Planning for Product Development Strategy (R34 Clinical Trial Not Allowed)
ID: 357945Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Award Range

$0 - $225K

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/357945

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-25-099.html
Timeline
    Description

    The National Institutes of Health (NIH) has announced a funding opportunity titled "Planning for Product Development Strategy," aimed at supporting the development of comprehensive strategies for next-generation treatments and preventive measures for HIV and its associated complications. This grant opportunity encourages eligible applicants, including various educational institutions and community organizations, to create innovative product development plans that align with FDA guidelines, facilitating the submission of Investigational New Drug (IND) applications. With a total estimated funding of $225,000 available for individual projects, applications are due by December 5, 2026, and must adhere to specific guidelines emphasizing scientific merit and compliance. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link provided in the announcement.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-25-099-Full-Announcement.html
    PAR-25-099.html
    The National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), has issued a Notice of Funding Opportunity (NOFO) titled "Planning for Product Development Strategy" to facilitate the development of strategies for next-generation HIV treatments and prevention. The program aims to assist organizations in creating comprehensive product development strategies that comply with FDA guidelines, thereby enabling the submission of Investigational New Drug (IND) applications. This grant opportunity, with a total funding of $1 million for fiscal year 2025, supports various institutions, including higher education, nonprofits, and government entities, to improve biomedical research in infectious diseases. The application process is highly structured, requiring adherence to specific guidelines, and is limited to non-clinical trial planning activities. Eligible applicants can propose unique projects with budgets up to $225,000 for a year, focusing on innovative therapies and preventive strategies against HIV and associated complications. The overall goal of the NOFO is to enhance the research ecosystem, ensuring effective translation of scientific findings into viable drug products. Applications are due by December 5, 2026, with significant emphasis on compliance and scientific merit in the review process.
    Similar Opportunities
    Planning for Product Development Strategy (R34 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a Notice of Funding Opportunity (NOFO) titled "Planning for Product Development Strategy," aimed at supporting the development of comprehensive strategies for next-generation treatments and preventive methods for HIV and associated complications. The primary objective of this grant is to facilitate the planning activities necessary for submitting an Investigational New Drug (IND) application to the FDA, with a focus on translating innovative research into effective drug products. This funding opportunity is particularly significant as it encourages collaboration among multidisciplinary teams to address critical health challenges related to HIV. Interested applicants can apply starting February 13, 2024, with a total funding amount of $1,000,000 anticipated for 2-3 awards in fiscal year 2025. For further inquiries, applicants may contact NIH Grants Information at grantsinfo@nih.gov, and additional details can be found at the provided link: https://grants.nih.gov/grants/guide/pa-files/PAR-24-029.html.
    Innovation for HIV Vaccine Discovery (R01 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a grant opportunity titled "Innovation for HIV Vaccine Discovery" (NOFO Number PAR-23-169) aimed at supporting high-risk, high-impact early discovery research focused on innovative vaccine approaches to prevent HIV acquisition and ongoing infection. This initiative emphasizes a Go/No-Go funding approach, requiring applicants to demonstrate measurable progress towards defined goals by the end of Year 2, with continued funding contingent upon meeting these criteria. The overall budget for this initiative is approximately $2 million for fiscal year 2024, with individual project budgets capped at $350,000 per year, and applications must be submitted via Grants.gov by August 2, 2025. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov.
    Innovations to Optimize HIV Prevention and Care Continuum Outcomes (R21 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting proposals for the R21 Exploratory/Developmental Research Grant under the funding opportunity titled "Innovations to Optimize HIV Prevention and Care Continuum Outcomes." This initiative aims to support innovative research that enhances HIV prevention and care strategies by exploring behavioral and social science approaches, new intervention methods, and implementation science, particularly addressing gaps in engagement, adherence, and retention in healthcare services. The grant, with a funding ceiling of $275,000 over two years, emphasizes collaboration with community organizations and the inclusion of diverse populations, aligning with national and global health objectives. Interested applicants can submit their proposals until January 9, 2026, and should direct inquiries to NIH Grants Information at grantsinfo@nih.gov.
    Development and Testing of Novel Interventions to Improve HIV Prevention, Treatment, and Program Implementation for People Who Use Substances (R34 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Development and Testing of Novel Interventions to Improve HIV Prevention, Treatment, and Program Implementation for People Who Use Substances" under the R34 planning grant mechanism. This initiative aims to encourage formative research and the development of innovative interventions that target HIV prevention and care, particularly for populations that engage in substance use, addressing critical gaps in HIV care and prevention. Eligible applicants include a wide range of organizations such as higher education institutions, nonprofit entities, and tribal governments, with grants available for up to $450,000 over three years. The application cycle begins on April 7, 2025, with subsequent due dates throughout the year, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    High Priority HIV and Substance Use Research (RM1 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "High Priority HIV and Substance Use Research (RM1 Clinical Trial Optional)" aimed at supporting innovative research that addresses the intersection of HIV and substance use. This initiative invites applications from individual researchers and research teams to develop projects that can lead to new prevention, treatment, and care strategies for individuals affected by both conditions, with a requirement for a detailed research plan and preliminary data. A total budget of $3.0 million is available for funding one to two awards, with individual project budgets capped at $1.5 million per fiscal year, and applications are due by February 12, 2027. Interested applicants can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries and are encouraged to consult with NIDA program staff early in the application process.
    Opportunities for HIV Cure Strategies at the Time of ART Initiation (R21 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity aimed at exploring innovative HIV cure strategies at the initiation of combination antiretroviral therapy (cART). This initiative seeks to identify and develop interventions that can be applied at the start of cART or following treatment interruptions, with the ultimate goal of achieving sustained treatment-free remission. The funding, available for up to two years with a maximum budget of $275,000, is open to a diverse range of eligible applicants, including higher education institutions, non-profits, and for-profit entities. Interested parties can find more information and application guidelines at the NIH grants website, with a submission deadline set for September 7, 2026.
    Advancing Translation of Long-Acting Strategies for HIV and HIV-Associated Co-infections (AT LASt) (R61/R33 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Advancing Translation of Long-Acting Strategies for HIV and HIV-Associated Co-infections (AT LASt)" aimed at supporting the development of long-acting/sustained release (LA/SR) technologies for the prevention and treatment of HIV and associated co-infections such as tuberculosis (TB), hepatitis B (HBV), and hepatitis C (HCV). This initiative seeks to fund preclinical activities that will advance these technologies toward submission of Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA), with a focus on ensuring safety and efficacy through rigorous studies. The program is particularly significant as it addresses public health challenges related to infectious diseases that disproportionately affect individuals living with HIV, and it will provide approximately $4 million to support 3-5 awards, with applications due by March 14, 2025. For further inquiries, interested applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    Advancing HIV/AIDS Research within the Mission of the NIDCD (R21 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH), through its National Institute on Deafness and Other Communication Disorders (NIDCD), has announced a funding opportunity titled "Advancing HIV/AIDS Research within the Mission of the NIDCD (R21 Clinical Trial Optional)." This grant aims to stimulate innovative research addressing critical issues related to communication disorders—such as hearing, balance, taste, smell, voice, speech, and language—specifically for individuals living with HIV/AIDS. The initiative encourages multidisciplinary collaborations and supports low-risk clinical trials that do not require FDA oversight, with a total funding limit of $275,000 for two-year projects, and no more than $200,000 in any single year. Interested applicants, including various academic institutions and nonprofits, must submit their proposals by January 7, 2026, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    Ending the Epidemic: New Models of Integrated HIV/AIDS, Addiction, and Primary Care Services (R34 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Ending the Epidemic: New Models of Integrated HIV/AIDS, Addiction, and Primary Care Services," aimed at supporting innovative research to enhance the integration of HIV, addiction, and primary care services. This initiative invites applications for R34 Planning Grants to develop and test models that improve healthcare delivery for individuals at risk for or living with HIV, Hepatitis B and C, and substance use disorders, with a focus on strategies such as integrating substance misuse prevention within HIV care settings. The total funding available for this project is $2 million, with awards potentially lasting up to three years, and applications are due by March 20, 2025. Interested applicants can find more information and contact NIH Grants Information at grantsinfo@nih.gov for inquiries.
    Priority HIV/AIDS Research within the Mission of NIDDK (R01 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), is offering a funding opportunity titled "Priority HIV/AIDS Research" under the R01 grant mechanism. This initiative aims to stimulate research that aligns with NIH’s priorities regarding HIV/AIDS, particularly focusing on systemic complications such as metabolic, gastrointestinal, and kidney issues arising from HIV, while encouraging the incorporation of health-impeding social determinants of health into research proposals. The anticipated funding amount is $2 million, with plans to support 3 to 5 awards over five years, and applications are due starting May 7, 2025. Interested applicants can find more information and application guidelines at the NIH Grants website or contact NIH Grants Information at grantsinfo@nih.gov for further inquiries.