💊FDA Notice on Patent Extension for KISUNLA Regulatory Review
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KISUNLA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More🧪Notice of NIH Closed Meetings for Grant Evaluations
The Department of Health and Human Services announces closed meetings of the Center for Scientific Review to evaluate grant applications related to various health and research topics. The meetings, held virtually, involve several committees dedicated to assessing the potential of submitted proposals in addressing key scientific challenges.
Learn More🌽Bayer CropScience Seeks Nonregulated Status for MON 95275 Maize
We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Bayer CropScience seeking a determination of nonregulated status for MON 95275 maize (corn) which has been developed using genetic engineering to produce two insecticidal proteins and a double-stranded RNA transcript to provide protection from feeding damage caused by targeted coleopteran (corn rootworm) insect pests. We are making the petition and draft plant pest risk assessment available for public review and comment.
Learn More🧬Government-Owned Inventions Available for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Learn More🦠Exclusive License Opportunity for Engineered Commensal Bacteria Technology
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive, Inter- Institutional Agreement-Institution Lead to CZ Biohub SF, LLC ("CZB"), located in San Francisco, California, in its rights to the technologies and patent applications listed in the Supplementary Information section of this notice.
Learn More💰NIH Center for Scientific Review
The Department of Health and Human Services announces closed meetings by the National Institutes of Health's Center for Scientific Review. These meetings aim to evaluate grant applications and contract proposals related to scientific innovation and public health, with specific agendas scheduled for discussion.
Learn More💉Government-Owned EV-D68 Antibodies Now Available for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Learn More💉NIH Proposes New Intellectual Property Policy for Cancer Research
The National Cancer Institute, an Institute of the National Institutes of Health, Department of Health and Human Services, Division of Cancer Prevention (DCP) is seeking comments on instituting a standard policy on Intellectual Property (IP) developed by certain funding recipients under NCI DCP funding agreements. This standard policy is entitled "The DIVISION OF CANCER PREVENTION INTELLECTUAL PROPERTY OPTION TO COLLABORATORS (IP Option)." The proposed policy, if finalized, shall apply to entities that conduct DCP-funded clinical studies under funding agreements which involve an NCI collaborator that provides its proprietary agent or technology for the DCP-supported studies where this IP Option is included as a term of applicable existing and future funding agreements.
Learn More🧬FDA Classifies Fluorescence Devices for Hematologic Malignancies
The Food and Drug Administration (FDA, the Agency, or we) is classifying the fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More🧬Requirements for Patent Applications with Nucleotide Sequence Disclosures
The United States Patent and Trademark Office (USPTO), as required by the Paperwork Reduction Act of 1995, invites comments on the extension and revision of an existing information collection: 0651- 0024 (Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures). The purpose of this notice is to allow 60 days for public comments preceding submission of the information collection to the Office of Management and Budget (OMB).
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