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] .
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United States Code U.S. Code: Title 21 - FOOD AND DRUGS
Title 21 published on 09-Jun-2018 03:51
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 556 after this date.
2018-03-30; vol. 83 # 62 - Friday, March 30, 2018 83 FR 13632 - 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 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 March 30, 2018, except for amendatory instructions 3 to 21 CFR 510.600, 9 to 21 CFR 522.300, 10 to 21 CFR 522.540, and 11 to 21 CFR 522.1081, which are effective April 9, 2018. 21 CFR Parts 510, 520, 522, 524, 556, 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 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.
2016-12-27; vol. 81 # 248 - Tuesday, December 27, 2016 81 FR 94991 - New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; 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 30, 2016. 21 CFR Parts 556 and 558 Summary The 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.
2016-10-28; vol. 81 # 209 - Friday, October 28, 2016 81 FR 74962 - 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; supplemental notice of proposed rulemaking. Submit either electronic or written comments on this proposed rule by December 27, 2016. 21 CFR Parts 514 and 556 Summary The Food and Drug Administration (FDA or we) is proposing to amend our 2012 document entitled “New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food.” The document proposed 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. We also proposed to add definitions for key terms. We are taking this action to more clearly explain our current thinking about certain provisions of the 2012 document based on comments from stakeholders, and to more accurately reflect the rationale FDA relied on in the past to approve certain new animal drugs without a tolerance. We are reopening the comment period only with respect to the specific issues identified in this supplemental proposed rule.
2016-06-08; vol. 81 # 110 - Wednesday, June 8, 2016 81 FR 36787 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal 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 amendment. This rule is effective June 8, 2016 except for the amendments to 21 CFR 520.1696b, 520.2325a, 520.2261a, 558.248, and 558.625, which are effective June 20, 2016. 21 CFR Parts 510, 520, 522, 556, 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 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.
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.
2015-12-18; vol. 80 # 243 - Friday, December 18, 2015 80 FR 78970 - New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of New Animal Drug Applications; Nitarsone
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective December 31, 2015. 21 CFR Parts 556 and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of three new animal drug applications (NADAs) providing for the use of nitarsone in medicated feed for chickens and turkeys. This action is being taken at the sponsor's request because these products are no longer manufactured or marketed.
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.
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.
2014-04-07; vol. 79 # 66 - Monday, April 7, 2014 79 FR 18990 - Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug; Correction
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of withdrawal of approval; correction. This correction is effective April 7, 2014. 21 CFR Parts 556 and 558 Summary The Food and Drug Administration (FDA) published a document in the Federal Register of February 27, 2014, concerning the voluntary withdrawal of approval of new animal drug applications (NADAs). The document contained an incorrect list of NADAs.
2014-02-27; vol. 79 # 39 - Thursday, February 27, 2014 79 FR 10974 - Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of withdrawal of approval. Withdrawal of approval is effective March 10, 2014. 21 CFR Parts 556 and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal 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.
79 FR 10974 - Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective March 10, 2014. 21 CFR Parts 556 and 558 Summary The 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.
2013-08-27; vol. 78 # 166 - Tuesday, August 27, 2013 78 FR 52852 - New Animal Drugs; Carprofen; Enrofloxacin; Florfenicol; Tildipirosin; Zilpaterol
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective August 27, 2013. 21 CFR Parts 510, 520, 524, 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 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.
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.
2012-09-10; vol. 77 # 175 - Monday, September 10, 2012 77 FR 55414 - New Animal Drugs; Enrofloxacin; Tylvalosin
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 10, 2012. 21 CFR Parts 520, 522, 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 July 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
2012-07-03; vol. 77 # 128 - Tuesday, July 3, 2012 77 FR 39390 - Implantation or Injectable Dosage Form New Animal Drugs; Maropitant; Tildipirosin
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective July 3, 2012. 21 CFR Parts 522 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 May 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
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