SOLICITATION NOTICE
R -- Consultation on Manufacture of Biological Agent and Associated Regulatory and Drug Development Path Options - Statement of Work
- Notice Date
- 4/17/2012
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- RFQ20120417
- Point of Contact
- Susan Nsangou, Phone: 3014432104
- E-Mail Address
-
nsangous@mail.nih.gov
(nsangous@mail.nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Statement of Work This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This is a total small business set-aside. This solicitation number is RFQ20120417 and the solicitation is issued as a request for quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-57. The National Institute on Drug Abuse (NIDA) on behalf of the National Institute of Neurological Disorders and Stroke (NINDS) consultation on manufacture of biological agent and associated regulatory and drug development path options. See attached Statement of Work. Period of performance is 45 days from award date. Specific evaluation criteria are: 1. prior experience in providing review and analysis of non-oral toxicology studies for biologics; 2. prior experience in providing review and analysis of manufacturing requirements and stipulations for biologics for use in first human clinical studies; and 3. prior successful experience, as measured by FDA approvals, in providing review and analysis of protocols and Food and Drug Agency (FDA) and European Medicines Agency (EMEA) regulatory review considerations, and guidelines for INDS for Phase 1 and 2a proof of concept clinical trials of biologic therapeutics for Orphan and non-Orphan disease indications. Offers will also be evaluated on best value in relation to price. Quotations are to be delivered electronically to nsangous@mail.nih.gov by the due date and time. Offerors must include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with its offer. Clause at 52.212-4, Contract Terms and Condition Commercial Items, applies to this acquisition. Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items, applies to this acquisition.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/RFQ20120417/listing.html)
- Record
- SN02724530-W 20120419/120417235950-f148c800488f19274448a2fd8bb1728e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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