Webinar Available on Progress Towards Reducing Administrative Burden While Maintaining Animal Welfare and Scientific Integrity
The NIH’s Office of Laboratory Animal Welfare (OLAW), along with their colleagues from the U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA), recently presented a webinar discussing progress towards implementing the 21st Century Cures Act. The new webinar focuses on how the three agencies recommend reducing administrative burden on investigators while maintaining the integrity and credibility of research findings and the protection of research animals. The actions discussed follow the release of their final report in 2019 (see also this NIH Open Mike blog). Topics of note for Assured instituti...
Source: NIH Extramural Nexus - March 17, 2021 Category: Research Authors: NIH Staff Tags: New Resources 21st Century Cures Act Administrative Burden Animal Welfare Source Type: funding

Maximizing the Scientific Value of Existing Biospecimen Collections (R21 Clinical Trial Not Allowed)
Funding Opportunity RFA-OD-21-004 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to invite R21 applications to stimulate exploratory research relevant to the mission of the Food and Drug Administration (FDA) - Center for Tobacco Products (CTP) using existing (publicly available) biospecimens currently stored in repositories in the United States. This will include, but not be limited to, collections associated with the Population Assessment of Tobacco and Health (PATH) Study, the National Health and Nutrition Examination Survey (NHANES), the National Heart, Lung...
Source: NIH Funding Opportunities (Notices, PA, RFA) - March 10, 2021 Category: Research Source Type: funding

Secondary Analyses of Existing Datasets of Tobacco Use and Health (R21 Clinical Trial Not Allowed)
Funding Opportunity RFA-OD-21-003 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to invite R21 applications proposing the innovative analysis of existing (publicly available) nationally representative U.S. cross-sectional and longitudinal data, to investigate novel scientific ideas and/or to generate new models, systems, tools, methods, or technologies that have the potential for significant impact on biomedical or biobehavioral research in areas relevant to the Food and Drug Administration (FDA) - Center for Tobacco Products (CTP). Other publicly available dat...
Source: NIH Funding Opportunities (Notices, PA, RFA) - March 10, 2021 Category: Research Source Type: funding

Tobacco Regulatory Science (R01 Clinical Trial Optional)
Funding Opportunity RFA-OD-21-002 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to invite R01 applications to support biomedical and behavioral research that will provide scientific data to inform regulation of tobacco products to protect public health. Research Projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP). The awards under this FOA will be administered by NIH using funds that have been made available through FDA CTP and the Family Smoking Preventio...
Source: NIH Funding Opportunities (Notices, PA, RFA) - February 17, 2021 Category: Research Source Type: funding

PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
Funding Opportunity PA-20-262 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA), issued by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) grant applications. United States SBCs that have the research capabilities and technological expertise to contribute to the R and D mission(s) of the NIH, CDC, and FDA awarding components identified in this FOA are encouraged to submit SBIR gra...
Source: NIH Funding Opportunities (Notices, PA, RFA) - July 14, 2020 Category: Research Source Type: funding

PHS 2020-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
Funding Opportunity PA-20-260 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA), issued by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) grant applications. United States SBCs that have the research capabilities and technological expertise to contribute to the R and D mission(s) of the NIH, CDC, and FDA awarding components identified in this FOA are encouraged to submit SBIR gra...
Source: NIH Funding Opportunities (Notices, PA, RFA) - July 14, 2020 Category: Research Source Type: funding

SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance (SB1, Clinical Trial Not Allowed)
Funding Opportunity PAR-20-128 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The FOA aims to facilitate the transition of previously funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance not typically supported through Phase II or Phase IIB grants or contracts. This may include preparation of documents for a Food and Drug Administration (F...
Source: NIH Funding Opportunities (Notices, PA, RFA) - July 10, 2020 Category: Research Source Type: funding

Preclinical Development of Novel Therapeutics Targeting Aging Mechanisms (SBIR U44 Clinical Trial Not Allowed)
Funding Opportunity RFA-AG-21-026 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) utilizes the SBIR cooperative agreement (U44) activity code to support the preclinical development of emerging therapeutics targeting fundamental mechanisms of aging (e.g., inflammation, cell senescence, proteostasis). This includes the translation of a broad range of potential geroscience-based therapies, such as new classes of compounds (e.g., senolytics), biologics, stem/progenitor cell-based therapies, repositioning of existing investigational drugs, and repurposing of Food and Drug Administrati...
Source: NIH Funding Opportunities (Notices, PA, RFA) - June 25, 2020 Category: Research Source Type: funding

Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)
Funding Opportunity RFA-HL-21-003 from the NIH Guide for Grants and Contracts. The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. App...
Source: NIH Funding Opportunities (Notices, PA, RFA) - June 2, 2020 Category: Research Source Type: funding

Tobacco Regulatory Science (R01 Clinical Trial Optional)
Funding Opportunity RFA-OD-19-028 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to invite R01 applications to support biomedical and behavioral research that will provide scientific data to inform regulation of tobacco products to protect public health. Research Projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP). The awards under this FOA will be administered by NIH using funds that have been made available through FDA CTP and the Family Smoking Preventio...
Source: NIH Funding Opportunities (Notices, PA, RFA) - September 25, 2019 Category: Research Source Type: funding

Final Report on Reducing Administrative Burdens Associated with Research Involving Laboratory Animals
This report, called for in the 21st Century Cures Act, is the culmination of more than two years of diligent work to address inconsistent and overlapping policies governing oversight of research involving animals, while ensuring research findings remain credible and research institutions safeguard animal welfare.  Regulations and policies overseeing federally-sponsored research help ensure NIH remains a responsible steward of public funds. This extends to properly enforcing the public’s expectation on how laboratory animals will be used in biomedical research, teaching, and testing. Many stakeholders have pointe...
Source: NIH Extramural Nexus - September 25, 2019 Category: Research Authors: Mike Lauer Tags: blog Open Mike Administrative Burden Animal Welfare Source Type: funding

Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)
Funding Opportunity RFA-HL-20-030 from the NIH Guide for Grants and Contracts. The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. App...
Source: NIH Funding Opportunities (Notices, PA, RFA) - August 14, 2019 Category: Research Source Type: funding

Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)
The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications submitted in response to this bi-phasic, milestone-driven cooperative ag...
Source: NIDDK Funding Opportunities - August 14, 2019 Category: Endocrinology Source Type: funding

SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance (SB1, R44) Clinical Trial Not Allowed
Funding Opportunity PAR-19-334 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The FOA aims to facilitate the transition of previously funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance not typically supported through Phase II or Phase IIB grants or contracts. This may include preparation of documents for a Food and Drug Administration (F...
Source: NIH Funding Opportunities (Notices, PA, RFA) - August 5, 2019 Category: Research Source Type: funding