cfr_sections

Current Code of Federal Regulations (eCFR) — the actual text of federal regulations in force. Covers 19 CFR titles with 123,000+ regulatory sections and full-text search.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

1 row where part_number = 1105 and title_number = 21 sorted by section_id

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title_number 1

part_number 1

  • 1105 · 1 ✖

agency 1

section_id ▼ title_number title_name chapter subchapter part_number part_name subpart subpart_name section_number section_heading agency authority source_citation amendment_citations full_text
21:21:8.0.1.4.47.1.1.1 21 Food and Drugs I K 1105 PART 1105—GENERAL A Subpart A—General Submission Requirements   § 1105.10 Refusal to accept a premarket submission. FDA       (a) FDA will refuse to accept for review, as soon as practicable, a premarket tobacco product application, modified risk tobacco product application, substantial equivalence application, or exemption request or subsequent abbreviated report for the following reasons, if applicable: (1) The submission does not pertain to a tobacco product as defined in 21 U.S.C. 321(rr). (2) The submission is not in English or does not contain complete English translations of any information submitted within. (3) If submitted in an electronic format, the submission is in a format that FDA cannot process, read, review, and archive. (4) The submission does not contain contact information, including the applicant's name and address. (5) The submission is from a foreign applicant and does not identify an authorized U.S. agent, including the agent's name and address, for the submission. (6) The submission does not contain a required FDA form(s). (7) The submission does not contain the following product-identifying information: The manufacturer of the tobacco product; the product name, including the brand and subbrand; the product category and subcategory; package type and package quantity; and characterizing flavor. (8) The type of submission is not specified. (9) The submission does not contain a signature of a responsible official, authorized to represent the applicant, who either resides in or has a place of business in the United States. (10) For premarket tobacco applications, modified risk tobacco product applications, substantial equivalence applications, and exemption requests only: The submission does not include a valid claim of categorical exclusion in accordance with part 25 of this chapter, or an environmental assessment. (b) If FDA finds that none of the reasons in paragraph (a) of this section exists for refusing to accept a premarket submission, FDA may accept the submission for processing and further review. FDA will send to the submitter an acknowledgement letter stating the submission has been accepted for…

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CREATE TABLE cfr_sections (
    section_id TEXT PRIMARY KEY,
    title_number INTEGER,
    title_name TEXT,
    chapter TEXT,
    subchapter TEXT,
    part_number TEXT,
    part_name TEXT,
    subpart TEXT,
    subpart_name TEXT,
    section_number TEXT,
    section_heading TEXT,
    agency TEXT,
    authority TEXT,
    source_citation TEXT,
    amendment_citations TEXT,
    full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);