SOLICITATION NOTICE
A -- Advance Development of a Medical Radiation Countermeasure (MRC)
- Notice Date
- 9/28/2009
- 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
- W9113M-09-R-0010
- Response Due
- 10/13/2009
- Archive Date
- 12/12/2009
- Point of Contact
- Sandra OConnell, 301-619-2895
- E-Mail Address
-
US Army Space and Missile Defense Command, Deputy Commander
(sandra.oconnell@us.army.mil)
- Small Business Set-Aside
- Total Small Business
- Description
- The U.S. Army Space and Missile Defense Command (USASMDC) is providing notice that a Request for Proposal (RFP), W9113M-09-R-0010, for the Advanced Development of Medical Radiation Countermeasure (MRC) will be issued on or about 13 October 2009 with an anticipated contract award on or about 31 March 2010. 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 MRC shall be a drug or biologic that can be expeditiously developed, and when used after exposure to doses of ionizing radiation sufficient to cause the gastrointestinal (GI) subsyndrome of acute radiation syndrome (ARS), will either prevent/reduce the extent of incipient radiation injury or promote repair of manifest radiation injury to allow preservation/restoration of the anatomic integrity and normal physiologic functioning of the GI tract resulting in increased survival, reduced incapacitation, and sustained operational effectiveness. MRCs carrying logistical burdens (e.g., special handling or storage conditions lower than -20 degrees Celsius) may be acceptable, but are much less desirable. The MRC should be delivered by minimally invasive means and in as few doses as possible. Development and delivery of the MRC product shall require a Contractor to coordinate and manage the activities associated with advanced development of the product. The Contractor will be responsible for conducting the various activities associated with drug/biologic development in manners that are consistent with eventual approval or licensure by the Food and Drug Administration (FDA). Associated Technology Development activities will include, but are not limited to: manufacturing process development and related tasks, current Good Manufacturing Practices (cGMP)-compliant small-scale manufacturing and testing of the radiation countermeasure product, Good Laboratory Practices (GLP)-compliant acute toxicology testing in animals, pilot animal efficacy studies, filing of an Investigational New Drug (IND) application, and conducting a Phase I clinical trial in accordance with FDA regulations and guidelines. After successful completion of the Technology Development efforts and Government review, the Contractor shall conduct necessary follow-on advanced developmental activities leading to FDA approval of the developmental end item. The Contractor will be required under the base contract to provide one (1) FDA approved MRC. The Government anticipates FDA approval of the MRC within 3 to 6 years after contract award, but all proposed delivery schedules will be evaluated. A CLIN for production quantities of the FDA approved MRC will also be included in the awarded contract as an option. Proposals will be evaluated based on Factors, Subfactors, and Elements representing the Best Value to the Government. Delivery schedules of the FDA approved MRC shall be proposed by the offerors and will be used as one of the evaluation criteria associated with a Best Value evaluation. The current FY10-15 program/budget funding for this project is $12.29M. Additional funding is envisioned in the subsequent DoD Budgets, starting with the FY12-17 Program Objectives Memorandum. All interested parties can view, download, and print a copy of the solicitation and any resulting amendments when released on or about 13 October 2009 at the JPEO-CBD website hyperlink http://www.jpeocbd.osd.mil/packs/Default2.aspx?pg=180. Scroll down to the bottom of the webpage and select the RFP number W9113M-09-R-0010. 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 Sandra.Oconnell@us.army.mil or Drake.Russell@us.army.mil, please reference RFP number W9113M-09-R-0010.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/SMDC/DASG60/W9113M-09-R-0010/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
- SN01973048-W 20090930/090929000152-8d6fa6180bf420b0fa414a387db06f02 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |