NIH Guide to Grants and Contracts

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Integrated Food Defense & Emergency Response Cooperative Agreement Program IFD&ER (U18) - RFA-FD-15-022

Organization: FDA 

Posting Date: 05-04-2015 

Expiration Date: 04-03-2019 

Activity Code: U18 

Summary: The Integrated Food Defense & Emergency Response Cooperative Agreement Program (IFD&ER CAP) grant awards are designed to generate food defense tools and resources that are easily replicated and can complement, aid in the development of, and/or improve State, local, Tribal and territorial (SLTT) food defense programs through unique, innovative, and reproducible projects . The known overlap between food safety (unintentional contamination) and food defense (intentional contamination) is extensive. And the pools of resources available are vast and sometimes difficult to locate and implement. As the Food Safety Modernization Act (FSMA) recognizes the evolution of the relationship between food safety and food defense, it is critical that these programs be integrated to the maximum extent possible in order to ensure the most efficient use of resources, as well as to optimize responses to incidents and events. 

NARMS Cooperative Agreement Program to Enhance and Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens (U01) - PAR-16-099

Organization: FDA 

Posting Date: 02-12-2016 

Expiration Date: 05-02-2020 

Activity Code: U01 

Summary: This Funding Opportunity Announcement (FOA) issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), builds upon the National Antimicrobial Resistance Monitoring System (NARMS) which was initiated in 1996 as one of the key activities in a national action plan to combat antibiotic resistance threats. The purpose of this FOA is to protect and promote public health by enhancing, strengthening and sustaining antibiotic resistance surveillance in retail food specimens within the NARMS program. The NARMS cooperative agreements will improve the detection of antibiotic resistance among enteric bacteria in food commodities, as well as potentially develop new sites as part of the program. Measurable outcomes of the program will be in alignment with the NARMS Objectives. 

Vet-LIRN Cooperative Agreement Program to Develop and Validate Testing Methods for Food Irradiation Specific Markers in Animal Feeds and Treats (U18) - PAR-16-132

Organization: FDA 

Posting Date: 03-15-2016 

Expiration Date: 05-02-2018 

Activity Code: U18 

Summary: Food irradiation is a food preservation method which is used in many countries, both in human and animal food manufacturing. Treating food with irradiation results in large reduction in microbial contamination and insect pests. It is also useful in slowing ripening of fruit and for inhibiting sprouting of plant products.In USA, the FDA regulates all aspects of irradiation, such as irradiation dose, product type, and labeling requirements.The use of irradiation requires development of analytical methods capable to determine the irradiation status of wide variety of foods, in order to ensure that food is properly labeled, as well as to insure that products were properly handled during irradiation process.Current FDA regulations allow a maximum absorbed dose of 50 kGy in animal feed, pet food, and treats that are irradiated to reduce microbial and insect pest contamination.There are however, very few tests, with limited application, to quantify the actual dose used when irradiating animal food products. Depending on the type of food, various methods are available to detect food irradiation. For fatty foods, the major methods are based on chemical determination of compounds formed from the irradiation of lipids (hydrocarbons and 2-alkylcyclobutanones). It is believed that 2-alkylcyclobutanones (2-ACBs) are formed in food only by irradiation, and they are considered as markers for detecting the irradiation in food.Electron spin resonance (ESP) spectroscopy detects irradiation induced paramagnetic centers (e.g. radicals). This method is applicable for detection of irradiated foods containing bone, cellulose or crystalline sugar. Thermoluminescence is a method applicable to those foods from which a sufficient amount of silicate minerals can be isolated. Photostimulated luminescence is a different method, which can be applied to detect irradiation of any food which contains mineral debris. DNA comet assay can be used to detect irradiation of any food containing DNA, with several limitations. Different microbiological methods are also available, but can only be used as a screening tool. 

State and Territory Cooperative Agreement to Enhance Produce Safety in Preparation of Implementation of FDA's Rule: Standards for the Growing, Harvesting, Packing, & Holding of Produce for Human Consumption (U18) - PAR-16-137

Organization: FDA 

Posting Date: 03-17-2016 

Expiration Date: 04-04-2019 

Activity Code: U18 

Summary: The overall purpose of this FOA is to establish or enhance State and Territory Produce Safety Programs to encourage the safe production of fresh fruits and vegetables and to promote compliance with the requirements of FDAs Regulation Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (commonly referred to as the Produce Safety Rule). 

FDA Scientific Conference Grant Program (R13) - PAR-16-378

Organization: FDA 

Posting Date: 07-27-2016 

Expiration Date: 10-12-2019 

Activity Code: R13 

Summary: The purpose of the FDA (R13) Scientific Conference Grant Program is to facilitate the provision of federal financial assistance in support of small conferences and scientific meetings clearly aligned with the FDA mission. The FDA recognizes the value of supporting high quality, small conferences and scientific meetings relevant to its mission and to the public health. A small conference or scientific meeting is defined as a symposium, seminar, workshop, or any formal meeting, whether conducted face-to-face or virtually to exchange information and explore a defined subject, issue, or area of concern impacting the public's health within the scope of the FDA's mission. Permission to submit a conference grant application does not assure funding or funding at the level requested. FDA will not issue a conference grant award unless it can be issued before the conference start date.  

CVM Vet-LIRN Veterinary Diagnostic Laboratory Program (U18) - PAR-17-141

Organization: FDA 

Posting Date: 01-27-2017 

Expiration Date: 02-16-2019 

Activity Code: U18 

Summary: The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications from institutions/ organizations for inclusion into FDA's Veterinary Laboratory Investigation and Response Network Cooperative Agreement Program for Veterinary Diagnostic laboratories. This cooperative agreement program is intended to build domestic laboratory capacity as put forth in the Food Safety Modernization Act (FSMA), by developing the Vet-LIRN laboratory Network capabilities and capacity to investigate potential animal foodborne illness outbreaks. 

Flexible Funding Model - Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U18) - RFA-FD-18-001

Organization: FDA 

Posting Date: 10-31-2017 

Expiration Date: 12-02-2021 

Activity Code: U18 

Summary: The intended outcome of this FOA is to advance efforts for a nationally integrated food safety system (IFSS) by supporting Manufactured Food Regulatory Program Standards (MFRPS), Rapid Response Teams (RRT) and Food Protection Task Force (FPTF) programs, as well as special projects. For the purposes of this FOA, the term State encompasses all eligible organizations as defined in Section 3. 

Vet-LIRN Network Capacity-Building Projects - PAR-18-604

Organization: FDA 

Posting Date: 01-29-2018 

Expiration Date: 09-02-2023 

Activity Code: U18 

Summary: The purpose of this Funding Opportunity Announcement (FOA) is to support enhanced human and animal food safety by strengthening the capacity, collaboration, and integration of food-safety laboratories and networks, thereby facilitating an effective and coordinated response to future human and animal food safety issues. The current FOA solicits applications from FDA's Veterinary Laboratory Investigation and Response Network laboratories for research related to emerging public food safety issues identified by the Vet-LIRN network office (VPO), for equipment and personnel necessary to expand laboratory capability and capacity, and for other related activities. This cooperative agreement program is intended to build domestic laboratory capacity as put forth in the Food Safety Modernization Act (FSMA), by developing the Vet-LIRN laboratory Network capabilities and capacity to investigate potential animal foodborne illness outbreaks. 

FDA Drug Residue Prevention Program (U18) - RFA-FD-18-006

Organization: FDA 

Posting Date: 03-12-2018 

Expiration Date: 05-17-2018 

Activity Code: U18 

Summary: The intended outcome of this program is to advance efforts to improve and develop state drug residue prevention programs. It is necessary to provide assistance to state drug residue programs that need a stronger foundation to promote the prevention of illegal drug residues in animal derived foods through educational outreach and training. This program is intended to ensure drug residue prevention programs are developed to protect consumer exposure to drug residues in the edible products of food animals and support activities related to drug residue prevention. In addition, these awards will assist state agencies to better direct their programs to reduce the outcomes of illegal drug residues in animal derived foods. This cooperative agreement program (CAP) will focus on outreach, education and training. In addition, grantees will focus on performing targeted on-site assessments related to drug residue violations and best practice visits to industry and individuals to communicate proper drug use and promote effective management practices for drug residue prevention. 

Data Standards for Clinical Research and Drug Development (U24) - RFA-FD-18-015

Organization: FDA 

Posting Date: 03-15-2018 

Expiration Date: 05-14-2018 

Activity Code: U24 

Summary: The FDA Center for Drug Evaluation and Research is encouraging applications for projects to expedite development of data standards and terminologies to support human drug development and evaluation. The primary objective is to support research and the development of non-proprietary, consensus-based, national data standards for use in clinical studies of human drugs and biologics. Projects may focus on solutions to general data standards development and implementation challenges or on specific clinical concepts, domains, or therapeutic areas where standardization is needed. 

Cooperative Agreement to Support the Western Center for Food Safety (U19) - RFA-FD-18-008

Organization: FDA 

Posting Date: 03-15-2018 

Expiration Date: 05-22-2018 

Activity Code: U19 

Summary: FDA is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2018 to the University of California-Davis (UC Davis) to support the Western Center for Food Safety (WCFS). The purposes of this continued support are to: 1. Carry out multidisciplinary applied research that addresses "real world" issues related to food safety and food defense, agricultural practices, and the impact of agricultural practices on subsequent food processing associated with FDA-regulated products; 2. Develop and implement outreach and communication programs with stakeholders to identify research needs and to facilitate the utilization of the knowledge produced by the research program; 3. Provide opportunities to leverage additional resources among U.S. government agencies, non-governmental organizations, universities, industry, and consumers to achieve real-world solutions that address food safety and food defense issues. 4. Support the implementation of the Food Safety Modernization Act (FSMA) through research, education, and outreach with particular emphasis on the science behind the standards associated with the produce safety and preventive controls regulation. 

Bioequivalence of Topical Products: Elucidating the Thermodynamic and Functional Characteristics of Compositionally Different Topical Formulations (U01) - RFA-FD-18-010

Organization: FDA 

Posting Date: 03-19-2018 

Expiration Date: 05-21-2018 

Activity Code: U01 

Summary: The purpose of this funding opportunity is to support the research necessary to elucidate how systematic alterations to the qualitative (Q1) and/or quantitative (Q2) composition of topical formulations impacts their physical, structural, and functional properties. A key aspect of the research relates to understanding how the thermodynamic properties of a topical dosage form change as it undergoes metamorphosis during dose application and drying on the skin, how the drug's thermodynamic activity profile during the metamorphosis of the dosage form may compare between compositionally different (non-Q1 and/or non-Q2) topical formulations, and how these and other forces may modulate the rate and extent to which topically applied drugs may become available at or near their site(s) of action in the skin. Another key aspect of the research relates to identifying and understanding other potential failure modes for bioequivalence (BE) and/or therapeutic equivalence (TE) (e.g., differences in irritation potential) that may arise between compositionally different (non-Q1 and/or non-Q2) topical formulations. 

Characterize skin physiology parameters utilized in dermal physiologically-based pharmacokinetic model development across different skin disease states - RFA-FD-18-017

Organization: FDA 

Posting Date: 03-20-2018 

Expiration Date: 05-30-2018 

Activity Code: U01 

Summary: The purpose of this project is to identify skin physiology characteristics that differ between healthy and skin disease population groups and incorporate them into dermal physiologically-based pharmacokinetic models to improve their predictability. The models developed will be utilized to perform virtual bioequivalence assessments between brand name and generic drug products to inform regulatory decisions relating to the development of generic topical dermatological drug products and transdermal delivery systems. 

Formulation drug product quality attributes in dermal physiologically-based pharmacokinetic models for topical dermatological drug products and transdermal delivery systems - RFA-FD-18-019

Organization: FDA 

Posting Date: 03-21-2018 

Expiration Date: 05-29-2018 

Activity Code: U01 

Summary: The purpose of this project is to incorporate drug product quality attributes into dermal physiologically-based pharmacokinetic models developed for dermatological topical dosage forms and transdermal delivery systems. The developed models will be utilized to identify drug-product specific critical quality attributes (model qualification) and perform virtual bioequivalence assessments between brand name and generic drug products to inform regulatory decisions relating to the development of dermatological drug products. 

Computational fluid dynamics (CFD) and discrete element modeling (DEM) approach for predictions of dry powder inhaler (DPI) drug delivery - RFA-FD-18-014

Organization: FDA 

Posting Date: 03-22-2018 

Expiration Date: 05-30-2018 

Activity Code: U01 

Summary: Current product-specific bioequivalence (BE) guidance published by the Office of Generic Drugs for dry powder inhalers (DPIs) include in vitro testing recommendations for single actuation content and aerodynamic particle size distribution, as well as recommendations for a pharmacokinetic study and a pharmacodynamic or clinical endpoint study. Given the extensive nature of current DPI BE guidance, it is desirable that current in vitro testing for DPIs be more reflective of in vivo performance. Computational fluid dynamics (CFD) and discrete element modeling (DEM) have been used to predict dry powder aerosol behavior, including the effects of agglomeration and deagglomeration. The purpose of the study will be to develop a CFD-DEM model which can be used to evaluate the impact of various physicochemical properties and device performance properties on regional deposition, to identify potentially biorelevant ranges for these properties that may be useful for future BE recommendations. 

Three-Dimensional Approach for Modeling Nasal Mucociliary Clearance via Computational Fluid Dynamics (CFD) - RFA-FD-18-020

Organization: FDA 

Posting Date: 03-21-2018 

Expiration Date: 06-05-2018 

Activity Code: U01 

Summary: FDA's CDER is seeking a computational modeling approach to study the effects of mucociliary clearance on localized drug absorption in the nasal cavity. The modeling approach would utilize computational fluid dynamics (CFD) simulations of inhalation and droplet/particle transport to provide regional nasal spray deposition data, while the three-dimensional mucociliary clearance model would demonstrate localized drug absorption and indicate the efficacy of drug products that target specific nasal regions. The model should be adaptable to cases of interindividual variability, which may include variations in mucociliary clearance rates, changes in nasal geometry, and the presence of relevant disease states (e.g., nasal inflammation, changes in mucus properties, etc.). 

Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Non-Invasive Techniques - RFA-FD-18-012

Organization: FDA 

Posting Date: 03-22-2018 

Expiration Date: 06-05-2018 

Activity Code: U01 

Summary: The purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., spectroscopic/ imaging tomography) technologies, methods, study designs, and methods of data analysis to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that measures the amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis or dermis) by repeated measurements over time. The ultimate intent is to support the eventual development of an alternative, scientifically valid, cutaneous PK-based approach to efficiently evaluate the bioequivalence (BE) of topical products in vivo in human subjects. 

Renewal Applications: Centers of Excellence in Regulatory Science and Innovation - RFA-FD-18-011

Organization: FDA 

Posting Date: 03-23-2018 

Expiration Date: 06-05-2018 

Activity Code: U01 

Summary: As part of FDA's Advancing Regulatory Science Initiative, the Office of the Chief Scientist supports innovation aimed at development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. This funding opportunity will provide support, depending on availability of FDA funding, for one or more of the following existing Centers of Excellence in Regulatory Science and Innovation (CERSIs): Yale University-Mayo Clinic, University of Maryland at College Park and Baltimore and Johns Hopkins University. The CERSI(s) will serve to advance the Agency's regulatory science goals predominantly through cutting-edge collaborative research with FDA; they may also provide training in regulatory science. 

Assuring Radiation Protection (U18) - RFA-FD-18-021

Organization: FDA 

Posting Date: 03-23-2018 

Expiration Date: 06-05-2018 

Activity Code: U18 

Summary: Food and Drug Administration/ Center for Devices and Radiological (CDRH) is announcing its intention to accept and consider a single source application for the award of a cooperative agreement in fiscal year 2018 to Conference of Radiation Control Program Directors, Inc. (CRCPD) in support of coordination of Federal and State actions to assure radiation protection of the American public. The primary purpose of this cooperative agreement is to assist CRCPD members (State radiation control programs) in their efforts to protect the public, radiation workers and patients from unnecessary radiation exposure. Its goals will include: 1.Producing radiation protection solutions that meet community needs. 2.Assisting States with improving tools for radiation control. 3.Coordinate Federal, State and Tribal activities to achieve effective solutions to present and future radiation control problems. 4.Be expected to obtain the States cooperation and participation on committees and working groups established to deal with individual problems. 5.Plan and facilitate an annual meeting, and develop and offer educational activities to demonstrate mutually beneficial techniques, procedures, and systems relevant to the mission of assuring radiation protection. 6.Establish committees to address, evaluate, and offer solutions for a wide range of radiation health and protection issues. 7. Providing training in radiation control for CRCPD members. 

Exploration of HL7 FHIR Standards for Clinical Research and Post-market Surveillance - RFA-FD-18-016

Organization: FDA 

Posting Date: 03-28-2018 

Expiration Date: 06-12-2018 

Activity Code: U24 

Summary: The FDA Center for Drug Evaluation and Research (CDER) is encouraging applications to explore the development of HL7 Fast Healthcare Interoperability Resources (FHIR) standards to address healthcare and clinical research information exchange. 

Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) - RFA-FD-18-018

Organization: FDA 

Posting Date: 04-11-2018 

Expiration Date: 06-21-2018 

Activity Code: U01 

Summary: The purpose of this project is to develop and implement a virtual bioequivalence trial simulation platform that can be used to perform population-based statistical analysis in complex and computationally intensive physiologically based pharmacokinetic (PBPK) models developed to describe the absorption, distribution and elimination of active pharmaceutical ingredients formulated in complex and non-complex dosage forms administered via oral or non-oral routes. The developed virtual bioequivalence trial simulation platform will be used to generate predictions on the in vivo drug product performance, to perform bioequivalence assessments between brand name and generic drug products and to inform regulatory decisions relating to generic drug development. 

Enhancing Innovations in Emerging Technologies for Advanced Manufacturing of Complex Biologic Products (R01) - RFA-FD-18-023

Organization: FDA 

Posting Date: 04-20-2018 

Expiration Date: 06-26-2018 

Activity Code: R01 

Summary: CBER seeks to support the application of novel technologies for advanced manufacturing of complex biologic products, and innovative analytical approaches to improve product manufacturing and quality through active research. 

Cooperative Agreement to Support the Food and Agriculture Organization (FAO) (U01) - RFA-FD-18-009

Organization: FDA 

Posting Date: 04-20-2018 

Expiration Date: 07-03-2018 

Activity Code: U01 

Summary: The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for award of a cooperative agreement in fiscal year 2018 (FY 2018) to the Food and Agriculture Organization (FAO) of the United Nations to support global strategies that address food safety, nutrition and public health. The purpose of this cooperative agreement is to: 1. Utilize FAO's extensive research and expertise on country development and aid activities. 2. Contribute to the research, knowledge base and development of food safety systems globally due to the increasingly diverse and complex food supply. 3. Enhance and broaden FDA's ability to address global food safety, nutrition, and public health issues associated with food. 4. Provide opportunities to leverage additional resources of other countries. 5. Support the FDA Food Safety Modernization Act (FSMA) and FDA's International Food Safety Capacity Building Plan, which emphasizes the concept of preventing food safety-related problems before they occur and the importance of establishing strong relationships and mutual support among all stakeholders, including multilateral organizations, to improve worldwide food safety. 6. Support food safety, nutrition and public health programs that align with FDA's mission. 

International Research Ethics Education and Curriculum Development Award (R25) - PAR-16-081

Organization: FIC 

Posting Date: 01-13-2016 

Expiration Date: 05-18-2018 

Activity Code: R25 

Summary: The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The goal of this FIC R25 program is to support educational activities that foster a better understanding of biomedical, behavioral and clinical research and its implications, by strengthening research ethics capacity in low- and middle-income countries (LMICs) through increasing the number of LMIC research intensive institutions that can provide advanced education in research ethics. Programs supported by this initiative will equip scientists, health professionals and academics in these countries with in-depth knowledge of the ethical principles, processes and policies related to international clinical and public health research. Programs should be designed to strengthen the critical competencies needed to provide research ethics education, ethical review leadership and expert consultation to LMIC researchers, their institutions, governments and international research organizations.  

Planning Grant for Fogarty HIV Research Training Program for Low-and Middle-Income Country Institutions (D71) - PAR-16-281

Organization: FIC 

Posting Date: 05-23-2016 

Expiration Date: 08-24-2018 

Activity Code: D71 

Summary: The Fogarty HIV Research Training Program supports research training that strengthens HIV research capacity of institutions in low-and middle-income countries (LMIC). This FOA offers an opportunity for LMIC institutions to submit a planning grant application to participate in the Fogarty HIV Research Training Program. These applications must propose a plan to develop a research training program and the subsequent application that will be submitted in response to the companion D43 FOA (PAR-16-279). The planned research training program should strengthen research capacity in a defined high priority HIV scientific area (NOT-OD-15-137) at a specific LMIC institution or at LMIC sites in an established HIV research network.  

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