SOURCES SOUGHT
A -- GMP Synthesis of Bulk Drug Substances
- Notice Date
- 11/7/2002
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Blvd. Room #3105, Bethesda, MD, 20892-9543
- ZIP Code
- 20892-9543
- Solicitation Number
- Reference-Number-NIDA-38840
- Archive Date
- 12/7/2002
- Point of Contact
- Kenneth Goodling, Contracting Officer, Phone (301)443-6677, Fax (301)443-7595,
- E-Mail Address
-
kg25d@nih.gov
- Description
- The National Institute on Drug Abuse (NIDA) seeks capability statements from qualified Small Businesses (NAICS 325411, small business size standard is 750 employees). Offerors must provide the Good Manufacturing Practices (GMP) synthesis of bulk drug substances to the medications development program of NIDA for clinical trials. Offerors must demonstrate the ability to manufacture bulk drug substances under Good Manufacturing Practices following relevant FDA guidance and regulations (e.g. CFR Title 21). Offerors must indicate experience in producing GMP drug substances in batch sizes of at least one kilogram or larger, store GMP materials on site, and maintain a facility in good standing with the FDA. Offerors must have on-site access to state-of-the-art equipment for analytical testing (HPLC, GC/LC-MS, IR and NMR). Offerors must show experience in preparing reports acceptable in format and substance for adaptation into a Chemistry, Manufacturing, and Control (CMC) section for each drug substance for submission to the FDA in support of IND and NDA applications. To handle substances or starting materials under the Controlled Substances Act of 1970, offerors must possess a DEA Registration for Schedules II to V and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances. 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 GMP work performed and any in-house research and development effort; (2) Personnel: Name, professional qualifications and specific experience of scientist, engineers and technical personnel who may be assigned as principal investigator and/or project director; (3) Facilities: Availability and description of special facilities required to perform synthesis, analysis, and storage of drug substances under GMP conditions, including security. 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. Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform the above tasks. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but not be 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. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. This is not a request for proposals. 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. Interested organizations presenting a capability statement in response to this sources sought announcement must identify their size status. Offerors must send written capability statements by November 22, 2002 to the NIDA Contracting Officer at address below: If using U.S. Postal Service: Kenneth E. Goodling, Contracting Officer National Institute on Drug Abuse, NIH Contracts Management Branch, OPRM 6001 Executive Boulevard Room 3105, MSC 9543 Bethesda, Maryland 20892-9543 OR, if hand-delivered or delivery service: Kenneth E. Goodling, Contracting Officer National Institute on Drug Abuse, NIH Contracts Management Branch, OPRM 6001 Executive Boulevard, Room 3105 Rockville, Maryland 20852
- Record
- SN00201434-W 20021109/021107213309 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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