80 FR 22953 - Abbreviated New Drug Applications and 505(b)(2) Applications; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 79 (April 24, 2015)

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.

[Federal Register Volume 80, Number 79 (Friday, April 24, 2015)]
[Proposed Rules]
[Pages 22953-22954]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09523]


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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


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.

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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

[[Page 22954]]

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.

    Dated: April 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09523 Filed 4-23-15; 8:45 am]
 BILLING CODE 4164-01-P