PKG00262847-instructions.docx

DEPARTMENT OF ENERGY

NATIONAL NUCLEAR SECURITY ADMINISTRATION

OFFICE OF ACQUISITION MANAGEMENT

DEFENSE NUCLEAR NONPROLIFERATION

OFFICE OF MATERIAL MANAGEMENT AND MINIMIZATION (NA-23)

Commercial Domestic Production of Molybdenum-99 without the Use of Highly Enriched Uranium _____________________________________________________________________________________________

FUNDING OPPORTUNITY ANNOUNCEMENT (FOA) NUMBER:

DE-FOA-0002303

FOA TYPE: INITIAL

CFDA NUMBER: 81.009

11:59 PM (ET)

Registration and Application Submission

Questions

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/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. For instructions on registering for FedConnect, refer to the website: www.fedconnect.net.

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.

Grants.gov Application Submission and Receipt Procedures

This section provides the application submission and receipt instructions for U.S. Department of Energy/National Nuclear Security Administration (DOE/NNSA) program applications. Please read the following instructions carefully and completely.

1. Electronic Delivery The DOE/NNSA is participating in the Grants.gov initiative to provide the grant community with a single site to find and apply for grant funding opportunities. DOE/NNSA encourages applicants to submit their applications online through Grants.gov.

2. How to Register to Apply through Grants.gov

a. Instructions: Read the instructions below about registering to apply for DOE/NNSA funds. Applicants should read the registration instructions carefully and prepare the information requested before beginning the registration process. Reviewing and assembling the required information before beginning the registration process will alleviate last-minute searches for required information.

Organizations must have a Data Universal Numbering System (DUNS) Number, active System for Award Management (SAM) registration, and Grants.gov account to apply for grants. If individual applicants are eligible to apply for this funding opportunity, then you may begin with step 3, Create a Grants.gov Account, listed below.

Creating a Grants.gov account can be completed online in minutes, but DUNS and SAM registrations may take several weeks. Therefore, an organization's registration should be done in sufficient time to ensure it does not impact the entity's ability to meet required application submission deadlines.

Complete organization instructions can be found on Grants.gov here: https://www.grants.gov/web/grants/applicants/organization-registration.html

1) Obtain a DUNS Number: All entities applying for funding, including renewal funding, must have a DUNS Number from Dun & Bradstreet (D&B). Applicants must enter the DUNS Number in the data entry field labeled "Organizational DUNS" on the SF-424 form. For more detailed instructions for obtaining a DUNS Number, refer to:

https://www.grants.gov/web/grants/applicants/organization-registration/step-1-obtain-duns-number.html

2) Register with SAM: All organizations applying online through Grants.gov must register with the System for Award Management (SAM). Failure to register with SAM will prevent your organization from applying through Grants.gov. SAM registration must be renewed annually. For more detailed instructions for registering with SAM, refer to:

https://www.grants.gov/web/grants/applicants/organization-registration/step-2-register-with-sam.html

3) Create a Grants.gov Account: The next step is to register an account with Grants.gov. Follow the on-screen instructions or refer to the detailed instructions here: https://www.grants.gov/web/grants/applicants/registration.html

4) Add a Profile to a Grants.gov Account: A profile in Grants.gov corresponds to a single applicant organization the user represents (i.e., an applicant) or an individual applicant. If you work for or consult with multiple organizations and have a profile for each, you may log in to one Grants.gov account to access all of your grant applications. To add an organizational profile to your Grants.gov account, enter the DUNS Number for the organization in the DUNS field while adding a profile. For more detailed instructions about creating a profile on Grants.gov, refer to: https://www.grants.gov/web/grants/applicants/registration/add-profile.html

5) EBiz POC Authorized Profile Roles: After you register with Grants.gov and create an Organization Applicant Profile, the organization applicant's request for Grants.gov roles and access is sent to the EBiz POC. The EBiz POC will then log in to Grants.gov and authorize the appropriate roles, which may include the AOR role, thereby giving you permission to complete and submit applications on behalf of the organization. You will be able to submit your application online any time after you have been assigned the AOR role. For more detailed instructions about creating a profile on Grants.gov, refer to:

https://www.grants.gov/web/grants/applicants/registration/authorize-roles.html

6) Track Role Status: To track your role request, refer to:

https://www.grants.gov/web/grants/applicants/registration/track-role-status.html

b. Electronic Signature: When applications are submitted through Grants.gov, the name of the organization applicant with the AOR role that submitted the application is inserted into the signature line of the application, serving as the electronic signature. The EBiz POC must authorize people who are able to make legally binding commitments on behalf of the organization as a user with the AOR role; this step is often missed and it is crucial for valid and timely submissions.

3. How to Submit an Application to DOE/NNSA via Grants.gov Grants.gov applicants can apply online using Workspace. Workspace is a shared, online environment where members of a grant team may simultaneously access and edit different webforms within an application. For each funding opportunity announcement (FOA), you can create individual instances of a workspace.

Below is an overview of applying on Grants.gov. For access to complete instructions on how to apply for opportunities, refer to:

https://www.grants.gov/web/grants/applicants/workspace-overview.html

a. Create a Workspace: Creating a workspace allows you to complete it online and route it through your organization for review before submitting.

b. Complete a Workspace: Add participants to the workspace to work on the application together, complete all the required forms online or by downloading PDF versions, and check for errors before submission. The Workspace progress bar will display the state of your application process as you apply. As you apply using Workspace, you may click the blue question mark icon near the upper-right corner of each page to access context-sensitive help.

c. Adobe Reader: If you decide not to apply by filling out webforms you can download individual PDF forms in Workspace. The individual PDF forms can be downloaded and saved to your local device storage, network drive(s), or external drives, then accessed through Adobe Reader.

NOTE: Visit the Adobe Software Compatibility page on Grants.gov to download the appropriate version of the software at: https://www.grants.gov/web/grants/applicants/adobe-software-compatibility.html

d. Mandatory Fields in Forms: In the forms, you will note fields marked with an asterisk and a different background color. These fields are mandatory fields that must be completed to successfully submit your application.

e. 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. Once it is completed, the information will transfer to the other forms.

f. Submit a Workspace: An application may be submitted through workspace by clicking the Sign and Submit button on the Manage Workspace page, under the Forms tab. Grants.gov recommends submitting your application package at least 24-48 hours prior to the close date to provide you with time to correct any potential technical issues that may disrupt the application submission.

g. Track a Workspace Submission: After successfully submitting a workspace application, a Grants.gov Tracking Number (GRANTXXXXXXXX) is automatically assigned to the application. The number will be listed on the Confirmation page that is generated after submission. Using the tracking number, access the Track My Application page under the Applicants tab or the Details tab in the submitted workspace.

For additional training resources, including video tutorials, refer to: https://www.grants.gov/web/grants/applicants/applicant-training.html

Applicant Support: Grants.gov provides applicants 24/7 support via the toll-free number 1-800-518-4726 and email at support@grants.gov. For questions related to the specific grant opportunity, contact the number listed in the application package of the grant you are applying for.

If you are experiencing difficulties with your submission, it is best to call the Grants.gov Support Center and get a ticket number. The Support Center ticket number will assist the DOE/NNSA with tracking your issue and understanding background information on the issue.

4. Timely Receipt Requirements and Proof of Timely Submission

a. Online Submission. All applications must be received by 11:59 PM Eastern time on the due date established for each program. Proof of timely submission is automatically recorded by Grants.gov. An electronic date/time stamp is generated within the system when the application is successfully received by Grants.gov. The applicant with the AOR role who submitted the application will receive an acknowledgement of receipt and a tracking number (GRANTXXXXXXXX) from Grants.gov with the successful transmission of their application. This applicant with the AOR role will also receive the official date/time stamp and Grants.gov Tracking number in an email serving as proof of their timely submission.

When DOE/NNSA successfully retrieves the application from Grants.gov, and acknowledges the download of submissions, Grants.gov will provide an electronic acknowledgment of receipt of the application to the email address of the applicant with the AOR role who submitted the application. Again, proof of timely submission shall be the official date and time that Grants.gov receives your application. Applications received by Grants.gov after the established due date for the program will be considered late and will not be considered for funding by DOE/NNSA.

Applicants using slow internet, such as dial-up connections, should be aware that transmission can take some time before Grants.gov receives your application. Again, Grants.gov will provide either an error or a successfully received transmission in the form of an email sent to the applicant with the AOR role attempting to submit the application. The Grants.gov Support Center reports that some applicants end the transmission because they think that nothing is occurring during the transmission process. Please be patient and give the system time to process the application.

NOTE: Applications submitted via FedConnect will not be accepted

TABLE OF CONTENTS

Section I – FUNDING OPPORTUNITY DESCRIPTION 8

Section II – AWARD INFORMATION 11

Section III – ELIGIBILITY INFORMATION 13

Section IV – APPLICATION & SUBMISSION INFORMATION 13

Section V – APPLICATION REVIEW INFORMATION 26

Section VI – AWARD ADMINISTRATION INFORMATION 29

Section VII – QUESTIONS/AGENCY CONTACTS 32

Section VIII – OTHER INFORMATION 33

APPENDIX A – Data Management Plan Guidance 36

APPENDIX B – Budget Guidance 39

Section I - FUNDING OPPORTUNITY DESCRIPTION

A. DESCRIPTION

The U.S. Department of Energy 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 one or more Cooperative Agreements to 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, 2020 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.

The applicant’s proposal will be evaluated, in accordance with Section V of this FOA, to measure the degree to which the applicant’s approach will enable their project to produce and sell at least 1,500 6-day Ci/week of Mo-99 without the use of HEU to the U.S. market on or before December 31, 2023.The applicant must also possess the ability and plans to increase the production of Mo-99 to 3,000 6-day Ci/week. This FOA is not intended to support Research and Development (R&D) projects, and the applicant must clearly demonstrate their ability to commercially produce Mo-99 on or before December 31, 2023.

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 can provide up to $35 million for one or more awards. The recipient will be required to match the U.S. Government contribution and must demonstrate funds are available by providing investor letters of commitment with each application. DOE/NNSA reserves the right to establish the maximum ceiling amount pre and post award. 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 Cooperative Agreement is terminated for any reason, following the award date, DOE/NNSA reserves the right to consider other qualified candidates from this FOA for evaluation and consideration.

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 of Mo-99 sufficient to meet the needs of the U.S. healthcare community, currently estimated at 4,500 6-day curies per week (Ci/week). The United States continues to import the majority of its supply from foreign producers. 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 often disrupted Mo-99 supplies to the United States. Spot shortages have occurred worldwide for a variety of reasons, demonstrating the fragility of the global supply chain, and reinforcing the need for the United States 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, domestic Mo-99 supply for U.S. patient care, and discouraging the use of proliferation-sensitive HEU in civilian applications. DOE/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 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; its ability and plans to increase the production of Mo-99 to 3,000 6-day Ci/week; its technical maturity; and its ability to explain to DOE/NNSA the current state of its technology. DOE/NNSA will evaluate the ability to implement Mo-99 commercial deployment in the U.S. market by December 31, 2023. Each applicant 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 production deployment of a reliable non-HEU-based Mo-99 production capability in the United States as soon as possible. To achieve this objective, DOE/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

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 avenue is through directed research funded by DOE/NNSA, which may be provided for the recipient’s use on a non-proprietary basis. These avenues are also available to potential domestic Mo-99 producers that do not have Cooperative Agreements with DOE/NNSA.

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 domestic production of a reliable supply of Mo-99 without the use of HEU, rather than R&D or 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 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. Investor Letters of Commitment will be required as part of the application.

Only work that is 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 may have a ceiling up to $35 million. However, the applicant is welcome to propose less than $35M based on their project requirements. Any project cost above $35 million must be borne by the recipient. DOE/NNSA reserves the right to increase the maximum ceiling amount 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 in the decision-making process. 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 EISs and EAs 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 achieve U.S. commercial Mo-99 production of at least 1,500 6-day Ci/week without the use of HEU in its facility or facilities 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.

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 Institutions of Higher Education in their teaming arrangements as long as they are not team leaders and are not performing a significant portion of the work. The participation of the national laboratories must be limited to research and development work that they are uniquely qualified to provide, and the financial arrangement is with the applicant directly.

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, or other DOE/NNSA M&O contractors for the commercial production of Mo-99 beyond the completion date of the Cooperative Agreement.

K. SUBSTANTIAL INVOLVEMENT

DOE/NNSA and the recipient(s) will enter into a Cooperative Agreement for the purpose of domestic production of a reliable supply of Mo-99 without the use of HEU. 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 one or more commercial Cooperative Agreements under FOA.

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): $35,000,000

The applicant’s budget shall not exceed $35 million federal and $35 million applicant cost share for a maximum of $70 million in total project costs. The applicant is welcome to propose less than $35M based on their project requirements.

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

D. EXPECTED NUMBER OF AWARDS

DOE/NNSA anticipates making one or more awards under this announcement. The number of awards will depend on factors including but not limited to: the availability of appropriated funds; the number of applications fulfilling the requirements specified in this FOA; and the results of the merit-based evaluations of each applicant’s ability to achieve U.S. commercial Mo-99 production of at least 1,500 6-day Ci/week in its facility or facilities without the use of HEU on or before December 31, 2023 and the ability and plan to increase the production of Mo-99 to 3,000 6-day Ci/week in its facility or facilities. DOE/NNSA reserves the right to fund, in whole or in part, any, all, or none of the applications at its sole discretion.

E. NUMBER OF YEARS

DOE/NNSA anticipates making awards with a maximum 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 activities resulting in commercial production. 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 commercial scale production of a reliable, domestic supply of molybdenum-99 (Mo-99) without the use of highly enriched uranium (HEU) is to be restricted. 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, all DOE/NNSA Management and Operating contractors, and Universities and Institutions of Higher Education) are not eligible to apply for an award under this FOA. However, applicants may include Institutions of Higher Education in their teaming arrangements as long as they are not team leaders and are not performing a significant portion of the work subject to the conditions in Section I.J of this FOA. The contractor effort, in aggregate, shall not exceed 50% of the total estimated cost of the project, including the applicant’s and the contractor’s portions of the effort. The participation of the national laboratories must be limited to research and development work that they are uniquely qualified to provide, and the financial arrangement is with the applicant directly.

The scope of work to be performed by the contractor may not be more significant than the scope of work to be performed by the applicant.

B. COST SHARING

The applicant’s cost share must be at least 50% of the total allowable costs for commercial production projects (i.e., the sum of the Government share 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-0002303). 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. If applicable, these forms are also required for all sub-awardees.

2. Required Application Forms:

The table below includes all forms each applicant and sub-awardee 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.

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 your application package, 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:

Document Name

Mandatory

Location / Instructions

Vendor quotes, and supply list

Excel Budget

Yes

Sample of an Excel Budget Form is located in Fedconnect.net.

As Attachment 1.

Applicant generated.

Please include only the yearly totals from Construction Budget Form (SF-424-C) on a separate line item in your Excel Budget From.

Attachment Field #12 “Research and Related Other Project Information Form”

Construction Budget Form

SF-424 C

Yes, Submit only if project involves Construction Costs.

Grants.gov Workspace under Manage Workspace Tab, Forms Tab. Must submit a Construction Budget Form (SF-424-C) for each year of the project.

Attachment Field #12 “Research and Related Other Project Information Form”

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

Projects only.

Assurances for Construction Programs

SF-424D

Yes-Submit only if project Involves Construction Costs.

(Contains 15 Fields)

Use for item numbers # 13-17

Applicant Generated

in Grants.gov Workspace

(See page 25)

(NEPA

Instructions /Guidance

Fedconnect.net Environmental Questionnaire Attachment 3

Applicant to provide.

NOTE: THIS SECTION IS ONLY APPLICABLE IF APPLICANT PROVIDES FUNDING TO A SUB-AWARDEE /(SUB-APPLICANT)- THIS SECTION DOES NOT APPLY TO

SUB-CONTRACTS /CONTRACTORS

The Sub-awardee must include the following documents:

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

Document Name

Mandatory

Location

(Sample)

Attachment #1

Excel

PDF

Construction Budget Form

SF-424 C

or Non-Construction Budget Form

(SF-424-C)

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

PDF

Disclosure of Lobbying Activities

PDF

Or Assurances for Construction Programs (SF-424-D)

PDF

Sub-awardees Application File:

Applicant is responsible for uploading sub-awardees application; budget; budget justification; budget spreadsheet form; lobbying form; rate agreement; and assurances as part of the Grants.gov Application Package. Sub-awardees package must be uploaded as 1 file, use up to 10 letters of the sub-awardees 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 Cooperative Agreement proposed amount is a subset) and explain how the applicant will 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 how the applicant possesses the ability to increase the production of Mo-99 to 3,000 6-day Ci/week. The narrative should also explain how the applicant believes it meets the eligibility requirements of this FOA. 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 build, license, and operate a facility or facilities to produce commercially acceptable Mo-99 to the U.S. medical community with a capacity of at least 1,500 6-day Ci/week without the use of HEU on or before December 31, 2023. The applicant must also clearly describe how they possess the ability to increase the production of Mo-99 to 3,000 6-day Ci/week. 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, in the form of a Gantt chart or equivalent, with accurate, adequate, and realistic performance milestones, including the following, as applicable. The milestones proposed should be very specific, achievable and clearly described. The project schedule should clearly show, at a minimum, detailed activities with durations, predecessors and successors, that are logically driven, at varying levels to establish a path forward in meeting project milestone completion dates, a critical path, as well as each anticipated milestone’s start and completion date. A Predecessor/Successor Report should also be included. The proposed milestones in each application will be reviewed and approved prior to award. Some examples of milestones are listed below:

· Process development

· Facility construction

· Facility licensing

· FDA approvals

· NRC/State 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 1,500 6-day Ci/week by December 31, 2023 or sooner and the ability and plans to increase to 3,000 6-day Ci/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…