federal_register: 2019-05787

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2019-05787 Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports Proposed Rule The Food and Drug Administration (FDA) is issuing a proposed rule to establish requirements for the content and format of reports intended to establish the substantial equivalence of a tobacco product (SE Reports). The proposed rule would establish the information an SE Report must include so that FDA may make a substantial equivalence determination. In addition, the proposed rule would establish the general procedures FDA intends to follow when evaluating SE Reports, including procedures that would address communications with the applicant and the confidentiality of data in an SE Report. The proposed rule is intended to provide more clarity to applicants and support efficient and predictable reviews of SE Reports. 2019-04-02 2019 4 https://www.federalregister.gov/documents/2019/04/02/2019-05787/content-and-format-of-substantial-equivalence-reports-food-and-drug-administration-actions-on https://www.govinfo.gov/content/pkg/FR-2019-04-02/pdf/2019-05787.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is issuing a proposed rule to establish requirements for the content and format of reports intended to establish the substantial equivalence of a tobacco product (SE Reports). The proposed rule would establish the...  

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