WASHINGTON, DC--(Marketwired - October 09, 2015) - 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.

The NIH wants to determine the availability of all small businesses (e.g., 8(a), veteran-owned small businesses, service-disabled veteran-owned small businesses, HUBZone 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.

Interested small businesses must:

  • Have the ability to conduct pre-formulation 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
  • Provide adequate facilities for the storage of bulk drug substance, including controlled substances and their finished dosage forms
  • 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
  • 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)
  • Prepare data and documentation in a format acceptable to the FDA for inclusion in Drug Master Files (DMF), Investigational New Drugs (IND), or New Drug Applications (NDA)

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:

  • Experience: An outline of previous similar projects, specifically the techniques employed in the areas described above
  • Personnel: Name, professional qualifications, and specific experience in the work requested.

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 and/or commendations.

All submitted capability statements must include:

  • Company name and address
  • Point of contact
  • Phone/fax/email
  • NAICS Code(s)
  • Business size and status
  • Capability information in response to the identified requirements and qualifications
  • 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))

All interested businesses almost must have a valid System for Award Management (SAM) Registration. If you are not registered on SAM and are interested in bidding on government contracts, please call US Federal Contractor Registration, the world's largest third-party registration firm, at (877) 252-2700 ext. 1. One of its specialists can help register you with SAM.

Capability statements and responses are due to Contract Specialist Cara Batenhorst by October 21, 2015 at 2 p.m. EST. Information can be sent via email (cara.batenhorst@nih.gov) or mailed to her at 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland 20892.

Contact Information:

US Federal Contractor Registration