SOLICITATION NOTICE
65 -- Advanced development and licensure of an Inhalation Atropine product for The Chemical Biological Medical Systems - Medical Identification and Treatment Systems (CBMS-MITS) Joint Product Management Office
- Notice Date
- 4/22/2010
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- RDECOM Contracting Center - Aberdeen (RDECOM-CC), ATTN: AMSSB-ACC-A, 4118 Susquehanna Avenue, Aberdeen Proving Ground, MD 21005-3013
- ZIP Code
- 21005-3013
- Solicitation Number
- W9113M-10-R-0008
- Response Due
- 5/10/2010
- Archive Date
- 7/9/2010
- Point of Contact
- Richard Totten, 301-619-2446
- E-Mail Address
-
RDECOM Contracting Center - Aberdeen (RDECOM-CC)
(richard.totten1@amedd.army.mil)
- Small Business Set-Aside
- Total Small Business
- Description
- Pre-Solicitation Notice The Chemical Biological Medical Systems - Medical Identification and Treatment Systems (CBMS-MITS) Joint Product Management Office has a requirement for the advanced development of, and licensure of, an Inhalation Atropine product to treat mild to moderate lingering symptoms associated with nerve agent-inducted intoxication. This requirement is a total set aside for small businesses, and all offerors must meet the definition of Small Business Concern as defined in FAR 19.001. No foreign entities may apply. In accordance with DFARS 252.204-7004, all interested offerors shall be registered in the Central Contractor Registration (CCR) database. The Request for Proposal (RFP) is expected to be issued on or about 10 May 2010. The North American Industry Classification System (NAICS) code for this procurement is 541712 with a size standard of 500 employees. The Government does not intend to use FAR Part 12 for this acquisition, because it has been determined that the Inhalation Atropine product is not a commercial item. It is anticipated a combination cost plus incentive fee/firm fixed price type contract shall be awarded. In accordance with FAR 16.301-3, for an anticipated cost type contract 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 the size status of subcontractors. The requested effort shall require a Contractor to coordinate and manage all activities associated with drug development consistent with eventual approval by the Food and Drug Administration. Associated activities will include: Obtaining FDA current Good Manufacturing Practices (cGMP) compliant active pharmaceutical ingredient (API); compounding an acceptable formulation that is compatible with and stable in the delivery system; cGMP-compliant manufacturing and testing of the delivery system; Incorporation of enabling technologies such as Item Unique Identification (IUID), Radio-Frequency Identification (RFID), and Time Temperature Indicators (TTIs); performing an International Conference on Harmonization (ICH)-compliant stability testing program on the cGMP product to establish product shelf life; necessary Good Laboratory Practices (GLP)-compliant non-clinical studies; Good Clinical Practices (GCP)-compliant Human clinical and pharmacokinetic studies; and electronic common technical document (eCTD) compatible electronic FDA submissions. The RFP will include a base effort with options to specific tasks and an anticipated initial production option of 300,000 units. The offeror must have the capacity to manufacture both the drug and the delivery system, either in its own facility, or with subcontracted effort, but the outcome of this requirement is for a total FDA approved product. Proposals will be evaluated on a Best Value basis. The New Drug Application will be submitted by the successful offeror. All interested parties will be able to view, download, and print a copy of the solicitation and any resulting amendments when released at the Joint Program Executive Office Chemical Biological Defense (JPEO-CBD) website hyperlink: http://www.jpeocbd.osd.mil/packs/Default.aspx?pg=1214&title=CBMS%20-%20Current%20Opportunities It is the potential offerors responsibility to monitor the JPEO-CBD website for any updates to this document. Proposals will be due 45 days after date of posting. No paper copies of the RFP will be provided and no mailing list will be maintained. Questions or correspondence should be directed to: In writing: CBMS-JPMO 64 Thomas Johnson Dr. Frederick, MD, 21702-5014 By fax: 301-619-5069 Or by e-mail: richard.totten1@amedd.army.mil, All inquiries should reference RFP number W9113M-10-R-0008. Questions will be received and answered for 15 days after posting of this announcement.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/ed165e7d0744255e0c6fa3f12f1c5dae)
- Place of Performance
- Address: RDECOM Contracting Center - Edgewood (RDECOM-CC) ATTN: CBMS-JPEO Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN02129673-W 20100424/100422235032-ed165e7d0744255e0c6fa3f12f1c5dae (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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