oppDE-FOA-0001925-cfda81.113-instructions.rtf

DEPARTMENT OF ENERGY

NATIONAL NUCLEAR SECURITY ADMINISTRATION

OFFICE OF ACQUISITION MANAGEMENT

DEFENSE NUCLEAR NONPROLIFERATION

OFFICE OF MATERIAL MANAGEMENT AND MINIMIZATION (NA-23)

Technology for Demonstration and Commercial-Scale Production of a Reliable, Domestic Supply of Molybdenum-99 without the Use of Highly Enriched Uranium _____________________________________________________________________________________________

FUNDING OPPORTUNITY ANNOUNCEMENT (FOA) NUMBER:

DE-FOA-0001925

FOA TYPE: INITIAL

CFDA NUMBER: 81.113

Registration Requirements

There are several actions that applicants must complete in order to submit an application in response to this Announcement (e.g., obtain a Dun and Bradstreet Data Universal Numbering System (DUNS) number, register with the System for Award Management (SAM), register with Grants.gov, or register with another portal as indicated in the FOA). Applicants who are not registered with SAM and Grants.gov should allow up to five weeks to complete these requirements. It is suggested that the process be started as soon as possible.

If an applicant has not already done so, they must:

1. Obtain a DUNS number. DUNS website: http://fedgov.dnb.com/webform.

2. Register with the SAM. SAM website: http://www.sam.gov/. For more information about SAM registration for applicants please refer to: https://www.sam.gov/sam/transcript/Quick_Guide_for_Grants_Registrations_v1.7.pdf.

3. Register with Grants.gov and set up your Workspace. There are multiple steps to this process, for more information about Grants.gov registration for applicants please refer to: https://www.grants.gov/web/grants/applicants/registration.html

For more information about setting up Workspace please refer to:

https://www.grants.gov/web/grants/applicants/workspace-overview.html For more detailed instructions about creating a profile on Grants.gov, refer to: https://www.grants.gov/web/grants/applicants/registration/authorize-roles.html

IMPORTANT NOTICE TO POTENTIAL APPLICANTS: When you have completed the Grants.Gov registration process, you should call the Grants.gov Helpdesk at 1-800-518-4726 to verify that you have completed the final step.

4. Register with FedConnect to submit questions. FedConnect website: https://www.fedconnect.net/FedConnect/default.htm

Questions regarding the content of the funding opportunity announcement must be submitted through the FedConnect portal. You must register with FedConnect to respond as an interested party to submit questions, and to view responses to questions. It is recommended that you register as soon after release of the FOA as possible to have the benefit of all responses. DOE/DOE/NNSA will try to respond to a question within 3 business days, unless a similar question and answer have already been posted on the website.

Questions relating to the Grants.Gov registration process, system requirements, or how an application form works must be directed to Grants.gov at 1-800-518-4726 or support@grants.gov.

Application Preparation

Applicants must prepare the application package and application forms from the Grants.gov website: http://www.grants.gov/

Additional instructions are provided in Section IV of this FOA.

Application Submission

Applications must be submitted through Grants.gov to be considered for award. You cannot submit an application through Grants.gov unless you are registered. Please read the registration requirements carefully and start the process immediately. Remember you have to update your SAM registration annually. If you have any questions about your registration, you should contact the Grants.gov Helpdesk at 1-800-518-4726 to verify that you are still registered in Grants.gov.

NOTE: Applications submitted via FedConnect will not be accepted

TABLE OF CONTENTS

Section I – FUNDING OPPORTUNITY DESCRIPTION 6

Section II – AWARD INFORMATION 10

Section III – ELIGIBILITY INFORMATION 11

Section IV – APPLICATION & SUBMISSION INFORMATION 12

Section V – APPLICATION REVIEW INFORMATION 24

Section VI – AWARD ADMINISTRATION INFORMATION 27

Section VII – QUESTIONS/AGENCY CONTACTS 30

Section VIII – OTHER INFORMATION 31

APPENDIX A – Data Management Plan Guidance 33

APPENDIX B – Budget Guidance 36

Section I - FUNDING OPPORTUNITY DESCRIPTION

A. DESCRIPTION

The U.S. Department of Energy (DOE) National Nuclear Security Administration’s (DOE/NNSA) Office of Material Management and Minimization (NA-23) is soliciting applications from commercial entities that will result in the award of up to four cooperative agreements to demonstrate and achieve commercial-scale production of the medical isotope, Molybdenum-99, hereafter referred to as Mo-99, without the use of highly enriched uranium (HEU) in the United States. This FOA closes and applications are due September 30, 2018 by 11:59 p.m. EST. Please be aware that technical difficulties are always possible when submitting applications electronically, therefore, ensure enough time is allotted for submission to DOE/NNSA. DOE/NNSA will not consider any applications that are received after the application deadline. This includes applications which are received by DOE/NNSA late as a result of technical difficulties. Therefore, applicants are strongly encouraged to submit their applications well in advance of the application deadline.

This invitation to submit applications is issued under Funding Opportunity Announcement (FOA) DE-FOA-0001925 entitled Technology for Demonstration and Commercial Scale Production of a Reliable, Domestic Supply of Molybdenum-99 without the Use of Highly Enriched Uranium.

The applications will be evaluated in accordance with Section V of this FOA and based on the ability of the recipient to produce Mo-99 in the United States and establish the capability to deliver to the U.S. market at least 3,000 6-day curies of Mo-99 per week, steady state, without the use of HEU. The criteria for evaluation and selection will be discussed within this FOA. Any commercial entity which already has the capability to currently produce at least 3,000 6-day curies of Mo-99 per week, steady state, without the use of HEU, will be eliminated from consideration. Awards under this FOA are subject to the availability of funds. Acceptance of an application for evaluation does not obligate DOE/NNSA to make an award. DOE/NNSA reserves the right to fund, in whole or in part, any, all or none of the applications submitted in response to this FOA. DOE/NNSA also reserves the right to award with or without discussions with applicants.

Cooperative agreements (CA) will be awarded on a 50%/50% Federal/non-Federal cost sharing basis whereby the U.S. Government will provide up to $10 million for each award. The recipient will be required to match the U.S. Government contribution. The Federal cost-share amount will be based on the entire cost of each project, and therefore, may be less than $10 million if the recipient’s total project cost or proposal is less than $20 million. DOE/NNSA reserves the right to increase the maximum ceiling amount if additional funds are appropriated or if fewer than four $10 million awards are made under this FOA. In this case, a budget revision would be required from each recipient for any upward adjustments to the ceiling amount. The funding will begin at or near the time of award and continue over the life of the stated project period of the CA, which will be for a period of three years from the date of award.

Interested parties should carefully read the instructions for preparation of the application. If material or forms are omitted, the application is received after the closing date, or for any other reason an applicant does not provide a complete application by the closing date, the application will be rejected and will not be evaluated. DOE/NNSA does not intend to reissue this FOA. Therefore, any qualified candidates are encouraged to submit applications at this time.

In the event that a recipient withdraws from the award anytime within twelve months after the award date, DOE/NNSA reserves the right to consider the next most qualified candidate from this FOA for evaluation to determine if it meets the requirements of the FOA.

B. BACKGROUND

Mo-99 is a critical radioisotope whose decay byproduct technetium-99m (Tc-99m), is used in approximately 40,000 nuclear medicine diagnostic procedures performed daily in the United States. Its primary uses include diagnosing heart disease, treating cancer, and studying organ structure and function. The isotope’s 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 community’s 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. Until any U.S. producer enters the market, the United States must import all of its supply from foreign producers, which in some instances use proliferation-sensitive HEU in its production processes. 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.

Over the years, technical difficulties and shutdowns at the major global Mo-99 production facilities have caused serious Mo-99 supply shortages. The supply disruptions caused by the shutdown of these reactors and production facilities resulted in severe impacts on the medical community and often forced U.S. medical facilities to ration material for procedures during the time when these facilities were shut down, impacting the medical community’s ability to carry out critical patient procedures. Most recently, the stoppage of Mo-99 production in South African facilities for several consecutive months resulted in spot shortages worldwide, demonstrated the fragility of the global supply chain, and reinforced the need for the U.S. to develop a domestic supply of this critical isotope.

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 is issuing this FOA 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 community’s reliance on foreign supplies of Mo-99.

In responding to this FOA, each applicant will be judged in large part on its ability to explain to DOE/NNSA the current state of its technology and its plan, costs, and schedule to scale up to commercial production. Unlike in previous FOAs, DOE/NNSA will not set one target date for commercial production. Instead, each applicant to this FOA will provide DOE/NNSA with its planned date to production, and will be judged on the credibility of its technical, logistical, and business plans to reach production by that date and to sustain its production thereafter. More details on DOE/NNSA’s review criteria are specified in Section V.B of this FOA.

C. PROGRAM OBJECTIVES

DOE/NNSA’s Mo-99 program objective is to accelerate the establishment of a reliable non-HEU-based Mo-99 production capability in the United States sufficient to supply the U.S. Mo-99 demand as soon as possible. This supply should rely on diversified technologies that utilize a variety of facilities to ensure that U.S. patients will have access to the Mo-99 they need without interruption. To achieve this objective, NNSA seeks cooperative agreement partners already undertaking projects to produce Mo-99 without HEU that can demonstrate both technically viable and sufficient private investment to bring their projects to commercial production and become long-term producers in the U.S. Mo-99 market.

D. TECHNOLOGY DEVELOPMENT

The DOE/NNSA approach is technology neutral, meaning that DOE/NNSA is pursuing the demonstration of multiple technical pathways to encourage as broad a technical spectrum as possible of domestic production methodologies. A diverse and reliable Mo-99 production industry in the United States should be developed to avoid a single point of failure, recognizing that the market will be the final arbiter of which technologies succeed.

In addition to funding cooperative agreements, DOE/NNSA solicits proposals on an annual basis to make available the resources of the national laboratories that have conducted research and development for non-HEU-based Mo-99 production methods. There are two avenues of engagement with the laboratories. Recipients can work with the national laboratories through a Strategic Partnership Project agreement executed in accordance with DOE/NNSA Order 481.1C and DOE Manual 481.1-1A and other applicable DOE/NNSA requirements whereby the national laboratories are required to protect the proprietary information of the recipient in accordance with the terms of the Strategic Partnership Project agreement. The second alternative is through directed research funded by DOE/NNSA which may be provided for the recipient’s use on a non-proprietary basis as DOE/NNSA and the recipients may agree in the cooperative agreements. These avenues are now also available to potential domestic Mo-99 producers that do not have cooperative agreements with NNSA.

While the national laboratories can assist recipients in research and development and demonstration of technologies during the period of the cooperative agreement, the goal of the agreement is to ensure a totally commercial venture emerges. The cooperative agreement cannot be utilized to support a commercial-governmental/national laboratory partnership for commercial production.

E. COOPERATIVE AGREEMENTS AND COST SHARING

The cooperative agreement will be the instrument for the arrangement between DOE/NNSA and the recipient for the production of Mo-99. These agreements are targeted for the demonstration and commercial application of existing technologies rather than on the invention of new technologies.

DOE/NNSA and the recipient will provide matching funds to underwrite the collaborative project, and will share to some extent in the technical results from the joint effort. To protect intellectual property, a recipient may apply for an Advanced Waiver of Patent Rights under 10 CFR Part 784 to seek a waiver following its award of the U.S. rights to patents for work performed under the cooperative agreement.

A 50%/50% cost-sharing arrangement between the U.S. Government and each recipient of federal funding in support of commercial application demonstration projects, such as the cooperative agreements contemplated under this FOA, is required by the Energy Policy Act of 2005, Section 988, codified at 42 U.S.C. § 16352. This statute also prohibits DOE/NNSA from counting “proceeds from the prospective sale of an asset of an activity,” such as the commercial sale of Mo-99 products, towards a recipient’s required cost-sharing contribution. Therefore, applications that propose less than a 50 percent cost share contribution from non-federal sponsors, or that propose the use of proceeds from the sale of assets generated under the activities of a cooperative agreement, shall not be considered for award. Repayment of the Federal share of the cost-shared activity shall not be required as a condition of the award.

Only work that is properly within the scope of activities stated in the cooperative agreement may be reimbursed by DOE/NNSA or counted as the recipient’s cost sharing contribution. Pre-award work for up to 90 days may be allowed by the Grants Officer. Recipients are reminded that all pre-award costs are incurred entirely at the risk of the recipient.

DOE/NNSA’s portion of the agreement will have a ceiling of $10 million. If the total cost of the project is less than $20 million, the cost of each party’s cost share will be 50% of the total cost. Any project cost above $20 million must be borne by the recipient. DOE/NNSA reserves the right to increase the maximum ceiling amount if additional funds are appropriated or if fewer than four $10 million awards are made under this FOA. DOE/NNSA also reserves the right to award more than four Cooperative Agreements if additional funds are appropriated. Each awardee will be required to submit a budget revision for any upward adjustments to the ceiling amount. Funding for the cooperative agreement will begin at or near the time of award as specified in the award document.

F. NATIONAL ENVIRONMENTAL POLICY ACT (NEPA)

The National Environmental Policy Act (NEPA) requires federal agencies to consider the environmental consequences of proposed actions before making decisions. To comply with NEPA, the DOE/NNSA must follow both the Council on Environmental Quality (CEQ) regulations (40 CFR Parts 1500-1508) and 10 CFR Part1021, respectively.

There are three levels of NEPA reviews, an Environmental Impact Statement (EIS), an Environmental Assessment (EA), and a Categorical Exclusion (CX) determination. Categorical exclusions are categories of actions that DOE/NNSA has determined do not individually or cumulatively have a significant effect on the human environment, and for which, therefore, neither an EA nor an EIS normally is required. DOE/NNSA's categorical exclusions are listed in Appendices A and B to Subpart D of its NEPA regulations, available at: http://www.gc.energy.gov/NEPA/documents/nepa1021_rev.pdf. Conducting NEPA Reviews for the development of EIS’s and EA’s often take months to complete and require a rigorous public review process.

Applicants may include in their proposed scopes of work activities that are categorically excluded under NEPA and activities that are not categorically excluded. However, all proposed activities must be executable within the 3-year term of the cooperative agreement and applicants’ proposed schedules to production must take into account any schedule impacts caused by the inclusion of activities that will require additional NEPA review.

G. REGULATORY APPROVAL

The recipient will be expected to develop all documentation, interpret all regulations, submit and defend its relevant information to the Nuclear Regulatory Commission (NRC) and/or state regulator to receive a construction and operating license or other approvals, licenses or permits necessary for operation of its facility. The development of all documentation and the physical product for Mo-99 must also be prepared and submitted to the U.S. Food and Drug Administration (FDA) for approval to distribute and market its product. Applicants must include the impacts of planned regulatory reviews in the project schedules they submit in part of their application.

H. WASTE TREATMENT AND DISPOSTION

The application should include a discussion of the applicant’s waste disposition strategy as part of the project narrative listed in Section 4.C.b.iii.

I. TECHNICAL SCOPE

Applications are sought for completion of the technical objective described below:

The ability of the recipient to establish the capability to produce at least 3,000 6-day curies of Mo-99 per week, steady state, without the use of HEU in the United States.

J. TEAMING CONSIDERATIONS

Teaming with organizations with advanced technical and scientific competencies, pharmaceutical production and distribution capabilities, program and project management, facility design and construction, NRC and FDA licensing expertise and other needed specialties is permitted and considered advantageous to successfully complete this complex project. Applicants may include national laboratories or other Federally Funded Research and Development Centers (FFRDCs) or other DOE/NNSA Management and Operations (M&O) contractors in their teaming arrangements as long as they are not team leaders and are not performing a significant portion of the work. The FFRDC contractor effort, in aggregate, shall not exceed 50% of the total estimated cost of the project, including the applicant’s and the FFRDC contractor’s portions of the effort. The participation of the national laboratories or other FFRDCs or DOE/NNSA M&O contractors must be limited to research and development work that they are uniquely qualified to provide. The purpose of the cooperative agreements contemplated under this FOA is to accelerate the establishment of sustainable commercial ventures that have the ability to produce 3,000 6-day curies per week, steady state, of Mo-99 in the United States without the use of HEU.

Therefore, to be eligible for award, applications must demonstrate that their technical approach will not require the further participation of the federal government, the national laboratories, other FFRDCs or other DOE/NNSA M&O contractors for the commercial production of Mo-99 beyond the completion date of the cooperative agreements.

K. SUBSTANTIAL INVOLVEMENT

DOE/NNSA and the recipient(s) will enter into a cooperative agreement for the purpose of performing research and development as appropriate, conceptual and preliminary design, routine administrative actions, preparation of technical documentation and studies, and process technology development and optimization that will expedite the establishment of a domestic capability to produce Mo-99 using a non-HEU process. Substantial involvement by DOE/NNSA is anticipated in the execution of the work scope of the cooperative agreement.

Section II - AWARD INFORMATION

A. TYPE OF AWARD INSTRUMENT

DOE/NNSA anticipates awarding up to four (4) demonstration and commercial application cooperative agreements under this funding opportunity announcement.

B. ESTIMATED FUNDING

Funding for all awards are contingent upon the availability of funds appropriated by Congress for the purpose of this program.

C. MAXIMUM AND MINIMUM AWARD SIZE

Ceiling (i.e., the maximum amount for an individual award made under this announcement): $10,000,000

The applicant’s budget should only include $10 million federal and $10 million applicant cost share for a maximum of $20 million in total project costs.

Note: DOE/NNSA reserves the right to increase the maximum ceiling amount or increase the number of awards made under this FOA if additional funds are appropriated. A budget revision will be required from each awardee for any upward adjustments to the ceiling amount.

D. EXPECTED NUMBER OF AWARDS

DOE/NNSA anticipates making up to 4 awards under this announcement. The number of awards will depend on, including but not limited to: the availability of appropriated funds; the number of applications fulfilling the requirements specified in this FOA; the results of the merit-based evaluations of each applicant’s ability to produce Mo-99 in the United States and establish the capability to deliver a significant percentage of the Mo-99 demanded by the U.S. healthcare community, without the use of HEU to the U.S. market. DOE/NNSA reserves the right to fund, in whole or in part, any, all, or none of the applications, or make fewer awards at its sole discretion.

E. NUMBER OF YEARS

DOE/NNSA anticipates making awards with a period of performance of 3 years.

F. TYPE OF APPLICATION

Consistent with Section 988 of The Energy Policy Act of 2005 (Public Law 109-58), cooperative agreements awarded under this FOA will fund demonstration and commercial application activities. All applicants, including existing cooperative agreement holders, will submit applications for new cooperative agreements.

Section III - ELIGIBILITY INFORMATION

A. ELIGIBLE APPLICANTS

In accordance with 2 CFR 910.126, the FOA and award of Cooperative Agreements for the demonstration and commercial scale production of a reliable, domestic supply of Molybdenum-99 without the use of Highly Enriched Uranium (HEU) is to be restricted. Only U.S. entities with existing technologies to achieve commercial-scale production of Molybdenum-99 in the United States in accordance with the goals of this FOA may submit applications. Any commercial entity which already has the capability to currently produce at least 3,000 6-day curies of Mo-99 per week, steady state, will be eliminated from consideration.

National laboratories, all DOE/NNSA Management and Operating contractors, and other Federally Funded Research and Development Centers (FFRDC) are not eligible to apply for an award under this FOA. Nevertheless, these entities may be included in teaming arrangements of the applicants or as subcontractors subject to the conditions in Section I.J of this FOA.

The scope of work to be performed by the FFRDC contractor may not be more significant than the scope of work to be performed by the applicant. In addition, the applicant must request from the DOE/NNSA cognizant field contracting officer, authorization in writing for the use of a DOE/NNSA FFRDC contractor on the proposed project and this authorization must be submitted with the application. The following wording is acceptable for this authorization:

“Authorization is granted for the (Name) Laboratory to participate in the proposed project. The work proposed for the laboratory is consistent with or complimentary to the missions of the laboratory, will not adversely impact execution of the DOE/NNSA assigned programs at the laboratory, and will not place the laboratory in direct competition with the domestic private sector”.

The applicant, if successful, will be the responsible authority regarding the settlement and satisfaction of all contractual and administrative issues, including but not limited to, disputes and claims arising out of any agreement between the applicant and the FFRDC contractor. The applicant’s cost share requirement will be based on the total project, including the applicant’s and the FFRDC contractor’s portions of the effort.

B. COST SHARING

The applicant’s cost share must be at least 50% of the total allowable costs for demonstration and commercial application projects (i.e., the sum of the Government share, including FFRDC contractor costs if applicable, and the recipient share of allowable costs equals the total allowable cost of the project) and must come from non-Federal sources unless otherwise allowed by law. (See 2 CFR part 200 as amended by 2 CFR part 910 [DOE/NNSA Financial Assistance Regulation] for the applicable cost sharing requirements.)

Section IV - APPLICATION AND SUBMISSION INFORMATION

A. APPLICATION PACKAGE

All applicants must complete the mandatory forms as provided under this FOA. All documents that are attached as forms must be submitted in Adobe Portable Document Format (PDF) unless otherwise specified in this FOA (refer to Application Package Requirements Summary Listing (please refer to the table stated below). Attached PDF files must be plain files consisting of text, numbers, and images without editable fields, signatures, passwords, redactions, or other advanced features available in some PDF-compatible software. Do not use PDF portfolios or binders.

Please note: you may only use the following UTF-8 characters when naming your application attachments: A-Z, a-z, 0-9, underscore (_), hyphen (-), space, period. You must limit the file name to 50 or fewer characters. Attachments that do not follow this rule may cause the entire application to be rejected or cause issues during processing.

To avoid interfering with the selection of peer reviewers, only list collaborators that will have an active part in the project. General letters of support will not be used in making funding decisions.

Application forms and instructions are available at Grants.gov. To access these materials, go to http://www.grants.gov , select "APPLICANTS”, then select “Apply for Grants," and then select "Get Application Package” button. Enter the funding opportunity number (DE-FOA-0001925). Under the PACKAGE tab, select “Apply” under the Actions column, and under Option: 1 Apply Now Using Workspace, select the Login to Apply “Now” button. Follow the prompts in Workspace to complete the application package. You are encouraged to review the Applicant FAQs in Grants.gov as you prepare and submit your application.

B. LETTER OF INTENT AND PRE-APPLICATION

Letters of Intent and Pre-applications are not required.

C. CONTENT AND APPLICATION FORMS

Please complete all mandatory forms listed below:

1. Application for Federal Assistance SF 424 (R&R):

You must create a workspace using Grants.gov Workspace (see https://www.grants.gov/help/html/help/Applicants/CreateWorkspace.htm) to complete the workspace online forms and submit your application workspace package. Forms can either be completed online within a web browser or individual PDF forms from within the Forms tab of the Manage Workspace page can be downloaded and uploaded to Workspace when completed:

https://www.grants.gov/help/html/help/ManageWorkspaces/ManageWorkspaces.htm).

In Grants.gov Workspace, Complete SF-424 Fields First: The forms are designed to fill in common required fields across other forms, such as the applicant name, address, and DUNS number. To trigger this feature, an applicant must complete the SF-424 information first. Once it is completed, the information will transfer to the other forms. These forms are required and must be completed for all sub-awardees.

2. Required Application Forms:

The table below includes all forms each applicant and subawardee are required to complete and submit with their application package. The table provides location, format submission, and where forms should be attached within your application package. The Forms Table for Subawardees is located on Page 14 of the FOA.

Application Package Requirements Summary Listing The Applicant’s (Lead Institution) proposal must include the following documents:

NOTE: If forms identified as “mandatory” are not submitted with the application package by both the Lead Applicant and Subawardees, the application package will be considered non-responsive during the initial review, and will be eliminated from further consideration.

Document Name

Mandatory

Location / Instructions

Submission Format

Submission Attached to:

(Either Cert or Disclosure must be completed, as applicable)

Attachment 1

Attachment 3 Environmental Questionnaire

Section III for instructions

The Subawardee must be include the following documents:

NOTE: If forms identified as “mandatory” are not submitted with the application package by both the Lead Applicant and Subawardees, the application package will be considered non-responsive during the initial review, and will be eliminated from further consideration.

Document Name

Mandatory

Location

Submission Format

Submission Attached to:

Attachment #1

Excel

PDF

https://www.grants.gov/web/grants/forms/sf-424-family.html

PDF

Disclosure of Lobbying Activities

PDF

PDF

Subawardees Application File:

Applicant is responsible for uploading subawardees application; budget; budget justification; budget spreadsheet form; lobbying form; rate agreement; and assurances as part of the Grants.gov Application Package. Subawardees package must be uploaded as 1 file, use up to 10 letters of the subawardees name as the file name. Filenames should not exceed 50 characters. Attach file to “Attachments Form” in any field numbered 11-15.

a. Project Summary/Abstract (R&R Other Project Information Form - Field #7)

The project summary/abstract must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained document that identifies the name of the applicant, the project director/principal investigator(s), the project title, the objectives of the project, a description of the project, including methods to be employed, the potential impact of the project (i.e., benefits, outcomes), and major participants (for collaborative projects). This document must not include any proprietary or sensitive business information as the Department may make it available to the public after awards are made. The project summary must not exceed 2 pages when printed using standard 8.5" by 11" paper with 1" margins (top, bottom, left and right) {single spaced} with font not smaller than 11 point. The completed project summary/abstract must be attached to Field #7 on the Research and Related Other Project Information Form.

b. Project Narrative (R&R Other Project Information Form - Field #8)

As part of the application, each applicant must submit a project narrative. This project narrative must clearly discuss the total project lifecycle (of which the $20 million scope proposed by the applicant is a subset) and explain how and by when the applicant will produce 3,000 6-day curies per week of Mo-99 in the United States without the use of HEU on an ongoing basis. This narrative should be written to address the merit review criteria specified in Section V of this FOA. The project narrative must not exceed 110 pages, including cover page, table of contents, charts, graphs, maps, photographs, tables, and other pictorial presentations, when printed using standard 8.5" by 11" paper with 1 inch margins (top, bottom, left, and right) {single spaced} with font not smaller than 11 point. EVALUATORS WILL ONLY REVIEW THE NUMBER OF PAGES SPECIFIED IN THE PRECEDING SENTENCE. Do not include any Internet addresses (URLs) that provide information necessary to review the application, as the information contained in these sites will not be reviewed. Please mark all documents that include proprietary information accordingly. All applications must address and include the following information at a minimum as outlined below, and may include any additional information that the applicant believes is important to include:

i. Statement of Objectives: This section should provide a clear, concise statement of the specific objectives/aims of the proposed project. The Statement of Objectives may be released to the public by DOE/NNSA in whole or in part after award. It is therefore required that it shall not contain proprietary or confidential business information. The Statement of Objectives is generally less than 5 pages in total for the proposed work.

ii. Scope: This section should not exceed 2 pages and should summarize the effort and approach to achieve the objective(s) of the work.

iii. Technology Plan and Technical Maturity:

· A discussion of the overall state of the maturity of the applicant’s technology and project and the likelihood that the technology will result in the applicant’s ability to extract and distribute Mo-99 to the medical community on a commercial scale in the timeframe specified in the lifecycle project schedule. If applicable, the applicant should explain how it plans to scale its technology from laboratory-level demonstration to commercial-scale production.

· A lifecycle project schedule with performance milestones, including the following, as applicable. The project schedule should clearly show, at a minimum, each anticipated milestone’s start and completion date, and the schedule linkages between the milestones in the schedule:

· Process development

· Facility construction

· Facility licensing

· FDA/NRC approvals

· Transportation components such as shipping containers

· Initial and commercial production ramp up and sustainment

· Waste treatment and disposition

· Initial Mo-99 production

· Establishment of the capability to produce 3,000 6-day curies per week

· A discussion of the body of the applicant’s and its teaming members’ existing publications, research and other work on the topic of Mo-99 production and extraction processes. This should address the following at a minimum:

· Professional publications directly related to Mo-99 production, and/or medical isotope production (media coverage of the organization’s activities does not constitute professional publication);

· Technical maturation of experiments that relate to Mo-99 production and extraction;

· Experience in medical isotope production (Mo-99 or other medical isotopes) and facility operations for the commercial market;

· Key personnel of the applicant or its teaming members which have experience in the Mo-99 or other medical isotope production business, and their primary qualifications relating to the technical aspects of Mo-99 or medical isotope production; and

· Approval from the FDA for medical isotopes already in production, if any.

· A discussion of the patents or licenses currently held by the applicant or its teaming members and/or that the applicant must obtain in order to allow it to proceed with the demonstrations and ultimately to commercially exploit the applicable technologies.

· A discussion of prior financial investment in development work toward commercial production of Mo-99.

· A discussion of any partnerships or teaming arrangements with other companies, individuals or entities that provide key expertise in the Mo-99 production and/or extraction business, including companies that produce Technetium-99m generators.

· A discussion of current or past research, experimentation and/or hands-on work with Technetium-99m generators.

· A discussion of the applicant’s staffing plan to hire and retain a qualified, full-time work force to produce the necessary quantities of Mo-99.

· A discussion of plans for waste disposition of radioactive materials, including the potential use of the DOE/NNSA Uranium Lease and Take-Back Program, if applicable.

· A discussion of plans to produce, extract, process and distribute Mo-99 to U.S. generators or radio-pharmacies, after the capability is established.

iv. Risks: The applicant must discuss any foreseeable risks/obstacles for the technical, logistic and business aspects of the project that could impact the success of the project and include a plan for mitigating such risks, if any.

v. Infrastructure: The applicant must provide a summary of its available commercial infrastructure necessary to achieve and maintain long-term commercial-scale production, including key technologies, NRC licensing and FDA approvals, facilities, distribution and transportation, and waste management. If the applicant does not yet possess any of the commercial infrastructure necessary to achieve and maintain long-term commercial-scale production, it must discuss how it will develop and manage this infrastructure, including the same variables listed above. The applicant must specifically address the following at a minimum:

· Existing investment in physical infrastructure to support the commercial production of Mo-99.

· Necessary construction and operation of any and all additional facilities, including construction schedules and planned locations.

· Key partnerships for transportation of rapidly decaying Mo-99 with adequate infrastructure to ship to Technetium-99m generator manufacturers that would be responsible for distribution of Technetium-99m to the medical community and adequate infrastructure to ship the rapidly decaying Mo-99.

· Use of existing nuclear facilities licensed by the applicant or its team members through the NRC or state regulatory body, and information on additional regulatory licensing required to meet the objectives of this FOA.

· The applicant’s plan to manage the radioactive wastes resulting from its Mo-99 production.

vi. Business Management Plan

The applicant must include or address the following:

· A business case discussing how and why the cost of construction and operation of the facilities and equipment necessary to produce significant quantities of Mo-99 without the use of HEU, as proposed by the applicant, will be a cost-effective and viable long-term business venture;

· A lifecycle cost estimate for the project;

· A description of the applicant’s approach for obtaining the necessary investment to complete the project;

· A discussion of how and why the applicant is skilled in project and construction management and has the necessary tools to manage the project. This should also address key management personnel and their primary qualifications; and

· A discussion of the teaming arrangement, corporate structure and management infrastructure that has allowed the organization to successfully manage medical isotope(s) or similar business ventures in the past and how the applicant’s current or proposed teaming arrangement, corporate structure, management infrastructure and key management personnel will allow it to succeed on the Mo-99 project.

c. Bibliography & References, (R&R-Other Project Information Form-Field #9)

Provide a bibliography of any references cited in the Project Narrative. Each reference must include the names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication. Include only bibliographic citations. Applicants should be especially careful to follow scholarly practices in providing citations for source materials relied upon when preparing any section of the application. This attachment will not count in the project narrative page limitation. This completed form must be attached to Field #9 of the Research and Related Other Project Information Form.

d. Facilities And Other Resources (R&R Other Project Information Form - Field #10)

Identify the facilities (e.g., office, laboratory, computer, etc.) to be used at each performance site listed and, if appropriate, indicate their capacities, pertinent capabilities, relative proximity, and extent of availability to the project. Describe only those resources that are directly applicable to the proposed work. Provide any information describing the other resources available to the project such as machine and electronics shops. This completed form must be attached to Field #10 of the Research and Related Other Project Information Form.

e. Equipment (R&R Other Project Information Form - Field #11)

List major items of equipment already available for this project and, if appropriate, note the location and pertinent capabilities of each. If you are proposing to acquire equipment, describe comparable equipment, if any, already at your organization and explain why it cannot be used. Your equipment list must be attached to Field #11 of the Research and Related Other Project Information Form.

f. Other Attachments (R&R Other Project Information Form - Field #12)

The following additional documents are required to complete your application, which must all be attached to Field #12 of the Research and Related Other Project Information Form.

Biographical Sketch (Appendix 1): Provide a biographical sketch for the project director/principal investigator (PD/PI) and each senior/key person listed in the R&R Budget Form. A senior/key person is any individual who contributes in a substantive, measurable manner to the scientific/technical development or execution of the project, whether or not a salary is proposed for this individual. Sub-recipients and consultants must be included if they meet this definition. Provide the biographical sketch information as an Appendix 1.