cfr_sections
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
7 rows where agency = "APHIS" and part_number = 101 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9:9:1.0.1.5.41.0.74.1 | 9 | Animals and Animal Products | I | E | 101 | PART 101—DEFINITIONS | § 101.1 Applicability. | APHIS | When used in parts 101 through 117 of this subchapter, the meaning of the words and phrases listed shall be as defined in this part. | ||||||
| 9:9:1.0.1.5.41.0.74.2 | 9 | Animals and Animal Products | I | E | 101 | PART 101—DEFINITIONS | § 101.2 Administrative terminology. | APHIS | [38 FR 8426, Apr. 2, 1973; 38 FR 9221, Apr. 12, 1973, as amended at 40 FR 46093, Oct. 6, 1975; 41 FR 44358, Oct. 8, 1976; 49 FR 22624, May 31, 1984; 52 FR 30131, Aug. 13, 1987; 56 FR 66782, 66783, Dec. 26, 1991; 57 FR 38756, Aug. 27, 1992; 62 FR 31328, June 9, 1997; 64 FR 43044, Aug. 9, 1999; 83 FR 22835, May 17, 2018] | The following administrative words and phrases shall mean: Adjacent herd. Adjacent herds are herds physically contiguous to the herd of origin; there are no herds between an adjacent herd and the herd of origin. Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator. Adverse event. Any observation in animals, whether or not the cause of the event is known, that is unfavorable and unintended, and that occurs after any use (as indicated on the label or any off-label use) of a biological product, including events related to a suspected lack of expected efficacy. For products intended to diagnose disease, adverse events refer to a failure in product performance that hinders an expected discovery of the correct diagnosis. Adverse event report. Direct communication concerning the occurrence of an adverse event from an identifiable first-hand reporter which includes the following information: (1) An identifiable reporter; (2) An identifiable animal; (3) An identifiable biologic product; and (4) One or more adverse events. Animal and Plant Health Inspection Service. The agency in the Department of Agriculture responsible for administering the Virus-Serum-Toxin Act. Biological products. The term biological products, also referred to in this subchapter as biologics, biologicals, or products, shall mean all viruses, serums, toxins (excluding substances that are selectively toxic to microorganisms, e.g., antibiotics), or analogous products at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of animals and which act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response. The term “biological products” includes but is not limited to vaccines, bacterins, allergens, antibodies, antitoxins, toxoids, immunostimulants, certain cytokines, antigenic or immunizing components of live organisms, and diagnostic components,… | |||||
| 9:9:1.0.1.5.41.0.74.3 | 9 | Animals and Animal Products | I | E | 101 | PART 101—DEFINITIONS | § 101.3 Biological products and related terms. | APHIS | [38 FR 8426, Apr. 2, 1973, as amended at 42 FR 63770, Dec. 20, 1977; 50 FR 24903, June 14, 1985; 56 FR 66782, Dec. 26, 1991; 60 FR 14354, Mar. 17, 1995; 81 FR 59433, Aug. 30, 2016] | When used in conjunction with or in reference to a biological product, the following terms shall mean: (a) Licensed biological product. A biological product prepared within a licensed establishment by a person holding an unexpired, unsuspended, and unrevoked product license for such product. (b) Experimental biological product. A biological product which is being evaluated to substantiate an application for a product license or permit. (c) Completed product. A biological product in bulk or final container produced in compliance with the regulations to final form and composition. (d) Finished product. A completed product which has been bottled, sealed, packaged, and labeled as required by the regulations. (e) Released product. A finished product released for marketing after all requirements have been satisfactorily complied with. (f) Fraction. A specific antigen, its antibodies, or its antitoxin which constitutes a component of a biological product. (g) Diluent. A liquid used to rehydrate a desiccated product or a liquid used to dilute another substance. (h) Serial. The total quantity of completed product which has been thoroughly mixed in a single container and identified by a serial number: Provided, That, when all or part of a serial of liquid biological product is packaged as diluent for all or part of a serial of desiccated product, the resulting combination packages shall be considered a serial of the multiple fraction product. (i) Subserial. Each of two or more properly identified portions of a serial which are further processed at different times or under different conditions such as, but not limited to, being desiccated in different size final containers and/or at different times. (j) Outline of production. A detailed protocol of methods of manufacture to be followed in the preparation of a biological product and which may sometimes be referred to as an outline. (k) Product Code Number. A number assigned by Animal and Plant Health Inspection Service to each type of licen… | |||||
| 9:9:1.0.1.5.41.0.74.4 | 9 | Animals and Animal Products | I | E | 101 | PART 101—DEFINITIONS | § 101.4 Labeling terminology. | APHIS | [38 FR 8426, Apr. 2, 1973, as amended at 42 FR 63770, Dec. 20, 1977; 56 FR 66782, Dec. 26, 1991; 61 FR 29464, June 11, 1996] | Terms pertaining to identification and packaging of biological products shall mean: (a) Label. All written, graphic, or printed matter: (1) Upon or attached to a final container of a biological product; (2) Appearing upon any immediate carton or box used to package such final container; and (3) Appearing on any accompanying enclosures (leaflets, inserts, or circulars) on which required information or directions as to the use of the biological product shall be found. (b) Labeling. All labels and other written, printed, or graphic matter accompanying the final container. (c) Final container. The unit, bottle, vial, ampule, tube, or other receptacle into which any biological product is filled for distribution and sale. (d) True name. The name entered on the product license or permit at the time of issuance to differentiate the biological product from others: Provided, That, the principal part of such name shall be emphasized on such license or permit by being more prominently lettered than descriptive terms which may be necessary to complete the differentiation. (e) Serial number. Numbers or numbers and letters used to identify and distinguish one serial from others. (f) Expiration date. A date designating the end of the period during which a biological product, when properly stored and handled, can be expected with reasonable certainty, to be efficacious. (g) Label number. A number assigned by Animal and Plant Health Inspection Service to each label or sketch submitted for review. (h) Master label. The finished carton, container, or enclosure label for the smallest size final container that is authorized for a biological product, that serves as the Master template label applicable to all other size containers or cartons of the same product that is marketed by a licensee, subsidiary, division, or distributor. | |||||
| 9:9:1.0.1.5.41.0.74.5 | 9 | Animals and Animal Products | I | E | 101 | PART 101—DEFINITIONS | § 101.5 Testing terminology. | APHIS | [38 FR 8426, Apr. 2, 1973, as amended at 40 FR 45419, Oct. 2, 1975; 41 FR 6751, Feb. 13, 1976; 43 FR 3701, Jan. 27, 1978; 56 FR 66782, 66783 Dec. 26, 1991; 62 FR 19037, Apr. 18, 1997; 79 FR 55969, Sept. 18, 2014; 83 FR 11143, Mar. 14, 2018] | Terms used when evaluating biological products shall mean: (a) Standard Requirement. Test methods, procedures, and criteria established by Animal and Plant Health Inspection Service for evaluating biological products to be pure, safe, potent, and efficacious, and not to be worthless, contaminated, dangerous, or harmful under the Act. (b) Log. Logarithm computed to the base 10. (c) Pure or purity. Quality of a biological product prepared to a final form relatively free of extraneous micro-organisms and extraneous material (organic or inorganic) as determined by test methods or procedures established by Animal and Plant Health Inspection Service in Standard Requirements or in the approved Outline of Production for such product, but free of extraneous microorganisms or material which in the opinion of the Administrator adversely affects the safety, potency, or efficacy of such product. (d) Safe or safety. Freedom from properties causing undue local or systemic reactions when used as recommended or suggested by the manufacturer. (e) Sterile or sterility. Freedom from viable contaminating microorganisms as demonstrated by procedures prescribed in part 113 of this subchapter, Standard Requirements, and approved Outlines of Production. (f) Potent or potency. Relative strength of a biological product as determined by test methods or procedures as established by Animal and Plant Health Inspection Service in Standard Requirements or in the approved Outline of Production for such product. (g) Efficacious or efficacy. Specific ability or capacity of the biological product to effect the result for which it is offered when used under the conditions recommended by the manufacturer. (h) Dose. The amount of a biological product recommended on the label to be given to one animal at one time. (i) Vaccinate. An animal which has been inoculated, injected, or otherwise administered a biological product being evaluated. (j) Control animal. An animal, which may be referred to as a control, used in a test pr… | |||||
| 9:9:1.0.1.5.41.0.74.6 | 9 | Animals and Animal Products | I | E | 101 | PART 101—DEFINITIONS | § 101.6 Cell cultures. | APHIS | [38 FR 8426, Apr. 2, 1973, as amended at 40 FR 45419, Oct. 2, 1975; 49 FR 22624, May 31, 1984] | When used in conjunction with or in reference to cell cultures, which may be referred to as tissue cultures, the following terms shall mean: (a) Batches of primary cells. A pool of original cells derived from normal tissue up to and including the 10th subculture. (b) Cell line. A pool of cells which are 11 or more subcultures from the tissue of origin. (c) Subculture. Each flask to flask transfer or passage regardless of the number of cell replications. (d) Master Cell Stock (MCS). The supply of cells of a specific passage level from which cells for production of biologics originate. | |||||
| 9:9:1.0.1.5.41.0.74.7 | 9 | Animals and Animal Products | I | E | 101 | PART 101—DEFINITIONS | § 101.7 Seed organisms. | APHIS | [49 FR 22625, May 31, 1984] | When used in conjunction with or in reference to seed organisms, the following shall mean: (a) Master Seed. An organism at a specific passage level which has been selected and permanently stored by the producer from which all other seed passages are derived within permitted levels. (b) Working Seed. An organism at a passage level between Master Seed and Production Seed. (c) Production Seed. An organism at a specified passage level which is used without further propagation for initiating preparation of a fraction. |
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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);