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Zdrowie i gospodarka · 30.08.2011

Draft Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation." This draft guidance provides recommendations to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding what criteria should be met to facilitate the evaluation and labeling of tablets that have been scored. (A scoring feature facilitates tablet splitting, which is the practice of breaking or cutting a higher- strength tablet into smaller portions.) Specifically, this draft guidance recommends guidelines to follow, data to provide, and criteria to meet and detail in an application to approve a scored tablet; and nomenclature and labeling for approved scored tablets. This guidance does not address specific finished-product release testing, where additional requirements may be appropriate for scored tablets.

Source: Federal Register — Health and Human ServicesOpen 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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