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Zdrowie i gospodarka · 3.10.2007

Electronic Nonclinical Study Data Submission; Notice of Pilot Project

The Center for Drug Evaluation and Research (CDER) is seeking sponsors interested in participating in a pilot project to test, in a regulatory setting, the electronic submission of nonclinical study data using the Standard for Exchange of Nonclinical Data (SEND). The purpose of this pilot is to test the ability of a new electronic data format to support nonclinical review activity. The pilot also will involve a collaboration of FDA, available pilot participants, and the SEND Consortium to update and create a new draft SEND implementation guide. FDA anticipates that a successful pilot will enable CDER to routinely accept nonclinical study data electronically in SEND format, instead of paper or portable document format (PDF), in investigational new drug applications (INDs), new drug applications (NDAs), and biologics licensing applications (BLAs).

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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