Development and Manufacture of Pharmaceutical Products for Addiction Treatment

Small Business Sources Sought Announcement The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), is seeking capability statements from Small Business organizations to provide the Government a resource for the development and manufacture of stable dosage forms for use in preclinical and clinical studies. This is a SMALL BUSINESS SOURCES SOUGHT NOTICE to determine the availability of ALL small businesses (e.g., 8(a), Veteran-owned small businesses, service-disabled Veteran-owned small businesses, HUB Zone small businesses, small disadvantaged businesses, women-owned small businesses, and other small businesses) having the in-house capability and multi-disciplinary knowledge, expertise, and experience required to continue the PATH Study, as described below. Information sent should be relevant and specific in the technical area under consideration, on each of the following qualifications: 1) Have the ability to 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) 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. 4) 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. 5) Contractor shall 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) The data and documentation prepared should be 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). The NAICS code is 541712. Associated with each of the six main components are activities that require demonstrated experience and expertise to manage this project, including high level organizational and management support. Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform the above tasks. In addition to demonstrating the above capabilities, information sent should be relevant and specific in the technical area under consideration on each of the following qualifications: 1) Experience: An outline of previous similar projects, specifically the techniques employed in the areas described above, and 2) Personnel: name, professional qualifications, and specific experience in the work requested. NIDA will consider appropriateness of professional and technical personnel classifications. NIDA will consider any other specific and relevant information about this particular announcement that would improve its evaluation of respondents. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but is not limited to, contracts in which the organization performed (Government and commercial); references (i.e., names, titles, telephone numbers, and any other information serving to document the organization's capability); and awards or commendations. THIS IS NOT A REQUEST FOR PROPOSALS: This notice is for information 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 nor 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 requirement and qualifications identified in this notice; and 7) type(s) of business, if any (e.g., small, Veteran-owned, service-disabled Veteran-Owned, women-owned, 8(a), Small Disadvantaged Business (SDB), and Historically Underutilized Business Zone (HUBZone)). Written capability statements must be submitted to Cara Batenhorst, whose contact information is included, NO LATER THAN October 21, 2015. Paper or electronic capability statements will be accepted.