Document ID: FDA-2013-N-0500-0006
Agency: fda
Document Type: Proposed Rule
Title: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Correction and Extension of Comment Period
Posted Date: 2013-12-27T05:00Z

[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Proposed Rules]
[Pages 78796-78797]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30881]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 314 and 601

[Docket No. FDA-2013-N-0500]
RIN 0910-AG94

Supplemental Applications Proposing Labeling Changes for Approved 
Drugs and Biological Products; Correction and Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction and extension of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting, and 
extending the comment period for, the proposed rule that appeared in 
the Federal Register of November 13, 2013. In the proposed rule, FDA 
requested comments on the proposal to revise and clarify procedures for 
application holders of an approved drug or biological product to change 
the product labeling to reflect certain types of newly acquired 
information in advance of FDA's review of the change. The proposed rule 
published without a reference or a link to the accompanying Regulatory 
Impact Analysis. The Agency is taking this action to correct this 
omission and to extend the comment period in response to requests for 
an extension to allow interested persons additional time to submit 
comments on the proposed rule.

DATES: FDA is extending the comment period on the proposed rule 
published November 13, 2013, at 78 FR 67985, and on information 
collection issues under the Paperwork Reduction Act of 1995. Submit 
either electronic or written comments on the proposed rule by March 13, 
2014. Submit comments on information collection issues under the 
Paperwork Reduction Act of 1995 by February 11, 2014 (see the 
``Paperwork Reduction Act of 1995'' section of the proposed rule).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0500 and/or Regulatory Information Number (RIN) 0910-AG94, by any of 
the following methods, except that comments on information collection 
issues under the Paperwork Reduction Act of 1995 must be submitted to 
the Office of Information and Regulatory Affairs, Office of Management 
and Budget (OMB) (see the ``Paperwork Reduction Act of 1995'' section 
of the proposed rule.

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 Agency name 
and Docket No. FDA-2013-N-0500 and RIN 0910-AG94 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 ``Request for 
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(s), 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. 6304, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 13, 2013 (78 FR 67985), FDA 
published a proposed rule with a 60-day comment period to request 
comments on the proposal to revise and clarify procedures for 
application holders of an approved drug or biological product to change 
the product labeling to reflect certain types of newly acquired 
information in advance of FDA's review of the change. Comments on the 
proposal to permit holders of abbreviated new drug applications to 
distribute revised product labeling that differs in certain respects, 
on a temporary basis, from the labeling of its reference listed drug 
upon submission of a ``changes being effected'' supplement will inform 
FDA's rulemaking.
    The proposed rule published without reference or a link to the 
accompanying Regulatory Impact Analysis. Accordingly, the following 
corrections are made to FR Doc. 2013-26799, appearing on page 67985, in 
the Federal Register of November 13, 2013:
    1. On page 67996, in the first column, at the end of section IV. 
Analysis of Impacts, the following is added as a third full paragraph: 
``The full discussion of economic impacts is available in docket FDA-
2013-N-0500 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 3).''
    2. On page 67997, in the third column, the following is added as a 
third reference: ``3. Preliminary Regulatory Impact Analysis, Initial 
Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act 
Analysis for Supplemental Applications Proposing Labeling Changes for 
Approved Drugs and Biological Products, available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.''
    The Agency has received requests for a 60-day extension of the 
comment period for the proposed rule. These requests conveyed concern 
that the current 60-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 60 days, until March 13, 2014. FDA also is 
extending the comment period for information collection issues under 
the Paperwork

[[Page 78797]]

Reduction Act of 1995 for 60 days, until February 11, 2014. The Agency 
believes that a 60-day extension 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: December 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30881 Filed 12-26-13; 8:45 am]
BILLING CODE 4160-01-P