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Commerce Department, National Institute of Standards and Technology · 2026-09-18
The National Institute of Standards and Technology (NIST) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB), a part of the National Institutes of Health (NIH), are requesting input from stakeholders in order to gain a better understanding of the future needs for medical metrology and standards around medical imaging, devices, and diagnostics. This request for information is coordinated with a NIST/NIBIB Symposium on Medical Metrology and Standards for American Healthcare and Commerce Medical Imaging, Devices, Diagnostics at the joint NIST/University of Maryland Institute (UMD) for Bioscience and Biotechnology Research (IBBR). The input received will inform a joint NIST and NIBIB medical metrology and standards roadmap, a document that will identify future needs for medical metrology and standards, identify major stakeholders, and provide guidance for future government programs.
Justice Department, Drug Enforcement Administration · 2026-09-23
The Drug Enforcement Administration proposes placing five tryptamine hallucinogens, 4-hydroxy-N,N-diisopropyltryptamine (other names: 4-OH-DiPT; 3-(2-(diisopropylamino)ethyl)-1H-indol-4- ol), 5-methoxy-alpha-methyltryptamine (other names: 5-MeO-AMT; 1-(5- methoxy-1H-indol-3-yl)propan-2-amine), 5-methoxy-N-methyl-N- isopropyltryptamine (other names: 5-MeO-MiPT; N-(2-(5-methoxy-1H-indol- 3-yl)ethyl)-N-methylpropan-2-amine), 5-methoxy-N,N-diethyltryptamine (other names: 5-MeO-DET; N,N-diethyl-2-(5-methoxy-1H-indol-3- yl)ethanamine), and N,N-diisopropyltryptamine (other names: DiPT; N-(2- (1H-indol-3-yl)ethyl)-N-isopropylpropan-2-amine), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle these five specific tryptamine hallucinogens.
Health and Human Services Department, Food and Drug Administration · 2026-09-22
The Food and Drug Administration (FDA, Agency, or we) is issuing a direct final rule that substitutes references to "animal" tests or studies with "nonclinical" tests or studies, adds a definition of the terms "nonclinical test" and "nonclinical study," and makes other comparable or conforming amendments in certain safety and reporting sections of its regulations. The direct final rule also substitutes "nonclinical" for "preclinical" and "in vitro" for consistency in terminology. The Agency is issuing these amendments directly as a final rule because we believe they are noncontroversial changes in terminology that are not expected to affect industry practice and FDA anticipates no significant adverse comments. These amendments align with recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act) and are intended to remove an emphasis, in certain places, on the use of animal testing as the only scientific methodology to assess the safety of a drug in the nonclinical setting. These changes may also foster the development and use of scientifically valid new testing methodologies, potentially improving predictive accuracy of product safety testing while replacing, reducing, or refining animal use. The rule adds no new requirements.
Health and Human Services Department, Food and Drug Administration · 2026-09-22
The Food and Drug Administration (FDA, Agency, or we) is proposing to substitute references to "animal" tests or studies with "nonclinical" tests or studies, add a definition of the terms "nonclinical test" and "nonclinical study," and make other comparable or conforming amendments in certain safety and reporting sections of its regulations. The proposed rule would also substitute "nonclinical" for "preclinical" and "in vitro" for consistency in terminology. These proposed amendments align with recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act) and are intended to remove an emphasis, in certain places, on the use of animal testing as the only scientific methodology to assess the safety of a drug in the nonclinical setting. These changes may also foster the development and use of scientifically valid new testing methodologies, potentially improving predictive accuracy of product safety testing while replacing, reducing, or refining animal use. The proposed rule would add no new requirements.
Agriculture Department, Animal and Plant Health Inspection Service · 2026-09-21
We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Bayer U.S.-Crop Science seeking a determination of nonregulated status for MON 89151 lepidopteran-protected cotton (Gossypium hirsutum) which has been developed using genetic engineering to express three insecticidal proteins to protect against feeding damage caused by target lepidopteran pests. We are making the petition and draft plant pest risk assessment available for public review and comment.
Agriculture Department, Animal and Plant Health Inspection Service · 2026-09-21
We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Bayer U.S.-Crop Science seeking a determination of nonregulated status for herbicide resistant MON 96012 cotton (Gossypium hirsutum) which has been developed using genetic engineering to tolerate glyphosate, glufosinate, dicamba, triketone 4-hydroxyphenylpyruvate dioxygenase -inhibiting, and PPO- inhibiting herbicides. We are making the petition and draft plant pest risk assessment available for public review and comment.
Health and Human Services Department, Food and Drug Administration · 2026-09-18
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #298 (VICH GL62) titled "Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products." This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance contributes to the international harmonization of methods used for the target animal safety (TAS) evaluation of veterinary monoclonal antibody products (VMAPs) and aids in preparing and conducting VMAP TAS studies under laboratory and field conditions. A harmonized standard is intended to aid in development of mutually acceptable VMAP TAS programs.
Commerce Department, International Trade Administration · 2026-09-16
Based on affirmative final determinations by the U.S. Department of Commerce (Commerce) and the U.S. International Trade Commission (ITC), Commerce is issuing antidumping duty (AD) and countervailing duty (CVD) orders on L-lysine (lysine) from the People's Republic of China (China).
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