The U.S. Department of Defense (DoD) is seeking input on ways to improve the military’s medical countermeasures development and acquisition approach, to include licensure strategy, solicitation processes, use of small businesses, and contract and program management approaches.
The current 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 current solicitation process uses Best Value Criteria. Currently, the solicitation requires offerors to submit five proposal volumes (Technical, Past Performance, Administrative, Small Business Participation, and Price/Cost). The technical volume addresses Product Profile, Technical Approach, and Program Management. DoD typically allows 45-60 days after issuance for offerors to submit a proposal. Contract awards usually occur six to nine 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 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.
Under this Request for Information (RFI), interested parties are invited to assist the Government in attracting a broader audience of potential offerors or 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.
The RFI is managed by the Medical Countermeasure Systems (MCS) Joint Project Management Office (JPMO), under the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), as 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.
Further details are available under Solicitation Number: W911QY14S0002.
