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 2015_register executive 2015-02-06 article Part II Proposed Rules D09002ee1c7f7f662 D09002ee1c7f7f76e 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 Food and Drug Administration (FDA) is proposing regulations to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). This proposed rule would implement portions of Title XI of the MMA that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. This proposed rule also would amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act. 80 FR 6802 https://www.govinfo.gov/app/details/FR-2015-02-06/2015-01666 2015-01666 fr06fe15-17 RIN 0910-AF97 4164-01-P Docket No. FDA-2011-N-0830 https://www.govinfo.gov/app/details/FR-2015-02-06/2015-01666 https://www.govinfo.gov/content/pkg/FR-2015-02-06/html/2015-01666.htm https://www.govinfo.gov/content/pkg/FR-2015-02-06/pdf/2015-01666.pdf Administrative Practice and Procedure Confidential Business Information Drugs Reporting and Recordkeeping Requirements 95 p. 6802 6896 80 FR 6802 Title 21 Part 314 21 CFR Part 314 Title 21 Part 320 21 CFR Part 320 RIN 0910-AF97 Abbreviated New Drug Applications and 505(b)(2) Applications; Federal Register Vol. 80, Issue PRORULE 2015-01666 II DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2015-05-07 Docket No. FDA-2011-N-0830 4164-01-P 2015-01666 Proposed rule.

The Food and Drug Administration (FDA) is proposing regulations to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). This proposed rule would implement portions of Title XI of the MMA that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. This proposed rule also would amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.

Submit either electronic or written comments on the proposed rule by May 7, 2015. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 9, 2015 (see the "Paperwork Reduction Act of 1995" section of this document). See section VII of this document for the proposed effective date of a final rule based on this document. Janice L. Weiner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6268, Silver Spring, MD 20993-0002, 301- 796-3601. Administrative Practice and Procedure Confidential Business Information Drugs Reporting and Recordkeeping Requirements Abbreviated New Drug Applications, etc. , http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm http://www.accessdata.fda.gov/scripts/cder/ob/docs/delist.cfm http://www.fda.gov http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm http://www.fda.gov/cder http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070111.pdf http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070636.pdf http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072868.pdf http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072887.pdf http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072892.pdf http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079320.pdf http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079345.pdf http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm http://www.ftc.gov/sites/default/files/documents/reports/generic-drug-entry-prior-patent-expiration-ftc-study/genericdrugstudy_0.pdf http://www.regulations.gov http://www.usdoj.gov/ag/foia-memo-march2009.pdf Vol. 80, no. 25 Office of the Federal Register, National Archives and Records Administration 2015-02-06 continuing daily deposited born digital 261 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-02-06 P0b002ee18afc1c6c 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr06fe15 https://www.govinfo.gov/app/details/FR-2015-02-06 https://www.govinfo.gov/content/pkg/FR-2015-02-06/pdf/FR-2015-02-06.pdf https://www.govinfo.gov/content/pkg/FR-2015-02-06/xml/FR-2015-02-06.xml fdlp 6645 6896 DGPO 2015-02-06 2024-06-02 FR-2015-02-06 machine generated eng FR FR-2015-02-06 80 25