cfr_sections
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
12 rows where part_number = 515 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 21:21:6.0.1.1.9.1.1.1 | 21 | Food and Drugs | I | E | 515 | PART 515—MEDICATED FEED MILL LICENSE | A | Subpart A—Applications | § 515.10 Medicated feed mill license applications. | FDA | [64 FR 63204, Nov. 19, 1999, as amended at 72 FR 69121, Dec. 6, 2007; 81 FR 60221, Aug. 31, 2016; 87 FR 58960, Sept. 29, 2022; 89 FR 51966, June 21, 2024] | (a) Medicated feed mill license applications (Form FDA 3448) may be obtained from the Public Health Service, Consolidated Forms and Publications Distribution Center, Washington Commerce Center, 3222 Hubbard Rd., Landover, MD 20785, or electronically from the Center for Veterinary Medicine at: https://www.fda.gov/animal-veterinary/animal-food-feeds/medicated-feeds. (b) A completed medicated feed mill license must contain the following information: (1) The full business name and address of the facility at which the manufacturing is to take place. (2) The facility's FDA registration number as required by section 510 of the Federal Food, Drug, and Cosmetic Act (the act). (3) The name, title, and signature of the responsible individual or individuals for that facility. (4) A certification that the animal feeds bearing or containing new animal drugs are manufactured and labeled in accordance with the applicable regulations published under section 512(i) of the act or in accordance with the index listing published under section 572(e)(2) of the act. (5) A certification that the methods used in, and the facilities and controls used for, manufacturing, processing, packaging, and holding such animal feeds conform to current good manufacturing practice as described in section 501(a)(2)(B) of the act and in part 225 of this chapter. (6) A certification that the facility will establish and maintain all records required by regulation or order issued under sections 512(m)(5)(A) or 504(a)(3)(A) of the act, and will permit access to, or copying or verification of such records. (7) A commitment that current approved or index listed Type B and/or Type C medicated feed labeling for each Type B and/or Type C medicated feed to be manufactured will be in the possession of the feed manufacturing facility prior to receiving the Type A medicated article containing such drug. (8) A commitment to renew registration every year with FDA as required in part 207 of this chapter. (c) Applications must be completed, signed, and submitt… | |||
| 21:21:6.0.1.1.9.1.1.2 | 21 | Food and Drugs | I | E | 515 | PART 515—MEDICATED FEED MILL LICENSE | A | Subpart A—Applications | § 515.11 Supplemental medicated feed mill license applications. | FDA | (a) After approval of a medicated feed mill license application to manufacture animal feed, a supplemental application shall be submitted for a change in ownership and/or a change in mailing address of the facility site. (b) Each supplemental application should be accompanied by a fully completed Form FDA 3448 and include an explanation of the change. (c) Within 30 working days after a supplemental application has been filed, if the Commissioner of Food and Drugs determines that the application provides adequate information respecting the change in ownership and/or postal address of the facility site, then an authorized employee of the Food and Drug Administration designated by the Commissioner shall notify the applicant that it is approved by signing and mailing to the applicant a copy of the Form FDA 3448. Supplemental applications that do not provide adequate information shall be returned to the applicant and all reasons for the return of the application shall be made known to the applicant. | ||||
| 21:21:6.0.1.1.9.2.1.1 | 21 | Food and Drugs | I | E | 515 | PART 515—MEDICATED FEED MILL LICENSE | B | Subpart B—Administrative Actions on Licenses | § 515.20 Approval of medicated feed mill license applications. | FDA | Within 90 days after an application has been filed under § 515.10, if the Commissioner of Food and Drugs (the Commissioner) determines that none of the grounds for denying approval specified in section 512(m)(3) of the Federal Food, Drug, and Cosmetic Act (the act) applies, an authorized employee of the Food and Drug Administration designated by the Commissioner shall notify the applicant that it is approved by signing and mailing to the applicant a copy of the Form FDA 3448. | ||||
| 21:21:6.0.1.1.9.2.1.2 | 21 | Food and Drugs | I | E | 515 | PART 515—MEDICATED FEED MILL LICENSE | B | Subpart B—Administrative Actions on Licenses | § 515.21 Refusal to approve a medicated feed mill license application. | FDA | [64 FR 63204, Nov. 19, 1999, as amended at 72 FR 69121, Dec. 6, 2007] | (a) The Commissioner of Food and Drugs (the Commissioner) shall within 90 days, or such additional period as may be agreed upon by the Commissioner and the applicant, after the filing of an application under § 515.10, inform the applicant in writing of his/her intention to issue a notice of opportunity for a hearing on a proposal to refuse to approve the application, if the Commissioner determines upon the basis of the application, on the basis of a preapproval inspection, or upon the basis of any other information before him that: (1) The application is incomplete, false, or misleading in any particular; or (2) The methods used in and the facilities and controls used for the manufacturing, processing, and packaging of such animal feed are not adequate to preserve the identity, strength, quality, and purity of the new animal drug therein; or (3) The facility manufactures animal feeds bearing or containing new animal drugs in a manner that does not accord with the specifications for manufacture or labels animal feeds bearing or containing new animal drugs in a manner that does not accord with the conditions or indications of use that are published under section 512(i) or 572(e)(2) of the act. (b) The Commissioner, as provided in § 515.30, shall expeditiously notify the applicant of an opportunity for a hearing on the question of whether such application is approvable, unless by the 30th day following the date of issuance of the letter informing the applicant of the intention to issue a notice of opportunity for a hearing the applicant: (1) Withdraws the application; or (2) Waives the opportunity for a hearing; or (3) Agrees with the Commissioner on an additional period to precede issuance of such notice of hearing. | |||
| 21:21:6.0.1.1.9.2.1.3 | 21 | Food and Drugs | I | E | 515 | PART 515—MEDICATED FEED MILL LICENSE | B | Subpart B—Administrative Actions on Licenses | § 515.22 Suspension and/or revocation of approval of a medicated feed mill license. | FDA | (a) The Secretary of Health and Human Services may suspend a medicated feed mill license approved under section 512(m)(2) of the Federal Food, Drug, and Cosmetic Act (the act) and give the person holding the medicated feed mill license application prompt notice of this action and afford the applicant the opportunity for an expedited hearing on a finding that there is an imminent hazard to the health of man or of the animals for which such animal feed is intended. (b) The Commissioner of Food and Drugs (the Commissioner) shall notify in writing the person holding an application approved under section 512(m)(2) of the act and afford an opportunity for a hearing on a proposal to revoke approval of such application if the Commissioner finds: (1) That the application contains any untrue statement of a material fact; or (2) That the applicant has made any changes that would cause the application to contain any untrue statements of material fact or that would affect the safety or effectiveness of the animal feeds manufactured at the facility unless the applicant has supplemented the application by filing a supplemental application under § 515.11. (c) The Commissioner may notify in writing the person holding an application approved under section 512(m)(2) of the act and afford an opportunity for a hearing on a proposal to revoke approval of such application if the Commissioner finds: (1) That the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain such records or to make required reports in accordance with a regulation or order under sections 512(m)(5)(A) or 504(a)(3)(A) of the act, or the applicant has refused to permit access to, or copying, or verification of, such records as required by sections 512(m)(5)(B) or 504(a)(3)(B) of the act; or (2) That on the basis of new information before him, evaluated together with the evidence before him when such license was issued, the methods used in, or the facilities and controls used for, the ma… | ||||
| 21:21:6.0.1.1.9.2.1.4 | 21 | Food and Drugs | I | E | 515 | PART 515—MEDICATED FEED MILL LICENSE | B | Subpart B—Administrative Actions on Licenses | § 515.23 Voluntary revocation of medicated feed mill license. | FDA | A license issued under section 512(m)(2) of the Federal Food, Drug, and Cosmetic Act (the act) will be revoked on the basis of a request for its revocation submitted in writing by a responsible individual holding such license on the grounds that the facility no longer manufactures any animal feed covered under § 558.4(b) of this chapter. A written request for such revocation shall be construed as a waiver of the opportunity for a hearing as otherwise provided for in this section. Revocation of approval of a medicated feed mill license under the provisions of this paragraph shall be without prejudice. | ||||
| 21:21:6.0.1.1.9.2.1.5 | 21 | Food and Drugs | I | E | 515 | PART 515—MEDICATED FEED MILL LICENSE | B | Subpart B—Administrative Actions on Licenses | § 515.24 Notice of revocation of a medicated feed mill license. | FDA | When a license approved under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) is revoked by the Commissioner of Food and Drugs (the Commissioner), the Commissioner will give appropriate public notice of such action by publication in the Federal Register. | ||||
| 21:21:6.0.1.1.9.2.1.6 | 21 | Food and Drugs | I | E | 515 | PART 515—MEDICATED FEED MILL LICENSE | B | Subpart B—Administrative Actions on Licenses | § 515.25 Revocation of order refusing to approve a medicated feed mill license application or suspending or revoking a license. | FDA | The Commissioner of Food and Drugs (the Commissioner), upon his/her own initiative or upon request of an applicant stating reasonable grounds therefor and if the Commissioner finds that the facts so require, may issue an order approving a medicated feed mill license application that previously has had its approval refused, suspended, or revoked. | ||||
| 21:21:6.0.1.1.9.2.1.7 | 21 | Food and Drugs | I | E | 515 | PART 515—MEDICATED FEED MILL LICENSE | B | Subpart B—Administrative Actions on Licenses | § 515.26 Services of notices and orders. | FDA | All notices and orders under this part 515 and section 512 of the Federal Food, Drug, and Cosmetic Act (the act) pertaining to medicated feed mill licenses shall be served: (a) In person by any officer or employee of the Department of Health and Human Services designated by the Commissioner of Food and Drugs; or (b) By mailing the order by certified mail addressed to the applicant or respondent at the applicant or respondent's last known address in the records of the Food and Drug Administration. | ||||
| 21:21:6.0.1.1.9.3.1.1 | 21 | Food and Drugs | I | E | 515 | PART 515—MEDICATED FEED MILL LICENSE | C | Subpart C—Hearing Procedures | § 515.30 Contents of notice of opportunity for a hearing. | FDA | (a) The notice to the applicant of opportunity for a hearing on a proposal by the Commissioner of Food and Drugs (the Commissioner) to refuse to approve a medicated feed mill license application or to revoke the approval of a medicated feed mill license will specify the grounds upon which the Commissioner proposes to issue this order. On request of the applicant, the Commissioner will explain the reasons for the action. The notice of opportunity for a hearing will be published in the Federal Register and will specify that the applicant has 30 days after issuance of the notice within which the Commissioner is required to file a written appearance electing whether: (1) To avail himself of the opportunity for a hearing; or (2) Not to avail himself of the opportunity for a hearing. (b) If the applicant fails to file a written appearance in answer to the notice of opportunity for hearing, this failure will be construed as an election not to avail himself of the opportunity for the hearing, and the Commissioner without further notice may enter a final order. (c) If the applicant elects to avail himself of the opportunity for a hearing, the applicant is required to file a written appearance requesting the hearing within 30 days after the publication of the notice, giving the reason why the application should not be refused or the medicated feed mill license should not be revoked, together with a well-organized and full-factual analysis of the information the applicant is prepared to prove in support of his opposition to the Commissioner's proposal. A request for a hearing may not rest upon mere allegations or denials, but must set forth specific facts showing there is a genuine and substantial issue of fact that requires a hearing. When it clearly appears from the information in the application and from the reasons and factual analysis in the request for the hearing that no genuine and substantial issue of fact precludes the refusal to approve the application or the revocation of approval of the application, the C… | ||||
| 21:21:6.0.1.1.9.3.1.2 | 21 | Food and Drugs | I | E | 515 | PART 515—MEDICATED FEED MILL LICENSE | C | Subpart C—Hearing Procedures | § 515.31 Procedures for hearings. | FDA | Hearings relating to new animal drugs under section 512(m)(3) and (m)(4) of the Federal Food, Drug, and Cosmetic Act (the act) shall be governed by part 12 of this chapter. | ||||
| 21:21:6.0.1.1.9.4.1.1 | 21 | Food and Drugs | I | E | 515 | PART 515—MEDICATED FEED MILL LICENSE | D | Subpart D—Judicial Review | § 515.40 Judicial review. | FDA | The transcript and record shall be certified by the Commissioner of Food and Drugs (the Commissioner). In any case in which the Commissioner enters an order without a hearing under § 314.200(g) of this chapter, the request(s) for hearing together with the data and information submitted and the Commissioner's findings and conclusions shall be included in the record certified by the Commissioner. |
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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);