Document ID: FDA-2015-N-0540-7641
Agency: fda
Document Type: Proposed Rule
Title: Homeopathic Product Regulation: Evaluating the Food and Drug
Administration’s Regulatory Framework After a Quarter-Century;
Reopening of the Comment Period
Posted Date: 2015-09-09T04:00Z

[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Proposed Rules]
[Page 54256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22682]

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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / 
Proposed Rules  

[[Page 54256]]

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; 
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening 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 
to allow interested persons additional time to submit comments.

DATES: FDA is reopening the comment period on the notice of public 
hearing published March 27, 2015 (80 FR 16327), and extended on June 
10, 2015 (80 FR 32868). Submit either electronic or written comments by 
November 9, 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 ``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, 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: Elaine Lippmann, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6214, Silver Spring, MD 20993-0002, 301-
796-2895.

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 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. In the Federal Register of June 10, 2015, in 
response to requests for an extension to allow interested persons 
additional time to submit comments, FDA extended the original comment 
period for 60 days, until August 21, 2015.
    FDA is reopening the comment period for an additional 60 days, 
until November 9, 2015. The Agency believes that reopening the comment 
period for an additional 60 days for the notice of public hearing will 
allow adequate time for interested persons to submit comments without 
significantly delaying Agency decisionmaking 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: September 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22682 Filed 9-8-15; 8:45 am]
 BILLING CODE 4164-01-P