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2016-10-06
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Abbreviated New Drug Applications and 505(b)(2) Applications
Part II
Rules and Regulations
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D09002ee1bdc0efe3
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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United States Government Agency or Subagency
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule 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 final rule implements 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 final rule also amends certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.
81 FR 69580
https://www.govinfo.gov/app/details/FR-2016-10-06/2016-22690
2016-22690
fr06oc16-14
RIN 0910-AF97
4164-01-P
Docket No. FDA-2011-N-0830
https://www.govinfo.gov/app/details/FR-2016-10-06/2016-22690
https://www.govinfo.gov/content/pkg/FR-2016-10-06/html/2016-22690.htm
https://www.govinfo.gov/content/pkg/FR-2016-10-06/pdf/2016-22690.pdf
Administrative Practice and Procedure
Confidential Business Information
Drugs
Reporting and Recordkeeping Requirements
79 p.
69580
69658
81 FR 69580
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. 81, Issue
RULE
2016-22690
II
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2016-12-05
Docket No. FDA-2011-N-0830
4164-01-P
2016-22690
Final rule.
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule 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 final rule implements 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 final rule also amends certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.
This rule is effective December 5, 2016.
With regard to the final rule: 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 and 505(b)(2) Applications
,
PRAStaff@fda.hhs.gov
http://www.fda.gov
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm
http://www.fda.gov/cder
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.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
Federal Register
Vol. 81, no. 194
Office of the Federal Register, National Archives and Records Administration
2016-10-06
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298 p.
Table of Contents:
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https://www.govinfo.gov/app/details/FR-2016-10-06
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https://www.govinfo.gov/app/details/FR-2016-10-06
https://www.govinfo.gov/content/pkg/FR-2016-10-06/pdf/FR-2016-10-06.pdf
https://www.govinfo.gov/content/pkg/FR-2016-10-06/xml/FR-2016-10-06.xml
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2016-10-06
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