Animal Biologics

animal-biologics
TitlePublishedFR Doc.Description
TitlePublishedFR Doc.Description
Agriculture Department -- VSTA Records and Reports Specific to International Standards for Pharmacovigilance2018-May-172018-10540We are amending the Virus-Serum-Toxin Act regulations concerning records and reports. This change requires 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 (APHIS) will be provided in separate guidance documents. These records and reports will help ensure that APHIS can provide complete and accurate information to consumers regarding adverse reactions or other problems associated with the use of licensed biological products.
Agriculture Department -- Rinderpest; Update of Communicable Animal Disease Provisions2018-Apr-112018-07232We are amending the regulations concerning communicable diseases of livestock and poultry, interstate transportation and importation of animals (including poultry) and animal products, and permits for biological products to remove references to the animal disease rinderpest. This action reflects recognition by the Animal and Plant Health Inspection Service that rinderpest has been eradicated worldwide, and removes restrictions that are no longer necessary due to eradication of the disease. This action better aligns our regulations with World Organization for Animal Health guidelines for international trade as they pertain to rinderpest.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Expiration Date Required for Serial and Subserials and Determination of Expiration Date of Product2018-Mar-142018-05143We are amending the regulations to clarify that the expiration date of a serial or subserial of a veterinary biologic should be computed from the date of the initiation of the first potency test. We are also requiring the expiration dating period (stability) of a product to be confirmed by conducting a real-time stability study with a stability-indicating assay, stability monitoring of products after licensing, and specifying a single standard for determining the expiration date for veterinary biologics
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Packaging and Labeling2016-Nov-082016-26936In 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.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Packaging and Labeling2016-Aug-302016-20749We 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.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Single Label Claim for Veterinary Biological Products2016-Jul-202016-17073In 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.
Agriculture Department -- VSTA Records and Reports Specific to International Standards for Pharmacovigilance2015-Sep-042015-21997We 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.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Single Label Claim for Veterinary Biological Products2015-Jul-102015-16898We 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.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Exemptions From Preparation Pursuant to an Unsuspended and Unrevoked License2015-May-112015-11311We 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.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Standard Requirements; Addition of Terminology To Define Veterinary Biologics Test Results2014-Sep-182014-22294We 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.
Agriculture Department -- In Vitro Tests for Serial Release2014-May-302014-12550We 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.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Standard Requirements; Addition of Terminology To Define Veterinary Biologics Test Results2014-May-302014-12551We 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.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Single Label Claim for Veterinary Biological Products2014-Apr-212014-08995We 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.
Agriculture Department -- Importation of Live Birds and Poultry, Poultry Meat, and Poultry Products From a Region in the European Union2013-Mar-292013-07345We 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.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Exemptions From Preparation Pursuant to an Unsuspended and Unrevoked License2012-Jul-182012-17533We 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.
Agriculture Department -- Importation of Live Birds and Poultry, Poultry Meat, and Poultry Products From a Region in the European Union2011-Jul-192011-18108We 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.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Packaging and Labeling2011-Jan-132011-648We 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.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Standard Requirements for Live Vaccines2007-Dec-217-24649We 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.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Suspension, Revocation, or Termination of Biological Licenses or Permits; Inspections2007-Apr-107-6700We 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.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Standard Requirements for Live Vaccines2007-Jan-317-1531We 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.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Detection of Avian Lymphoid Leukosis Virus2007-Jan-317-1528We 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.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Records and Reports2005-Aug-1705-16266We 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.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Expiration Date Required for Serials and Subserials and Determination of Expiration Date of Product2005-Apr-2805-8516We 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.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Standard Requirements for Bovine Virus Diarrhea and Bovine Rhinotracheitis Vaccines2003-Oct-0603-25252We are proposing to amend the Virus-Serum-Toxin Act regulations concerning Standard Requirements for Bovine Virus Diarrhea Vaccine, Killed Virus, and Bovine Rhinotracheitis Vaccine, Killed Virus, to require that those vaccines elicit specific antibody titer that is at least 80 percent of the geometric mean antibody titer obtained in the vaccinates in the host animal protection study to pass the potency test. We are proposing these changes based on data showing that the 1:8 minimum antibody titer for vaccinates specified in the current standard requirement potency tests may not be adequate to protect animals challenged with virulent virus. The effect of the proposed changes would be to establish potency test requirements for these vaccines that are based on the host animal protection study performed by the licensee.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Determination of Moisture Content in Desiccated Biological Products2003-Oct-0603-25251We are amending the Virus-Serum-Toxin Act regulations for the determination of moisture content in desiccated biological products to require that such determinations be made using a gravimetric method that expresses moisture content as the percentage of weight a product loses during a drying cycle, and to require that the maximum percentage of moisture permitted for a satisfactory test must be specified in a filed Outline of Production. The gravimetric method has been adopted as an international standard by scientific experts and regulatory authorities in the United States, Canada, Japan, and the European Union. In addition, we are amending the regulations pertaining to general requirements for live bacterial vaccines and general requirements for live virus vaccines to specify the gravimetric method when testing for moisture content. These actions will update the regulations by providing a uniform method of determining moisture content in desiccated products and ensure the stability of that product during its dating period.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Standard Requirements for Determination of Residual Free Formaldehyde Content of Biological Products2003-Jun-1303-14957We are amending the Virus-Serum-Toxin Act regulations for the determination of residual free formaldehyde in veterinary biologics to specify that such determinations be made using the ferric chloride method, and that the residual free formaldehyde content be measured in grams per liter. The ferric chloride method has been adopted as an international standard by scientific experts and regulatory authorities in the United States, Canada, Japan, and the European Union. The effect of this rule will be to reduce the differences in technical requirements for veterinary biologics among regulatory agencies in different countries and further ensure the safety and shelf life of veterinary biologics by adopting a method that has been standardized and accepted internationally.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Suspension, Revocation, or Termination of Biological Licenses or Permits; Inspections2003-Apr-0903-8599We are proposing to amend the Virus-Serum-Toxin Act regulations to specify the actions that would have to be taken by veterinary biologics licensees and permittees upon their 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 to stop the preparation, distribution, sale, barter, exchange, shipment, or importation of any worthless, contaminated, dangerous, harmful, or unsatisfactory veterinary biological product, licensees and permittees would be required to notify wholesalers, dealers, jobbers, or other persons known to have veterinary biological products in their possession to stop the preparation, distribution, sale, barter, exchange, shipment, or importation of any worthless, contaminated, dangerous, harmful, or unsatisfactory veterinary biological product. In addition, licensees and permittees would be required to submit a complete accounting of the inventory of affected serials or subserials of biological products in the current possession of each person involved in the distribution or sale of the product, and provide written documentation concerning the required notifications as directed by the Administrator of APHIS. These proposed changes are necessary in order to clarify the regulations, provide for the most expeditious means of notification, and to prevent 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.
Agriculture Department -- Animal Health Protection Act; Revisions to Authority Citations2003-Feb-0703-3058We are amending the regulations in title 7, chapter III, and title 9, chapter I, to reflect the enactment of the Animal Health Protection Act (Pub. L. 107-171, 116 Stat. 494, 7 U.S.C. 8301 et seq.) in our lists of legal authorities. We are also removing or revising citations and references to animal health statutes that were repealed by the Animal Health Protection Act. In addition, we are updating the authority citations throughout our regulations in titles 7 and 9, where appropriate, to remove duplicative or outdated citations and are making other nonsubstantive editorial changes in the regulations for the sake of clarity.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Determination of Moisture Content in Desiccated Biological Products2002-Aug-0502-19669We are proposing to amend the Virus-Serum-Toxin Act regulations for the determination of moisture content in desiccated biological products to specify that such determinations be made using the harmonized gravimetric method adopted by the International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products that expresses moisture content as the percentage of weight a product loses during a drying cycle, and to require that the maximum percentage of moisture permitted for a satisfactory test must be specified in a filed Outline of Production. We are proposing this change in order to replace the variety of tests for moisture determination that are currently described by manufacturers in Outlines of Production filed with the Animal and Plant Health Inspection Service with a test recognized as an international standard by scientific experts and regulatory authorities in the United States, Japan, and the European Union. In addition, we are proposing to amend sections of the regulations pertaining to general requirements for live bacterial vaccines and general requirements for live virus vaccines to specify the gravimetric method when testing for moisture content. These actions would update the regulations by providing a uniform method of determining moisture content in desiccated products and ensure the stability of that product during its dating period.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Equine Influenza Vaccine, Killed Virus2002-May-1502-12134We are proposing to amend the Virus-Serum-Toxin Act regulations concerning Standard Requirements for veterinary biologics by adding a Standard Requirement for Equine Influenza Vaccine, Killed Virus. This proposed rule would require that such vaccines be shown to protect vaccinates for at least 60 days based on a vaccination- challenge study conducted in horses. In addition, we would establish a serum hemagglutination inhibition test in guinea pigs as the serial release potency test for the vaccine; establish procedures for adding and removing strains of virus based on evidence of changes in the antigenic character of the equine influenza viruses in current circulation; and add labeling requirements to the regulations. The effect of these proposed changes would be to standardize purity, safety, potency, and efficacy requirements for equine influenza vaccine to ensure that such products will provide a minimum level of protection to vaccinated horses.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Standard Requirements for Determination of Residual Free Formaldehyde Content of Biological Products2002-Apr-0502-8260We are proposing to amend the Virus-Serum-Toxin Act regulations for the determination of residual free formaldehyde in veterinary biologics. This amendment would specify that such determinations be made using the ferric chloride method, and that the residual free formaldehyde content be measured in grams per liter . We are proposing this amendment because the ferric chloride method has been adopted as an international standard by scientific experts and regulatory authorities in the United States, Canada, Japan, and the European Union. The effect of the proposed amendment would be to reduce the differences in technical requirements for veterinary biologics among regulatory agencies in different countries and further ensure the safety and shelf life of veterinary biologics by adopting a method which has been standardized and accepted internationally.
Agriculture Department -- Viruses, Serums, and Toxins and Analogous Products; Autogenous Biologics2002-Apr-0302-8058We are amending the Virus-Serum-Toxin Act regulations for autogenous biologics by reducing the number of test summaries that manufacturers must submit to the Animal and Plant Health Inspection Service. In addition, we are amending the requirement concerning the submission of containers selected from each serial of autogenous biologic that exceeds 50 containers. Manufacturers will hold these containers, and submission is not required unless requested by the Animal and Plant Health Inspection Service. These actions will result in savings in time and resources for autogenous biologics manufacturers and the Animal and Plant Health Inspection Service without a significant reduction in regulatory oversight.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Records and Reports2002-Jan-1502-938We are proposing to amend the Virus-Serum-Toxin Act regulations concerning records and reports. First, we are proposing to require veterinary biologics licensees and permittees to record and submit reports to the Animal and Plant Health Inspection Service concerning adverse events associated with the use of biological products that they produce or distribute. Second, we are proposing to require veterinary biologics licensees and permittees to report to the Animal and Plant Health Inspection Service the number of doses of each licensed product that they distribute. Third, we are proposing to provide definitions for adverse event and adverse event report. These actions would assist the Animal and Plant Health Inspection Service in providing complete and accurate information to consumers regarding adverse reactions or other problems associated with the use of licensed biological products.
Agriculture Department -- Viruses, Serums, Toxins, and Analogous Products; Erysipelothrix Rhusiopathiae Bacterin2001-Jul-1701-17802We are proposing to amend the regulations regarding the standard requirement for Erysipelothrix Rhusiopathiae Bacterin to specify that those requirements apply only to bacterins recommended for use in swine and turkeys, to require that the immunogenicity of such bacterins be demonstrated in a host animal protection study, to establish ``protection to market weight/age'' as the minimum duration of immunity requirement, and to replace the current mouse protection potency test used for serial release with an in vitro potency test. We are proposing these changes as a result of our evaluation that showed that some swine vaccinated with Erysipelothrix Rhusiopathiae Bacterins that meet the current standard requirement may be diagnosed with acute erysipelas infection before they reach market age. These actions would update the regulations by standardizing the efficacy and duration of immunity requirements, provide for the use of a validated serial release potency test, and ensure that serials that pass the serial release potency test will also protect swine and turkeys to market weight.
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