SOLICITATION NOTICE
A -- Development and Manufacture of Pharmaceutical Products for Treatment of Substance Abuse Disorders
- Notice Date
- 1/21/2016
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- N01DA-16-8926
- Point of Contact
- Tracy Cain, Phone: 3014436677, Brian H O'Laughlin, Phone: (301) 443-6677
- E-Mail Address
-
tracy.cain@nih.gov, olaughlinb@mail.nih.gov
(tracy.cain@nih.gov, olaughlinb@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address NIDA R&D Contracts Management Branch National Institutes of Health 6001 Executive Boulevard Room 4211, MSC 9559 Bethesda, Maryland 20892-9559* *Use Rockville, MD 20852 for Fed-Ex/USPS/Courier/Hand-Delivery Description The procurement is a total small business set aside. The National Institute on Drug Abuse (NIDA) plans to solicit proposals from qualified small businesses (NAICS Code 541712) to serve as a resource for developing and manufacturing dosage forms to be used in preclinical pharmacological/ toxicological evaluations and clinical trials. In brief, the objectives of this contract are: (1) preformulation studies on bulk drug substances; (2) formulation studies to select a formulation(s); (3) manufacture of active formulations and placebos; (4) analytical method development and validation; (5) preparation of drug product specifications; (6) packaging of the dosage forms; (7) determination of stability of finished dosage forms under accelerated and/or long-term storage; (8) maintenance of an adequate storage facility for drug substances and finished dosage forms including controlled substances; (9) shipment of drug substances and dosage forms to NIDA designated sites; and (10) generation of reports, data, and documentation to be used by NIDA in the preparation of Investigational New Drug (IND), New Drug Application (NDA), and/or Drug Master File (DMF). From small businesses having the capability to: 1. Conduct preformulation studies on drug substances, developing and manufacturing dosage forms, developing and validating analytical methods for dosage forms, carrying out stability studies, packaging and delivery of the pharmaceutical products to NIDA designated sites. 2. Provide adequate facilities for the storage of bulk drug substance, including controlled substances and their finished dosage forms. 3. 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. 4. 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. Offerors must possess these required licenses or demonstrate their ability to obtain them at the time of contract award. Award will not be made to any offeror who has not obtained the specified licenses. 5. Carry out the tasks in compliance with the Food and Drug Administration's (FDA) current Good Manufacturing Practice regulations (cGMP) and/or Good Laboratory Practice (GLP). 6. Prepare data and documentation in a format acceptable to the Food and Drug Administration (FDA) for inclusion in Drug Master Files (DMF), Investigational New Drugs (IND), or New Drug Applications (NDA). NIDA anticipates the award of one cost reimbursement indefinite delivery indefinite quantity contract for a period of five years. NIDA anticipates awarding cost reimbursement and fixed price task orders as needed throughout the period of performance to maintain flexibility in issuing work. RFP No. N01DA-16-8926 will be available electronically on or about February 10, 2016 but at least 15 days from the posting of this notice. You can access the RFP through the FedBizOpps (URL: http://fedbizopps.gov), 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 anticipates an August 2016 award date. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract. 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N01DA-16-8926/listing.html)
- Record
- SN03997581-W 20160123/160121234459-80fa898adbd79782443b60d5d7cd881c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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