federal_register: 00-31587
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 00-31587 | Revision to Requirements for Licensed Anti-Human Globulin and Blood Grouping Reagents; Companion to Direct Final Rule | Proposed Rule | The Food and Drug Administration (FDA) is proposing to amend the biologics regulations applicable to microbiological controls for licensed Anti-Human Globulin (AHG) and Blood Grouping Reagents (BGR). FDA is proposing to remove the requirements that the products be sterile. FDA is taking this action because the requirement that these products be sterile is not necessary for the products to be safe, pure, and potent. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. FDA is taking this action final because the proposed changes are noncontroversial and FDA anticipates that it will receive no significant adverse comment. | 2000-12-12 | 2000 | 12 | https://www.federalregister.gov/documents/2000/12/12/00-31587/revision-to-requirements-for-licensed-anti-human-globulin-and-blood-grouping-reagents-companion-to | https://www.govinfo.gov/content/pkg/FR-2000-12-12/pdf/00-31587.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 applicable to microbiological controls for licensed Anti-Human Globulin (AHG) and Blood Grouping Reagents (BGR). FDA is proposing to remove the requirements that the... |