Title 21 published on 2014-04-01
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.
2014-12-15; vol. 79 # 240 - Monday, December 15, 2014 79 FR 74018 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of 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 15, 2014, except for the amendment to 21 CFR 520.1660d, which is effective December 26, 2014. 21 CFR Parts 510, 520, 522, 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 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.
2014-10-28; vol. 79 # 208 - Tuesday, October 28, 2014 79 FR 64114 - New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor
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 28, 2014. 21 CFR Parts 510, 520, 522, 524, and 556 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 August 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 two NADAs and one ANADA, and to reflect a revised food safety warning.
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.
2014-05-20; vol. 79 # 97 - Tuesday, May 20, 2014 79 FR 28813 - Oral Dosage Form 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 May 20, 2014. 21 CFR Parts 510 and 520 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 172 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) for oral dosage form new animal drug products from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc. FDA is also amending the animal drug regulations to remove entries describing conditions of use for new animal drug products for which no NADA is approved, to make minor corrections, and to reflect a current format. This is being done to increase the accuracy and readability of the regulations.
2014-04-10; vol. 79 # 69 - Thursday, April 10, 2014 79 FR 19814 - Withdrawal of Approval of New Animal Drug Applications; Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and Sulfamethazine; Virginiamycin
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of withdrawal. Withdrawal of approval is effective April 21, 2014. 21 CFR Parts 510 and 558 Summary The Food and Drug Administration (FDA) is withdrawing 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.
79 FR 19814 - 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; Virginiamycin
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This final rule is effective April 21, 2014. 21 CFR Parts 510 and 558 Summary The 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.
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 2014-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 510 after this date.
2014-12-15; vol. 79 # 240 - Monday, December 15, 2014 79 FR 74018 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of 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 15, 2014, except for the amendment to 21 CFR 520.1660d, which is effective December 26, 2014. 21 CFR Parts 510, 520, 522, 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 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.
2014-10-28; vol. 79 # 208 - Tuesday, October 28, 2014 79 FR 64114 - New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor
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 28, 2014. 21 CFR Parts 510, 520, 522, 524, and 556 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 August 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 two NADAs and one ANADA, and to reflect a revised food safety warning.
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.
2014-05-20; vol. 79 # 97 - Tuesday, May 20, 2014 79 FR 28813 - Oral Dosage Form 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 May 20, 2014. 21 CFR Parts 510 and 520 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 172 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) for oral dosage form new animal drug products from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc. FDA is also amending the animal drug regulations to remove entries describing conditions of use for new animal drug products for which no NADA is approved, to make minor corrections, and to reflect a current format. This is being done to increase the accuracy and readability of the regulations.
2014-04-10; vol. 79 # 69 - Thursday, April 10, 2014 79 FR 19814 - Withdrawal of Approval of New Animal Drug Applications; Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and Sulfamethazine; Virginiamycin
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of withdrawal. Withdrawal of approval is effective April 21, 2014. 21 CFR Parts 510 and 558 Summary The Food and Drug Administration (FDA) is withdrawing 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.
79 FR 19814 - 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; Virginiamycin
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This final rule is effective April 21, 2014. 21 CFR Parts 510 and 558 Summary The 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.
