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GrantExec

Consumer Protection Grants

Explore 110 grant opportunities for consumer protection initiatives

Pool Safely Grant Program (PSGP) 2024
$400,000
CPSC (Consumer Product Safety Commission)
Federal

Application Deadline

Jul 12, 2024

Date Added

May 11, 2024

The Pool Safely Grant Program funding opportunity assists states, local governments, and Native American Tribal Governments in implementing enforcement and education programs to prevent the drowning and drain entrapment of children in pools and spas.

Consumer Protection
State governments
Utah Food Security Processing Grant Program 2024
$200,000
Utah Department of Agriculture and Food (UDAF)
Local

Application Deadline

May 31, 2024

Date Added

May 9, 2024

The Utah Department of Agriculture and Food (UDAF) is accepting applications for its Food Security Processing Grant Program. Donor Name: Utah Department of Agriculture and Food (UDAF) State: Utah County: All Counties Type of Grant: Grant Deadline: 05/31/2024 Size of the Grant: $100,000 to $500,000 Grant Duration: 1 Year Details: The Utah Food Security Processing Grant (UFSPG) was created in 2022 with a $1 million appropriation from the Utah State Legislature. With these funds, UDAF issued grants to Utah-based businesses to increase processing capacity of agricultural products produced in the state. UDAF received additional funding to continue this program during the 2023 and 2024 legislative sessions. The UFSPG covers expenses including processing equipment, coolers/freezers, contractor costs (plumbing, draining, electrical work), portion cutters, slaughter equipment, sorting equipment, bottling equipment, etc. Funding Information Individual grant awards will be capped at $200,000. 50% of the funds will be set aside for meat and poultry processing. $20,000 will be held for microgrants of $5,000 or less. Applicants must complete planned improvement, purchase equipment, etc. no earlier than July 1, 2024, and no later than June 30, 2025. Eligible Expenses May include, but are not limited to Coolers/freezers Portion cutters Processing equipment (smoking units, sausage stuffers, etc.) Slaughter equipment (cradles, saws, hooks, scalders, sinks, etc.) Electronic sorting equipment (e.g. grading and sizing for apples, cherries, or peaches) Bottling equipment for juices Contractor costs (plumbing, draining, venting, electrical work) Eligibility Criteria Grants of up to $200,000 are available to processors located in Utah with no more than 100 employees who use at least 51% of ingredients or product inputs that were grown/raised in Utah, or that sell at least 51% of their products to Utah consumers. Meat/poultry processors wishing to apply must be either: A state-inspected โ€œequal-toโ€ slaughter and/or processing plant, A licensed custom-exempt slaughter plant, or A Talmadge-Aiken (TA) or very small federally inspected plant. For more information, visit UDAF.

Food and Nutrition
For profit organizations other than small businesses
City of Jackson Commercial Faรงade Improvement Grant Program
$15,000
City of Jackson
Local
Rolling

Application Deadline

Not specified

Date Added

May 9, 2024

This program provides financial assistance to small business and commercial property owners in Jackson, Mississippi, to improve the appearance of their buildings and attract more customers and investors.

Housing
Small businesses
Resilient Food Systems Infrastructure Grant Program
$3,200,000
Vermont Agency of Agriculture Food & Markets (VAAFM)
State

Application Deadline

Jun 5, 2024

Date Added

May 9, 2024

The Vermont Agency of Agriculture has entered into a cooperative agreement with the US Department of Agriculture (USDA) and the Agricultural Marketing Service (AMS) to administer the Resilient Food System Infrastructure (RFSI) grant program in Vermont. Donor Name: Vermont Agency of Agriculture Food & Markets (VAAFM) State: Vermont County: All Counties Type of Grant: Grant Deadline:ย  06/05/2024 Size of the Grant: $100,000 to $500,000 Grant Duration: 3 Years Details: The program aims to: Promote development of Vermont value-added products; Support initiatives that provide fair prices, fair wages, and new and safe job opportunities that keep profits in rural communities; Increase and diversify processing capacity across the state, with an emphasis on underserved communities; Improve the aggregation, processing, manufacturing, storing, transporting, wholesaling, and distribution of Vermont food products for local and regional markets; Target gaps and opportunities in pandemic assistance and existing USDA grant programs that support the agricultural supply chain. Funding will be focused on projects that: Improve job quality through increased wages, benefits, and/or worker safety and well being; Focus on small and medium-sized enterprises that expand services and product offerings for consumers and producers (with an emphasis on value-added products); Demonstrate local support for the project; Are submitted by cooperatives, farmer, and worker-owned enterprises. Funding Information Approximately $2,000,000 will be available for infrastructure projects. Grants can range from $100,000 โ€“ $500,000 and will run from fall 2024 through February 2027.ย  Eligibility Criteria Eligible applicants must be domestically owned, physically located in Vermont, and registered in Vermont with the Vermont Secretary of State. Sole proprietors using a business name other than their own name must have their assumed business name (formerly known as a trade name) registered with the Vermont Secretary of State. Eligible entities can include: Agricultural producers or processors, or groups of agricultural producers and processors operating middle-of-the-supply-chain activities such as processing, aggregation, distribution of targeted agricultural products. Nonprofit organizations operating middle-of-the-supply-chain activities such as processing, aggregation, distribution of targeted agricultural products. Local government entities operating middle-of-the-supply-chain activities such as processing, aggregation, distribution of targeted agricultural products. Institutions such as schools, universities, or hospitals bringing producers together to establish cooperative or shared infrastructure or invest in equipment that will benefit multiple producers middle-of-the-supply-chain activities such as processing, aggregation, distribution of targeted agricultural product. These include organizations such schools (K-12; colleges/universities), hospitals, food banks, gleaners, food rescue, workplace cafeterias, correctional facilities, farmers markets, and care centers (senior, preschools). For-profit entities operating middle-of-the-supply-chain activities such as processing, aggregation, or distribution of targeted agricultural products, whose activities are primarily focused for the benefit of local and regional producers, and that meet the eligibility requirements of the Small Business Administration (SBA) small business size standards, matched to North American Industry Classification System (NAICS) code. For more information, visit VAAFM.

Food and Nutrition
Small businesses
CalMoneySmart Grant Program
$500,000
California Department of Financial Protection and Innovation (DFPI)
State

Application Deadline

May 6, 2024

Date Added

May 3, 2024

The California Department of Financial Protection and Innovation (DFPI) is now accepting applications for CalMoneySmart Grant Program, which will award a total of $2 million to nonprofits annually to provide free financial education and empowerment programs for people experiencing financial insecurity in California. Donor Name: Department of Financial Protection and Innovation (DFPI) State: California County: All Counties Type of Grant: Grant Deadline: 05/06/2024 Size of the Grant: $100,000 to $500,000 Grant Duration: 2 Years Details: Funding Information CalMoneySmart offers qualifying nonprofit organizations grants of up to $200,000. Grant Period Grant awards will be announced for a two-year period covering two consecutive fiscal years. Grant Funding Uses The grants may be used to: Design, develop, or offer free classroom- or web-based financial education and empowerment content intended to help unbanked and underbanked consumers achieve, identify, and access lower-cost financial products and services, establish or improve their credit, increase their savings, or lower their debt. Provide individualized, free financial coaching to unbanked and underbanked consumers. Design, develop, or offer a free financial product or service intended to help unbanked and underbanked consumers identify and access responsible financial products and financial services, establish or improve their credit, increase their savings, or lower their debt. Eligibility Criteriaย  To be eligible for a grant, an Applicant must meet the following criteria: The Applicant is exempt from federal income taxes under Section 501(c)(3) of the Internal Revenue Code and is organized and operated exclusively for one or more of the purposes described in Section 501(c)(3) of the Internal Revenue Code; and No part of the net earnings of the Applicant shall inure to the benefit of a private shareholder or individual. The Applicant must be in good standing with the Secretary of State of California and the state of the Applicantโ€™s incorporation, if applicable. Submission of a satisfactory final report for any and all prior grant funding awarded by DFPI. For more information, visit DFPI.

Education
Nonprofits
Greenhouse Accelerator to empower Hispanic-owned Startups and Entrepreneurs
$100,000
PepsiCo
Private

Application Deadline

May 6, 2024

Date Added

May 3, 2024

The Greenhouse Accelerator Program Juntos Crecemos Edition is a five-month, mentor-guided program to support the acceleration of emerging Hispanic food and beverages innovations that are transforming the way consumers live their lives. Donor Name: PepsiCo State: All States County: All Counties Type of Grant: Program Deadline: 05/06/2024 Size of the Grant: $10,000 to $100,000 Grant Duration: Grant Duration Not Mentioned Details: This edition is an extension of the initial Greenhouse Accelerator program launched in 2018, in collaboration with PepsiCo Juntos Crecemos, part of PepsiCoโ€™s Pep+ transformation agenda, designed to provide short and long-term support to Hispanic small businesses. The mission is to identify up to 8 high-potential emerging Hispanic-owned food and beverage consumer packaged goods small businesses. Driving growth for Hispanic founders in the food and beverage industry with operating businesses in the U.S. Program Benefits What the Greenhouse Accelerator can offer you: Grants Guaranteed $20,000 USD grant for each finalist. Winner awarded an additional $100,000 USD Guidance Expert guidance and learning modules across all aspects of business development Network Access and exposure to PepsiCo network and resources, industry experts, VCs and investors Collaboration Unlocking of potential collaboration opportunities with PepsiCo Mentorship Hands-on mentorship and support for refining business models, fortifying strategies, and enhancing impact Growth Accelerated pathways to launch, scale, and grow your breakthrough innovations. Eligibility Requirementsย  Net-revenue between $100,000 to $2,000,000 USD in the last financial year Be a Hispanic-owned business licensed and operating in the United States Be willing to work with PepsiCo Greenhouse Accelerator mentors and public relations team throughout six-month Accelerator program and attend Accelerator events. An external third party will review all submissions. The selection committee will choose finalists based on the following criteria: A clear go-to-market strategy and plan for sustained in-market execution Post-prototype, ready for review with a multinational corporation or company Uniqueness in the market Balanced gender and ethnic diversity Clear & active social responsibility mission aligned with PepsiCoโ€™s Juntos Crecemos Strategy Aligned with PepsiCoโ€™s PepsiCo Positive Strategy Scalable business model. For more information, visit PepsiCo.

Food and Nutrition
Small businesses
Alexion Rare Belonging - Mental Health & Wellbeing Grant Program
Contact for amount
Alexion Charitable Foundation
Private

Application Deadline

Mar 31, 2025

Date Added

May 3, 2024

The Alexion Charitable Foundationโ€™s Rare Belongingยฎ Grant Program specifically addresses the mental health and wellbeing of people affected by rare diseases. The foundation supports initiatives designed to improve access to mental health services, develop training and tools for practitioners, enhance practitioner diversity, and facilitate emotional support through family and peer connections. This targeted grant aims to tackle systemic barriers in mental health support for those living with rare diseases, including patients and caregivers.

Health
Nonprofits
Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trials Optional
$7,500,000
HHS-FDA (Food and Drug Administration)
Federal

Application Deadline

Jul 3, 2024

Date Added

May 2, 2024

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) is announcing its intent to accept and consider a single source application for the award of a Cooperative Agreement to the Duke Universitys Duke Clinical Research Institute (DCRI) to support the Clinical Trials Transformation Initiative (CTTI).

Agriculture
Exclusive - see details
Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional
$350,000
HHS-FDA (Food and Drug Administration)
Federal

Application Deadline

Jul 3, 2024

Date Added

May 2, 2024

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is announcing its intent to accept and consider continuation of the award of a grant to the American Society of Nephrology (ASN) to support the Kidney Health Initiative (KHI).

Agriculture
Exclusive - see details
Healthy Soils Block Grant Program
$200,000
California Bountiful Foundation
Private
Rolling

Application Deadline

Not specified

Date Added

Apr 25, 2024

This grant provides financial support to citrus growers in select California counties to implement sustainable farming practices that improve soil health, enhance climate resilience, and promote environmental stewardship, with a focus on assisting socially disadvantaged farmers, women, and veterans.

Health
County governments
FY 2024 SNAP Fraud Framework Implementation Grant
$750,000
USDA-FNS1 (Food and Nutrition Service)
Federal

Application Deadline

Jun 24, 2024

Date Added

Apr 24, 2024

The purpose of the SNAP Fraud Framework Implementation Grant Program is to support State agency efforts to improve and expand recipient fraud prevention, detection, and investigation efforts using the procedures, ideas and practices outlined in the SNAP Fraud Framework.Organizational Management: This objective aims to help States establish and communicate priorities, organize employees, and manage both large-scale and day-to-day processes. Many of the concepts described in this component are the foundation for successful program integrity initiatives.Performance Measurement: This objective offers recommendations encouraging States to consistently capture and analyze their own performance.Recipient Integrity Education: This objective provides targeted integrity education initiatives to help ensure recipients have the necessary information and tools to use SNAP benefits as intendedpreventing fraud before it occurs. When producing recipient integrity education materials, States are encouraged to educate the public and applicants about SNAP fraud, rather than emphasize the consequences as a deterrent to applying.Fraud Detection: Here, the SNAP Fraud Framework stresses the importance of proactively detecting fraud from the application process and continuing throughout the recipients time in the Program.Investigations and Dispositions: This objective aims to provide states with tools and suggestions to improve fraud case management from initial fraud referral through disposition.Analytics and Data Management: This objective details the necessary people, processes, and technology to launch and maintain an analytics capability. Data analytics can play a valuable role in preventing, detecting, and investigating SNAP fraud.Learning and Development: The final objective contains recommendations for States to invest in training and professional development opportunities to promote employee engagement and to ensure employees are aware of new and emerging trends in fraud.Please read the entire request for applications (RFA) for additional information.

Agriculture
State governments
CalMoneySmart 2024-26 Grant
$200,000
California Department of Financial Protection and Innovation
State

Application Deadline

May 6, 2024

Date Added

Apr 22, 2024

The CalMoneySmart program, funded by the Department of Financial Protection and Innovation, is designed to boost financial empowerment among California's unbanked and underbanked populations by providing up to $200K annually for two years to eligible nonprofit organizations. These funds support activities like financial education, empowerment services, and the development of financial products aimed at improving financial literacy and economic security. The program emphasizes adherence to the principles of effective financial education to ensure impactful outcomes.

Education
Nonprofits
Illinois Grocery Initiative - New Stores in Food Deserts (Notice of Funding Opportunity 3295-2673)
$2,400,000
Illinois Department of Commerce and Economic opportunity
State

Application Deadline

May 24, 2024

Date Added

Apr 19, 2024

Description: The Illinois Grocery Initiative aims to establish new grocery stores in food deserts to increase access to fresh food in underserved areas. This grant, under the funding opportunity number FY24-2 and CSFA number 420-35-3295, anticipates awarding 8 grants with a total program funding of $14,000,000. Eligible projects must involve capital expenditures, as operational costs are not covered. Grants will range from $160,000 to $2,400,000, and applicants are required to meet cost-sharing requirements. The application window opens on 04/09/2024 and closes on 05/24/2024. Indirect costs are allowed but restricted to capital-only expenditures. There are mandatory and optional technical assistance sessions provided to assist applicants, with registration required through provided links.

Food and Nutrition
City or township governments
2024 Spring Lake Shore Savings Bank Community Reinvestment Fund Grants
$2,500
Lake Shore Savings Bank
Private

Application Deadline

Jun 1, 2024

Date Added

Apr 17, 2024

Lake Shore Savings Bank invites applications biannually for projects and programs that offer innovative and efficient solutions to community needs, with an emphasis on supporting underserved citizens and testing new approaches to community problem-solving. Special projects by educational or religious institutions that benefit the wider community will be considered. Organizations must demonstrate fiscal responsibility, management capability, and the ability to deliver the proposed services or programs. Eligibility is limited to organizations benefiting Chautauqua and Erie County, New York. Notifications and payments following in July and January, respectively. Grant renewed every year. Grant Annual Spring deadline: June 1st

Community Development
Nonprofits
2024 Fall Lake Shore Savings Bank Community Reinvestment Fund Grants
$2,500
Lake Shore Savings Bank
Private

Application Deadline

Dec 1, 2024

Date Added

Apr 17, 2024

This grant provides funding for innovative community projects in Chautauqua and Erie County, New York, focusing on underserved populations and new problem-solving approaches.

Community Development
Nonprofits
Convener and Organizer of Activities and Engagements Related to Processes, Surveillance, and Policy Development of Medical Products for Ongoing Public Health Activities, U01 Clinical Trial Not Allowed
$700,000
HHS-FDA (Food and Drug Administration)
Federal

Application Deadline

Jun 17, 2024

Date Added

Apr 16, 2024

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit grant applications from neutral, independent institutions and/or organizations to support meetings (e.g., conferences, workgroups, roundtables) that convene a broad range of multiple stakeholders, including those with relevant expertise, to explore, research, and address issues related to medical products, policy, and surveillance methods and systems. Support includes, but is not limited to the design, planning, execution, synthesis, summary, and communication of findings from these forums to a broad range of organizations and individuals.

Agriculture
State governments
The Resilient Food Systems Simplified Equipment Program
$100,000
Pennsylvania Department of Agriculture
State

Application Deadline

May 15, 2024

Date Added

Apr 15, 2024

The Pennsylvania Department of Agriculture (PDA) is currently accepting applications for grant projects under the Resilient Food Systems Infrastructure program (RFSI). Donor Name: Pennsylvania Department of Agriculture State: Pennsylvania County: All Counties Type of Grant: Grant Deadline:ย 05/15/2024 Size of the Grant: $10,000 to $100,000 Grant Duration: 2 Years Details: The RFSI program will transform the food system to benefit consumers, producers, and rural communities by providing more options, increasing access, and creating new, more, and better markets for small and mid-size producers. To be more resilient, the food system of the future needs to be more diversified, distributed, and local. Funding Priorities The USDA encourages projects that benefit underserved farmers and ranchers, new and beginning farmers and ranchers, veteran producers, and processors and other middle of the supply chain businesses owned by socially disadvantaged individuals, as defined by the Small Business Administration (SBA). The Pennsylvania Department of Agriculture will prioritize funding projects that pertain to the following gaps identified in the middle of the food supply chain in Pennsylvania. Aggregation Points โ€“ Aggregation points, include food hubs or farmer cooperatives to help individual producers fulfill bigger orders while saving costs on storage, packaging, and distribution. Food Processing Infrastructure โ€“ As Pennsylvanian food processors look to expand their production capacities by adding product types, increasing production volumes, or increasing packaging and labeling capacities for retail product lines, they need to upgrade equipment and often need to move to a licensed space outside of their homes. Food processing infrastructure also includes large-scale commercial equipment. Storage โ€“ In Pennsylvania, more storage is needed to hold produce to be washed and distributed. Limited cold storage is available in urban areas. More storage is also needed to segregate and supply identity preserved grains, whole grains, and dry bean for human consumption to processing plants in Pennsylvania. Funding Information Simplified Equipment-Only Grants will range in value from a minimum award of $10,000 and a maximum award of $100,000 and do not require cost sharing or matching. The Simplified Equipment-Only Grant is a fixed price grant, meaning it will fund only equipment purchases (and not associated facility upgrades, staffing, or other costs), and the amount awarded will be equal to the cost of the equipment up to $100,000. Funds will be awarded no earlier than July 1, 2024, and projects must be completed by June 30, 2026. Eligibility Criteriaย  The following are eligible to apply for grants under the Program: Agricultural producers or processors, or groups of agricultural producers and processors. Nonprofit organizations operating middle of-the-supply-chain activities such as processing, aggregation or distribution of targeted agricultural products. For-profit entities operating middle of-the-supply-chain activities such as processing, aggregation or distribution of targeted agricultural products, whose activities are primarily focused for the benefit of local and regional producers and that meet the eligibility requirements of the SBA small business size standards. Local government entities operating middle of-the-supply-chain activities such as processing, aggregation or distribution of targeted agricultural products. Tribal governments operating middle of-the-supply-chain activities such as processing, aggregation or distribution of targeted agricultural products. Institutions such as schools, universities or hospitals bringing producers together to establish cooperative or shared infrastructure or investing in equipment that will benefit multiple producersโ€™ middle of-the-supply-chain activities such as processing, aggregation or distribution of targeted agricultural products. For-profit entities must meet the eligibility requirements of the SBA small business size standards matched to industries described in the North American Industry Classification System. Applicant businesses and organizations must be domestically owned and applicantsโ€™ facilities must be physically located within this Commonwealth. Applicants doing business along the Commonwealthโ€™s border should only apply in one state to avoid duplication of Federal funds. For more information, visit PDA.

Food and Nutrition
Small businesses
2024-2026 CalMoneySmart Grant
$200,000
California Department of Financial Protection and Innovation
State

Application Deadline

May 6, 2024

Date Added

Apr 10, 2024

The CalMoneySmart program aims to enhance financial empowerment among unbanked and underbanked Californians by funding nonprofit organizations. Through financial education and empowerment services, it seeks to reduce disparities, improve financial literacy, and foster wealth-building opportunities. The program awards grantees up to $200K per year for two consecutive fiscal years to promote financial stability and security statewide.ย ; Grant funds may only be used for the following financial education and empowerment services for the targeted at-risk unbanked and underbanked populations: 1) Designing, developing, or offering, free of charge to consumers, classroom or web-based financial education and empowerment content intended to help unbanked and underbanked consumers achieve, identify, and access lower cost financial products and services, establish or improve their credit, increase their savings, or lower their debt. 2) Providing individualized, free financial coaching to unbanked and underbanked consumers. 3) Designing, developing, or offering, free of charge to consumers, a financial product or service intended to help unbanked and underbanked consumers identify and access responsible financial products and financial services, establish or improve their credit, increase their savings, or lower their debt. Every project funded with a grant from the Financial Empowerment Fund shall meet the following criteria: 1) Promote and enhance the economic security of consumers. 2) Adhere to the five principles of effective financial education described in the June 2017 report issued by the federal Consumer Financial Protection Bureau titled โ€œEffective financial education: Five principles and how to use them.โ€ Grant awards will be announced for a two-year period covering two consecutive fiscal years. Funds for each fiscal year are disbursed separately and any unexpended funds must be returned to the DFPI. Disbursement of funding for the second fiscal year is contingent on submission of a satisfactory annual report. A mandatory in-person training for grantees will be held during the grant cycle. Final details will be included in the grant agreement.ย ย  Grantees may use no more than 15 percent of the grant to cover administrative (indirect) costs. Failure to comply shall render the Applicant ineligible for a grant during the subsequent fiscal year and until the noncompliance is corrected.ย  A grantee may subcontract services that it has agreed to provide under the grant agreement, so long as those services are conducted on behalf of the grantee. Subcontract arrangements must be clearly described in the scope of work and budget. Accepting grant funds with the intent of distributing those funds to other nonprofit organizations (for example, sub-grants or fiscal sponsorship) is not allowed. Grant funding may not be used for financial incentives for individuals. Prohibited incentives include, but are not limited to, match funding for savings accounts, participant stipends, or gift cards with a cash value. Grantees are required to submit preliminary and final annual reports, in a form and by a date specified by the Commissioner of Financial Protection and Innovation, documenting: 1) The specific uses to which grant funds were allocated, 2) The number of individuals aided through use of the funds, 3) Quantitative results regarding the impact of grant funding, and 4) Any other information requested by the Commissioner. Failure to submit satisfactory reports shall render the Applicant ineligible for any DFPI grant during the subsequent fiscal year and until the required report is submitted.โ€ฏ

Consumer Protection
Nonprofits
STEP Grants
$10,000
Louisiana Economic Development
State
Rolling

Application Deadline

Not specified

Date Added

Apr 8, 2024

This program provides financial assistance to small businesses in Louisiana to help them expand their international sales and export activities through reimbursements for various related expenses.

Business and Commerce
Small businesses
Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional
$1,100,000
HHS-FDA (Food and Drug Administration)
Federal

Application Deadline

May 20, 2024

Date Added

Mar 15, 2024

Notice of Funding Opportunity Description Background The Food and Drug Administration (FDA) protects the public health by ensuring that medical products intended to be marketed in the United States are safe and effective for their intended use. FDA stakeholders are exploring innovative ways to produce scientific evidence in support of regulatory submissions, including the development of new data sources, study designs, methodologies, and technologies. FDA encourages and facilitates the use of such innovative approaches while ensuring that the scientific evidence supporting marketing approvals meet our high evidentiary standards. The Prescription Drug User Fee Act VII (PDUFA VII) commitment letter represents the product of discussions between the FDA, regulated industry, and public stakeholders, as mandated by Congress. The performance and procedural goals and other commitments specified in the PDUFA VII commitment letter apply to aspects of the human drug review program that are important for facilitating timely access to safe, effective, and innovative new medicines for patients. The commitment letter includes goals relating to the use of digital health technologies (DHTs) to support drug development and review. A DHT is a system that uses computing platforms, connectivity, software, and/or sensors, for health care and related uses. DHTs for remote data acquisition in clinical investigations can include hardware and/or software to perform one or more functions. DHTs may rely on or work with other technologies that support their operation, such as general-purpose computing platforms (e.g., smartphones) and communication networks. Among other activities relating to the use of DHTs, FDA has established a Framework for the Use of DHTs in Drug and Biological Product Development to guide the use of DHT-derived data in regulatory decision-making for drugs (hereinafter Framework ). The Framework highlights FDAโ€™s DHT efforts including workshops and demonstration projects; engagement with stakeholders; establishment of internal processes to support the evaluation of DHTs for use in drug development; promotion of shared learning and consistency regarding DHT-based policy, procedure, and analytic tool development; and publication of guidance documents. In addition, FDAโ€™s webpage DHTs for Drug Development (available at: https://www.fda.gov/science-research/science-and-research-special-topics/digital-health-technologies-dhts-drug-development) provides an overview of the ongoing DHT efforts, including demonstration projects. A variety of project types are welcomed under this NOFO, applicable to drugs and biologics (not devices). FDA is particularly interested in projects that evaluate the use of DHTs in drug development. Project Objectives The overarching goal of this notice of funding opportunity (NOFO) is to explore the role of DHTs (e.g., actigraphy, photography, environmental sensors) in the evaluation of new drugs. These projects may involve engagement with researchers from academia, the biopharmaceutical industry, patient groups, and other stakeholders. The objectives of these projects are to advance DHTs for clinical drug development, expand the ability to capture early manifestations of chronic diseases, determine outcomes in populations with unmet medical needs and enhance convenience for trial participants by allowing for remote data acquisition in clinical investigations. The scope includes, but is not limited to, projects that focus on: Comparing digital measurements to traditional measurements in clinical trials to evaluate drugs Developing and evaluating novel endpoints using DHTs to address unmet needs for drug clinical trials (e.g., use of environmental sensors to capture apnea in pediatric patients) Comparing metrics to evaluate continuous measurements (e.g., maximum activity and stamina) Capturing early manifestations of chronic diseases (e.g., dementia) through the use of DHTs

Agriculture
State governments

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