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Zdrowie i gospodarka · 4.05.2001

Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Postmarketing Expedited Safety Reports; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Providing Regulatory Submissions in Electronic Format--Postmarketing Expedited Safety Reports." This is one in a series of guidance documents on providing regulatory submissions to FDA in electronic format. This specific guidance discusses issues related to the electronic submission of postmarketing expedited safety reports for drug products marketed for human use with new drug applications (NDAs) and abbreviated new drug applications (ANDAs), prescription drug products marketed for human use without an approved NDA or ANDA, and therapeutic biological products marketed for human use with biologic license applications (BLAs). This guidance does not apply to vaccines. The submission of these reports in an electronic format will significantly improve the agency's efficiency in processing, archiving, and reviewing the reports.

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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