Document ID: FDA-2007-N-0363-0059
Agency: fda
Document Type: Proposed Rule
Title: Electronic Distribution of Prescribing Information for Human Prescription
Drugs, Including Biological Products; Extension of Comment Period
Posted Date: 2015-03-09T04:00Z

[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Proposed Rules]
[Pages 12364-12365]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05336]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 606, and 610

[Docket No. FDA-2007-N-0363]
RIN 0910-AG18

Electronic Distribution of Prescribing Information for Human 
Prescription Drugs, Including Biological Products; 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 December 18, 2014. In the proposed rule, FDA requested 
comments on its proposal to amend its labeling regulations for human 
prescription drugs and biological products to require that the 
prescribing information intended for health care professionals that is 
on or within the package from which the product is dispensed be 
distributed electronically and not in paper form, except as provided by 
the proposed rule. The Agency is taking this action in response to a 
request for an extension to allow interested persons additional time to 
submit comments.

DATES: FDA is extending the comment period on the proposed rule 
published on December 18, 2014 (79 FR 75506). Submit either electronic 
or written comments by May 18, 2015.

[[Page 12365]]

ADDRESSES: You may submit comments to the proposed rule 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-2007-N-0363 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: Emily Gebbia, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993, 240-402-
0980.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of December 18, 2014, FDA published a 
proposed rule to amend its labeling regulations for human prescription 
drugs and biological products to require that the prescribing 
information intended for health care professionals that is on or within 
the package from which the product is dispensed be distributed 
electronically and not in paper form, except as provided by the 
proposed rule. The proposed rule is intended to facilitate the 
distribution of updated prescribing information as new information 
becomes available and as changes in prescribing information are made. 
FDA is proposing the change to help ensure that the most current 
prescribing information will be available and readily accessible to 
health care professionals at the time of clinical decision making and 
dispensing. FDA provided a 90-day comment period (i.e., until March 18, 
2015) for the proposed rule.
    The Agency has received a request for a 60-day extension of the 
comment period for the proposed rule. The request conveyed concern that 
the current 90-day comment period does not allow sufficient time for 
entities and individuals who will be most affected by a final rule to 
examine and to comment upon the proposed rule. The request suggested 
that FDA would benefit by granting stakeholders sufficient time to 
develop their comments and to address as many relevant issues as 
possible.
    FDA has considered the request and is extending the comment period 
for the proposed rule for 60 days, until May 18, 2015. The Agency 
believes that a 60-day extension allows adequate time for interested 
persons to submit comments without significantly delaying rulemaking on 
this important issue.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
the proposed rule 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: March 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05336 Filed 3-6-15; 8:45 am]
BILLING CODE 4164-01-P