Title 21 published on 2015-04-01 .
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
2015-12-09; vol. 80 # 236 - Wednesday, December 9, 2015 80 FR 76384 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of 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 amendments. This rule is effective December 9, 2015, except for the amendments to 21 CFR 520.446, 520.2043, 558.625, and 558.630, which are effective December 21, 2015. 21 CFR Parts 510, 520, 522, 524, 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 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.
2015-11-24; vol. 80 # 226 - Tuesday, November 24, 2015 80 FR 73104 - New Animal Drugs in Genetically Engineered Animals; opAFP-GHc2 Recombinant Deoxyribonucleic Acid Construct
GPO FDSys: XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective November 24, 2015. 21 CFR Parts 510 and 528 Summary The Food and Drug Administration (FDA, the Agency) is amending the animal drug regulations to reflect the approval of a new animal drug application (NADA) filed by AquaBounty Technologies, Inc. The NADA provides for use of a recombinant deoxyribonucleic acid (rDNA) gene construct in a lineage of genetically engineered Atlantic salmon.
2015-10-13; vol. 80 # 197 - Tuesday, October 13, 2015 80 FR 61293 - 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 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 October 13, 2015, except for the amendment to 21 CFR 558.460, which is effective October 23, 2015. 21 CFR Parts 510, 520, 522, 524, 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 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.
2015-06-16; vol. 80 # 115 - Tuesday, June 16, 2015 80 FR 34276 - New Animal Drugs; Approval of New Animal Drug Applications; 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 June 16, 2015. 21 CFR Parts 510, 520, 522, 526, and 528 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 March and April 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 nonsubstantive changes. These technical amendments are being made to improve the accuracy of the regulations.
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.
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 2015-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 510 after this date.
2015-12-09; vol. 80 # 236 - Wednesday, December 9, 2015 80 FR 76384 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of 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 amendments. This rule is effective December 9, 2015, except for the amendments to 21 CFR 520.446, 520.2043, 558.625, and 558.630, which are effective December 21, 2015. 21 CFR Parts 510, 520, 522, 524, 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 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.
2015-11-24; vol. 80 # 226 - Tuesday, November 24, 2015 80 FR 73104 - New Animal Drugs in Genetically Engineered Animals; opAFP-GHc2 Recombinant Deoxyribonucleic Acid Construct
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective November 24, 2015. 21 CFR Parts 510 and 528 Summary The Food and Drug Administration (FDA, the Agency) is amending the animal drug regulations to reflect the approval of a new animal drug application (NADA) filed by AquaBounty Technologies, Inc. The NADA provides for use of a recombinant deoxyribonucleic acid (rDNA) gene construct in a lineage of genetically engineered Atlantic salmon.
2015-10-13; vol. 80 # 197 - Tuesday, October 13, 2015 80 FR 61293 - 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 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 October 13, 2015, except for the amendment to 21 CFR 558.460, which is effective October 23, 2015. 21 CFR Parts 510, 520, 522, 524, 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 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.
2015-06-16; vol. 80 # 115 - Tuesday, June 16, 2015 80 FR 34276 - New Animal Drugs; Approval of New Animal Drug Applications; 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 June 16, 2015. 21 CFR Parts 510, 520, 522, 526, and 528 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 March and April 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 nonsubstantive changes. These technical amendments are being made to improve the accuracy of the regulations.
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.
