Notice Number: NOT-DA-19-062
Key Dates
Release Date: April 02, 2019
None
Issued by
National Institute on Drug Abuse (NIDA)
Purpose
The National Institute on Drug Abuse (NIDA) intends to solicit proposals from offerors having the capability to analyze and characterize various drugs of abuse including cannabinoids and other research chemicals. Organizations will be able to produce drug dosage forms, such as delta-9-tetrahydrocannabinol (delta-9-THC), methadone, morphine, and naltrexone pellets. Furthermore, they will acquire, develop, and produce marijuana and nicotine research cigarettes of varying strengths and specifications and maintain an inventory and supply of various DEA scheduled and unscheduled chemicals and drugs.
A. General Requirements:
The contractor must possess extensive experience in carrying out the project tasks and must demonstrate the availability of adequate facilities and equipment. The contractor must indicate possession of a current Schedule I and II manufacturer license, Schedule I and II researcher license, Schedule I and II distributor license, and Schedule I and II exporter and importer license. Contractors must possess these required licenses or demonstrate their ability to obtain them at the time of contract award (estimated at September 2019). Award will not be made to any contractor who has not obtained the specified licenses.
B. Specific Requirements:
1. Acquire hard-to-find controlled and uncontrolled drug compounds and/or drug dosage forms and analyze purity, authenticity, and stability of these compounds while storing them in a secure and DEA-approved facility and having the capability to ship these compounds to research investigators.
2. Manufacture standardized marijuana cigarettes within a range of varying concentrations of delta-9-THC and analyze strength and stability of them at various intervals while having the capability to maintain a secure shipping facility and to ship marijuana cigarettes to research investigators.
3. Manufacture nicotine research cigarettes and analyze them for required chemical constituents at various intervals while having the capability to store and ship securely these nicotine research cigarettes to research investigators.
C. Mandatory Evaluation Criteria:
1. 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.
2. 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.
3. The offeror must possess 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.
4. 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 for drug dosage forms prior to the award
D. Additional Information:
NIDA anticipates the award of a single, five-year, indefinite delivery, indefinite quantity (IDIQ), task order contract. NIDA may award either cost reimbursement and/or fixed price task orders under this contract. The use of option periods within task orders may be included. NIDA anticipates that at least one task order will be awarded with the contract. RFP No. 75N9519R0040 will be available electronically on or about April 16, 2019. You will be able to access the RFP through the FedBizOpps (URL: http://www.fedbizopps.gov or through the NIDA website at the following address: (URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps ). All information required for the submission of an offer will be contained in or accessible through the RFP package.
Responses to the RFP will be due on or about 30 days after we release the RFP. 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 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.
Inquiries
Please direct all inquiries to:
Lisa Bielen
Contracting Officer
Phone: 301.443.6677
Email: lisa.bielen@nih.gov
and Human Services (HHS)
