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