United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2007_register executive 2010-09-22 article Part IV Rules and Regulations D09002ee1c809c89c D09002ee1c809c9b7 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The 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. 72 FR 69108 https://www.govinfo.gov/app/details/FR-2007-12-06/E7-23580 E7-23580 fr06de07-9 RIN 0910-AF67 4160-01-S Docket No. 2006N-0067 https://www.govinfo.gov/app/details/FR-2007-12-06/E7-23580 https://www.govinfo.gov/content/pkg/FR-2007-12-06/html/E7-23580.htm https://www.govinfo.gov/content/pkg/FR-2007-12-06/pdf/E7-23580.pdf Confidential Business Information Courts Freedom of Information Government Employees Drugs Labeling Advertising Prescription Drugs Environmental Impact Statements Foreign Relations Reporting and Recordkeeping Requirements Animal Drugs Animal Feeds Packaging and Containers Cancer Polychlorinated Biphenyls (Pcbs) Administrative Practice and Procedure Medical Research Animal Foods Food Additives 24 p. 69108 69131 72 FR 69108 Title 21 Part 201 21 CFR Part 201 Title 21 Part 202 21 CFR Part 202 Title 21 Part 207 21 CFR Part 207 Title 21 Part 20 21 CFR Part 20 Title 21 Part 225 21 CFR Part 225 Title 21 Part 226 21 CFR Part 226 Title 21 Part 25 21 CFR Part 25 Title 21 Part 500 21 CFR Part 500 Title 21 Part 510 21 CFR Part 510 Title 21 Part 511 21 CFR Part 511 Title 21 Part 515 21 CFR Part 515 Title 21 Part 516 21 CFR Part 516 Title 21 Part 558 21 CFR Part 558 Title 21 Part 589 21 CFR Part 589 RIN 0910-AF67 Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Federal Register Vol. 72, Issue RULE E7-23580 IV DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2008-02-19 Docket No. 2006N-0067 4160-01-S E7-23580 Final rule.

The 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.

This rule is effective February 19, 2008. Bernadette Dunham, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9090, e-mail: Bernadette.Dunham@fda.hhs.gov. Confidential Business Information Courts Freedom of Information Government Employees Drugs Labeling Advertising Prescription Drugs Environmental Impact Statements Foreign Relations Reporting and Recordkeeping Requirements Animal Drugs Animal Feeds Packaging and Containers Cancer Polychlorinated Biphenyls (Pcbs) Administrative Practice and Procedure Medical Research Animal Foods Food Additives Animal drugs, feeds, and related products: Legally marketed unapproved new animal drugs for minor species; index, Bernadette.Dunham@fda.hhs.gov www.bls.gov/oes/current/naics4_325400.htm Vol. 72, no. 234 Office of the Federal Register, National Archives and Records Administration 2007-12-06 continuing daily deposited born digital 404 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2007-12-06 P0b002ee180942d68 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr06de07 https://www.govinfo.gov/app/details/FR-2007-12-06 https://www.govinfo.gov/content/pkg/FR-2007-12-06/pdf/FR-2007-12-06.pdf https://www.govinfo.gov/content/pkg/FR-2007-12-06/xml/FR-2007-12-06.xml fdlp 68743 69136 DGPO 2010-09-22 2024-06-05 FR-2007-12-06 machine generated eng FR FR-2007-12-06 72 234