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2015-02-06
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Abbreviated New Drug Applications and 505(b)(2) Applications
Part II
Proposed Rules
D09002ee1be3231ea
D09002ee1be32393d
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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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
Code of Federal Regulations
Title 21 Part 314
21 CFR Part 314
Code of Federal Regulations
Title 21 Part 320
21 CFR Part 320
Regulation Identification Number 0910-AF97
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
Federal Register
Vol. 80, no. 25
Office of the Federal Register, National Archives and Records Administration
2015-02-06
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https://www.govinfo.gov/app/details/FR-2015-02-06
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