Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of February 6, 2015. In the proposed rule, FDA requested comments on its proposal to implement portions of 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 (FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). FDA also requested comment on its proposal to amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Parts 314 and 320 [Docket No. FDA-2011-N-0830] RIN 0910-AF97 AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; extension of comment period. SUMMARY: The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of February 6, 2015. In the proposed rule, FDA requested comments on its proposal to implement portions of 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 (FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). FDA also requested comment on its proposal to amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the proposed rule published February 6, 2015 ( 80 FR 6802 ). Submit either electronic or written comments on the proposed rule by June 8, 2015. ADDRESSES: You may submit comments by any of the following methods: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for …
Other Federal Register documents from the same docket.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Abbreviated New Drug Applications and 505(b)(2) Applications
Abbreviated New Drug Applications and 505(b)(2) Applications
Abbreviated New Drug Applications and 505(b)(2) Applications
Abbreviated New Drug Applications and 505(b)(2) Applications
Citation: 80 FR 22953
