SOLICITATION NOTICE
A -- Trivalent Filovirus Vaccine
- Notice Date
- 2/16/2011
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- RDECOM Contracting Center - Natick R&D (RDECOM-CC), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-11-R-0013
- Response Due
- 4/30/2011
- Archive Date
- 6/29/2011
- Point of Contact
- Lawrence Mize, 301-619-9813
- E-Mail Address
-
RDECOM Contracting Center - Natick R&D (RDECOM-CC)
(lawrence.mize@amedd.army.mil)
- Small Business Set-Aside
- Total Small Business
- Description
- The U.S. Research, Development and Engineering Command (RDECOM) is providing notice that a Request for Proposal (RFP), W911QY-11-R-0013, for the Advanced Development of a Trivalent Filovirus vaccine will be issued on or about 16 March 2011 with an anticipated contract award on or about 30 June 2011. This requirement is a 100% small business set-aside. Small business prime contractors are required to comply with FAR 52.219-14, Limitations on Subcontracting and 13 CFR 125.6 (known as the 50% rule). Rules on affiliation and joint ventures are at FAR 19.101, 13 CFR 121.103, 13 CFR 124.513 and 13 CFR 125.6. Under the 50% rule where the preponderance of support is for supplies (other than procurement from a nonmanufacturer of such supplies), the concern shall perform work for at least 50% of the cost of manufacturing the supplies, not including the cost of materials. The small business prime contractor must meet this requirement (1) individually, or (2) together with other small business members of a formal joint venture, or (3) together with a small number of small business subcontractors forming an informal joint venture, in which those subcontractors meet the definition of ostensible subcontractor as set forth in 13 CFR 121.103(h)(4). Team members in such formal and informal joint ventures are exempt from affiliation rules under the conditions set forth in 13 CFR 121.103(h)(3). There is no limit to the number of other team subcontractors or size status of subcontractors. In accordance with DFARS 252.204-7004, all interested contractors shall be registered in the Central Contractor Registration (CCR) database. CCR registration can be accomplished at the following website: http://www.ccr.gov. The North American Industry Classification System (NAICS) code for this procurement is 541711, Research and Development in Biotechnology, with a size standard of 500 employees. The Government does not intend to use FAR Part 12 for this acquisition. The objective of this procurement is to deliver, after limited advance development, a current Good Manufacturing Practices (cGMP) trivalent filovirus vaccine using the Government Licensed Venezuelan Equine Encephalitis (VEE) Replicon Particle (VRP) system that will be suitable/acceptable for use in humans by the Government to support non-clinical and Phase 1 studies under an Investigational New Drug (IND) application. The manufacturer shall develop, abide by and document cGMP and processes consistent with the International Conference on Harmonisation (ICH) Q7 guidelines on Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, FDA regulation 21 CFR Part 211-cGMP for Finished Pharmaceuticals, and 21 CFR Part 600. The Contractor shall conduct formulation studies to support the development of a trivalent vaccine as well as analytical assay development, including in-process and release assays of cGMP bulk(s) and final product, and International Conference on Harmonization (ICH)-compliant stability testing. The small scale manufacturing process developed must be scalable and transferrable to another facility, if necessary. The viral glycoprotein genes from each strain shall be cloned into a cGMP compliant optimized VEE replicon vector. The replicon technology is derived from an attenuated strain of the VEE virus, V3014. Specific pathogen genes of interest are inserted as replacements for VEE virus structural genes, thereby making the particle replication defective. Note: The initial manufacturing efforts must be conducted at BioSafety Level (BSL) 3. Downstream processing can occur at BSL-2 following negative testing results for live virus. Through market research, the government has identified BSL-3 facilities available for leasing. Interested parties may submit a request for the list by email to cbmsfilorfp@amedd.army.mil prior to March 16, 2011. The list is not intended to be all-inclusive, and interested parties are welcome to conduct their own market research to identify BSL-3 facilities. Proposals will be evaluated based on Factors, Subfactors, and Elements representing the "Best Value" to the Government. Delivery schedules of the vaccine product shall be proposed by the offerors and will be used as one of the criteria associated with a Best Value evaluation. Proposed schedule calling for delivery of the Trivalent Filovirus Vaccine, as described above, is anticipated within 3 to 4 years after contract award, but all proposed delivery schedules will be evaluated. All interested parties can view, download, and print a copy of the solicitation and any resulting amendments when released on or about 16 March 2011 at the FedBizOpps website hyperlink https://www.fbo.gov/. Search on solicitation number W911QY-11-R-0013. No paper copies of the RFP will be provided and no mailing list will be maintained because the acquisition will be posted on the above website. Questions or correspondence should be directed by e-mail to cbmsfilorfp@amedd.army.mil and please reference the RFP number W911QY-11-R-0013. Contracting Office Address: U.S. Army Research, Development, and Engineering Command, Contracts and Acquisition Management Office, 64 Thomas Johnson Drive, Frederick, MD 21702 Point of Contact(s): Lawrence Mize, lawrence.mize@us.army.mil
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/0db46567ef32b13ca0784a74ecd2f1a0)
- Place of Performance
- Address: RDECOM Contracting Center - Natick R&D (RDECOM-CC) ATTN: 64 Thomas Johnson Drive Frederick MD
- Zip Code: 21742
- Zip Code: 21742
- Record
- SN02381865-W 20110218/110216234732-0db46567ef32b13ca0784a74ecd2f1a0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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