federal_register: 2016-31370
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016-31370 | Refuse To Accept Procedures for Premarket Tobacco Product Submissions | Rule | The Food and Drug Administration (FDA) is issuing a final rule describing when FDA will refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for FDA review. Under the rule, FDA will refuse to accept a tobacco product submission, for example, that is not in English, does not pertain to a tobacco product, or does not identify the type of submission. By refusing to accept submissions that have the deficiencies identified in the proposed rule, FDA will be able to focus our review resources on submissions that meet a threshold of acceptability and encourage quality submissions. | 2016-12-29 | 2016 | 12 | https://www.federalregister.gov/documents/2016/12/29/2016-31370/refuse-to-accept-procedures-for-premarket-tobacco-product-submissions | https://www.govinfo.gov/content/pkg/FR-2016-12-29/pdf/2016-31370.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is issuing a final rule describing when FDA will refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for FDA review. Under the... |