Molybdenum-99 Program

 

In 2012, Congress passed the American Medical Isotopes Production Act (AMIPA), which directed the Department of Energy to establish a technology-neutral program to support the establishment of domestic supplies of molybdenum-99 (Mo-99) without the use of highly enriched uranium (HEU). The Department of Energys National Nuclear Security Administration (DOE/NNSA) has implemented this by competitively awarding 50%/50% cost-shared cooperative agreements to commercial entities and providing funds to the DOE National Laboratories to support development of non-HEU Mo-99 production technologies. Mo-99 is a critical radioisotope whose decay byproduct technetium-99m (Tc-99m), is used in over 40,000 nuclear medicine diagnostic procedures performed daily in the United States. Its primary uses include diagnosing heart disease and cancer, as well as studying organ structure and function. The isotopes short half-life and excellent binding properties make it uniquely suited for medical procedures. However, due to its short half-life it must be produced continuously to meet the medical communitys requirements. The United States does not currently have a domestic production capability for Mo-99 sufficient to meet the needs of the U.S. healthcare community, currently estimated at 4,500 6-day curies per week. The establishment of reliable, commercial, non-HEU-based Mo-99 production in the United States complements the long-standing U.S. policy to minimize and eliminate the use of proliferation-sensitive HEU in civilian applications in order to prevent the potential theft of this material for malevolent use. The United States is at the nexus of two related priorities: the need to ensure a reliable, robust Mo-99 supply for U.S. patient care, and discouraging the use of proliferation-sensitive HEU in civilian applications. NNSA will issue Cooperative Agreements with the purpose of providing additional federal funding to accelerate commercial Mo-99 projects time to market so that industry and government can fulfill these two critical priorities and decrease the U.S. medical communitys reliance on foreign supplies of Mo-99.

Active 81.009 National Nuclear Security Administration B - Project Grants Not applicable. Act to reorganize and consolidate certain functions of the Federal Government in a new Energy Research and Development Administration and in a new Nuclear Regulatory Commission in order to promote more efficient management of such functions., Title Energy Reorganization Act of 1974, Part Title I, Section Section 107 Public Law 93-438; 88 Stat. 1240, 42 U.S.C. 5817, Title I, Section 107, 93-438; 88 , Statute 1240,42, 5817, Public Law 5817-93-438
A United States federal law that covers for the development, regulation, and disposal of nuclear materials and facilities in the United States, Title Atomic Energy Act of 1954, Section Section 3157, Public Law 101-189, 103 Stat. 1684, 42 U.S.C. 2051 , Section 3157, 1684 Stat. 42, 2051 U.S.C , Section 3157, 101-189, 103 , Statute 1684,42, 2051 US Code 3157, Public Law 2051-101-189
A bill to establish a Department of Energy in the executive branch by the reorganization of energy functions within the Federal Government in order to secure effective management, to assure a coordinated National energy policy., Title Department of Energy (DOE) Organization Act of 1977, Public Law 42 U.S.C. 7101-95-91
AN ACT To establish a national program for research and development in nonnuclear energy sources., Title Federal Nonnuclear Energy Research and Development Act of 1974, Public Law -93-577
Directs the Secretary of Energy (DOE) to implement a technology-neutral program to evaluate and support projects for the production in the United States (except in certain circumstances without the use of highly enriched uranium) of significant quantities of molybdenum-99 for medical uses, implemented in cooperation with non-federal entities, whose costs shall be shared in accordance with certain cost sharing requirements of the Energy Policy Act of 2005., Title The American Medical Isotopes Production Act of 2012, Public Law -112-239 Only U.S. commercial entities with mature technologies to achieve commercial-scale production of Mo-99 in a facility or using facilities located in the United States in accordance with the goals of this FOA may submit applications. National Laboratories, M&O Contractors, Institutions of Higher Education, and Federally Funded Research and Development Centers (FFRDC) are not eligible to apply for an award under this FOA, but can be included in teaming arrangements. The general public. For Non-government organizations, Costs will be determined in accordance with OMB Circular No. A-122 . 2 CFR 200, Subpart E - Cost Principles applies to this program. Preapplication coordination is required. An environmental impact statement is required for this listing. 2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. 2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. No additional FOAs are currently open or planned to be issued under this Assistance Listing. The previous FOA was posted on Grants.gov (opens in new window) and applicants were required to submit applications through that website to be considered for award. All applications that were received by the application due date and time, as specified in the FOA, were subjected to an initial Compliance Review, and upon satisfactorily passing the initial review were subjected to a comprehensive evaluation. The Merit Review Panel Chairperson was responsible for reviewing the independent findings and ratings of each evaluator, and ultimately completing a Merit Review Panel Chairperson's Report to summarize the findings and make recommendations for awards to the Selection Official. The Selection Official considered the merit review recommendation, program policy factors, budget evaluations of the Project Management Plan, and the amount of funds available, when making a decision for awards. The program policy factors and budget evaluations were not point scored, but the Selection Official could consider them in making the selections for negotiation of award. The Selection Official made a decision to select for award a group of projects which represented a diversity of technical approaches, methods, applications and/or market segments, which included four awards. Upon the Selection Official making the final decisions, the Contracting Officer notified selectees and non-selectees. No additional FOAs are currently open or planned to be issued under this Assistance Listing. The previous FOA was open for 60 days. 30 Days - Selection Process 135 Days - Prepare for Award/Negotiate/Award 1 - 4 Cooperative Agreements Not applicable. Not applicable. All timely applications under the previous FOA that satisfactorily passed the initial compliance review were eligible for a comprehensive merit review. Prior to conducting the comprehensive merit review, an initial review was performed to determine whether: (1) the applicant is eligible for award; (2) the information required by the FOA has been submitted; (3) all other mandatory requirements of the FOA are satisfied; and (4) the proposed project is responsive to the program objectives of the FOA. This review is a thorough, consistent, and objective examination of applications based on the pre-established evaluation criteria set forth in the FOA. Each application was evaluated on the strengths and weaknesses it exhibited in relation to scientific and technological merit; technical approach; and business strategy and management capabilities. The technical objective of the assistance is to achieve U.S. commercial Mo-99 production of at least 1,500 6-day Ci/week without the use of HEU on or before December 31, 2023 and the ability and plans to increase the production of Mo-99 in its facility or facilities to 3,000 6-day Ci/week. Performance Reports: Final Report is required. In accordance with the provisions of 2 CFR 200, Subpart F - Audit Requirements, nonfederal entities that expend financial assistance of $750,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Non-Federal entities that expend less than $750,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in 2 CFR 200.503. In accordance with 2 CFR Part 200 as amended by 2 CFR Part 910, DOE reserves the right to initiate a final incurred cost audit on this award. If the audit has not been performed or completed prior to the closeout of the award, DOE retains the right to recover an appropriate amount after fully considering the recommendations on disallowed costs resulting from the final audit. Records of all project costs that are claimed as cost sharing, including in-kind costs, as well as records of costs to be paid by DOE/NNSA must be maintained. Statutory formula is not applicable to this assistance listing.

Matching is mandatory. 50%. Cooperative agreements (CA) will be awarded on a 50%/50% Federal/non-Federal cost sharing basis . The recipient will be required to match the U.S. Government contribution.

MOE requirements are not applicable to this assistance listing. Generally, agreements are approved for two-year or five year project periods and either fully funded or funded per budget period, depending on budget appropriation, at the discretion of the program office. None/Not specified. Max Postman
1000 Independence Avenue, SW
Washington, DC 20585 USA
max.postman@nnsa.doe.gov
Phone: 202-586-9114 https://www.energy.gov/nnsa/nnsa-s-molybdenum-99-program-establishing-reliable-supply-mo-99-produced-without-highly 89-0309-0-1-053 (Cooperative Agreements) FY 22$62,000,000.00; FY 23 est $0.00; FY 24 est $0.00; - Range: $13M - $35M Average: $21M 2 CFR Part 200 as amended by 2 CFR Part 910 The authority for this financial assistance action is the Department of Energy Act of 1977 (Public Law 95-91); the Federal Grant and Cooperative Agreement Act of 1977 (Public Law 95-224), as amended by (Public Law 97-258); and 10 CFR 600.6(b). Signed into law on January 2, 2013, The American Medical Isotopes Production Act of 2012 (Title XXXI, Subtitle F, National Defense Authorization Act for Fiscal Year 2013, [Public Law 112-239]) (AMIPA). Fiscal Year 2021 Cooperative Agreements with NorthStar Medical Technologies, LLC [FY 2021]
Fiscal Year 2022 Cooperative Agreement with Niowave Inc. Cooperative Agreement with SHINE Technologies, LLC