SOURCES SOUGHT
A -- Development and Manufacture of Pharmaceutical Products for Addiction Treatment
- Notice Date
- 11/18/2005
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6101 Executive Boulevard Room 260 - MSC 8402, Bethesda, MD, 20892
- ZIP Code
- 20892
- Solicitation Number
- Reference-Number-NIDA68866
- Response Due
- 12/2/2005
- Archive Date
- 12/17/2005
- Description
- The National Institute on Drug Abuse (NIDA) seeks capability statements to determine the availability of small businesses (e.g., 8(a), veteran-owned small businesses, service-disabled veteran owned small businesses, HUB Zone small businesses, small disadvantaged businesses, and women-owned small businesses) with the capability to develop and manufacture pharmaceutical products for addiction treatment. This includes, but is not limited to, conducting 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. Qualified organizations must also be able to provide adequate facilities for the storage of bulk drug substances, including controlled substances, and their finished dosage forms as directed by the NIDA Project Officer. The organizations 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, and 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. The organizations shall be able to carry out the tasks in compliance with the Food and Drug Administration's (FDA's) current Good Manufacturing Practice regulations (cGMP) and/or Good Laboratory Practices (GLP). 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). . Interested organizations must demonstrate and document, in the capability statement submitted, familiarity with issues relating to: (a) preformulation and formulation studies to develop drug products including oral and sterile parenteral formulations; (b) establishment of drug products specifications; (c) analytical methods development and validation for drug substances and drug products; (d) manufacture of drug products under GMP conditions for clinical studies; (e) designing and monitoring stability studies for drug substances and drug products under accelerated and long-term conditions and determining shelf-life; (f) DEA regulations dealing with research, chemical analysis, manufacturing, storage and shipment of controlled drug substances or drug products and; (g) FDA regulations on chemistry, manufacturing and control data for Drug Master Files (DMF), Investigational New Drugs (IND) and New Drug Applications (NDA) submissions. 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 projects, specific to the work to be performed, and work in the field of drug abuse; (2) personnel: name, professional qualifications and specific experience of scientists and/or project director and other key positions; (3) Facilities: Availability and description of facilities and equipment to perform the work required. Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable. Documentation may include, but not limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc. The North American Industrial Classification System (NAICS) code identified for this requirement is 541710 with a size standard of 500 employees. THIS IS NOT A REQUEST FOR PROPOSAL. This notice is for information purposes only and does not commit the Government to any contractual agreement. Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via e-mail to pospisilg@nida.nih.gov. The subject line shall read: Development and Manufacture of Pharmaceutical products for Addiction Treatment. All capability statements must provide the following: 1) company name; 2) address; 3) point of contact; 4) phone/fax/e-mail; 5) NAICS Codes; and 6) business size and status; (e.g., small business, 8(a), veteran-owned small business, service-disabled veteran owned small business, HUB Zone small business, small disadvantaged business, and women owned small business) capability information in response to the requirement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent or the Government?s use of the information. Any proprietary information should be so marked. Written capability statements must be received no later than 3:00p.m. November December 2, 2005.
- Record
- SN00934324-W 20051120/051118211756 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |