2024-NIST-RMSC-01 NOFO_.pdf

2024-NIST-RMSC-01

Notice of Funding Opportunity January 10, 2024

NOTICE OF FUNDING OPPORTUNITY (NOFO)

Regenerative Medicine Standards Curricula Development Program (RMSC)

EXECUTIVE SUMMARY

• Federal Agency Name: National Institute of Standards and Technology (NIST), United States Department of Commerce (DoC)

• Funding Opportunity Title: Regenerative Medicine Standards Curricula Development Program

• Announcement Type: Initial

• Funding Opportunity Number: 2024-NIST-RMSC-01

• Assistance Listing (CFDA Number): 11.620: Science, Technology, Business and/or Education Outreach,

• Dates: Full Applications must be received at Grants.gov no later than 11:59 p.m.

Eastern Time, March 10, 2024. Applications received after this deadline will not be reviewed or considered.

Applicants should be aware, and factor in their application submission planning, that the Grants.gov system closes periodically for routine maintenance.

Applicants should visit Grants.gov for information on any scheduled closures.

NIST expects to complete its review, selection of successful applicants, and award processing by June 2024. NIST expects the earliest start date for awards under this NOFO to be July 2024.

• Application Submission Address: Applications must be submitted using Grants.gov. Paper applications will not be accepted.

• Funding Opportunity Description: The NIST Regenerative Medicine Standards Curricula Development Program is seeking applications from eligible applicants for activities to develop and implement undergraduate or graduate level curriculum, or a continuing education training for the existing workforce to support broader implementation of critical underpinning standards in regenerative medicine.

The recipients should expect to work with NIST to help prioritize and select regenerative medicine documentary standards for course development and to develop educational content for standards that are supported by NIST scientific programs. The recipients will incorporate regenerative medicine documentary standards, standards development, standards implementation, and https://www.grants.gov/ https://www.grants.gov/

Notice of Funding Opportunity January 10, 2024 standardization information and content into seminars, modules, courses, laboratory training, and learning resources.

• Anticipated Amounts: In Fiscal Year 2024 (FY24), NIST anticipates funding two

(2) or more awards for up to $250,000 per award per year with a project performance period of up to three (3) years.

• Funding Instrument: COOPERATIVE AGREEMENT

• Eligibility: Eligibility for the program listed in this NOFO is open to all non- Federal entities. Eligible applicants include accredited institutions of higher education; non-profit organizations; for-profit organizations incorporated in the United States; state, local, territorial, and Indian tribal governments; foreign public entities; and foreign organizations. Please note that individuals and unincorporated sole proprietors are not considered “non-Federal entities” and are not eligible to apply under this NOFO. Although Federal entities are not eligible to receive funding under this NOFO, they may participate as unfunded collaborators.

• Cost Sharing Requirements: Non-federal cost share is not required.

Table of Contents I. Program Description

II. Federal Award Information

III. Eligibility Information

IV. Application and Submission Information

V. Application Review Information

VI. Federal Award Administration Information

VII. Federal Awarding Agency Contacts

VIII. Other Information

FULL ANNOUNCEMENT TEXT

I. Program Description

Program Description. Regenerative medicine therapy, including cell therapy, gene therapy, and therapeutic tissue engineering, provides unprecedented potential to treat, modify, reverse, or cure previously intractable diseases, such as cancer and organ failures. Broad clinical translation and patient access requires advances in manufacturing technologies and measurements to ensure the safety, quality, and consistency of the therapy and to reduce the cost. The NIST Regenerative Medicine Program is committed to solving the measurement challenges of this fast-moving sector of the bioeconomy by providing underpinning measurement infrastructure and platform technologies, as well as standards to

Notice of Funding Opportunity January 10, 2024 promote measurement and manufacturing innovation, improve supply chain resilience, and support characterization and testing to facilitate regulatory approval.

The NIST Regenerative Medicine program is working closely with stakeholders to develop global documentary standards needed to advance product development, translation, and commercialization for regenerative medicine.

In this notice, NIST seeks applications for the development and implementation of educational programs that strengthen and enhance utilization of standards and workforce preparedness to support regenerative medicine product development.

Applications should at a minimum include development of training programs (“proposed programs”) for at least one of the following standards that align with NIST scientific programs:

• ISO 20391-1:2018 Cell counting Part 1: General guidance on cell counting methods

• ISO 20391-2:2019 Cell counting Part 2: Experimental design and statistical analysis

• ISO 23033:2021 Biotechnology — Analytical methods — General requirements and considerations for the testing and characterization of cellular therapeutic products

• ASTM F3294-18 Standard Guide for Performing Quantitative Fluorescence Intensity Measurements in Cell-based Assays with Widefield Epifluorescence Microscopy.

• ISO 5058-1:2021 Biotechnology — Genome editing — Part 1: Vocabulary

• ISO 20395:2019 Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR

• ISO 20688-1:2020 Biotechnology — Nucleic acid synthesis — Part 1:

Requirements for the production and quality control of synthesized oligonucleotides

• ISO 20397-1:2022 Biotechnology — Massively parallel sequencing — Part 1:

Nucleic acid and library preparation

• ISO 20397-2:2021 Biotechnology — Massively parallel sequencing — Part 2:

Quality evaluation of sequencing data

• ISO 24190:2023 Biotechnology — Analytical methods — Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses

• ISO/TS 24420:2023 Biotechnology — Massively parallel DNA sequencing — General requirements for data processing of shotgun metagenomic sequences

• ISO 24421:2023 Biotechnology — Minimum requirements for optical signal measurements in photometric methods for biological samples

Additional standards not listed above can also be addressed. Helpful resources for identifying relevant standards for regenerative medicine standards training programs include the Food and Drug Administration (FDA) Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies (Guidance https://www.fda.gov/media/159237/download

Notice of Funding Opportunity January 10, 2024 for Industry, October 2023) and the Regenerative Medicine Standards Portal maintained by the Standards Coordinating Body (SCB).

Proposed programs should include plans for recruitment of instructors with appropriate qualifications and technical background for teaching and/or developing the course curriculum. Plans should also include recruitment of trainees from the regenerative medicine sector to participate in the developed programs.

Proposed programs should include implementation of the course and the evaluation of the success of the course including assessments of knowledge of course materials.

Proposed programs may include courses, units or modules, independent study projects, internships or other possible training experiences, student competitions or other curriculum elements and training tools or resources. Related purchases and installation of equipment may also be included.

Activities involving researching a potential area for a project is not within the scope of the NIST Regenerative Medicine Standards Curricula Development program and will not be funded; ideas for curriculum projects should be fully developed prior to submitting an application for consideration. Any activities involving the conduct of research should be limited to addressing needs that directly support curriculum development and/or implementation.

A critical factor in effective workforce training is the sustainability and transferability of training infrastructure. As such, it is important that applications consider and address the challenges associated with sustaining, advancing, and sharing an effective program. Documentation, community engagement, and other forms of dissemination geared towards expanded adoption and long-term utility of concepts and tools is critical and should be a supported component of any successful application.

NIST’s mission is to drive innovation and industrial competitiveness through measurement science and standards. One component of this mission is NIST’s ongoing effort to develop a diverse, world-class pool of scientists and engineers to engage in NIST's measurement science and standards research, and to support the development of a general population that understands and appreciates measurement science and standards. NIST also seeks to collaborate with a wide range of organizations, including but not limited to minority-serving institutions such as Historically Black colleges and universities, as well as community colleges, in support of NIST's mission.

The statutory authority for the NIST Regenerative Medicine Standards Curricula Development Program is 15 U.S.C. §§ 272(b) and (c).

https://portal.standardscoordinatingbody.org/

Notice of Funding Opportunity January 10, 2024

II. Federal Award Information

1. Funding Instrument The funding instrument that will be used is a Cooperative Agreement. Where cooperative agreements are used, the nature of NIST’s “substantial involvement” will generally include collaboration with the recipient organization in developing and implementing the approved scope of work, consistent with the definition of cooperative agreement in 2 CFR § 200.1.

2. Multi-Year Funding Policy

When a proposal for a multi-year award is approved, funding will usually be provided for only the first year of the program. If a project is selected for funding, NIST has no obligation to provide any additional funding in connection with that award. Continuation of an award to increase funding or extend the period of performance is at the sole discretion of NIST. Continued funding will be contingent upon satisfactory performance, continued relevance to the mission and priorities of NIST, and the availability of funds. Under this NOFO, NIST may elect to fully fund awards or to fund awards incrementally, in accordance with the Multi-Year Funding policy.

3. Funding Availability

In FY24, NIST anticipates funding two (2) or more awards for up to $250,000 per award per year with a project performance period of up to three (3) years.

4. Indirect (F&A) Costs

NIST will reimburse applicants for proposed indirect (F&A) costs in accordance with 2 CFR § 200.414. Applicants proposing indirect (F&A) costs must follow the application requirements set forth in Section IV of this NOFO.

III. Eligibility Information

1. Eligible Applicants Eligibility for the program listed in this NOFO is open to all non-Federal entities. Eligible applicants include accredited institutions of higher education;

non-profit organizations; for-profit organizations incorporated in the United States; state, local, territorial, and Indian tribal governments; foreign public entities; and foreign organizations. Please note that individuals and unincorporated sole proprietors are not considered “non-Federal entities” and are not eligible to apply under this NOFO. Although Federal entities are not eligible to receive funding under this NOFO, they may participate as unfunded collaborators.

2. Cost Sharing or Matching funds ARE NOT required for awards issued pursuant to this NOFO.

Notice of Funding Opportunity

IV. Application and Submission Information

1. Address to Request Application Package

The application package is available at Grants.gov under Funding Opportunity Number 2024-NIST-RMSC-01.

2. Content and Form of Application Submission. Set forth below are the required content and form of applications submitted pursuant to this NOFO.

a. Required Forms and Documents. The Application must contain the following:

(1) SF-424, Application for Federal Assistance. The SF-424 must be signed by an authorized representative of the applicant organization.

For SF-424, Item 8.d. Zip/Postal Code field, should reflect the Zip code + 4 (#####-####) format.

For SF-424, Item 12, should list the NOFO number 2024-NIST-RMSC- 01.

SF-424, Item 18, should list the total budget information for the duration of the project.

The list of certifications and assurances referenced in Item 21 of the SF-424 is contained in the Federal Financial Assistance Certifications and Representations (Certs and Reps) as part of the SAM.gov entity registration.

(2) SF-424A, Budget Information for Non-Construction Programs

The budget should reflect anticipated Federal and non-Federal expenses for the entire project, considering all potential cost increases, including cost of living adjustments.

a) The applicant should reflect each year of the project on the SF-

424A form that appears as part of the mandatory forms in the Grants.gov application package.

b) In Section A, the Grant Program Function or Activity on Line 1 under Column (a) should be entered as Regenerative Medicine Standards Curricula Development Program, CFDA 11.620, or an abbreviation thereof. The Catalog of Federal Domestic Assistance Number on Line 1 under Column (b) should be entered as “11.620”. The total federal budget amount for the term of the award should be listed in Section A, Line 1, Column (e).

http://www.grants.gov/

Notice of Funding Opportunity January 10, 2024

c) Section B, Column (1) of the SF-424A should reflect the costs for each object class category, to include indirect charges, for the first year of the award. These costs should reflect the total Federal share plus non-Federal cost share for each category. Section B, Column (2) of the SF-424A should reflect the costs for each object class category, to include indirect charges, for the second year of the award. These costs should reflect the total Federal share plus non-Federal cost share for each category. Section B, Column (3) of the SF-424A should reflect the costs for each object class category, to include indirect charges, for the third year of the award. These costs should reflect the total Federal share plus non- Federal cost share for each category.

d) Section C may be blank since Non-Federal cost sharing is not required for awards issued pursuant to this NOFO.

e) Section D requires a breakdown of the first year’s Federal share of the budget by quarter.

f) Section E requires the budget estimate of Federal funds needed for each year of the project. The budget estimate for the first year of the award should be entered in Section E, Line 16, Column (b).

The budget estimate for the second year of the award should be entered in Section E, Line 16, Column (c). The budget estimate for the third year of the award should be entered in Section E, Line 16, Column (d).

(3) CD-511, Certification Regarding Lobbying. Enter “2024-NIST-

RMSC-01” in the Award Number field. Enter the title of the application, or an abbreviation of that title, in the Project Name field.

(4) SF-LLL, Disclosure of Lobbying Activities (if applicable).

(5) Project Narrative. The Project Narrative is a word-processed document of no more than twenty (20) pages (double-spaced between lines), which is responsive to the program description and the evaluation criteria.

The page limit includes Cover Page; Table of Contents (if included); Project Narrative with all required information, including figures, graphs, tables, images, and pictures).

The projective narrative should contain the following information:

a. Executive Summary. An executive summary of the proposed project, consistent with the objectives, requirements and priorities of this program (see Section I. of this NOFO). The executive summary should include information indicating how each evaluation criterion (see Section V.1. of this NOFO) and its sub-

Notice of Funding Opportunity January 10, 2024 factors are addressed. A table can be helpful in providing this information. The executive summary should not exceed two (2) pages.

b. Project Approach and Project Execution Plan. A detailed discussion of the applicant’s approach in planning for and in executing the proposed project consistent with the objectives, requirements and priorities of this program (see Section I. of this NOFO). This section should provide a description of the proposed project plan and execution strategy sufficient to permit evaluation of the proposal, in accordance with details included in the proposal Evaluation Criteria (see Section V.1. of this NOFO).

c. Project Impacts and Evaluation: A detailed discussion of the: (i) anticipated impacts of the proposed project; (ii) methodology for identifying and evaluating project outcomes; and (iii) dissemination of project learnings consistent with the objectives, requirements, and priorities of this program.

d. Qualifications. A description of the qualifications of the key personnel, the time commitments of the key personnel, and how the project staff qualifications will enable them to complete the project work. This section should address the Qualifications and Experience of Key Personnel and Resource Availability evaluation criterion.

e. Dissemination Plan. A description of the applicant’s approach to broadly disseminate the results of the project to the public. The plan should include an approach to publish results in appropriate literature, and through presentations at public meetings or events.

(6) Resume(s) of Key Personnel. Resumes for all key personnel assigned to the project must be provided. Resumes are limited to two (2) pages per individual.

(7) Budget Narrative and Justification. There is no set format for the

Budget Narrative and Justification; however, further explanation must be provided for the specific cost categories and line items that you identified in the SF-424A form as well as any other information you deem necessary for NIST’s consideration.

The written justification should include the necessity and the basis for the cost, as described below. Proposed funding levels must be consistent with the project scope, and only allowable costs should be included in the budget. Information on cost allowability is available in the Uniform

Notice of Funding Opportunity January 10, 2024

Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards at 2 C.F.R. Part 200, which apply to awards in this program.

The Budget Narrative does not count against the twenty (20) page limit of the Project Narrative.

This section will be evaluated in accordance with the Budget Narrative evaluation criteria. It will also be reviewed to determine if all costs are reasonable, allocable, and allowable under 2 C.F.R. Part 200 Subpart E, Cost Principles.

Information needed for each budget category is as follows:

a) Personnel- At a minimum, the budget justification for all personnel should include the following: job title, commitment of effort on the proposed project in terms of average number of hours per week or percentage of time, salary rate, total personnel charges for each identified position on the proposed project, description of the role of the individual on the proposed project and the work to be performed.

b) Fringe Benefits– Fringe benefits for each position should be identified separately from salaries and wages and based on rates determined by organizational policy. The items included in the fringe benefit rate (e.g., health insurance, parking, etc.) should not be charged under another cost category.

c) Travel- For all travel costs, the budget justification for travel should include the following: destination; names or number of people traveling; dates and/or duration; mode of transportation, lodging and subsistence rates; and description of how the travel is directly related to the proposed project. For travel that is yet to be determined, please provide best estimates based on prior experience. If a destination is not known, an approximate amount may be used with the assumptions given for the location of the meeting.

d) Equipment- Equipment is defined as an item of property that has an acquisition cost of $5,000 or more (unless the organization has established lower levels) and an expected service life of more than one year. The budget justification should list each piece of equipment, the cost, and a description of how it will be used and why it is necessary to the successful completion of the proposed project. Please note that any general use equipment (computers, https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200

Notice of Funding Opportunity January 10, 2024 etc.) charged directly to the award should be allocated to the award according to expected usage on the project.

e) Supplies– Supplies are defined as all tangible personal property other than that described as equipment. Provide a list of each supply, and the breakdown of the total costs by quantity or unit of cost. Include the necessity of the cost for the completion of the proposed project.

f) Contractual (i.e., Contracts or Subawards)– Each contract or subaward should be treated as a separate item. Identify the cost and describe the services to be provided and the necessity of the subaward or contract to the successful performance of the proposed project. Contracts are for obtaining goods and services for the Non-Federal Entity’s own use and creates a procurement relationship with the contractor. A subaward is for the purpose of carrying out a portion of a Federal award and creates a Federal assistance relationship with the subrecipient.

g) Construction– Not an allowable cost under this NOFO.

h) Other Direct Costs– For costs that do not easily fit into the other cost categories, please list the cost, and the breakdown of the total costs by quantity or unit of cost. Include the necessity of the cost for the completion of the proposed project. Only allowable costs can be charged to the award.

i) Indirect Costs- Commonly referred to as Facilities & Administrative Costs, Indirect Costs are defined as costs incurred by the applicant organization that cannot otherwise be directly assigned or attributed to a specific project. The justification should include a cost calculation that reflects the applicable indirect cost rate. For more details, see Section IV.2.a.(8) of this NOFO.

(8) Indirect Cost Rate Agreement.

If indirect costs are included in the proposed budget, provide a copy of the approved negotiated agreement if this rate was negotiated with a cognizant Federal audit agency. If the rate was not established by a cognizant Federal audit agency, provide a statement to this effect. If the successful applicant includes indirect costs in the budget and has not established an indirect cost rate with a cognizant Federal audit agency, the applicant will be required to obtain such a rate in accordance with Section B.06 of the

Department of Commerce Financial Assistance Standard Terms and Conditions, dated November 12, 2020.

https://www.commerce.gov/sites/default/files/2020-11/DOC%20Standard%20Terms%20and%20Conditions%20-%2012%20November%202020%20PDF_0.pdf https://www.commerce.gov/sites/default/files/2020-11/DOC%20Standard%20Terms%20and%20Conditions%20-%2012%20November%202020%20PDF_0.pdf

Notice of Funding Opportunity

Alternatively, in accordance with 2 C.F.R. § 200.414(f), applicants that do not have a current negotiated (including provisional) indirect cost rate except for those non-Federal entities described in appendix VII, paragraph D.1.b. of 2 CFR 200 may elect to charge a de minimis rate of 10 percent of modified total direct costs (MTDC). Applicants proposing a 10 percent de minimis rate pursuant to 2 C.F.R. § 200.414(f) should note this election as part of the budget portion of the application. Please be aware that foreign applicants will be limited to use of the de minimis rate and will not have the opportunity to negotiate an indirect cost rate with NIST.

(9) Letters of Support.

A letter from leadership within the applicant’s organization is required to demonstrate the extent to which the applicant has the overall support necessary to accomplish project goals and the organization’s intent to incorporate the project results into curriculum, which will be evaluated under the Budget and Resource Availability Evaluation Criterion (see Section V.1.d. of this NOFO). Letters of Support are not included in the page count of the Project Narrative.

(10) Letters of Commitment.

Letters of Commitment must be submitted by all funded and unfunded entities that will have an active role in executing the activities outlined in the Project Narrative. Letters of commitment from other organizations who will collaborate on the project to integrate the proposed curricula into their programs may also be submitted. Letters of Commitment must address the level of participation, qualifications of the personnel who will be actively involved, and how successful completion of this project would positively impact their profession or community. Letters of Commitment must also specify any voluntary committed cost-share, including the specific services and/or products to be used in the project. Letters of Commitment must be signed by an individual with authority to legally bind the organization to its commitment. Letters of Commitment will be evaluated under the Budget and Resource Availability Evaluation Criterion but do not count against the page limit of the Project Narrative.

(11) Current and Pending Support Form.

Any application that includes investigators, researchers, and key personnel must identify all sources of current and potential funding, including this proposal. Any current project support (e.g., Federal, state, local, public or private foundations, etc.) must be listed on this form. The proposed project and all other projects or activities requiring a portion of time of the Principal Investigator (PI), co-PI, and key personnel must be included, even if no salary support is received. The total award amount for the entire award period covered, including indirect costs, must be shown https://www.ecfr.gov/cgi-bin/text-idx?SID=dd7e460e397e25e8c7f2d685f71d953c&mc=true&node=ap2.1.200_1521.vii&rgn=div9 https://www.ecfr.gov/cgi-bin/text-idx?SID=dd7e460e397e25e8c7f2d685f71d953c&mc=true&node=ap2.1.200_1521.vii&rgn=div9

Notice of Funding Opportunity January 10, 2024 as well as the number of person-months per year to be devoted to the project, regardless of the source of support. Similar information must be provided for all proposals already submitted or that are being submitted concurrently to other potential funders.

Applicants must complete the Current and Pending Support Form, using multiple forms as necessary to account for all activity for each individual identified in the PI, co-PI and key personnel roles. A separate form should be used for each identified individual.

Applicants must download the Current and Pending Support Form from the NIST website at https://www.nist.gov/oaam/grants-management-division/current-and-pending-support and reference the guidance provided as it contains information to assist with accurately completing the form.

b. Attachment of Required Documents

Items IV.2.a.(1) through IV.2.a.(4) above are part of the standard application package in Grants.gov and can be completed through the download application process.

Items IV.2.a.(5) through IV.2.a.(11) should be attached to field 15 of the SF-424 form by clicking on “Add Attachment”.

Following these directions will create zip files which permit transmittal of the documents electronically via Grants.gov.

Applicants should carefully follow specific Grants.gov instructions at www.Grants.gov to ensure the attachments will be accepted by the Grants.gov system. A receipt from Grants.gov indicates only that an application was transferred to a system. It does not provide details concerning whether all attachments (or how many attachments) transferred successfully. Applicants will receive a series of e-mail messages over a period of up to two business days before learning whether a Federal agency’s electronic system has received its application.

Applicants are strongly advised to use Grants.gov’s “Download Submitted Forms and Applications” option to check that their application’s required attachments were contained in their submission.

After submitting the application, check the status of your application here:

CHECK APPLICATION STATUS. If any, or all, of the required attachments are absent from the submission, follow the attachment directions found above, resubmit the application, and check again for the presence of the required attachments.

https://www.nist.gov/oaam/grants-management-division/current-and-pending-support https://www.nist.gov/oaam/grants-management-division/current-and-pending-support http://www.grants.gov/ https://www.grants.gov/help/html/help/Applicants/CheckApplicationStatus/DownloadSubmittedFormsAndApplications.htm https://www.grants.gov/help/html/help/Applicants/CheckApplicationStatus/DownloadSubmittedFormsAndApplications.htm https://www.grants.gov/help/html/help/index.htm#t=Applicants%2FCheckApplicationStatus%2FCheckApplicationStatus.htm

Notice of Funding Opportunity January 10, 2024

If the directions found on the Grants.gov Online Help page are not effective, please contact the Grants.gov Help Desk immediately. If calling from within the United States or from a U.S. territory, please call 800-518- 4726. If calling from a place outside the United States or a U.S. territory, please call 606-545-5035. E-mails should be addressed to support@grants.gov. Assistance from the Grants.gov Help Desk will be available around the clock every day, with the exception of Federal holidays. Help Desk service will resume at 7:00 a.m. Eastern Time the day after Federal holidays.

Applicants can track their submission in the Grants.gov system by following the procedures at the Grants.gov Track My Application page. It can take up to two business days for an application to fully move through the Grants.gov system to NIST.

NIST uses the Tracking Numbers assigned by Grants.gov and does not issue Agency Tracking Numbers.

c. Application Format

(1) Paper, Email, and Facsimile (fax) Submissions. Will not be accepted.

(2) Figures, Graphs, Images, and Pictures. Should be of a size that is easily readable or viewable and may be displayed in landscape orientation. Any figures, graphs, images, or pictures will count toward the page limits for the Project Narrative.

(3) Font. Easy to read font (10-point minimum). Smaller type may be used in figures and tables but must be clearly legible.

(4) Page Limit. The Project Narrative is limited to twenty (20) pages double-spaced, noting the limit of two (2) pages for the Executive Summary.

Resumes are not included in the page count of the Project Narrative.

However, if resumes are included, resumes must be a maximum of two

(2) pages each.

(5) Page Limit Exclusions:

SF-424, Application for Federal Assistance;

SF-424A, Budget Information for Non-Construction Programs;

CD-511, Certification Regarding Lobbying;

SF-LLL, Disclosure of Lobbying Activities (if applicable);

Resume(s) of Key Personnel;

Budget Narrative and Justification;

Indirect Cost Rate Agreement;

https://www.grants.gov/help/html/help/index.htm#t=GetStarted%2FGetStarted.htm mailto:support@grants.gov https://www.grants.gov/web/grants/applicants/track-my-application.html

Notice of Funding Opportunity January 10, 2024

Letters of Support;

Letters of Commitment;

Current and Pending Support Form.

(6) Page Layout. The Proposal must be in portrait orientation.

(7) Page size. 21.6 centimeters by 27.9 centimeters (8 ½ inches by 11 inches).

(8) Page numbering. Number pages sequentially.

(9) Application language. All documents must be in English, including but not limited to the initial application, any additional documents submitted in response to a NIST request, all reports, and any correspondence with

NIST.

(10) Typed document. All applications, including forms, must be typed;

handwritten forms will not be accepted.

d. Application Replacement Pages. Applicants may not submit replacement pages and/or missing documents once an application has been submitted.

Any revisions must be made by submission of a new application that must be received by NIST by the submission deadline.

e. Pre-Applications. Pre-applications will not be accepted under this NOFO.

3. Unique Entity Identifier and System for Award Management (SAM) Pursuant to 2 C.F.R. part 25, applicants and recipients are required to: (i) be registered in SAM before submitting its application; (ii) provide a valid unique entity identifier in its application; and (iii) continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application or plan under consideration by a Federal awarding agency, unless otherwise excepted from these requirements pursuant to 2 C.F.R. § 25.110. NIST will not make a Federal award to an applicant until the applicant has complied with all applicable unique entity identifier and SAM requirements and, if an applicant has not fully complied with the requirements by the time that NIST is ready to make a Federal award pursuant to this NOFO, NIST may determine that the applicant is not qualified to receive a Federal award and use that determination as a basis for making a Federal award to another applicant.

4. Submission Dates and Times Applications must be received at Grants.gov no later than 11:59 p.m. Eastern Time, March 10, 2024. NIST will consider the date and time recorded by Grants.gov as the official submission time. Applications received after this

Notice of Funding Opportunity January 10, 2024 deadline will not be reviewed or considered. Paper applications will not be accepted.

Applicants should be aware, and factor in their application submission planning, that the Grants.gov system closes periodically for routine maintenance.

Applicants should visit Grants.gov for information on any scheduled closures.

When developing the submission timeline, please keep in mind that: (1) all applicants are required to have current registrations in the electronic System for Award Management (SAM.gov) and Grants.gov; (2) the free annual registration process in the SAM.gov generally takes between three and five business days but can take more than three weeks; and applicants will receive e-mail notifications over a period of up to two business days as the application moves through intermediate systems before the applicant learns via a validation or rejection notification whether NIST has received the application. (See Grants.gov for full information on application and notification through Grants.gov.) Please note that a Federal assistance award cannot be issued if the designated recipient’s registration in the System for Award Management (SAM.gov) is not current at the time of the award.

5. Intergovernmental Review Applications submitted by State and local governments are subject to Executive Order (E.O.) 12372, "Intergovernmental Review of Federal Programs,” pursuant to which each State designates an entity to coordinate, and review proposed federal financial assistance and direct federal development. All other applicants should consult the Intergovernmental Review State Single Point of Contact (SPOC) to determine whether the application is subject to State review pursuant to E.O. 12372. The current SPOC List may be found here:

https://www.whitehouse.gov/wp-content/uploads/2020/04/SPOC-4-13-20.pdf

6. Funding Restrictions Construction activities are not an allowable cost under this program. In addition, a recipient or a subrecipient may not charge profits, fees or other increments above cost to an award issued pursuant to this NOFO. Applications for product development and/or commercialization are not considered responsive to this

NOFO.

7. Other Submission Requirements

a. Applications must be submitted at Grants.gov. Paper applications will not be accepted.

(1) Applicants should carefully follow specific Grants.gov instructions to ensure that all attachments will be accepted by the Grants.gov system. A receipt from Grants.gov indicating an application is received does not provide information about whether attachments https://www.grants.gov/ http://www.grants.gov/ https://www.whitehouse.gov/wp-content/uploads/2020/04/SPOC-4-13-20.pdf http://www.grants.gov/

Notice of Funding Opportunity January 10, 2024 have been received. For further information or questions regarding applying electronically for the 2024-NIST-RMSC-01 announcement, contact the Grants.gov Help Desk at 800-518-4726.

b. Amendments. Any amendments to this NOFO will be announced through

Grants.gov. Applicants may sign up on Grants.gov to receive amendments by e-mail or may request copies by e-mail from grants@nist.gov.

V. Application Review Information

1. Evaluation Criteria The evaluation criteria that will be used in evaluating applications and their assigned weights are as follows:

a. Technical Project Approach and Methodology.

Reviewers will evaluate the following subcategories for a total of 0-50 points:

(1) The technical merit of the project and the extent to which the project and approach supports, advances, or integrates content on regenerative medicine standards, standards development, and standards implementation into associate’s or bachelor’s courses, modules, seminars, internships, continuing education programs, or other out of classroom experiences, and learning resources, including approaches, methods, and models that can be sustained, replicated and/or built upon by the applicant and by other educational programs. This also includes assessing the usefulness and effectiveness of the project with respect to educating undergraduate students, graduate students and/or employees in the existing relevant workforce about relevant documentary standards. (0-25 points)

(2) The completeness, appropriateness, quality, and reasonableness of the detailed project narrative to implement the project, including a plan to manage the project tasks and work of all project staff; final deliverables and measurable performance objectives; key interim outputs reflecting the performance objectives; milestones and timelines; short-term and potential long-term impacts; the intended audience; and an evaluation plan for the new curricula developed under this award. This also includes the extent to which the proposed methodology of program management is likely to ensure effective operations and oversight and meet program goals and objectives.

(0-25 points)

b. Dissemination Plan.

Reviewers will evaluate the following subcategories for a total of 0-15 points:

(1) The extent to which the proposed Dissemination Plan demonstrates how the proposed approaches, methods, and models can be sustained, replicated

Notice of Funding Opportunity January 10, 2024 and/or built upon by other educational and training programs across the U.S.

(0-5 points)

(2) The extent to which the proposed Dissemination Plan enables broadly sharing project information, resources and outcomes with relevant organizations, communities, or fields of practice. (0-5 points)

(3) The quality and completeness of the approach to implement the Dissemination Plan. (0-5 points)

c. Qualifications and Experience of Key Personnel.

Reviewers will evaluate the following subcategories for a total of 0-25 points:

(1) Relevant qualifications and experience of key personnel and their knowledge of the current state, impact, and nature of regenerative medicine standards and education activities. (0-10 points)

(2) The demonstrated ability of the key personnel to collaborate with diverse stakeholders (e.g., subject matter experts, curricula development professionals, industry, etc.) to successfully complete the project. (0-5 points)

(3) Experience in curricula development and implementation. (0-5 points)

(4) Ability to recruit qualified instructors and regenerative medicine trainees (0-5 points)

d. Budget and Resources Availability.

Reviewers will evaluate the following for a total of 0-10 points:

(1) The extent to which the applicant has demonstrated overall support necessary to successfully achieve the project goals, including the applicant’s intent to incorporate the proposed project results into curriculum and access to necessary infrastructure and expertise to develop the curriculum materials.

This includes assessing the appropriateness of proposed resources in relation to the project’s scope. (0-4 points)

(2) The extent to which the letters of commitment and letters of support (see Sections IV.2.a.(9) and (10) of this NOFO), indicate a commitment to the project and demonstrate relevance to the project scope. (0-2 points)

(3) The appropriateness and cost effectiveness of the proposed budget to carry out the objectives of the project as described in Section I. of this NOFO.

(0-4 points)

Notice of Funding Opportunity

2. Selection Factors

a. The Selection Factors for this competition are:

(1) The availability of funding.

(2) Whether the project duplicates other projects funded by NIST or other Federal agencies.

(3) Regional diversity.

(4) Diversity of the proposed project topics relative to the overall portfolio of activities funded under this NOFO.

(5) The diversity of project participants, which may include the extent of active project participation of women, minority, and veteran owned enterprises; state, local, and Tribal governments; and career and technical education schools, community colleges, and universities.

3. Review and Selection Process

Proposals, reports, documents, and other information related to applications submitted to NIST and/or relating to financial assistance awards issued by NIST will be reviewed and considered by Federal employees, or non-Federal personnel who have entered into conflict of interest and confidentiality agreements covering such information, when applicable.

a. Initial Administrative Review of Applications.

Applications received by the deadline will be reviewed to determine eligibility, completeness, and responsiveness to this NOFO and to the scope of the stated program objectives. Applications determined to be ineligible, incomplete, and/or nonresponsive may be eliminated from further review. However, NIST, in its sole discretion, may continue the review process for an application that is missing non-substantive information, the absence of which may easily be rectified during the review process.

b. Full Review of Eligible, Complete, and Responsive Applications.

Applications that are determined to be eligible, complete, and responsive will proceed for full reviews in accordance with the review and selection process below:

(1) Merit Review.

At least three (3) independent, objective reviewers, who may be Federal employees or non-Federal personnel, with appropriate professional and technical expertise relating to the topics covered in this NOFO, will evaluate and score each eligible, complete, and responsive application based on the evaluation criteria. While every application will have at least three (3) reviewers, applications may

Notice of Funding Opportunity January 10, 2024 have more than three (3) reviewers if specialized expertise is needed to evaluate an application. During the review process, the reviewers may discuss the applications with each other, but scores will be determined on an individual basis, not a consensus. Based on the numerical average of the reviewers’ scores, a rank order will be prepared and provided to the Selecting Official for further consideration.

(2) Selection. The Selecting Official, who is the MML Executive Officer, Business Operations Specialist, Senior Management Advisor, or designee, will make final award recommendations to the NIST Grants Officer. The Selecting Official shall generally select and recommend the most meritorious application[s] for an award based upon the rank order of the applications. The Selecting Official retains the discretion to select and recommend an application out of rank order based on one or more of the Selection Factors.

NIST reserves the right to negotiate the budget costs with any applicant selected to receive an award, which may include requesting that the applicant removes certain costs. Additionally, NIST may request that successful applicants modify objectives or work plans and provide supplemental information required by the agency prior to award. NIST also reserves the right to reject an application where information is uncovered that raises a reasonable doubt as to the responsibility of the applicant. NIST may select some, all, or none of the applications, or part(s) of any application. The final approval of selected applications and issuance of awards will be by the NIST Grants Officer. The award decisions of the NIST Grants Officer are final.

c. Federal Awarding Agency Review of Risk Posed by Applicants. After applications are proposed for funding by the Selecting Official, the NIST Grants Management Division (GMD) performs pre-award risk assessments in accordance with 2 C.F.R. § 200.206, which may include a review of the financial stability of an applicant, the quality of the applicant’s management systems, the history of performance, and/or the applicant’s ability to effectively implement statutory, regulatory, or other requirements imposed on non-Federal entities.

In addition, prior to making an award where the total Federal share is expected to exceed the simplified acquisition threshold (currently $250,000), NIST GMD will review and consider the publicly available Responsibility/Qualification records about that applicant in SAM.gov (formerly available via the Federal Awardee Performance and Integrity Information System (FAPIIS)). An applicant may, at its discretion, review https://www.fsd.gov/gsafsd_sp?id=kb_article_view&sysparm_article=KB0062291 https://sam.gov/content/home

Notice of Funding Opportunity January 10, 2024 and comment on information about itself previously entered into SAM.gov by a Federal awarding agency. As part of its review of risk posed by applicants, SAM.gov in making its determination about the applicant’s integrity, business ethics, and record of performance under Federal awards. Upon completion of the pre-award risk assessment, the Grants Officer will make a responsibility determination concerning whether the applicant is qualified to receive the subject award and, if so, whether appropriate specific award conditions that correspond to the degree of risk posed by the applicant should be applied to an award.

4. Anticipated Announcement and Award Date Review of applications, selection of successful applicants, and award processing is expected to be completed by June 2024. The earliest start date for awards under this NOFO is expected to be July 2024.

5. Additional Information

a. Safety. Safety is a top priority at NIST. Employees and affiliates of award recipients who conduct project work at NIST will be expected to be safety-conscious, to attend NIST safety training, and to comply with all NIST safety policies and procedures, and with all applicable terms of their guest research agreement.

b. Notification to Unsuccessful Applicants. Unsuccessful applicants will be notified by e-mail and will have the opportunity to receive a debriefing after the opportunity is officially closed. Applicants must request within 10 business days of the email notification to receive a debrief from the program office. The program office will then work with the unsuccessful applicant in arranging a date and time of the debrief.

c. Retention of Unsuccessful Applications. Unsuccessful applications will be retained in accordance with the General Record Schedule 1.2/021.

VI. Federal Award Administration Information

1. Federal Award Notices. Successful applicants will receive an award package from the NIST Grants Officer.

2. Administrative and National Policy Requirements

a. Uniform Administrative Requirements, Cost Principles and Audit Requirements. Through 2 C.F.R. § 1327.101, the Department of Commerce adopted Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards at 2 C.F.R. Part 200, which apply to awards in this program.

https://sam.gov/content/home https://sam.gov/content/home https://www.archives.gov/files/records-mgmt/grs/grs01-2.pdf https://www.ecfr.gov/current/title-2/subtitle-B/chapter-XIII/part-1327

Notice of Funding Opportunity

b. Department of Commerce Financial Assistance Standard Terms and

Conditions. The Department of Commerce will apply to each award in this program, the Financial Assistance Standard Terms and Conditions in effect on the date of award. The current version, dated November 12, 2020, is accessible at Department of Commerce Financial Assistance Standard Terms and Conditions. Refer to Section VII. of this NOFO, Federal Awarding Agency Contacts, Grant Rules and Regulations, if you need more information.

c. Pre-Award Notification Requirements. The Department of Commerce will apply the Pre-Award Notification Requirements for Grants and Cooperative Agreements dated December 30, 2014 (79 FR 78390). Refer to Section VII. of this NOFO, Federal Awarding Agency Contacts, Grant Rules and Regulations, for more information.

d. Funding Availability and Limitation of Liability. Funding for the program listed in this NOFO is contingent upon the availability of appropriations. NIST or the Department of Commerce will not be responsible for application preparation costs, including but not limited to if this program fails to receive funding or is cancelled because of agency…