The National Institute on Drug Abuse (NIDA) intends to solicit proposals from qualified organizations (NAICS Code 541715) having in-house capability to carry out development of formulations, manufacture, quality control tests, stability studies and distribution of pharmaceutical drug products to be used in the medications development program for treating substance use disorders).
Development of medications for the treatment of substance use disorders is a major mission of NIDA. Some of the potential treatment drugs currently being investigated are new chemical entities (e.g., Mitragynine, etc.) and previously approved drug substances. The Government acquires these drugs from private industries, Government contractors/grantees, or independent investigators. This contract is to provide the Government a resource for the development and manufacture of pharmaceutical dosage forms for use in preclinical and clinical studies.
The Contractor shall be responsible for carrying out pre-formulation studies on drug substances, developing and manufacturing dosage forms, developing and validating analytical methods for dosage forms, carrying out stability studies, and packaging and delivering of the pharmaceutical products to the sites designated by the NIDA. In addition, the Contractor shall provide adequate facilities for the storage of bulk drug substances, including controlled substances and their finished dosage forms. The Contractor shall have appropriate DEA Registrations for Schedules II-V Controlled Substances in order to use the controlled substances in research and manufacture of dosage forms under the Controlled Substance Act of 1970. The Contractor must either possess or demonstrate the ability to obtain DEA Registrations for Schedule I Controlled Substances should the research and manufacture of the Schedule I drugs be required under this indefinite delivery, indefinite quantity (task order) type contract.
The Contractor shall carry out the tasks in compliance with the Food and Drug Administration's (FDA) current Good Manufacturing Practice regulations (cGMP) and Good Laboratory Practices (GLP). The data and documents prepared should be in a format acceptable to the FDA for inclusion in Drug Master Files (DMF), Investigational New Drugs (IND), or New Drug Applications (NDA) submitted by NIDA or investigators supported by NIDA. The work required under this contract includes:
- Pre-formulation Study: The Contractor shall perform physicochemical characterization of drug substances and physicochemical stability of drug-excipients mixtures either in solid or solution state under accelerated and/or long-term conditions.
- Formulation Study: The Contractor shall perform formulation studies for drug substances designated by the COR. Formulation studies should put emphasis on dosage form development for Phase I and II clinical trials, evaluation of physicochemical stability of candidate formulations including solid, liquid, or semi-solid under accelerated and/or long-term storage conditions, manufacturing procedures, and product specifications.
- Development and Validation of Stability-Indicating Analytical Methods for Drug Products: The Contractor shall develop and validate stability-indicating analytical methods for release of the products and stability testing in accordance with FDA regulations/ International Conference on Harmonization (ICH) guidelines. Parameters for validation include accuracy, detection limit, quantitation limit, linearity, precision, range, recovery, robustness, sample solution stability, specificity/selectivity, and system suitability specifications/tests.
- Manufacture of Drug Products for Phase I and II Clinical Trials (tablets, sublingual tablets, hard gelatin capsules, soft gelatin capsules, etc. except parenteral dosage forms): The Contractor shall manufacture under cGMP a batch of active drug product and matching placebo for each of two strengths based on the formulation and manufacturing procedures developed under formulation studies or based on the data provided by the COR in case the product had been manufactured elsewhere and the information on formulation, manufacturing procedures, test methods, and product specifications are available. The typical batch size falls within 30,000 tablets/capsules. The batches may be manufactured manually or using automatic or semi-automatic production equipment. Production for oral dosage forms shall be completed within 8 weeks of assignment, and quality control for batch release, labeling, and packaging shall be completed within the following 4 weeks.
- Stability Study I: The Contractor shall initiate stability studies for the drug products manufactured under the Task D. The Contractor shall set up a 5-year stability study protocol to monitor the stability of the products during the preclinical/clinical studies. The stability study will be conducted under long-term (usually 60 months), accelerated (6 months), intermediate (12 months), and photostability conditions in compliance with FDA regulations and ICH guidance on stability studies on drug products.
- Stability Study II: This task is for continuing stability studies that were previously initiated. The Contractor shall follow the established stability protocols to conduct the stability testings.
- Manufacture of Drug Products for Phase III Clinical Trials (mainly Tablets or Capsules): The Contractor shall manufacture under cGMP a batch of active drug product and matching placebo based on the formulation and manufacturing procedures developed under formulation studies or based on the data provided by the COR in case the product had been manufactured elsewhere and the information on formulation, manufacturing procedures, test methods, and product specifications are available. It may be necessary to modify the formulation or manufacturing procedures to scale up to the larger batch sizes. The typical batch size is 400,000 tablets or capsules. Production shall be completed within 12 weeks of assignment, and quality control, labeling, and packaging shall be completed within the following 4 weeks.
- Manufacture of Parenteral Dosage Form: The Contractor shall manufacture a batch of single or multiple dose vials at an appropriate manufacturing facility under cGMP based on the formulation and manufacturing procedures developed under formulation studies or based on the data provided by the COR in case the product had been manufactured elsewhere and the information on formulation, manufacturing procedures, test methods, and product specifications are available. The parenteral dosage forms to be manufactured include cocaine, methamphetamine, and other drugs as designated by the COR. The typical batch size is 5,000 multiple dose vials of 5 mL/vial or its equivalent number of vials in case of using single dose vials. Production shall be completed within 6 months of assignment, and quality control for batch release, labeling, and packaging shall be completed within the following 2 months.
- Purchase of Drug Substances and/or Drug Products for Manufacture of Drug Products for Phase I-III Clinical Trials: The Contractor shall purchase drug substances and/or drug products from vendors on the open market for the manufacture of clinical supplies for Phase I-III clinical trials.
- End of Contract Transition Activities and Archival Maintenance of Records: At the end of the Contract, all drug substances and drug products shall be delivered to a NIDA Contractor for storage and/or stability testing as designated by the COR. At the end of the Contract, if the Government opts to issue a Task Order for Task J, all data including laboratory notebooks, hard copies of raw data, and databases of assay results on disk shall be placed in secure storage for a period of 5 years after the Contract ends for a cGMP audit, which may be required by the FDA in connection with a DMF, IND or NDA submission. During this period, the contractor shall be responsible for the integrity and organization of the material and its confidentiality. At any time during this task, all reference material, data files, etc. will be disposed of per instructions of the COR.
- Phase-In Transition Activities: At the beginning of the Contract, if a Contractor other than the incumbent receives the follow-on award, the Contractor shall receive from the incumbent all inventory of drug substances and drug products under storage and stability studies and all data including laboratory notebooks, hard copies of raw data, and databases of assay results on disk. Additional activity shall include adoption of the received stability-indicating methods for all stability samples. Most of the drug substances, drug products, and data require storage and handling specified under cGMP regulations. Some of the drug substances and drug products require storage and handling specified under DEA regulations.
Due to the nature of the drug substances and drug products which will be evaluated under this contract, it is mandatory that offerors possess the following qualifications:
- DEA REGISTRATIONS: In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that offerors possess a DEA Research Registration for Schedules II to V for both narcotics and non-narcotics, and demonstrate capability to obtain DEA Registration for Schedule I substances. In addition, the successful offeror must also possess DEA registrations for distribution, importation and exportation of controlled substances.
- DEA APPROVED VAULT: The offeror must have a vault for Schedules I and II and Schedules III-V raw materials and finished drug products that meets standards described in 21 CFR Part 1301.72. The vault should have an adequate storage space for refrigerators and/or freezers located inside the vault.
- cGMP COMPLIANCE OF FACILITY: The facility must meet cGMP compliance.
Place of Performance:
The place of performance will be the Contractor’s work site.
Set Aside Status:
NIDA anticipates that one (1) indefinite delivery, indefinite quantity (IDIQ), task order contract will be awarded for a period of performance 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 option 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 or more task orders 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. Various task orders will be issued to support distinct tasks and studies which will separately support the CTN and the NIH launched HEAL (Helping to End Addiction Long-term) Initiative.
RFP No. 75N95020R00036 will be available electronically on or about March 1, 2021. You can access the RFP through the FedBizOpps (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 45 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.