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Zdrowie i gospodarka · 27/01/2000

Plans to Develop Guidance on Submitting an Archival Copy of an ANDA in Electronic Format; Request for Comments

The Food and Drug Administration's (FDA's) Office of Generic Drugs (OGD), within its Center for Drug Evaluation and Research, is announcing plans to develop guidance on submitting an archival copy of a complete abbreviated new drug application (ANDA) in electronic format. OGD has encouraged the electronic submission of some types of data on a voluntary basis since 1997. However, these submissions are not archivable and are made in addition to a complete paper submission. OGD plans to expand its electronic data submission program to include all parts of the ANDA, so that the archivable electronic submission can replace the paper submission as the ANDA of record. OGD is soliciting comments from the public on its current program so it can consider these comments as it develops guidance for industry on the submission of complete, archivable ANDA's in electronic format. A draft guidance will be developed and made available for public comment. The ANDA electronic submission guidance will be one in a series of guidances the agency is developing to enable sponsors to submit archivable regulatory submissions in electronic format.

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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