Animal Feeds

animal-feeds
TitlePublishedFR Doc.Description
TitlePublishedFR Doc.Description
Health and Human Services Department -- Food Additives Permitted in Feed and Drinking Water of Animals; Marine Microalgae2018-May-072018-09636The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of dried marine microalgae as a source of docosahexaenoic acid (DHA) for use in complete, dry foods for adult dogs. This action is in response to a food additive petition filed by DSM Nutritional 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.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address2018-Apr-052018-06961The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and a change of a sponsor's name and address.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address2018-Mar-302018-06358The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the withdrawal of approval of applications, changes of sponsorship of applications, and a change of a sponsor's name and address, and to make technical amendments to improve the accuracy of the regulations.
Health and Human Services Department -- Food Additives Permitted in Feed and Drinking Water of Animals; Silicon Dioxide as a Carrier for Flavors2018-Mar-022018-04275The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of silicon dioxide as a carrier for flavors for use in animal feed. This action is in response to a food additive petition filed by Idemitsu Kosan, Cp. Ltd.
Health and Human Services Department -- Food Additives Permitted in Feed and Drinking Water of Animals; Formic Acid as a Feed Acidifying Agent in Complete Poultry Feeds2018-Jan-022017-28251The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of formic acid as a feed acidifying agent in complete poultry feeds. This action is in response to a food additive petition filed by BASF Corp.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications2017-Dec-132017-26753The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during May and June 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations.
Health and Human Services Department -- Food Additives Permitted in Feed and Drinking Water of Animals; Ammonium Formate and Formic Acid2017-Nov-132017-24366The Food and Drug Administration (FDA, we, the Agency) is amending food additive regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of formic acid and ammonium formate. This action is in response to a food additive petition filed by BASF Corp for Feed Grade Sodium Formate (FAP 2286), which also proposed to amend the animal food additive regulations for formic acid and ammonium formate to limit formic acid and formate salts from all added sources.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address2017-Sep-182017-19602The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during March and April 2017. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address and to make technical amendments to improve the accuracy of the regulations.
Health and Human Services Department -- Food Additives Permitted in Feed and Drinking Water of Animals; Gamma-Linolenic Acid Safflower Oil2017-Aug-152017-17214The Food and Drug Administration (FDA or we or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of oil from a variety of bioengineered safflower as a source of omega-6 fatty acids in complete dry adult maintenance dog food. This action is in response to a food additive petition filed by Arcadia Biosciences, Inc.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship2017-May-102017-09364The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2017. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect several changes of sponsorship of applications and to make correcting amendments to improve the accuracy of the regulations.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Name2017-Mar-012017-03930The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the change of sponsorship of an application and a change of a sponsor's name.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Address2017-Feb-242017-03677The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of several applications and a change of a sponsor's address.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications2017-Feb-242017-03596The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of eight supplemental new animal drug applications (NADAs). The effect of these supplemental applications will be to change the marketing status from over-the- counter (OTC) use to use by veterinary feed directive (VFD) for these antimicrobial drugs of importance to human medicine, administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for production indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and abbreviated new animal drug applications (ANADAs) that were affected by this initiative.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications2016-Dec-272016-31083The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 71 supplemental new animal drug applications (NADAs) and 35 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) use to use by veterinary feed directive (VFD) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for growth promotion indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and ANADAs that were affected by this initiative. The animal drug regulations are also being amended to reflect several non-substantive changes in format. These technical amendments are being made to improve the consistency and readability of the regulations.
Health and Human Services Department -- Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate2016-Dec-272016-31079The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of feed grade sodium formate as a feed acidifying agent in complete poultry feeds. This action is in response to a food additive petition filed by BASF Corp.
Health and Human Services Department -- Food Additives Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid2016-Nov-302016-28754The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of guanidinoacetic acid as a substance that spares arginine and serves as a precursor of creatine in broiler chicken and turkey feeds. This action is in response to a food additive petition filed by Alzchem AG.
Health and Human Services Department -- Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate2016-Sep-302016-23671The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of feed grade sodium formate as a feed acidifying agent in complete swine feeds. This action is in response to a food additive petition filed by BASF Corp.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address2016-Sep-302016-23230The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline, Procaine Penicillin, and Sulfamethazine2016-Sep-142016-21985The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a 3-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for production indications in swine and to reflect the reformulation of the Type A medicated article as a 2- way, fixed-ratio, combination drug product without penicillin.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address; Change of Sponsor's Address2016-Aug-292016-19914The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May and June 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications, changes of sponsors' names and addresses, and the voluntary withdrawals of approval of applications.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feed; Category Definitions2016-Aug-242016-20148The Food and Drug Administration (FDA, the Agency, we) is amending the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. This revision will preserve the availability of medicated feeds intended for therapeutic use in minor animal species and prevent a significant disincentive for future development of additional minor species therapies.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feed; Category Definitions2016-Aug-242016-20149The Food and Drug Administration (FDA, the Agency, we) proposes to amend the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. The proposed revision will preserve the availability of medicated feeds intended for therapeutic use in minor animal species and prevent a significant disincentive for future development of additional minor species therapies.
Health and Human Services Department -- Substances Generally Recognized as Safe2016-Aug-172016-19164The Food and Drug Administration (FDA or we) is issuing a final rule that amends and clarifies the criteria in our regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the substance is generally recognized as safe (GRAS) under the conditions of its intended use. We also are amending our regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use. The clarified criteria for GRAS status should help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies with the FD&C Act, and the notification procedure will enable stakeholders to be aware of whether we have questioned the basis of a conclusion of GRAS status.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor2016-Jul-262016-17501The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 57 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) from Elanco Animal Health, A Division of Eli Lilly & Co. to Elanco US, Inc.
Agriculture Department -- Importation of Sheep, Goats, and Certain Other Ruminants2016-Jul-182016-16816We are proposing to amend the regulations that govern the importation of animals and animal products to revise the conditions for the importation of live sheep, goats, and certain other non-bovine ruminants, and products derived from sheep and goats, with regard to transmissible spongiform encephalopathies such as bovine spongiform encephalopathy (BSE) and scrapie. We are proposing to remove BSE- related import restrictions on sheep and goats and most of their products, and to add import restrictions related to transmissible spongiform encephalopathies for certain wild, zoological, or other non- bovine ruminant species. The conditions we are proposing for the importation of specified commodities are based on internationally accepted scientific literature and will in general align our regulations with guidelines set out in the World Organization for Animal Health's Terrestrial Animal Health Code.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship2016-Jun-082016-13517The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March and April 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and the voluntary withdrawals of approval of applications that occurred in January and February.
Health and Human Services Department -- Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate2016-Jun-032016-13082The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium propionate as a source of chromium in broiler chicken feed. This action is in response to a food additive petition filed by Kemin Industries, Inc.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship2016-Apr-182016-08827The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications that occurred in January and February.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship2016-Mar-302016-07135The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications that occurred in November and December 2015.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Removal of Obsolete and Redundant Regulations2016-Mar-072016-04945The Food and Drug Administration (FDA) is removing regulations that required sponsors to submit data regarding the subtherapeutic use of certain antibiotic, nitrofuran, and sulfonamide drugs administered in animal feed as these regulations have been determined to be obsolete. FDA has other strategies for assessing the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern, and the only remaining animal drug use listed in these regulations is now listed elsewhere in the new animal drug regulations.
Health and Human Services Department -- Center for Food Safety and Applied Nutrition Library Address; Technical Amendments2016-Feb-032016-01787The Food and Drug Administration (FDA or we) is amending certain regulations to update the location of references cited in our food regulations. We are taking this action to reflect the transfer of those references from our facility in College Park, MD, to our library at our main campus in Silver Spring, MD. We also are updating certain regulations to reflect the current names for specific FDA offices.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Bacitracin Methylenedisalicylate2015-Dec-222015-32000The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmgate LLC for the use of a Type A medicated article containing bacitracin methylenedisalicylate to manufacture Type B and Type C medicated feeds for chickens, turkeys, pheasants, quail, and feedlot cattle. This supplemental approval reflects FDA's effectiveness conclusions that relied on the National Academy of Sciences/National Research Council Drug Efficacy Study Group's evaluation of the effectiveness of this drug as well indications for use not subject to this review.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship2015-Dec-092015-31042The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and the voluntary withdrawals of approval of applications that occurred in September and October 2015.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Address2015-Oct-132015-25918The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsor, a change of sponsor's address, a revised food safety warning, the voluntary withdrawal of approval of an NADA, and a technical amendment. This technical amendment is being made to improve the accuracy of the regulations.
Health and Human Services Department -- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals2015-Sep-172015-21921The Food and Drug Administration (FDA or we) is adding regulations for the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals. These regulations will, for the first time, establish requirements for the current good manufacturing practice (CGMP) for food for animals. In addition, we are adding requirements for certain domestic and foreign animal food facilities to establish and implement hazard analysis and risk-based preventive controls for food for animals. We are taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to humans and animals and to implement new statutory provisions in the FDA Food Safety Modernization Act (FSMA). The rule is intended to build an animal food safety system for the future that makes modern science- and risk-based preventive controls the norm across all sectors of the animal food system.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications2015-Sep-042015-21905The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May and June 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a nonsubstantive change. This technical amendment is being made to improve the accuracy of the regulations.
Health and Human Services Department -- Food Additives Permitted in Feed and Drinking Water of Animals; Gamma-Linolenic Acid Safflower Meal2015-Jun-222015-15220The Food and Drug Administration (FDA or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of seed meal from a variety of bioengineered safflower in cattle and poultry feeds. This action is in response to a food additive petition filed by Arcadia Biosciences, Inc.
Health and Human Services Department -- Veterinary Feed Directive2015-Jun-032015-13393The Food and Drug Administration (FDA) is amending its animal drug regulations regarding veterinary feed directive (VFD) drugs. FDA's current VFD regulation established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. This amendment is intended to improve the efficiency of FDA's VFD program while protecting human and animal health.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor's Name; Change of Sponsor's Address2015-Apr-082015-08025The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect several non-substantive changes. These technical amendments are being made to improve the accuracy of the regulations.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor2015-Mar-132015-05644The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of eight NADAs and nine ANADAs, and to make correcting amendments for a drug labeler code.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications2014-Dec-152014-29249The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of six NADAs and four ANADAs, the voluntary withdrawal of approval of an ANADA, and a correcting amendment.
Agriculture Department -- Highly Pathogenic Avian Influenza2014-Dec-012014-28244We are adopting as a final rule, with changes, an interim rule that amended the regulations concerning the importation of animals and animal products to prohibit or restrict the importation of live birds and poultry (including hatching eggs) and bird and poultry products from regions where any subtype of highly pathogenic avian influenza (HPAI) is considered to exist. The interim rule also added restrictions concerning importation of live birds and poultry that have been moved through regions where HPAI is considered to exist, or that have been vaccinated for certain types of avian influenza. This final rule amends the interim rule to allow the importation of live zoological birds and poultry that have been vaccinated for avian influenza as part of an official program and under specific conditions as determined by the Administrator and to allow the importation of HPAI-resistant pigeons, doves, and other Columbiform species under certain conditions from regions where HPAI is considered to exist. This action will provide for the importation of certain zoological birds and poultry under specified conditions designed to minimize the risk of introducing HPAI into the United States.
Health and Human Services Department -- New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin2014-Sep-082014-20325The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to add a cross reference to a tolerance.
Health and Human Services Department -- New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin2014-Jul-312014-17912The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to remove a cross-reference to a combination drug medicated feed that is no longer codified.
Health and Human Services Department -- New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor's Address2014-Jul-022014-15276The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April and May 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to remove an obsolete entry for a drug for which approval was withdrawn in 1996.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline; Procaine Penicillin; and Sulfamethazine2014-Jul-022014-15274The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a three-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for growth promotion indications in swine and to reflect the reformulation of the Type A medicated article as a two-way, fixed-ratio, combination drug product without penicillin.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Withdrawal of Approval of New Animal Drug Applications; Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and Sulfamethazine; Virginiamycin2014-Apr-102014-08011The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of 19 new animal drug applications (NADAs) for certain Type A medicated articles and Type B medicated feeds. This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.
Health and Human Services Department -- New Animal Drugs; Amprolium; Bambermycins; Ceftiofur; Deslorelin; Florfenicol; Florfenicol and Flunixin; Paclitaxel; Phenylbutazone; Pimobendan; Salinomycin; Tilmicosin; Tiludronate; Change of Sponsor2014-Apr-012014-07220The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect previous approval of revised food safety warnings. This is being done to improve the accuracy of the regulations. The animal drug regulations are also being amended to reflect a change of sponsorship of an NADA and a change to a sponsor's address.
Health and Human Services Department -- Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug; Correction2014-Mar-312014-06994The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect the withdrawal of approval of new animal drug applications (NADAs) that appeared in the Federal Register of February 27, 2014 (79 FR 10976). That document listed an NADA for which a withdrawal of approval (WOA) was not intended and failed to remove all conditions of use associated with the withdrawn NADAs. This correction is being made to improve the accuracy of the animal drug regulations.
Health and Human Services Department -- Zoetis Inc., Withdrawal of Approval of New Animal Drug Applications; Chlortetracycline; Sulfathiazole; Penicillin2014-Mar-202014-05882The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of a new animal drug application (NADA) and two abbreviated new animal drug applications (ANADAs) for three-way, fixed-ratio combination drug Type A medicated articles containing chlortetracycline, sulfathiazole, and penicillin. This action is being taken at the sponsor's request because these products are no longer manufactured or marketed.
Health and Human Services Department -- Food Additives Permitted in Feed and Drinking Water of Animals; Benzoic Acid2014-Mar-132014-05440The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of benzoic acid as an acidifying agent in swine feed. This action is in response to a food additive petition filed by DSM Nutritional Products.
Health and Human Services Department -- New Animal Drugs; Bambermycins; Clopidol; Ivermectin; Penicillin G Procaine and Dihydrostreptomycin Sulfate; Progesterone; Robenicoxib; Sulfadimethoxine; Change of Sponsor; Change of Sponsor's Address2014-Feb-272014-01959The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during December 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of an NADA and a change to a sponsor's address.
Health and Human Services Department -- Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug2014-Feb-272014-02617The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of 69 new animal drug applications (NADAs) and 22 abbreviated new animal drug applications (ANADAs) for use of arsanilic acid, carbarsone, or roxarsone Type A medicated articles to manufacture combination drug Type B and Type C medicated feeds. This action is being taken at the sponsor's request because the products are no longer manufactured or marketed. FDA is also amending the animal drug regulations to remove entries describing conditions of use for combination drug medicated feeds for which no NADA is approved. This action is being taken to improve the accuracy of the regulations.
Health and Human Services Department -- Current Good Manufacturing Practice for Medicated Feeds2014-Jan-232014-01299The Food and Drug Administration (FDA) is amending the regulations for good manufacturing practice of animal feeds containing a new animal drug to correctly cite the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This action is being taken to improve the accuracy of the regulations.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Bambermycins2013-Dec-162013-29810The Food and Drug Administration (FDA) is amending the animal drug regulations to remove dairy replacement heifers from the pasture cattle class for which free-choice, loose-mineral medicated feeds containing bambermycins are approved. This action is being taken because a level of selenium for inclusion in such feeds has not been established for dairy cattle under the food additive regulation for selenium.
Health and Human Services Department -- Veterinary Feed Directive2013-Dec-122013-29696The Food and Drug Administration (FDA) is proposing to amend its animal drug regulations regarding veterinary feed directive (VFD) drugs. FDA's VFD regulation, which became effective on January 8, 2001, established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. This proposed amendment is intended to improve the efficiency of FDA's VFD program.
Agriculture Department -- Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine Products2013-Dec-042013-28228We are amending the regulations that govern the importation of animals and animal products to revise the conditions for the importation of live bovines and products derived from bovines with regard to bovine spongiform encephalopathy (BSE). We are basing importation conditions on the inherent risk of BSE infectivity in specified commodities, as well as on the BSE risk status of the region in which the commodities originate. We are establishing a system for classifying regions as to BSE risk that is consistent with the system employed by the World Organization for Animal Health (OIE), the international standard-setting organization for guidelines related to animal health. The conditions we are adopting for the importation of specified commodities are based on internationally accepted scientific literature, and are, in general, consistent with guidelines set out in the OIE's Terrestrial Animal Health Code. We are also classifying certain specified countries as to BSE risk and are removing BSE restrictions on the importation of cervids and camelids and products derived from such animals. We are making these amendments after conducting a thorough review of relevant scientific literature and a comprehensive evaluation of the issues and concluding that the changes to the regulations will continue to guard against the introduction of BSE into the United States, while allowing the importation of additional animals and animal products into this country.
Health and Human Services Department -- Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid2013-Nov-262013-28256The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of a new animal drug application (NADA) for an arsanilic acid Type A medicated article at the sponsor's request because the product is no longer manufactured or marketed.
Health and Human Services Department -- Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone2013-Nov-222013-27917The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of three new animal drug applications (NADAs) for roxarsone or carbarsone Type A medicated articles at the sponsor's request because the products are no longer manufactured or marketed.
Health and Human Services Department -- New Animal Drugs; Afoxolaner; Carprofen; Ceftiofur Hydrochloride; Monensin2013-Nov-052013-26473The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2013. FDA is also informing the public of the availability of summaries on the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for an ANADA.
Health and Human Services Department -- Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals2013-Oct-292013-25126The Food and Drug Administration (FDA) is proposing regulations for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish requirements for current good manufacturing practice in manufacturing, processing, packing, and holding of animal food. FDA also is proposing regulations to require that certain facilities establish and implement hazard analysis and risk-based preventive controls for food for animals. FDA is taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to animals or humans and is intended to build an animal food safety system for the future that makes modern, science and risk-based preventive controls the norm across all sectors of the animal food system.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor; Gonadorelin; Ivermectin; Ractopamine; Trimethoprim and Sulfadiazine Suspension; Tulathromycin2013-Oct-252013-25172The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for an ANADA.
Health and Human Services Department -- New Animal Drugs; Carprofen; Enrofloxacin; Florfenicol; Tildipirosin; Zilpaterol2013-Aug-272013-20538The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin2013-Aug-232013-20616The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of four new animal drug applications (NADAs), held by Quali-Tech Products, Inc., at the sponsor's request because the products are no longer manufactured or marketed.
Health and Human Services Department -- New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine; Nicarbazin; Penicillin2013-Aug-232013-20540The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of three new animal drug applications (NADAs) at the sponsors' request because the products are no longer manufactured or marketed.
Health and Human Services Department -- Food Additives Permitted in Feed and Drinking Water of Animals; Ammonium Formate2013-Jul-172013-17106The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and drinking water of animals to correct the description of ammonium formate used as an acidifying agent in swine feed. This action is being taken to improve the accuracy of the regulations.
Health and Human Services Department -- Animal Feeds Contaminated With Salmonella Microorganisms2013-Jul-162013-16971The Food and Drug Administration (FDA or Agency) is revoking an advisory opinion on animal feeds contaminated with Salmonella microorganisms. This action is being taken because that advisory opinion is being superseded by the current FDA enforcement strategy articulated in a final compliance policy guide (CPG) on Salmonella in food for animals.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Nicarbazin; Oclacitinib; Zilpaterol2013-Jul-152013-16258The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food; Electron Beam and X-Ray Sources for Irradiation of Poultry Feed and Poultry Feed Ingredients; Correction2013-Jun-102013-13648The Food and Drug Administration (FDA) is correcting a document amending the regulations for irradiation of animal feed and pet food that appeared in the Federal Register of May 10, 2013 (78 FR 27303). That document used incorrect style for the strength units describing radiation sources. This correction is being made to improve the accuracy of the animal drug regulations.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor's Name and Address; Change of Sponsor2013-May-132013-11283The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name and address from Purina Mills, Inc., to Purina Nutrition LLC, and a change of sponsor for a new animal drug application (NADA) from Land O'Lakes Purina Feed LLC to Purina Nutrition LLC. The regulations are also being amended to reflect that Zoetis Inc. is a sponsor of approved NADAs.
Health and Human Services Department -- Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food; Electron Beam and X-Ray Sources for Irradiation of Poultry Feed and Poultry Feed Ingredients2013-May-102013-11147The Food and Drug Administration (FDA) is amending the regulations for irradiation of animal feed and pet food to provide for the safe use of electron beam and x-ray sources for irradiation of poultry feed and poultry feed ingredients. This action is in response to a food additive petition filed by Sadex Corp.
Health and Human Services Department -- New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin2013-Apr-302013-10152The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during March 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor2013-Apr-092013-07542The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 43 approved new animal drug applications (NADAs) and 3 approved abbreviated new animal drug applications (ANADAs) from Boehringer Ingelheim Vetmedica, Inc. to Strategic Veterinary Pharmaceuticals, Inc.
Health and Human Services Department -- New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin2013-Apr-032013-07571The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during February 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
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.
Health and Human Services Department -- New Animal Drugs; Changes of Sponsor2013-Mar-222013-06126The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 21 approved new animal drug applications (NADAs) and 43 approved abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Bayer HealthCare LLC.
Health and Human Services Department -- New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Fumagillin; N2013-Mar-072013-04999The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of 19 new animal drug applications (NADAs) and one abbreviated new animal drug application (ANADA). The applications are being withdrawn for lack of compliance with the reporting requirements in an FDA regulation.
Health and Human Services Department -- New Animal Drugs; Meloxicam; Nicarbazin2013-Jan-022012-31234The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food2012-Dec-052012-29322The Food and Drug Administration (FDA) is proposing to revise the animal drug regulations regarding tolerances for residues of approved and conditionally approved new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style. In addition, we are proposing to add definitions for key terms. The purpose of the revision is to enhance understanding of tolerance determination and improve the readability of the regulations.
Health and Human Services Department -- New Animal Drugs; Approvals; Changes of Sponsor; Change of Sponsor's Name; Change of Sponsor's Address; Alfaxalone; Ivermectin and Clorsulon; Narasin; Triptorelin2012-Oct-232012-25989The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for four ophthalmic ointments, a change of sponsor's name, and a change of sponsor's address.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor's Address; Monensin; Spinosad; Tilmicosin2012-Oct-042012-24475The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) during August 2012 and to reflect a change of sponsor's address for Baxter Healthcare Corp. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- New Animal Drugs; Butorphanol; Doxapram; Triamcinolone; Tylosin2012-Oct-032012-24331The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of a new animal drug application (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Monensin2012-Sep-192012-23065The Food and Drug Administration (FDA) is amending the animal drug regulations to remove a warning for growing cattle on pasture or in dry lot and to codify all monensin free-choice Type C medicated feeds in 21 CFR part 558. This action is being taken to improve the accuracy of the regulations.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Regulation of Carcinogenic Compounds in Food-Producing Animals2012-Aug-222012-20609The Food and Drug Administration (FDA) is amending its regulations regarding compounds of carcinogenic concern used in food- producing animals. Specifically, the Agency is clarifying the definition of ``S<INF>o</INF>'' and revising the definition of ``S<INF>m</INF>'' so that it conforms to the clarified definition of S<INF>o</INF>. Other clarifying and conforming changes are also being made.
Health and Human Services Department -- New Animal Drugs; Altrenogest; Dexamethasone; Florfenicol2012-May-312012-13095The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor; Estradiol; Estradiol Benzoate and Testosterone Propionate; Progesterone and Estradiol Benzoate; Trenbolone Acetate; Trenbolone Acetate and Estradiol; Melengestrol; Ractopamine; Zilpaterol2012-May-302012-13010The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 17 new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) for various steroid ear implants for cattle and for melengestrol acetate liquid Type A medicated article and use in combination medicated feeds for heifers fed in confinement for slaughter from Ivy Laboratories, Division of Ivy Animal Health, Inc., to Elanco Animal Health, Division of Eli Lilly & Co.
Health and Human Services Department -- New Animal Drugs; Ceftiofur Sodium; Lincomycin Powder; Naracin; Tylosin2012-May-172012-11937The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- New Animal Drugs; Ceftiofur Crystalline Free Acid; Gamithromycin; Tylosin2012-May-032012-10632The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during February 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Tiamulin2012-Apr-232012-9708The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for approval of a new concentration of a Type A medicated article.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Tiamulin2012-Apr-172012-9196The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a tiamulin Type A medicated article that pertain to the production indications for use of increased rate of weight gain and improved feed efficiency in swine.
Health and Human Services Department -- Veterinary Feed Directive; Draft Text for Proposed Regulation2012-Apr-132012-8844The Food and Drug Administration (FDA) is announcing the availability of draft text for a proposed regulation intended to improve the efficiency of FDA's Veterinary Feed Directive (VFD) program. The Agency is making this draft text for a proposal available because of the complex scientific and regulatory issues involved, and because of the potential impact that changes to the VFD regulations may have on stakeholders. The Agency invites the public to submit comments with questions and concerns about the draft text for a proposed regulation.
Agriculture Department -- Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine Products2012-Mar-162012-6151We are proposing to amend the regulations that govern the importation of animals and animal products to revise the conditions for the importation of live bovines and products derived from bovines with regard to bovine spongiform encephalopathy (BSE). We are proposing to base importation conditions on the inherent risk of BSE infectivity in specified commodities, as well as on the BSE risk status of the region from which the commodities originate. We are proposing to establish a system for classifying regions as to BSE risk that is consistent with the system employed by the World Organization for Animal Health (OIE), the international standard-setting organization for guidelines related to animal health. The conditions we are proposing for the importation of specified commodities are based on internationally accepted scientific literature and, except in a few instances, are consistent with guidelines set out in the OIE's Terrestrial Animal Health Code. We are also proposing to classify certain specified countries as to BSE risk and are proposing to remove BSE restrictions on the importation of cervids and camelids and products derived from such animals. We are proposing to make these amendments after conducting a thorough review of relevant scientific literature and a comprehensive evaluation of the issues and concluding that the proposed changes to the regulations would continue to guard against the introduction of BSE into the United States, while allowing the importation of additional animals and animal products into this country. In this document we are also affirming the position we took in removing the delay of applicability of certain provisions of the rule entitled ``Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities,'' published in the Federal Register on January 4, 2005 (70 FR 460-553). The delay of applicability was removed in a final rule entitled ``Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines,'' published in the Federal Register on September 18, 2007 (72 FR 53314-53379).
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; N-Methyl-2-Pyrrolidone; Correction2012-Feb-172012-3747The Food and Drug Administration (FDA) published a document in the Federal Register of November 25, 2011 (76 FR 72617), codifying a method of detection for residues of n-methyl-2-pyrrolidone in edible tissues of cattle. That document contained a universal resource locator (URL) linking to the Agency's Web site that did not reflect the most recent URL.
Health and Human Services Department -- New Animal Drugs; Chloramphenicol, Diethylcarbamazine Citrate, Hygromycin B, Methoxyflurane, Neomycin Sulfate, Penicillin G, Phenylbutazone, Pyrantel Tartrate, Tylosin Phosphate, and Sulfamethazine2012-Feb-012012-2103The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of 20 new animal drug applications (NADAs).
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Monensin2012-Jan-272012-1755The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA provides for approval of free-choice feeds for growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers).
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Monensin2011-Dec-212011-32427The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA revises a manufacturing specification for monensin free-choice Type C medicated feed for growing cattle on pasture or in dry lot.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Tilmicosin2011-Dec-092011-31613The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, a division of Eli Lilly & Co. The supplemental NADA provides for use of tilmicosin Type C medicated feeds by veterinary feed directive for the control of bovine respiratory disease in groups of beef and nonlactating dairy cattle.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Eprinomectin; N-Methyl-2-Pyrrolidone2011-Nov-252011-30329The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Merial Ltd. The NADA provides for the veterinary prescription use of eprinomectin by injection for the treatment and control of internal and external parasites of cattle on pasture with persistent effectiveness. The current tolerance for the marker residue for total residues of eprinomectin in edible tissues of cattle is being lowered. The method of detection for residues of the carcinogenic excipient n-methyl-2- pyrrolidone (NMP) in edible tissues of cattle is also being codified.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin; Tylosin2011-Oct-202011-27139The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for use of increased dose levels of monensin in three-way, combination drug Type C medicated feeds for heifers fed in confinement for slaughter containing melengestrol acetate, monensin, and tylosin.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin2011-Sep-302011-25220The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for use of increased dose levels of melengestrol acetate and monensin in two-way, combination drug Type C medicated feeds for heifers fed in confinement for slaughter.
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 -- Importation of Swine Hides and Skins, Bird Trophies, and Ruminant Hides and Skins; Technical Amendment2011-May-192011-12319In a final rule that was published in the Federal Register on December 15, 2009, and effective on January 14, 2010, we amended the regulations governing the importation of animal byproducts to, among other things, provide specific conditions under which deer and other ruminant hides and skins from Mexico could be imported into the United States in order to protect U.S. livestock from the introduction of bovine babesiosis. It was our intent to indicate that deer and ruminant hides and skins from Mexico may not go to an approved establishment upon importation into the United States rather than comply with the specific conditions established in the final rule. This document corrects that error.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Chorionic Gonadotropin; Cuprimyxin; Diethylcarbamazine; Levamisole; Nitrofurazone; Phenylbutazone; Pyrantel; Tylosin; Tylosin and Sulfamethazine2011-Mar-312011-7560The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of 13 new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.
Health and Human Services Department -- New Animal Drugs; Arsanilate Sodium; Sulfaethoxypyridazine2011-Mar-282011-7214The Food and Drug Administration (FDA) is amending the animal drug regulations to remove sections pertaining to use of arsanilate sodium and sulfaethoxypyridazine in medicated feed because there are no currently approved new animal drug applications (NADAs) for such uses. Conforming amendments are also being made. This action is being taken to improve the accuracy of the regulations.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Florfenicol; Correction2011-Mar-242011-6789The Food and Drug Administration (FDA) published a document in the Federal Register of June 17, 2010 (75 FR 34361) revising the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA). That document contained an incorrect table entry describing the maximum florfenicol concentration in Type B medicated swine feeds. This correction is being made to improve the accuracy of the animal drug regulations.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran; Roxarsone; Correction2011-Mar-242011-6790The Food and Drug Administration (FDA) published a document in the Federal Register of October 26, 2010 (75 FR 65565) amending the animal drug regulations. The October 26, 2010, final rule amended the regulations by removing those portions that reflect approval of eight new animal drug applications. The final rule inadvertently failed to add conforming amendments in Sec. 558.530. FDA is correcting the animal drug regulations by removing cross references for use of the withdrawn drugs in combination drug medicated feed. This correction is being made to improve the accuracy of the animal drug regulations.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin2011-Mar-022011-4546The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of eight new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.
Health and Human Services Department -- Food Additives Permitted in Feed and Drinking Water of Animals; Formic Acid2011-Feb-092011-2789The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of formic acid as an acidifying agent in swine feed. This action is in response to a food additive petition filed by Kemira Oyj of Finland.
Agriculture Department -- Highly Pathogenic Avian Influenza2011-Jan-242011-1289We are amending the regulations concerning the importation of animals and animal products to prohibit or restrict the importation of bird and poultry products from regions where any subtype of highly pathogenic avian influenza is considered to exist. We are also adding restrictions concerning importation of live poultry and birds that have been vaccinated for certain types of avian influenza, or that have moved through regions where any subtype of highly pathogenic avian influenza is considered to exist. These restrictions supplement or replace existing restrictions on the importation of live birds and poultry, and bird and poultry products and byproducts from regions where exotic Newcastle disease or highly pathogenic avian influenza subtype H5N1 are considered to exist. They are necessary to prevent the introduction of highly pathogenic avian influenza into the United States.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Regulation of Carcinogenic Compounds in Food-Producing Animals2010-Dec-202010-31887The Food and Drug Administration (FDA) is proposing to amend its regulations regarding compounds of carcinogenic concern used in food-producing animals. Specifically, the Agency is clarifying the definition of ``S<INF>o</INF>'' and revising the definition of ``S<INF>m</INF>'' so that it conforms to the clarified definition of S<INF>o</INF>. Other clarifying and conforming changes are also being made.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran2010-Oct-262010-27011The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of eight new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Melengestrol2010-Sep-302010-24480The Food and Drug Administration (FDA) is amending the animal drug regulations to more accurately reflect the recent approval of two supplemental new animal drug applications (NADAs) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADAs provided for increased levels of monensin in two-way Type C medicated feeds containing melengestrol acetate and monensin, and in three-way Type C medicated feeds containing melengestrol acetate, monensin, and tylosin phosphate for heifers fed in confinement for slaughter. These amendments are being made to improve the accuracy of the regulations.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Chloramphenicol; Lincomycin; Pyrantel Tartrate; and Tylosin Phosphate and Sulfamethazine2010-Sep-142010-22808The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of four new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.
Health and Human Services Department -- Food Additives Permitted in Feed and Drinking Water of Animals; Ammonium Formate2010-Jul-192010-17565The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of ammonium formate as an acidifying agent in swine feed. This action is in response to a food additive petition filed by Kemira Oyj of Finland.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Florfenicol2010-Jun-172010-14611The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Intervet, Inc. The supplemental NADA provides for the manufacture of florfenicol Type B medicated swine feeds.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Application; Buquinolate; Coumaphos2010-May-052010-10564The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of two new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.
Health and Human Services Department -- New Animal Drugs; Removal of Obsolete and Redundant Regulations2010-Mar-312010-7108The Food and Drug Administration (FDA) is removing portions of a regulation that required sponsors to submit data regarding the subtherapeutic use of certain antibiotic, nitrofuran, and sulfonamide drugs administered in animal feed as these regulations have been determined to be obsolete or redundant. The portions of the regulation being removed are provisions listing certain feed use combinations for oxytetracycline and neomycin in the tables contained in that regulation. This rule does not finalize the provisions of the proposed rule regarding removing the remainder of the regulation.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Zilpaterol2010-Mar-112010-5224The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of three abbreviated new animal drug applications (ANADAs) filed by Ivy Laboratories, Div. of Ivy Animal Health, Inc. The ANADAs provides for use of single-ingredient Type A medicated articles containing zilpaterol, melengestrol, monensin, and tylosin to make two-way, three-way, and four-way combination drug Type B and Type C medicated feeds for heifers fed in confinement for slaughter.
Health and Human Services Department -- Reporting Information Regarding Falsification of Data2010-Feb-192010-3123The Food and Drug Administration (FDA) is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects or animal subjects conducted by or on behalf of a sponsor or relied on by a sponsor. A sponsor would be required to report this information to the appropriate FDA center promptly, but no later than 45 calendar days after the sponsor becomes aware of the information. This proposal is necessary because ambiguity in the current reporting scheme has caused confusion among sponsors. The proposed rule is intended to help ensure the validity of data that the agency receives in support of applications and petitions for FDA product approvals and authorization of certain labeling claims and to protect research subjects.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Ractopamine; Monensin2010-Feb-052010-2427The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The NADA provides for use of single-ingredient Type A medicated articles containing ractopamine hydrochloride and monensin to formulate two-way combination Type C medicated feeds for finishing hen and tom turkeys.
Health and Human Services Department -- New Animal Drugs; Ractopamine2010-Jan-112010-208The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA provides for administering ractopamine hydrochloride Type C medicated feeds as a top dress to cattle fed in confinement for slaughter.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin; Tylosin2009-Nov-239-28019The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for use of the same dose levels approved for single-ingredient Type C medicated feeds containing melengestrol acetate, monensin, or tylosin phosphate for heifers fed in confinement for slaughter in three-way, combination drug Type C medicated feeds containing melengestrol acetate, monensin, and tylosin phosphate.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Change of Sponsor2009-Nov-239-28009The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 10 new animal drug applications (NADAs) from Merial Ltd. to Huvepharma AD.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin2009-Nov-199-27744The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for use of the same increased dose levels approved for single-ingredient Type C medicated feeds for heifers fed in confinement for slaughter containing melengestrol acetate or monensin in two-way, combination drug Type C medicated feeds containing melengestrol acetate and monensin.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Monensin; Tylosin2009-Oct-159-24716The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA revises limitations for liquid Type B medicated cattle feeds containing tylosin phosphate.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Oxytetracycline; Neomycin2009-Aug-139-19414The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pennfield Oil Co. The supplemental NADA provides for the use of fixed-combination Type A medicated articles containing oxytetracycline and neomycin sulfate to formulate two-way, fixed-combination drug Type B and Type C medicated feeds for chickens, turkeys, swine, cattle, and sheep. This approval reflects FDA's effectiveness conclusions which relied on the National Academy of Sciences/National Research Council (NAS/NRC) Drug Efficacy Study Group's evaluation of the effectiveness of these drugs when used in animal feed as single ingredients.
Agriculture Department -- Livestock Indemnity Program and General Provisions for Supplemental Agricultural Disaster Assistance Programs2009-Jul-029-15537This rule implements the general eligibility provisions for all the supplemental agricultural disaster assistance programs authorized by the Food, Conservation, and Energy Act of 2008 (2008 Farm Bill) and the specific requirements for the Livestock Indemnity Program (LIP). LIP provides disaster assistance for livestock losses. LIP applies only to livestock owners and contract growers that had losses due to livestock deaths in excess of normal mortality due to adverse weather during the calendar year, including losses due to hurricanes, floods, blizzards, disease, wildfires, extreme heat, and extreme cold. Eligible LIP losses must have occurred on or after January 1, 2008, and before October 1, 2011. This rule specifies how the LIP payments are calculated and when producers may apply for benefits. This rule also removes some outdated rules from the Code of Federal Regulations (CFR).
Health and Human Services Department -- Food Additives Permitted in Feed and Drinking Water of Animals; Methyl Esters of Conjugated Linoleic Acid (Cis-9, Trans-11 and Trans-10, Cis-12-Octadecadienoic Acids)2008-Oct-298-25719The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of methyl esters of conjugated linoleic acid (cis-9, trans-11 and trans-10, cis-12 octadecadienoic acids) as a source of fatty acids in swine diets. This action is in response to a food additive petition filed by BASF Corp. (BASF), 100 Campus Dr., Florham Park, NJ.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Fenbendazole2008-Oct-088-23845The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Intervet Inc. The supplemental NADA provides for use of a fenbendazole free choice, liquid Type C medicated feed in dairy and beef cattle for the removal and control of various internal parasites.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor's Drug Labeler Code2008-Jun-238-14149The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's drug labeler code for ADM Alliance Nutrition, Inc. This action is being taken to improve the accuracy of the regulations.
Health and Human Services Department -- New Animal Drugs For Use in Animal Feeds; Tylosin2008-Jun-178-13606The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA provides for revision of an effectiveness claim and pathogen nomenclature for a tylosin phosphate and sulfamethazine Type A medicated article used to manufacture medicated swine feeds.
Health and Human Services Department -- Substances Prohibited From Use in Animal Food or Feed2008-Apr-2508-1180The Food and Drug Administration (FDA) is amending the agency's regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals. These materials include the following: The entire carcass of bovine spongiform encephalopathy (BSE)-positive cattle; the brains and spinal cords from cattle 30 months of age and older; the entire carcass of cattle not inspected and passed for human consumption that are 30 months of age or older from which brains and spinal cords were not removed; tallow that is derived from BSE-positive cattle; tallow that is derived from other materials prohibited by this rule that contains more than 0.15 percent insoluble impurities; and mechanically separated beef that is derived from the materials prohibited by this rule. These measures will further strengthen existing safeguards against BSE.
Health and Human Services Department -- New Animal Drugs For Use in Animal Feed; Zilpaterol2008-Apr-108-7583The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet Inc. The NADA provides for use of approved, single-ingredient Type A medicated articles containing zilpaterol hydrochloride, monensin USP, and melengestrol acetate in three-way combination Type B and Type C medicated feeds for heifers fed in confinement for slaughter.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of NADAs; Technical Amendment2008-Apr-048-7103The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of seven new animal drug applications (NADAs) because FDA is withdrawing approval of the NADAs.
Health and Human Services Department -- New Animal Drugs For Use in Animal Feed; Zilpaterol2008-Mar-318-6601The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet Inc. The NADA provides for use of approved, single-ingredient Type A medicated articles containing zilpaterol hydrochloride and melengestrol acetate in two-way combination Type B and Type C medicated feeds for heifers fed in confinement for slaughter.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feed; Pyrantel; Technical Amendment2008-Mar-258-5928The Food and Drug Administration (FDA) is amending its animal drug regulations to correct an inadvertent omission in the list of concentrations of pyrantel tartrate Type A medicated articles approved for use by Phibro Animal Health. This action is being taken to improve the accuracy of the animal drug regulations.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feed; Zilpaterol2008-Mar-188-5450The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for use of approved, single-ingredient zilpaterol hydrochloride and monensin U.S.P. Type A medicated articles to make two-way combination Type B and Type C medicated feeds for cattle fed in confinement for slaughter.
Health and Human Services Department -- New Animal Drugs For Use in Animal Feed; Zilpaterol2008-Feb-018-1903The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for use of zilpaterol, monensin, and tylosin in three-way combination Type B and Type C medicated feeds for cattle fed in confinement for slaughter.
Agriculture Department -- Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Identification of Ruminants, and Processing and Importation of Commodities2008-Jan-188-883We are amending the regulations regarding the importation of animals and animal products to remove several restrictions regarding the identification of animals and the processing of ruminant materials from regions that present a minimal risk of introducing bovine spongiform encephalopathy into the United States. We are removing these restrictions because they are not necessary to prevent the introduction of bovine spongiform encephalopathy into the United States.
Health and Human Services Department -- Index of Legally Marketed Unapproved New Animal Drugs for Minor Species2007-Dec-067-23580The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) amended the Federal Food, Drug, and Cosmetic Act (the act) to authorize the U.S. Food and Drug Administration (FDA, the agency) to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. At this time, FDA is issuing final regulations to implement section 572 of the act entitled ``Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.'' These regulations establish administrative procedures and criteria for index listing a new animal drug for use in a minor species. Such indexing provides a basis for legally marketing an unapproved new animal drug intended for use in a minor species.
Health and Human Services Department -- New Animal Drugs For Use in Animal Feeds; Monensin USP2007-Dec-057-23517The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA removes the requirement for 30-day expiration on labeling of monensin Type C medicated feeds for several classes of cattle and goats.
Health and Human Services Department -- New Animal Drugs For Use in Animal Feeds; Monensin2007-Dec-057-23519The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA revises the concentration of monensin in two-way Type B and Type C medicated feeds containing monensin and tylosin to cattle fed in confinement for slaughter and a revision to bacterial pathogen nomenclature.
Health and Human Services Department -- New Animal Drugs For Use in Animal Feeds; Fenbendazole2007-Nov-277-22987The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Intervet Inc. The supplemental NADA provides for a revised food safety warning on labeling for fenbendazole Type A medicated article and Type B and Type C medicated horse feeds.
Health and Human Services Department -- New Animal Drugs; Ractopamine2007-Nov-067-21816The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for an increased level of monensin in three-way combination Type C medicated feeds containing ractopamine, monensin, and tylosin for cattle fed in confinement for slaughter and a revision to bacterial pathogen nomenclature.
Health and Human Services Department -- New Animal Drugs; Ractopamine2007-Oct-057-19732The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for an increased level of monensin in four-way combination Type C medicated feeds containing ractopamine, melengestrol, monensin, and tylosin for heifers fed in confinement for slaughter, a revision to bacterial pathogen nomenclature, and an increase in liver tolerance.
Agriculture Department -- Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived From Bovines2007-Sep-1807-4595We are amending the regulations regarding the importation of animals and animal products to establish conditions for the importation of the following commodities from regions that present a minimal risk of introducing bovine spongiform encephalopathy into the United States: Live bovines for any use born on or after a date determined by the Animal and Plant Health Inspection Service to be the date of effective enforcement of a ruminant-to-ruminant feed ban in the region of export; blood and blood products derived from bovines; and casings and part of the small intestine derived from bovines. We are making these amendments after conducting a risk assessment and comprehensive evaluation of the issues and concluding that such bovines and bovine products can be safely imported under the conditions described in this rule. This document also removes the delay in applicability of certain provisions of a final rule published in January 2005.
Health and Human Services Department -- Food Substances Affirmed as Generally Recognized as Safe in Feed and Drinking Water of Animals; Ethyl Alcohol Containing Ethyl Acetate2007-Jul-317-14700The Food and Drug Administration (FDA) is amending the animal drug regulations for food substances affirmed as generally recognized as safe (GRAS) in feed and drinking water of animals to correct a cross-reference. This action is being taken to improve the accuracy of the regulations.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Melengestrol and Lasalocid2007-Apr-047-6180The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Div. of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol and lasalocid to make two- way combination drug Type B or Type C medicated feeds for heifers fed in confinement for slaughter.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Melengestrol, Ractopamine, and Monensin2007-Mar-087-4100The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol, ractopamine, and monensin to make three-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter.
Health and Human Services Department -- New Animal Drugs For Use in Animal Feeds; Zilpaterol2007-Mar-017-3615The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Intervet Inc. The supplemental NADA provides for the removal of a caution statement against the formulation of pelleted feeds from labeling of zilpaterol hydrochloride Type A medicated article and Type B and Type C medicated feeds.
Health and Human Services Department -- New Animal Drugs For Use in Animal Feeds; Monensin2007-Mar-017-3621The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for minor revisions to labeling of monensin Type A medicated articles for chickens. FDA is also amending the regulations to simplify the organization of special labeling requirements for formulations (Type A medicated articles, Type B and Type C medicated feeds) containing monensin for poultry and game birds. This action is being taken to improve the clarity of the regulations.
Health and Human Services Department -- Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants2007-Jan-126-22329The Food and Drug Administration (FDA) is proposing to prohibit the use of certain cattle material in, or in the manufacture (including processing) of, drugs, biologics, and medical devices intended for use in humans and human cells, tissues, and cellular and tissue-based products (HCT/Ps) (collectively, medical products for humans), and in drugs intended for use in ruminant animals (drugs for ruminants). FDA is also proposing new recordkeeping requirements for medical products for humans and drugs for ruminants that are manufactured from or otherwise contain material from cattle. FDA is proposing these actions as part of its continuing efforts to strengthen defenses against the potential risk of exposure to, and spread of, bovine spongiform encephalopathy (BSE) and related human disease in the United States.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor2007-Jan-107-118The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 14 approved new animal drug applications (NADAs) from ADM Animal Health & Nutrition Division to ADM Alliance Nutrition, Inc.
Agriculture Department -- Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived From Bovines2007-Jan-0907-17We are proposing to amend the regulations regarding the importation of animals and animal products to establish conditions for the importation of the following commodities from regions that present a minimal risk of introducing bovine spongiform encephalopathy (BSE) into the United States: Live bovines for any use born on or after a date determined by APHIS to be the date of effective enforcement of a ruminant-to-ruminant feed ban in the region of export; blood and blood products derived from bovines; and casings and part of the small intestine derived from bovines. We are proposing these amendments after conducting a risk assessment and comprehensive evaluation of the issues that concluded that such bovines and bovine products can be safely imported under the conditions described in this proposed rule.
Health and Human Services Department -- New Animal Drugs For Use in Animal Feeds; Monensin2007-Jan-087-4The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA revises the concentration of monensin in Type C medicated feeds used for improved feed efficiency, and for the prevention and control of coccidiosis in cattle fed in confinement for slaughter.
Health and Human Services Department -- New Animal Drugs For Use in Animal Feeds; Florfenicol2006-Dec-046-20398The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The NADA provides for the use of a florfenicol Type A medicated article by veterinary feed directive to formulate swine feed used for the control of respiratory disease.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Bambermycins2006-Nov-076-18680The Food and Drug Administration (FDA) is amending the animal drug regulations to correct an inadvertent error in the conditions of use of bambermycins free-choice cattle feeds. This action is being taken to improve the accuracy of the animal drug regulations.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Lasalocid2006-Sep-2606-8261The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Purina Mills, Inc. The supplemental NADA provides for the use of a lasalocid Type A medicated article containing 20 percent lasalocid activity per pound to make free-choice Type C medicated feed mineral blocks used for increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers).
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Chlortetracycline2006-Sep-136-15103The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Alpharma Inc. The supplemental NADA provides for use of an approved Type A medicated article containing chlortetracycline to formulate a free-choice loose mineral Type C medicated feed for beef and nonlactating dairy cattle.
Health and Human Services Department -- New Animal Drugs For Use in Animal Feeds; Amprolium2006-Sep-066-14673The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Merial Ltd. The supplemental NADA provides for formulation of Type C medicated calf feeds containing amprolium used for the prevention and treatment of coccidiosis at a broader range of concentrations.
Agriculture Department -- Bovine Spongiform Encephalopathy; Minimal-Risk Regions, Identification of Ruminants and Processing and Importation of Commodities2006-Aug-096-12944In a final rule published in the Federal Register on January 4, 2005, we amended the regulations regarding the importation of animals and animal products to establish a category of regions that present a minimal risk of introducing bovine spongiform encephalopathy (BSE) into the United States via live ruminants and ruminant products and byproducts, and we added Canada to this category. We also established conditions for the importation of certain live ruminants and ruminant products and byproducts from such regions. In this document, we are proposing to remove several restrictions regarding the identification of animals and the processing of ruminant materials from BSE minimal-risk regions, as well as BSE-based restrictions on gelatin derived from bovine hides. We do not believe these restrictions are necessary to prevent the introduction of BSE into the United States.
Agriculture Department -- Importation of Swine Hides and Skins, Bird Trophies, and Ruminant Hides and Skins2006-Aug-046-12639We are proposing to amend the regulations governing the importation of animal byproducts to require that untanned swine hides and skins from regions with African swine fever and bird trophies from regions with exotic Newcastle disease go directly to an approved establishment upon importation into the United States. We would also set out certain requirements for the importation of untanned bovine, deer, and other ruminant hides and skins into the United States from Mexico to prevent the spread of bovine babesiosis. These proposed requirements would provide for the importation of these articles under conditions intended to prevent the introduction of African swine fever, bovine babesiosis, and exotic Newcastle disease.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Lasalocid; Correction2006-Jun-156-9321The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) that appeared in the Federal Register of April 27, 2006 (71 FR 24814). FDA is correcting a paragraph designation in the table for lasalocid cattle feeds which was drafted in error. This correction is being made to improve the accuracy of the animal drug regulations.
Agriculture Department -- Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities; Technical Amendments2006-Mar-1406-2406In a final rule published in the Federal Register on January 4, 2005, we amended the regulations regarding the importation of animals and animal products to establish a category of regions that present a minimal risk of introducing bovine spongiform encephalopathy into the United States via live ruminants and ruminant products and byproducts, and added Canada to this category. We also established conditions for the importation of certain live ruminants and ruminant products and byproducts from such regions. In this document, we are clarifying our intent with regard to certain provisions in the final rule and are correcting several inconsistencies within the rule. These technical amendments will clarify the regulations.
Agriculture Department -- Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities; Unsealing of Means of Conveyance and Transloading of Products2005-Nov-2805-23334In a final rule published in the Federal Register on January 4, 2005, we amended the regulations regarding the importation of animals and animal products to establish a category of regions that present a minimal risk of introducing bovine spongiform encephalopathy into the United States via live ruminants and ruminant products and byproducts, and added Canada to this category. We also established conditions for the importation of certain live ruminants and ruminant products and byproducts from such regions. In this document, we are amending the regulations to broaden who is authorized to break seals on means of conveyances carrying certain ruminants of Canadian origin. Additionally, we are amending the regulations regarding the transiting through the United States of certain ruminant products from Canada to allow for direct transloading of the products from one means of conveyance to another in the United States under Federal supervision. These actions will contribute to the humane treatment of ruminants shipped to the United States from Canada and remove an impediment to international trade, without increasing the risk of the BSE disease agent entering the United States.
Agriculture Department -- Highly Pathogenic Avian Influenza; Additional Restrictions2005-Jul-2005-14262We are adopting as a final rule, without change, an interim rule that amended the regulations concerning the importation of animals and animal products to prohibit or restrict the importation of birds, poultry, and unprocessed birds and poultry products from regions that have reported the presence of the H5N1 subtype of highly pathogenic avian influenza and to establish additional permit and quarantine requirements for U.S. origin pet birds and performing or theatrical birds and poultry returning to the United States. The interim rule was necessary to prevent the introduction of highly pathogenic avian influenza subtype H5N1 into the United States.
Agriculture Department -- Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities; Partial Delay of Applicability2005-Mar-1105-4917The amendments in this final rule delay until further notice the applicability of certain provisions of the rule entitled ``Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities,'' published in the Federal Register on January 4, 2005, 70 FR 460-553. That rule was scheduled to amend the regulations in 9 CFR parts 93, 94, 95, and 96, effective March 7, 2005, to establish a category of regions that present a minimal risk of introducing bovine spongiform encephalopathy into the United States via live ruminants and ruminant products and byproducts and to add Canada to this category. That rule included conditions for the importation of certain live ruminants and ruminant products from such regions.
Agriculture Department -- Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities2005-Jan-0404-28593We are amending the regulations regarding the importation of animals and animal products to establish a category of regions that present a minimal risk of introducing bovine spongiform encephalopathy (BSE) into the United States via live ruminants and ruminant products and byproducts, and we are adding Canada to this category. We are also establishing conditions for the importation of certain live ruminants and ruminant products and byproducts from such regions. These actions will continue to protect against the introduction of BSE into the United States while removing unnecessary prohibitions on the importation of certain commodities from minimal-risk regions for BSE, currently only Canada.
Agriculture Department -- Highly Pathogenic Avian Influenza; Additional Restrictions2004-May-1004-10524We are amending the regulations concerning the importation of animals and animal products to prohibit or restrict the importation of birds, poultry, and unprocessed bird and poultry products from regions that have reported the presence of the H5N1 subtype of highly pathogenic avian influenza and to establish additional permit and quarantine requirements for U.S. origin pet birds and performing or theatrical birds and poultry returning to the United States. This action is necessary to prevent the introduction of highly pathogenic avian influenza subtype H5N1 into the United States.
Agriculture Department -- Bovine Spongiform Encephalopathy; Minimal Risk Regions and Importation of Commodities2003-Nov-0403-27611We are proposing to amend the regulations regarding the importation of animals and animal products to recognize a category of regions that present a minimal risk of introducing bovine spongiform encephalopathy (BSE) into the United States via live ruminants and ruminant products, and are proposing to add Canada to this category. We are also proposing to allow the importation of certain live ruminants and ruminant products and byproducts from such regions under certain conditions. We believe this action is warranted because it would continue to protect against the introduction of BSE into the United States while removing unnecessary prohibitions on certain commodities from Canada and other regions that qualify as BSE minimal-risk regions.
Agriculture Department -- Removal of Obsolete Regulations2003-Oct-2803-27086This action removes regulations rendered obsolete by expiration of their statutory authority and the ending of their respective programs. There are no impacts on past or current program operations.
Agriculture Department -- 2003 Agricultural Assistance Act-Crop Disaster Program and Livestock Assistance Program2003-Jun-2603-16161This rule implements portions of the Agricultural Assistance Act of 2003 to provide crop-loss disaster assistance for producers who suffered 2001 or 2002 crop losses and to establish a Livestock Assistance Program. This rule also implements provisions of the Consolidated Appropriations Resolution, 2003 (2003 Appropriations Act) that add the commodities crambe and sesame seed to the list of commodities eligible for CCC direct and counter-cyclical payments and marketing assistance loans and that provide that popcorn planted acreage is to be considered corn for determining corn crop acreage bases and yields. Other provisions of these Acts will be implemented under separate rules.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Tiamulin2002-Feb-1902-3831The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The supplemental NADA provides for use of approved tiamulin Type A medicated articles to make Type B and Type C medicated feeds used for the control of porcine proliferative enteropathies (ileitis) in swine.
Agriculture Department -- Livestock Indemnity Program2002-Feb-1902-3933This final rule implements provisions of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2001 related to the Livestock Indemnity Program- 2000 (LIP-2000). This final rule announces the program's availability and requirements. The Commodity Credit Corporation (CCC) published a proposed rule on March 7, 2001, (66 FR 13679) seeking public comment. No comments were received and the proposed rule is adopted as final with a minor change to reflect a statutory reduction in program funding.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Diclazuril2001-Dec-0401-29983The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The NADA provides for use of the approved diclazuril Type A medicated article to make Type B and Type C medicated feeds used for prevention of coccidiosis in growing turkeys. Also, tolerances for diclazuril residues in turkey liver, muscle, and skin with adherent fat are being established.
Agriculture Department -- Importation Prohibitions Because of Bovine Spongiform Encephalopathy2001-Aug-1401-20399We are amending the regulations to prohibit, with limited exceptions, the importation of certain animal materials and their derivatives, and any products they are used in, from regions considered to present an unacceptable risk of introducing bovine spongiform encephalopathy into the United States. Additionally, we are requiring that those materials, when imported from regions not considered at risk for bovine spongiform encephalopathy, be accompanied by government certification regarding the species, region of origin, processing, and handling of the materials and the animals from which they were derived. These actions are necessary to ensure that materials containing the bovine spongiform encephalopathy agent are not imported into the United States.
Agriculture Department -- Dairy Price Support, Dairy Recourse Loan, Livestock Assistance, American Indian Livestock Feed, and Pasture Recovery Programs2001-Mar-1901-6626This rule implements provisions of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2001 (the 2001 Act) related to the Dairy Price Support, Dairy Recourse Loan, Livestock Assistance (LAP), American Indian Livestock Feed (AILFP), and Pasture Recovery (PRP) Programs. Dairy price support is extended through calendar year 2001 and dairy recourse loans are postponed until January, 2002. The LAP and PRP are being extended to cover disaster-related losses that occurred in calendar year 2000 and the AILFP was given additional funding. Other provisions of the 2001 Act will be implemented under separate rules.
Agriculture Department -- Livestock Indemnity Program2001-Mar-0701-5493This proposed rule implements provisions of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2001 related to the Livestock Indemnity Program- 2000 (LIP-2000). This proposed rule announces the program's availability and requirements and seeks comments on the program.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Monensin and Tylosin2001-Mar-0501-5219The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for use of monensin and tylosin single-ingredient Type A medicated articles to make combination drug Type C medicated feeds used for improved feed efficiency, prevention and control of coccidiosis, and reduction of the incidence of liver abscesses in cattle fed in confinement for slaughter.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Monensin, Bacitracin Methylene Disalicylate, and Roxarsone2001-Mar-0501-5220The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Alpharma, Inc. The NADA provides for use of approved, single-ingredient monensin and bacitracin methylene disalicylate Type A medicated articles to make two-way combination drug Type C medicated feeds for broiler and replacement chickens. These combination medicated feeds are used as an aid in the prevention of coccidiosis, as an aid in the prevention and control of necrotic enteritis, and for increased rate of weight gain and improved feed efficiency.
Health and Human Services Department -- Premarket Notice Concerning Bioengineered Foods2001-Jan-1801-1046The Food and Drug Administration (FDA) is proposing to require the submission to the agency of data and information regarding plant- derived bioengineered foods that would be consumed by humans or animals. FDA is proposing that this submission be made at least 120 days prior to the commercial distribution of such foods. FDA is taking this action to ensure that it has the appropriate amount of information about bioengineered foods to help to ensure that all market entry decisions by the industry are made consistently and in full compliance with the law. The proposed action will permit the agency to assess on an ongoing basis whether plant-derived bioengineered foods comply with the standards of the Federal Food, Drug, and Cosmetic Act (the act).
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Decoquinate, Monensin, and Tylosin2001-Jan-1001-628The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Alpharma, Inc. The NADA provides for use of approved, single-ingredient decoquinate, monensin, and tylosin Type A medicated articles to make three-way combination drug Type B and Type C medicated feeds used for prevention of coccidiosis, improved feed efficiency, and reduction of incidence of liver abscesses in growing-finishing cattle fed in confinement for slaughter.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Decoquinate and Monensin2000-Dec-2900-33217The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Alpharma, Inc. The NADA provides for use of approved, single-ingredient decoquinate and monensin Type A medicated articles to make two-way combination drug Type B and Type C medicated feeds used for prevention of coccidiosis and improved feed efficiency in cattle fed in confinement for slaughter.
Agriculture Department -- Livestock Indemnity Program for Contract Growers2000-Dec-2900-33382This rule implements provisions of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2001 (the 2001 Act) related to the Livestock Indemnity Program for Contract Growers (LIP-CG). That statute amended the time period during which eligible losses could have occurred and the Commodity Credit Corporation (CCC) is publishing this rule to extend the availability of benefits under LIP-CG to include benefits for livestock losses incurred during the period January 1, 2000 through February 7, 2000. Other provisions of the Act will be implemented under separate rules.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Salinomycin and Bacitracin Methylene Disalicylate2000-Nov-2800-30327The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Alpharma, Inc. The NADA provides for use of approved, single-ingredient salinomycin and bacitracin methylene disalicylate Type A medicated articles to make two-way combination drug Type C medicated feeds for broiler, roaster, and replacement (breeder and layer) chickens. The Type C medicated feeds are used for prevention of coccidiosis and as an aid in the prevention and control of necrotic enteritis in broiler, roaster, and replacement (breeder and layer) chickens; and for prevention of coccidiosis, increased rate of weight gain, and improved feed efficiency in roaster and replacement (breeder and layer) chickens. Previously established acceptable daily intakes (ADI's) for total residues of bacitracin and salinomycin are also being codified.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Pyrantel Tartrate2000-Nov-0700-28523The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Farnam Companies, Inc. The ANADA provides for use of pyrantel tartrate in horse feed for the prevention and control of various species of internal parasites.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Decoquinate and Chlortetracycline2000-Nov-0700-28524The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Alpharma, Inc. The NADA provides for use of approved decoquinate and chlortetracycline (CTC) Type A medicated articles to make two-way combination Type B and Type C medicated feeds for calves, beef and nonlactating dairy cattle used for prevention of coccidiosis, treatment of bacterial enteritis, and treatment of bacterial pneumonia.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Narasin and Tylosin Phosphate2000-Nov-0100-27967The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Elanco Animal Health. The NADA provides for use of approved, single-ingredient narasin and tylosin phosphate Type A medicated articles to make two-way combination Type C medicated feeds used as an aid in the prevention of coccidiosis, for increased rate of weight gain, and improved feed efficiency in broiler chickens.
Health and Human Services Department -- Administrative Practices and Procedures; Good Guidance Practices2000-Sep-1900-23887The Food and Drug Administration (FDA) is amending its administrative regulations to codify its policies and procedures for the development, issuance, and use of guidance documents. This action is necessary to comply with requirements of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The Modernization Act codified certain parts of the agency's current ``Good Guidance Practices'' (GGP's) and directed the agency to issue a regulation consistent with the act that specifies FDA's policies and procedures for the development, issuance, and use of guidance documents. The intended effect of this regulation is to make the agency's procedures for development, issuance, and use of guidance documents clear to the public.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Narasin and Bacitracin Zinc2000-Sep-1500-23799The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Roche Vitamins, Inc. The NADA provides for use of approved narasin and bacitracin zinc Type A medicated articles to make two-way combination Type C medicated feeds used for prevention of coccidiosis, increased rate of weight gain, and improved feed efficiency in broiler chickens.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Monensin and Roxarsone2000-Sep-0800-23053The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Alpharma, Inc. The NADA provides for use of approved single-ingredient monensin and roxarsone Type A medicated articles to make two-way combination drug Type C medicated feed used as an aid in the prevention of coccidiosis and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in replacement chickens.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Bacitracin Methylene Disalicylate2000-Sep-0800-23054The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Alpharma, Inc. The NADA provides for use of approved, single-ingredient chlortetracycline (CTC) and bacitracin methylene disalicylate Type A medicated articles to make two-way combination Type C medicated feeds used for control of porcine proliferative enteropathies (ileitis) and for increased rate of weight gain and improved feed efficiency in swine.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Technical Amendment2000-Sep-0700-22949The Food and Drug Administration (FDA) is updating the animal drug regulations to add Triple ``F'', Inc., to the list of sponsors of approved animal drug applications, and to add the drug labeler code (DLC) number for ADM Animal Health & Nutrition Division (ADM) to the list of approvals for bambermycins. These corrections amend the animal drug regulations to reflect currently approved new animal drug applications (NADA's).
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Monensin, Bacitracin Methylene Disalicylate, and Roxarsone2000-Sep-0500-22620The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Alpharma, Inc. The NADA provides for use of approved, single-ingredient monensin, bacitracin methylene disalicylate (BMD), and roxarsone Type A medicated articles to make three-way combination drug Type C medicated feed used as an aid in the prevention of coccidiosis, as an aid in the prevention and control of necrotic enteritis, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in replacement chickens.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Monensin and Bambermycins2000-Sep-0500-22570The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Elanco Animal Health. The NADA provides for use of approved, single ingredient monensin and bambermycins Type A medicated articles to make two-way combination Type C medicated feeds used for prevention of coccidiosis, increased rate of weight gain, and improved feed efficiency in growing turkeys.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Monensin and Tylosin Phosphate2000-Sep-0500-22572The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Elanco Animal Health. The NADA provides for use of approved, single-ingredient monensin and tylosin phosphate Type A medicated articles to make two-way combination Type C medicated feeds used as an aid in the prevention of coccidiosis, for increased rate of weight gain, and improved feed efficiency in broiler chickens. Technical corrections are also being made.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene Disalicylate, Robenidine Hydrochloride, and Roxarsone2000-Aug-2200-21412The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Alpharma, Inc. The NADA provides for use of approved bacitracin methylene disalicylate (BMD), robenidine hydrochloride, and roxarsone Type A medicated articles to make three-way combination Type C medicated broiler chicken feeds used for prevention of coccidiosis; as an aid in the prevention and control of necrotic enteritis; and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Diclazuril, Bacitracin Methylene Disalicylate, Bambermycins, and Virginiamycin2000-Aug-1700-20936The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of three new animal drug applications (NADA's) filed by Schering-Plough Animal Health Corp. The NADA's provide for use of the approved, single-ingredient diclazuril Type A medicated article together with approved, single-ingredient Type A medicated articles for either bacitracin methylene disalicylate (BMD), virginiamycin, or bambermycins to make two-way combination Type C medicated feeds used for prevention of coccidiosis, increased rate of weight gain, and improved feed efficiency in broiler chickens.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Chlortetracycline2000-Jul-2600-18823The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Alpharma, Inc. The supplemental NADA provides for use of approved chlortetracycline (CTC) Type A medicated articles to make Type C medicated feeds used for control of porcine proliferative enteropathies (ileitis) in swine.
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