This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office] .
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
United States Code U.S. Code: Title 21 - FOOD AND DRUGS
Title 21 published on 20-Sep-2017 03:51
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 529 after this date.
2017-03-01; vol. 82 # 39 - Wednesday, March 1, 2017 82 FR 12167 - 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 Name
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective March 1, 2017, except for amendments 2.a and 2.c to 21 CFR 510.600, and the amendments to 21 CFR 522.313c and 529.1186, which are effective March 13, 2017. 21 CFR Parts 510, 516, 520, 522, 529, and 558 Summary The 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.
82 FR 12170 - New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of withdrawal. Withdrawal of approval is effective March 13, 2017. 21 CFR Parts 510, 522, and 529 Summary The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and an abbreviated new animal drug application (ANADA) at the sponsors' requests because the products are no longer manufactured or marketed.
2016-12-27; vol. 81 # 248 - Tuesday, December 27, 2016 81 FR 94987 - Oral Dosage Form New Animal Drugs; Approval of New Animal Drug Applications
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective December 31, 2016. 21 CFR Parts 520 and 529 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 43 supplemental new animal drug applications (NADAs) and 52 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) to prescription (Rx) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated drinking water. These applications were submitted in voluntary compliance with the goals of the FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative.
2016-09-30; vol. 81 # 190 - Friday, September 30, 2016 81 FR 67149 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective September 30, 2016. 21 CFR Parts 510, 520, 522, 524, 529, and 558 Summary The 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.
2016-04-18; vol. 81 # 74 - Monday, April 18, 2016 81 FR 22520 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective April 18, 2016. 21 CFR Parts 520, 522, 524, 529, 556, and 558 Summary The 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.
2016-04-01; vol. 81 # 63 - Friday, April 1, 2016 81 FR - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 528, 529, 556, and 558 Summary
2016-03-30; vol. 81 # 61 - Wednesday, March 30, 2016 81 FR 17604 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective March 30, 2016. 21 CFR Parts 510, 520, 522, 524, 528, 529, 556, and 558 Summary The 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.
2015-04-08; vol. 80 # 67 - Wednesday, April 8, 2015 80 FR 18773 - 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 Address
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective April 8, 2015, except for the amendment to 21 CFR 522.1004, which is effective April 20, 2015. 21 CFR Parts 510, 520, 522, 524, 529, and 558 Summary The 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.
2014-07-31; vol. 79 # 147 - Thursday, July 31, 2014 79 FR 44277 - New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective July 31, 2014. 21 CFR Parts 520, 522, 529, and 558 Summary The 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.
2014-07-02; vol. 79 # 127 - Wednesday, July 2, 2014 79 FR 37617 - New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor's Address
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective July 2, 2014. 21 CFR Parts 510, 520, 522, 529, 556, and 558 Summary The 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.
2014-02-27; vol. 79 # 39 - Thursday, February 27, 2014 79 FR 10963 - New Animal Drugs; Bambermycins; Clopidol; Ivermectin; Penicillin G Procaine and Dihydrostreptomycin Sulfate; Progesterone; Robenicoxib; Sulfadimethoxine; Change of Sponsor; Change of Sponsor's Address
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective February 27, 2014. 21 CFR Parts 510, 520, 522, 526, 529, and 558 Summary The 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.
79 FR 10965 - New Animal Drugs; Change of Sponsor
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective February 27, 2014. 21 CFR Parts 524, 526, and 529 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 54 approved new animal drug applications (NADAs) and 1 approved abbreviated new animal drug application (ANADA) for topical, intramammary, and certain other dosage form new animal drug products from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc.
2014-01-16; vol. 79 # 11 - Thursday, January 16, 2014 79 FR 2785 - Withdrawal of Approval of New Animal Drug Applications; Argent Laboratories; Formalin; Tricaine Methanesulfonate
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This final rule is effective January 27, 2014. 21 CFR Parts 510 and 529 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of two new animal drug applications (NADAs) held by Argent Laboratories. Withdrawal of approval of these NADAs was at the sponsor's request because the products are no longer manufactured or marketed.
79 FR 2785 - Withdrawal of Approval of New Animal Drug Applications; Argent Laboratories; Formalin; Tricaine Methanesulfonate
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of withdrawal. Withdrawal of approval is effective January 27, 2014. 21 CFR Parts 510 and 529 Summary The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) held by Argent Laboratories. Withdrawal of approval of these NADAs was at the sponsor's request because the products are no longer manufactured or marketed.
2013-12-09; vol. 78 # 236 - Monday, December 9, 2013 78 FR 73697 - New Animal Drugs; Hyaluronate Sodium; Hydrogen Peroxide; Imidacloprid and Moxidectin; Change of Sponsor
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective December 9, 2013. 21 CFR Parts 510, 522, 524, and 529 Summary The 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 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 ANADA.
2013-04-09; vol. 78 # 68 - Tuesday, April 9, 2013 78 FR 21058 - New Animal Drugs; Change of Sponsor
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective April 9, 2013. 21 CFR Parts 510, 520, 522, 524, 526, 529, and 558 Summary The 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.
2013-03-25; vol. 78 # 57 - Monday, March 25, 2013 78 FR 17866 - New Animal Drug Approvals; Change of Sponsor; Change of Sponsor's Drug Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel; Propofol; Sevoflurane; Triamcinolone Acetonide
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective March 25, 2013. 21 CFR Parts 510, 522, 524, and 529 Summary The 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 2013. 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 changes of sponsorship for an NADA and ANADA, and a change of a sponsor's drug labeler code.
2013-03-22; vol. 78 # 56 - Friday, March 22, 2013 78 FR 17595 - New Animal Drugs; Changes of Sponsor
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective March 22, 2013. 21 CFR Parts 510, 520, 522, 524, 529, and 558 Summary The 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.
2013-03-07; vol. 78 # 45 - Thursday, March 7, 2013 78 FR 14667 - New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Fumagillin; N -Butyl Chloride; Competitive Exclusion Culture; Dichlorophene and Toluene; Flurogestone Acetate; Isoflurane; Pyrantel; Tylosin; Tylosin and Sulfamethazine
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule, technical amendment. This rule is effective March 18, 2013. 21 CFR Parts 510, 520, 522, 529, and 558 Summary The 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.
2012-12-31; vol. 77 # 250 - Monday, December 31, 2012 77 FR 76862 - New Animal Drugs; Enrofloxacin; Melengestrol; Meloxicam; Pradofloxacin; Tylosin
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective December 31, 2012. 21 CFR Parts 520, 522, 529, and 558 Summary The 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 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
2012-12-05; vol. 77 # 234 - Wednesday, December 5, 2012 77 FR 72254 - New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments by March 5, 2013. See section VI of this document for the proposed effective date of a final rule based on this proposed rule. 21 CFR Parts 500, 520, 522, 524, 529, 556, and 558 Summary The 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.
2012-10-23; vol. 77 # 205 - Tuesday, October 23, 2012 77 FR 64715 - New Animal Drugs; Approvals; Changes of Sponsor; Change of Sponsor's Name; Change of Sponsor's Address; Alfaxalone; Ivermectin and Clorsulon; Narasin; Triptorelin
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 23, 2012. 21 CFR Parts 510, 522, 524, 529, and 558 Summary The 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.
2012-02-01; vol. 77 # 21 - Wednesday, February 1, 2012 77 FR 4895 - New Animal Drugs; Chloramphenicol, Diethylcarbamazine Citrate, Hygromycin B, Methoxyflurane, Neomycin Sulfate, Penicillin G, Phenylbutazone, Pyrantel Tartrate, Tylosin Phosphate, and Sulfamethazine
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. Withdrawal of approval is effective February 13, 2012. 21 CFR Parts 510, 520, 522, 524, 529, and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of 20 new animal drug applications (NADAs).
