Homeopathic Product Regulation: Evaluating the Food and Drug Administration's Regulatory Framework After a Quarter-Century; Reopening of the Comment Period, 54256 [2015-22682]

Download as PDF 54256 Proposed Rules Federal Register Vol. 80, No. 174 Wednesday, September 9, 2015 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. 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. Notice of public hearing; reopening of the comment period. ACTION: 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. SUMMARY: 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. DATES: You may submit comments by any of the following methods: ADDRESSES: Lhorne on DSK5TPTVN1PROD with PROPOSALS Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// 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 VerDate Sep<11>2014 14:18 Sep 08, 2015 Jkt 235001 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 https:// 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 https:// 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 PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 delaying Agency decisionmaking on these important issues. II. Request for Comments Interested persons may submit either electronic comments regarding this document to https://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 https:// 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 DEPARTMENT OF STATE 22 CFR Part 171 [Public Notice: 9263] RIN 1400–AD78 Privacy Act; STATE–75, Family Advocacy Case Records Department of State. Notice of proposed rulemaking. AGENCY: ACTION: The Department of State is giving notice that certain portions of the Family Advocacy Case Records, STATE –75, system of records are proposed to be exempt from one or more provisions of the Privacy Act of 1974. DATES: Comments on this rule are due by October 19, 2015. FOR FURTHER INFORMATION CONTACT: John Hackett, Director; Office of Information Programs and Services, A/GIS/IPS; Department of State, SA–2; 515 22nd Street NW., Washington, DC 20522– 8001, or at Privacy@state.gov. SUPPLEMENTARY INFORMATION: The Department of State maintains the Family Advocacy Case Records system of records. The primary purpose of this system of records is to be utilized at post by members of the Family Advocacy Team and in the Department SUMMARY: E:\FR\FM\09SEP1.SGM 09SEP1

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[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]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

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.

========================================================================


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.

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

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: https://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 https://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 https://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 https://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 https://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

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