MODIFICATION
A -- Advance Development of a Medical Radiation Countermeasure (MRC)
- Notice Date
- 1/19/2010
- Notice Type
- Modification/Amendment
- 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
- W9113M09R0010
- Response Due
- 2/17/2010
- Archive Date
- 4/18/2010
- Point of Contact
- Drake Russell, 301-619-8472
- E-Mail Address
-
US Army Space and Missile Defense Command, Deputy Commander
(drake.russell@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- SUMMARY OF CHANGES A.This amendment is issued to make the following changes to sections C, E, F, L, and M as listed below. As a result of this amendment, the hour and date specified for receipt of Offers is not extended and remains February 17, 2010. 1.Section C Statement of Objectives a.Added C.4.10 to require submission of Contractor Code of Business Ethics and Conduct per FAR 52.203-13 and FAR 3.1004(a). 2.Section E Inspection and Acceptance a.Clause 52.246-3 Inspection of Supplies Cost-Reimbursement is deleted in full from Clauses Incorporated by Reference b.Clause 52.246-2 Inspection of Supplies Fixed Price is directly linked to CLINs 0006, 0007, 0008, 0009, and 0010 c.Clause 52.246-7 Inspection of Research and Development Fixed Price is directly linked to CLINs 0001, 0003, 0005, 0011, and 0012 d.Clause 52.246-8 Inspection of Research and Development Cost Reimbursement is directly linked to CLINs 0002 and 0004 3.Section F Deliveries of Performance a.For CLIN 0006, the Ship to Address is amended to read Ship in place. b.For CLIN 0011, the quantity is amended to read 1 Technical Data Package. c.For CLIN 0012, the quantity is amended to read 1 Drug Master File. 4.Section L Cost a.Section L.4.1.4.6 Other Costs is deleted in its entirety and replaced with the following: L.4.1.4.6. Other Costs. List direct costs not included in the above categories (i.e., special tooling, computer services, preservation, and packaging). Provide basis of estimate (i.e., vendor quotes, catalog pricing, subcontracting estimates). Competitive historical price information of prior purchases is adequate. 5.Section M Evaluation Factors for Award a.Section M.1.1 General Basis for Contract Award is deleted in its entirety and replaced with the following: M.1.1. GENERAL BASIS FOR CONTRACT AWARD - This will be a competitive source selection conducted in accordance with Federal Acquisition Regulation (FAR) 15.101.1. The contract award is based on a determination of Best Value to the Government (see FAR 15.1). This determination is based on an integrated assessment of ratings for Evaluation Factors (Section M.3.2), Proposal Risk rating, and Performance Risk rating. Offeror(s) shall be responsible under the FAR procedures and shall submit proposals conforming to the solicitation requirements. The Government intends to select the source whose offer is most overall advantageous to the Government; however, the Government reserves the right to reject any or all proposals and to award no contract at all, depending on the quality of the proposal(s) submitted and the availability of funds. The Government reserves the right to conduct written or oral discussions and surveys as it deems necessary or appropriate before contract award. The proposals shall be complete, shall arrive by the date and time indicated, and shall be compliant with all instructions. The Offeror shall refer to Section L (Instructions, Conditions, and Notices to Offerors) for proposal preparation. It is anticipated that only one award will be made as a result of this Request for Proposal (RFP) Questions and Answers B.This amendment is issued to answer the questions submitted as of January 7, 2010 and listed below. As a result of this amendment, the hour and date specified for receipt of Offers is not extended and remains February 17, 2010. 1.What is the technology readiness level of an acceptable product? The minimum acceptable Technology Readiness Level (TRL) for this solicitation is a TRL 3. The definition of a TRL 3 product is detailed in the attached memorandum dated December 17, 2008. 2.Is there a target product profile for this countermeasure? If so, where is it published? "The Capability Development Document (CDD) is in draft form and is not published at this time. The target product profile is described in the Statement of Objectives (SOO), as shown in the references below. "A therapeutic countermeasure that demonstrates efficacy when administered a minimum of 4 hours following exposure to radiation sufficient to cause the gastrointestinal (GI) subsyndrome of Acute Radiation Syndrome (ARS). (C.2.) "Countermeasure exerts its effect directly on the incipient or manifest radiation injury suffered by the GI tract. (C.2.) " Minimal logistical burden oThe medical radiation countermeasure shall be operational across a wide range of temperatures. It is favorable to have a shelf life greater than 2 years at a storage temperature of 20-35 degrees Celsius. (C.3.3.1) oA final product formulation suitable for administration in humans and a delivery system suitable for military use. (C.3.3.2) 3.What does the Government require as a back up for insurance estimates? The Government requires vendor quotes, catalog pricing, or competitive historical price information of prior purchases. See amended Section L.4.1.4.6 - Other Costs. 4.If the Offeror cannot procure insurance, will the Government provide indemnification? Under 10 USC 2354 (DFARS 235.070-1) SEC ARMY may, if justified by an awardee, authorize indemnification of resulting contract(s) for advanced development. Indemnification before award is not feasible and only a contract may be indemnified. Proposals shall not be conditioned on receipt of indemnification and performance shall not be delayed because of a request of indemnification is being processed. 5.On Pg. 12, CLIN 0006 states within 1 year of exercise of 2,500, to ship to address same as above which means ship to CBMS-MITS 64 Thomas Johnson Drive Frederick, MD 21702. Please confirm that 2,500 MRC are to be delivered to this address. Section F - CLIN 0006 was amended to Ship in place. 6.Likewise, on Pg. 12, CLINs 0007, 0008, 0009, 0010 state to deliver the MRC to Ship in place. Does this mean to retain the MRC in storage at the location where it was developed? Please clarify. The delivery location will be provided following exercise of the option. 7.Given the nature of this type of research and development effort, and that the majority of the proposed CLINs are to be Firm Fixed Price, and that they will most likely go out several years, along with the current volatile economy, would the Government consider receipt of a legitimate estimate of the pricing for the out-years? We are certain that the pricing will change over time of which we have little control. Will the Government accept this type of pricing estimate for initial consideration, and then permit the Offeror to update the costs annually? The Government understands the nature of the Research and Development effort. Firm-fixed pricing is required for low-risk areas and the Government will not accept updating the costs annually for Firm-fixed price CLINs. 8.By my reading, funding is anticipated in October 2010 and the first deliverable is due June 2011. That first deliverable includes the completion of a Phase I trial. Therefore, would an IND need to be filed within 2-3 months of funding? The timing of IND filing is specific to each Offeror. However, it is expected that the Offeror complete the activities associated with CLIN 0001 and CLIN 0002 no later than June, 2011. Funding will be available at time of contract award and contract award is anticipated in May/June 2010. 9.When would you anticipate having completed the review and being able to commit that funding will be forthcoming? As shown in Section L Instructions to Offerors, additional funds are envisioned in subsequent DoD Budgets, starting with the FY12-17 POM (L.1.1.9). A better estimate of the FY12-17 POM funding will be available by mid-FY11. However, the funding provided in L.1.1.9 provides the current planned budget for this program. Unfunded requirements and additional POM funding will be requested in addition to the current budget. 10.Given that $12.9M has been budgeted through 2013, will there be multiple awards under this solicitation? As stated in Section M.1.1 The Government intends to select the source whose offer is most overall advantageous to the Government; however, the Government reserves the right to reject any or all proposals and to award no contract at all, depending on the quality of the proposal(s) submitted and the availability of funds. It is anticipated that only one award will be made as a result of this Request for Proposal. 11.Can you further define the Phase 1 study? Is the Phase 1 study the complete human safety trial (dose finding, safety, large population)? The Phase 1 study is the complete human safety trial needed to initiate expanded Phase 2 clinical trials. Any human safety studies needed for FDA approval that are not completed shall be included in the technical approach provided in the proposal in order to complete Phase 1. 12.Is it correct that the Past Performance section requires both submission by the Offeror (us) and reports by the PO's on ongoing and prior Government grants and contracts? Yes, the Offeror shall provide Attachment A Past Performance Information as described in L.3.3.1. The Offerors Reference(s) noted in Attachment A shall provide Attachment B Past Performance Questionnaire as described in L.3.3.2. 13.Is it acceptable for Offerors to propose a higher cost than the current funding listed at L.1.1.9? Yes, it is acceptable to propose a higher cost than the current funding listed at L.1.1.9. As stated in the Notes section of L.1.1.9, strict adherence to the funding profile incorporated herein shall not be a consideration in the source selection decision and Offerors are encouraged to develop best-value proposals. The current funding profile is used as a guideline for Offerors; however, additional POM funding will be requested in addition to the current budget. 14.Is it feasible that funding will be made available other than what is listed at L.1.1.9? The current funding profile is used as a guideline for Offerors; however, unfunded requirements and additional POM funding will be requested in addition to the current budget. The Government makes no assurances that the projected funds shall be made available for this program nor shall this solicitation provision be the basis for a claim under the contract in the event the projected funds fail to materialize. This provision will not be incorporated in any contracts awarded as a result of this solicitation. This answer shall be considered part of Section L.
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- 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
- SN02044715-W 20100121/100119235022-ba577ca44c0bf457e054c92a83fab3db (fbodaily.com)
- Source
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