Grants for Native American tribal organizations - Agriculture

The California Department of Food and Agriculture is offering a competitive grant of over $1 million for California dairy and livestock operations to implement non-digester manure management practices and technologies that reduce long-term methane emissions and maximize environmental benefits, with applications due by October 18, 2024.

This program is listed in the Assistance Listings (previously referred to as theCatalog of Federal Financial Assistance) on Sam.gov under:Soil and Water Conservation 10.902which can be found at: https://sam.gov/content/home.SAM is a web-based, government-wide application that collects, validates, stores, and disseminates business information about the federal government's trading partners in support of the contract awards, grants, and electronic payment processes.Notice of Funding Opportunity SummaryThe Natural Resources Conservation Service, an agency under the United States Department of Agriculture, is announcing potential availability of agreements for the purpose of leveraging NRCS resources to promote public awareness of Farm Bill activities throughout Maryland.Proposals must be for projects based in Maryland and focus on Farm Bill conservation. Research proposals will need to meet the requirements in order to be accepted.Proposals will be accepted from eligible entities identified in Section C of this announcement for competitive consideration of awards for projects between one and five years in duration.This notice identifies the objectives, eligibility criteria, and application instructions. Proposals will be screened for completeness and compliance with the provisions of this notice. Incomplete and/or noncompliant proposals will be eliminated from competition, and notification of elimination will be sent to the applicant. The Maryland State Conservationist reserves the right not to fund any or all applications.For new users of Grants.gov, see Section D. of the full Notice of Funding Opportunity for information about steps required before submitting an application via Grants.gov.Key DatesApplicants must submit their applications via Grants.gov by 11:59 pm Eastern Time on July 5th, 2024. For technical issues with Grants.gov, contact Grants.gov Applicant Support at 1-800-518-4726 or support@grants.gov. Awarding agency staff cannot support applicants regarding Grants.gov accounts.For inquiries specific to the content of the NFO requirements, contact the federal awarding agency contact (section G of this NFO). Please limit questions to those regarding specific information contained in this NFO (such as dates, page numbers, clarification of discrepancies, etc.). Questions related to eligibility, or the merits of a specific proposal will not be addressed.The agency anticipates making selections by July 15th, 2024, and expects to execute awards by August 1st, 2024. These dates are estimates and are subject to change.

This funding opportunity supports projects that improve the competitiveness of California's specialty crops, benefiting a wide range of organizations, including nonprofits, government entities, and educational institutions.

Federal Awarding Agency Name: U.S. Department of Agriculture U.S. Department of Agriculture Natural Resources Conservation Service NHQ Office of Urban Agriculture and Innovative Production (OUAIP)The U.S. Department of Agriculture U.S. Department of Agriculture Natural Resources Conservation Service NHQ Office of Urban Agriculture and Innovative Production (OUAIP) is collaborating with National Institute of Food and Agriculture (NIFA) through an interagency agreement for implementation of the Composting and Food Waste Reduction (CFWR) Pilot Project Cooperative Agreement Program.Notice of Funding Opportunity Title: Composting and Food Waste Reduction (CFWR) Pilot ProjectNotice of Funding Opportunity Number: USDA-NRCS-NHQ-CFWR-24-NOFO0001412Assistance Listing: This program is listed in the Assistance Listings (previously referred to as the Catalog of Federal Financial Assistance) on Sam.gov under 10.935, which can be found at: https://sam.gov/content/home.SAM is a web-based, government-wide application that collects, validates, stores, and disseminates business information about the federal government's trading partners in support of the contract awards, grants, and electronic payment processes.Notice of Funding Opportunity SummaryThe U.S. Department of Agriculture (USDA), Natural Resources Conservation Service (NRCS), under OUAIP, is soliciting proposals from eligible applicants to host a CFWR pilot project for fiscal year (FY) 2024For new users of Grants.gov, see Section D. of the full Notice of Funding Opportunity for information about steps required before submitting an application via Grants.gov.Key DatesApplicants must submit their applications via Grants.gov by 11:59 pm Eastern Time on September 4, 2024. For technical issues with Grants.gov, contact Grants.gov Applicant Support at 1-800-518-4726 or support@grants.gov. Awarding agency staff cannot support applicants regarding Grants.gov accounts.For inquiries specific to the content of the NFO requirements, contact the federal awarding agency contact (section G of this NFO). Please limit questions to those regarding specific information contained in this NFO (such as dates, page numbers, clarification of discrepancies, etc.). Questions related to eligibility, or the merits of a specific proposal will not be addressed.A webinar has been pre-recorded and is available at: https://www.youtube.com/watch?v=QvexAMyuY2o.The presentation and supporting information are posted in the Related Documents tab of this opportunity. The recorded webinar is also available on https://www.usda.gov/topics/urban/coop-agreements.The agency anticipates making selections by November 2024 and expects to execute awards by January 2025. These dates are estimates and are subject to change.Federal Funding Floor and Ceiling AmountsThe estimated funding floor for this opportunity is $75,000, and the estimated funding ceiling is $400,000. The funding floor means the minimum agreement funding amount for the Federal share per agreement awarded. The funding ceiling is the maximum agreement funding amount for the Federal share per agreement awarded. These numbers refer to the total agreement amount, not any specific budget period.Federal Financial Assistance TrainingThe funding available through this NFO is Federal financial assistance. Grants 101 Training is highly recommended for those seeking knowledge about Federal financial assistance. The training is free and available to the public via https://www.cfo.gov/resources/federal-financial-assistance-training/.It consists of five modules covering each of the following topics:1) laws, regulations, and guidance; 2) financial assistance mechanisms; 3) uniform guidance administrative requirements; 4) cost principles; and 5) risk management and single audit. FPAC agencies also apply Federal financial assistance regulations to certain non-assistance awards (e.g., non-assistance cooperative agreements).

Federal Awarding Agency Name: U.S. Department of Agriculture Natural Resources Conservation Service (NRCS), Commodity Credit Corporation (CCC) Notice of Funding Opportunity Title: Announcement for Program Funding for NRCS Conservation Innovation Grants (CIG) for Federal fiscal year (FY) 2024 - Arkansas Notice of Funding Opportunity Number: USDA-NRCS-AR-CIG-24-NOFO0001409 Assistance Listing: This program is listed in the Assistance Listings (previously referred to as the Catalog of Federal Financial Assistance) on Sam.gov under 10.912, Environmental Quality Incentives Program, which can be found at: https://sam.gov/content/home. The System for Award Management (SAM) is a web-based, government-wide application that collects, validates, stores, and disseminates business information about the federal government's trading partners in support of the contract awards, grants, and electronic payment processes. Notice of Funding Opportunity Summary NRCS is announcing the availability of Conservation Innovation Grants (CIG) State Program funding to stimulate the development and adoption of innovative conservation approaches and technologies. Applications are accepted from eligible entities (Section C) for projects carried out in the state of Arkansas A total of up to $300,000 is available for the Arkansas CIG competition in FY 2024. All non-Foreign, non-federal entities (NFE) and individuals are invited to apply, with the sole exception of federal agencies. Projects may be between one and three years in duration. The maximum award amount for a single award in FY 2024 is $100,000. For new users of Grants.gov, see Section D. of the full Notice of Funding Opportunity for information about steps required before submitting an application via Grants.gov. Completing all steps required to start an application can take a significant amount of time, plan accordingly. Key Dates Applicants must submit their applications via Grants.gov by 11:59 pm Eastern Time on Monday August 5, 2024. For technical issues with Grants.gov, contact Grants.gov Applicant Support at 1-800-518-4726 or support@grants.gov. Awarding agency staff cannot support applicants regarding Grants.gov accounts. For inquiries specific to the content of the NFO requirements, contact the federal awarding agency contact (section G of this NFO). Please limit questions to those regarding specific information contained in this NFO (such as dates, page numbers, clarification of discrepancies, etc.). Questions related to eligibility, or the merits of a specific proposal will not be addressed. A webinar for CIG applicants is scheduled for June 24, 2024, at 9:00 a.m. CST Standard Time. Information on how to participate in the webinar will be posted to the https://us02web.zoom.us/j/86163563163?pwd=tnK9zjCgTahBoafsgddhcaMJaQaK9q.1. Applicants are encouraged to visit the Arkansas State CIG website to learn more about the CIG program. The agency anticipates making selections by 9-15-2024 and expects to execute awards by 09-30-2024.These dates are estimates and are subject to change. Federal Funding Floor and Ceiling Amounts The estimated funding floor for this opportunity is $25,000, and the estimated funding ceiling is $100,000. The funding floor means the minimum agreement funding amount for the Federal share per agreement awarded. The ceiling is the maximum agreement funding amount for the Federal share per agreement awarded. These numbers refer to the total agreement amount, not any specific budget period. Federal Financial Assistance Training The funding available through this NFO is Federal financial assistance. Grants 101 Training is highly recommended for those seeking knowledge about Federal financial assistance. The training is free and available to the public via https://www.cfo.gov/resources/federal-financial-assistance-training/. It consists of five modules covering each of the following topics: 1) laws, regulations, and guidance; 2) financial assistance mechanisms; 3) uniform guidance administrative requirements; 4) cost principles; and 5) risk management and single audit. FPAC agencies also apply Federal financial assistance regulations to certain non-assistance awards (e.g., non-assistance cooperative agreements).

The Minnesota Department of Agriculture (MDA) is offering the Fiscal Year 2025 Soil Health Financial Assistance Program, a grant designed to support healthy soil management practices across Minnesota. This program, funded by the 2023 and 2024 Legislative Sessions, aims to enhance agricultural sustainability and environmental health by promoting the adoption of soil health farming practices. The MDA, through its Pesticide and Fertilizer Management Division, administers this competitive grant, aligning with its mission to protect and enhance Minnesota's agricultural resources. The program's primary beneficiaries are owners and lessees of farmland in Minnesota, as well as Local Government Units (LGUs) such including cities, towns, counties, soil and water conservation districts, Tribal Nations, and joint powers boards. LGUs that receive grants for equipment purchases are required to make this equipment available for public use, broadening the program's impact. The overarching impact goal is to establish, improve, or accelerate soil health practices statewide, contributing to long-term agricultural resilience and environmental benefits. The core priority of this grant is to provide financial assistance for purchasing and retrofitting equipment essential for implementing soil health farming practices. This includes both new and used equipment, as well as parts and materials for retrofitting existing machinery. By focusing on equipment acquisition, the program directly addresses a common barrier to adopting soil health practices, thereby facilitating their widespread implementation across various farming operations. The MDA anticipates awarding approximately $2.375 million in FY 2025. Applicants can request up to 50% of their project's total cost, with individual grant awards ranging from a minimum of $500 to a maximum of $45,000. Expected outcomes include an increase in the number of farms utilizing soil-healthy practices and the availability of specialized equipment for public use through LGUs. The measurable results will be tied to the successful acquisition and deployment of equipment, leading to improved soil health metrics on participating lands, although specific metrics are not detailed in the provided information.

Notice of Funding Opportunity SummaryThe Natural Resources Conservation Service (NRCS), an agency under the United States Department of Agriculture (USDA) is announcing potential availability of cooperative agreements for the purpose of leveraging NRCS resources to assist our agency with conducting and implementing important NRCS Farm Bill Program contract management on multiple private landowner properties throughout Massachusetts. NRCS recognizes the importance of utilizing partners to help facilitate project management for NRCS customers throughout Massachusetts. The agreement holder could be asked to assist with customer technical assistance, conservation planning, certification packets for completed conservation practices, and writing Comprehensive Nutrient Management Plans (CNMPs). The agreement holder will also be responsible for providing training to NRCS staff and affiliates to demonstrate the ability to have direct conversations with agricultural producers, investigate and navigate conservation opportunities, demonstrate project management and implementation skills, as well as customer outreach.NRCS-Massachusetts is making a funding opportunity available for applicants to submit proposals with an award ceiling of $400,000 and a minimum project award of $200,000. NRCS will be awarding a cooperative agreement for up to a five-year period. If, in coordination with NRCS, additional resources are needed at a rate that exceeds this schedule, NRCS may add funds to this agreement to support continued partnership over the performance period.The primary goal is to expand conservation technical assistance to NRCS customers throughout Massachusetts. The project list ranges in size from less than 1-acre farms to several hundred-acre farms. Applicants will identify the average number of conservation application site visits with written conservation plans, existing contract conservation technical assistance site visits, and CNMPs that they could complete in any year with a minimum of fifteen application based and 15 contract based site visits per year being acceptable for this agreement (5 of those including CNMP development). NRCS will work with the selected applicant to make the choice of priority conservation site visits each year of the agreement based on interest and need. Applicants will be required to hold 1-2 conservation focused trainings per year for NRCS staff and partners to expand their technical knowledge. Applicants should provide a list of training ideas to NRCS for the length of the agreement. Applicants will be awarded based on the specified scoring criteria in Section E of this announcement. Eligible applicants are identified in Section C of this announcement. Applicants should be familiar with all applicable state, federal, local laws, policies, and regulations that apply to conservation improvements in the locales of Massachusetts.For new users of Grants.gov, see Section D. of the full Notice of Funding Opportunity for information about steps required before submitting an application via Grants.gov.Key DatesApplicants must submit their applications via Grants.gov by 11:59 pm Eastern Time on June 29, 2024. For technical issues with Grants.gov, contact Grants.gov Applicant Support at 1-800-518-4726 or support@grants.gov. Awarding agency staff cannot support applicants regarding Grants.gov accounts.For inquiries specific to the content of the NFO requirements, contact the federal awarding agency contact (section G of this NFO). Please limit questions to those regarding specific information contained in this NFO (such as dates, page numbers, clarification of discrepancies, etc.). Questions related to eligibility, or the merits of a specific proposal will not be addressed.The agency anticipates making selections by June 30, 2024, and expects to execute awards by August 15, 2024. These dates are estimates and are subject to change.

The project sites eligible for the grant must be located on 'farm and ranch' property, encompassing both private and public land, where the owner is not held responsible for the illegal disposal. The definition of 'farm and ranch' property can be found in the Eligible Geographies section below. Grantees are given approximately two years to complete the project(s). The sites should be fully remediated (cleaned up) using grant funds, or a combination of grant funds and in-kind contributions in terms of funds or services. The funding covers various costs, including Administrative, Recycling/Disposal (tires), Equipment, Material, and Personnel expenses. If necessary, measures for abatement and prevention, such as site security and public education/outreach efforts, should also be addressed. The program encourages innovative approaches. For further information and requirements, please refer to the Notice of Funds Available FY24-25 webpage, particularly the Application Guidelines and Instructions and Procedures and Requirements resource documents. The application typically includes several items for each project/site, such as Budget, Land Use/Zoning Designation, photos, Property Affidavit, Site Characterization, map, Work Plan, and Resolution. The Resolution is carried out through the governing body of the applicant (additional information is available). It is possible to include multiple projects/sites within a single application.

This funding opportunity provides financial support to Alaska-based municipal, tribal, and non-profit organizations to enhance USDA Natural Resources Conservation Service programs and build Tribal capacity, including costs for easements and land trusts.

The Effectiveness Monitoring Committee (EMC), serving as an advisory body to the Board of Forestry and Fire Protection, aims to fund scientific research that tests the effectiveness of the California Forest Practice Rules and associated regulations. This includes addressing natural resource issues such as watershed science, wildlife concerns, and wildfire hazard. Proposals are sought that focus on one or more of EMC's Research Themes and Critical Monitoring Questions, particularly those that contribute to understanding and enhancing wildfire resilience and response to climate change across California's forestlands. Projects must directly relate to management activities on private timberlands in the state, although those on public lands may qualify if they demonstrate relevance to non-federal timberland activities.

FMPP funds projects that develop, coordinate, and expand direct producer-to-consumer markets to help increase access to and availability of locally and regionally produced agricultural products. The program focuses on: Supporting and promoting domestic direct producer-to-consumer (including direct producer-to-retail, direct producer-to-restaurant, and direct producer-to-institutional marketing) marketing such as farmers markets, roadside stands, agritourism activities, community-supported agriculture (CSA) programs, or online sales; Encouraging the development of value-added agricultural products; Developing marketing strategies for producers of local food and value-added products; Facilitating regional food chain coordination development; Promoting new business opportunities and marketing strategies to reduce on-farm food waste; Responding to changing technology needs in direct producer-to-consumer marketing; and Covering expenses related to costs incurred in obtaining food safety certification and improvements to food safety practices and equipment.

This funding opportunity supports U.S.-based organizations in conducting research to better understand and manage heart-related side effects of cancer treatments, with a focus on improving detection, monitoring, and data sharing.

This funding opportunity supports a variety of organizations in California to develop and implement safer, sustainable pest management practices that protect public health and the environment while promoting economic vitality.

Federal Awarding Agency Name: U.S. Department of Agriculture (USDA), Natural Resources Conservation Service (NRCS), Commodity Credit Corporation (CCC) Funding Opportunity Title: Regional Conservation Partnership Program (RCPP) Classic for Federal fiscal year (FY) 2024 Funding Opportunity Number: USDA-NRCS-NHQ-RCPP-24-NOFO0001354 Assistance Listing: 10.932, Regional Conservation Partnership Program (RCPP) Due Date: NRCS must receive proposals by 4:59 p.m. Eastern Time on July 2, 2024. Note: The RCPP Classic and Alternative Funding Arrangement (AFA) FY 2024 notices of funding opportunity (NFO) will run concurrently. For information on AFA proposals please see Funding Opportunity Number USDA-NRCS-NHQ-RCPPAFA-24-NOFO0001355. The RCPP promotes the coordination of NRCS conservation activities with partners that offer value-added contributions to expand our ability to address on-farm, watershed, and regional natural resource concerns. Through the RCPP, NRCS seeks to co-invest with partners to implement projects that provide solutions to conservation challenges thereby measurably improving the resource concerns they seek to address. RCPP promotes collaboration with partners, stakeholders, and various communities, which is paramount to achieving equity in NRCS programs and services. Using guidance contained in this notice, partners propose projects that generate conservation benefits by addressing specific natural resource concerns in a state or multistate area by addressing one or more priority resource concerns within an NRCS-designated critical conservation area (CCA). NRCS and partners collaborate to design, promote, and implement RCPP projects on agricultural and nonindustrial private forest land. Through RCPP, NRCS may provide both financial assistance (FA) and technical assistance (TA) funds to project partners and agricultural producers for implementing projects. RCPP proposals are evaluated through a competitive proposal process based on three criteria: impact, partner contributions, and partnership and management. Up to $1.5 billion is available for RCPP projects through this announcement and the FY 2024 AFA announcement, which includes $300 million of the Agriculture Improvement Act of 2018 (2018 Farm Bill) funding and $1.2 billion of Inflation Reduction Act (IRA) funding. Proposals are accepted from all 50 States, the Caribbean Area (Puerto Rico and the U.S. Virgin Islands), and U.S. territories in the Pacific Island Areas (Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands). NRCS will prioritize using IRA funds for projects that will implement climate-smart agriculture and forestry conservation activities as described in section F.(3)a. of this announcement. Up to $100 million is being made available specifically for NRCS to enter into programmatic partnership agreements with Indian tribes. This set aside will be shared by this announcement and the FY 2024 AFA announcement. Any unused funds may be available for other partnership agreements. Submissions: Proposals must be submitted through the RCPP portal. See section E of this announcement for information on using the RCPP portal to submit proposals. Access to the RCPP portal requires a level 2 eAuthentication credential or a Login.gov credential. Obtaining a new Login.gov credential involves multiple steps and can take several days to complete. Instructions are posted on the How to Apply to RCPP web page listed below. For More Information: Applicants are expected to contact the appropriate State Conservationists and state RCPP coordinators prior to submitting a proposal. NRCS will use a state conservation questionnaire to record the results of this conversation. Proposals without a completed questionnaire may have their score and ranking reduced. A list of state RCPP coordinators (as of the date of this announcements posting) is on the NRCS How to Apply to RCPP web page. Applicants can also email the RCPP inbox (rcpp@usda.gov) with any questions about the announcement. The RCPP website is also a great source of current information about the program. Interested applicants are encouraged to participate in one or more of the webinars below to learn about the program and how to apply. 2024 RCPP NFO Applicant Outreach Webinar This webinar will provide general information for applicants submitting proposals for the Regional Conservation Partnership Program (RCPP). The same material will be covered at both webinars followed by a question-and-answer section. Please refer to the RCPP website for more information. Regional Conservation Partnership Program Natural Resources Conservation Service (usda.gov) April 23, 2024, RCPP Applicant Outreach Webinar Registration Link 2pm to 4pm EDT - https://events.gcc.teams.microsoft.com/event/e2f45f75-7ea4-410b-b1c9-567537cd2454@ed5b36e7-01ee-4ebc-867e-e03cfa0d4697 May 30, 2024, RCPP Applicant Outreach Webinar Registration Link 2pm to 4pm EDT - https://events.gcc.teams.microsoft.com/event/226dcb51-0b57-43b1-b340-95e535238713@ed5b36e7-01ee-4ebc-867e-e03cfa0d4697 NRCS will schedule additional webinars on RCPP easements and providing outreach to tribal applicants. Information on all webinars will be posted to the RCPP how to apply page.

The purpose of this funding opportunity announcement (FOA) is to support efficient natural history studies alone or in conjunction with the development and validation of clinical outcome assessments (COAs) and/or biomarker studies to address the unmet needs in rare neurodegenerative diseases for children and adults. Through the support of studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare neurodegenerative disease or multiple rare neurodegenerative diseases with similar pathophysiology, and facilitate rare disease product development.

The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Wildlife Services (WS) is announcing the availability of around $5,500,000 in cooperative agreement funding to control and prevent chronic wasting disease (CWD) in wild cervids. The amount available will be based on the amount appropriated by Congress less administrative costs. Proposals may further develop and implement wild CWD surveillance, testing, management, and response activities, including further development and evaluation of techniques and strategies to prevent or control CWD in wild cervids. WS intends to achieve a balance between management and research proposals. USDA APHIS Wildlife Services (WS) is also announcing the availability of cooperative agreement funding for a separate funding opportunity for the control and prevention of CWD in wild cervids on Tribal lands under the title “FY24 Tribal Nations Wild Cervid CWD Opportunities”. These funds will be made available for Federally recognized Native American Tribal governments. Once posted, applicants can find this funding opportunity information on the ezFedGrants website or the Grants.gov website by searching this title, the Catalog of Federal Domestic Assistance Number (CFDA) Number 10.028, or the Funding Opportunity Number USDA-APHIS-10028-WSNWRC00-24-0005. USDA APHIS Veterinary Services (VS) is announcing a separate funding opportunity for the control and prevention of CWD in farmed cervids under the title “FY24 Farmed Cervid CWD Management and Response Activities.” Applicants can find this funding opportunity information on the ezFedGrants website or the Grants.gov website by searching this title, the CFDA number 10.025, or the Funding Opportunity Number USDA-APHIS-10025-VSSPRS00-24-0007.

Under the Resilient Food Systems Infrastructure Program managed by the Pennsylvania Department of Agriculture (PDA) and funded by the USDA Agricultural Marketing Service (AMS), Simplified Equipment-Only Grants are designed to support Pennsylvania's food system transformation. These grants, focusing on equipment purchases for small to mid-size producers and processors, aim to diversify, distribute, and localize food systems to enhance consumer access, producer options, and rural community markets. Grant amounts range from $10,000 to $100,000, requiring no cost sharing. Eligible equipment expenses include purchase costs, delivery, and installation if included in the official bid. Applications are accepted electronically, with project completion required by June 30, 2026.

This funding opportunity provides financial support to organizations working to improve food security, nutrition, and education for children, particularly girls, in select developing countries through school feeding programs and related initiatives.

This program provides financial assistance to counties and tribal governing bodies to enhance fish and wildlife programs. Established in 1965 by the Wisconsin Legislature as an alternative to bounty payments on coyote, foxes, and bobcats, it now supports a wide range of county-sponsored fish and wildlife habitat projects. After the state budget approval, funds are allocated based on the ratio of each county's area to the total state area. The program is designed as a cost-share initiative for projects that include development of outdoor recreation structures, habitat restoration, stocking projects, maintenance, and miscellaneous projects directly related to fish and wildlife. Grant renewed every year. Grant annual deadline: October 1st

The U.S. Food and Drug Administration (FDA) seeks applications to develop, implement, and evaluate a human abuse potential (HAP) study of botanical Kratom. FDA has previously warned consumers about the use of Kratom (Mitragyna speciosa), a plant indigenous to Southeast Asia. Kratom alkaloids have demonstrated both affinity and activity at receptor sites known to be associated with abuse, such as mu opioid receptors. Although Kratom use is prevalent, to date, clinical evaluations of its abuse potential have been limited. The proposed HAP study should be performed in accordance with the guidance for industry, "Assessment of Abuse Potential of Drugs," including (but not limited to) the selection of an appropriate comparator(s) and outcome measures, statistical analyses etc. Interested parties, will also complete the submission of an Investigational New Drug (IND) application and obtain Institutional Review Board (IRB) clearance.