Abbreviated New Drug Applications and 505(b)(2) Applications; Extension of Comment Period

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 submitting comments.

Written Submissions

Submit written submissions in the following ways:

• Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Instructions: All submissions received must include the Docket No. FDA-2011-N-0830 for this rulemaking. All comments received may be posted without change to http://www.regulations.gov,, including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document.

Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

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.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of February 6, 2015, FDA published a proposed rule with a 90-day comment period to request comments on its proposal to implement portions of Title XI of the MMA, which amended provisions of the FD&C Act that govern the approval of 505(b)(2) applications and 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. Comments on the proposed rule will inform FDA's rulemaking on ANDAs and 505(b)(2) applications.

The Agency has received requests for a 60-day extension of the comment period for the proposed rule. Each request conveyed concern that the current 90-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule.

FDA has considered the requests and is extending the comment period for the proposed rule for 30 days, until June 8, 2015. The Agency believes that a 30-day extension of the comment period for the proposed rule allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues.

II. Request for Comments

Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.