing facilities must be included with Offeror’s proposal. The offeror and/or offeror's subcontractor, if responsible for the production of dosage forms for human use, must be registered with the FDA as a pharmaceutical manufacturer for both sterile products and drug dosage forms prior to the award. C. Additional Information: RFP No. 75N95024R00003 will be available electronically on or about September 20, 2024. You can access the RFP through the ww.SAM.gov or through the NIDA website: (URL: https://nida.nih.gov/funding/nida-office-acquisitions-contracting#RFP). 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 approximately 45 days from the release date. NIDA will consider proposals submitted by any responsible offeror. 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 or organizations 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. This advertisement does not commit the Government to award a contract.
