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Zdrowie i gospodarka · 26.09.2016

Generic Drug User Fees; Public Meeting; Request for Comments

The Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA), which authorizes FDA to collect fees and use them for the review of certain generic human drug applications and associated Type II active pharmaceutical ingredient (API) drug master files (DMFs), and for conducting associated inspections for fiscal years (FYs) 2018 through 2022. The legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to present the recommendations to the relevant Congressional committees, publish the recommendations for the reauthorized program in the Federal Register, provide for a period of 30 days for the public to provide written comments on such recommendations, and hold a meeting at which the public may present its views on such recommendations. FDA will then conside

Source: Federal Register — Food and Drug AdministrationOpen original release →
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Zdrowie i gospodarka · 10/5/2026

Proposed Data Collection Submitted for Public Comment and Recommendations

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 proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Public Health Crisis Response (PHCR) Cooperative Agreement. The Public Health Crisis Response (PHCR) Cooperative Agreement provides rapid funding to help existing public health programs respond to major public health emergencies and crises.

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Zdrowie i gospodarka · 10/5/2026

Proposed Data Collection Submitted for Public Comment and Recommendations

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 Respiratory Protective Devices--42 CFR 84. The purpose of this data collection is to enable 42 CFR part 84 respirator approval certification activities.

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Zdrowie i gospodarka · 9/28/2026

Proposed Data Collection Submitted for Public Comment and Recommendations

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 proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Public Health Emergency Preparedness (PHEP) Cooperative Agreement. This request proposes to collect information from the PHEP Cooperative Agreement awardees to document and monitor their performance measure progress and fulfillment.

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