animal-biologics

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TitleActionFR DocPublishedAgencyAgency NameExcerptsAbstractHTMLPDF
TitleActionFR DocPublishedAgencyAgency NameExcerptsAbstractHTMLPDF
Viruses, Serums, Toxins, and Analogous Products; Packaging and LabelingRule2016-2693611/08/2016DEPARTMENT OF AGRICULTUREAgriculture DepartmentIn a final rule published in the Federal Register on August 30, 2016, and effective on October 31, 2016, we amended the Virus- Serum-Toxin Act regulations to make veterinary biologics labeling requirements more consistent with … In a final rule published in the Federal Register on August 30, 2016, and effective on October 31, 2016, we amended the Virus- Serum-Toxin Act regulations to make veterinary biologics labeling requirements more consistent with current science and veterinary practice. However, we inadvertently removed a requirement for an indications statement that should appear on final container labels, carton labels, and enclosures. This document corrects that error.viruses-serums-toxins-and-analogous-products-packaging-and-labelingFR-Doc-2016-26936
Viruses, Serums, Toxins, and Analogous Products; Packaging and LabelingRule2016-2074908/30/2016DEPARTMENT OF AGRICULTUREAgriculture DepartmentWe 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; … 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.viruses-serums-toxins-and-analogous-products-packaging-and-labelingFR-Doc-2016-20749
Viruses, Serums, Toxins, and Analogous Products; Single Label Claim for Veterinary Biological ProductsRule2016-1707307/20/2016DEPARTMENT OF AGRICULTUREAgriculture DepartmentIn a final rule published in the Federal Register on July 10, 2015, and effective on September 8, 2015, we amended the Virus-Serum- Toxin Act regulations to provide for the use of a simpler labeling format that would better communicate … In a final rule published in the Federal Register on July 10, 2015, and effective on September 8, 2015, we amended the Virus-Serum- Toxin Act regulations to provide for the use of a simpler labeling format that would better communicate product performance to the user. Among other things, we provided the address of a Web site for accessing transmittal forms to be used with each submission of sketches and labels. However, the Web site address provided is incorrect. Therefore, we are amending the regulations to provide the correct address.viruses-serums-toxins-and-analogous-products-single-label-claim-for-veterinary-biological-productsFR-Doc-2016-17073
VSTA Records and Reports Specific to International Standards for PharmacovigilanceProposed Rule2015-2199709/04/2015DEPARTMENT OF AGRICULTUREAgriculture DepartmentWe 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 associa … 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.vsta-records-and-reports-specific-to-international-standards-for-pharmacovigilanceFR-Doc-2015-21997
Viruses, Serums, Toxins, and Analogous Products; Single Label Claim for Veterinary Biological ProductsRule2015-1689807/10/2015DEPARTMENT OF AGRICULTUREAgriculture DepartmentWe are amending the Virus-Serum-Toxin Act regulations to provide for the use of a simpler labeling format that would better communicate product performance to the user. Under this rulemaking, the previous label format, which re … We are amending the Virus-Serum-Toxin Act regulations to provide for the use of a simpler labeling format that would better communicate product performance to the user. Under this rulemaking, the previous label format, which reflected any of four different levels of effectiveness, is replaced with a single, uniform label format. We are also requiring biologics licensees to provide a standardized summary, with confidential business information removed, of the efficacy and safety data submitted to the Animal and Plant Health Inspection Service in support of the issuance of a full product license or conditional license. A simpler label format, along with publicly available safety and efficacy data, will help biologics producers to more clearly communicate product performance to their customers.viruses-serums-toxins-and-analogous-products-single-label-claim-for-veterinary-biological-productsFR-Doc-2015-16898
Viruses, Serums, Toxins, and Analogous Products; Exemptions From Preparation Pursuant to an Unsuspended and Unrevoked LicenseRule2015-1131105/11/2015DEPARTMENT OF AGRICULTUREAgriculture DepartmentWe are amending the Virus-Serum-Toxin Act regulations to require that veterinary biologics prepared under the veterinary practitioner exemption must be prepared at the same facility the veterinarian utilizes in conducting the da … We are amending the Virus-Serum-Toxin Act regulations to require that veterinary biologics prepared under the veterinary practitioner exemption must be prepared at the same facility the veterinarian utilizes in conducting the day-to-day activities associated with his or her practice. This exemption applies to veterinary biologics prepared by a veterinary practitioner solely for administration to animals in the course of a State-licensed professional practice of veterinary medicine under a veterinarian- client-patient relationship. This rule is necessary to ensure that veterinary biologics are not prepared in unlicensed establishments in violation of the Virus-Serum-Toxin Act and to clarify the regulations regarding the preparation of product by a veterinary practitioner under a veterinarian-client-patient relationship.viruses-serums-toxins-and-analogous-products-exemptions-from-preparation-pursuant-to-an-unsuspendedFR-Doc-2015-11311
Viruses, Serums, Toxins, and Analogous Products; Standard Requirements; Addition of Terminology To Define Veterinary Biologics Test ResultsRule2014-2229409/18/2014DEPARTMENT OF AGRICULTUREAgriculture DepartmentWe 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 … 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.viruses-serums-toxins-and-analogous-products-standard-requirements-addition-of-terminology-to-defineFR-Doc-2014-22294
In Vitro Tests for Serial ReleaseRule2014-1255005/30/2014DEPARTMENT OF AGRICULTUREAgriculture DepartmentWe are amending the ``In vitro tests for serial release'' regulations by removing a footnote that refers to one method to calculate the relative antigen content of inactivated veterinary biological products and relative potency c … We are amending the ``In vitro tests for serial release'' regulations by removing a footnote that refers to one method to calculate the relative antigen content of inactivated veterinary biological products and relative potency calculation software available from Veterinary Services' Center for Veterinary Biologics (CVB). CVB will no longer provide or update the software and the written method for using the software will no longer be used. This action will update the regulations.in-vitro-tests-for-serial-releaseFR-Doc-2014-12550
Viruses, Serums, Toxins, and Analogous Products; Standard Requirements; Addition of Terminology To Define Veterinary Biologics Test ResultsProposed Rule2014-1255105/30/2014DEPARTMENT OF AGRICULTUREAgriculture DepartmentWe 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 pr … 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.viruses-serums-toxins-and-analogous-products-standard-requirements-addition-of-terminology-to-defineFR-Doc-2014-12551
Viruses, Serums, Toxins, and Analogous Products; Single Label Claim for Veterinary Biological ProductsProposed Rule2014-0899504/21/2014DEPARTMENT OF AGRICULTUREAgriculture DepartmentWe are proposing to amend the Virus-Serum-Toxin Act regulations to provide for the use of a simpler labeling format that would better communicate product performance to the user. We intend to replace the current label format, which r … We are proposing to amend the Virus-Serum-Toxin Act regulations to provide for the use of a simpler labeling format that would better communicate product performance to the user. We intend to replace the current label format, which reflects any of four different levels of effectiveness, with a single, uniform label format. We are also proposing to require biologics licensees to provide a standardized summary, with confidential business information removed, of the efficacy and safety data submitted to the Animal and Plant Health Inspection Service in support of the issuance of a full product license or conditional license. A simpler label format along with publicly available safety and efficacy data will help biologics producers to more clearly communicate product performance to their customers.viruses-serums-toxins-and-analogous-products-single-label-claim-for-veterinary-biological-productsFR-Doc-2014-08995
Importation of Live Birds and Poultry, Poultry Meat, and Poultry Products From a Region in the European UnionRule2013-0734503/29/2013DEPARTMENT OF AGRICULTUREAgriculture DepartmentWe are amending the regulations governing the importation of animals and animal products by recognizing 25 Member States of the European Union (EU) as the Animal and Plant Health Inspection Service (APHIS)-defined EU poultry trade regi … We are amending the regulations governing the importation of animals and animal products by recognizing 25 Member States of the European Union (EU) as the Animal and Plant Health Inspection Service (APHIS)-defined EU poultry trade region and adding it to the list of regions we consider to be free of Newcastle disease. We are taking this action based on a risk evaluation that we prepared in which we determined that the region meets our requirements for being considered free of Newcastle disease. We also determined that the region meets our requirements for being considered free of highly pathogenic avian influenza (HPAI). In addition, we are establishing requirements governing the importation of live birds and poultry and poultry meat and products from the APHIS-defined EU poultry trade region and updating avian disease terms and definitions. We are also allowing importation from the APHIS-defined EU poultry trade region of hatching eggs under official seal, including those that have transited a restricted zone established because of detection of HPAI within the boundaries of the APHIS-defined EU poultry trade region. These actions will facilitate the importation of live birds and poultry, including hatching eggs, and poultry meat and products from the APHIS-defined EU poultry trade region while maintaining safeguards to protect the United States from the introduction of communicable avian diseases.importation-of-live-birds-and-poultry-poultry-meat-and-poultry-products-from-a-region-in-theFR-Doc-2013-07345
Viruses, Serums, Toxins, and Analogous Products; Exemptions From Preparation Pursuant to an Unsuspended and Unrevoked LicenseProposed Rule2012-1753307/18/2012DEPARTMENT OF AGRICULTUREAgriculture DepartmentWe are proposing to amend the Virus-Serum-Toxin Act regulations to require that veterinary biologics prepared under the veterinary practitioner exemption must be prepared at the same facility the veterinarian utilizes in conduc … We are proposing to amend the Virus-Serum-Toxin Act regulations to require that veterinary biologics prepared under the veterinary practitioner exemption must be prepared at the same facility the veterinarian utilizes in conducting the day-to-day activities associated with his or her practice. This exemption applies to veterinary biologics prepared by a veterinary practitioner solely for administration to animals in the course of a State-licensed professional practice of veterinary medicine under a veterinarian- client-patient relationship. This proposed amendment is necessary to ensure that veterinary biologics are not prepared in unlicensed establishments in violation of the Virus-Serum-Toxin Act. The effect of the proposed amendment would be to clarify the regulations regarding the preparation of product by a veterinary practitioner under a veterinarian-client-patient relationship.viruses-serums-toxins-and-analogous-products-exemptions-from-preparation-pursuant-to-an-unsuspendedFR-Doc-2012-17533
Importation of Live Birds and Poultry, Poultry Meat, and Poultry Products From a Region in the European UnionProposed Rule2011-1810807/19/2011DEPARTMENT OF AGRICULTUREAgriculture DepartmentWe are proposing to amend the regulations governing the importation of animals and animal products by recognizing 25 Member States of the European Union as the APHIS-defined European Union poultry trade region and adding it to the … We are proposing to amend the regulations governing the importation of animals and animal products by recognizing 25 Member States of the European Union as the APHIS-defined European Union poultry trade region and adding it to the list of regions we consider to be free of Newcastle disease. We are taking this action based on a risk evaluation that we prepared in which we determined that the proposed region meets our requirements for being considered free of Newcastle disease. We also determined that the region meets our requirements for being considered free of highly pathogenic avian influenza. In addition, we are proposing to establish requirements governing the importation of live birds and poultry, including hatching eggs, and poultry meat and products from the APHIS-defined European Union poultry trade region, and to update avian disease terms and definitions. These actions would facilitate the importation of live birds and poultry, and poultry meat and products, from the APHIS- defined European Union poultry trade region while protecting the United States from communicable avian diseases.importation-of-live-birds-and-poultry-poultry-meat-and-poultry-products-from-a-region-in-theFR-Doc-2011-18108
Viruses, Serums, Toxins, and Analogous Products; Packaging and LabelingProposed Rule2011-64801/13/2011DEPARTMENT OF AGRICULTUREAgriculture DepartmentWe are proposing to amend 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 … We are proposing to amend 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 labeling for autogenous biologics to specify the microorganism(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 also propose to amend 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 proposed amendments are necessary in order to update and clarify labeling requirements and ensure that information provided in labeling is accurate with regard to the expected performance of the product.viruses-serums-toxins-and-analogous-products-packaging-and-labelingFR-Doc-2011-648
Viruses, Serums, Toxins, and Analogous Products; Standard Requirements for Live VaccinesRuleE7-2464912/21/2007DEPARTMENT OF AGRICULTUREAgriculture DepartmentWe are amending the Virus-Serum-Toxin Act regulations for certain live bacterial and viral vaccines by removing the requirement to retest the Master Seeds for immunogenicity 3 years after the initial qualifying immunogenicity test. … We are amending the Virus-Serum-Toxin Act regulations for certain live bacterial and viral vaccines by removing the requirement to retest the Master Seeds for immunogenicity 3 years after the initial qualifying immunogenicity test. In addition, we are amending the requirement concerning mouse safety tests prescribed for a biological product recommended for animals other than poultry. These changes update the standard requirements by eliminating unnecessary testing of Master Seed bacteria and viruses and other forms of bulk or completed biological product.https://www.federalregister.gov/documents/2007/12/21/E7-24649/viruses-serums-toxins-and-analogous-products-standard-requirements-for-live-vaccinesFR-Doc-E7-24649
Viruses, Serums, Toxins, and Analogous Products; Suspension, Revocation, or Termination of Biological Licenses or Permits; InspectionsRuleE7-670004/10/2007DEPARTMENT OF AGRICULTUREAgriculture DepartmentWe are amending the Virus-Serum-Toxin Act regulations to specify the actions to be taken by veterinary biologics licensees and permittees upon receipt of notice from the Animal and Plant Health Inspection Service (APHIS) to st … We are amending the Virus-Serum-Toxin Act regulations to specify the actions to be taken by veterinary biologics licensees and permittees upon receipt of notice from the Animal and Plant Health Inspection Service (APHIS) to stop the preparation, distribution, sale, barter, exchange, shipment, or importation of any worthless, contaminated, dangerous, harmful, or unsatisfactory veterinary biological product. After receiving notice from APHIS, licensees and permittees must notify each wholesaler, dealer, jobber, consignee, or other recipient known to have any such product in their possession to stop the preparation, distribution, sale, barter, exchange, shipment, or importation of such product. In addition, licensees and permittees must provide a complete accounting of the remaining inventory of affected serials or subserials of such product in the current possession of known wholesalers, dealers, jobbers, consignees, or other known recipients and provide written documentation concerning the required notification(s) as directed by the Administrator of APHIS. These changes are necessary in order to clarify the regulations, provide for the most expeditious means of disseminating stop distribution and sale notices, and to mitigate the risk that any worthless, contaminated, dangerous, harmful, or unsatisfactory veterinary biological product may cause harm to animals, the public health, or to the environment.https://www.federalregister.gov/documents/2007/04/10/E7-6700/viruses-serums-toxins-and-analogous-products-suspension-revocation-or-termination-of-biologicalFR-Doc-E7-6700
Viruses, Serums, Toxins, and Analogous Products; Detection of Avian Lymphoid Leukosis VirusProposed RuleE7-152801/31/2007DEPARTMENT OF AGRICULTUREAgriculture DepartmentWe are proposing to amend the Virus-Serum-Toxin Act regulations concerning testing for avian lymphoid leukosis in veterinary biologics to specify that the test is for the detection of extraneous replicating avian leukosis virus; requir … We are proposing to amend the Virus-Serum-Toxin Act regulations concerning testing for avian lymphoid leukosis in veterinary biologics to specify that the test is for the detection of extraneous replicating avian leukosis virus; require such testing to be conducted using a procedure that will detect extraneous replicating avian leukosis virus and that is acceptable to the Animal and Plant Health Inspection Service; require firms to develop a procedure to test for lymphoid leukosis virus contamination in the case of vaccine virus cytopathic to chick embryo cell cultures; and specify the equivalent inoculum dose of vaccine to be used when testing certain specified chicken vaccines for lymphoid leukosis virus. These proposed changes would update the testing for lymphoid leukosis virus contamination by prescribing a test procedure that increases the probability of detecting atypical lymphoid leukosis viruses such as those recently found in a contaminated vaccine.https://www.federalregister.gov/documents/2007/01/31/E7-1528/viruses-serums-toxins-and-analogous-products-detection-of-avian-lymphoid-leukosis-virusFR-Doc-E7-1528
Viruses, Serums, Toxins, and Analogous Products; Standard Requirements for Live VaccinesProposed RuleE7-153101/31/2007DEPARTMENT OF AGRICULTUREAgriculture DepartmentWe are proposing to amend the Virus-Serum-Toxin Act regulations for certain live bacterial and viral vaccines by removing the requirement to retest the Master Seeds for immunogenicity 3 years after the initial qualifying immunogenicity … We are proposing to amend the Virus-Serum-Toxin Act regulations for certain live bacterial and viral vaccines by removing the requirement to retest the Master Seeds for immunogenicity 3 years after the initial qualifying immunogenicity test. In addition, we are proposing to amend the requirement concerning mouse safety tests prescribed for a biological product recommended for animals other than poultry. These proposed changes would update the standard requirements by eliminating unnecessary testing of Master Seed bacteria and viruses and other forms of bulk or completed biological product.https://www.federalregister.gov/documents/2007/01/31/E7-1531/viruses-serums-toxins-and-analogous-products-standard-requirements-for-live-vaccinesFR-Doc-E7-1531
Viruses, Serums, Toxins, and Analogous Products; Records and ReportsProposed Rule05-1626608/17/2005DEPARTMENT OF AGRICULTUREAgriculture DepartmentWe are proposing to amend the Virus-Serum-Toxin Act regulations concerning records and reports to require veterinary biologics licensees and permittees to record specific information concerning adverse events associated with the use of … We are proposing to amend the Virus-Serum-Toxin Act regulations concerning records and reports to require veterinary biologics licensees and permittees to record specific information concerning adverse events associated with the use of biological products that they produce or distribute and to compile and submit those records in a summary report to the Animal and Plant Health Inspection Service (APHIS) every 12 months for products licensed for 1 year or more; for newly licensed products, a summary report would have to be submitted at 6-month intervals during the first year of the product license and at 12-month intervals thereafter. The summary report would also have to identify the number of doses, or the average number of doses, of the product in distribution channels, if available. These records and reports would help ensure that APHIS will be able to provide complete and accurate information to consumers regarding adverse reactions or other problems associated with the use of licensed biological products. This proposed rule replaces a previously published proposed rule, which we are withdrawing as part of this document, that contained fewer specifics concerning the information that would have to be recorded in adverse event reports associated with the use of veterinary biologics that are submitted to the Agency.https://www.federalregister.gov/documents/2005/08/17/05-16266/viruses-serums-toxins-and-analogous-products-records-and-reportsFR-Doc-05-16266
Viruses, Serums, Toxins, and Analogous Products; Expiration Date Required for Serials and Subserials and Determination of Expiration Date of ProductProposed Rule05-851604/28/2005DEPARTMENT OF AGRICULTUREAgriculture DepartmentWe are proposing to amend the Virus-Serum-Toxin Act regulations to require licensees and permittees to confirm the proposed expiration dating period of products by potency testing serials on multiple occasions throughout the proposed d … We are proposing to amend the Virus-Serum-Toxin Act regulations to require licensees and permittees to confirm the proposed expiration dating period of products by potency testing serials on multiple occasions throughout the proposed dating period, rather than only at release and at the approximate expiration date as is currently required. We would require that those stability test data be submitted to the Animal and Plant Health Inspection Service for review and filing, and that the approval date be specified in a filed Outline of Production. In addition, after a product is licensed and its dating period confirmed, the licensee or permittee would have to submit a plan to monitor the stability of the product and the suitability of its dating period; that plan would have to include regular testing of serials for potency during and at the end of dating. The proposed changes would help clarify the distinction between specifying an expiration date for an individual serial of a product and establishing the appropriate expiration dating period for the product. The effect of these proposed changes would be to establish a single uniform standard for determining expiration dates for veterinary biological products.https://www.federalregister.gov/documents/2005/04/28/05-8516/viruses-serums-toxins-and-analogous-products-expiration-date-required-for-serials-and-subserials-andFR-Doc-05-8516
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