federal_register: 2016-28120
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016-28120 | Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications | Rule | The Food and Drug Administration (FDA or Agency) is amending its nonprescription (over-the-counter or OTC) drug regulations. This final rule supplements the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA's review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). It also amends the existing TEA process to include filing determination and withdrawal provisions to make the TEA process more efficient. | 2016-11-23 | 2016 | 11 | https://www.federalregister.gov/documents/2016/11/23/2016-28120/food-and-drug-administration-review-and-action-on-over-the-counter-time-and-extent-applications | https://www.govinfo.gov/content/pkg/FR-2016-11-23/pdf/2016-28120.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is amending its nonprescription (over-the-counter or OTC) drug regulations. This final rule supplements the time and extent application (TEA) process for OTC drugs by establishing timelines and... |