Named after the hundred-eyed watchman of Greek myth, Argus watches the education landscape: spotting new opportunities, pressure-testing the ventures we're building, and tracing every read back to the real-world signals behind it.
The evidence library: the raw signals the pipeline is watching across the education ecosystem. Every idea is built from these.
The Food and Drug Administration (FDA, Agency, or we) is announcing the rates for prescription drug user fees for fiscal year (FY) 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2022 (PDUFA VII), authorizes FDA to collect application fees for certain applications for the review of human drug and biological products and prescription drug program fees for certain approved products. This notice establishes the fee rates for FY 2027.
The Food and Drug Administration (FDA, Agency, or we) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2027, which apply from October 1, 2026, through September 30, 2027, and provides information on how the fees for FY 2027 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA).
The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). We are also announcing the fee rate for certification bodies applying for direct FDA accreditation.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the fee rates and payment procedures for fiscal year (FY) 2027 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Drug User Fee Amendments of 2023 (ADUFA V), authorizes FDA to collect user fees for certain animal drug applications and supplemental animal drug applications, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2027.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the fee rates and payment procedures for fiscal year (FY) 2027 generic new animal drug program user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2023 (AGDUFA IV), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs (JINADs), and for certain submissions related to JINAD files. This notice establishes the fee rates for FY 2027.
The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 rates for the establishment and reinspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a reinspection fee for each reinspection of an outsourcing facility. This document establishes the FY 2027 rates for the small business establishment fee ($7,142), the non-small business establishment fee ($22,074), and the reinspection fee ($21,427) for outsourcing facilities; provides information on how the fees for FY 2027 were determined; and describes the payment procedures outsourcing facilities should follow.
The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2022 (GDUFA III), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs); drug master files (DMFs); generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, and contract manufacturing organization (CMO) facilities; and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2027 rates for GDUFA III fees.
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Over-the-Counter Monograph Drug User Fee Amendments (herein referred to as "OMUFA II"), authorizes the Food and Drug Administration (FDA, the Agency, or we) to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and submitters of OTC monograph order requests (OMORs) for fiscal years 2026 through 2030. This notice publishes the OMUFA fee rates for fiscal year (FY) 2027.
The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). This fee is effective on August 1, 2026, and will remain in effect through September 30, 2027.
The Food and Drug Administration (FDA, Agency, or we) is announcing the rates for biosimilar user fees for fiscal year (FY) 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA III directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year.
This document withdraws a proposed rule that was published in the Federal Register on January 31, 2005. The proposed rule would have amended the regulations for Child and Family Services with respect to title IV-E administrative costs and eligibility determinations and re- determinations for title IV-E foster care recipients and foster care "candidates" to implement title IV-E foster care eligibility and administrative cost provisions in sections 472 and 474 of the Social Security Act (the Act) and incorporates previously issued policy guidance.
ACF/OHS announces its intent to award multiple single-source grants totaling $143,436,162 to select organizations operating a Head Start grant in Florida, South Carolina, and Puerto Rico who demonstrated Head Start services in the affective areas were either disrupted or impacted by Hurricanes Fiona and Ian. These awards are for necessary expenses directly related to the consequences of Hurricanes Fiona and Ian, including replacement of damaged or destroyed property and facilities, and increased mental health support.
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
The Food and Drug Administration (FDA or we) is reopening the comment period for the notice titled "Butylated Hydroxytoluene (BHT); Request for Information," which published in the Federal Register of May 13, 2026. We are taking this action in response to a request from stakeholders to extend the comment period to allow additional time for interested parties to develop and submit data, other information, and comments for this request for information.
This document announces updates to the Healthcare Common Procedure Coding System (HCPCS) codes on the Master List. It also announces updates to the HCPCS codes on the Required Face-to-Face Encounter and Written Order Prior to Delivery List and the Required Prior Authorization List.
In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of the re-establishment of a matching program between CMS and the Office of Personnel Management, "Verification of Eligibility for Minimum Essential Coverage Under the Patient Protection and Affordable Care Act through an Office of Personnel Management Health Benefit Plan". The matching program provides CMS and State Administering Entities with the Office of Personnel Management (OPM) data to use in determining individuals' eligibility to enroll in a qualified health plan through an exchange established under the ACA; for insurance affordability programs, certifications of exemption, and to make eligibility redeterminations and renewals, including appeal determinations.
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on September 18th, 2026. The topic for this meeting will be "Type 1 Diabetes and Cardiorenal Outcomes: Informing a Practice Changing Trial".
The Food and Drug Administration's (FDA) plans to centralize and enhance key functions across the agency. These changes will reduce redundancies, improve efficiency, and advance alignment to better serve the American public.
The Food and Drug Administration (FDA) is classifying the phase-changing fiducial marker for radiation therapy 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 classification of the phase-changing fiducial marker for radiation therapy. We are taking this action because we have determined that classifying the device into class II 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.
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $1.5 million for Year 1 funding to the Public Health Foundation. The award will support the modernization and enhancement of CDC TRAIN and the TRAIN Learning Network overall; capacity building and training to improve the skills and competence of the public health workforce; performance management, quality improvement, and innovation in governmental public health; and expanded collaborations between health departments and academic institutions. Funding amounts for years 2-5 will be set at continuation.
The Food and Drug Administration (FDA) is amending a notice entitled "Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026" that appeared in the Federal Register on September 18, 2025. The notice established the FY 2026 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a rare pediatric disease, material threat medical countermeasure, or tropical disease priority review voucher and outlined the payment procedures for such fees. This amendment is being made to reflect that on February 3, 2026, Congress amended section 529 of the FD&C Act, including to require a sponsor of a human drug application that is the subject of a rare pediatric disease priority review voucher to submit a priority review user fee "upon the submission of a human drug application under section 505(b)(1) or section 351(a) of the Public Health Service Act for which the priority review voucher is used."
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with expanded access to investigational drugs for treatment use.
The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). The general function of the committee is to provide advice and recommendations to FDA on pediatric regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
ANA is issuing final interpretive rules, general statements of policy, and rules of agency organization, procedure, or practice relating to the following Fiscal Year (FY) 2026 Notices of Funding Opportunity (NOFOs): Economic Advancement Grants for Local Empowerment (EAGLE), AI3 Action Institute--Artificial Intelligence for American Indians (AI3 Action Institute), and the National Center for Native Training and Technical Assistance (NCNTTA).
HHS gives notice of a decision to designate a class of employees from the Savannah River Site in Aiken, South Carolina, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled "Cancer Clinical Trial Eligibility Criteria: Performance Status." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation Research (CBER) for the treatment of cancer. Specifically, this guidance includes recommendations regarding expanding eligibility criteria to include patients with a wider range of performance status. This guidance finalizes the draft guidance of the same title issued on April 26, 2024.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation Research (CBER) for the treatment of cancer. Specifically, this draft guidance includes recommendations regarding the appropriate use of washout periods and concomitant medication exclusions. This guidance finalizes the draft guidance of the same title issued on April 26, 2024.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Laboratory Values." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation Research (CBER) for the treatment of cancer. Specifically, this guidance includes recommendations for selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of trial participants. This guidance finalizes the draft guidance of the same title issued on April 26, 2024.
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
The Food and Drug Administration (FDA) is classifying the non- medicated topical formulation for treatment of erectile dysfunction 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 classification of the non-medicated topical formulation for treatment of erectile dysfunction. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the active noise attenuation system for infant incubators 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 classification of the active noise attenuation system for infant incubators. We are taking this action because we have determined that classifying the device into class II 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.
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Customer Surveys Generic Clearance for the National Center for Health Statistics. This Generic Clearance uses customer surveys to assess strengths in agency products and services.
The Administration for Children and Families (ACF) Office of Refugee Resettlement (ORR) is requesting a 3-year extension with changes of the Mental Health Assessment Form and Onsite Health Intervention Form (formerly Public Health Investigation Form: Non-TB Illness, and Public Health Investigation Form: Active TB, OMB # 0970- 0509, expiration 9/30/2026). Proposed revisions include merging two forms (Public Health Investigation Forms, Active TB and Non-TB Illness) into the single Onsite Health Intervention (OHI) Form. The proposed restructuring and revisions will improve transparency, lessen burden, improve data quality, and ensure alignment with ORR requirements. In addition, to ensure continuity of care, the request has been revised to include the sharing of health information with the Department of Homeland Security (DHS) in specific circumstances.
This notice announces our decision to approve the National Committee for Quality Assurance's renewal application for Medicare Advantage "deeming authority" of Health Maintenance Organizations and Preferred Provider Organizations for a term of 6 years.
This quarterly notice lists Centers for Medicare & Medicaid Services (CMS) manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the 3-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS.
In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Administration for Children and Families (ACF), ACF Tech, is providing notice of a re-established matching program between the Department of Veterans Affairs (VA) and State Public Assistance Agencies (SPAAs) participating in the Public Assistance Reporting Information System (PARIS) Program. The matching program provides the SPAAs with VA's compensation and pension data on a periodic basis to use in determining public assistance applicants' and recipients' eligibility for certain public assistance benefits. ACF Tech facilitates the matching program, and the Department of Treasury, Bureau of Fiscal Services, Do Not Pay (DNP) conducts the matches of SPAA and VA data and provides associated support.
The National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is giving notice of the invention listed below, which 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.
The National Eye Institute (NEI) seeks research co-development partners and/or licensees for the development of an AAV2-based delivery system or an eyedrop formulation to deliver a Pigment Epithelium- Derived Factor (PEDF) peptide as a gene-agnostic approach to treating inherited retinal diseases.
The NCI seeks research co-development partners or licensees for NPM1 Mutation-Specific T Cell Receptors for Targeted Treatment of AML.