Document ID: FDA-2015-N-0540-2724
Agency: fda
Document Type: Proposed Rule
Title: Homeopathic Product Regulation: Evaluating the Food and Drug
Administration’s Regulatory Framework After a Quarter-Century;
Extension of Comment Period
Posted Date: 2015-06-10T04:00Z

[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Proposed Rules]
[Pages 32868-32869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14143]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2015-N-0540]

Homeopathic Product Regulation: Evaluating the Food and Drug 
Administration's Regulatory Framework After a Quarter-Century; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the notice of public hearing that appeared in the 
Federal Register of March 27, 2015. In the notice of public hearing, 
FDA requested comments on a number of specific questions identified in 
the document. 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 notice of public 
hearing published March 27, 2015 (80 FR 16327). Submit either 
electronic or written comments by August 21, 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-2015-N-0540) for this notice of public hearing. 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(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: Lesley DeRenzo, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5161, Silver Spring, MD 20993-0002, 240-
402-4612.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 27, 2015, FDA published a notice 
of public hearing with a 60-day comment period following the public 
hearing and requested comments on a number of specific questions 
identified throughout the document. Comments on the notice

[[Page 32869]]

of public hearing will inform FDA's decision about whether and how to 
adjust the current enforcement policies for drug products labeled as 
homeopathic to reflect changes in the homeopathic product marketplace 
over the last approximately 25 years.
    FDA is extending the comment period for an additional 60 days, 
until August 21, 2015. The Agency believes that an additional 60-day 
extension of the comment period for the notice of public hearing will 
allow adequate time for interested persons to submit comments without 
significantly delaying Agency decision making 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). You should annotate and 
organize your comments to identify the specific questions or topic to 
which they refer. 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: June 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14143 Filed 6-9-15; 8:45 am]
 BILLING CODE 4164-01-P