This is a Request for Information (RFI) for planning purposes only, as defined in FAR 15.201(e.) This is not a solicitation or request for competitive proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted and the Government will not reimburse respondents for preparation of the response. The Medical Countermeasure Systems (MCS) Joint Project Management Office (JPMO), under the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), is the DoD organization responsible for the advanced development, procurement, fielding, and sustaining of medical treatment, prophylactic, and diagnostic capabilities against chemical, biological, radiological, and nuclear warfare agents. The current MCS portfolio includes therapeutics, pretreatments, prophylactics, and diagnostics at varying stages of advancement and clinical development, including drugs approved by the U.S. Food and Drug Administration (FDA). MCS is seeking information/input on suggested strategies/processes in which the current approach (to include licensure strategy, solicitation process, use of small businesses, contract and program management approaches), as detailed below, can be modified/improved to attract a broader audience of potential offerors/ subcontractors. The current MCS licensure strategy extends from early development through the Investigational New Drug (IND) submission whereby the Government acts as an integrator. After IND submission and extending through FDA licensure, the Government seeks a contractor competitively (unless other than full and open competition has been approved) to serve as the integrator (a prime contractor). As the integrator, the prime contractor, acts as sponsor and works collaboratively with the Government in all interactions with FDA. Contracted quantities are limited to the needs of the warfighters for the specific product. The MCS preference is for unencumbered technology. The current solicitation process uses Best Value Criteria. Currently, the solicitation requires offerors to submit five (5) proposal volumes (Technical, Past Performance, Administrative, Small Business Participation, and Price/Cost). The technical volume addresses Product Profile, Technical Approach, and Program Management. MCS typically allows 45-60 days after issuance for offerors to submit a proposal. Contract awards usually occur six (6) to nine (9) months after initial proposal receipt. Contracts can require delivery of FDA approved/licensed products based upon needs of the warfighter, use of the Animal Rule, and complexity of the end product among other things. The portion of the contracts requiring development and licensure of the end product are cost-plus line items requiring offerors have an approved accounting system, while portions of the contracts requiring delivery of initial procurement quantities are Firm Fixed-Price. Contracts also require various data deliverables including, but not limited to: Integrated Master Schedule, Contract Work Breakdown Structure, Technical Data Package, and Drug Master File. The Government oversees and/or monitors contractor performance under its contracts by using personnel and methods such as Integrated Product Teams, Earned Value Management Systems, Contracting Officer Representatives and operational and scientific reports. Information from interested parties is requested to assist the Government in attracting a broader audience of potential offerors/ subcontractors. Specifically, if a different approach was used by the Government in its solicitations and contracts to develop FDA licensed products, what changes in the above would be necessary for your company to be interested in working with the Government. Respondents may submit questions regarding this RFI or request a meeting through the Point of Contact listed below. All meeting requests may not be granted. SUBMISSION INSTRUCTIONS: All written responses must be received within seventeen (17) days of issuance of this RFI. Submissions should: (1) use Microsoft Word or Adobe Portable Document Format (.pdf); (2) be sent to Leo Fratis;(3) be minimum 11 point font on 8.5 quote mark X 11 quote mark paper; (4) be complete, sufficiently detailed, and organized in a manner that is responsive to the information requested in this RFI; (5) include a single company point of contact with name, title, address, telephone and fax numbers, and e-mail address(es); and (6) not to exceed 10 single-sided pages in total (not including cover page and cover letter). Other media types (i.e., CD, printed technical information) that meet the submission criteria above will be accepted and should be sent to the Contracting Office Address and Point of Contact identified below. Material that is advertisement only in nature is not desired. In addition to the above, please indicate your company's willingness to be added to a database of vendors to be published for the purposes of sharing with other vendors with interests specific to medical countermeasure type work. Contracting Office Address: US Army Contracting Command, Aberdeen Proving Grounds Natick Division ATTN: Leo Fratis, 1564 Freedman Dr, Fort Detrick, Maryland 21702 Point of Contact(s): Questions and submissions regarding this RFI should be forwarded to
[email protected]