federal_register: 99-21293

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
99-21293 Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma; Companion Document to Direct Final Rule Proposed Rule The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. FDA is taking this action as part of the agency's ``Blood Initiative'' in which FDA is reviewing and revising, when appropriate, its regulations, policies, guidance, and procedures related to blood, blood components, and Source Plasma. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. FDA is publishing this companion proposed rule under FDA's usual procedure for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives a significant adverse comment and withdraws the direct final rule. 1999-08-19 1999 8 https://www.federalregister.gov/documents/1999/08/19/99-21293/revisions-to-the-requirements-applicable-to-blood-blood-components-and-source-plasma-companion https://www.govinfo.gov/content/pkg/FR-1999-08-19/pdf/99-21293.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the...  

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