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Zdrowie i gospodarka · 24.07.1997

Guidance for Industry: Changes To An Approved Application: Biological Products; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled, ``Guidance for Industry: Changes To An Approved Application: Biological Products.'' The guidance document is intended to assist manufacturers in determining which reporting mechanism is appropriate for a change to an approved application, to reduce the burden on manufacturers of reporting changes, and to facilitate the approval process. The guidance document applies to all licensed biological products and establishments, including Whole Blood, blood components, Source Plasma, and Source Leukocytes, but not including specified biotechnology and specified synthetic biological products, or products formerly referred to as well-characterized therapeutic recombinant DNA-derived and monoclonal antibody biotechnology products. The guidance document announced in this notice revises the draft guidance entitled, ``Changes To An Approved Application; Draft Guidance,'' announced in the Federal Register of January 29, 1996 (61 FR 2749).

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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