federal_register: 2021-21009
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021-21009 | Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports | Rule | The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule to provide additional information on the content and format of reports intended to demonstrate the substantial equivalence of a tobacco product (SE Reports). The final rule also establishes the general procedures FDA intends to follow when evaluating SE Reports, including procedures that address communications with the applicant and the confidentiality of data in an SE Report. The final rule will provide applicants with more certainty and clarity related to preparing and submitting SE Reports. | 2021-10-05 | 2021 | 10 | https://www.federalregister.gov/documents/2021/10/05/2021-21009/content-and-format-of-substantial-equivalence-reports-food-and-drug-administration-actions-on | https://www.govinfo.gov/content/pkg/FR-2021-10-05/pdf/2021-21009.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule to provide additional information on the content and format of reports intended to demonstrate the substantial equivalence of a tobacco product (SE Reports). The final... |