cfr_sections
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
8 rows where part_number = 571 and title_number = 21 sorted by section_id
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| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 21:21:6.0.1.1.22.1.2.1 | 21 | Food and Drugs | I | E | 571 | PART 571—FOOD ADDITIVE PETITIONS | A | Subpart A—General Provisions | § 571.1 Petitions. | FDA | [41 FR 38647, Sept. 10, 1976, as amended at 42 FR 15675, Mar. 22, 1977; 50 FR 7518, Feb. 22, 1985; 50 FR 16668, Apr. 26, 1985; 52 FR 8583, Mar. 19, 1987; 57 FR 6476, Feb. 25, 1992; 62 FR 40600, July 29, 1997] | (a) Petitions to be filed with the Commissioner under the provisions of section 409(b) of the act shall be submitted in triplicate. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petition shall state petitioner's post office address to which published notices or orders issued or objections filed pursuant to section 409 of the act may be sent. (b) Pertinent information may be incorporated in, and will be considered as part of, a petition on the basis of specific reference to such information submitted to and retained in the files of the Food and Drug Administration. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized in a written statement signed by the person who submitted it. Any reference to published information offered in support of a food-additive petition should be accompanied by reprints or photostatic copies of such references. (c) Petitions shall include the following data and be submitted in the following form: (Date) Name of petitioner Post office address Date Name of food additive and proposed use Food and Drug Administration Center for Veterinary Medicine, Director, Division of Animal Feeds ( HFV-220 ), 7500 Standish Pl., Rockville, MD 20855. Dear Sirs: The undersigned, ____ submits this petition pursuant to section 409(b)(1) of the Federal Food, Drug, and Cosmetic Act with respect to (Name of the food additive and proposed use) Attached hereto, in triplicate, and constituting a part of this petition, are the following: A. The name and all pertinent information concerning the food additive, including chemical identity and composition of the food additive, its physical, chemical, and biological properties, and specifications prescribing the minimum content of the desired component(s) and identifying and limiting the reaction byproducts an… | |||
| 21:21:6.0.1.1.22.1.2.2 | 21 | Food and Drugs | I | E | 571 | PART 571—FOOD ADDITIVE PETITIONS | A | Subpart A—General Provisions | § 571.6 Amendment of petition. | FDA | [41 FR 38647, Sept. 10, 1976, as amended at 50 FR 7518, Feb. 22, 1985; 50 FR 16668, Apr. 26, 1985] | After a petition has been filed, the petitioner may submit additional information or data in support thereof. In such cases, if the Commissioner determines that the additional information or data amounts to a substantive amendment, the petition as amended will be given a new filing date, and the time limitation will begin to run anew. If nonclinical laboratory studies are involved, additional information and data submitted in support of filed petitions shall include, with respect to each such study, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason or the noncompliance. | |||
| 21:21:6.0.1.1.22.1.2.3 | 21 | Food and Drugs | I | E | 571 | PART 571—FOOD ADDITIVE PETITIONS | A | Subpart A—General Provisions | § 571.7 Withdrawal of petition without prejudice. | FDA | (a) In some cases the Commissioner will notify the petitioner that the petition, while technically complete, is inadequate to justify the establishment of a regulation or the regulation requested by petitioner. This may be due to the fact that the data are not sufficiently clear or complete. In such cases, the petitioner may withdraw the petition pending its clarification or the obtaining of additional data. This withdrawal will be without prejudice to a future filing. Upon refiling, the time limitation will begin to run anew from the date of refiling. (b) At any time before the order provided for in § 571.100(a) has been forwarded to the Federal Register for publication, the petitioner may withdraw the petition without prejudice to a future filing. Upon refiling the time limitation will begin to run anew. | ||||
| 21:21:6.0.1.1.22.2.2.1 | 21 | Food and Drugs | I | E | 571 | PART 571—FOOD ADDITIVE PETITIONS | B | Subpart B—Administrative Actions on Applications | § 571.100 Regulation based on petition. | FDA | (a) The Commissioner will forward for publication in the Federal Register, within 90 days after filing of the petition (or within 180 days if the time is extended as provided for in section 409(c)(2) of the act), a regulation prescribing the conditions under which the food additive may be safely used (including, but not limited to, specifications as to the particular food or classes of food in or on which such additive may be used, the maximum quantity that may be used or permitted to remain in or on such food, the manner in which such additive may be added to or used in or on such food, and any directions or other labeling or packaging requirements for such additive deemed necessary by him to assure the safety of such use), and prior to the forwarding of the order to the Federal Register for publication shall notify the petitioner of such order and the reasons for such action; or by order deny the petition, and shall notify the petitioner of such order and of the reasons for such action. (b) If the Commissioner determines that additional time is needed to study and investigate the petition, he shall by written notice to the petitioner extend the 90-day period for not more than 180 days after the filing of the petition. | ||||
| 21:21:6.0.1.1.22.2.2.2 | 21 | Food and Drugs | I | E | 571 | PART 571—FOOD ADDITIVE PETITIONS | B | Subpart B—Administrative Actions on Applications | § 571.102 Effective date of regulation. | FDA | A regulation published in accordance with § 571.100(a) shall become effective upon publication in the Federal Register. | ||||
| 21:21:6.0.1.1.22.2.2.3 | 21 | Food and Drugs | I | E | 571 | PART 571—FOOD ADDITIVE PETITIONS | B | Subpart B—Administrative Actions on Applications | § 571.110 Procedure for objections and hearings. | FDA | [42 FR 4717, Jan. 25, 1977, as amended at 42 FR 15676, Mar. 22, 1977] | Objections and hearings relating to food additive regulations under section 409(c), (d), or (h) of the act shall be governed by part 12 of this chapter. | |||
| 21:21:6.0.1.1.22.2.2.4 | 21 | Food and Drugs | I | E | 571 | PART 571—FOOD ADDITIVE PETITIONS | B | Subpart B—Administrative Actions on Applications | § 571.115 Application of the cancer clause of section 409 of the act. | FDA | [52 FR 49588, Dec. 31, 1987] | Food additives intended for use as an ingredient in food for animals that are raised for food production and that have the potential to contaminate human food with residues whose consumption could present a risk of cancer to people must satisfy the requirements of subpart E of part 500 of this chapter. | |||
| 21:21:6.0.1.1.22.2.2.5 | 21 | Food and Drugs | I | E | 571 | PART 571—FOOD ADDITIVE PETITIONS | B | Subpart B—Administrative Actions on Applications | § 571.130 Procedure for amending and repealing tolerances or exemptions from tolerances. | FDA | [42 FR 4717, Jan. 25, 1977; 42 FR 15676, Mar. 22, 1977] | (a) The Commissioner, on his own initiative or on the petition of any interested person, pursuant to part 10 of this chapter, may propose the issuance of a regulation amending or repealing a regulation pertaining to a food additive or granting or repealing an exception for such additive. (b) Any such petition shall include an assertion of facts, supported by data, showing that new information exists with respect to the food additive or that new uses have been developed or old uses abandoned, that new data are available as to toxicity of the chemical, or that experience with the existing regulation or exemption may justify its amendment or repeal. New data shall be furnished in the form specified in § 571.1 for submitting petitions. |
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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);