Document ID: FDA-2014-D-0622-0006
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry on Best Practices in Developing Proprietary
Names for Drugs; Reopening of the Comment Period
Posted Date: 2014-08-14T04:00Z

[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Page 47654]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19261]

[[Page 47654]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0622]

Draft Guidance for Industry on Best Practices in Developing 
Proprietary Names for Drugs; 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comment period for the draft guidance entitled ``Best Practices in 
Developing Proprietary Names for Drugs,'' which published in the 
Federal Register of May 29, 2014 (79 FR 30852). FDA is reopening the 
comment period in response to several requests for additional time and 
to allow interested persons more time to submit comments.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 15, 2014.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: Kellie Taylor, Center for Drug 
Evaluation and Research, Food and Drug Administration, Office of 
Surveillance and Epidemiology, 10903 New Hampshire Ave., Bldg. 22, Rm. 
4418, Silver Spring, MD 20993-0002, 301-796-0157.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of May 29, 2014 (79 FR 30852), FDA 
announced the availability of a draft guidance for industry entitled 
``Best Practices in Developing Proprietary Names for Drugs.'' In that 
document, FDA requested comments on the draft guidance, which describes 
best practices for developing and selecting proposed proprietary names 
to minimize medication errors. Interested persons were originally given 
until July 28, 2014, to submit comments on the draft guidance to ensure 
that the Agency considers their comments before it begins work on the 
final version of the guidance.
    The Agency has received several requests to reopen the comment 
period for an additional 60 days. The requests conveyed concern that 
the original 60-day comment period did not allow sufficient time to 
develop a meaningful or thoughtful response.
    FDA has considered the requests and will reopen the comment period 
for an additional 30 days. The Agency believes that an additional 30 
days allows adequate time for interested persons to submit comments 
without significantly delaying the Agency's consideration of these 
important issues.

II. 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). 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: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19261 Filed 8-13-14; 8:45 am]
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