federal_register: 2019-06187
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2019-06187 | Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products | Rule | The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule amending the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements. FDA is taking this action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug and device establishments, thereby providing flexibility without diminishing public health protections. This action is part of FDA's implementation of Executive Orders (E.O.s) 13771 and 13777. Under these E.O.s, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations. | 2019-04-02 | 2019 | 4 | https://www.federalregister.gov/documents/2019/04/02/2019-06187/removal-of-certain-time-of-inspection-and-duties-of-inspector-regulations-for-biological-products | https://www.govinfo.gov/content/pkg/FR-2019-04-02/pdf/2019-06187.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule amending the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements. FDA is taking this action to... |