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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.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
§ 151 - Preparation and sale of worthless or harmful products for domestic animals prohibited; preparation to be in compliance with rules at licensed establishments
§ 152 - Importation regulated and prohibited
§ 153 - Inspection of imports; denial of entry and destruction
§ 154 - Regulations for preparation and sale; licenses
§ 154a - Special licenses for special circumstances; expedited procedure; conditions; exemptions; criteria
§ 155 - Permits for importation
§ 156 - Licenses conditioned on permitting inspection; suspension of licenses
§ 157 - Inspection
§ 158 - Offenses; punishment
§ 159 - Enforcement; penalties applicable; Congressional findings
Title 9 published on 14-Sep-2017 03:43
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 9 CFR Part 101 after this date.
We are amending the Virus-Serum-Toxin Act regulations regarding the packaging and labeling of veterinary biological products to provide for the use of an abbreviated true name on small final container labeling for veterinary biologics; require labeling to bear a consumer contact telephone number; change the format used to show the establishment or permit number on labeling and require such labeling to show the product code number; change the storage temperature recommended in labeling for veterinary biologics; require vaccination and revaccination recommendations in labeling to be consistent with licensing data; require labeling information placed on carton tray covers to appear on the outside face of the tray cover; remove the restriction requiring multiple-dose final containers of veterinary biologics to be packaged in individual cartons; require labeling for bovine virus diarrhea vaccine containing modified live virus to bear a statement warning against use in pregnant animals; reduce the number of copies of each finished final container label, carton label, or enclosure required to be submitted for review and approval; require labels for autogenous biologics to specify the organism(s) and/or antigen(s) they contain; and require labeling for conditionally licensed veterinary biologics to bear a statement concerning efficacy and potency requirements. In addition, we are also amending the regulations concerning the number of labels or label sketches for experimental products required to be submitted for review and approval, and the recommended storage temperature for veterinary biologics at licensed establishments. These changes are necessary in order to update and clarify labeling requirements and to ensure that information provided in labeling is accurate with regard to the expected performance of the product.
We are proposing to amend the Virus-Serum-Toxin Act regulations concerning records and reports. This change would require veterinary biologics licensees and permittees to record and submit reports concerning adverse events associated with the use of biological products they produce or distribute. The information that must be included in the adverse event reports submitted to the Animal and Plant Health Inspection Service would be provided in separate guidance documents. This proposed rule replaces a previously published proposed rule, which we are withdrawing as part of this document.
We are amending the veterinary biological product regulations by defining the terms used for reporting the results of tests performed on veterinary biological products. Licensees and permittees of veterinary biological products must conduct these tests and report the results to the Animal and Plant Health Inspection Service so that the Agency can determine if the products are eligible for release. Defining these terms will clarify the circumstances under which the results of a prescribed test can be reported as satisfactory, unsatisfactory, inconclusive, or a No Test. We are also removing several obsolete testing standard requirements from the regulations. These changes will update our regulations and improve communication between regulators and product licensees and permittees with respect to reporting test results.
We are proposing to amend the veterinary biological product regulations by defining the terms used for reporting the results of tests performed on veterinary biological products. Licensees and permittees of veterinary biological products must conduct these tests and report the results to the Animal and Plant Health Inspection Service so that the Agency can determine if the products are eligible for release. Defining these terms would clarify the circumstances under which the results of a prescribed test can be reported as satisfactory, unsatisfactory, inconclusive, or a No Test. We are also proposing to remove several obsolete testing standard requirements from part 113. These changes would update our regulations and improve communication between regulators and product licensees and permittees with respect to reporting test results.