SOURCES SOUGHT
A -- Regulatory Affairs Support for IND Applications
- Notice Date
- 10/22/2004
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6101 Executive Boulevard, Bethesda, MD, 20892
- ZIP Code
- 20892
- Solicitation Number
- N01DA-5-8852
- Response Due
- 11/12/2004
- Archive Date
- 11/27/2004
- Small Business Set-Aside
- Total Small Business
- Description
- Sources Sought Solicitation The National Institute on Drug Abuse (NIDA) is seeking information in the form of capability statements from qualified Small Businesses (NAICS 541990, small business standard size is $6 million). The requirements of this project are to provide regulatory support to the Division of Pharmacotherapies and Medical Consequences of Drug Abuse Regulatory Affairs Branch to support the development of new pharmacotherapeutic approaches to the treatment of drug addiction. Interested organizations must show experience in medical writing, including but not limited to writing Investigational New Drug (IND) Applications, IND annual reports, IND protocol amendments, information amendments, and investigator brochures. Offerors must demonstrate knowledge of electronic submissions. In addition, capabilities must also include ability to perform other support functions including but not limited to literature searches, Powerpoint presentations, preparation of regulatory standard operating procedures, and preparation of meeting minutes. Information sent should be relevant and specific in the technical area under consideration, on each of the following qualifications: 1. Experience: examples of previous projects whether government or commercial, that the offeror has performed, including references such as names, titles, telephone numbers, etc.; 2. Personnel: Names, professional qualifications and specific experience of technical personnel who may be assigned as project officer; 3. Facilities: Availability and description of facilities required to perform the work; 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 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. Please submit written capability statements by November 12, 2004 to the NIDA Contracting Officer.
- Record
- SN00697910-W 20041024/041022211805 (fbodaily.com)
- Source
-
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