SOLICITATION NOTICE
65 -- Development of Medical Countermeasures (therapeutics) for the Treatment of Hemorrhagic Fever Viruses (HFV)
- Notice Date
- 9/21/2009
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801
- ZIP Code
- 35807-3801
- Solicitation Number
- W9113M09R0008
- Response Due
- 9/30/2009
- Archive Date
- 11/29/2009
- Point of Contact
- Richard Totten, 301-619-2446
- E-Mail Address
-
US Army Space and Missile Defense Command, Deputy Commander
(richard.totten1@amedd.army.mil)
- Small Business Set-Aside
- Total Small Business
- Description
- PRESOLICITATION NOTICE: The U.S. Army Space and Missile Defense Command (USASMDC) is providing notice that a Request for Proposal (RFP), W9113M-09-R-0008, for the Development of Medical Countermeasures (therapeutics) for the Treatment of Hemorrhagic Fever Viruses (HFV) will be issued on or about 16 October 2009 with an anticipated contract award on or about 30 April 2010. This requirement is a total set aside for small businesses. In accordance with DFARS 252.204-7004, all interested offerors 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 541710 with a size standard of 500 employees. The Government does not intend to use FAR Part 12 for this acquisition. In accordance with FAR 16.301-3, for an anticipated cost plus incentive type to be awarded, potential offerors must ensure that they have an adequate accounting system, as determined by their cognizant Defense Contract Audit Agency (DCAA) office. If you are a small business prime you would be required to comply with FAR 52.219-14, Limitations on Subcontracting and 13 CFR 125.6 (known as the 50% rule). Under the 50% rule in the case of a contract for supplies (other than procurement from a non-manufacturer 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). Rules on affiliation and joint ventures are at FAR 19.101, 13 CFR 121.103, 13 CFR 124.513 and 13 CFR 125.6. There is no limit to the number of other team subcontractors or size status of subcontractors. The Transformational Medical Technical Initiative (TMTI) mission is to protect the Warfighter from bioengineered or newly emergent biological threats by providing a response capability from identification of pathogens through the delivery of medical countermeasures. To support this effort, TMTI anticipates multiple awards for development of therapeutics for the treatment of Hemorrhagic Fever Viruses (HFV). Only those therapeutics that have reached the HFV Class entry criteria are eligible to be considered for these contracts. The HFV Class threshold entry criterion is: Compound has demonstrated and achieved Technical Readiness Level (TRL) 4 (as defined by the Integrated Medical TRLs https://www.fbo.gov/index?s=opportunity&mode=form&id=f6246b5fa678b0b327ab299902ed2015&tab=core&_cview=0) Achievement of a TRL is predicated on successful completion of all activities listed for that TRL, as well as all previous TRLs. For instance, achieving TRL 4 status indicates that a therapeutic has successfully demonstrated all activities as defined by the Integrated Medical TRL for TRL 1, 2, 3 and 4. The focus of these contracts is the advanced development and delivery of therapeutics that ideally are broad spectrum and flexible. The base contract effort requires therapeutics meeting or exceeding the HFV Class threshold entry criterion. Ultimately, the proposed therapeutic shall, assuming exercise of all options, undergo the New Drug Application/Biologic License Application (NDA/BLA) process and be delivered as a Food and Drug Administration (FDA) approved and licensed therapeutic. TMTI intends to award up to six (6) HFV therapeutic development contracts. The base award for each of these contracts is intended to be cost plus incentive fee. The base contract will include all activities required to proceed with development of a HFV therapeutic to complete Phase I Clinical Trials exclusive of those activities required to achieve TRL 4. The specific activities to be conducted will depend on the FDA licensure status of the proposed HFV therapeutic. Offerors proposing a HFV therapeutic meeting the HFV Class threshold entry criterion but that have not been granted FDA permission to continue into Phase I Clinical Trials will conduct activities to support the submission of their IND, any subsequent tests required by the FDA, and Phase I Clinical Trials. Offerors proposing a HFV therapeutic meeting HFV Class threshold entry criterion that have been granted permission to continue into Phase I Clinical Trials will conduct activities associated with Phase I Clinical Trials. The exercise of options will depend on successful completion of the current activities and a favorable evaluation at down-select points, pursuant to a limited competition and stated evaluation criteria, and subject to the Governments paramount right to unilaterally decide not to exercise all options and to discontinue the advanced development of all HFV therapeutics. TMTI intends to pursue schedule incentives for the base CPIF and each of the options exercised. A TMTI regulatory compliance team may conduct a facility compliance review to verify the accuracy of the offerors affirmations. The regulatory compliance team will provide advance notice of its visit to the offerors facilities. The team shall provide its findings and recommendations to the HFV Source Selection Evaluation Board (SSEB) technical team. The offeror is solely responsible for furnishing the regulatory compliance team the necessary information to demonstrate meeting the qualifications. Subcontractors may be used. If an offerors approach includes subcontract performance, the offeror shall provide the same qualification information for the subcontractor(s). The government regulatory compliance team may similarly conduct a site visit of the subcontractor(s). This acquisition is open to participation by foreign firms at both the prime contract and subcontract level, subject to FAR/DFARS Part 25 limitations. Proposals will be evaluated based on Factors, Subfactors, and Elements representing the Best Value to the Government. Delivery schedules reflecting each phase of the end items development, to include the ultimate delivery of an FDA licensed product, will be proposed by the offerors and will be evaluated under the evaluation criteria associated with a Best Value evaluation. TMTI anticipates delivery of an FDA licensed therapeutic product within 4 to 6 years from an offerors receipt of an FDA IND acceptance, 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 October 2009, at the following website: http://www.tmti-cbdefense.org/. 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 only to sandra.oconnell@us.army.mil and please reference the RFP number W9113M-09-R-0008. No telephone inquiries will be accepted. Only questions received within 14 days of issuance of the RFP will be entertained by the Government.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/SMDC/DASG60/W9113M09R0008/listing.html)
- Place of Performance
- Address: US Army Space and Missile Defense Command, Deputy Commander ATTN SMDC-CM-AP, P.O. Box 1500 Huntsville AL
- Zip Code: 35807-3801
- Zip Code: 35807-3801
- Record
- SN01964602-W 20090923/090922001635-f6a3ee8d0f4e93bcc402442c1e0ce492 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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