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Zdrowie i gospodarka · 23.09.2008

Ophthalmic Balanced Salt Solutions for Ocular Surgical Procedures; Enforcement Action Dates

The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved ophthalmic balanced salt solutions for irrigation of the eye during surgery and persons\1\ who manufacture or cause the manufacture of such products or their shipment in interstate commerce. Unapproved ophthalmic balanced salt solutions have been associated with adverse events, some of them leading to permanent loss of visual acuity, because of contamination of the product or other product defects. Ophthalmic balanced salt solutions are new drugs that require approved applications because they are not generally recognized as safe and effective. Two firms have approved applications to market these products. Manufacturers who wish to market ophthalmic balanced salt solutions must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA). ---------------------------------------------------------------------------

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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