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Zdrowie i gospodarka · 5.03.2021

Data Standards; Requirement Begins for the Clinical Data Interchange Standards Consortium Version 1.1 of the Standard for Exchange of Nonclinical Data Developmental and Reproductive Toxicology Implementation Guide and Version 1.6 of the Study Data Tabulation Model; Clarification to Food and Drug Administration Data Standards

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is announcing the date that support will begin for version 1.1 of the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data Developmental and Reproductive Toxicology Implementation Guide (SENDIG- DART) and version 1.6 of the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and the dates when such new standard and version update will be required in certain submissions. The Agency will update the FDA Data Standards Catalog (Catalog) to reflect these changes. An additional note is added to the Catalog clarifying the requirements for the submission of a simplified trial summary dataset to determine a study start date at the point of submission at the electronic gateway.

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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