Notice 1 May 2025 compliance, healthcare, regulation, fda, infectious diseases, xenotransplantation

🩺FDA Notice on Xenotransplantation and Infectious Disease Guidelines

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 this notice. This notice solicits comments on the collection of information contained in the Public Health Service (PHS) guideline entitled "PHS Guideline on Infectious Disease Issues in Xenotransplantation" dated January 19, 2001.

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Notice 1 May 2025 compliance, pharmaceuticals, fda, recordkeeping, export requirements, food regulation

📦FDA Export Notification and Recordkeeping Requirements Overview

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 notifications and records required for human drug, biological product, device, animal drug, food, cosmetic, and tobacco product exports.

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Notice 1 May 2025 compliance, pharmaceuticals, fda, regulatory requirements, health, tropical diseases

💊FDA Comment Request on Tropical Disease Priority Review Vouchers

The Food and Drug Administration (FDA or Agency) 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 Tropical Disease Priority Review Vouchers.

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Notice 1 May 2025 regulatory compliance, fda, health, medical devices, influenza

🧪FDA Notice on Reagents for Detection of Specific Novel Influenza A Viruses

The Food and Drug Administration (FDA or Agency) 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 the information collection associated with Agency guidance on reagents for detection of specific novel influenza A viruses.

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Notice 1 May 2025 compliance, public comment, fda, veterinary, animal health, drug regulations

🐾FDA Notice on Compounding Animal Drugs from Bulk Substances

The Food and Drug Administration (FDA or Agency) 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 the recordkeeping provisions set forth in Guidance for Industry, GFI #256--Compounding Animal Drugs from Bulk Substances.

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Notice 1 May 2025 regulatory compliance, information collection, fda, consumer behavior, food products, cosmetic products

📊FDA Seeks Comments on Information Collection for Effective Communications

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 (PRA).

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Notice 1 May 2025 compliance, business regulation, fda, pharmaceutical industry, user fees, prescription drugs

💊FDA Notice on Prescription Drug User Fee Program Details

The Food and Drug Administration (FDA, Agency, or we) 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.

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Notice 1 May 2025 compliance, regulations, international trade, business operations, fda, human food program, food export

🍽️FDA Proposed Collection for Exporting Human Food Products

The Food and Drug Administration (FDA or Agency) 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 the information collection associated with export lists for products regulated by the Human Food Program (HFP).

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Notice 1 May 2025 compliance, information collection, fda, regulatory requirements, user fees, tobacco

🚬FDA Request for Comments on Tobacco User Fees Information Collection

The Food and Drug Administration (FDA or Agency) 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 "Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products."

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Notice 1 May 2025 regulatory compliance, fda, food safety, medicated feed, animal feed

📋Medicated Feed Mill Licensing Information Collection Notice

The Food and Drug Administration (FDA or we) 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.

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