[Federal Register Volume 79, Number 126 (Tuesday, July 1, 2014)]
[Notices]
[Page 37332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15375]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0202]


Over-the-Counter Drug Monograph System--Past, Present, and 
Future; Public Hearing; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; 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, published in the 
Federal Register of February 24, 2014 (79 FR 10168), requesting comment 
on how to improve or alter the current Over-the-Counter (OTC) Monograph 
Process for reviewing nonprescription drugs marketed under the OTC Drug 
Review. FDA is reopening the comment period to update comments and to 
receive any new information.

DATES: Submit either electronic or written comments by July 31, 2014.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mary Gross, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20903-0002, 301-796-3519, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of February 24, 2014 (79 FR 10168), FDA 
announced a public hearing to obtain input on the OTC Drug Review 
(sometimes referred to as the OTC Monograph Process, OTC Monograph, or 
OTC Drug Review). As stated in the Federal Register notice, FDA has 
been assessing the OTC Monograph Process and, in particular, has been 
considering how effectively the monograph system is functioning in 
today's world, 40 years after its inception, from the scientific, 
policy, and process perspectives. In the February 24, 2014, notice of 
public hearing, FDA announced it was soliciting comments about whether 
and how to modernize the process for the future. The public hearing was 
held to obtain information and comments from the public on the 
strengths and weaknesses of the current OTC Monograph Process, and to 
obtain and discuss ideas about modifications or alternatives to this 
process. Interested persons were originally given until May 12, 2014, 
to comment on the OTC Monograph Process.

II. Request for Comments

    On our own initiative, we are reopening the comment period to allow 
interested persons additional time to comment to respond fully to FDA's 
specific requests for comments and to allow potential respondents to 
thoroughly evaluate and address pertinent issues.

III. How To Submit 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 identified by 
the topic to which they refer (see 79 FR 10168 at 10171, section III). 
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 26, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15375 Filed 6-30-14; 8:45 am]
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